专利摘要:
The present invention relates to a central surgical controller that is configured to transmit generator data associated with a surgical procedure from a central surgical controller generator to a cloud based system. The central surgical controller comprises a processor and a memory that stores instructions executable by the processor to: receive data from the generator; encrypt the generator data; generate a message authentication code based on the generator data; generate a datagram comprising: the encrypted generator data, the generated message authentication code, a source identifier and a destination identifier; and transmit the datagram to the cloud-based system. The datagram allows the cloud-based system to: decrypt the encrypted generator data; verify the integrity of the generator data based on the message authentication code; authenticate the central surgical controller as the origin of the datagram; and validate a transmission path followed by the datagram between the central surgical controller and the cloud-based system.
公开号:BR112020012737A2
申请号:R112020012737-0
申请日:2018-07-27
公开日:2020-12-01
发明作者:Eitan T. Wiener;Frederick E. Shelton Iv;David C. Yates
申请人:Ethicon Llc;
IPC主号:
专利说明:

[0001] [0001] This application claims the priority benefit set forth in Title 35 of USC 119 (e) of US provisional patent application Serial No. 62 / 649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES, filed on March 28, 2018 , whose disclosure is hereby incorporated as a reference in its entirety.
[0002] [0002] This application also claims the priority benefit provided for in Title 35 of USC 119 (e) of US provisional patent application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, of the application US Provisional Patent Serial No. 62 / 611,340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed December 28, 2017, and US Provisional Patent Application Serial No. 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, whose disclosure of each of which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION
[0003] [0003] The present disclosure refers to several surgical systems. Surgical procedures are typically performed in centers or operating rooms in a health care facility, for example, a hospital. A sterile field is typically created around the patient. The sterile field may include members of the brushing team, who are properly dressed, and all furniture and accessories in the area. Various surgical devices and systems are used to perform a surgical procedure. SUMMARY OF THE INVENTION
[0004] [0004] In a general aspect, a central surgical controller is provided. The central surgical controller is configured to transmit generator data associated with a surgical procedure from a central surgical controller generator to a cloud-based system communicatively coupled to a plurality of central surgical controllers. The central surgical controller comprises a processor and a memory attached to the processor. The memory stores instructions executable by the processor to: receive data from the generator; encrypt the generator data; generate a message authentication code based on the generator data; generate a datagram comprising the encrypted generator data, the generated message authentication code, a source identifier and a destination identifier; and transmit the datagram to a cloud-based system. The datagram enables the cloud-based system to: decrypt the generator data encrypted from the transmitted datagram; verify the integrity of the generator data based on the message authentication code; authenticate the central surgical controller as the origin of the datagram; and validate a transmission path followed by the datagram between the central surgical controller and the cloud-based system. The generator data is structured in a data package that comprises at least two of the following fields: a field that indicates the source of the data; an exclusive timestamp; a field indicating a generator power mode; a field that indicates a power output from the generator; and a field indicating the duration of the generator's power output.
[0005] [0005] In another general aspect, another central surgical controller is provided. The central surgical controller is configured to transmit generator data associated with a surgical procedure from a central surgical controller generator to a cloud-based system communicatively coupled to a plurality of central surgical controllers. The central surgical controller comprises a control circuit configured to: receive data from the generator; encrypt the generator data; generate a message authentication code based on the generator data; generate a datagram comprising the encrypted generator data, the generated message authentication code, a source identifier and a destination identifier; and transmit the datagram to a cloud-based system. The generator data is structured in a data package that comprises at least two of the following fields: a field that indicates the source of the data; an exclusive timestamp; a field indicating a generator power mode; a field that indicates a power output from the generator; and a field indicating the duration of the generator's power output. The datagram enables the cloud-based system to: decrypt the generator data encrypted from the transmitted datagram; verify the integrity of the generator data based on the message authentication code; authenticate the central surgical controller as the origin of the datagram; and validating a transmission path followed by the datagram between the central surgical controller and the cloud-based system.
[0006] [0006] In yet another general aspect, another central surgical controller is provided. The central surgical controller is configured to prioritize surgical data associated with a surgical procedure from a surgical device from the central surgical controller to a cloud-based system communicatively coupled to a plurality of central surgical controllers. The central surgical controller comprises a processor and a memory attached to the processor. The memory stores instructions executable by the processor to: capture surgical data that comprise data associated with the surgical device. apply a timestamp to the captured surgical data; identify a failure event; identify a period of time associated with the failure event; isolate surgical data from the failure event and surgical data not associated with the failure event based on the identified time period; create a chronology of the surgical data of the failure event using timestamps; encrypt the surgical data of the failure event created by chronology; and generating a datagram comprising the encrypted failure event surgical data. The datagram is structured to include a field that includes an indicator that prioritizes the encrypted failure event surgical data over other encrypted data in the datagram. The memory stores instructions executable by the processor to also transmit the datagram to the cloud-based system. The datagram enables the cloud-based system to: decrypt the encrypted surgical event data; focus the analysis on the surgical data of the failure event instead of on the surgical data not associated with the failure event; and mark the surgical device associated with the failure event for at least one of: be removed from the operating room; be returned to the manufacturer; future inoperability in the cloud-based system; or downloading an update to prevent failure events. FIGURES
[0007] [0007] The appeals of various aspects are presented with particularity in the attached claims. The various aspects, however, with regard to both the organization and the methods of operation, together with additional objects and advantages of the same, can be better understood in reference to the description presented below, considered together with the attached drawings, as follows.
[0008] [0008] Figure 1 is a block diagram of an interactive surgical system implemented by computer, in accordance with at least one aspect of the present disclosure.
[0009] [0009] Figure 2 is a surgical system being used to perform a surgical procedure in an operating room, in accordance with at least one aspect of the present disclosure.
[0010] [0010] Figure 3 is a central surgical controller paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present disclosure.
[0011] [0011] Figure 4 is a partial perspective view of a central surgical controller compartment, and of a generator module in combination received slidably in a drawer of the central surgical controller compartment, in accordance with at least one aspect of the present disclosure.
[0012] [0012] Figure 5 is a perspective view of a generator module in combination with bipolar, ultrasonic and monopolar contacts and a smoke evacuation component, in accordance with at least one aspect of the present disclosure.
[0013] [0013] Figure 6 illustrates different power bus connectors for a plurality of side coupling ports of a side modular cabinet configured to receive a plurality of modules, in accordance with at least one aspect of the present disclosure.
[0014] [0014] Figure 7 illustrates a vertical modular housing configured to receive a plurality of modules, according to at least one aspect of the present disclosure.
[0015] [0015] Figure 8 illustrates a surgical data network comprising a central modular communication controller configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a healthcare facility. health specially equipped for surgical operations, to the cloud, in accordance with at least one aspect of this disclosure.
[0016] [0016] Figure 9 illustrates an interactive surgical system implemented by computer, in accordance with at least one aspect of the present disclosure.
[0017] [0017] Figure 10 illustrates a central surgical controller that comprises a plurality of modules coupled to the modular control tower, according to at least one aspect of the present disclosure.
[0018] [0018] Figure 11 illustrates an aspect of a universal serial bus (USB) network central controller device, in accordance with at least one aspect of the present disclosure.
[0019] [0019] Figure 12 illustrates a logical diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure.
[0020] [0020] Figure 13 illustrates a control circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present disclosure.
[0021] [0021] Figure 14 illustrates a combinational logic circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present disclosure.
[0022] [0022] Figure 15 illustrates a sequential logic circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present disclosure.
[0023] [0023] Figure 16 illustrates an instrument or surgical tool that comprises a plurality of motors that can be activated to perform various functions, according to at least one aspect of the present disclosure.
[0024] [0024] Figure 17 is a schematic diagram of a robotic surgical instrument configured to operate a surgical tool described therein, in accordance with at least one aspect of the present disclosure.
[0025] [0025] Figure 18 illustrates a block diagram of a surgical instrument programmed to control the distal translation of the displacement member, according to an aspect of the present disclosure.
[0026] [0026] Figure 19 is a schematic diagram of a surgical instrument configured to control various functions, in accordance with at least one aspect of the present disclosure.
[0027] [0027] Figure 20 is a simplified block diagram of a generator configured to provide adjustment without inductor, among other benefits, in accordance with at least one aspect of the present disclosure.
[0028] [0028] Figure 21 illustrates an example of a generator, which is a form of the generator of Figure 20, according to at least one aspect of the present disclosure.
[0029] [0029] Figure 22 illustrates a combined generator, in accordance with at least one aspect of the present disclosure.
[0030] [0030] Figure 23 illustrates a method of capturing data from a combined generator and communicating captured generator data to a cloud-based system, in accordance with at least one aspect of the present disclosure.
[0031] [0031] Figure 24 illustrates a data package of the combined generator data, in accordance with at least one aspect of the present disclosure.
[0032] [0032] Figure 25 illustrates an encryption algorithm, in accordance with at least one aspect of the present disclosure.
[0033] [0033] Figure 26 illustrates another encryption algorithm, in accordance with at least one aspect of the present disclosure.
[0034] [0034] Figure 27 illustrates yet another encryption algorithm, in accordance with at least one aspect of the present disclosure.
[0035] [0035] Figure 28 illustrates a high-level representation of a datagram, in accordance with at least one aspect of the present disclosure.
[0036] [0036] Figure 29 illustrates a more detailed representation of the datagram in Figure 28, in accordance with at least one aspect of the present disclosure.
[0037] [0037] Figure 30 illustrates another representation of the datagram in Figure 28, in accordance with at least one aspect of the present disclosure.
[0038] [0038] Figure 31 illustrates a method for identifying surgical data associated with a failure event and communicating the identified surgical data to a cloud-based system on a prioritized basis, in accordance with at least one aspect of the present disclosure.
[0039] [0039] Figure 32 illustrates yet another representation of the datagram in Figure 28, in accordance with at least one aspect of the present disclosure.
[0040] [0040] Figure 33 illustrates a partial artificial timeline of a surgical procedure performed in an operating room using a surgical system, in accordance with at least one aspect of the present disclosure.
[0041] [0041] Figure 34 illustrates the ultrasonic ping of an operating room wall to determine a distance between a central surgical controller and the operating room wall, in accordance with at least one aspect of the present disclosure.
[0042] [0042] Figure 35 is a logical flowchart of a process that represents a control program or a logical configuration for the pairing of the central surgical controller with surgical devices of a surgical system that are located within the limits of an operating room, from accordance with at least one aspect of this disclosure.
[0043] [0043] Figure 36 is a logical flow chart of a process that represents a control program or a logical configuration to selectively form and interrupt connections between devices in a surgical system, in accordance with at least one aspect of the present disclosure.
[0044] [0044] Figure 37 is a logical flowchart of a process that represents a control program or a logical configuration to selectively re-evaluate the limits of an operating room after the detection of a new device, according to at least one aspect of the present disclosure.
[0045] [0045] Figure 38 is a logical flowchart of a process that represents a control program or a logical configuration to selectively reassess the limits of an operating room after disconnecting a paired device, in accordance with at least one aspect of this disclosure.
[0046] [0046] Figure 39 is a logical flow chart of a process that represents a control program or a logical configuration to reevaluate the limits of an operating room by a central surgical controller after detecting a change in the position of the central surgical controller, in accordance with at least one aspect of this disclosure.
[0047] [0047] Figure 40 is a logical flowchart of a process that represents a control program or a logical configuration to selectively form the connections between devices in a surgical system, according to at least one aspect of the present disclosure.
[0048] [0048] Figure 41 is a logical flow chart of a process that represents a control program or a logical configuration to selectively form and interrupt connections between devices in a surgical system, in accordance with at least one aspect of the present disclosure.
[0049] [0049] Figure 42 illustrates a central surgical controller pairing a first device and a second device of a surgical system in an operating room, in accordance with at least one aspect of the present disclosure.
[0050] [0050] Figure 43 illustrates a central surgical controller unpairing a first device and a second device from a surgical system in an operating room, and pairing the first device with a third device in the operating room, according to at least one aspect of this disclosure.
[0051] [0051] Figure 44 is a logical flowchart of a process that represents a control program or a logical configuration to form and interrupt connections between devices in a surgical system in an operating room during a surgical procedure based on the progression of the steps surgical procedure, in accordance with at least one aspect of the present disclosure.
[0052] [0052] Figure 45 is a logical flowchart of a process that represents a control program or a logical configuration to superimpose information derived from one or more static frames from a live transmission from a remote surgical site to the live transmission, from accordance with at least one aspect of this disclosure.
[0053] [0053] Figure 46 is a logical flowchart of a process that represents a control program or a logical configuration to differentiate the surgical steps from a surgical procedure, according to at least one aspect of the present disclosure.
[0054] [0054] Figure 47 is a logical flow chart of a 3230 process that represents a control program or a logical configuration to differentiate the surgical steps from a surgical procedure, according to at least one aspect of the present disclosure.
[0055] [0055] Figure 48 is a logical flowchart of a 3240 process that represents a control program or a logical configuration for identifying a staple cartridge from information derived from one or more static frames of staples implanted from the staple cartridge in the fabric, in accordance with at least one aspect of the present disclosure.
[0056] [0056] Figure 49 is a partial view of a surgical system in an operating room, the surgical system including a central surgical controller that has an imaging module in communication with an imaging device at a remote surgical site, according to at least one aspect of this disclosure.
[0057] [0057] Figure 50 illustrates a partial view of the stapled fabric that received a first shot of staples and a second shot of staple disposed from end to end, according to at least one aspect of the present disclosure.
[0058] [0058] Figure 51 illustrates three rows of staples implanted on one side of stapled tissue and cut by a surgical stapler, in accordance with at least one aspect of the present disclosure.
[0059] [0059] Figure 52 illustrates a non-anodized clamp and an anodized clamp, in accordance with at least one aspect of the present disclosure.
[0060] [0060] Figure 53 is a logical flowchart of a process that represents a control program or a logical configuration to coordinate a control arrangement between central surgical controllers, in accordance with at least one aspect of the present disclosure.
[0061] [0061] Figure 54 illustrates an interaction between two central surgical controllers in an operating room, in accordance with at least one aspect of the present disclosure.
[0062] [0062] Figure 55 is a logical flowchart of a process that represents a control program or a logical configuration to coordinate a control arrangement between central surgical controllers, in accordance with at least one aspect of the present disclosure.
[0063] [0063] Figure 56 illustrates an interaction between two central surgical controllers in different operating rooms ("OR1" and "OR3"), in accordance with at least one aspect of the present disclosure.
[0064] [0064] Figure 57 illustrates a secondary view in an operating room ("OR3") showing a surgical site in a colorectal procedure, in accordance with at least one aspect of the present disclosure.
[0065] [0065] Figure 58 illustrates a personal interface or tablet in OR1 showing the OR3 surgical site, in accordance with at least one aspect of the present disclosure.
[0066] [0066] Figure 59 illustrates an expanded view of the OR3 surgical site shown in a main view of OR1, in accordance with at least one aspect of the present disclosure.
[0067] [0067] Figure 60 illustrates a personal interface or tablet showing an OR1 layout that shows the available screens, according to at least one aspect of this disclosure.
[0068] [0068] Figure 61 illustrates a recommendation for a transection site for an OR3 surgical site made by a surgical operator on OR1 through a personal interface or tablet on OR1, in accordance with at least one aspect of this disclosure.
[0069] [0069] Figure 62 illustrates a timeline that represents the situational recognition of a central surgical controller, according to at least one aspect of the present disclosure. DESCRIPTION
[0070] [0070] The applicant for this application holds the following provisional US patent applications, filed on March 28, 2018, each of which is incorporated herein by reference in its entirety: ● US Provisional Patent Application Serial No. 62 / 649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; ● US Provisional Patent Application Serial No. 62 / 649,294,
[0071] [0071] The applicant for this application holds the following US patent applications, filed on March 29, 2018, each of which is incorporated herein by reference in its entirety: ● US Patent Application Serial No. ____________, titled INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES; Attorney document number END8499USNP1 / 170766-1; ● US patent application Serial No. ____________, entitled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES; Attorney document number END8499USNP2 / 170766-2; ● US patent application Serial No. ____________, entitled SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS; Attorney document number END8499USNP3 / 170766-3; ● US patent application Serial No. ____________, entitled COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS; Attorney's document number END8499USNP4 / 170766-4; ● US patent application Serial No. ____________, entitled SURGICAL HUB CONTROL ARRANGEMENTS; Attorney document number END8499USNP5 / 170766-5; ● US patent application Serial No. ____________, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT
[0072] [0072] The applicant for this application holds the following US patent applications, filed on March 29, 2018, each of which is incorporated herein by reference in its entirety: ● US Patent Application Serial No. ____________, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES; Attorney document number END8506USNP / 170773; ● US patent application Serial No. ____________, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR
[0073] [0073] The applicant for this application holds the following US patent applications, filed on March 29, 2018, each of which is incorporated herein by reference in its entirety: ● US Patent Application Serial No. ____________,
[0074] [0074] Before explaining in detail the various aspects of surgical instruments and generators, it should be noted that the illustrative examples are not limited, in terms of application or use, to the details of construction and arrangement of parts illustrated in the drawings and description attached. Illustrative examples can be implemented or incorporated into other aspects, variations and modifications, and can be practiced or performed in a variety of ways. Furthermore, except where otherwise indicated, the terms and expressions used in the present invention were chosen for the purpose of describing illustrative examples for the convenience of the reader and not for the purpose of limiting it. In addition, it should be understood that one or more of the aspects, expressions of aspects, and / or examples described below can be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.
[0075] [0075] Referring to Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (for example, cloud 104 which may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one central surgical controller 106 in communication with the cloud 104 which can include a remote server 113. In one example, as illustrated in Figure 1, surgical system 102 includes a visualization system 108, a robotic system 110, a smart handheld surgical instrument 112, which are configured to communicate with one another and / or the central controller 106. In some respects, a surgical system 102 may include a number of central controllers M 106, an N number of visualization systems 108, an O number of robotic systems 110, and a P number of smart, hand-held surgical instruments 112, where M, N, O, and P are whole numbers greater than or equal to one.
[0076] [0076] Figure 3 represents an example of a surgical system 102 being used to perform a surgical procedure on a patient who is lying on an operating table 114 in a surgical operating room 116. A robotic system 110 is used in the surgical procedure as a part of surgical system 102. Robotic system 110 includes a surgeon console 118, a patient car 120 (surgical robot), and a robotic central surgical controller
[0077] [0077] Other types of robotic systems can be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical instruments that are suitable for use with the present disclosure are described in provisional patent application Serial No. 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, whose disclosure is hereby incorporated by reference in its entirety.
[0078] [0078] Several examples of cloud-based analysis that are performed by the cloud 104, and are suitable for use with the present disclosure, are described in US provisional patent application Serial No. 62 / 611.340, entitled CLOUD-BASED MEDICAL ANALYTICS , filed on December 28, 2017, the disclosure of which is incorporated herein by reference, in its entirety.
[0079] [0079] In several respects, the imaging device 124 includes at least one Image sensor and one or more optical components. Suitable image sensors include, but are not limited to, load-coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.
[0080] [0080] The optical components of the imaging device 124 may include one or more light sources and / or one or more lenses. One or more light sources can be directed to illuminate portions of the surgical field. The one or more image sensors can receive reflected or refracted light from the surgical field, including reflected or refracted light from tissue and / or surgical instruments.
[0081] [0081] The one or more light sources can be configured to radiate electromagnetic energy in the visible spectrum, as well as in the invisible spectrum. The visible spectrum, sometimes called the optical spectrum or light spectrum, is that portion of the electromagnetic spectrum that is visible to (that is, can be detected by) the human eye and can be called visible light or simply light. A typical human eye will respond to wavelengths in the air that are from about 380 nm to about 750 nm.
[0082] [0082] The invisible spectrum (that is, the non-luminous spectrum) is that portion of the electromagnetic spectrum located below and above the visible spectrum (that is, wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the visible red spectrum, and they become invisible infrared (IR), microwaves, radio and electromagnetic radiation. Wavelengths shorter than about 380 nm are shorter than the ultraviolet spectrum, and they become invisible ultraviolet, x-ray, and electromagnetic gamma-ray radiation.
[0083] [0083] In several respects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, an arthroscope, angioscope, bronchoscope, choledocoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagus-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngoscope neproscope, sigmoidoscope, thoracoscope and ureteroscope.
[0084] [0084] In one aspect, the imaging device employs multiple spectrum monitoring to discriminate topography and underlying structures. A multispectral image is one that captures image data within wavelength bands across the electromagnetic spectrum. Wavelengths can be separated by filters or using instruments that are sensitive to specific wavelengths, including light from frequencies beyond the visible light range, for example, IR and ultraviolet light. Spectral images can allow the extraction of additional information that the human eye cannot capture with its receivers for the colors red, green and blue. The use of multispectral imaging is described in greater detail under the heading "Advanced Imaging Acquisition Module" in US provisional patent application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the disclosure of which is here incorporated as a reference in its entirety. Multispectral monitoring can be a useful tool for relocating a surgical field after a surgical task is completed to perform one or more of the tests previously described on the treated tissue.
[0085] [0085] It is axiomatic that strict sterilization of the operating room and surgical equipment is necessary during any surgery. The strict hygiene and sterilization conditions required in an "operating room", that is, an operating or treatment room, justify the highest possible sterilization of all medical devices and equipment. Part of this sterilization process is the need to sterilize anything that comes into contact with the patient or enters the sterile field, including imaging device 124 and its connectors and components. It will be understood that the sterile field can be considered a specified area, such as inside a tray or on a sterile towel, which is considered free of microorganisms, or the sterile field can be considered an area, immediately around a patient, who was prepared to perform a surgical procedure. The sterile field may include members of the brushing team, who are properly dressed, and all furniture and accessories in the area.
[0086] [0086] In several aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays and one or more screens that are strategically arranged in relation to the sterile field, as shown in Figure 2. In one aspect, the display system 108 includes an interface for HL7, PACS and EMR. Various components of the 108 display system are described under the heading "Advanced Imaging Acquisition Module" in US provisional patent application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the disclosure of which is incorporated herein as a reference in its entirety.
[0087] [0087] As shown in Figure 2, a primary screen 119 is positioned in the sterile field to be visible to the operator on the operating table 114. In addition, a viewing tower 111 is positioned outside the sterile field. The display tower 111 includes a first non-sterile screen 107 and a second non-sterile screen 109, which are opposite each other. The visualization system 108, guided by the central controller 106, is configured to use screens 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the central controller 106 can have the visualization system 108 display a snapshot of a surgical site, as recorded by an imaging device 124, on a non-sterile screen 107 or 109, while maintaining a live transmission of the surgical site on main screen 119. Snapshot on non-sterile screen 107 or 109 can allow a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
[0088] [0088] In one aspect, central controller 106 is also configured to route a diagnostic input or feedback by a non-sterile operator in the display tower 111 to the primary screen 119 within the sterile field, where it can be seen by a sterile operator on the operating table. In one example, the entry may be in the form of a modification of the snapshot displayed on the non-sterile screen 107 or 109, which can be routed to main screen 119 by central controller 106.
[0089] [0089] With reference to Figure 2, a 112 surgical instrument is being used in the surgical procedure as part of the surgical system
[0090] [0090] Now with reference to Figure 3, a central controller 106 is shown in communication with a visualization system 108, a robotic system 110 and a smart handheld surgical instrument 112. Central controller 106 includes a central controller screen 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132 and a storage matrix 134. In certain respects, as shown in Figure 3, central controller 106 additionally includes a smoke evacuation module 126 and / or a suction / irrigation module 128.
[0091] [0091] During a surgical procedure, the application of energy to the tissue, for sealing and / or cutting, is generally associated with the evacuation of smoke, suction of excess fluid and / or irrigation of the tissue. Fluid, power, and / or data lines from different sources are often intertwined during the surgical procedure. Valuable time can be wasted in addressing this issue during a surgical procedure. To untangle the lines, it may be necessary to disconnect the lines from their respective modules, which may require a restart of the modules. The central compartment of the central controller 136 offers a unified environment for managing power, data and fluid lines, which reduces the frequency of entanglement between such lines.
[0092] [0092] Aspects of this disclosure feature a central surgical controller for use in a surgical procedure that involves applying energy to tissue at a surgical site. The central surgical controller includes a central controller compartment and a combined generator module received slidingly at a central controller compartment docking station. The docking station includes data and power contacts. The combined generator module includes two or more of an ultrasonic energy generating component, a bipolar RF energy generating component, and a monopolar RF energy generating component which are housed in a single unit. In one aspect, the combined generator module also includes a smoke evacuation component, at least one power application cable to connect the combined generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid , and / or particulates generated by applying therapeutic energy to the tissue, and a fluid line that extends from the remote surgical site to the smoke evacuation component.
[0093] [0093] In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to a suction and irrigation module received slidingly in the central controller compartment. In one aspect, the central controller compartment comprises a fluid interface.
[0094] [0094] Certain surgical procedures may require the application of more than one type of energy to the tissue. One type of energy may be more beneficial for cutting the fabric, while another type of energy may be more beneficial for sealing the fabric. For example, a bipolar generator can be used to seal the tissue while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which a modular compartment of central controller 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the central modular compartment 136 is that it allows quick removal and / or replacement of several modules.
[0095] [0095] Aspects of the present disclosure present a modular surgical compartment for use in a surgical procedure that involves applying energy to the tissue. The modular surgical compartment includes a first energy generator module, configured to generate a first energy for application to the tissue, and a first docking station that comprises a first docking port that includes first data contacts and energy contacts, the the first power generator module is slidably movable in an electric coupling with the power and data contacts and the first power generator module is slidably movable out of the electric coupling with the first power and data contacts.
[0096] [0096] In addition to the above, the modular surgical compartment also includes a second energy generator module configured to generate a second energy, different from the first energy, for application to the tissue, and a second docking station comprising a second docking port which includes second data and power contacts, the second power generating module being slidably movable in an electrical coupling with the power and data contacts, and the second power generating module being slidingly movable outwards electrical coupling with the second power and data contacts.
[0097] [0097] In addition, the modular surgical compartment also includes a communication bus between the first coupling port and the second coupling port, configured to facilitate communication between the first energy generating module and the second energy generating module.
[0098] [0098] With reference to Figures 3 to 7, aspects of the present disclosure are presented for a modular compartment of the central controller 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation 128. The central modular compartment 136 further facilitates interactive communication between modules 140, 126, 128. As illustrated in Figure 5, generator module 140 can be a generator module with integrated monopolar, bipolar and ultrasonic components, supported on a single cabinet unit 139 slidably insertable in the central modular compartment 136. As shown in Figure 5, generator module 140 can be configured to connect to a monopolar device 146, a bipolar device 147 and an ultrasonic device 148. Alternatively, the generator module 140 can comprise a series of monopoly, bipolar and / or ultrasonic generator modules that interact through the central modular compartment 136. The central modular compartment 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators anchored in the central modular compartment 136 so that the generators would act as a single generator.
[0099] [0099] In one aspect, the central modular compartment 136 comprises a modular power and a rear communication board 149 with external and wireless communication heads to allow removable fixing of modules 140, 126, 128 and interactive communication between them.
[0100] [0100] In one aspect, the central modular compartment 136 includes docking stations, or drawers, 151, here also called drawers, which are configured to receive modules 140, 126, 128 in a sliding manner. Figure 4 illustrates a view in partial perspective of a central surgical controller compartment 136, and a combined generator module 145 slidably received at a docking station 151 of the central surgical controller compartment 136. A docking port 152 with power and data contacts on one side rear of the combined generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of a corresponding docking station 151 from the central controller modular compartment 136 as the combined generator module 145 is slid into position at the station matching coupling 151 of the modular compartment of the central controller 136. In one aspect, the generator module combined 145 includes a bipolar, ultrasonic and monopolar module and a smoke evacuation module integrated into a single compartment unit 139, as shown in Figure 5.
[0101] [0101] In several respects, the smoke evacuation module 126 includes a fluid line 154 that carries captured / collected smoke fluid away from a surgical site and to, for example, the smoke evacuation module 126. Suction a vacuum that originates from the smoke evacuation module 126 can pull the smoke into an opening of a utility conduit at the surgical site. The utility conduit, coupled to the fluid line, can be in the form of a flexible tube that ends in the smoke evacuation module 126. The utility conduit and the fluid line define a fluid path that extends towards the smoke evacuation module 126 which is received in the central controller compartment
[0102] [0102] In several respects, the suction / irrigation module 128 is coupled to a surgical tool comprising a fluid suction line and a fluid suction line. In one example, the suction and suction fluid lines are in the form of flexible tubes that extend from the surgical site towards the suction / irrigation module 128. One or more drive systems can be configured to cause irrigation and aspiration of fluids to and from the surgical site.
[0103] [0103] In one aspect, the surgical tool includes a drive shaft that has an end actuator at a distal end of the same and at least an energy treatment associated with the end actuator, a suction tube, and a suction tube. irrigation. The suction tube can have an inlet port at a distal end of it and the suction tube extends through the drive shaft. Similarly, an irrigation pipe can extend through the drive shaft and may have an entrance port close to the power application implement. The power application implement is configured to deliver ultrasonic and / or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the drive shaft.
[0104] [0104] The irrigation tube can be in fluid communication with a fluid source, and the suction tube can be in fluid communication with a vacuum source. The fluid source and / or the vacuum source can be housed in the suction / irrigation module 128. In one example, the fluid source and / or the vacuum source can be housed in the central controller compartment 136 separately from the control module. suction / irrigation 128. In such an example, a fluid interface can be configured to connect the suction / irrigation module 128 to the fluid source and / or the vacuum source.
[0105] [0105] In one aspect, modules 140, 126, 128 and / or their corresponding docking stations in the central modular compartment 136 may include alignment features that are configured to align the docking ports of the modules in engagement with their counterparts at the stations coupling module of the central modular compartment 136. For example, as shown in Figure 4, the combined generator module 145 includes side brackets 155 that are configured to slide the corresponding brackets 156 of the corresponding docking station 151 of the central modular compartment 136 slidably. The brackets cooperate to guide the coupling port contacts of the combined generator module 145 in an electrical coupling with the coupling port contacts of the central modular compartment 136.
[0106] [0106] In some respects, the drawers 151 of the central modular compartment 136 are the same, or substantially the same size, and the modules are adjusted in size to be received in the drawers 151. For example, the side brackets 155 and / or 156 can be larger or smaller depending on the size of the module. In other respects, drawers 151 are different in size and are each designed to accommodate a specific module.
[0107] [0107] In addition, the contacts of a specific module can be switched to engage with the contacts of a specific drawer to avoid the insertion of a module in a drawer with unpaired contacts.
[0108] [0108] As shown in Figure 4, the coupling port 150 of a drawer 151 can be coupled to the coupling port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between the modules housed in the modular compartment central 136. The coupling ports 150 of the central modular compartment 136 can, alternatively or additionally, facilitate interactive wireless communication between the modules housed in the central modular compartment 136. Any suitable wireless communication can be used, for example, Air Titan Bluetooth.
[0109] [0109] Figure 6 illustrates individual power bus connectors for a plurality of side coupling ports of a side modular compartment 160 configured to receive a plurality of modules from a central surgical controller 206. Side modular compartment 160 is configured to receive and laterally interconnect modules 161. Modules 161 are slidably inserted into docking stations 162 of side modular compartment 160, which includes a back plate for interconnecting modules 161. As shown in Figure 6, modules 161 are arranged laterally in the side modular cabinet
[0110] [0110] Figure 7 illustrates a vertical modular cabinet 164 configured to receive a plurality of modules 165 from the central surgical controller 106. The modules 165 are slidably inserted into docking stations, or drawers, 167 of the vertical modular cabinet 164, the which includes a rear panel for interconnecting modules 165. Although the drawers 167 of the vertical modular cabinet 164 are arranged vertically, in certain cases, a vertical modular cabinet 164 may include drawers that are arranged laterally. In addition, modules 165 can interact with each other through the coupling ports of the vertical modular cabinet
[0111] [0111] In several respects, imaging module 138 comprises an integrated video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is comprised of a modular compartment that can be mounted with a light source module and a camera module. The compartment can be a disposable compartment. In at least one example, the disposable compartment is removably coupled to a reusable controller, a light source module, and a camera module. The light source module and / or the camera module can be selected selectively depending on the type of surgical procedure. In one aspect, the camera module comprises a CCD sensor. In another aspect, the camera module comprises a CMOS sensor. In another aspect, the camera module is configured for imaging the scanned beam. Similarly, the light source module can be configured to provide a white light or a different light, depending on the surgical procedure.
[0112] [0112] During a surgical procedure, removing a surgical device from the surgical field and replacing it with another surgical device that includes a different camera or other light source may be inefficient. Temporarily losing sight of the surgical field can lead to undesirable consequences. The imaging device module of the present disclosure is configured to allow the replacement of a light source module or a "midstream" camera module during a surgical procedure, without the need to remove the imaging device from the surgical field.
[0113] [0113] In one aspect, the imaging device comprises a tubular compartment that includes a plurality of channels. A first channel is configured to receive the Camera module in a sliding way, which can be configured for a snap-fit fit (pressure fit) with the first channel. A second channel is configured to slide the camera module, which can be configured for a snap-fit fit (pressure fit) with the first channel. In another example, the camera module and / or the light source module can be rotated to an end position within their respective channels. A threaded coupling can be used instead of a pressure fitting.
[0114] [0114] In several examples, multiple imaging devices are placed in different positions in the surgical field to provide multiple views. Imaging module 138 can be configured to switch between imaging devices to provide an ideal view. In several respects, imaging module 138 can be configured to integrate images from different imaging devices.
[0115] [0115] Various image processors and imaging devices suitable for use with the present disclosure are described in US patent No. 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, granted on August 9, 2011 which is incorporated herein as reference in its entirety. In addition, US patent No. 7,982,776, entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, issued on July 19, 2011, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems can be integrated with imaging module 138. In addition to these, the publication of US patent application No. 2011/0306840, entitled CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS, published on December 15, 2011, and the publication of the application US Patent No. 2014/0243597, entitled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published on August 28, 2014, which are each incorporated herein by reference in their entirety.
[0116] [0116] Figure 8 illustrates a surgical data network 201 comprising a central modular communication controller 203 configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a healthcare facility. of health specially equipped for surgical operations, to a cloud-based system (for example, cloud 204 which may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communication central controller 203 comprises a central network controller 207 and / or a network key 209 in communication with a network router. The central modular communication controller 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 can be configured as a passive, intelligent, or switching network. A passive surgical data network serves as a conduit for the data, allowing the data to be transmitted from one device (or segment) to another and to cloud computing resources. An intelligent surgical data network includes features to allow traffic to pass through the surgical data network to be monitored and to configure each port on the central network controller 207 or network key 209. An intelligent surgical data network can be called a a central controller or manageable key. A central switching controller reads the destination address of each packet and then forwards the packet to the correct port.
[0117] [0117] Modular devices 1a to 1n located in the operating room can be coupled to the central controller of modular communication 203. The central network controller 207 and / or the network switch 209 can be coupled to a network router 211 to connect devices 1a through 1n to the 204 cloud or the local computer system
[0118] [0118] It will be understood that the surgical data network 201 can be expanded by interconnecting the multiple central network controllers 207 and / or the multiple network switches 209 with multiple network routers 211. The central communication controller 203 may be contained in a modular control tower configured to receive multiple devices 1a to 1n / 2a to 2m. The local computer system 210 can also be contained in a modular control tower. The modular communication central controller 203 is connected to a screen 212 to display the images obtained by some of the devices 1a to 1n / 2a to 2m, for example, during surgical procedures. In several respects, devices 1a to 1n / 2a to 2m can include, for example, several modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, an evacuation module smoke 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage matrix 134, a surgical device attached to a screen, and / or a non-contact sensor module, among others modular devices that can be connected to the modular communication central controller 203 of the surgical data network 201.
[0119] [0119] In one aspect, the surgical data network 201 may comprise a combination of central network controllers, network switches, and network routers that connect devices 1a to 1n / 2a to 2m to the cloud. Any or all of the devices 1a to 1n / 2a to 2m coupled to the central network controller or network key can collect data in real time and transfer the data to cloud computers for data processing and manipulation. It will be understood that cloud computing depends on sharing computing resources instead of having local servers or personal devices to handle software applications. The word "cloud" can be used as a metaphor for "the Internet", although the term is not limited as such. Consequently, the term "cloud computing" can be used here to refer to "a type of Internet-based computing", in which different services - such as servers, storage, and applications - are applied to the modular communication central controller 203 and / or computer system 210 located in the operating room (for example, a fixed, mobile, temporary, or operating room or operating space) and devices connected to the modular communication central controller 203 and / or computer system 210 via from Internet. The cloud infrastructure can be maintained by a cloud service provider. In this context, the cloud service provider may be the entity that coordinates the use and control of devices 1a to 1n / 2a to 2m located in one or more operating rooms. Cloud computing services can perform a large number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The central controller hardware allows multiple devices or connections to be connected to a computer that communicates with cloud computing and storage resources.
[0120] [0120] The application of cloud computer data processing techniques to data collected by devices 1a to 1n / 2a to 2m, the surgical data network provides better surgical results, reduced costs, and better patient satisfaction. At least some of the devices 1a to 1n / 2a to 2m can be used to view tissue status to assess leakage or perfusion of sealed tissue after a tissue sealing and cutting procedure. At least some of the devices 1a to 1n / 2a to 2m can be used to identify the pathology, such as the effects of disease, with the use of cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes confirmation of the location and margin of the tissue and phenotypes. At least some of the devices 1a to 1n / 2a to 2m can be used to identify anatomical structures of the body using a variety of sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. The data collected by devices 1a to 1n / 2a to 2m, including the image data, can be transferred to the cloud 204 or the local computer system 210 or both for data processing and manipulation including image processing and manipulation. The data can be analyzed to improve the results of the surgical procedure by determining whether additional treatment, such as application of endoscopic intervention,
[0121] [0121] In an implementation, devices in the operating room 1a to 1n can be connected to the central modular communication controller 203 via a wired channel or a wireless channel depending on the configuration of devices 1a to 1n on a central controller of network. The central network controller 207 can be implemented, in one aspect, as a local network transmission device that acts on the physical layer of the OSI model ("open system interconnection"). The central network controller provides connectivity to devices 1a to 1n located on the same network as the operating room. The central network controller 207 collects data in the form of packets and sends it to the router in half - duplex mode. "The central network controller 207 does not store any media / Internet protocol (MAC / IP) access control for transfer device data Only one of the devices 1a to 1n at a time can send data via the central network controller 207. The central network controller 207 does not have routing tables or intelligence about where to send information and transmits all data from the network through each connection and to a remote server 213 (Figure 9) through the cloud 204. The central network controller 207 can detect basic network errors, such as collisions, but have all (admit that) the information transmitted to multiple network ports. entry can be a security risk and cause bottlenecks.
[0122] [0122] In another implementation, operating room devices 2a to 2m can be connected to a network switch 209 via a wired or wireless channel. The network key 209 works in the data connection layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operation center to the network. The network key 209 sends data in frame form to the network router 211 and works in full duplex mode. Multiple devices 2a to 2m can send data at the same time via network key 209. Network key 209 stores and uses MAC addresses of devices 2a to 2m to transfer data.
[0123] [0123] The central network controller 207 and / or the network key 209 are coupled to the network router 211 for a connection to the cloud
[0124] [0124] In one example, the central network controller 207 can be implemented as a central USB controller, which allows multiple USB devices to be connected to a host computer. The central USB controller can expand a single port
[0125] [0125] In other examples, operating room devices 1a to 1n / 2a to 2m can communicate with the central modular communication controller 203 via standard Bluetooth wireless technology for exchanging data over short distances (with the use of short-wavelength UHF radio waves in the 2.4 to 2.485 GHz ISM band) from fixed and mobile devices and build personal area networks (PANs). In other respects, operating room devices 1a to 1n / 2a to 2m can communicate with the central modular communication controller 203 via a number of wireless and wired communication standards or protocols, including, but not limited to a, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long-term evolution (LTE, "long-term evolution"), and Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM , GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond. The computing module can include a plurality of communication modules. For example, a first communication module can be dedicated to short-range wireless communications like Wi-Fi and Bluetooth, and a second communication module can be dedicated to longer-range wireless communications like GPS, EDGE, GPRS, CDMA , WiMAX, LTE, Ev-DO, and others.
[0126] [0126] The modular communication central controller 203 can serve as a central connection for one or all operating room devices 1a to 1n / 2a to 2m and handles a data type known as frames. The tables carry the data generated by the devices 1a to 1n / 2a to 2m. When a frame is received by the modular central communication controller 203, it is amplified and transmitted to the network router 211, which transfers data to cloud computing resources using a series of wireless communication standards or protocols or wired, as described in the present invention.
[0127] [0127] The 203 modular communication central controller can be used as a standalone device or be connected to compatible central network controllers and network switches to form a larger network. The 203 modular communication central controller is, in general, easy to install, configure and maintain, making it a good option for the network of devices 1a to 1n / 2a to 2m from the operating room.
[0128] [0128] Figure 9 illustrates an interactive surgical system, implemented by computer 200. The interactive surgical system implemented by computer 200 is similar in many aspects to the interactive surgical system, implemented by computer 100. For example, the interactive, implemented, surgical system per computer 200 includes one or more surgical systems 202, which are similar in many respects to surgical systems 102. Each surgical system 202 includes at least one central surgical controller 206 in communication with a cloud 204 which may include a remote server
[0129] [0129] Figure 10 illustrates a central surgical controller 206 that comprises a plurality of modules coupled to the modular control tower 236. The modular control tower 236 comprises a central controller for modular communication 203, for example, a network connectivity device , and a computer system 210 for providing local processing, visualization, and imaging, for example. As shown in Figure 10, the modular communication central controller 203 can be connected in a layered configuration to expand the number of modules (for example, devices) that can be connected to the modular communication central controller 203 and transfer data associated with modules to computer system 210, cloud computing resources, or both. As shown in Figure 10, each of the central controllers / network switches in the modular communication central controller 203 includes three downstream ports and one upstream port. The central controller / network switch upstream is connected to a processor to provide a communication connection to the cloud computing resources and a local display 217. Communication with the cloud 204 can be done via a wired communication channel or wireless.
[0130] [0130] The central surgical controller 206 employs a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using non-contact measuring devices such as laser or ultrasonic. An ultrasound-based non-contact sensor module scans the operating room by transmitting an ultrasound explosion and receiving the echo when it bounces outside the perimeter of the operating room walls, as described under the heading Surgical Hub Spatial Awareness Within an Operating Room "in US provisional patent application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, which is hereby incorporated by reference in its entirety, in which the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limits. A laser-based non-contact sensor module scans the operating room by transmitting pulses of laser light, receiving pulses of laser light that bounce off the perimeter walls. operating room, and comparing the phase of the transmitted pulse to the received pulse to determine the size of the operating room and to adjust the limits s Bluetooth pairing distance, for example.
[0131] [0131] Computer system 210 comprises a processor 244 and a network interface 245. Processor 244 is coupled to a communication module 247, storage 248, memory 249, non-volatile memory 250, and an input / output interface 251 through of a system bus. The system bus can be any of several types of bus structures, including the memory bus or memory controller, a peripheral bus or external bus, and / or a local bus that uses any variety of available bus architectures including, but not limited to, not limited to, 9-bit bus, industry standard architecture (ISA), Micro-Charmel Architecture (MSA), extended ISA (EISA), smart drive electronics (IDE), VESA local bus (VLB), component interconnection peripherals (PCI), USB, accelerated graphics port (AGP), PCMCIA bus (International Personal Computer Memory Card Association, "Personal Computer Memory Card International Association"), Small Computer Systems Interface (SCSI), or any another proprietary bus.
[0132] [0132] Processor 244 can be any single-core or multi-core processor, such as those known under the ARM Cortex trade name available from Texas Instruments. In one respect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz , a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with the StellarisWare® program, memory only programmable, electrically erasable (EEPROM) reading of 2 KB, one or more pulse width modulation (PWM) modules, one or more analogs of quadrature encoder (QEI) inputs, one or more analog to digital converters (ADC) 12-bit with 12 channels of analog input, details of which are available for the product data sheet.
[0133] [0133] In one aspect, processor 244 may comprise a safety controller comprising two controller-based families, such as TMS570 and RM4x, known under the tradename Hercules ARM Cortex R4, also available from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[0134] [0134] System memory includes volatile and non-volatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within the computer system, such as during startup, is stored in non-volatile memory. For example, non-volatile memory can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM or flash memory. Volatile memory includes random access memory (RAM), which acts as an external cache memory. In addition, RAM is available in many forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct RAM Rambus RAM (DRRAM).
[0135] [0135] Computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card or memory stick (pen drive). drive). In addition, the storage disc may include storage media separately or in combination with other storage media including, but not limited to, an optical disc drive such as a compact disc ROM (CD-ROM) device recordable (CD-R Drive), rewritable compact disc drive (CD-RW drive), or a versatile digital ROM drive (DVD-ROM). To facilitate the connection of disk storage devices to the system bus, a removable or non-removable interface can be used.
[0136] [0136] It is to be understood that computer system 210 includes software that acts as an intermediary between users and basic computer resources described in an appropriate operating environment. Such software includes an operating system. The operating system, which can be stored on disk storage, acts to control and allocate computer system resources. System applications benefit from the management capabilities of the operating system through program modules and program data stored in system memory or on the storage disk. It is to be understood that the various components described in the present invention can be implemented with various operating systems or combinations of operating systems.
[0137] [0137] A user enters commands or information into computer system 210 through the input device (s) coupled to the I / O interface 251. Input devices include, but are not limited to, a device pointer such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, game pad, satellite card, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices connect to the processor via the system bus via the interface port (s). The interface ports include, for example, a serial port, a parallel port, a game port and a USB. Output devices use some of the same types of ports as input devices. In this way, for example, a USB port can be used to provide input to the computer system and to provide information from the computer system to an output device. An output adapter is provided to illustrate that there are some output devices such as monitors, screens, speakers, and printers, among other output devices, that need special adapters. Output adapters include, by way of illustration and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and / or device systems, such as remote computers, provide input and output capabilities.
[0138] [0138] Computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computers, or local computers. Remote cloud computers can be a personal computer, server, router, personal network computer, workstation, microprocessor-based device, peer device, or other common network node, and the like, and typically include many or all elements described in relation to the computer system. For the sake of brevity, only one memory storage device is illustrated with the remote computer. Remote computers are logically connected to the computer system via a network interface and then physically connected via a communication connection. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet / IEEE 802.3, Token / IEEE 802.5 ring and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks such as digital integrated service networks (ISDN) and variations in them, packet switching networks and digital subscriber lines (DSL).
[0139] [0139] In several respects, computer system 210 of Figure 10, imaging module 238 and / or display system 208, and / or processor module 232 of Figures 9 to 10, may comprise an image processor, image processing engine, media processor, or any specialized digital signal processor (DSP) used for processing digital images. The image processor can employ parallel computing with single multi-data instruction (SIMD) or multiple multi-data instruction (MIMD) technologies to increase speed and efficiency. The digital image processing engine can perform a number of tasks. The image processor can be an integrated circuit system with a multi-core processor architecture.
[0140] [0140] Communication connections refer to the hardware / software used to connect the network interface to the bus. Although the communication connection is shown for illustrative clarity within the computer system, it can also be external to computer system 210. The hardware / software required for connection to the network interface includes, for illustrative purposes only, internal and external technologies such as modems, including regular telephone serial modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.
[0141] [0141] Figure 11 illustrates a functional block diagram of an aspect of a USB 300 central network controller device, in accordance with at least one aspect of the present disclosure. In the illustrated aspect, the USB 300 network central controller device uses a TUSB2036 integrated circuit central controller available from Texas Instruments. The central USB network controller 300 is a CMOS device that provides one USB transceiver port 302 and up to three USB transceiver ports downstream 304, 306, 308 in accordance with the USB 2.0 specification. Upstream USB transceiver port 302 is a differential data root port comprising a "minus" (DM0) differential data input paired with a "plus" (DP0) differential data input. The three ports of the downstream USB transceiver 304, 306, 308 are differential data ports, with each port including "more" differential data outputs (DP1-DP3) paired with "less" differential data outputs (DM1-DM3) .
[0142] [0142] The USB 300 central network controller device is implemented with a digital state machine instead of a microcontroller, and no firmware programming is required. Fully compatible USB transceivers are integrated into the circuit for the upstream USB transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full speed as low speed automatically configuring the scan rate according to the speed of the device attached to the doors. The central network controller device
[0143] [0143] The USB 300 network central controller device includes a 310 series interface engine (SIE). The SIE 310 is the front end of the USB 300 central network controller hardware and handles most of the protocol described in chapter 8 of the USB specification. SIE 310 typically comprises signaling down to the transaction level. The functions it handles could include: packet recognition, transaction sequencing, SOP, EOP, RESET, and RESUME signal detection / generation, clock / data separation, data encoding / decoding non-inverted zero (NRZI) , generation and verification of CRC (token and data), generation and verification / decoding of packet ID (PID), and / or series-parallel / parallel-series conversion. The 310 receives a clock input 314 and is coupled with a suspend / resume logic circuit and frame timer 316 and a central controller repeat circuit 318 to control communication between the upstream USB transceiver port 302 and the USB transceiver ports downstream 304, 306, 308 through the logic circuits of ports 320, 322, 324. The SIE 310 is coupled to a command decoder 326 through the logic interface to control the commands of a serial EEPROM via an EEPROM interface in 330 series.
[0144] [0144] In several aspects, the USB 300 central network controller can connect 127 functions configured in up to six logical layers (levels) to a single computer. In addition, the USB 300 central network controller can connect all peripherals using a standardized four-wire cable that provides both communication and power distribution. The power settings are bus-powered and self-powered modes. The USB 300 central network controller can be configured to support four power management modes: a bus-powered central controller with individual port power management or grouped port power management, and the self-powered central controller with power management. individual port power or grouped port power management. In one aspect, using a USB cable, the USB 300 central network controller, the USB upstream transceiver port 302 is plugged into a USB host controller, and the downstream USB transceiver ports 304, 306, 308 are exposed to connect compatible USB devices, and so on. Surgical Instrument Hardware
[0145] [0145] Figure 12 illustrates a logic diagram of a module of a 470 control system of a surgical instrument or tool, according to one or more aspects of the present disclosure. The 470 system comprises a control circuit. The control circuit includes a microcontroller 461 comprising a processor 462 and a memory 468. One or more of the sensors 472, 474, 476, for example, provide real-time feedback to processor 462. A motor 482, driven by a driver of motor 492, operationally couples a longitudinally movable displacement member to drive the beam element with I-shaped beam. A tracking system 480 is configured to determine the position of the longitudinally movable displacement member. Position information is provided to the 462 processor, which can be programmed or configured to determine the position of the longitudinally movable drive member, as well as the position of a firing member, firing bar and profile beam member in I. Additional motors can be provided at the instrument driver interface to control the firing of the beam with an i-profile, the displacement of the closing tube, the rotation of the drive shaft and the articulation. A 473 screen displays a variety of instrument operating conditions and can include touchscreen functionality for data entry. The information displayed on screen 473 can be overlaid with images captured using endoscopic imaging modules.
[0146] [0146] In one aspect, the 461 microcontroller can be any single-core or multi-core processor, such as those known under the ARM Cortex trade name available from Texas Instruments. In one respect, the main microcontroller 461 can be an LM4F230H5QR ARM Cortex-M4F processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single cycle flash memory, or other non-volatile memory, up to 40 MHz, a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with the StellarisWare® program, memory programmable and electrically erasable read-only (EEPROM) of 2 KB, one or more pulse width modulation (PWM) modules, one or more analogs of quadrature encoder (QEI) inputs, and / or one or more analog converters for 12 bit digital (ADC) with 12 channels of analog input, details of which are available for the product data sheet.
[0147] [0147] In one aspect, the 461 microcontroller can comprise a safety controller that comprises two families based on controllers, such as TMS570 and RM4x known under the trade name of Hercules ARM Cortex R4, also available from Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[0148] [0148] The 461 microcontroller can be programmed to perform various functions, such as precise control of the speed and position of the articulation and cutting systems. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 can be a brushed direct current (DC) motor with a gearbox and mechanical connections with a hinge or cut system. In one aspect, a motor drive 492 can be an A3941 available from Allegro Microsystems, Inc. Other motor drives can be readily replaced for use in tracking system 480 which comprises an absolute positioning system. A detailed description of an absolute positioning system is given in US Patent Application Publication No. 2017/0296213, entitled SYSTEMS AND METHODS FOR
[0149] [0149] The 461 microcontroller can be programmed to provide precise control of the speed and position of the displacement members and articulation systems. The 461 microcontroller can be configured to compute a response in the 461 microcontroller software. The computed response is compared to a measured response from the real system to obtain an "observed" response, which is used for actual feedback-based decisions. The observed response is a favorable and adjusted value, which balances the uniform and continuous nature of the simulated response with the measured response, which can detect external influences in the system.
[0150] [0150] In one aspect, motor 482 can be controlled by motor driver 492 and can be used by the instrument's trigger system or surgical tool. In many ways, the 482 motor can be a brushed direct current (DC) drive motor, with a maximum speed of approximately 25,000 RPM, for example. In other arrangements, the 482 motor may include a brushless motor, a wireless motor, a synchronous motor, a stepper motor or any other suitable type of electric motor. Motor starter 492 may comprise an H bridge starter comprising field effect transistors (FETs), for example. The 482 motor can be powered by a feed assembly releasably mounted on the handle assembly or tool compartment to provide control power for the instrument or surgical tool. The power pack may comprise a battery that may include several battery cells connected in series, which can be used as the power source to power the instrument or surgical tool. In certain circumstances, the battery cells in the power pack may be replaceable and / or rechargeable. In at least one example, the battery cells can be lithium-ion batteries that can be coupled and separable from the power pack.
[0151] [0151] The 492 motor driver can be an A3941, available from Allegro Microsystems, Inc. The 492 A3941 driver is an entire bridge controller for use with external power semiconductor metal oxide field (MOSFET) transistors. , of N channel, specifically designed for inductive loads, such as brushed DC motors. The 492 actuator comprises a single charge pump regulator that provides full door drive (> 10 V) for batteries with voltage up to 7 V and allows the A3941 to operate with a reduced door drive, up to 5.5 V. A capacitor input control can be used to supply the voltage surpassing that supplied by the battery required for the N channel MOSFETs. An internal charge pump for the upper side drive allows operation in direct current (100% duty cycle). The entire bridge can be triggered in fast or slow drop modes using diodes or synchronized rectification. In the slow drop mode, the current can be recirculated by means of FET from the top or from the bottom. The energy FETs are protected from the shoot-through effect through programmable dead-time resistors. Integrated diagnostics provide indication of undervoltage, overtemperature and faults in the power bridge, and can be configured to protect power MOSFETs in most short-circuit conditions. Other motor drives can be readily replaced for use in the tracking system 480 comprising an absolute positioning system.
[0152] [0152] The tracking system 480 comprises a controlled motor drive circuit arrangement comprising a position sensor 472 in accordance with an aspect of the present disclosure. The position sensor 472 for an absolute positioning system provides a unique position signal that corresponds to the location of a displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for engagement with a corresponding drive gear of a gear reduction assembly. In other respects, the displacement member represents the firing member, which can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing bar or the I-shaped beam, each of which can be adapted and configured to include a rack of driving teeth.
[0153] [0153] The 482 electric motor may include a rotary drive shaft, which interfaces operationally with a gear set, which is mounted on a coupling hitch with a set or rack of drive teeth on the drive member. A sensor element can be operationally coupled to a gear assembly so that a single revolution of the position sensor element 472 corresponds to some linear longitudinal translation of the displacement member. An array of gears and sensors can be connected to the linear actuator by means of a rack and pinion arrangement, or by a rotary actuator, by means of a sprocket or other connection. A power supply supplies power to the absolute positioning system and an output indicator can display the output from the absolute positioning system. The drive member represents the longitudinally movable drive member comprising a rack of drive teeth formed thereon for engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents the longitudinally movable firing member, the firing bar, the I-beam or combinations thereof.
[0154] [0154] A single revolution of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement d1 of the displacement member, where d1 represents the longitudinal linear distance by which the displacement member moves from point "a" to point "b" after a single revolution of the sensor element coupled to the displacement member. The sensor arrangement can be connected by means of a gear reduction which results in the position sensor 472 completing one or more revolutions for the complete travel of the displacement member.
[0155] [0155] A series of switches, where n is an integer greater than one, can be used alone or in combination with a gear reduction to provide a single position signal for more than one revolution of the 472 position sensor. of the switches is transmitted back to microcontroller 461 which applies logic to determine a single position signal corresponding to the longitudinal linear displacement of d1 + d2 +… dn of the displacement member. The output of the position sensor 472 is supplied to the microcontroller 461. In several embodiments, the position sensor 472 of the sensor arrangement may comprise a magnetic sensor, an analog rotary sensor, such as a potentiometer, or a series of analog Hall effect elements. , which emit a unique combination of position of signs or values.
[0156] [0156] The position sensor 472 can comprise any number of magnetic detection elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector components of the magnetic field. The techniques used to produce both types of magnetic sensors cover many aspects of physics and electronics. Technologies used for magnetic field detection include flow meter, saturated flow, optical pumping, nuclear precession, SQUID, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piesoelectric compounds, magnetodiode, magnetic transistor, fiber optics, magneto-optics and magnetic sensors based on microelectromechanical systems, among others.
[0157] [0157] In one aspect, the position sensor 472 for the tracking system 480 which comprises an absolute positioning system comprises a magnetic rotating absolute positioning system. The 472 position sensor can be implemented as a rotary, magnetic, single-circuit, AS5055EQFT position sensor, available from Austria Microsystems, AG. The position sensor 472 interfaces with the 461 microcontroller to provide an absolute positioning system. The 472 position sensor is a low voltage, low power component and includes four effect elements in an area of the 472 position sensor located above a magnet. A high-resolution ADC and an intelligent power management controller are also provided on the integrated circuit. A CORDIC (digital computer for coordinate rotation) processor, also known as the digit-for-digit method and Volder algorithm, is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, displacement operations bits and lookup table. The angle position, alarm bits and magnetic field information are transmitted via a standard serial communication interface, such as a serial peripheral interface (SPI), to the 461 microcontroller. The 472 position sensor provides 12 or 14 bits of resolution. The position sensor 472 can be an AS5055 integrated circuit supplied in a small 16-pin QFN package whose measurement corresponds to 4x4x0.85 mm.
[0158] [0158] The tracking system 480 comprising an absolute positioning system can comprise and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts the signal from the feedback controller to a physical input to the system, in this case the voltage. Other examples include a voltage, current and force PWM. Other sensors can be provided to measure the parameters of the physical system in addition to the position measured by the position sensor 472. In some respects, the other sensors may include sensor arrangements as described in US patent No. 9,345,481 entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, granted on May 24, 2016, which is incorporated by reference in its entirety in this document; US patent application Serial No. 2014/0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, published on September 18, 2014, is incorporated by reference in its entirety into this document; and US patent application Serial No. 15 / 628,175, entitled TECHNIQUES FOR ADAPTIVE
[0159] [0159] The absolute positioning system provides an absolute positioning of the displaced member on the activation of the instrument without having to retract or advance the longitudinally movable driving member to the restart position (zero or initial), as may be required by the encoders conventional rotating machines that merely count the number of progressive or regressive steps that the 482 motor has traveled to infer the position of a device actuator, actuation bar, scalpel, and the like.
[0160] [0160] A 474 sensor, such as a strain gauge or a micro strain gauge, is configured to measure one or more parameters of the end actuator, such as the amplitude of the strain exerted on the anvil during a gripping operation, which may be indicative of tissue compression. The measured effort is converted into a digital signal and fed to the 462 processor. Alternatively, or in addition to the 474 sensor, a 476 sensor, such as a load sensor, can measure the closing force applied by the drive system. anvil closure. The 476 sensor, such as a load sensor, can measure the firing force applied to a beam with an I-profile in a firing stroke of the instrument or surgical tool. The i-profile beam is configured to engage a wedge slider, which is configured to move the clamp actuators upward to force the clamps to deform in contact with an anvil. The i-profile beam includes a sharp cutting edge that can be used to separate fabric, as the i-profile beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current drained by the 482 motor. The force required to advance the trigger member can correspond to the current drained by the 482 motor, for example. The measured force is converted into a digital signal and supplied to the 462 processor.
[0161] [0161] In one form, a 474 strain gauge sensor can be used to measure the force applied to the tissue by the end actuator. A strain gauge can be attached to the end actuator to measure the force applied to the tissue being treated by the end actuator. A system for measuring forces applied to the tissue attached by the end actuator comprises a 474 strain gauge sensor, such as, for example, a microstrain gauge, which is configured to measure one or more parameters of the end actuator, for example. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain exerted on a claw member of an end actuator during a gripping operation, which can be indicative of tissue compression. The measured effort is converted into a digital signal and fed to the 462 processor of a microcontroller
[0162] [0162] Measurements of tissue compression, tissue thickness and / or force required to close the end actuator on the tissue, as measured by sensors 474, 476 respectively, can be used by microcontroller 461 to characterize the selected position of the trigger member and / or the corresponding trigger member speed value. In one case, a 468 memory can store a technique, an equation and / or a look-up table that can be used by the 461 microcontroller in the evaluation.
[0163] [0163] The control system 470 of the instrument or surgical tool can also comprise wired or wireless communication circuits for communication with the modular central communication controller shown in Figures 8 to 11.
[0164] [0164] Figure 13 illustrates a control circuit 500 configured to control aspects of the instrument or surgical tool according to an aspect of the present disclosure. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 may comprise a microcontroller comprising one or more processors 502 (for example, microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores instructions executable on a machine that, when executed by the processor 502, cause the 502 processor to execute machine instructions to implement several of the processes described here. The 502 processor can be any one of a number of single-core or multi-core processors known in the art. The memory circuit 504 may comprise volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present disclosure.
[0165] [0165] Figure 14 illustrates a combinational logic circuit 510 configured to control aspects of the instrument or surgical tool according to an aspect of the present disclosure. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 may comprise a finite state machine comprising a combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data by combinational logic 512 and provide an output 516.
[0166] [0166] Figure 15 illustrates a sequential logic circuit 520 configured to control aspects of the surgical instrument or tool according to an aspect of the present disclosure. Sequential logic circuit 520 or combinational logic 522 can be configured to implement the process described herein. Sequential logic circuit 520 may comprise a finite state machine. Sequential logic circuit 520 may comprise combinational logic 522, at least one memory circuit 524, a clock 529 and, for example. The at least one memory circuit 524 can store a current state of the finite state machine. In certain cases, the sequential logic circuit 520 may be synchronous or asynchronous. Combinational logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data by combinational logic 522, and provide an output 528. In other respects, the circuit may comprise a combination of a processor (for example , processor 502, Figure 13) and a finite state machine for implementing various processes of the present invention. In other respects, the finite state machine may comprise a combination of a combinational logic circuit (for example, a combinational logic circuit 510, Figure 14) and the sequential logic circuit 520.
[0167] [0167] Figure 16 illustrates an instrument or surgical tool that comprises a plurality of motors that can be activated to perform various functions. In certain cases, a first engine can be activated to perform a first function, a second engine can be activated to perform a second function, a third engine can be activated to perform a third function, a fourth engine can be activated to perform a fourth function, and so on. In certain cases, the plurality of motors of the robotic surgical instrument 600 can be individually activated to cause firing, closing, and / or articulation movements in the end actuator. The firing, closing and / or articulation movements can be transmitted to the end actuator through a drive shaft assembly, for example.
[0168] [0168] In certain cases, the instrument or surgical tool system may include a 602 firing motor. The 602 firing motor can be operationally coupled to a 604 firing motor drive assembly, which can be configured to transmit movements triggers generated by the 602 motor to the end actuator, particularly to move the I-beam beam element. In certain cases, the triggering movements generated by the 602 motor can cause the clamps to be positioned from the clamp cartridge in the fabric captured by the end actuator and / or the cutting edge of the I-beam beam element to be advanced in order to cut the captured fabric, for example. The I-beam member can be retracted by reversing the direction of the 602 motor.
[0169] [0169] In certain cases, the surgical instrument or tool may include a closing motor 603. The closing motor 603 can be operationally coupled to a drive assembly of the closing motor 605 that can be configured to transmit closing movements generated by the motor 603 to the end actuator, particularly to move a closing tube to close the anvil and compress the fabric between the anvil and the staple cartridge. Closing movements can cause the end actuator to transition from an open configuration to an approximate configuration to capture tissue, for example. The end actuator can be moved to an open position by reversing the direction of the 603 motor.
[0170] [0170] In certain cases, the surgical instrument or tool may include one or more articulation motors 606a, 606b, for example. The motors 606a, 606b can be operationally coupled to the drive assemblies of the articulation motor 608a, 608b, which can be configured to transmit articulation movements generated by the motors 606a, 606b to the end actuator. In certain cases, the articulation movements can cause the end actuator to be articulated in relation to the drive shaft assembly, for example.
[0171] [0171] As described above, the surgical instrument or tool can include a plurality of motors that can be configured to perform various independent functions. In certain cases, the plurality of motors of the instrument or surgical tool can be activated individually or separately to perform one or more functions, while other motors remain inactive. For example, the articulation motors 606a, 606b can be activated to cause the end actuator to be articulated, while the firing motor 602 remains inactive. Alternatively, the firing motor 602 can be activated to fire the plurality of clamps, and / or advance the cutting edge, while the hinge motor 606 remains inactive. In addition, closing motor 603 can be activated simultaneously with firing motor 602 to cause the closing tube or I-beam beam element to move distally, as described in more detail later in this document.
[0172] [0172] In certain cases, the surgical instrument or tool may include a common control module 610 that can be used with a plurality of the instrument's instruments or surgical tool. In certain cases, the common control module 610 can accommodate one of the plurality of motors at a time. For example, the common control module 610 can be coupled to and separable from the plurality of motors of the robotic surgical instrument individually. In certain cases, a plurality of surgical instrument or tool motors may share one or more common control modules, such as the common control module 610. In certain cases, a plurality of surgical instrument or tool motors may be individually and selectively engaged to the common control module 610. In certain cases, the common control module 610 can be selectively switched between interfacing with one of a plurality of instrument motors or surgical tool to interface with another among the plurality of instrument motors or surgical tool.
[0173] [0173] In at least one example, the common control module 610 can be selectively switched between the operating coupling with the 606a, 606B articulation motors, and the operating coupling with the 602 firing motor or the closing motor 603. In at least one example, as shown in Figure 16, a key 614 can be moved or transitioned between a plurality of positions and / or states. In the first position 616, the switch 614 can electrically couple the common control module 610 to the trip motor 602; in a second position 617, the switch 614 can electrically couple the control module 610 to the closing motor 603; in a third position 618a, the switch 614 can electrically couple the common control module 610 to the first articulation motor 606a; and in a fourth position 618b, the switch 614 can electrically couple the common control module 610 to the second articulation motor 606b, for example. In certain cases, separate common control modules 610 can be electrically coupled to the firing motor 602, closing motor 603, and hinge motors 606a, 606b at the same time. In certain cases, key 614 can be a mechanical key, an electromechanical key, a solid state key, or any suitable switching mechanism.
[0174] [0174] Each of the 602, 603, 606a, 606b motors can comprise a torque sensor to measure the output torque on the motor drive shaft. The force on an end actuator can be detected in any conventional manner, such as by means of force sensors on the outer sides of the jaws or by a motor torque sensor that drives the jaws.
[0175] [0175] In several cases, as shown in Figure 16, the common control module 610 may comprise a motor starter 626 that may comprise one or more H-Bridge FETs. The motor driver 626 can modulate the energy transmitted from a power source 628 to a motor coupled to the common control module 610, based on an input from a microcontroller 620 (the "controller"), for example. In certain cases, the microcontroller 620 can be used to determine the current drawn by the motor, for example, while the motor is coupled to the common control module 610, as described above.
[0176] [0176] In certain examples, the microcontroller 620 may include a microprocessor 622 (the "processor") and one or more non-transitory computer-readable media or 624 memory units (the "memory"). In certain cases, memory 624 can store various program instructions which, when executed, can cause processor 622 to perform a plurality of functions and / or calculations described herein. In certain cases, one or more of the memory units 624 can be coupled to the processor 622, for example.
[0177] [0177] In certain cases, the power supply 628 can be used to supply power to the microcontroller 620, for example. In certain cases, the 628 power source may comprise a battery (or "battery pack" or "power source"), such as a Li ion battery, for example. In certain cases, the battery pack can be configured to be releasably mounted to the handle to supply power to the surgical instrument 600. Several battery cells connected in series can be used as the power supply
[0178] [0178] In several cases, the 622 processor can control the motor drive 626 to control the position, direction of rotation and / or speed of a motor that is coupled to the common control module 610. In certain cases, the processor 622 can signal the motor driver 626 to stop and / or disable a motor that is coupled to the common control module 610. It should be understood that the term "processor", as used here, includes any microprocessor, microcontroller or other control device. adequate basic computing that incorporates the functions of a central computer processing unit (CPU) in an integrated circuit or, at most, some integrated circuits. The processor is a programmable multipurpose device that accepts digital data as input, processes it according to instructions stored in its memory, and provides results as output. This is an example of sequential digital logic, as it has internal memory. Processors operate on numbers and symbols represented in the binary numeral system.
[0179] [0179] In one example, the 622 processor can be any single-core or multi-core processor, such as those known by the Texas Instruments ARM Cortex trade name. In certain cases, the 620 microcontroller may be an LM 4F230H5QR, available from Texas Instruments, for example. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that comprises a 256 KB single cycle flash integrated memory, or other non-volatile memory, up to 40 MHz, an early seek buffer for optimize performance above 40 MHz, a 32 KB single cycle SRAM, an internal ROM loaded with StellarisWare® software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, one or more ADCs 12-bit with 12 channels of analog input, among other features that are readily available for the product data sheet. Other microcontrollers can be readily replaced for use with the 4410 module. Consequently, the present disclosure should not be limited in this context.
[0180] [0180] In certain cases, memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 which are attachable to the common control module 610. For example, memory 624 may include program instructions for controlling the motor trigger 602, closing motor 603 and hinge motors 606a, 606b. Such program instructions can cause the 622 processor to control the trigger, close, and link functions according to inputs from the instrument or surgical tool control algorithms or programs.
[0181] [0181] In certain cases, one or more mechanisms and / or sensors, such as 630 sensors, can be used to alert the 622 processor to program instructions that need to be used in a specific configuration. For example, sensors 630 can alert the 622 processor to use the program instructions associated with triggering, closing, and pivoting the end actuator. In certain cases, sensors 630 may comprise position sensors that can be used to detect the position of switch 614, for example. Consequently, the processor 622 can use the program instructions associated with the firing of the I-beam of the end actuator by detecting, through sensors 630, for example, that the switch 614 is in the first position 616; the processor 622 can use the program instructions associated with closing the anvil upon detection through sensors 630, for example, that switch 614 is in second position 617; and processor 622 can use the program instructions associated with the articulation of the end actuator upon detection through sensors 630, for example, that switch 614 is in the third or fourth position 618a, 618b.
[0182] [0182] Figure 17 is a schematic diagram of a robotic surgical instrument 700 configured to operate a surgical tool described in this document, in accordance with an aspect of that disclosure. The robotic surgical instrument 700 can be programmed or configured to control the distal / proximal translation of a displacement member, the distal / proximal displacement of a closing tube, the rotation of the drive shaft, and articulation, either with a single type or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to individually control a firing member, a closing member, a driving shaft member and / or one or more hinge members. The surgical instrument 700 comprises a control circuit 710 configured to control motor-driven firing members, closing members, driving shaft members and / or one or more hinge members.
[0183] [0183] In one aspect, the robotic surgical instrument 700 comprises a control circuit 710 configured to control an anvil 716 and a beam portion with I-profile 714 (including a sharp cutting edge) of an end actuator 702, a cartridge of removable clamps 718, a drive shaft 740 and one or more hinge members 742a, 742b through a plurality of motors 704a to 704e. A position sensor 734 can be configured to provide feedback on the I-profile beam 714 to control circuit 710. Other sensors 738 can be configured to provide feedback to control circuit 710. A timer / counter 731 provides timing information and control circuit 710. A power source 712 can be provided to operate motors 704a to 704e and a current sensor 736 provides motor current feedback to control circuit 710. Motors 704a to 704e can be operated individually by the control circuit 710 in an open loop or closed loop feedback control.
[0184] [0184] In one aspect, the control circuit 710 may comprise one or more microcontrollers, microprocessors or other processors suitable for executing instructions that cause the processor or processors to perform one or more tasks. In one aspect, a timer / counter 731 provides an output signal, such as elapsed time or a digital count, to control circuit 710 to correlate beam position with I-shaped profile 714, as determined by position sensor 734, with the timer / counter output 731 so that the control circuit 710 can determine the position of the I-profile beam 714 at a specific time (t) in relation to an initial position or time (t) when the profile-beam I 714 is in a specific position in relation to an initial position. Timer / counter 731 can be configured to measure elapsed time, count external events or measure timeless events.
[0185] [0185] In one aspect, control circuit 710 can be programmed to control functions of end actuator 702 based on one or more tissue conditions. Control circuit 710 can be programmed to directly or indirectly detect tissue conditions, such as thickness, as described here. Control circuit 710 can be programmed to select a trigger control program or closing control program based on tissue conditions. A trigger control program can describe the distal movement of the displacement member. Different trigger control programs can be selected to better treat different tissue conditions. For example, when thicker tissue is present, control circuit 710 can be programmed to translate the displacement member at a lower speed and / or with a lower power. When a thinner tissue is present, the control circuit 710 can be programmed to move the displacement member at a higher speed and / or with greater power. A closing control program can control the closing force applied to the tissue by the anvil 716. Other control programs control the rotation of the drive shaft 740 and the hinge members 742a, 742b.
[0186] [0186] In one aspect, the 710 motor control circuit can generate motor setpoint signals. Motor setpoint signals can be supplied to several motor controllers 708a through 708e. Motor controllers 708a to 708e can comprise one or more circuits configured to provide motor drive signals to motors 704a to 704e in order to drive motors 704a to 704e, as described here. In some instances, motors 704a to 704e may be brushed DC motors. For example, the speed of motors 704a to 704e can be proportional to the respective motor start signals. In some examples, motors 704a to 704e may be brushless DC electric motors, and the respective motor drive signals may comprise a PWM signal provided for one or more stator windings of motors 704a to 704e. In addition, in some instances, motor controllers 708a through 708e can be omitted and control circuit 710 can directly generate motor drive signals.
[0187] [0187] In one aspect, the control circuit 710 can initially operate each of the motors 704a to 704e in an open circuit configuration for a first open circuit portion of a travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open circuit portion of the stroke, control circuit 710 can select a trigger control program in a closed circuit configuration. The instrument response may include a translation of the distance of the displacement member during the open circuit portion, a time elapsed during the open circuit portion, the energy supplied to one of the motors 704a to 704e during the open circuit portion, a sum pulse widths of a motor start signal, etc. After the open circuit portion, control circuit 710 can implement the selected trigger control program for a second portion of the travel member travel. For example, during a portion of the closed loop course, control circuit 710 can modulate one of the motors 704a to 704e based on the translation of data describing a position of the closed displacement member to translate the displacement member to a constant speed.
[0188] [0188] In one aspect, motors 704a through 704e can receive power from a 712 power source. Power source 712 can be a DC power source powered by an alternating main power source, a battery, a super capacitor, or any other suitable power source. Motors 704a to 704e can be mechanically coupled to individual moving mechanical elements such as the I-profile beam 714, the anvil 716, the drive shaft 740, the joint 742a and the joint 742b, through the respective transmissions 706a to 706e. Transmissions 706a through 706e may include one or more gears or other connecting components for coupling motors 704a to 704e to moving mechanical elements. A position sensor 734 can detect a position of the beam with an I-profile 714. The position sensor 734 can be or can include any type of sensor that is capable of generating position data that indicate a position of the beam with an I-profile 714 In some examples, the position sensor 734 may include an encoder configured to supply a series of pulses to the control circuit 710 according to the beam with I-profile 714 translated distally and proximally. Control circuit 710 can track pulses to determine the position of the I-profile beam 714. Other suitable position sensors can be used, including, for example, a proximity sensor. Other types of position sensors can provide other signals that indicate the movement of the I-profiled beam 714. In addition, in some examples, the position sensor 734 may be omitted. When any of the motors 704a to 704e is a stepper motor, control circuit 710 can track the position of the I-profile beam 714 by aggregating the number and direction of the steps that the 704 motor has been instructed to perform. Position sensor 734 can be located on end actuator 702 or any other portion of the instrument. The outputs of each of the engines 704a to 704e include a torque sensor 744a to 744e to detect force and have an encoder to detect the rotation of the drive shaft.
[0189] [0189] In one aspect, control circuit 710 is configured to drive a firing member like the portion of the I-profile beam 714 of end actuator 702. Control circuit 710 provides a motor setpoint for a motor control 708a, which provides a drive signal to motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a which is coupled to the I-profile beam 714. The transmission 706a comprises moving mechanical elements, such as rotating elements, and a firing member to control the movement of the beam beam distally and proximally. in I 714 along a longitudinal geometric axis of end actuator 702. In one aspect, motor 704a can be coupled to the knife gear assembly, which includes a knife gear reduction assembly that includes a first drive gear and a second knife drive gear. A torque sensor 744a provides a trigger force feedback signal to control circuit 710. The trigger force signal represents the force required to fire or move the I-profile beam 714. A 734 position sensor can be configured to provide the position of the I-beam beam 714 along the firing stroke or the firing member position as a feedback signal to control circuit 710. End actuator 702 may include additional sensors 738 configured to provide signals feedback to control circuit 710. When ready for use, control circuit 710 can provide a trip signal to the 708a motor control. In response to the trigger signal, motor 704a can drive the trigger member distally along the longitudinal geometry axis of end actuator 702 from an initial proximal position of the stroke to an end distal position of the stroke relative to the initial position of course. As the firing member moves distally, an I-profile beam 714 with a cutting element positioned at a distal end advances distally to cut the fabric between the staple cartridge 718 and the anvil 716.
[0190] [0190] In one aspect, control circuit 710 is configured to drive a closing member, such as anvil portion 716 of end actuator 702. Control circuit 710 provides a motor setpoint to a motor control 708b, which provides a drive signal to motor 704b. The output shaft of the 704b motor is coupled to a 744b torque sensor. The torque sensor 744b is coupled to a transmission 706b which is coupled to the anvil 716. The transmission 706b comprises moving mechanical elements, such as rotating elements and a closing member, to control the movement of the anvil 716 between the open and closed positions. In one aspect, the 704b motor is coupled to a closing gear assembly, which includes a closing reduction gear assembly that is supported in gear engaged with the closing sprocket. The torque sensor 744b provides a closing force feedback signal for control circuit 710. The closing force feedback signal represents the closing force applied to the anvil 716. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal to control circuit 710. Additional sensors 738 on end actuator 702 can provide the feedback signal of closing force to control circuit 710. A pivoting anvil 716 is positioned opposite the cartridge of clamps 718. When ready for use, control circuit 710 can provide a closing signal to motor control 708b. In response to the closing signal, motor 704b advances a closing member to secure the fabric between the anvil 716 and the staple cartridge 718.
[0191] [0191] In one aspect, control circuit 710 is configured to rotate a drive shaft member, such as drive shaft 740, to rotate end actuator 702. Control circuit 710 provides a motor setpoint to a motor control 708c, which provides a drive signal to the motor 704c. The output shaft of the 704c motor is coupled to a 744c torque sensor. The torque sensor
[0192] [0192] In one aspect, control circuit 710 is configured to link end actuator 702. Control circuit 710 provides a motor setpoint to a 708d motor control, which provides a drive signal to motor 704d . The output shaft of the 704d motor is coupled to a 744d torque sensor. The torque sensor 744d is coupled to a transmission 706d which is coupled to a pivot member 742a. The 706d transmission comprises moving mechanical elements, such as pivoting elements, to control the articulation of the 702 ± 65 ° end actuator. In one aspect, the 704d motor is coupled to a pivot nut, which is rotatably seated on the proximal end portion of the distal column portion and is pivotally driven thereon by a pivot gear assembly. The torque sensor
[0193] [0193] In another aspect, the articulation function of the robotic surgical system 700 may comprise two articulation members, or connections, 742a, 742b. These hinge members 742a, 742b are driven by separate disks at the robot interface (the rack), which are driven by the two motors 708d, 708e. When the separate firing motor 704a is provided, each hinge link 742a, 742b can be antagonistically driven with respect to the other link to provide a resistive holding movement and a load to the head when it is not moving and to provide a movement of articulation when the head is articulated. The hinge members 742a, 742b attach to the head in a fixed radius when the head is rotated. Consequently, the mechanical advantage of the push and pull link changes when the head is rotated. This change in mechanical advantage can be more pronounced with other drive systems for the articulation connection.
[0194] [0194] In one aspect, the one or more motors 704a to 704e may comprise a brushed DC motor with a gearbox and mechanical connections to a firing member, closing member or articulation member. Another example includes electric motors 704a to 704e that operate the moving mechanical elements such as the displacement member, the articulation connections, the closing tube and the drive shaft. An external influence is an excessive and unpredictable influence on things like tissue, surrounding bodies, and friction in the physical system. This external influence can be called drag, which acts in opposition to one of the electric motors 704a to 704e. External influence, such as drag, can cause the functioning of the physical system to deviate from a desired operation of the physical system.
[0195] [0195] In one aspect, the position sensor 734 can be implemented as an absolute positioning system. In one aspect, the 734 position sensor can comprise an absolute rotary magnetic positioning system implemented as a single integrated circuit rotary magnetic position sensor, AS5055EQFT, available from Austria Microsystems, AG. The position sensor 734 can interface with the control circuit 710 to provide an absolute positioning system. The position can include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit by digit method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions which only require addition, subtraction, bit shift and lookup table operations.
[0196] [0196] In one aspect, the control circuit 710 can be in communication with one or more sensors 738. The sensors 738 can be positioned on the end actuator 702 and adapted to work with the robotic surgical instrument 700 to measure various derived parameters such as span distance in relation to time, compression of the tissue in relation to time, and deformation of the anvil in relation to time. The 738 sensors can comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor and / or any other sensor suitable for measuring one or more parameters of end actuator 702. Sensors 738 may include one or more sensors. Sensors 738 may be located on the staple cartridge platform 718 to determine the location of the tissue using segmented electrodes. The torque sensors 744a to 744e can be configured to detect force such as firing force, closing force, and / or articulation force, among others. Consequently, the control circuit 710 can detect (1) the closing load experienced by the distal closing tube and its position, (2) the trigger member in the rack and its position, (3) the portion of the ultrasonic blade 718 that presents tissue in it and (4) the load and position on both articulation rods.
[0197] [0197] In one aspect, the one or more sensors 738 may comprise a stress meter such as, for example, a microstrain meter, configured to measure the magnitude of the stress on the anvil 716 during a clamped condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. Sensors 738 can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. Sensors 738 can be configured to detect the impedance of a section of tissue located between the anvil 716 and the staple cartridge 718 which is indicative of the thickness and / or completeness of the fabric located between them.
[0198] [0198] In one aspect, the 738 sensors can be implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magneto-resistive devices (MR) giant magneto-resistive devices (GMR), magnetometers, among others. In other implementations, the 738 sensors can be implemented as solid state switches that operate under the influence of light, such as optical sensors, infrared sensors, ultraviolet sensors, among others. In addition, the switches can be solid state devices such as transistors (for example, FET, junction FET, MOSFET, bipolar, and the like). In other implementations, the 738 sensors can include driverless electric switches, ultrasonic switches, accelerometers and inertia sensors, among others.
[0199] [0199] In one aspect, sensors 738 can be configured to measure the forces exerted on the anvil 716 by the closing drive system. For example, one or more sensors 738 may be at a point of interaction between the closing tube and the anvil 716 to detect the closing forces applied by the closing tube on the anvil 716. The forces exerted on the anvil 716 may be representative of the tissue compression experienced by the tissue section captured between the anvil 716 and the staple cartridge 718. The one or more sensors 738 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied to the anvil 716 by the closing drive system. The one or more sensors 738 can be sampled in real time during a gripping operation by the processor of the control circuit 710. The control circuit 710 receives sample measurements in real time to provide and analyze information based on time and evaluate, in real time the closing forces applied to the anvil 716.
[0200] [0200] In one aspect, a current sensor 736 can be used to measure the current drawn by each of the 704a to 704e motors. The force required to advance any of the moving mechanical elements, such as the I-profile beam 714, corresponds to the current drained by one of the motors 704a to 704e. The force is converted into a digital signal and supplied to control circuit 710. Control circuit 710 can be configured to simulate the response of the instrument's actual system in the controller software. A displacement member can be actuated to move an I-beam beam 714 on end actuator 702 at or near a target speed. The robotic surgical instrument 700 may include a feedback controller, which may be one or any of the feedback controllers, including, but not limited to, a PID controller, state feedback, linear quadratic (LQR) and / or an adaptive controller , for example. The robotic surgical instrument 700 can include a power source to convert the signal from the feedback controller to a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque and / or force, for example. Additional details are disclosed in US patent application Serial No. 15 / 636,829, entitled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, filed on June 29, 2017, which is hereby incorporated by reference in its entirety.
[0201] [0201] Figure 18 illustrates a block diagram of a surgical instrument 750 programmed to control the distal translation of a displacement member in accordance with an aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control the distal translation of a displacement member, such as the I-profile beam 764. The surgical instrument 750 comprises an end actuator 752 that can comprise an anvil 766, a beam with I-shaped profile 764 (including a sharp cutting edge) and a removable staple cartridge 768.
[0202] [0202] The position, movement, displacement and / or translation of a linear displacement member, such as the beam with I-764 profile, can be measured by an absolute positioning system, sensor arrangement and a position sensor 784. Since the I-beam beam 764 is coupled to a longitudinally movable drive member, the position of the I-beam beam 764 can be determined by measuring the position of the longitudinally mobile drive member employing the 784 position sensor Consequently, in the following description, the position, displacement and / or translation of the I-profile beam 764 can be obtained by the position sensor 784, as described in the present invention. A control circuit 760 can be programmed to control the translation of the displacement member, such as the I-profile beam 764. The control circuit 760, in some examples, may comprise one or more microcontrollers, microprocessors or other suitable processors the instructions that cause the processor or processors to control the displacement member, for example, the I 764 profile beam, as described. In one aspect, a timer / counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate beam position with I-shaped profile 764 as determined by position sensor 784 with output of timer / counter 781 so that control circuit 760 can determine the position of the I-profile beam 764 at a specific time (t) in relation to an initial position. The 781 timer / counter can be configured to measure elapsed time, count external events, or measure timeless events.
[0203] [0203] Control circuit 760 can generate a 772 motor setpoint signal. The 772 motor setpoint signal can be supplied to a 758 motor controller. The 758 motor controller can comprise one or more circuits configured to provide a motor 774 drive signal to motor 754 to drive motor 754, as described in the present invention. In some instances, the 754 motor may be a DC motor with a brushed DC electric motor. For example, the speed of motor 754 can be proportional to the drive signal of motor 774. In some instances, motor 754 can be a brushless DC electric motor and the motor drive signal 774 can comprise a PWM signal provided for a or more motor stator windings 754. In addition, in some examples, motor controller 758 may be omitted, and control circuit 760 can generate motor drive signal 774 directly.
[0204] [0204] The 754 motor can receive power from a power source
[0205] [0205] The control circuit 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end actuator 752 and adapted to work with the surgical instrument 750 to measure the various derived parameters, such as span distance in relation to time, compression of the tissue in relation to time and tension of the anvil in relation to time. The 788 sensors can comprise a magnetic sensor, a magnetic field sensor, a stress meter, a pressure sensor, a force sensor, an inductive sensor such as a eddy current sensor, a resistive sensor, a capacitive sensor, a sensor optical and / or any other sensors suitable for measuring one or more parameters of the 752 end actuator. The 788 sensors may include one or more sensors.
[0206] [0206] The one or more sensors 788 may comprise an effort meter, such as a microstrain meter, configured to measure the magnitude of the stress on the anvil 766 during a grip condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. The 788 sensors can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The 788 sensors can be configured to detect the impedance of a section of tissue located between the anvil 766 and the staple cartridge 768 which is indicative of the thickness and / or completeness of the fabric located between them.
[0207] [0207] The 788 sensors can be configured to measure the forces exerted on the anvil 766 by a closing drive system. For example, one or more sensors 788 can be at a point of interaction between a closing tube and anvil 766 to detect the closing forces applied by a closing tube to anvil 766. The forces exerted on anvil 766 can be representative of the tissue compression experienced by the tissue section captured between the anvil 766 and the staple cartridge 768. The one or more sensors 788 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied anvil 766 by the closing drive system. The one or more 788 sensors can be sampled in real time during a gripping operation by a processor of the control circuit 760. The control circuit 760 receives sample measurements in real time to provide and analyze information based on time and evaluate, in real time, the closing forces applied to the anvil 766.
[0208] [0208] A current sensor 786 can be used to measure the current drained by the 754 motor. The force required to advance the beam with I-shaped profile 764 corresponds to the current drained by the motor
[0209] [0209] The control circuit 760 can be configured to simulate the actual system response of the instrument in the controller software. A displacement member can be actuated to move a beam with I-profile 764 on end actuator 752 at or near a target speed. The surgical instrument 750 may include a feedback controller, which can be one or any of the feedback controllers, including, but not limited to, a PID controller, state feedback, LQR, and / or an adaptive controller, for example. The surgical instrument 750 can include a power source to convert the signal from the feedback controller to a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque and / or force, for example.
[0210] [0210] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member or beam with I-764 profile, by a brushed DC motor with gearbox and mechanical connections to a control system. articulation and / or cutting. Another example is the 754 electric motor that operates the displacement member and the articulation drive, for example, from an interchangeable drive shaft assembly. An external influence is an excessive and unpredictable influence on things like tissue, surrounding bodies, and friction in the physical system. This external influence can be called drag, which acts in opposition to the 754 electric motor. External influence, like drag, can cause the functioning of the physical system to deviate from a desired operation of the physical system.
[0211] [0211] Several exemplifying aspects are directed to a 750 surgical instrument that comprises a 752 end actuator with motor-driven surgical stapling and cutting implements. For example, a motor 754 can drive a displacement member distally and proximally along a longitudinal geometric axis of end actuator 752. End actuator 752 can comprise an articulating anvil 766 and, when configured for use, a staple cartridge 768 positioned on the opposite side of anvil 766. A doctor can hold the tissue between the anvil 766 and the staple cartridge 768, as described here. When ready to use the 750 instrument, the physician can provide a trigger signal, for example, by pressing a trigger on the instrument
[0212] [0212] In several examples, the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of the displacement member, such as the I-profile beam 764, for example, based on one or more tissue conditions . The control circuit 760 can be programmed to directly or indirectly detect tissue conditions, such as thickness, as described here. Control circuit 760 can be programmed to select a control program based on tissue conditions. A trigger control program can describe the distal movement of the displacement member. Different trigger control programs can be selected to better treat different tissue conditions. For example, when a thicker tissue is present, control circuit 760 can be programmed to translate the displacement member at a lower speed and / or with a lower power. When a thinner tissue is present, the control circuit 760 can be programmed to move the displacement member at a higher speed and / or with greater power.
[0213] [0213] In some examples, control circuit 760 may initially operate motor 754 in an open circuit configuration for a first open circuit portion of a travel member travel. Based on an instrument response 750 during the open circuit portion of the course, control circuit 760 can select a trip control program. The response of the instrument may include a travel distance of the displacement member during the open circuit portion, a time elapsed during the open circuit portion, the power supplied to the motor 754 during the open circuit portion, a sum of pulse widths a motor start signal, etc. After the open circuit portion, control circuit 760 can implement the selected trigger control program for a second portion of the travel member travel. For example, during the closed loop portion of the stroke, control circuit 760 can modulate motor 754 based on translation data that describes a position of the displacement member in a closed circuit manner to translate the displacement member into a constant speed. Additional details are disclosed in US patent application Serial No. 15 / 720,852, entitled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT, filed on September 29, 2017, which is hereby incorporated by reference in its entirety.
[0214] [0214] Figure 19 is a schematic diagram of a 790 surgical instrument configured to control various functions in accordance with an aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as the I-profile beam 764. The surgical instrument 790 comprises an end actuator 792 that can comprise an anvil 766, a beam with I-profile 764 and a removable staple cartridge 768 that can be interchanged with an RF cartridge 796 (shown in dashed line).
[0215] [0215] In one aspect, the 788 sensors can be implemented as a limit switch, electromechanical device, solid state switches, Hall effect devices, MRI devices, GMR devices, magnetometers, among others. In other implementations, 638 sensors can be solid state switches that operate under the influence of light, such as optical sensors, infrared sensors, ultraviolet sensors, among others. In addition, the switches can be solid state devices such as transistors (for example, FET, junction FET, MOSFET, bipolar, and the like). In other implementations, 788 sensors can include driverless electric switches, ultrasonic switches, accelerometers, inertia sensors, and more.
[0216] [0216] In one aspect, the position sensor 784 can be implemented as an absolute positioning system, which comprises a rotating magnetic absolute positioning system implemented as a single integrated circuit rotary magnetic position sensor, AS5055EQFT, available from Austria Microsystems, AG. The position sensor 784 can interface with the control circuit 760 to provide an absolute positioning system. The position can include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit by digit method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions which only require addition, subtraction, bit shift and lookup table operations.
[0217] [0217] In one aspect, the I 764 profile beam can be implemented as the knife member comprising a knife body that operationally supports a fabric cutting blade on it and can additionally include anvil hitches or hinge features and channel hitch features or a base. In one aspect, the staple cartridge 768 can be implemented as a standard (mechanical) surgical clamp cartridge. In one aspect, the RF cartridge 796 can be implemented as an RF cartridge. These and other sensor provisions are described in US Common Ownership Patent Serial No. 15 / 628,175, entitled
[0218] [0218] The position, movement, displacement and / or translation of a linear displacement member, such as the beam with I 764 profile, can be measured by an absolute positioning system, sensor arrangement and represented position sensor as the position sensor 784. Since the I-beam beam 764 is coupled to a longitudinally movable drive member, the position of the I-beam beam 764 can be determined by measuring the position of the longitudinally mobile drive member it employs the position sensor 784. Consequently, in the following description, the position, displacement and / or translation of the I-profile beam 764 can be obtained by the position sensor 784, as described in the present invention. A control circuit 760 can be programmed to control the translation of the displacement member, such as the I-profile beam 764, as described here. The control circuit 760, in some examples, may comprise one or more microcontrollers, microprocessors or other suitable processors to execute the instructions that cause the processor or processors to control the displacement member, for example, the I-shaped beam 764 , as described. In one aspect, a timer / counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate beam position with I-shaped profile 764 as determined by position sensor 784 with output of timer / counter 781 so that control circuit 760 can determine the position of the I-profile beam 764 at a specific time (t) in relation to an initial position. The 781 timer / counter can be configured to measure elapsed time, count external events, or measure timeless events.
[0219] [0219] Control circuit 760 can generate a motor setpoint signal 772. Motor setpoint signal 772 can be supplied to a motor controller 758. Motor controller 758 can comprise one or more circuits configured to provide a motor 774 drive signal to motor 754 to drive motor 754, as described in the present invention. In some instances, the 754 motor may be a DC motor with a brushed DC electric motor. For example, the speed of motor 754 can be proportional to the drive signal of motor 774. In some instances, motor 754 can be a brushless DC electric motor and the motor drive signal 774 can comprise a PWM signal provided for a or more motor stator windings 754. In addition, in some examples, motor controller 758 may be omitted, and control circuit 760 can generate motor drive signal 774 directly.
[0220] [0220] The 754 motor can receive power from a power source
[0221] [0221] The control circuit 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end actuator 792 and adapted to work with the surgical instrument 790 to measure the various derived parameters, such as span distance in relation to time, compression of the tissue in relation to time and tension of the anvil in relation to time. The 788 sensors can comprise a magnetic sensor, a magnetic field sensor, a stress meter, a pressure sensor, a force sensor, an inductive sensor such as a eddy current sensor, a resistive sensor, a capacitive sensor, a sensor optical and / or any other sensors suitable for measuring one or more parameters of the end actuator 792. The 788 sensors may include one or more sensors.
[0222] [0222] The one or more sensors 788 may comprise an effort meter, such as a microstrain meter, configured to measure the magnitude of the strain on the anvil 766 during a grip condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. The 788 sensors can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The 788 sensors can be configured to detect the impedance of a section of tissue located between the anvil 766 and the staple cartridge 768 which is indicative of the thickness and / or completeness of the fabric located between them.
[0223] [0223] The 788 sensors can be configured to measure the forces exerted on the anvil 766 by the closing drive system. For example, one or more sensors 788 can be at a point of interaction between a closing tube and anvil 766 to detect the closing forces applied by a closing tube to anvil 766. The forces exerted on anvil 766 can be representative of the tissue compression experienced by the tissue section captured between the anvil 766 and the staple cartridge 768. The one or more sensors 788 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied anvil 766 by the closing drive system. The one or more 788 sensors can be sampled in real time during a gripping operation by a processor of the control circuit 760. The control circuit 760 receives sample measurements in real time to provide and analyze information based on time and evaluate, in real time, the closing forces applied to the anvil 766.
[0224] [0224] A current sensor 786 can be used to measure the current drained by the 754 motor. The force required to advance the beam with I-shaped profile 764 corresponds to the current drained by the motor
[0225] [0225] An RF power source 794 is coupled to the end actuator 792 and is applied to the RF 796 cartridge when the RF 796 cartridge is loaded on the end actuator 792 in place of the staple cartridge 768. The control circuit 760 controls the supply of RF energy to the 796 RF cartridge.
[0226] [0226] Additional details are disclosed in US patent application Serial No. 15 / 636,096, entitled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed on June 28, 2017, which is hereby incorporated as a reference in its entirety. Generator hardware
[0227] [0227] Figure 20 is a block diagram of a generator 800 configured to provide adjustment without inductor, among other benefits. Additional details of generator 800 are described in US patent no.
[0228] [0228] In certain forms, ultrasonic and electrosurgical trigger signals can be delivered simultaneously to separate surgical instruments and / or to a single surgical instrument, such as a multifunctional surgical instrument, with the ability to supply both ultrasonic and electrosurgical energy to the tissue. It will be noted that the electrosurgical signal provided by both the dedicated electrosurgical instrument and the multifunctional electrosurgical / ultrasonic combined instrument can be both a therapeutic and subtherapeutic signal, where the subtherapeutic signal can be used, for example, to monitor tissue or condition of the instruments and provide feedback to the generator. For example, RF and ultrasonic signals can be provided separately or simultaneously from a generator with a single output port in order to provide the desired output signal to the surgical instrument, as will be discussed in more detail below. Consequently, the generator can combine the RF and ultrasonic electrosurgical energies and supply the combined energies to the multifunctional electrosurgical / ultrasonic instrument. Bipolar electrodes can be placed on one or both claws of the end actuator. A claw can be triggered by ultrasonic energy in addition to RF electrosurgical energy, working simultaneously. Ultrasonic energy can be used to perform tissue dissection while RF electrosurgical energy can be used to cauterize vessels.
[0229] [0229] The non-isolated stage 804 may comprise a power amplifier 812 having an output connected to a primary winding 814 of the power transformer 806. In certain forms, the power amplifier 812 may comprise a push-pull amplifier. For example, the non-isolated stage 804 may additionally comprise a logic device 816 for providing a digital output to a digital-to-analog converter (DAC) circuit 818 which, in turn, provides an analog signal corresponding to an input from the power amplifier 812. In certain ways, the logic device 816 may comprise a programmable gate array ("PGA"), a field programmable gate array ("FPGA" - field-programmable gate array), a programmable logic device ("PLD" - programmable logic device), among other logic circuits, for example. The logic device 816, by controlling the input of the power amplifier 812 through the DAC circuit 818, can therefore control any of several parameters (for example frequency, waveform, amplitude of the waveform) of drive signals appearing at the trigger signal outputs 810a, 810b and 810c. In certain ways and as discussed below, logic device 816, in conjunction with a processor (for example, a PSD discussed below), can implement various control algorithms based on digital signal processing (PSD) and / or others to control the drive signal output parameters provided by generator 800.
[0230] [0230] Power can be supplied to a power rail of the power amplifier 812 by a key mode regulator 820, such as a power converter. In certain forms, the key mode regulator 820 may comprise an adjustable antagonistic regulator, for example. The non-isolated stage 804 may further comprise a first processor 822 which, in one form, may comprise a PSD processor such as an ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, MA, USA,
[0231] [0231] In certain forms, the logic device 816, in conjunction with the PSD 822 processor, can implement a digital synthesis circuit as a control scheme with direct digital synthesizer to control the waveform, frequency and / or amplitude of the trigger signals emitted by the generator 800. In one way, for example, the logic device 816 can implement a DDS control algorithm by retrieving waveform samples stored in a lookup table (LUT, "look- up table ") dynamically updated, like a RAM LUT that can be integrated into an FPGA. This control algorithm is particularly useful for ultrasonic applications in which an ultrasonic transducer, such as an ultrasonic transducer, can be driven by a clean sinusoidal current at its resonant frequency. Since other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the branching current can correspondingly minimize or reduce the undesirable effects of the resonance. As the waveform of a drive signal output by generator 800 is affected by several sources of distortion present in the output drive circuit (for example, power transformer 806, power amplifier 812), feedback data from voltage and current based on the trigger signal can be provided to an algorithm, such as an error control algorithm implemented by the PSD 822 processor, which compensates for the distortion by adequate pre-distortion or modification of the waveform samples stored in the LUT dynamically and continuously (for example, in real time). In one way, the amount or degree of pre-distortion applied to the LUT samples can be based on the error between a current from the computerized motion branch and a desired current waveform, the error being determined on a basis of sample by sample. In this way, pre-distorted LUT samples, when processed through the drive circuit, can result in a drive signal from the motion branch that has the desired waveform (for example, sinusoidal) to optimally drive the transducer ultrasonic. In such forms, the LUT waveform samples will therefore not represent the desired waveform of the trigger signal, but rather the waveform that is needed to ultimately produce the desired waveform of the trigger signal of the movement branch, when the distortion effects are taken into account.
[0232] [0232] The non-isolated stage 804 may additionally comprise a first ADC 826 circuit and a second circuit
[0233] [0233] In certain forms, voltage and current feedback data can be used to control the frequency and / or amplitude (for example, current amplitude) of the drive signals. In one way, for example, feedback data about voltage and current can be used to determine the impedance phase. The frequency of the trigger signal can then be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (eg 0 °), thereby minimizing or reducing the effects of harmonic distortion. and, correspondingly, accentuating the accuracy of the impedance phase measurement. The determination of phase impedance and a frequency control signal can be implemented in the PSD 822 processor, for example, with the frequency control signal being supplied as input to a DDS control algorithm implemented by the programmable logic device 816.
[0234] [0234] In another form, for example, the current feedback data can be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude set point can be specified directly or indirectly determined based on the specified set points for voltage and power amplitude. In certain ways, the control of the current amplitude can be implemented by the control algorithm, such as, for example, a proportional-integral-derivative control algorithm (PID), in the DSP 822 processor. The variables controlled by the control algorithm to control suitably the current amplitude of the drive signal may include, for example, the scaling of the LUT waveform samples stored in logic device 816 and / or the full-scale output voltage of the DAC 818 circuit (which provides the input to the power amplifier 812) via a DAC 834 circuit.
[0235] [0235] The non-isolated stage 804 may additionally comprise a second processor 836 to provide, among other things, user interface (UI) functionality. In one form, the UI 836 processor can comprise an Atmel AT91SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation, of San Jose, CA, USA, for example. Examples of UI functionality supported by the UI 836 processor may include audible and visual feedback from the user, communication with peripheral devices (eg via a USB interface), communication with the foot switch, communication with a data entry device (for example, a touchscreen) and communication with an output device (for example, a speaker). The UI processor 836 can communicate with the DSP processor 822 and logic device 816 (for example, via SPI buses). Although the UI 836 processor can primarily support UI functionality, it can also coordinate with the PSD 822 processor to implement risk mitigation in certain ways. For example, the 836 processor can be programmed to monitor various aspects of user inputs and / or other inputs (for example, touchscreen inputs, foot switch inputs, temperature sensor inputs) and can disable the output generator 800 when an error condition is detected.
[0236] [0236] In certain ways, both the PSD 822 processor and the UI 836 processor can, for example, determine and monitor the operational state of generator 800. For the PSD 822 processor, the operational state of generator 800 can determine, for example, which control and / or diagnostic processes are implemented by the PSD 822 processor. For the UI 836 processor, the operational state of generator 800 can determine, for example, which elements of the UI (e.g., display screens, sounds) are presented to a user. The respective UI and PSD processors 822 and 836 can independently maintain the current operational state of generator 800, as well as recognize and evaluate possible transitions out of the current operational state. The PSD 822 processor can act as the master in this relationship and can determine when transitions between operational states should occur. The UI 836 processor can be aware of valid transitions between operational states and can confirm that a specific transition is appropriate. For example, when the PSD 822 processor instructs the UI 836 processor to transition to a specific state, the UI 836 processor can verify that the requested transition is valid. If a requested transition between states is determined to be invalid by the UI 836 processor, the UI 836 processor can cause generator 800 to enter a fault mode.
[0237] [0237] The non-isolated platform 804 may also contain an 838 controller for monitoring input devices (for example, a capacitive touch sensor used to turn generator 800 on and off, a capacitive touch screen). In certain forms, controller 838 may comprise at least one processor and / or other controller device in communication with the UI processor
[0238] [0238] In certain forms, when generator 800 is in an "off" state, controller 838 can continue to receive operational power (for example, through a line from a generator 800 power supply, such as the power supply 854 discussed below). In this way, controller 838 can continue to monitor an input device (for example, a capacitive touch sensor located on a front panel of generator 800) to turn generator 800 on and off. When generator 800 is in the off state, the controller 838 can activate the power supply (for example, enable one or more DC / DC voltage converters 856 of the power supply 854 to operate), if the activation of the "on / off" input device is detected by a user . Controller 838 can therefore initiate a sequence to transition the generator 800 to an "on" state. On the other hand, controller 838 can initiate a sequence to transition the generator 800 to the off state if activation of the "on / off" input device is detected, when the generator 800 is in the on state. In certain ways, for example, controller 838 may report activation of the "on / off" input device to processor 836 which, in turn, implements the necessary process sequence to transition generator 800 to the off state. In such forms, controller 838 may not have any independent capacity to cause the removal of power from generator 800 after its on state has been established.
[0239] [0239] In certain ways, controller 838 can cause generator 800 to provide audible feedback or other sensory feedback to alert the user that an on or off sequence has been initiated. This type of alert can be provided at the beginning of an on or off sequence, and before the start of other processes associated with the sequence.
[0240] [0240] In certain forms, the isolated stage 802 may comprise an instrument interface circuit 840 to, for example, provide a communication interface between a control circuit of a surgical instrument (for example, a control circuit comprising switches handle) and non-isolated stage 804 components, such as logic device 816, DSP processor 822 and / or UI processor 836. Instrument interface circuit 840 can exchange information with non-isolated stage 804 components via a communication link that maintains an adequate degree of electrical isolation between the isolated and non-isolated stages 802 and 804, for example, an infrared (IR) based communication link. Power can be supplied to the instrument interface circuit 840 using, for example, a low-drop voltage regulator powered by an isolation transformer driven from the non-isolated stage 804.
[0241] [0241] In one form, the instrument interface circuit 840 may comprise a logic circuit 842 (for example, a logic circuit, a programmable logic circuit, PGA, FPGA, PLD) in communication with a signal conditioning circuit 844. The signal conditioning circuit 844 can be configured to receive a periodic signal from logic circuit 842 (e.g., a 2 kHz square wave) to generate a bipolar interrogation signal that has an identical frequency. The question mark can be generated, for example, using a bipolar current source powered by a differential amplifier. The question mark can be communicated to a surgical instrument control circuit (for example, using a conductive pair on a cable that connects the generator 800 to the surgical instrument) and monitored to determine a state or configuration of the control circuit . The control circuit can comprise numerous switches, resistors and / or diodes to modify one or more characteristics (for example, amplitude, rectification) of the question mark so that a state or configuration of the control circuit is unambiguously discernible, based on that one or more characteristics. In one form, for example, the signal conditioning circuit 844 may comprise an ADC circuit for generating samples of a voltage signal appearing between inputs of the control circuit, resulting from the passage of the interrogation signal through it. The logic instrument 842 (or a non-isolated stage component 804) can then determine the status or configuration of the control circuit based on the samples of ADC circuits.
[0242] [0242] In one form, the instrument interface circuit 840 may comprise a first data circuit interface 846 to enable the exchange of information between logic circuit 842 (or another element of the instrument interface circuit 840) and a first data circuit disposed in a surgical instrument or otherwise associated with it. In certain forms, for example, a first data circuit may be arranged on a cable integrally attached to a handle of the surgical instrument or on an adapter to interface between a specific type or model of surgical instrument and the generator 800. The first data circuit can be implemented in any suitable way and can communicate with the generator according to any suitable protocol, including, for example, as described here with respect to the first data circuit. In certain forms, the first data circuit may comprise a non-volatile storage device, such as an EEPROM device. In certain ways, the first data circuit interface 846 can be implemented separately from logic circuit 842 and comprises a suitable circuitry (for example, separate logic devices, a processor) to allow communication between logic circuit 842 and the first data circuit. In other forms, the first data circuit interface 846 can be integral with logic circuit 842.
[0243] [0243] In certain forms, the first data circuit can store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other types of information. This information can be read by the instrument interface circuit 840 (for example, logic circuit 842), transferred to a component of the non-isolated stage 804 (for example, to logic device 816, PSD processor 822 and / or processor UI 836) for presentation to a user by means of an output device and / or to control a function or operation of the generator 800. Additionally, any type of information can be communicated to the first data circuit for storage in the same via the first interface of data circuit 846 (for example, using logic circuit 842). This information may include, for example, an updated number of operations in which the surgical instrument was used and / or the dates and / or times of its use.
[0244] [0244] As discussed earlier, a surgical instrument can be removed from a handle (for example, the multifunctional surgical instrument can be removed from the handle) to promote interchangeability and / or disposability of the instrument. In such cases, conventional generators may be limited in their ability to recognize specific instrument configurations being used, as well as to optimize the control and diagnostic processes as needed. The addition of readable data circuits to surgical instruments to address this issue is problematic from a compatibility point of view, however. For example, designing a surgical instrument so that it remains backward compatible with generators that lack the indispensable data reading functionality may be impractical due, for example, to different signaling schemes, design complexity and cost. The forms of instruments discussed here address these concerns through the use of data circuits that can be implemented in existing surgical instruments, economically and with minimal design changes to preserve the compatibility of surgical instruments with current generator platforms.
[0245] [0245] Additionally, the shapes of the generator 800 can allow communication with instrument-based data circuits. For example, generator 800 can be configured to communicate with a second data circuit contained in an instrument (for example, a multifunctional surgical instrument). In some ways, the second data circuit can be implemented in a manner similar to that of the first data circuit described here. The instrument interface circuit 840 may comprise a second data circuit interface 848 to enable such communication. In one form, the second data circuit interface 848 can comprise a three-state digital interface, although other interfaces can also be used. In certain ways, the second data circuit can generally be any circuit for transmitting and / or receiving data. In one form, for example, the second data circuit can store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other types of information.
[0246] [0246] In some ways, the second data circuit can store information about the ultrasonic and / or electronic properties of an associated ultrasonic transducer, end actuator or ultrasonic drive system. For example, the first data circuit can indicate an initialization frequency slope, as described here. In addition or alternatively, any type of information can be communicated to the second data circuit for storage in it via the second data circuit interface 848 (for example, using logic circuit 842). This information may include, for example, an updated number of operations in which the surgical instrument was used and / or the dates and / or times of its use. In certain ways, the second data circuit can transmit data captured by one or more sensors (for example, an instrument-based temperature sensor). In certain ways, the second data circuit can receive data from generator 800 and provide an indication to a user (for example, a light-emitting indication or other visible indication) based on the received data.
[0247] [0247] In certain ways, the second data circuit and the second data circuit interface 848 can be configured so that communication between logic circuit 842 and the second data circuit can be carried out without the need to provide additional conductors for this purpose (for example, dedicated cable conductors connecting a handle to the 800 generator). In one way, for example, information can be communicated to and from the second data circuit using a wire bus communication scheme, implemented in the existing wiring, as one of the conductors used transmitting interrogation signals from from signal conditioning circuit 844 to a control circuit on a handle. In this way, changes or modifications to the design of the surgical device that may otherwise be necessary are minimized or reduced. In addition, due to the fact that different types of communications implemented on a common physical channel can be separated based on frequency, the presence of a second data circuit can be "invisible" to generators that do not have the essential functionality of reading data, which, therefore, allows the backward compatibility of the surgical instrument.
[0248] [0248] In certain forms, the isolated stage 802 may comprise at least one blocking capacitor 850-1 connected to the output of the drive signal 810b to prevent the passage of direct current (DC) to a patient. A single blocking capacitor may be required to comply with medical regulations and standards, for example. Although failures in single-capacitor designs are relatively uncommon, such failures can still have negative consequences. In one form, a second blocking capacitor 850-2 can be placed in series with the blocking capacitor 850-1, with current dispersion of one point between the blocking capacitors 850-1 and 850-2 being monitored, for example , by an ADC 852 circuit for sampling a voltage induced by leakage current. Samples can be received, for example, via logic circuit 842. Changes based on the leakage current (as indicated by the voltage samples), generator 800 can determine when at least one of the blocking capacitors 850-1, 850- 2 has failed, thus offering a benefit over single capacitor designs that have a single point of failure.
[0249] [0249] In certain embodiments, the non-isolated stage 804 may comprise a power supply 854 to provide DC power with adequate voltage and current. The power supply may comprise, for example, a 400 W power supply to deliver a system voltage of 48 VDC. The power supply 854 can additionally comprise one or more DC / DC voltage converters 856 to receive the output from the power supply to generate DC outputs at the voltages and currents required by the various components of generator 800. As discussed above in relation to the controller 838, one or more of the 856 DC / DC voltage converters can receive an input from the 838 controller when the activation of the "on / off" input device by a user is detected by the 838 controller, to enable the operation or activation of the 856 DC / DC voltage converters.
[0250] [0250] Figure 21 illustrates an example of generator 900, which is a form of generator 800 (Figure 20). The 900 generator is configured to supply multiple types of energy to a surgical instrument. The 900 generator provides ultrasonic and RF signals to power a surgical instrument, independently or simultaneously. Ultrasonic and RF signals can be provided alone or in combination and can be provided simultaneously. As indicated above, at least one generator output can provide multiple types of energy (for example, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be supplied separately or simultaneously to the end actuator to treat tissue. The generator 900 comprises a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory coupled to the processor 902 , not shown for the sake of clarity of disclosure. The digital information associated with a waveform is provided to the waveform generator 904 that includes one or more DAC circuits to convert the digital input to an analog output. The analog output is powered by an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to a power transformer 908. The signals are coupled by the power transformer 908 to the secondary side, which is on the patient isolation side. A first signal of a first energy modality is supplied to the surgical instrument between the terminals identified as ENERGY1 and RETURN. A second signal of a second energy modality is coupled by a 910 capacitor and is supplied to the surgical instrument between the terminals identified as ENERGY2 and RETURN. It will be recognized that more than two types of energy can be issued and, therefore, the subscript "n" can be used to designate that up to n ENERGY terminals can be provided, where n is a positive integer greater than 1. acknowledged that up to "n" return paths, RETURN can be provided without departing from the scope of this disclosure.
[0251] [0251] A first 912 voltage detection circuit is coupled through the terminals identified as ENERGY1 and the RETURN path to measure the output voltage between them. A second voltage detection circuit 924 is coupled through the terminals identified as ENERGY2 and the RETURN path to measure the output voltage between them. A current detection circuit 914 is arranged in series with the RETURN leg on the secondary side of the power transformer 908, as shown to measure the output current for any type of energy. If different return paths are provided for each energy modality, then a separate current detection circuit would be provided on each return leg. The outputs of the first and second voltage detection circuits 912, 924 are supplied to the respective isolation transformers 916, 922 and the output of the current detection circuit 914 is supplied to another isolation transformer 918. The outputs of the isolation transformers 916 , 928, 922 on the primary side of the power transformer 908 (non-isolated side of the patient) are supplied to one or more ADC 926 circuits. The digitized output from the ADC 926 circuit is provided to processor 902 for further processing and computing. The output voltages and the output current feedback information can be used to adjust the output voltage and the current supplied to the surgical instrument, and to compute the output impedance, among other parameters. Input / output communications between the 902 processor and the patient's isolated circuits are provided via a 920 interface circuit. The sensors may also be in electrical communication with the 902 processor via the 920 interface circuit.
[0252] [0252] In one aspect, impedance can be determined by processor 902 by dividing the output of the first voltage detection circuit 912 coupled over the terminals identified as ENERGY1 / RETURN or the second voltage detection circuit 924 coupled over the terminals identified as ENERGY2 / RETURN by the output of the current detection circuit 914 arranged in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first and second voltage detection circuits 912, 924 are provided to separate the isolation transformers 916, 922 and the current detection circuit 914 output is provided to another isolation transformer 916. The digitalized voltage and current detection measurements from the ADC 926 circuit are provided to processor 902 to compute the impedance. As an example, the first ENERGIA1 energy modality can be ultrasonic energy and the second ENERGIA2 energy modality can be RF energy. However, in addition to the ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. In addition, although the example shown in Figure 21 shows a single RETURN return path that can be provided for two or more energy modes, in other respects, multiple RETURN return paths can be provided for each ENERGY energy mode. Thus, as described here, the impedance of the ultrasonic transducer can be measured by dividing the output of the first voltage detection circuit 912 by the current detection circuit 914 and the tissue impedance can be measured by dividing the output of the second voltage detection circuit 924 by current detection circuit 914.
[0253] [0253] As shown in Figure 21, generator 900 comprising at least one output port may include a single-output, multiple-lead 908 power transformer to provide power in the form of one or more energy modalities, such as ultrasonic , Bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others, for example, to the end actuator depending on the type of tissue treatment being performed. For example, the 900 generator can supply higher voltage and lower current power to drive an ultrasonic transducer, lower voltage and higher current to drive RF electrodes to seal the tissue or with a coagulation waveform for point clotting using electrosurgical electrodes Monopolar or bipolar RF. The output waveform of generator 900 can be oriented, switched or filtered to provide frequency to the end actuator of the surgical instrument. The connection of an ultrasonic transducer to the output of generator 900 would preferably be located between the output identified as ENERGY1 and RETURN, as shown in Figure 21. In one example, a connection of bipolar RF electrodes to the output of generator 900 would preferably be located between the output identified as ENERGY2 and the RETURN. In the case of a monopolar output, the preferred connections would be an active electrode (for example, light beam or other probe) for the ENERGIA2 output and a suitable return block connected to the RETURN output.
[0254] [0254] Additional details are disclosed in US Patent Application Publication No. 2017/0086914 entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING
[0255] [0255] As used throughout this description, the term "wireless" and its derivatives can be used to describe circuits, devices, systems, methods, techniques, communication channels etc., which can communicate data through the use of electromagnetic radiation modulated using a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some ways they may not. The communication module can implement any of a number of wireless and wired communication standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),
[0256] [0256] As used in the present invention, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually memory or some other data flow. The term is used in the present invention to refer to the central processor (central processing unit) in a computer system or systems (specifically systems on a chip (SoCs)) that combine several specialized "processors".
[0257] [0257] As used here, a system on a chip or system on the chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all components of a computer or other electronic systems . It can contain digital, analog, mixed and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), i-Fi module, or coprocessor. An SoC may or may not contain internal memory.
[0258] [0258] As used here, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; a SoC can include a microcontroller as one of its components. A microcontroller can contain one or more core processing units (CPUs) along with memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash or OTP ROM is also often included on the chip, as well as a small amount of RAM. Microcontrollers can be used for integrated applications, in contrast to microprocessors used in personal computers or other general purpose applications that consist of several separate integrated circuits.
[0259] [0259] As used in the present invention, the term controller or microcontroller may be an independent chip or IC (integrated circuit) device that interfaces with a peripheral device. This can be a connection between two parts of a computer or a controller on an external device that manages the operation of (and connection to) that device.
[0260] [0260] Any of the processors or microcontrollers in the present invention can be any implemented by any single-core or multi-core processor, such as those known under the trade name of ARM Cortex available from Texas Instruments. In one respect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz , a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with the StellarisWare® program, memory only programmable, electrically erasable (EEPROM) reading of 2 KB, one or more pulse width modulation (PWM) modules, one or more analogs of quadrature encoder (QEI) inputs, one or more analog to digital converters (ADC) 12-bit with 12 channels of analog input, details of which are available for the product data sheet.
[0261] [0261] In one aspect, the processor may comprise a safety controller that comprises two controller-based families, such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also available from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[0262] [0262] The modular devices include the modules (as described in connection with Figures 3 and 9, for example) that are receivable within a central surgical controller and the devices or surgical instruments that can be connected to the various modules in order to connect or pair with the corresponding central surgical controller. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, power generators, fans, insufflators and displays. The modular devices described here can be controlled by control algorithms. The control algorithms can be executed on the modular device itself, on the central surgical controller to which the specific modular device is paired, or on both the modular device and the central surgical controller (for example, surgical (for example, through a distributed computing.) In some examples, the control algorithms of the modular devices control the devices based on the data detected by the modular device itself (ie, by sensors on, over or connected to the modular device). These data can be related to the patient being operated (for example, tissue properties or inflation pressure) or the modular device itself (for example, the rate at which a knife is being advanced, the motor current, or energy levels). control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument's motor drives its knife until through the fabric according to the resistance encountered by the knife as it progresses. Long distance communication and manipulation of device and data condition
[0263] [0263] Surgical procedures are performed by different surgeons in different locations, some with much less experience than others. For a given surgical procedure, there are many parameters that can be varied to try to achieve a desired result. For example, for a given surgical procedure that uses energy supplied by a generator, the surgeon often relies on experience only to determine which mode of energy to use, what level of output power to use, the duration of energy application, etc., in order to try to get the desired result. To increase the likelihood of obtaining the desired results from a plurality of different surgical procedures, each surgeon should receive recommendations for good practice that are based on important relationships identified within large, accurate data sets of information associated with multiple surgical procedures performed at multiple locations over time. However, there are many ways in which such data sets can become compromised, inaccurate, and / or unsafe, thus questioning the applicability of the best practice recommendations derived from them. For example, for data sent from a source to a cloud-based system, data may be lost while in transit to the cloud-based system, data may be corrupted while in transit to the cloud-based system, the Data confidentiality can be understood while in transit to the cloud-based system and / or the content of the data can be changed while in transit to the cloud-based system.
[0264] [0264] Each of a plurality of operating rooms located in multiple locations can be equipped with a central surgical controller. When a particular surgical procedure is performed in a given operating room, the central surgical controller can receive data associated with the surgical procedure and communicate the data to a cloud-based system. Over time, the cloud-based system will receive large data sets of information associated with the surgeries. Data can be communicated from the central surgical controllers to the cloud-based system in a way that allows the cloud-based system (1) to verify the authenticity of the reported data, (2) authenticate each of the respective central surgical controllers that have communicated the data and (3) tracks the data paths followed from the respective central surgical controllers to the cloud-based system.
[0265] [0265] Consequently, in one aspect, the present disclosure provides a central surgical controller for transmitting generator data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of central surgical controllers. The central surgical controller comprises a processor and a memory attached to the processor. The memory stores instructions executable by the processor to receive data from a generator, encrypt the data, generate a message authentication code (MAC) based on the data, generate a datagram that comprises the encrypted data, the generated MAC, a source identifier and a destination identifier, and transmit the datagram to a cloud-based system. The data is structured in a data package comprising at least two of the following fields: a field indicating the source of the data, an exclusive timestamp, a field indicating a generator power mode, a field indicating the output generator power and a field indicating a duration of the generator power output. The datagram allows the cloud-based system to decrypt the encrypted data from the transmitted datagram, verify the data integrity based on the MAC, authenticate the central surgical controller as the source of the datagram, and validate a transmission path followed by the datagram between the surgical controller central and the cloud-based system.
[0266] [0266] In several respects, the present disclosure provides a control circuit to transmit the generator data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of central surgical controllers, as described above. In several respects, the present disclosure provides a non-transitory, computer-readable medium that stores computer-readable instructions that, when executed, cause a machine to transmit generator data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of central surgical controllers, as described above.
[0267] [0267] In another aspect, the present disclosure provides a cloud-based system communicatively coupled to a plurality of central surgical controllers. Each central surgical controller is configured to transmit data from the generator associated with a surgical procedure to the cloud-based system. The cloud-based system comprises a processor and memory attached to the processor. The memory stores instructions executable by the processor to receive a datagram generated by a central surgical controller of the surgical instrument, decrypt the encrypted generator data, verify the integrity of the generator data based on MAC data, authenticate the central surgical controller as the source of the datagram and validate a transmission path followed by the datagram the central surgical controllers and the cloud-based system. The generator comprises generator data captured from a generator associated with the central surgical controller, a MAC generator by the central surgical controller based on the generator data, a source identifier and a destination identifier. The data generator was encrypted by the central surgical controller. The encrypted generator data was structured in a data packet comprising at least two of the following fields: a field indicating the source of the data, an exclusive timestamp, a field indicating a power mode, a field indicating a power output and a field indicating an applied power duration.
[0268] [0268] In several respects, this disclosure provides a control circuit to transmit data from the generator associated with a surgical procedure to the cloud-based system. In many respects, the present disclosure provides a non-transitory, computer-readable medium that stores computer-readable instructions that, when executed, cause a machine to transmit generator data associated with a surgical procedure to the cloud-based system.
[0269] [0269] In another aspect, the present disclosure provides a method that comprises capturing data from a combined generator from a central surgical controller during a surgical procedure, the combined generator being configured to provide two or more different modes of energy. Encrypt the captured generator data, generate a MAC based on the captured generator data, generate a datagram comprising the encrypted generator data, the MAC, a source identifier and a destination identifier, and communicate the datagram from the surgical controller central to a cloud-based system. The datagram allows the cloud-based system to authenticate the integrity of the reported generator data, authenticate the central surgical controller as a source of the datagram, and determine a communication path followed by the datagram between the central surgical controller and the cloud-based surgical system.
[0270] [0270] By sending generator data captured from a plurality of different central surgical controllers to a cloud-based system, the cloud-based system is able to quickly build large data sets of information associated with multiple surgical procedures performed in multiple locations over time. In addition, due to the composition of the respective datagrams, for a given datagram, the cloud-based system is able to determine whether the datagram was originally sent by one of the central surgical controllers (origin validation), thus providing an indication that the data generator received in the cloud-based system are legitimate. For the given datagram, the cloud-based system is also able to determine whether the generator data received in the cloud-based system is identical to the generator data sent by the central surgical controller (data integrity), thus enabling data authenticity generator received is verified. Additionally, for the given datagram, the cloud-based system is also capable of re-tracking the communication path followed by the datagram, thus enabling improved problem resolution if a datagram received by the cloud-based system was originally sent from a device other than central surgical controllers and / or if the content of the datagram changes during transit to the cloud-based system. Notably, the present disclosure refers to the generator data, in particular. Here, the present disclosure should not be limited to being able to process only generator data. For example, the central surgical controller 206 and / or the cloud-based system 205 can process data received from any component (for example, imaging module 238, generator module 240, smoke evacuation module 226, suction module / irrigation 228, communication module 230, processor module 232, storage matrix 234, smart device / instrument 235, non-contact sensor module 242, robotic central surgical controller 222, non-robotic central surgical controller 206, smart device / wireless instrument 235, display system 208 of surgical system 202 which is coupled to the central surgical controller 206 and / or data from any device (eg endoscope 239, power device 241) coupled to / through such components (for example, see Figures 9 and 10), similarly, as discussed here.
[0271] [0271] Unfortunately, the result of a surgical procedure is not always ideal. For example, a failure event, such as a surgical device failure, unwanted tissue perforation, postoperative bleeding, or the like, can occur. The occurrence of a failure event can be attributed to any one of a variety of different people and devices, including one or more surgeons, one or more devices associated with the surgery, a patient's condition and combinations thereof. When a given failure occurs, it is not always clear who or what caused the failure event or how the occurrence of the failure event can be mitigated in connection with future surgery.
[0272] [0272] During a given surgical procedure, a large amount of data associated with the surgical procedure can be generated and captured. All captured data can be communicated to a central surgical controller, and captured data can be stamped with a date and time before or after being received at the central surgical controller. When a failure event associated with the surgical procedure is detected and / or identified, it is possible to determine which captured data is associated with the failure event and / or which captured data is not associated with the failure event. To make this determination, the failure event can be defined to include a period of time before the detection / identification of the failure event. Once the determination is made in relation to the captured data associated with the failure event, the central surgical controller can separate the captured data associated with the failure event from all other captured data, and the captured data can be separated based on marking , signage or similar. The captured data associated with the failure event can then be placed in chronological order based on the timestamp and the defined time period applicable to the failure event. The data captured in chronological order can then be communicated to a cloud-based system in a prioritized manner for analysis, where the prioritized mode is relative to the captured data that is not associated with the failure event. With the analysis identifying or not a device associated with the surgical procedure as the cause of the failure event, the central surgical controller can mark the device for removal of the device for future use, additional analysis of the device and / or return of the device to the manufacturer .
[0273] [0273] When a given surgical procedure is performed, a large amount of data associated with the surgical procedure can be generated and captured. All captured data can be communicated to a central surgical controller, where the information can be removed from all "personal" associations. Captured data can be timestamped before being received at the central surgical controller, after being received at the central surgical controller, before being stripped of "personal" associations or after being stripped of "personal" associations. The central surgical controller can communicate the deprived data to the cloud-based system for subsequent analysis. Over time, the cloud-based system will receive large data sets of information associated with the surgeries.
[0274] [0274] Consequently, in one aspect, the present disclosure provides a central surgical controller to prioritize surgical data associated with a surgical procedure for a cloud-based system communicatively coupled to a plurality of central surgical controllers. The central surgical controller comprises a processor and a memory attached to the processor. The memory stores instructions executable by the processor to capture surgical data, the surgical data comprising data associated with a surgical device, stamping the captured surgical data with date and time, identifying a failure event, identifying a time period associated with the surgical event. failure, isolate the surgical data from the failure event from the surgical data not associated with the failure event based on the period of time identified, place the surgical data from the failure event by timestamp in chronological order, encrypt the surgical data from the failure event in chronological order, generate a datagram comprising the surgical data of the failure event and transmit the datagram to a cloud-based system. The datagram is structured to include a field that includes an indicator that prioritizes the encrypted failure event surgical data over other encrypted data in the datagram. The datagram enables the cloud-based system to decrypt the encrypted failure event surgical data, concentrate the analysis on the surgical data of the failure event and not on the surgical data not associated with the failure event, and indicate the surgical device associated with the failure event. failure during at least one of them: removal of an operating room, return to a manufacturer or future inoperability in the cloud-based system.
[0275] [0275] In several respects, the present disclosure provides a control circuit to prioritize surgical data associated with a surgical procedure for a cloud-based system communicatively coupled to a plurality of central surgical controllers. In several respects, the present disclosure provides a non-transitory, computer-readable medium that stores computer-readable instructions that, when executed, cause a machine to prioritize surgical data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of central surgical controllers.
[0276] [0276] In another aspect, the present disclosure provides a method that comprises capturing data during a surgical procedure, communicating the captured data to a central surgical controller, stamping the date and time on the captured data, identifying a failure event associated with the procedure determine which captured data is associated with the failure event, separate the captured data associated with the failure event from all other captured data, place the captured data associated with the failure event in chronological order and report the captured data in chronological order to a cloud-based system in a prioritized way.
[0277] [0277] By capturing the large amount of data associated with the surgical procedure and with the data stamped with date and time, the portion of captured data that is relevant to the detected / identified failure event can be more easily isolated from all others captured data, thus enabling a more focused subsequent analysis on only the relevant captured data. The data associated with the failure event can then be placed in chronological order (this requires less processing power than placing all captured data in chronological order), thus allowing the events that lead to the detection / identification of the event failures are more easily considered during the subsequent analysis of the failure event. The data in chronological order can then be communicated to the cloud-based system (this requires less communication resources than communicating all the captured data at the same time) in a prioritized manner, thus allowing the subsequent focused analysis of the failure event by the cloud-based system in a more time-sensitive manner.
[0278] [0278] To help ensure that best practice recommendations are developed based on accurate data, it would be desirable to ensure that the generator data received in the cloud-based system is the same as the generator data communicated to the cloud-based system. In addition, to help determine the cause of a failure event as soon as possible, it would be desirable to ensure that surgical data associated with the failure event is communicated to the cloud-based system in a prioritized manner (in relation to surgical data not associated with the failure event) so that the analysis of surgical data can be carried out in an accelerated way.
[0279] [0279] Aspects of a system and method for communicating data associated with a surgical procedure are described in the present invention. As shown in Figure 9, various aspects of the computer-implemented interactive surgical system 200 include a device / instrument 235, a generator module 240, a modular control tower 236 and a cloud-based system 205. As shown in Figure 10, the device / instrument 235, generator module 240 and modular control tower 236 are components / portions of a central surgical controller 206.
[0280] [0280] In several respects, generator module 240 of central surgical controller 206 can deliver radio frequency energy, such as monopolar radio frequency energy, bipolar radio frequency energy, advanced bipolar energy and / or ultrasonic energy, to a device / instrument 235 for use in a surgical procedure. Thus, generator module 240 can be called a combined generator. An example of this type of combined generator is shown in Figure 22, where the combined generator 3700 generator is shown as including a monopolar module 3702, a bipolar module 3704, an advanced bipolar module 3706 and an ultrasound module 3708. When used during a surgical procedure, the respective power modules (for example, 3702, 3704, 3706 and / or 3708) of the combined generator 3700 can provide data from the generator, such as the type of energy supplied to the device instrument (for example, radio frequency energy, energy ultrasound, radio frequency energy and ultrasonic energy), type of radio frequency energy (eg monopolar, bipolar, advanced bipolar), frequency, power output, duration, etc., for the 3710 combined generator 3700 data communication module .
[0281] [0281] Figure 23 illustrates various aspects of a method of capturing data from a combined 3700 generator and communicating captured data to a 205 cloud-based system. Notably, as discussed in this document, the present disclosure should not be limited data processing of the generator. Thus, the method of Figure 23 extends, in a similar way, to other types of data received from other components coupled to the central surgical controller 206 (for example, data from imaging module data, smoke evacuator data, suction data / irrigation, device / instrument data). The method comprises (1) capturing 3712 data from a combined generator 3700 from a central surgical controller 206 during a surgical procedure, with the combined generator 3700 being configured to provide two or more different energy modes; (2) encrypt 3714 captured generator data; (3) generate 3716 a MAC based on the captured generator data; (4) generate a 3718 datagram comprising the encrypted generator data, the MAC, a source identifier and a destination identifier; (5) and communicate the datagram 3720 from the central surgical controller 206 to a cloud-based system 205, the datagram enabling the cloud-based system 205 (i) to authenticate the integrity of the reported generator data, (ii) authenticate the central surgical controller as a source of the datagram and (iii) determine a communication path followed by the datagram between the central surgical controller 206 and the cloud-based surgical system 205.
[0282] [0282] More specifically, since the data generator is received in the data communication module 3710 of the combined generator 3700, the generator data can be communicated to the modular communication center 203 of the central surgical controller 206 for subsequent communication to the system cloud-based 205. The data communication module 3710 can communicate data from the generator to the modular communication center 203 in series over a single communication line or in parallel over a plurality of communication lines, and such communication it can be done in real time or in near real time.
[0283] [0283] In addition, the 3710 data communication module can compress the generator data and / or encrypt the generator data before communicating the generator data to the modular communication center 203. The specific method of compression and / or encryption can be equal to or different from the compression and / or encryption that can be performed by the central surgical controller 206, as described in detail below.
[0284] [0284] The modular communication center 203 can receive the generator data communicated from the combined generator 3700 (for example, via the data communication module 3710), and the generator data can subsequently be communicated to the cloud-based system 205 (for example, via the internet). According to several aspects, the modular communication core 203 can receive the generator data via a central controller / key 207/209 of the modular communication core 203 (see Figure 10), and the generator data can be communicated to the cloud-based system 205 by a router 211 of the modular communication core 203 (see Figure 10). Generator data can be communicated in real time, close to real time or in batches to the cloud-based system 205 or can be stored in the central surgical controller 206 before being communicated to the cloud-based system 205. Generator data can be stored, for example, in storage matrix 234 or in memory 249 of computer system 210 of central surgical controller 206.
[0285] [0285] In several respects, for cases where the data received from the generator at the modular communication center 203 is not encrypted, before the data received from the generator is transmitted to the cloud-based system 205, the generator data is encrypted to help ensure the confidentiality of generator data, while it is being stored in the central surgical controller 206 or while it is being transmitted to the cloud 204 using the internet or other computer networks. According to several aspects, a component of the central surgical controller 206 uses an encryption algorithm to convert the generator data from a readable version to an encrypted version, thus forming encrypted generator data. The component of the central surgical controller 206 that uses / performs the encryption algorithm can be, for example, processor module 232, processor 244 of computer system 210 and / or combinations thereof. The encryption algorithm used / executed can be a symmetric encryption algorithm and / or an asymmetric encryption algorithm.
[0286] [0286] Using a symmetric encryption algorithm, the central surgical controller 206 would encrypt the generator data using a shared secret (for example, private key, passphrase, password). In this respect, a recipient of the encrypted generator data (for example, cloud-based system 205) would then decrypt the generator data encrypted using the same shared secret. In such an aspect, the central surgical controller 206 and the recipient would need to access and / or know the same shared secret. In one aspect, a shared secret can be generated / chosen by the central surgical controller 206 and delivered securely (for example, physically) to the recipient before encrypted communications to the recipient.
[0287] [0287] Alternatively, using an asymmetric encryption algorithm, the central surgical controller 206 would encrypt the generator data using a public key associated with a recipient (for example, cloud-based system 205). This public key could be received by the central surgical controller 206 from a certificate authority that issues a digital certificate certifying that the public key is owned by the recipient. The certificate authority can be any entity trusted by the central surgical controller 206 and the recipient. In such an aspect, the recipient of the encrypted generator data would then decrypt the generator data encrypted using a private key (ie known only to the recipient) paired with the public key used by the central surgical controller 206 to encrypt the data the generator. Notably, in such an aspect, the encrypted generator data can be decrypted only using the recipient's private key.
[0288] [0288] According to aspects of the present disclosure, the components (eg surgical device / instrument 235, energy device 241, endoscope 239) of surgical system 202 are associated with unique identifiers, which can be in the form of serial numbers . Thus, according to various aspects of the present disclosure, when a component is coupled to a central surgical controller 206, the component can establish a shared secret with the central surgical controller 206 using the unique identifier of the coupled component as the shared secret . In addition, in such an aspect, the component can derive a checksum value by applying a checksum function / algorithm for the unique identifier and / or other data that is communicated to the central surgical controller 206. Here, the checksum function / algorithm is configured to produce a significantly different checksum value if there is a change in the underlying data.
[0289] [0289] In one aspect, the component can initially encrypt the unique identifier of a coupled component using a public key associated with the central surgical controller (for example, received by the central surgical controller component 206 through / after connection) and communicate the identifier encrypted unique to the central surgical controller 206. In other respects, the component can encrypt the unique identifier and the checksum value derived from a coupled component using a public key associated with the central surgical controller 206 and communicate the encrypted unique identifier and the value checksum connected / associated to central surgical controller 206.
[0290] [0290] In still other aspects, the component can encrypt the unique identifier and a checksum function / algorithm using a public key associated with the central surgical controller 206 and communicate the encrypted unique identifier and the sum verification function / algorithm to the central surgical controller 206. In these respects, the central surgical controller 206 would then decrypt the encrypted unique identifier or the encrypted unique identifier and the linked / associated checksum value or the encrypted unique identifier and the function sum algorithm / verification using a private key (i.e. known only to the central surgical controller 206) paired with the public key used by the component to encrypt the unique identifier.
[0291] [0291] Since the encrypted unique identifier can only be decrypted using the central surgical controller 206 private key and the private key is known only to the central surgical controller, this is a secure way to communicate a shared secret (for example, the unique identifier component) for the central surgical controller 206. Additionally, in aspects where a checksum value is linked / associated with the unique identifier, the central surgical controller 206 can apply the same function / checksum algorithm to the decrypted unique identifier to generate a validation checksum value. If the validation checksum value matches the decrypted checksum value, the integrity of the decrypted unique identifier is further verified. In addition, in such respects, with an established shared secret, the component can encrypt future communications to the central surgical controller 206, and the central surgical controller 206 can decrypt future communications from the component using the shared secret (for example, the unique identifier of the component). coupled component). Here, according to several aspects, a checksum value can be derived for and communicated with each communication between the component and the central surgical controller 206 (for example, the checksum value based on the reported data or at least designated portion thereof). Here, a checksum function / algorithm (for example, known to the central surgical controller 206 and / or component or communicated by establishing the shared secret between the central surgical controller 206 and the component as described above) can be used to generate values checksum for comparison with the reported checksum values in order to further verify the integrity of the data reported in each communication.
[0292] [0292] Notably, asymmetric cryptography algorithms can be complex and may require significant computational resources to perform each communication. Thus, establishing the unique identifier of the coupled component as a shared secret, in addition to being faster (for example, there is no need to generate a shared secret using a pseudo-random key generator), it also increases computational efficiency (for example, allows the execution of faster, less complex symmetric encryption algorithms) for all subsequent communications. In several respects, this shared shared secret can be used by the component and the central surgical controller 206 until the component is decoupled from the central surgical controller (for example, the surgical procedure has ended).
[0293] [0293] In accordance with other aspects of this disclosure, components (eg surgical device / instrument 235,
[0294] [0294] Again, asymmetric encryption algorithms can be complex and may require significant computational resources to perform each communication. Thus, establishing the exclusive compilation / sequence of the coupled component (that is, readily combinable by the component), since the shared secret is not only faster (for example, there is no need to generate a shared secret with the use of a pseudo-random key generator), it also increases computational efficiency (for example, allows the execution of faster, less complex symmetric encryption algorithms) for all subsequent communications. In several respects, this shared shared secret can be used by the component and the central surgical controller 206 until the component is decoupled from the central surgical controller 206 (for example, the surgical procedure has ended). In addition, in such an aspect, since several subcomponents may be reusable (for example, grip, drive shaft, end actuator), while other subcomponents may not be reusable (for example, end actuator, cartridge), each new combination of subcomponents that combine to form the coupled component provides a unique build / sequence usable as a shared secret for component communications to the central surgical controller 206.
[0295] [0295] In accordance with additional aspects of the present disclosure, the components (e.g., surgical device / instrument 235, energy device 241, endoscope 239) of surgical system 202 are associated with unique identifiers. Thus, according to several aspects of the present disclosure, when a component is coupled to the central surgical controller 206, the central surgical controller 206 can establish a shared secret with a recipient (for example, cloud-based system 205) using the unique identifier of the coupled component. In one aspect, the central surgical controller 206 can initially encrypt the unique identifier of a coupled component using a public key associated with the recipient and communicate the encrypted unique identifier to the recipient. In such an aspect, the recipient would then decrypt the unique identifier using a private key (i.e., known only to the recipient) paired with the public key used by the central surgical controller 206 to encrypt the unique identifier. Since the encrypted unique identifier can only be decrypted using the recipient's private key and the private key is known only to the recipient, this is a secure way to communicate a shared secret (for example, the unique identifier of the attached component) to the recipient (for example, example, cloud-based system). In addition, with a shared secret established, the central surgical controller 206 can encrypt future communications to the recipient (for example, cloud-based system 205), and the recipient can decrypt future communications from the central surgical controller 206 with the use of the shared secret (for example, the unique identifier of the coupled component).
[0296] [0296] Notably, asymmetric cryptography algorithms can be complex and may require significant computational resources to perform each communication. Thus, establishing the unique identifier of the coupled component (that is, readily available to the central surgical controller 206), since the shared secret is not only faster (for example, there is no need to generate a shared secret with the use of a pseudo-random key generator), it also increases computational efficiency, for example, allowing the execution of faster, less complex symmetric encryption algorithms for all subsequent communications. In several respects, this shared shared secret can be used by the central surgical controller 206 until the component is decoupled from the central surgical controller (for example, the surgical procedure has ended).
[0297] [0297] In accordance with yet other aspects of the present disclosure, the components (for example, surgical device / instrument 235, energy device 241, endoscope 239) of the surgical system 202 may comprise subcomponents (for example, handle, drive shaft, end actuator, cartridge), each associated with its own unique identifier. Thus, according to various aspects of the present disclosure, when a component is coupled to the central surgical controller 206, the central surgical controller 206 can establish a shared secret with a recipient (for example, cloud-based system 205) with the use of a unique compilation / sequence (for example, ordered or random) of the unique identifiers associated with the subcomponents that combine to form the coupled component.
[0298] [0298] In one aspect, the central surgical controller 206 can initially encrypt the compilation / sequence of the coupled component using a public key associated with the recipient and communicate the exclusive compilation / sequence to the recipient. In such an aspect, the recipient would then decrypt the unique compilation / sequence encrypted using a private key (i.e., known only to the recipient) paired with the public key used by the central surgical controller 206 to encrypt exclusive compilation / sequence. Since the encrypted unique build / string can only be decrypted using the recipient's private key and the private key is known only to the recipient, this is a secure way to communicate a shared secret (for example, the unique build / string of the attached component) to the recipient. With a shared secret established, the central surgical controller 206 can encrypt future communications to the recipient (e.g., cloud-based system 205), and the recipient can decrypt future communications from the central surgical controller 206 using the shared secret ( for example, the exclusive compilation / sequence of the coupled component). Again, asymmetric encryption algorithms can be complex and can require significant computational resources to perform each communication. Thus, establishing the exclusive compilation / sequence of the coupled component (that is, readily combinable by the central surgical controller 206), since the shared secret is not only faster (for example, there is no need to generate a shared secret with the use of a pseudo-random key generator), it also increases computational efficiency (for example, allows the execution of faster, less complex symmetric encryption algorithms) for all subsequent communications.
[0299] [0299] In many respects, this shared shared secret can be used by the central surgical controller 206 until the component is decoupled from the central surgical controller (for example, the surgical procedure has ended). In addition, in such an aspect, since several subcomponents may be reusable (for example, grip, drive shaft, end actuator), while other subcomponents may not be reusable (for example, end actuator, cartridge), each new combination of subcomponents that combine to form the coupled component provides a unique build / sequence usable as a shared secret for communications from the central surgical controller 206 to the recipient.
[0300] [0300] In some respects, a cryptography-after-MAC (EtM) approach can be used to produce the encrypted generator data. An example of this approach is shown in Figure 25, in which the generator's unencrypted data (ie, plain text 3742, for example, data packet 3722) is first encrypted 3743 (for example, via key 3746) for produce a ciphertext 3744 (ie, the encrypted generator data), then a MAC 3745 is produced based on the resulting ciphertext 3744, key 3746 and the MAC algorithm (ie, a hash function 3747). More specifically, the ciphertext 3744 is processed using the MAC algorithm using the 3746 key. In a similar aspect to the symmetric encryption discussed in the present invention, the 3746 key is a secret key accessible / known to the central surgical controller 206 and the recipient (for example, cloud-based system 205). In such an aspect, the secret key is a shared secret associated with / chosen by the central surgical controller 206, a shared secret associated with / chosen by the recipient, or a key selected by means of a pseudo-random key generator. For this approach, as generally shown in 3748, the encrypted generator data (that is, the ciphertext 3744) and MAC 3745 would be communicated together to the 205 cloud-based system.
[0301] [0301] In other respects, an encryption-and-MAC (E&M) approach can be used to produce the encrypted generator data. An example of this approach is shown in Figure
[0302] [0302] In some respects, a MAC-after-encryption (MtE) approach can be used to produce encrypted generator data. An example of this approach is shown in Figure 27, in which MAC 3765 is produced based on unencrypted generator data (that is, a plain text 3762), a 3766 key and a MAC algorithm (for example, a hash function 3767 ). More specifically, plain text 3762 is processed using the MAC algorithm using the 3766 key. In a similar aspect to the symmetric cryptography discussed in the present invention, key 3766 is a secret key accessible / known to the central surgical controller 206 and the recipient (for example, cloud-based system 205). In such an aspect, the secret key is a shared secret associated with / chosen by the central surgical controller 206, a shared secret associated with / chosen by the recipient, or a key selected by means of a pseudo-random key generator. Then, the generator's unencrypted data (that is, plain text 3762) and MAC 3765 are encrypted together 3763 (for example, using key 3766) to produce a 3764 cipher text based on both. For this approach, as shown in general in 3768, the ciphertext 3764 (that is, which includes the generator encrypted data and the 3765 encrypted MAC) would be communicated to the cloud-based system 205.
[0303] [0303] In alternative aspects, the key used to encrypt the generator's unencrypted data (for example, Figure 25 and Figure 26) or the generator's unencrypted data and the MAC (for example, Figure 27) may be different from the key (for example, keys 3746, 3756, 3766) used to produce the MAC. For example, the key used to encrypt the generator's unencrypted data (for example, Figure 25 and Figure 26) or the generator's unencrypted data and the MAC (for example, Figure 27) can be a different shared secret or key. public address associated with the recipient.
[0304] [0304] Instead of using the MAC to provide a subsequent guarantee of data integrity to the cloud-based system 205, according to other aspects, the central surgical controller 206 can use a digital signature to enable the cloud-based system 205 subsequently authenticate the integrity of the reported generator data. For example, processor module 232 and / or processor 244 of computer system 210 may use one or more algorithms to generate a digital signature associated with the generator data, and the cloud-based system 205 may use an algorithm to determine the authenticity of data received from the generator. The algorithms used by processor module 232 and / or processor 244 of computer system 210 may include: (1) a key generation algorithm that randomly selects a private key from a set of possible private keys, in which the key generation algorithm issues the private key and a corresponding public key; and (2) a signature algorithm that, given the data generator and a private key, produces a digital signature associated with the generator data. The cloud-based system 205 can use a signature verification algorithm which, given the received generator data, public key and digital signature, can accept the received generator data as authentic if the digital signature is determined to be authentic or considers the data generator to be compromised or changed if the digital signature is not determined to be authentic.
[0305] [0305] In accordance with other aspects of the present disclosure, the central surgical controller 206 may use a commercial authentication program (for example, Secure Hash Algorithm (SHA-2 comprising SHA-256)) to provide a subsequent guarantee of integrity of the generator data communicated to the 205 cloud-based system.
[0306] [0306] After the generator data has been encrypted (for example, through EtM, E&M, MtE), a component of the central surgical controller 206 can communicate the encrypted generator data to the cloud-based system 205. The controller component central surgical unit 206 that communicates the encrypted generator data to the cloud-based system 205 can be, for example, processor module 232, a central surgical controller / a 207/209 key from the modular communication center 203, the router 211 from the center modular communication module 203, communication module 247 of computer system 210, etc.
[0307] [0307] According to several aspects, the communication of the encrypted generator data over the internet can follow an IP that: (1) defines datagrams that encapsulate the encrypted generator data to be delivered and / or (2) defines addressing methods which are used to tag the datagram with the source and destination information. A high-level representative of an example 3770 datagram is shown in Figure 28, where datagram 3770 includes a header 3772 and a payload 3774 and, in other respects, may also include a trailer (not shown). A more detailed representation of an example of datagram 3780 is shown in Figure 29, where header 3782 can include fields for information such as the IP address of the source 3786 sending the datagram (for example, router 211 of the modular communication center 203), destination IP address 3788 which is to receive the datagram (for example, cloud 204 and / or remote server 213 associated with cloud-based system 205), a type of service designation (not shown), a header length 3790, a payload length 3792 and a checksum value 3794. In such an aspect, the central surgical controller 206 can additionally apply a checksum function / algorithm to the unencrypted generator data (i.e., plain text 3742, for example data pack 3722) or at least a portion of the unencrypted generator data (for example, a combined generator ID 3726) to derive the checksum value 3794. Here, the checksum function / algorithm is configured to produce a significantly different checksum value if there is any change (for example even a small change) in the underlying data (for example, generator data). After decrypting generator data encrypted by its recipient (for example, cloud-based system 205), the recipient can apply the same checksum function / algorithm to decrypted generator data to generate a validation checksum value . If the validation checksum value matches the checksum value 3794 (that is, stored in header 3782 of received datagram 3780), the integrity of the received generator data is additionally verified. Payload 3784 can include encrypted generator data 3796 and can also include padding 3798 if the generator data encrypted 3796 has a payload length less than specified. Notably, the encrypted generator data communicated 3796 can comprise a MAC, as discussed in Figures 25, 26 and 27 above (for example, references 3748, 3758 and 3768, respectively). In some respects, header 3782 may additionally include a specific path that the datagram must follow when the datagram is communicated from the central surgical controller 206 to the cloud-based system 205 (for example, from the source IP address to the IP address of ao least one intermediate network component (for example, specific routers, specific servers), for the destination IP address).
[0308] [0308] According to several aspects, before the generator data is encrypted, the generator data can be stamped with date and time (if they have not already been stamped with date and time by the combined generator 3700) and / or the data of the generator can be compressed (if they have not already been compressed by the combined generator 3700). The timestamp allows the cloud-based system 205 to correlate generator data with other data (for example, removed patient data) that can be communicated to the cloud-based system 205. Compression allows for less representation of generator data is subsequently encrypted and communicated to the cloud-based system 205. For compression, a component of the central surgical controller 206 can use a compression algorithm to convert a representation of the generator data into a smaller representation of the generator data, enabling thus more efficient and economical encryption of generator data (for example, less data to encrypt uses less processing resources) and more efficient and economical communication of encrypted generator data (for example, smaller representations of generator data within the load) datagrams (for example, Figures 28 and 29) enable more data from the g erator are included in a given datagram, that more generator data is communicated within a given period of time and / or that generator data is communicated with less communication resources). The component of the central surgical controller 206 that uses / performs the compression algorithm can be, for example, processor module 232, processor 244 of the computer system and / or combinations thereof. The compression algorithm used / executed can be a lossless compression algorithm or a lossy compression algorithm.
[0309] [0309] Once the data generator and MAC for a given datagram has been received in the 205 cloud-based system (for example Figure 25, reference 3748; Figure 26, 3758; and Figure 27, reference 3768), the system based in cloud 205 it can decrypt the generator data encrypted from the communicated datagram payload to obtain the communicated generator data.
[0310] [0310] In one respect, again with reference to Figure 25, the recipient (for example, cloud-based system 205) can, similar to central surgical controller 206, process the ciphertext
[0311] [0311] In another aspect, with reference again to Figure 26, the recipient (for example, cloud-based system 205) can decrypt cipher text 3754 (for example, using key 3756) to obtain plain text 3752 (for example example, data package comprising generator data). Then, similar to central surgical controller 206, the recipient (e.g., cloud-based system 205) can process plain text 3752 using the same MAC algorithm using the same known / accessible secret key to produce an authenticating MAC. If the received MAC 3755 matches that authenticating MAC, the recipient (for example, cloud-based system 205) can safely assume that the ciphertext 3752 has not been altered and comes from the central surgical controller 206.
[0312] [0312] In yet another aspect, with reference again to Figure 27, the recipient (for example, cloud-based system 205) can decrypt the ciphertext 3764 (for example, using the key 3766) to obtain the plain text 3762 ( for example, data package comprising generator data) and MAC 3765. Next, similar to central surgical controller 206, the recipient (eg cloud-based system 205) can process plain text 3762 using the same MAC algorithm with the use of the same known / accessible secret key to produce an authenticating MAC. If the received MAC 3765 matches that authenticating MAC, the recipient (for example, cloud-based system 205) can safely assume that the ciphertext 3762 has not been altered and comes from the central surgical controller 206.
[0313] [0313] In alternative aspects, the key used to encrypt generator data not encrypted (for example, Figure 25 and Figure 26) or generator data unencrypted and the MAC (for example, Figure 27) may be different from the key (for example example, keys 3746, 3756, 3766) used to produce the MAC. For example, the key used to encrypt the generator's unencrypted data (for example, Figure 25 and Figure 26) or the generator's unencrypted data and the MAC (for example, Figure 27) can be a different shared secret or key. public address associated with the recipient. In such respects, with reference to Figure 25, the recipient (for example, cloud-based system 205), after verifying MAC authentication using key 3746 (described above), can then decrypt the ciphertext 3744 (by example, through the different shared secrets or private key associated with the recipient) to obtain the plain text 3742 (for example, data package comprising the data generator). In such aspects, with reference to Figure 26, the recipient can decrypt the 3754 ciphertext (for example, through the different shared secrets or private key associated with the recipient) to obtain the plain text 3752 (for example, data package comprising data then verify the MAC authentication using key 3756 (described above). In such respects, with reference to Figure 27, the recipient can decrypt the 3764 ciphertext (for example, through the different shared secrets or private key associated with the recipient)
[0314] [0314] In short, with reference to Figures 25 to 27, if a MAC authentication, as determined / calculated by the cloud-based system 205, is the same as the MAC that was received with the datagram, the cloud-based system 205 may have certainty that the generator data received is authentic (that is, it is the same as the generator data that was communicated by the central surgical controller 206) and that the integrity of the data from the reported generator has not been compromised or changed. As described above, the recipient can additionally apply plain text 3742, 3752, 3762, or at least a portion of it, to the checksum function / algorithm (that is, used by the central surgical controller 206) to generate a value of validation checksum in order to recheck the generator data integrity based on the checksum value stored in the communicated datagram header.
[0315] [0315] Additionally, based on the decrypted datagram, the source's IP address (for example, Figure 29, reference 3786) that originally communicated the datagram to the cloud-based system 205 can be determined from the communicated datagram header. If the determined source is a recognized source, the cloud-based system 205 can be sure that the generator data originates from a trusted source, thereby providing origin authentication and further guaranteeing the integrity of the generator data. In addition, as each router through which the datagram passed on its way to the cloud-based system 205 includes its IP address with its forwarded communication, the cloud-based system 205 is able to track the trajectory followed by the datagram and identify each router that handled the datagram. The ability to identify the respective routers can be useful in cases where the content of the datagram received in the cloud-based system 205 is not the same as the content of the datagram as originally communicated by the central surgical controller 206. For aspects where the communication path was pre-specified and included in the header of the communicated datagram, the ability to identify the respective routers can enable the trajectory to be validated and provide additional security for the authenticity of the generator data received.
[0316] [0316] Furthermore, according to various aspects, after authentication of the generator data received, the cloud-based system 205 can communicate a message (for example, a handshake or similar message) to the central surgical controller 206 via the internet or another communication network, confirming / guaranteeing that the datagram communicated from the central surgical controller 206 was received intact by the cloud-based system 205, thus effectively closing the loop of that specific datagram.
[0317] [0317] Aspects of the communication method described above, and / or variations thereof, can also be used to communicate data in addition to generator data to the cloud-based system 205 and / or to communicate generator data and / or other data from the central surgical controller 206 for systems and / or devices in addition to the cloud-based system 205. For example, according to various aspects, generator data and / or other data can be communicated from the central surgical controller 206 to the surgical device / instrument handheld (for example, wireless device / instrument 235), for a robotic interface of a surgical device / instrument (for example the robotic central surgical controller 222) and / or for other servers, including servers (for example, similar to the server 213) associated with other cloud-based systems (for example, similar to the cloud-based system 205), according to the communication method described above. For example, in certain cases, an EEPROM integrated circuit for a given surgical instrument may initially be provided with only one device ID of the electronic integrated circuit. By connecting the given surgical instrument to the combined generator 3700, the data can be downloaded from the cloud-based system 205 to the central surgical controller 206 and subsequently to the EEPROM of the surgical instrument, according to the communication method described above.
[0318] [0318] In addition to communicating generator data to the cloud-based system 205, the central surgical controller 206 can also use the communication method described above, and / or variations thereof, to communicate data in addition to the generator data for the cloud-based system 205. For example, the central surgical controller 206 can also communicate other information associated with the surgical procedure to the cloud-based system 205. This other information may include, for example, the type of surgical procedure to be performed, the name of the facilities where the surgical procedure is being performed, the location of the facilities where the surgical procedure is being performed, an identification of the operating room within the facility where the surgical procedure is being performed, the name of the surgeon performing the surgical procedure, the patient's age and data associated with the patient's condition (eg blood pressure, heart rate current medications). According to various aspects, this other information can be devoid of all information that could identify the specific surgery, patient or surgeon, so that the information is essentially anonymized for further processing and analysis by the cloud-based system 205. In in other words, the data removed is not correlated to a specific surgery, patient or surgeon. Deprived information can be communicated to the cloud-based system 205 in conjunction with or separately from the reported generator data.
[0319] [0319] For cases in which the deprived / other data must be communicated separately from the generator data, the deprived / other data can be stamped with the date and time, compressed and / or encrypted in the same or different way as described above in relation to to the generator data, and the central surgical controller 206 can be programmed / configured to generate a datagram that includes the encrypted / other deprived information in place of the encrypted generator data. The datagram can then be communicated from the central surgical controller 206 over the internet to the cloud-based system 205 following an IP that: (1) defines datagrams that encapsulate the cryptographic generator data removed / other data to be sent and (2 ) defines addressing methods that are used to identify the datagram with the source and destination information.
[0320] [0320] For cases in which the deprived / other information must be communicated separately from the generator data, the deprived / other data can be stamped with the date and time, compressed and / or encrypted in the same or different way as described above in relation to to the generator data, and the central surgical controller 206 can be programmed / configured to generate a datagram that includes the encrypted generator data and the encrypted / other deprived information. An example of such a datagram is shown in Figure 30, where the payload 3804 of the datagram is 3800 divided into two or more distinct portions of payload data (for example, one for the encrypted generator data 3834, one for the information unencrypted / other 3836), with each portion having an identification bit (eg generator data (GD) 3806, other data (OD) 3812), the associated encrypted data 3808, 3814 and the associated padding 3810, 3816, if necessary, respectively.
[0321] [0321] As presented above, it is a sad reality that the results of all surgical procedures are not always ideal and / or adequate. For cases where a failure event is detected and / or identified, a variation of the communication methods described above can be used to isolate surgical data that is associated with the failure event (for example, surgical data from the failure event) from the data surgical data that are not associated with the failure event (for example, non-failure event surgical data) and communicate the surgical data that are associated with the failure event (for example, failure event data) from the central surgical controller 206 for the cloud-based surgical system 205 in a prioritized way for analysis. According to one aspect of the present disclosure, surgical data from the failure event is communicated from the central surgical controller 206 to the cloud-based system 205 in a prioritized manner in relation to the non-failure event surgical data.
[0322] [0322] Figure 31 illustrates various aspects of a method implemented by the system to identify surgical data associated with a failure event (for example, surgical data from the failure event) and communicate the surgical data identified for surgical to a cloud-based system 205 in a prioritized way. The method comprises (1) receiving 3838 surgical data in a central surgical controller 206, the surgical data being associated with a surgical procedure; (2) stamping the 3840 date and time of the surgical data; (3) identifying 3842 a failure event associated with the surgical procedure; (4) determine 3844 which surgical data are associated with the failure event (for example, surgical data from the failure event); (5) separate 3846 data associated with the failure event from all other surgical data (for example, non-failure event surgical data) received at the central surgical controller 206; (6) placing the surgical data associated with the failure event in chronological order 3848; (7) encrypt 3850 surgical data associated with the failure event; and (8) communicate 3852 encrypted surgical data in a cloud-based system 205 in a prioritized manner.
[0323] [0323] More specifically, various surgical data can be captured during a surgical procedure and the captured surgical data, as well as other surgical data associated with the surgical procedure, can be communicated to the central surgical controller 206. Surgical data can include, for example, data associated with a surgical device / instrument (for example, Figure 9, surgical device / instrument 235) used during surgery, data associated with the patient, data associated with the facilities where the surgical procedure was performed and data associated with the surgeon. Before or after being communicated and received by the central surgical controller 206, surgical data can be stamped with the date and time and / or removed from all information that could identify the specific surgery, patient or surgeon, so that information is essentially anonymized for further processing and analysis by the cloud-based system 205.
[0324] [0324] Once a failure event has been detected and / or identified (for example, which can be during or after the surgical procedure), the central surgical controller 206 can determine which surgical data is associated with the failure event (for example , surgical data from the failure event) and which surgical data are not associated with the surgical event (for example, surgical data not from the failure event). In accordance with one aspect of the present disclosure, a failure event may include, for example, a detection of one or more clamps erroneously fired during a stapling portion of a surgical procedure. For example, in one aspect, with reference to Figure 9, an endoscope 239 can take snapshots while a surgical device / instrument 235 comprises an end actuator including a staple cartridge performs a stapling portion of a surgical procedure.
[0325] [0325] In some respects, a failure event is considered to cover a certain period of time, and all data associated with that particular period of time can be considered to be associated with the failure event.
[0326] [0326] Once the surgical data associated with the failure event is identified, the identified surgical data (for example, surgical data from the failure event) can be separated or isolated from all other surgical data associated with the surgical procedure (for example, surgical data not from the failure event). The separation can be performed, for example, by marking or flagging the identified surgical data, storing the identified surgical data separately from all other surgical data associated with the surgical procedure, or storing only the other surgical data, while continuing, at the same time, the processing of the identified surgical data for subsequent prioritized communication to the cloud-based system 205. According to several aspects, the marking or signaling of the identified surgical data can occur during the communication process when the datagram is generated as described in more detail below.
[0327] [0327] The timestamp of all surgical data (for example, before or after surgical data is received at the central surgical controller) can be used by a component of the central surgical controller 206 to chronologically place the surgical data identified associated with the failure event. The central surgical controller component 206 that uses the time stamp to chronologically identify the identified surgical data can be, for example, processor module 232, processor 244 of computer system 210 and / or combinations thereof . By placing surgical data in chronological order, the cloud-based system 205 and / or other interested parties can subsequently better understand the conditions that were present that led to the occurrence of the failure event and possibly identify the exact cause of the failure event, thus providing the knowledge to possibly mitigate a similar failure event that may occur during a similar surgical procedure performed at a future date.
[0328] [0328] Once the surgical data has been placed in chronological order, the surgical data in chronological order can be encrypted in a manner similar to that described above in relation to the encryption of the generator data. In this way, the identified surgical data can be encrypted to help ensure the confidentiality of the identified surgical data, while being stored in the central surgical controller 206 or while being transmitted to the cloud-based system 205 using the internet or other computer networks. . According to several aspects, a component of the central surgical controller 206 uses an encryption algorithm to convert the identified surgical data from a readable version to a coded version, thus forming encrypted surgical data associated with the failure event (for example, Figures 25 to 27). The component of the central surgical controller using the encryption algorithm can be, for example, processor module 232, processor 244 of computer system 210 and / or combinations thereof. The encryption algorithm used can be a symmetric encryption algorithm or an asymmetric encryption algorithm.
[0329] [0329] After the identified surgical data has been encrypted, a component of the central surgical controller can communicate the encrypted surgical data associated with the failure event (for example, encrypted surgical failure event data)
[0330] [0330] According to several aspects, before being encrypted, the identified surgical data (for example, surgical data from the failure event) can be compressed (if not already compressed by the source (or sources) of the relevant surgical data) . Compression enables a smaller representation of the surgical data associated with the failure event to be subsequently encrypted and communicated to the cloud-based system 205. For compression, a component of the central surgical controller 206 can use a compression algorithm to convert a representation of the data identified in a smaller representation of the identified surgical data, thus enabling more efficient and economical encryption of the identified surgical data (for example, less data to encrypt uses less processing resources) and more efficient and economical communication of the identified surgical data (for example, For example, smaller representations of surgical data within the payload of datagrams allow more identified surgical data to be included in a given datagram, more identified surgical data to be communicated within a given period of time and / or surgical data id communicated with fewer communication resources). The component of the central surgical controller 206 that uses the compression algorithm can be, for example, processor module 232, processor 244 of computer system 210 and / or combinations thereof. The compression algorithm used can be a lossless compression algorithm or a lossy compression algorithm.
[0331] [0331] In cases where other non-prioritized surgical data (for example, non-failure event surgical data) must be communicated to the prioritized surgical data (for example, failure event surgical data), the other non-prioritized surgical data may be stamped with the date and time, compressed and / or encrypted in the same or different way as described above with respect to surgical data identified as associated with a failure event (for example, surgical data of the failure event), and the surgical controller central 206 can be programmed / configured to generate a datagram that includes the prioritized encrypted surgical surgical data (for example, encrypted surgical failure event data) and the other non-prioritized surgical encrypted surgical data (for example, non-failure surgical surgical data encrypted). For example, in view of Figure 32, the payload 3864 of datagram 3860 can be divided into two or more distinct portions of payload data (for example, one for prioritized surgical data 3834, one for non-prioritized surgical data 3836 ), with each portion having an identification bit (for example, generator data (GD) 3866, other data (OD) 3872), the associated encrypted data (for example, encrypted prioritized surgical data 3868, encrypted non-prioritized surgical data 3874 ) and the associated filling 3870, 3876, if necessary, respectively.
[0332] [0332] In some respects, once a failure event associated with a surgical procedure has been identified, the central surgical controller 206 and / or the cloud-based system 205 can subsequently mark or signal a surgical device / instrument 235 that has been used during the surgical procedure as inoperative and / or removed. For example, in one aspect, information (e.g., serial number, ID) associated with surgical device / instrument 235 and stored in the central surgical controller 206 and / or cloud-based system 205 can be used to effectively block the device / surgical instrument 235 to be used again (for example, blacklisted). In another aspect, information (for example, serial number, ID) associated with the surgical device / instrument can initiate the printing of a delivery note and shipping instructions to return the 235 device / surgical instrument to a manufacturer or other designated party. so that a thorough analysis / inspection of the surgical device / instrument 235 can be performed (for example, to determine the cause of the failure). According to several aspects described here, once the cause of a failure is determined (for example, via the central surgical controller 206 and / or the cloud-based system 205), the central surgical controller 206 can download a cloud-based system program 205 to be executed by the surgical device / instrument 235 that corrects the determined cause of the failure (i.e., program that alters the parameters of the surgical device / instrument to prevent the failure from occurring again).
[0333] [0333] According to some aspects, the central surgical controller 206 and / or the cloud-based system 205 may also provide / display a reminder (for example, via the central surgical controller 215 screen and / or the device / surgical instrument 237) for administrators, staff and / or other employees to physically remove the surgical device / instrument 235 from the operating room (for example, if detected as still present in the operating room) and / or send the surgical device / instrument 235 for the manufacturer or other designated party. In one aspect, the reminder can be set to be provided / displayed periodically until an administrator can remove the signaling or marking of the surgical device / instrument 235 from the central surgical controller 206 and / or the cloud-based system 205. According to several aspects, an administrator can remove the flagging or marking once the administrator can confirm (for example, system tracking of the surgical device / instrument 235 through its serial / ID number) that the device / surgical instrument 235 has been received by the manufacturer or by the other designated party. Using the method described above to signal and / or track surgical data associated with a failure event, a closed loop control of the surgical data associated with the failure event and / or a 235 surgical device / instrument can be performed. In addition, in view of the above, it will be understood that the central surgical controller 206 can be used to effectively manage the use (or non-use) of surgical devices / instruments 235 that were or could be used during a surgical procedure.
[0334] [0334] In various aspects of the present disclosure, the central surgical controller 206 and / or cloud-based system 205 may want to control which components (eg, surgical device / instrument 235, energy device 241) are being used in their surgical system interactive 100/200 to perform surgical procedures (for example, to minimize future failure events, to avoid the use of unauthorized or counterfeit components).
[0335] [0335] As such, in various aspects of the present disclosure, since an interactive surgical system 100 can comprise a plurality of central surgical controllers 106, a cloud-based system 105 and / or each central surgical controller 106 of the interactive surgical system 100 you may wish to track combinations of central surgical controller-components used over time. In one aspect, when / after a component (see Figure 9, for example, surgical device / instrument 235, energy device 241) is connected to / used with a specific central surgical controller 106 (for example, surgical device / instrument 235 wired / wireless connected to a specific central surgical controller 106, the power device 241 connected to the central surgical controller 106 via generator module 240), the specific central surgical controller 106 can communicate a record / block of that connection / use (for example, by linking the respective unique identifiers of the connected devices) to the cloud-based system 105 and / or to the other central surgical controllers 106 in the interactive surgical system 100. For example, by / after connecting / using a power device 241, a central surgical controller 106 can communicate register / block (for example, by connecting a unique identifier of the power device 241 to a unique identifier of a generator module 240 to a unique identifier of the central surgical controller 106) for the cloud-based system 105 and / or for the other central surgical controllers 106 in the interactive surgical system 100. In such an aspect, if this is the first time the component (for example, power device) is connected to / used with a central surgical controller 106 in the interactive surgical system 100, the cloud-based system 105 and / or each central surgical controller 106 of the interactive surgical system 100 can store the record / block as a genesis record / block.
[0336] [0336] According to various aspects of the present disclosure, the cloud-based system 105 and / or each central surgical controller 106 can use such registers / blocks to trace the use of a specific component and / or a subcomponent to its initial use in the interactive surgical system 100. For example, if a specific component (eg surgical instrument / device 235) is flagged / marked as related to a failure event, the cloud-based system 105 and / or a central surgical controller 106 can analyze such records / blocks to determine whether past use of that component and / or a subcomponent of that component contributed to or caused the failure event (for example, overuse). In one example, the cloud-based system 105 may determine that a subcomponent (for example, end actuator) of that component may actually be contributing / causing the failure event and then flagging / signaling that component for inoperability and / or removal based on the determination.
[0337] [0337] According to another aspect, the cloud-based system 205 and / or the central surgical controller 206 can control which components (e.g. surgical device / instrument 235, energy device 241) are being used in an interactive surgical system 200 to perform surgical procedures by authenticating the component and / or its supplier / manufacturer.
[0338] [0338] According to another aspect, the electronic integrated circuit of a component (for example, surgical device / instrument 235, energy device 241) can store (for example, in memory) data associated with the use of that component (ie , usage data, for example number of uses with a limited use device, number of uses remaining, triggering algorithms performed, designation as a single use component). In such an aspect, the central surgical controller 206 and / or the cloud-based system 205, upon / after connecting the component to the interactive surgical system, can read such data from the memory of a component and write at least a portion of that data for use for storage (e.g., within memory 249) in the central surgical controller 206 and / or for storage in the cloud-based system 205 (e.g., individually and / or under a chain-block approach discussed here). According to this aspect, the central surgical controller 206 and / or the cloud-based system 205, upon / after a subsequent connection of this component to the interactive surgical system, can read such usage data again and compare that usage to the stored usage data previously. Here, if there is a discrepancy or if a predetermined / authorized use has been met, the central surgical controller 206 and / or the cloud-based system 205 can avoid the use of that component (for example, blacklisted, rendered inoperable, marked for removal ) in the interactive surgical system 200. In many respects, such an approach prevents diversion of cryptographic integrated circuit systems. If the component's electronic integrated circuit / memory has been tampered with (for example, reconfigured memory, changed number of uses, changed triggering algorithms, single-use device designated as multipurpose device), there will be a discrepancy, and the use of the component will be controlled / prevented.
[0339] [0339] Additional details are disclosed in US Patent Application Publication No. 2017/0086914 entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING
[0340] [0340] One of the functions of the central surgical controller 106 is to pair (also referred to in the present invention as "connecting" or "coupling") with other components of the surgical system 102 to control, collect information from or coordinate interactions between the components of the surgical system 102. Since the operating rooms of a hospital are likely to be in physical proximity to each other, a central surgical controller 106 of a surgical system 102 may inadvertently pair with components of a surgical system 102 in a operating room. neighboring operation, which could significantly interfere with the functions of the central surgical controller 106. For example, the central surgical controller 106 may accidentally activate a surgical instrument in a different operating room or record information about a different continuous surgical procedure in an operating room neighbor.
[0341] [0341] Aspects of the present disclosure present a solution, in which a central surgical controller 106 pairs only with detected devices of the surgical system 102 that are located within the limits of its operating room.
[0342] [0342] In addition, the central surgical controller 106 depends on its knowledge of the location of other components of the surgical system 102 within its operating room to make decisions on, for example, which surgical instruments should be paired with each other or activated. A change in the position of the central surgical controller 106 or another component of the surgical system 102 can be problematic.
[0343] [0343] Aspects of the present disclosure additionally present a solution in which the central surgical controller 106 is configured to reevaluate or redeterminate the limits of its operating room upon detecting that the central surgical controller 106 has been moved. Aspects of the present disclosure additionally present a solution in which the central surgical controller 106 is configured to redetermin the limits of its operating room by detecting a potential device in the surgical system 102, which may be an indication that the central surgical controller 106 has been moved.
[0344] [0344] In several respects, a central surgical controller 106 is used with a surgical system 102 in a surgical procedure performed in an operating room. The central surgical controller 106 comprises a control circuit configured to determine the limits of the operating room, determine the devices of the surgical system 102 located within the limits of the operating room and pair the central surgical controller 106 with the devices of the operating system 102 located within the limits of the operating room.
[0345] [0345] In one aspect, the control circuit is configured to determine the limits of the operating room after activation of the central surgical controller 106. In one aspect, the central surgical controller 106 includes a communication circuit configured to detect and pair- with the devices of the surgical system located within the limits of the operating room. In one aspect, the control circuit is configured to redetermin the limits of the operating room after a possible device in the surgical system 102 is detected. In one aspect, the control circuit is configured to periodically determine the limits of the operating room.
[0346] [0346] In one aspect, the central surgical controller 106 comprises an operating room mapping surgical that includes a plurality of non-contact sensors configured to measure the limits of the operating room.
[0347] [0347] In several respects, the central surgical controller 106 includes a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to pair the central surgical controller with devices of the surgical system 102 located within the limits of the operating room, as described above. In many respects, the present disclosure provides a non-transitory, computer-readable medium that stores computer-readable instructions that, when executed, cause a machine to pair the central surgical controller 106 with devices of the surgical system 102 located within the confines of the operating room. operation as described above.
[0348] [0348] Figures 35 and 36 are logical flowcharts of processes representing control programs or logic configurations for the pairing of the central surgical controller 106 with devices of the surgical system 102 located within the limits of the operating room, as described above.
[0349] [0349] Central surgical controller 106 performs a wide range of functions that require short- and long-range communication, such as assisting in a surgical procedure, coordination between devices in the surgical system 102 and data collection and transmission to the cloud
[0350] [0350] The central surgical controller 106 is also equipped with an operating room mapping module 133 that is capable of identifying the limits of an operating room and identifying devices of the surgical system 102 within the operating room. The central surgical controller 106 is configured to identify the limits of an operating room and to pair or connect only to possible devices in the surgical system 102 that are detected within the operating room.
[0351] [0351] In one aspect, the pairing comprises establishing a link or communication route. In another aspect, the pairing comprises establishing a link or control route.
[0352] [0352] An initial mapping or evaluation of the operating room boundaries occurs during an initial activation of the central surgical controller 106. In addition, the central surgical controller 106 is configured to maintain spatial recognition during operation by periodically mapping your room of operation, which can be useful in determining whether central surgical controller 106 has been moved. The 3017 revaluation can be performed periodically or it can be triggered by an event such as the observation of a change in the devices of the surgical system 102 that are considered inside the operating room. In one aspect, the change is the 3010 detection of a new device that was not previously considered to be within the limits of the operating room, as shown in Figure 37. In another aspect, the change is a disappearance, disconnection or unpairing of a paired device that was previously considered to reside within the operating room, as shown in Figure 38. The central surgical controller 106 can continuously monitor the connection with the paired devices 3035 to detect 3034 missing, disconnected or not paired a paired device.
[0353] [0353] In other respects, the events triggering the reassessment may be, for example, changes in the positions of surgeons, changes in instrumentation or detection of a new set of tasks performed by the central surgical controller 106.
[0354] [0354] In one aspect, the evaluation of the room boundaries by the central surgical controller 106 is performed by activating a sensor matrix from the mapping module of the operating room 133 inside the central surgical controller 106 that allows it to detect the walls the operating room.
[0355] [0355] Other components of the surgical system 102 can be made to have spatial recognition in the same or similar way as the central surgical controller 106. For example, a robotic central controller 122 can also be equipped with an operating room mapping module 133 .
[0356] [0356] The spatial recognition of the central surgical controller 106 and its ability to map the operating room in relation to possible components of the surgical system 102 enables the central surgical controller 106 to make autonomous decisions on whether to include or exclude these possible components as part of surgical system 102, which relieves the surgical team to deal with such tasks. In addition, the central surgical controller 106 is configured to make inferences about, for example, the type of surgical procedure to be performed in the operating room based on information collected before, during and / or after the performance of the surgical procedure. Examples of information collected include the types of devices that are taken to the operating room, the time of introduction of such devices into the operating room and / or the sequence of activation devices.
[0357] [0357] In one aspect, the central surgical controller 106 employs the operating room mapping module 133 to determine the limits of the operating room (for example, an operating room or a fixed, mobile or temporary space) using ultrasonic or laser non-contact measuring devices.
[0358] [0358] Referring to Figure 34, non-contact sensors based on ultrasound 3002 can be used to scan the operating room by transmitting an ultrasound explosion and receiving echo when it bounces outside the perimeter of the 3006 walls of a room operating modes to determine the size of the operating room and adjust the Bluetooth pairing distance limits. In one example, the 3002 non-contact sensors can be Ping ultrasonic distance sensors, as shown in Figure
[0359] [0359] Figure 34 shows how an ultrasonic sensor 3002 sends a brief hiss with its ultrasonic speaker 3003 and allows a microcontroller 3004 of the operating room mapping module 133 to measure how long it takes the echo to return to the ultrasonic microphone of the ultrasonic sensor 3005. The microcontroller 3004 must send a pulse to the ultrasonic sensor 3002 to start the measurement. The 3002 ultrasonic sensor then waits long enough for the microcontroller program to start a pulse input command. So, almost at the same time that the ultrasonic sensor 3002 sends out a 40 kHz hiss, it sends a loud signal to the microcontroller 3004. When the ultrasonic sensor 3002 detects the echo with its 3005 ultrasonic microphone, it changes the high signal back down . The microcontroller pulse input command of the microcontroller measures the time between changes between high and low and stores your measurement in a variable. This value can be used together with the speed of sound in the air to calculate the distance between the central surgical controller 106 and the wall of the operating room 3006.
[0360] [0360] In one example, as shown in Figure 33, a central surgical controller 106 can be equipped with four ultrasonic sensors 3002, each of the four ultrasonic sensors being configured to assess the distance between central surgical controller 106 and a wall operating room 3000. Central surgical controller 106 can be equipped with more or less than four ultrasonic sensors 3002 to determine the limits of an operating room.
[0361] [0361] Other distance sensors can be used by the operating room mapping module 133 to determine the limits of an operating room. In one example, the operating room mapping module 133 can be equipped with one or more photoelectric sensors that can be used to assess the limits of an operating room. In one example, suitable laser distance sensors can also be employed to assess the limits of an operating room. Laser-based non-contact sensors scan the operating room by transmitting pulses of laser light, receiving pulses of laser light that hit the perimeter walls of the operating room and comparing the phase of the transmitted pulse to the received pulse to determine the size of the operating room. operation and to adjust the Bluetooth pairing distance limits, for example.
[0362] [0362] With reference to the upper left corner of Figure 33, a central surgical controller 106 is placed in an operating room
[0363] [0363] In artificial real time 07:36:01, the operating room mapping module 133 employs ultrasonic distance sensors to ultrasonic ping the room (for example, send an ultrasound explosion and hear the echo when it hits the perimeter of the operating room walls as described above) to check the size of the operating room and adjust the pairing distance limits.
[0364] [0364] In artificial real time 07:36:03, data is removed and stamped with date and time. In artificial real time 07:36:05, the central surgical controller 106 begins to pair the devices located only within the operating room 3000, as verified with the use of ultrasonic distance sensors 3002 from the operating room mapping module 133. The upper right corner of Figure 33 illustrates several exemplifying devices that are within the limits of the operating room 3000 and are paired with the central surgical controller 106, including a secondary display device 3020, a secondary central controller 3021, a common interface device 3022, a stapler equipped with a 3023 motor, a video tower module 3024 and a handheld dissector equipped with a 3025 motor. On the other hand, the secondary central controller 3021 ', the secondary display device 3020' and the stapler equipped with a motor 3026 are all outside the limits of the operating room 3000 and are therefore not paired with the central surgical controller 106.
[0365] [0365] In addition to establishing a communication link with the devices of the surgical system 102 that are inside the operating room, the central surgical controller 106 also assigns a unique sequence or number of communication and identification to each of the devices. The unique string can include the device name and a timestamp when the communication was first established. Other appropriate device information can also be incorporated into the unique device string.
[0366] [0366] As shown in the upper left corner of Figure 33, the central surgical controller 106 determined that the limits of operating room 3000 are at distances a, -a, b and -b from the central surgical controller 106. Like device "D" it is outside the determined limits of its operating room 3000, the central surgical controller 106 does not match the device "D". Figure 35 is an example of an algorithm illustrating how the central surgical controller 106 pairs only with devices within the limits of its operating room. After activation, the central surgical controller 106 determines the operating room limits 3007 using the operating room mapping module 133, as described above. After the initial determination, the central surgical controller 106 continuously searches for or detects 3008 devices within a pairing range. If a device is detected 3010, the central surgical controller 106 then determines 3011 whether the detected device is within the limits of the operating room. Central surgical controller 106 pairs 3012 with the device if the device is determined to be within the limits of the operating room. In certain cases, the central surgical controller 106 will also assign 3013 an identifier to the device. If, however, the central surgical controller 106 determines that the detected device is outside the limits of the operating room, the central surgical controller 106 ignores 3014 the device.
[0367] [0367] With reference to Figure 36, after an initial determination of the room boundaries and after an initial pairing of the devices located within those limits, the central surgical controller 106 continues to detect 3015 new devices that become available for pairing. If a new device is detected 3016, the central surgical controller 106 is configured to re-evaluate 3017 the limits of the operating room before pairing with the new device. If the new device 3018 is determined to be within the recently determined limits of the operating room, then the central surgical controller 106 pairs with device 3019 and assigns 3030 a unique identifier to the new device. If, however, the central surgical controller 106 determines that the new device is outside the newly determined limits of the operating room, the central surgical controller 106 ignores 3031 the device.
[0368] [0368] For pairing, the operating room mapping module 133 contains an integrated Bluetooth compass and transceiver. Other communication mechanisms, which are not significantly affected by the hospital environment or geographical location, can be employed. Bluetooth low energy ("BLE") Bluetooth radio beacon technology can currently obtain indoor distance measurements with an accuracy of about 1 to 2 meters, with improved accuracy in closer positions (0 to 6 meters) ). To improve the accuracy of distance measurements, a compass is used with the BLE. The operating room mapping module 133 uses the BLE and the compass to determine where the modules are located in relation to the patient. For example, two modules facing each other (detected by the compass) more than one meter apart can clearly indicate that the modules are on opposite sides of the patient. The more modules activated by the central controller that resides in the operating room, the greater the precision obtained due to triangulation techniques.
[0369] [0369] In situations where multiple central surgical controllers 106 and / or other peripherals are present in the same operating room, as shown in the upper right corner of Figure 33, the operating room mapping module 133 is configured to map the location of each module that resides inside the operating room. This information could be used by the user interface to display a virtual map of the room, allowing the user to more easily identify which modules are present and enabled, as well as their current situation. In one aspect, the mapping data collected by the central surgical controllers 106 is sent to the cloud 104, where the data is analyzed to identify how an operating room is physically configured, for example.
[0370] [0370] The central surgical controller 106 is configured to determine a device location by assessing the transmission of the radio signal strength and direction.
[0371] [0371] In one aspect, one or more of the processes shown in Figures 35 to 39 can be performed by a control circuit of a central surgical controller 106, as shown in Figure 10 (processor 244). In another aspect, one or more of the processes shown in Figures 35 to 39 can be performed by a cloud computing system 104, as shown in Figure 1. In yet another aspect, one or more of the processes shown in Figures 35 to 39 can be performed by at least one of the aforementioned cloud computing systems 104 and / or a control circuit of a central surgical controller 106 in combination with a control circuit of a modular device, such as the 461 microcontroller of the represented surgical instrument in Figure 12, the microcontroller 620 of the surgical instrument shown in Figure 16, the control circuit 710 of the robotic surgical instrument shown 700 in Figure 17, the control circuit 760 of the surgical instruments 750, 790 shown in Figures 18 and 19 or the controller 838 of generator 800 shown in Figure 20. Spatial recognition of central surgical controllers in operating rooms
[0372] [0372] During a surgical procedure, a surgical instrument, such as an ultrasonic or RF surgical instrument, can be attached to a generator module 140 of the central surgical controller 106. In addition, a separate surgical instrument controller, such as a foot or a hand, a key or an activation device, can be used by a surgical instrument operator to activate the flow of energy from the generator to the surgical instrument. Multiple surgical instrument controllers and multiple surgical instruments can be used simultaneously in an operating room. Pressing or activating the wrong surgical instrument controller can have undesirable consequences. Aspects of the present disclosure present a solution in which the central surgical controller 106 coordinates the pairing of the surgical instrument controllers and the surgical instruments to ensure the safety of the patient and the operator.
[0373] [0373] Aspects of the present disclosure are presented for a central surgical controller 106 configured to establish and separate the pairings between the components of the surgical system 102 within the limits of the operating room to coordinate the flow of information and the control actions between such components . Central surgical controller 106 can be configured surgical to establish a pairing between a surgical instrument controller and a surgical instrument that reside within the confines of an operating room of central surgical controller 106.
[0374] [0374] In several respects, the central surgical controller 106 can be configured to establish and separate the pairings between the components of the surgical system 102 based on the operator's request and the situational and / or spatial recognition. Situational recognition of the central controller is described in more detail below in connection with Figure 62.
[0375] [0375] Aspects of the present disclosure are presented for a central surgical controller for use with a surgical system in a surgical procedure performed in an operating room. The central surgical controller includes a control circuit that selectively forms and separates the pairings between devices in the surgical system. In one aspect, the central surgical controller includes a control circuit configured to pair the central surgical controller with a first device in the surgical system, assign a first identifier to the first device, pair the central controller with a second device in the surgical system, assign a second identifier to the second device and selectively pair the first device with the second device. In one aspect, the central surgical controller includes a storage medium, the control circuit being configured to store a record indicative of the pairing between the first device and the second device on the storage media. In one aspect, the pairing between the first device and the second device defines a communication route between them. In one aspect, the pairing between the first device and the second device defines a control route for transmitting control actions from the second device to the first device.
[0376] [0376] In addition to the above, in one aspect, the control circuit is additionally configured to pair the central surgical controller with a third device of the surgical system, assign a third identifier to the third device, separate the pairing between the first device and the second device and selectively pair the first device with the third device. In one aspect, the control circuit is further configured to store a record indicative of the pairing between the first device and the third device on the storage media. In one aspect, the pairing between the first device and the third device defines a communication route between them. In one aspect, the pairing between the first device and the third device defines a control route for transmitting control actions from the third device to the first device.
[0377] [0377] In several respects, the central surgical controller includes a processor and a memory attached to the processor. The memory stores instructions executable by the processor to selectively form and separate pairs between devices in the surgical system, as described above. In many respects, the present disclosure provides a non-transient, computer-readable medium that stores computer-readable instructions that, when executed, cause a machine to selectively form and separate pairs between devices in the surgical system, as described above. Figures 40 and 41 are logical flowcharts of processes representing control programs or logical configurations to selectively form and separate the pairings between the devices of the surgical system, as described above.
[0378] [0378] In one aspect, the central surgical controller 106 establishes a first pairing with a surgical instrument and a second pairing with the surgical instrument controller. The central surgical controller 106 then links the pairings allowing the surgical instrument and the surgical instrument controller to operate with each other. In another aspect, the central surgical controller 106 can separate an existing communication link between a surgical instrument and a surgical instrument controller, then connect the surgical instrument to another surgical instrument controller that is connected to the central surgical controller
[0379] [0379] In one aspect, the surgical instrument controller is paired with two sources. First, the surgical instrument controller is paired with the central surgical controller 106, which includes generator module 140 to control its activation. Second, the surgical instrument controller is also paired with a specific surgical instrument to prevent inadvertent activation of the wrong surgical instrument.
[0380] [0380] With reference to Figures 40 and 42, the central surgical controller 106 can cause the communication module 130 to pair 3100 or establish a first communication link 3101 with a first device 3102 of the surgical system 102, which can be a first surgical instrument. Then, the central surgical controller 3104 can assign a first identification number to the first device 3102. This is a unique identification and communication sequence or number that can include the name of the device and a time stamp of when the communication was established for the first time.
[0381] [0381] In addition, the central surgical controller 106 can then cause communication module 130 to pair 3106 or establish a second communication link 3107 with a second device 3108 of surgical system 102, which can be a surgical instrument. Central surgical controller 106 then assigns 3110 to a second identification number for second device 3108.
[0382] [0382] In several respects, the steps of pairing a central surgical controller 106 with a device may include detecting the presence of a new device, determining that the new device is within the limits of the operating room, as described above in more details, and pairing only with the new device, if the new device is located within the limits of the operating room.
[0383] [0383] The central surgical controller 106 can then pair 3112 or allow a communication link 3114 to be established between the first device 3102 and the second device 3108, as shown in Figure 42. An indicative record of the communication link 3114 is stored by the central surgical controller 106 in the storage matrix 134. In one aspect, the communication link 3114 is established through the central surgical controller 106. In another aspect, as illustrated in Figure 42, the communication link 3114 is a direct link between the first device 3102 and the second device 3108.
[0384] [0384] With reference to Figures 41 and 43, the central surgical controller 106 can then detect and pair 3120 or establish a third communication link 3124 with a third device 3116 of surgical system 102, which can be another central surgical controller , for example. The central surgical controller 106 can then assign 3126 a third identification number to the third device 3116.
[0385] [0385] In certain respects, as shown in Figure 43, the central surgical controller 106 can then pair 3130 or allow a communication link 3118 to be established between the first device 3102 and the third device 3116, while causing the communication link 3114 is separated 3128, as shown in Figure 43. A record indicating the formation of communication link 3118 and separation of communication link 3114 is stored by the central surgical controller 106 in storage matrix 134. In one aspect, the link communication link 3118 is established through central surgical controller 106. In another aspect, as illustrated in Figure 43, communication link 3118 is a direct link between the first device 3102 and the third device 3116.
[0386] [0386] As described above, the central surgical controller 106 can manage indirect communication between devices in the surgical system 102. For example, in situations where the first device 3102 is a surgical instrument and the second device 3108 is an instrument controller surgical, an output from the surgical instrument controller can be transmitted via the communication link 3107 to the central surgical controller 106, which can then transmit the output to the surgical instrument via the communication link 3101.
[0387] [0387] When making a decision to connect or separate a connection between devices in the surgical system 102, the central surgical controller 106 may depend on the perioperative data received or generated by the central surgical controller 106. Perioperative data includes input data from the operator, situational recognition of the central controller, spatial recognition of the central controller and / or cloud. For example, a request can be transmitted to the central surgical controller 106 from an operator user interface to assign a surgical instrument controller to a surgical instrument. If the central surgical controller 106 determines that the surgical instrument controller is already connected to another surgical instrument, the central surgical controller 106 can separate the connection and establish a new connection at the request of the operator.
[0388] [0388] In certain examples, the central surgical controller 106 can establish a first communication link between the display system 108 and the primary screen 119 to transmit an image, or other information, from the display system 108, which resides outside from the sterile field, to the main screen 119, which is located within the sterile field. The central surgical controller 106 can then separate the first communication link and establish a second communication link between a robotic central surgical controller 122 and the main screen 119 to transmit another image, or other information, from the central surgical controller robot 122 for main screen 119, for example. The ability of the central surgical controller 106 to assign and reassign the main screen 119 to different components of the surgical system 102 allows the central surgical controller 106 to manage the flow of information within the operating room, particularly between components within the sterile field and outside of the sterile field, without physically moving these components.
[0389] [0389] In another example involving situational recognition of the central controller, the central surgical controller 106 can selectively connect or disconnect devices from the surgical system 102 within an operating room based on the type of surgical procedure being performed or based on a determination of a next step in the surgical procedure that requires devices to be connected or disconnected. Situational recognition of the central controller is described in more detail below in connection with Figure 62.
[0390] [0390] Referring to Figure 44, the central surgical controller 106 can track 3140 the progression of the surgical steps in a surgical procedure and can coordinate the pairing and unpairing of the devices of the surgical system 102 based on such progression. For example, the central surgical controller 106 may determine that a first surgical step requires the use of a first surgical instrument, while a second surgical step, which occurs after the completion of the first surgical step, requires the use of a second surgical instrument. Consequently, the central surgical controller 106 can assign a surgical instrument controller to the first surgical instrument over the duration of the first surgical step. After detecting completion 3142 of the first surgical step, the central surgical controller 106 can cause the communication link between the first surgical instrument and the surgical instrument controller to be separated 3144. The central surgical controller 106 can then assign the controller from surgical instrument to the second surgical instrument by pairing 3146 or authorize the establishment of a communication link between the surgical instrument controller and the second surgical instrument.
[0391] [0391] Several other examples of situational recognition of the central controller, which can influence the decision to connect or disconnect devices from the surgical system 102, are described in more detail below in connection with Figure 62.
[0392] [0392] In certain respects, the central surgical controller 106 can use its spatial recognition capabilities, as described in more detail elsewhere in the present invention, to track the progression of the surgical steps of a surgical procedure and to reassign a controller autonomously from a surgical instrument from one surgical instrument to another surgical instrument within the operating room of the central surgical controller 106. In one aspect, the central surgical controller 106 uses Bluetooth pairing information and compass to determine the physical position of the components of the surgical system 102 .
[0393] [0393] In the example illustrated in Figure 2, the central surgical controller 106 is paired with a first surgical instrument held by a surgical operator on the operating table and a second surgical instrument positioned on a side tray. A surgical instrument controller can be selectively paired with the first surgical instrument or the second surgical instrument. Using the pairing information via Bluetooth and compass, the central surgical controller 106 autonomously assigns the surgical instrument controller to the first surgical instrument due to its proximity to the patient.
[0394] [0394] After the completion of the surgical step that involved the use of the first surgical instrument, the first surgical instrument can be returned to the side tray or, otherwise, moved in the opposite direction to the patient. Upon detecting a change in the position of the first surgical instrument, the central surgical controller 106 can separate the communication link between the first surgical instrument and the surgical instrument controller to protect against inadvertent activation of the first surgical instrument by the surgical instrument controller. Central surgical controller 106 can also reassign the surgical instrument controller to another surgical instrument if central surgical controller 106 detects that it has been moved to a new position on the operating table.
[0395] [0395] In several respects, surgical system devices 102 are equipped with an easy control transfer operation mode that would allow a user to provide activation control of a device he currently controls to another surgical instrument controller within range. another operator. In one aspect, the devices are equipped to perform the transfer of control through a predetermined activation sequence of the devices that cause the devices that are activated in the predetermined activation sequence to pair with each other.
[0396] [0396] In one aspect, the activation sequence is performed by energizing the devices to be paired with each other in a specific order. In another aspect, the activation sequence is carried out by energizing the devices to be paired with each other within a predetermined period of time. In one aspect, the activation sequence is carried out by activating communication components, such as Bluetooth, from the devices to be paired with each other in a specific order. In another aspect, the activation sequence is carried out by activating communication components, such as Bluetooth, of the devices to be paired with each other within a predetermined period of time.
[0397] [0397] Alternatively, the transfer of control can also be performed by selecting a device using one of the surgical operator input devices. After the selection is complete, the next activation by another controller would allow the new controller to gain control.
[0398] [0398] In several respects, the central surgical controller 106 can be configured to directly identify components of the surgical system 102, as they are placed in an operating room. In one aspect, the devices of the surgical system 102 can be equipped with an identifiable identifier by the central surgical controller 106, such as, for example, a bar code or a radio frequency identification tag ("RFID" - Radio-Frequency Identification ). Proximity field communication ("NFC" - Near Field Communication) can also be used. The central surgical controller 106 can be equipped with a surgical reader or scanner suitable for detecting devices placed in the operating room.
[0399] [0399] Central surgical controller 106 can also be configured to check and / or update various control programs for surgical system devices 102. Upon detecting and establishing a communication link from a surgical system memory device 102, the surgical controller Central 106 can verify that your control program is up to date. If central surgical controller 106 determines that a newer version of the control program is available, central surgical controller 106 can download the latest version from cloud 104 and can update the device to the latest version. Central surgical controller 106 can issue a sequential identification and communication number for each paired or connected device.
[0400] [0400] In a surgical procedure, the attention of a surgical operator must be focused on immediate tasks. Receiving information from multiple sources, such as multiple monitors, while useful, can also be distracting. The imaging module 138 of the central surgical controller 106 is configured to surgically collect, analyze, organize / prepare and intelligently disseminate information relevant to the surgical operator in a way that minimizes distractions.
[0401] [0401] Aspects of the present disclosure are presented for the cooperative use of data resulting from multiple sources, such as, for example, an imaging module 138 of the central surgical controller 106. In one aspect, imaging module 138 is configured to overlap the data derived from one or more sources to a live stream intended for main screen 119, for example. In one aspect, the overlapping data can be derived from one or more frames captured by the imaging module 138. The imaging module 138 can appropriate image frames on the way for display on a local screen, such as the screen main 119. Imaging module 138 also comprises an image processor which can preform a local image processing matrix on the appropriate images.
[0402] [0402] In addition, a surgical procedure, in general, includes several surgical tasks that can be performed by one or more surgical instruments guided by a surgical operator or a surgical robot, for example. The success or failure of a surgical procedure depends on the success or failure of each of the surgical tasks. Without relevant data on individual surgical tasks, determining the reason for a failed surgical procedure is a matter of probability.
[0403] [0403] Aspects of the present disclosure are presented to capture one or more frames from a live broadcast of a surgical procedure for further processing and / or pairing with other data. Tables can be captured at the completion of a surgical task (also referred to in this document as a "surgical step") to assess whether the surgical task has been successfully completed. In addition, paired frames and data can be sent to the cloud for further analysis.
[0404] [0404] In one aspect, one or more captured images are used to identify at least one surgical task completed previously to assess the outcome of the surgical task. In one aspect, the surgical task is a tissue stapling task. In another aspect, the surgical task is an advanced energy transection.
[0405] [0405] Figure 45 is a logical flow chart of a 3210 process that represents a control program or a logical configuration for overlapping information derived from one or more static frames from a live transmission from a remote surgical site to the live transmission. The 3210 process includes receiving 3212 a live transmission from a remote surgical site from a medical imaging device 124, for example, capturing 3214 at least one picture of a surgical step in the surgical procedure from the live transmission, derive 3216 the relevant information for the surgical stage from data extracted from at least one image frame and superimpose 3218 the information to the live transmission.
[0406] [0406] In one aspect, the static pictures can be from a surgical stage performed at the remote surgical site. Static charts can be analyzed for information regarding the completion of the surgical stage. In one aspect, the surgical step comprises stapling the tissue at the surgical site. In another aspect, the surgical task involves applying energy to the tissue at the surgical site.
[0407] [0407] Figure 46 is a logical flow chart of a 3220 process that represents a control program or a logical configuration to differentiate surgical steps from a surgical procedure. The 3220 process includes receiving 3222 a live transmission from a surgical site from a medical imaging device 124, for example, capturing 3224 at least a first image frame from a first surgical step of the surgical procedure from the live transmission , derive 3226 information relevant to the first surgical step from data extracted from at least one image frame, capture 3228 at least one second image frame from a second surgical step of the surgical procedure from live transmission and differentiate 3229 between the first surgical step and the second surgical step based on at least a first image frame and at least a second image frame.
[0408] [0408] Figure 47 is a logical flow chart of a 3230 process that represents a control program or a logical configuration to differentiate between the surgical steps of a surgical procedure. The 3232 process includes receiving 3232 a live transmission of the surgical site from a medical imaging device 124, for example, capturing 3234 image frames of the surgical steps of the surgical procedure from the live transmission and differentiating 3236 between the surgical steps based on data extracted from the image frames.
[0409] [0409] Figure 48 is a logical flow chart of a 3240 process that represents a control program or a logical configuration for identifying a staple cartridge from information derived from one or more static staple frames implanted from the staple cartridge. on the fabric. The 3240 process includes receiving 3242 a live transmission of the surgical site from the medical imaging device 124, for example, capturing a 3244 image frame from the live transmission, detecting a 3246 clip pattern in the image frame, being that the staple pattern is defined by the staples implanted from a staple cartridge into the tissue at the surgical site. The 3240 process further includes identifying the 3248 staple cartridge based on the staple pattern.
[0410] [0410] In several respects, one or more of the process steps 3210, 3220, 3230, 3240 can be performed by a control circuit of an imaging module of a central surgical controller, as shown in Figures 3, 9, 10. In certain examples, the control circuit may include a processor and memory attached to the processor, the memory storing instructions executable by the processor to perform one or more of the steps in processes 3210, 3220, 3230, 3240. In certain examples, a computer-readable non-transitory media stores computer-readable instructions that, when executed, cause a machine to perform one or more of the steps in processes 3210, 3220, 3230, 3240. For simplicity, the following description of processes 3210, 3220, 3230, 3240 will be described as being executed by the control circuit of an imaging module of a central surgical controller; however, it must be understood that the execution of processes 3210, 3220, 3230, 3240 can be performed by any of the above examples.
[0411] [0411] With reference to Figures 34 and 49, a central surgical controller 106 is in communication with a medical imaging device 124 located at a remote surgical site during a surgical procedure. The imaging module 138 receives a live transmission from the remote surgical site transmitted by the imaging device 124 to a main screen 119, for example, according to steps 3212, 3222, 3232, 3242.
[0412] [0412] In addition to the above, imaging module 138 of the central surgical controller 106 includes a 3200 frame capture device. The 3200 frame capture device is configured to capture (i.e., "take") individual digital static frames of the live transmission transmitted by the imaging device 124, for example, to a main screen 119, for example, during a surgical procedure, according to steps 3214, 3224, 3234, 3244. The captured static frames are stored and processed by a computer platform 3203 (Figure 49) of the imaging module 138 to derive information about the surgical procedure. The processing of captured frames can include performance of simple operations, such as histogram calculations, 2D filtering and pixel matrix arithmetic operations for the performance of more complex tasks, such as object detection, 3D filtering and the like.
[0413] [0413] In one aspect, the derived information can be superimposed on the live broadcast. In one aspect, the static frames and / or information resulting from the processing of the static frames can be communicated to a cloud 104 for data aggregation and further analysis.
[0414] [0414] In several respects, the 3200 frame capture device may include a digital video decoder and memory to store the captured static frames, such as a frame buffer. The 3200 frame capture device can also include a bus interface through which a processor can control capture and access data and general purpose I / O to trigger image capture or control external equipment.
[0415] [0415] As described above, imaging device 124 may be in the form of an endoscope, including a camera and a light source positioned at a remote surgical site and configured to provide a live broadcast of the remote surgical site on the main screen 119, for example.
[0416] [0416] In several respects, image recognition algorithms can be implemented to identify resources or objects in static frames of a surgical site that are captured by the 3200 frame capture device. Useful information related to the surgical steps associated with the captured frames can be derived from the identified resources. For example, the identification of staples in the captured frames indicates that a surgical step of stapling tissue was performed at the surgical site. The type, color, layout and size of the identified staples can also be used to derive useful information about the staple cartridge and the surgical instrument used to implant the staples. As described above, this information can be superimposed on a live broadcast directed to a main screen 119 in the operating room.
[0417] [0417] Image recognition algorithms can be performed at least in part locally by computer platform 3203 (Figure 49) of imaging module 138. In certain cases, image recognition algorithms can be performed at least in part by processor module 132 of central surgical controller 106. An image database can be used in the performance of image recognition algorithms and can be stored in a 3202 memory of the 3203 computer platform. Alternatively, the imaging database can be stored in the storage matrix 134 (Figure 3) of the central surgical controller 106. The image database can be updated from the cloud 104.
[0418] [0418] An exemplary image recognition algorithm that can be performed by computer platform 3203 can include a comparison based on key points and a color comparison based on region. The algorithm includes: receiving input from a processing device, such as the 3203 computer platform; the entry, including data related to a static picture of a remote surgical site; perform a recovery step, which includes recovering an image from an image database and, until the image is accepted or rejected, designating the image as a candidate image; performing an image recognition step, which includes using the processing device to execute an image recognition algorithm on the static frame and candidate images in order to obtain an image recognition algorithm output; and perform a comparison step, which includes: if the output of the image recognition algorithm is within a pre-selected range, accept the candidate image as the static frame and, if the output of the image recognition algorithm is not within of the pre-selected track, reject the candidate image and repeat the steps of recovery, image recognition and comparison.
[0419] [0419] With reference to Figures 50 to 52, in one example, a surgical step involves stapling and cutting the tissue. Figure 50 represents a static frame 3250 of stapled and cut tissue T. A 3252 staple implant includes the 3252 ', 3252 "staples from a first staple cartridge. A second 3254 staple implant includes 3254', 3254" staples. a second staple cartridge. A proximal portion 3253 of the staple implant 3252 overlaps a distal portion 3255 of the staple implant
[0420] [0420] In several respects, imaging module 138 identifies one or more of the clips 3252 ', 3252 ", 3254', 3254" the static frame 3250, which were missing from a previous static frame captured by the 3200 frame capture device Imaging module 138 then concludes that a surgical cutting and stapling instrument was used at the surgical site.
[0421] [0421] In the example in Figure 50, staple implant 3252 includes two different staples 3252 ', 3252 ". Likewise, staple implant 3254 includes two different staples 3254', 3254". For the sake of brevity, the following description focuses on clamps 3252 ', 3252 ", but is equally applicable to clamps 3254', 3254". Staples 3252 ', 3252 "are arranged in a pattern or predetermined sequence that forms a unique identifier corresponding to the staple cartridge that housed staples 3252', 3252". The unique pattern can be in a single row or in multiple rows of the 3250 clips. In one example, the unique pattern can be obtained by alternating the clips 3252 ', 3252 "in a predetermined arrangement.
[0422] [0422] In one aspect, multiple patterns can be detected in one shot of the clips. Each pattern can be associated with a unique characteristic of the staples, the staple cartridge that housed the staples and / or the surgical instrument that was used to trigger the staple. For example, a shot of the clips may include patterns that represent the shape of the clip, the size of the clip and / or the location of the shot.
[0423] [0423] In the example in Figure 50, imaging module 138 can identify a unique pattern for 3252 staples from the 3250 static frame. A database that stores staple patterns and corresponding staple cartridge identification numbers can then , be exploited to determine a staple cartridge identification number that housed staples
[0424] [0424] The patterns in the example in Figure 50 are based on just two different clips; however, other aspects may include three or more different clips. The different clamps can be coated with different coatings, which can be applied to the clamps by one or more of the following methods: anodizing, coloring, electro-coating, photoluminescent coating, nitride application, methyl methacrylate, painting, powder coating, coating with paraffins, oily stains or phosphorescent coatings, the use of hydroxyapatite, polymers, titanium oxynitrides, zinc sulfides, carbides, etc. It should be noted that, while the coatings mentioned are reasonably specific, as disclosed herein, other coatings known in the art for distinguishing the clip are contemplated within the scope of the present disclosure.
[0425] [0425] In the example of Figures 50 to 52, clips 3252 'are anodized clips, while clips 3252 "are non-anodized clips. In one aspect, different clips can comprise two or more different colors. Different metal clips can comprise markers magnetic or radioactive clips that differentiate them from unmarked clips.
[0426] [0426] Figure 51 illustrates a staple implant 3272 implanted in the tissue from a staple cartridge using a surgical instrument. Only three rows of staples 3272a, 3272b, 3272c are shown in Figure 51. Rows 3272a, 3272b, 3272c are arranged between a center line, where the fabric has been cut, and a side line at the edge of the fabric. For clarity, the inner row
[0427] [0427] Staple 3272 deployment includes two different staples 3272 ', 3272 "which are arranged in predetermined patterns that serve various functions. For example, inner row 3272a comprises a pattern of alternating staples 3272', 3272", which defines a metric for distance measurements in the surgical field. In other words, the inner row pattern 3272a acts as a ruler for measuring distances, which can be useful in accurately determining the position of a leak, for example. The outer rows 3272b, 3272c define a pattern representing an identification number of the staple cartridge that housed the staples 3272 ', 3272 ".
[0428] [0428] In addition, unique patterns at the ends of staple 3272 implantation identify the proximal end portion 3273 and the distal end portion 3275. In the example in Figure 51, a unique arrangement of three staples 3272 "identifies the distal end 3275, while a unique arrangement of four staples 3272 "identifies the proximal end 3273. The identification of the proximal and distal ends of a staple implant makes it possible to distinguish by the imaging module 128 from different staple deployments within a captured frame, which can be useful to indicate the source of a leak, for example.
[0429] [0429] In several respects, imaging module 138 can detect a sealed tissue in a static frame of a surgical site captured by the 3200 frame capture device. Detection of the sealed tissue may be indicative of a surgical step that involves application of therapeutic energy to the tissue.
[0430] [0430] The sealing of the tissue can be performed by applying energy, such as electrical energy, for example, to the tissue captured or trapped inside an end actuator of a surgical instrument, in order to cause thermal effects within the tissue. Several monopolar and bipolar RF surgical instruments and harmonic surgical instruments have been developed for such purposes. In general, the application of energy to the captured tissue can raise the temperature of the tissue and, as a result, the energy can at least partially denature the proteins inside the tissue. Such proteins, such as collagen, for example, can be denatured into a proteinaceous amalgam that mixes and fuses or seals as the proteins are renatured.
[0431] [0431] Consequently, the sealed fabric has a different color and / or shape that can be detected by the imaging module 138 with the use of image recognition algorithms, for example. In addition, smoke detection at the surgical site may indicate that the application of therapeutic energy to the tissue is underway.
[0432] [0432] In addition to the above, the imaging module 138 of the central surgical controller 106 is able to differentiate between the surgical steps of a surgical procedure based on the captured frames. As described above, a static frame comprising triggered clips is indicative of a surgical step involving stapling tissue, while a static frame comprising a sealed tissue is indicative of a surgical step involving the application of energy to the tissue.
[0433] [0433] In one aspect, the central surgical controller 106 can selectively overlay information relevant to a surgical task completed prior to live transmission. For example, the overlapping information may comprise image data from a static picture of the surgical site captured during the previously completed surgical task. In addition, guided by common reference sites on the surgical site, imaging module 138 can interweave one image frame to another to establish and detect surgical sites and relationship data for a previously completed surgical task.
[0434] [0434] In one example, the central surgical controller 106 is configured to superimpose information regarding a potential leak in a tissue treated by stapling or applying therapeutic energy to a previously completed surgical task. The potential leak can be recognized by the imaging module 138 when processing a static frame of the tissue. The surgical operator can be alerted about the leak by overlapping information about the possible leak to the live broadcast.
[0435] [0435] In several respects, static pictures of a surgical instrument end actuator at a surgical site can be used to identify the surgical instrument. For example, the end actuator may include an identification number that can be recognized by the imaging module 138 during still frame image processing. Consequently, the static frames captured by the imaging module 138 can be used to identify a surgical instrument used in a surgical step of a surgical procedure. Static charts can also include useful information about the performance of the surgical instrument. All of this information can be sent to cloud 104 for data aggregation and further analysis.
[0436] [0436] In several instances, the central surgical controller 106 can also selectively overlay relevant information for a current or future surgical task, such as an anatomical site or a surgical instrument suitable for the surgical task.
[0437] [0437] Imaging module 138 can employ various edge and image detection techniques to track a surgical site when a surgical instrument has been used to complete a surgical task. The success or failure of the surgical task can then be assessed. For example, a surgical instrument can be used to seal and / or cut tissue at the surgical site. A static picture of the surgical site can be stored in memory 3202 or in the storage matrix 134 of the central surgical controller 106, for example, after the completion of the surgical task.
[0438] [0438] In the next surgical step, the quality of the seal can be tested through different mechanisms. To ensure that the test is applied accurately to the treated tissue, the stored static picture of the surgical site is superimposed on the live broadcast in search of a match. When a match is found, testing can take place. One or more additional static frames can be obtained during the test, they can be further analyzed by the imaging module 138 of the central surgical controller 106. Test mechanisms include bubble detection, bleeding detection, dye detection (where a dye is employed in the surgical site) and / or detection of rupture elongation (where a localized deformation is applied adjacent to an anastomosis site), for example.
[0439] [0439] Imaging module 138 can capture static frames of the tissue response treated for these tests, which can be stored in memory 3202 or in the storage matrix 134 of central surgical controller 106, for example. Static charts can be stored alone or in combination with other data, such as data from the surgical instrument that performed the tissue treatment. Paired data can also be uploaded to cloud 104 for further analysis and / or pairing.
[0440] [0440] In several respects, the static frames captured by the 3200 frame capture device can be processed locally, paired with other data and can also be transmitted to the cloud 104. The size of the data processed and / or transmitted will depend on the number of captured frames. In many ways, the rate at which the 3200 frame capture device captures the static frames from the live stream can be varied in an effort to reduce the size of the data without sacrificing quality.
[0441] [0441] In one aspect, the rate of picture capture may depend on the type of surgical task being performed. Certain surgical tasks may require a greater number of static pictures than others for an assessment of success or failure. The frame rate can be scaled to accommodate such needs.
[0442] [0442] In one aspect, the frame rate is dependent on the detected movement of the imaging device 124. In use, an imaging device 124 can target a surgical site over a period of time. Observing no or small changes in the captured static frames while the imaging device 124 is not being moved, imaging module 138 can reduce the frame capture rate of the 3200 frame capture device. If the situation changes, however, where frequent movement is detected, the imaging module 138 can respond by increasing the frame capture rate of the 3200 frame capture device. In other words, the imaging module 138 can be configured to correlate the frame capture rate of the frame capture device. frame capture device 3200 with the degree of movement detected from imaging device 124.
[0443] [0443] For more efficiency, only portions of the static frames, where movement is detected, need to be stored, processed and / or transmitted to the cloud 104. Imaging module 138 can be configured to select the portions of the static frames where it is motion detected. In one example, motion detection can be achieved by comparing a static frame to a previously captured static frame. If motion is detected, the imaging module 138 can cause the frame capture device 3200 to increase the frame capture rate, but only the portions where motion is detected are stored, processed and / or transmitted to the cloud 104.
[0444] [0444] In another aspect, the data size can be managed by scaling the resolution of the captured information based on the area of the screen where the focal point is or where the end actuators are located, for example. The rest of the screen could be captured at a lower resolution.
[0445] [0445] In one aspect, the corners and edges of the screen can, in general, be captured at a lower resolution. The resolution, however, can be scaled if an important event is observed.
[0446] [0446] During a surgical procedure, the central surgical controller 106 can be connected to various monitoring devices in the operating room, such as heart rate monitors and inflation pumps. The data collected from these devices can improve situational recognition of the central surgical controller 106. Situational recognition of the central controller is described in more detail below in connection with Figure 62.
[0447] [0447] In one example, the central surgical controller 106 can be configured to use patient data received from a connected heart rate monitor together with data regarding the location of the surgical site to assess the proximity of the surgical site to sensory nerves. An increase in the patient's heart rate, when combined with anatomical data indicating that the surgical site is in a region rich in sensory nerves, can be interpreted as an indication of proximity to the sensory nerve. Anatomical data may be available to the central surgical controller 106 through access to patient records (for example, a PEP database containing patient records).
[0448] [0448] Central surgical controller 106 can be configured surgical to determine the type of surgical procedure to be performed on a patient from data received from one or more operating room monitoring devices, such as frequency monitors cardiac arrest and inflation pumps. Abdominal surgical procedures generally require insufflation of the abdomen, while insufflation is not necessary in theoretical surgery. Central surgical controller 106 can be configured to determine whether a surgical procedure is an abdominal or thoracic surgical procedure by detecting whether the insufflation pump is active. In one aspect, the central surgical controller 106 can be configured to monitor inflation pressure on the outlet side of the inflation pump to determine whether the surgical procedure being performed requires inflation.
[0449] [0449] The central surgical controller 106 can also collect information from other secondary devices in the operating room to assess, for example, whether the surgical procedure is a vascular or avascular procedure.
[0450] [0450] Central surgical controller 106 can also monitor the supply of AC current to one or more of its components to assess whether a component is active. In one example, the central surgical controller 106 is configured to monitor the supply of AC current to the generator module to assess whether the generator is active, which may be an indication that the surgical procedure being performed is requires the application of energy to seal the fabric.
[0451] [0451] In several respects, secondary devices in the operating room that are unable to communicate with the central surgical controller 106 can be equipped with communication interface devices (communication modules) which can facilitate the pairing of these devices with the controller central surgical
[0452] [0452] In one aspect, the central surgical controller 106 can be configured to control one or more operating parameters of a secondary device via a communication interface device. For example, the central surgical controller 106 can be configured to increase or decrease the inflation pressure through a communication interface device coupled to an inflation device.
[0453] [0453] In one aspect, the communication interface device can be configured to engage with a device interface port. In another aspect, the communication interface device may comprise an overlay or other interface that interacts directly with a control panel of the secondary device. In other respects, secondary devices, such as the heart rate monitor and / or insufflation devices, can be equipped with integrated communication modules that allow them to pair with the central controller for bidirectional communication between them.
[0454] [0454] In one aspect, the central surgical controller 106 can also be connected via a communication interface device, for example, muscle patches that are connected to nerve stimulation detection devices to improve the resolution of a nerve detection device .
[0455] [0455] In addition, the central surgical controller 106 can also be configured to manage supplies in the operating room. Different surgical procedures need different supplies. For example, two different surgical procedures may require different sets of surgical instruments. Certain surgical procedures may involve the use of a robotic system, while others do not. In addition, two different surgical procedures may require staple cartridges that are different in number, type and / or size. Consequently, supplies brought to the operating room can provide clues as to the nature of the surgical procedure to be performed.
[0456] [0456] In several respects, the central surgical controller 106 can be integrated with an operating room supplies scanner to identify items brought into the operating room and introduced into the sterile field. Central surgical controller 106 can use data from the operating room supply scanner, along with data from surgical system devices 102 that are paired with central surgical controller 106, to autonomously determine the type of surgical procedure to be performed . In one example, central part 106 can record a list of smart cartridge serial numbers that will be used in the surgical procedure. During the surgical procedure, the central surgical controller 106 can gradually remove the clips that have been triggered, based on information collected from the integrated circuits of the staple cartridge. In one aspect, the central surgical controller 106 is configured to make sure that all items are accounted for at the end of the procedure. Control Provisions of the Central Surgical Controller
[0457] [0457] In a surgical procedure, a second central surgical controller can be placed in an operating room already under the control of a first central surgical controller. The second central surgical controller can be, for example, a robotic central surgical controller placed in the operating room as part of a robotic system. Without coordination between the first and second central surgical controllers, the central surgical controller will attempt to pair with all other components of surgical system 102 that are within the operating room. The confusion resulting from competition between the two central controllers in a single operating room can have undesirable consequences. In addition, the classification of instrument distribution among central controllers during the surgical procedure can be time-consuming.
[0458] [0458] Aspects of the present disclosure are presented for a central surgical controller for use with a surgical system in a surgical procedure performed in an operating room. A control circuit of the central surgical controller is configured to determine the limits of the operating room and establish a control arrangement with a detected central surgical controller located within the limits of the operating room.
[0459] [0459] In one aspect, the control disposition is an arrangement between peers. In another aspect, the control arrangement is a master-slave arrangement. In one aspect, the control circuit is configured to select one of a master operating mode or a slave operating mode in the master-slave arrangement. In one aspect, the control circuit is configured to deliver control of at least one surgical instrument to the central surgical controller detected in the slave operating mode.
[0460] [0460] In one aspect, the central surgical controller includes an operating room mapping surgical that includes a plurality of non-contact sensors configured to measure the limits of the operating room.
[0461] [0461] In several respects, the central surgical controller includes a processor and a memory attached to the processor. The memory stores instructions executable by the processor to coordinate a control arrangement between central surgical controllers, as described above. In many respects, the present disclosure provides a non-transitory, computer-readable medium that stores computer-readable instructions that, when executed, cause a machine to coordinate a control arrangement between central surgical controllers, as described above.
[0462] [0462] Aspects of the present disclosure are presented for a surgical system that comprises two independent central surgical controllers that are configured to interact with each other. Each of the central surgical controllers has its own attached surgical device and the control and distribution designation from which the data is recorded and processed. This interaction causes one or both central surgical controllers to change their behavior from before the interaction. In one respect, the change involves a redistribution of devices previously assigned to each of the central surgical controllers. In another aspect, the change involves establishing a master-slave arrangement between central surgical controllers. In yet another aspect, the change may be a change in the processing location shared between central surgical controllers.
[0463] [0463] Figure 53 is a logical flow chart of a process that represents a control program or a logical configuration for coordinating a control arrangement between central surgical controllers. The process in Figure 53 is similar in many respects to the process in Figure 35 except that the process in Figure 53 addresses detection of a central surgical controller by another central surgical controller. As shown in Figure 53, the central surgical controller 106 determines 3007 the limits of the operating room. After the initial determination, the central surgical controller 106 continuously searches for or detects 3008 devices within a pairing range. If a device is detected 3010, and if the device detected is located 3011 within the limits of the operating room, the central surgical controller 106 pairs 3012 with the device and assigns 3013 an identifier to the device. If through an initial interaction, as described in more detail below, the central surgical controller 106 determines 3039 that the device is another central surgical controller, a control arrangement is established 3040 between them.
[0464] [0464] Referring to Figure 54, a robotic central surgical controller 3300 enters an operating room already occupied by a central surgical controller 3300. The robotic central surgical controller 3310 and central surgical controller 3300 are similar in many respects to others central surgical controllers described in more detail elsewhere in the present invention, such as central surgical controllers 106. For example, the robotic central surgical controller 3310 includes non-contact sensors configured to measure the limits of the operating room, as described in more detail elsewhere in the present invention in connection with Figures 33, 34.
[0465] [0465] When the 3310 robotic central surgical controller is triggered, it determines the limits of the operating room and begins to pair with other components of the surgical system 102 that are located within the limits of the operating room. The 3310 robotic central surgical controller pairs with a 3311 advanced robotic power tool, a 3312 robotic stapler, a 3313 monopolar power tool and a 3314 robotic display tower, all of which are located within the limits of the operating room. The central surgical controller 3300 is already paired with the hand stapler 3301, a dissector equipped with the hand motor 3302, a secondary screen 3303, a surgeon interface 3304 and a viewing tower 3305. Since the hand stapler 3301, the dissector equipped with handheld motor 3302, the secondary screen 3303, the surgeon interface 3304 and the viewing tower 3305 are already paired with the central surgical controller 3300, such devices cannot pair with another central surgical controller without permission from the controller central surgical unit 3300.
[0466] [0466] In addition to the above, the central surgical controller 3310 detects and / or is detected by the central surgical controller
[0467] [0467] In the example in Figure 54, a master-slave arrangement is established. Central surgical controllers 3300, 3310 request permission from a surgical operator for the robotic central surgical controller 3310 to obtain control of the operating room from the central surgical controller 3300. Permission can be requested through an interface or 3304 surgeon console. Once authorization is granted, the 3310 central surgical controller requests the 3300 central surgical controller to transfer control to the 3310 robotic central surgical controller.
[0468] [0468] Alternatively, central surgical controllers 3300, 3310 can negotiate the nature of their interaction without external input based on previously collected data. For example, central surgical controllers 3300, 3310 can collectively determine that the next surgical task requires the use of a robotic system. This determination can cause the central surgical controller 3300 to autonomously deliver control of the operating room to the robotic central surgical controller 3310. Upon completion of the surgical task, the robotic central surgical controller 3310 can then autonomously return control from the operating room to the 3300 central surgical controller.
[0469] [0469] The result of the interaction between the central surgical controllers 3300, 3310 is illustrated on the right side of Figure 54. The central surgical controller 3300 transferred control to the central surgical controller 3310, which also gained control of the 3304 surgeon interface and screen secondary controller 3303 of the central surgical controller
[0470] [0470] Figure 55 is a logical flow chart of a process that represents a control program or a logical configuration to coordinate a control arrangement between central surgical controllers. In several respects, two independent central surgical controllers will interact with each other in a predetermined manner to assess the nature of their relationship. In one example, after establishing a 3321 communication link, the central surgical controllers exchange 3322 data packets. A data packet can include the type, identification number, and / or status of a central surgical controller. A data package may additionally include a register of devices under the control of the central surgical controller and / or any limited communication connection, such as data ports for other secondary devices in the operating room.
[0471] [0471] The control arrangement between central surgical controllers is then determined 3323 based on the input of a surgical operator or autonomously between central surgical controllers. Central surgical controllers can store instructions on how to determine a control arrangement with each other. The control arrangement between two central surgical controllers may depend on the type of surgical procedure being performed. The control arrangement between two central surgical controllers may depend on their types, identification information and / or situation. The control arrangement between two central surgical controllers may depend on the devices paired with the central surgical controllers. The central surgical controllers then redistribute 3324 devices from surgical system 102 to each other based on the determined control arrangement.
[0472] [0472] In the master-slave arrangement, the registration communication can be unidirectional from the slave central controller to the master central controller. The master central controller may also require the central controller to transfer some of its wireless devices to consolidate communication routes. In one aspect, the slave central controller can be relegated to a relay configuration with the master central controller originating all commands and recording all data. The slave central controller can remain connected to the master central controller for distributed subprocessing of master commands, registers and / or controls. Such an interaction expands the processing capacity of the pair of connected central controllers beyond the capabilities of the master central controller alone.
[0473] [0473] In a pairwise arrangement, each central surgical controller can retain control of its devices. In one aspect, central surgical controllers can collaborate to control a surgical instrument. In one aspect, a surgical instrument operator can designate the central surgical controller who will control the surgical instrument at the time of use.
[0474] [0474] With generic reference to Figures 56 to 61, the interaction between central surgical controllers can be extended beyond the limits of the operating room. In several respects, operating rooms in separate operating rooms can interact with each other within predefined limits. Depending on their relative proximity, central surgical controllers in separate operating rooms can interact via any wired or wireless data communication network, such as Bluetooth and WiFi. As used here, a "data communication network" represents any number of physical, virtual or logical components, including hardware, software, firmware and / or processing logic configured to support data communication between a source component and a target component, where data communication is performed according to a or more designated communication protocols over one or more designated communication media.
[0475] [0475] In several respects, a first surgical operator in a first operating room may wish to consult a second surgical operator in a second operating room, as in the case of an emergency. A temporary communication link can be established between the central surgical controllers in the first and second operating rooms to facilitate consultation while the first and second surgical operators remain in their respective operating rooms.
[0476] [0476] The surgical operator to be consulted can receive a consultation request through the central surgical controller in the operating room. If the surgical operator accepts, he will have access to all data compiled by the central surgical controller requesting the consultation. The surgical operator can access all previously stored data, including a complete history of the procedure. In addition, a live transmission from the surgical site in the order operating room can be done via the central surgical controllers to a screen in the receiving operating room.
[0477] [0477] When a request for consultation begins, the receiving central surgical controller begins to record all information received in a temporary storage location, which may be a dedicated portion of the central surgical controller's storage matrix. At the end of the consultation, the temporary storage location is purged of all information. In one aspect, during a consultation, the central surgical controller records all accessible data, including blood pressure, ventilation, oxygen statistics, generator settings and uses, and all electronic patient data. There will likely be more data recorded than data stored by the central surgical controller during normal operation, which is useful for providing the surgical operator with as much information as possible for consultation.
[0478] [0478] With reference to Figure 56, a non-limiting example of an interaction between central surgical controllers in different operating rooms is shown. Figure 56 represents an OR 1 operating room that includes a 3400 surgical system that supports a thoracic segmentectomy and a second OR 3 operating room that includes a 3410 surgical system that supports a colorectal procedure. The 3400 surgical system includes the central surgical controller 3401, the central surgical controller 3402 and the robotic central surgical controller 3403. The surgical system 3400 additionally includes a personal interface 3406, a primary screen 3408 and secondary screens 3404, 3405. The surgical system 3410 includes a 3411 central surgical controller and a 3412 secondary screen. For clarity, the various components of the 3400, 3410 surgical systems are removed.
[0479] [0479] In the example in Figure 56, the OR 3 surgical operator is requesting an appointment from the OR 1 surgical operator. The OR 3 central surgical controller 3411 transmits the query request to one of the OR 1 central surgical controllers, as the central surgical controller 3401. In OR 1, the central surgical controller 3401 presents the request on a personal interface 3406 made by the surgical operator. The consultation is about selecting an ideal site for a colon transection. The OR 1 surgical operator, through a 3406 personal interface, recommends an ideal location for the transection site that avoids a section of high colon vascularization. The recommendation is transmitted in real time via the central surgical controllers 3401, 3411. Consequently, the surgical operator is able to respond to the consultation request in real time without having to leave the sterile field of his own operating room. The surgical operator who requested the consultation also did not have to leave the sterile OR 3 field.
[0480] [0480] If the central surgical controller 3401 is not communicating with the personal interface 3406, it can transmit the message to another central surgical controller, such as
[0481] [0481] In any case, if the OR 1 surgical operator decides to accept the consultation request, a live transmission from a 3413 surgical site of the OR 3 colorectal procedure will be done to OR 1 through a connection established between the surgical controllers exchanges 3401, 3411, for example. Figure 57 illustrates a live transmission from surgical site 3413 displayed on a secondary OR 3 screen. Central surgical controllers 3401, 3411 cooperate to send live transmission from OR 3 surgical site to personal interface 3406 on OR 1 or as shown in Figure 58.
[0482] [0482] With reference to Figures 59 to 61, the surgical operator can expand the live transmission from OR 3 to primary screen 3405 in OR 1, for example, through the controls on the 3406 personal interface. The 3406 personal interface allows the surgical operator select a destination for live transmission by presenting icons to the surgical operator representing the views that are available in OR 1, as shown in Figure 60. Other 3407 navigation controls are available to the surgical operator via the personal interface 3406, as shown in Figure 61. For example, the 3406 personal interface includes navigation controls to adjust the live transmission from the OR 3 surgical site to OR 1 by the surgical operator by moving your fingers on the live transmission displayed on the 3406 personal interface. To view the regions of high vascularity, the surgical operator can change the view of the live transmission of OR 3 through the person interface l 3406 for an advanced imaging screen. The surgical operator can then manipulate the image in multiple planes to see vascularization using a wide multispectral viewing angle, for example.
[0483] [0483] As illustrated in Figure 61, the surgical operator also has access to an array of relevant 3420 information, such as heart rate, blood pressure, ventilation, oxygen statistics, generator settings and usage data, and all electronic patient data in OR 3. Situational Recognition
[0484] [0484] Situational recognition is the ability of some aspects of a surgical system to determine or infer information related to a surgical procedure from data received from databases and / or instruments. The information may include the type of procedure being performed, the type of tissue being operated on or the body cavity undergoing the procedure. With contextual information related to the surgical procedure, the surgical system can, for example, improve the way in which it controls the modular devices (for example, a robotic arm and / or robotic surgical instrument) that are connected to it and provide information or contextualized suggestions to the surgeon during the course of the surgical procedure.
[0485] [0485] Now with reference to Figure 62, a timeline 5200 represents the situational recognition of a central controller, such as the central surgical controller 106 or 206, for example. Timeline 5200 is an illustrative surgical procedure and the contextual information that the central surgical controller 106, 206 can derive from data received from data sources at each stage in the surgical procedure. Timeline 5200 represents the typical steps that would be taken by nurses, surgeons, and other medical personnel during the course of a pulmonary segmentectomy procedure, starting with the setup of the operating room and ending with the transfer of the patient to an operating room. postoperative recovery.
[0486] [0486] Situational recognition of a central surgical controller 106, 206 receives data from data sources throughout the course of the surgical procedure, including data generated each time medical personnel use a modular device that is paired with the central surgical controller 106, 206. Central surgical controller 106, 206 can receive this data from paired modular devices and other data sources and continually derive inferences (that is, contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being performed at any given time. The situational recognition system of the central surgical controller 106, 206 is capable of, for example, recording data related to the procedure to generate reports, checking the steps being taken by medical personnel, providing data or warnings (for example, through a display) that may be relevant to the specific step of the procedure, adjust the modular devices based on the context (for example, activate monitors, adjust the field of view of the medical imaging device, or change the energy level of an ultrasonic surgical instrument or electrosurgical instrument RF) and take any other action described above.
[0487] [0487] In the first step 5202, in this illustrative procedure, members of the hospital team retrieve the patient's electronic medical record (PEP) from the hospital's PEP database. Based on patient selection data in the PEP, the central surgical controller 106, 206 determines that the procedure to be performed is a thoracic procedure.
[0488] [0488] In the second step 5204, the team members scan the incoming medical supplies for the procedure. Central surgical controller 106, 206 cross-references the scanned supplies with a list of supplies that are used in various types of procedures and confirms that the supply mix corresponds to a thoracic procedure. In addition, the central surgical controller 106, 206 is also able to determine that the procedure is not a wedge procedure (because the inlet supplies have an absence of certain supplies that are necessary for a thoracic wedge procedure or, otherwise, that inlet supplies do not correspond to a thoracic wedge procedure).
[0489] [0489] In the third step 5206, the medical team scans the patient's bracelet with a scanner that is communicably connected to the central surgical controller 106, 206. The central surgical controller 106, 206 can then confirm the patient's identity based on the scanned data.
[0490] [0490] In the fourth step 5208, the medical team turns on the auxiliary equipment. The auxiliary equipment being used may vary according to the type of surgical procedure and the techniques to be used by the surgeon, but in this illustrative case, they include a smoke evacuator, an insufflator and a medical imaging device. When activated, auxiliary equipment that is modular devices can automatically pair with the central surgical controller 106, 206 which is located within a specific neighborhood of modular devices as part of their initialization process. The central surgical controller 106, 206 can then derive contextual information about the surgical procedure by detecting the types of modular devices that correspond with it during that preoperative or initialization phase. In this particular example, the central surgical controller 106, 206 determines that the surgical procedure is a VATS (video-assisted thoracic surgery) procedure based on this specific combination of paired modular devices. Based on the combination of data from the electronic patient record (PEP), the list of medical supplies to be used in the procedure, and the type of modular devices that connect to the central controller, the central surgical controller 106, 206 can, in general , infer the specific procedure that the surgical team will perform. After the central surgical controller 106, 206 recognizes which specific procedure is being performed, the central surgical controller 106, 206 can then retrieve the steps of that process from a memory or from the cloud and then cross the data it subsequently receives from the connected data sources (for example, modular devices and patient monitoring devices) to infer which stage of the surgical procedure the surgical team is performing.
[0491] [0491] In the fifth step 5210, members of the medical team fix the electrocardiogram (ECG) electrodes and other patient monitoring devices on the patient. ECG electrodes and other patient monitoring devices are able to pair with the central surgical controller 106, 206. As central surgical controller 106, 206 begins to receive data from patient monitoring devices, the central surgical controller 106, 206 thus confirming that the patient is in the operating room.
[0492] [0492] In the sixth step 5212, medical personnel induce anesthesia in the patient. Central surgical controller 106, 206 can infer that the patient is under anesthesia based on data from modular devices and / or patient monitoring devices, including ECG data, blood pressure data, ventilator data, or combinations of themselves, for example. After the completion of the sixth step 5212, the preoperative portion of the lung segmentectomy procedure is completed and the operative portion begins.
[0493] [0493] In the seventh step 5214, the lung of the patient being operated on collapses (while ventilation is diverted to the contralateral lung). The central surgical controller 106, 206 can infer from the ventilator data that the patient's lung has collapsed, for example. Central surgical controller 106, 206 can infer that the operative portion of the procedure has started when it can compare the detection of the patient's lung collapse at the expected stages of the procedure (which can be accessed or retrieved earlier) and thus determine that the lung collapse is the first operative step in this specific procedure.
[0494] [0494] In the eighth step 5216, the medical imaging device (for example, a display device) is inserted and the video from the medical imaging device is started. Central surgical controller 106, 206 receives data from the medical imaging device (i.e., video or image data) through its connection to the medical imaging device. Upon receipt of data from the medical imaging device, the central surgical controller 106, 206 can determine that the portion of the laparoscopic surgical procedure has started. In addition, the central surgical controller 106, 206 can determine that the specific procedure being performed is a segmentectomy, rather than a lobectomy (note that a wedge procedure has already been discarded by the central surgical controller 106, 206 based on the data received in the second step 5204 of the procedure). The data from the medical imaging device 124 (Figure 2) can be used to determine contextual information about the type of procedure being performed in several different ways, including by determining the angle at which the medical imaging device is oriented in relation to viewing of the patient's anatomy, monitoring the number of medical imaging devices being used (ie, that are activated and paired with the central surgical controller 106, 206) and monitoring the types of visualization devices used. For example, a technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest cavity above the diaphragm, while a technique for performing a VATS segmentectomy places the camera in an anterior intercostal position in relation to the segment fissure. With the use of standard recognition or machine learning techniques, for example, the situational recognition system can be trained to recognize the positioning of the medical imaging device according to the visualization of the patient's anatomy. As another example, a technique for performing a VATS lobectomy uses a single medical imaging device, while another technique for performing a VATS segmentectomy uses multiple cameras. As yet another example, a technique for performing a VATS segmentectomy uses an infrared light source (which can be communicably coupled to the central surgical controller as part of the visualization system) to visualize the segment crack, which is not used in a VATS lobectomy. By tracking any or all of these data from the medical imaging device, the central surgical controller 106, 206 can thus determine the specific type of surgical procedure being performed and / or the technique being used for a specific type of procedure surgical.
[0495] [0495] In the ninth step 5218, the surgical team starts the dissection step of the procedure. Central surgical controller 106, 206 can infer that the surgeon is in the process of dissecting to mobilize the patient's lung because he receives data from the RF or ultrasonic generator that indicate that an energy instrument is being fired. The central surgical controller 106, 206 can cross-check the received data with the steps retrieved from the surgical procedure to determine that an energy instrument being fired at that point in the process (that is, after the completion of the previously discussed steps of the procedure) corresponds to the step of dissection. In certain cases, the energy instrument may be a power tool mounted on a robotic arm in a robotic surgical system.
[0496] [0496] In the tenth step 5220, the surgical team proceeds to the step of connecting the procedure. Central surgical controller 106, 206 can infer that the surgeon is ligating the arteries and veins because he receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired. Similar to the previous step, the central surgical controller 106, 206 can derive this inference by crossing the reception data of the stapling and surgical cutting instrument with the steps recovered in the process. In certain cases, the surgical instrument can be a surgical tool mounted on a robotic arm of a robotic surgical system.
[0497] [0497] In the eleventh step 5222, the segmentectomy portion of the procedure is performed. Central surgical controller 106, 206 can infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond to the size or type of clamp being triggered by the instrument, for example. As different types of staples are used for different types of fabrics, the cartridge data can thus indicate the type of fabric being stapled and / or transected. In this case, the type of clamp that is fired is used for the parenchyma (or other similar types of tissue), which allows the central surgical controller 106, 206 to infer which segmentectomy portion of the procedure is being performed.
[0498] [0498] In the twelfth step 5224, the node dissection step is then performed. The central surgical controller 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on the data received from the generator that indicates which ultrasonic or RF instrument is being fired. For this specific procedure, an RF or ultrasonic instrument being used after the parenchyma has been transected corresponds to the node dissection step, which allows the central surgical controller 106, 206 to make this inference. It should be noted that surgeons regularly switch between surgical stapling / cutting instruments and surgical energy instruments (that is, RF or ultrasonic) depending on the specific step in the procedure because different instruments are better adapted for specific tasks. Therefore, the specific sequence in which the cutting / stapling instruments and surgical energy instruments are used can indicate which stage of the procedure the surgeon is performing. In addition, in certain cases, robotic tools can be used for one or more steps in a surgical procedure and / or hand-held surgical instruments can be used for one or more steps in a surgical procedure. The surgeon can switch between robotic tools and hand-held surgical instruments and / or can use the devices simultaneously, for example. After the completion of the twelfth stage 5224, the incisions are closed and the post-operative portion of the process begins.
[0499] [0499] In the thirteenth stage 5226, the patient's anesthesia is reversed. The central surgical controller 106, 206 can infer that the patient is emerging from anesthesia based on ventilator data (i.e., the patient's respiratory rate begins to increase), for example.
[0500] [0500] Finally, in the fourteenth step 5228, medical personnel remove the patient's various patient monitoring devices. Central surgical controller 106, 206 can thus infer that the patient is being transferred to a recovery room when the central controller loses ECG, blood pressure and other data from patient monitoring devices. As can be seen from the description of this illustrative procedure, the central surgical controller 106, 206 can determine or infer when each step of a given surgical procedure is taking place according to the data received from the various data sources that are communicably coupled to the controller central surgery 106, 206.
[0501] [0501] Situational perception is further described in US provisional patent application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, which is hereby incorporated by reference in its entirety. In certain cases, the operation of a robotic surgical system, including the various robotic surgical systems disclosed here, for example, can be controlled by the central surgical controller 106, 206 based on its situational perception and / or feedback from its components and / or based on information from the cloud 102.
[0502] [0502] Various aspects of the subject described here are defined in the following numbered examples.
[0503] [0503] Example 1. Central surgical controller configured to transmit generator data associated with a surgical procedure from a central surgical controller generator to a cloud-based system communicatively coupled to a plurality of central surgical controllers, the surgical controller being central comprises: a processor; and a memory coupled to the processor, the memory stores instructions executable by the processor to: receive data from the generator, the data from the generator being structured in a data package comprising at least two of the following fields: a field indicating a source of the data; an exclusive timestamp; a field indicating a generator power mode; a field that indicates a power output from the generator; and a field indicating a duration of the generator's power output; encrypt the generator data; generate a message authentication code based on the generator data; generate a datagram comprising the encrypted generator data, the generated message authentication code, a source identifier and a destination identifier; and transmitting the datagram to a cloud-based system, the datagram enabling the cloud-based system to: decrypt the encrypted generator data of the transmitted datagram; verify the integrity of the generator data based on the message authentication code; authenticate the central surgical controller as the origin of the datagram; and validating a transmission path followed by the datagram between the central surgical controller and the cloud-based system.
[0504] [0504] Example 2. Central surgical controller, according to Example 1, in which the generation of the datagram comprises: generating a data header, the datagram header being structured to understand: a field indicating an associated IP address the central surgical controller; and a field indicating an IP address associated with the cloud-based system; and generate a datagram payload, the datagram payload being structured to understand the encrypted generator data and the generated message authentication code.
[0505] [0505] Example 3. Central surgical controller, according to
[0506] [0506] Example 4. Central surgical controller, according to any of Examples 1 to 3, in which the instructions are additionally executable by the processor to: receive a reception message from the cloud-based system in response to the transmitted datagram, the reception message indicates at least one among: the integrity of the generator data, which was decrypted from the transmitted datagram, was verified by the cloud-based system; the central surgical controller has been authenticated as the origin of the datagram by the cloud-based system; or the transmission path followed by the datagram transmitted between the central surgical controller and the cloud-based system has been validated by the cloud-based system.
[0507] [0507] Example 5. Central surgical controller, from any of Examples 1 to 4, in which the instructions are additionally executable by the processor to: send a message to the cloud-based system, the message requesting data recommended for the generator associated with a specific surgical procedure; receiving a response datagram from the cloud-based system, the response datagram comprising encrypted recommended data for the generator and a response message authentication code; decrypt the data recommended for the generator encrypted from the response datagram, the data recommended for the generator being structured and placed in a response data package comprising at least one of the following fields: a field indicating a power mode the generator for the specific surgical procedure; a field that indicates an energy output from the generator for the specific surgical procedure; or a field that indicates a duration of the generator's energy output for the specific surgical procedure; verify the integrity of the data recommended for the generator based on the response message authentication code; and send the recommended data for the generator to the generator for implementation, through a generator module, during the specific surgical procedure.
[0508] [0508] Example 6. Central surgical controller, according to Example 5, in which the data recommended for the generator are based on generator data associated with the specific surgical procedure as safely transmitted by the plurality of central surgical controllers for the system based on cloud over time.
[0509] [0509] Example 7. Central surgical controller, according to Example 1, in which the generation of the message authentication code comprises: calculating the message authentication code based on a key, a hash function and one of the data received generator data or encrypted generator data.
[0510] [0510] Example 8. Central surgical controller, according to Example 7, in which the key is a secret key and the hash algorithm is a message authentication code algorithm, and the calculation of the authentication code of The message comprises processing the encrypted generator data using the message authentication code algorithm using the secret key.
[0511] [0511] Example 9. Central surgical controller, according to any of Examples 7 and 8, in which the key is a secret key and the hashing algorithm is a message authentication code algorithm, and the calculation of the message authentication code comprises processing the generator data received through the message authentication code algorithm using the secret key.
[0512] [0512] Example 10. Central surgical controller, according to Example 1, in which the encryption of the generator data comprises encrypting the generator data received using a shared secret or a public key associated with the cloud-based system .
[0513] [0513] Example 11. Central surgical controller configured to transmit generator data associated with a surgical procedure from a generator of the central surgical controller to a cloud-based system communicatively coupled to a plurality of central surgical controllers, the surgical controller being central comprises: receiving data from the generator generator, the data of the generator being structured in a data package comprising at least two of the following fields: a field that indicates a source of the data; an exclusive timestamp; a field indicating a generator power mode; a field that indicates a power output from the generator; and a field indicating a duration of the generator's power output; encrypt the generator data; generate a message authentication code based on the generator data; generate a datagram comprising the encrypted generator data, the generated message authentication code, a source identifier and a destination identifier; and transmitting the datagram to a cloud-based system, the datagram enabling the cloud-based system to: decrypt the encrypted generator data of the transmitted datagram; verify the integrity of the generator data based on the message authentication code; authenticate the central surgical controller as the origin of the datagram; and validating a transmission path followed by the datagram between the central surgical controller and the cloud-based system.
[0514] [0514] Example 12. Central surgical controller, according to Example 11, in which the control circuit is additionally configured to: send a message to the cloud-based system, the message requesting recommended data for the generator associated with a specific surgical procedure; receiving a response datagram from the cloud-based system, the response datagram comprising encrypted recommended data for the generator and a response message authentication code; decrypt the data recommended for the generator encrypted from the response datagram, the data recommended for the generator being structured and placed in a response data package comprising at least one of the following fields: a field indicating a power mode the generator for the specific surgical procedure; a field that indicates an energy output from the generator for the specific surgical procedure; or a field that indicates a duration of the generator's energy output for the specific surgical procedure; verify the integrity of the data recommended for the generator based on the response message authentication code; and send the recommended data for the generator to the generator for implementation, through a generator module, during the specific surgical procedure.
[0515] [0515] Example 13. Central surgical controller, according to any of Examples 11 and 12, in which the data recommended for the generator are based on generator data associated with the specific surgical procedure as safely transmitted by the plurality of central surgical controllers for the cloud-based system over time.
[0516] [0516] Example 14. Central surgical controller configured to prioritize surgical data associated with a surgical procedure from a surgical device of the central surgical controller to a cloud-based system communicatively coupled to a plurality of central surgical controllers, the surgical controller being central comprises: a processor; and a memory attached to the processor, the memory stores instructions executable by the processor to: capture surgical data, and the surgical data comprises data associated with the surgical device; apply a timestamp to the captured surgical data; identify a failure event; identify a period of time associated with the failure event; isolate surgical data from the failure event and surgical data not associated with the failure event based on the identified time period; create a chronology of the surgical data of the failure event using timestamps; encrypt the surgical data of the failure event created by chronology; generate a datagram that comprises the encrypted failure event surgical data, the datagram is structured to include a field that includes a flag that prioritizes the encrypted failure event surgical data over other encrypted data in the datagram; transmit the datagram to the cloud-based system, the datagram being the cloud-based system: decrypt the surgical data of the encrypted failure event; focus the analysis on the surgical data of the failure event instead of on the surgical data not associated with the failure event; and mark the surgical device associated with the failure event for at least one of: be removed from the operating room; be returned to the manufacturer; future inoperability in the cloud-based system; or downloading an update to prevent failure events.
[0517] [0517] Example 15. Central surgical controller, according to
[0518] [0518] Example 16. Central surgical controller, according to any of Examples 14 and 15, in which instructions are additionally executable by the processor to: download a program from the cloud-based system for execution by the surgical device , and the execution of the program modifies the surgical device to avoid poorly implanted staples.
[0519] [0519] Example 17. Central surgical controller, according to any of Examples 14 to 16, in which the surgical device comprises an end actuator that includes a temperature sensor, the captured surgical data comprising at least one detected temperature by the temperature sensor during a tissue sealing portion of a surgical procedure, and the identification of the failure event comprises comparing at least one detected temperature with a temperature or a temperature range associated with that surgical procedure to detect a temperature inadequate sealing.
[0520] [0520] Example 18. Central surgical controller, according to Example 17, in which instructions are additionally executable by the processor to: download a program from the cloud-based system for execution by the surgical device, the execution of which program modifies the surgical device to avoid inadequate sealing temperatures.
[0521] [0521] Example 19. Central surgical controller, according to Example 14, in which the identified period of time includes a period of time before the failure event is identified.
[0522] [0522] Example 20. Central surgical controller, according to any of Examples 14 to 18, where the instructions are additionally executable by the processor to: receive an action message from the cloud-based system, with the action message indicating the surgical device as marked for at least one of: to be removed from the operating room; be returned to the manufacturer; future inoperability in the cloud-based system; or download an update to prevent failure events; and providing a notification, via at least one of a central surgical controller user interface or a surgical device user interface, to perform an action associated with the action message.
[0523] [0523] Although various forms have been illustrated and described, it is not the applicant's intention to restrict or limit the scope of the claims attached to such detail. Numerous modifications, variations, alterations, substitutions, combinations and equivalents of these forms can be implemented and will occur to those skilled in the art without departing from the scope of this disclosure. In addition, the structure of each element associated with the shape can alternatively be described as a means of providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials can be used. It should be understood, therefore, that the preceding description and the appended claims are intended to cover all such modifications,
[0524] [0524] The previous detailed description presented various forms of devices and / or processes through the use of block diagrams, flowcharts and / or examples. Although these block diagrams, flowcharts and / or examples contain one or more functions and / or operations, it will be understood by those skilled in the art that each function and / or operation within these block diagrams, flowcharts and / or examples can be implemented, individually and / or collectively, through a wide range of hardware, software, firmware or virtually any combination thereof. Those skilled in the art will recognize, however, that some aspects of the aspects disclosed herein, in whole or in part, may be implemented in an equivalent manner in integrated circuits, such as one or more computer programs running on one or more computers (for example, as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (for example, as one or more programs running on one or more microprocessors), as firmware, or virtually as any combination of them, and that designing the circuitry and / or writing the code for the software and firmware would be within the scope of practice of those skilled in the art, in light of this disclosure. In addition, those skilled in the art will understand that the mechanisms of the subject described herein can be distributed as one or more program products in a variety of ways and that an illustrative form of the subject described here is applicable regardless of the specific type of transmission medium. signals used to effectively carry out the distribution.
[0525] [0525] The instructions used to program the logic to execute various disclosed aspects can be stored in a memory in the system, such as dynamic random access memory (DRAM), cache, flash memory or other storage. In addition, instructions can be distributed over a network or through other computer-readable media. Thus, machine-readable media can include any mechanism to store or transmit information in a machine-readable form (for example, a computer), but is not limited to, floppy disks, optical discs, read-only compact disc ( CD-ROMs), and optical-dynamos discs, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), cards magnetic or optical, flash memory, or machine-readable tangible storage media used to transmit information over the Internet via an electrical, optical, acoustic cable or other forms of propagation signals (for example, carrier waves, infrared signal, digital signals, etc.). Consequently, computer-readable non-transitory media includes any type of machine-readable media suitable for storing or transmitting instructions or electronic information in a machine-readable form (for example, a computer).
[0526] [0526] As used in any aspect of the present invention, the term "control circuit" can refer to, for example, a set of wired circuits, programmable circuits (for example, a computer processor comprising one or more cores individual instruction processing units, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic matrix (PLA), or field programmable port arrangement ( FPGA)), state machine circuits, firmware that stores instructions executed by the programmable circuit, and any combination thereof. The control circuit can, collectively or individually, be incorporated as an electrical circuit that is part of a larger system, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), an on-chip system (SoC ), desktop computers, laptop computers, tablet computers, servers, smart headsets, etc. Consequently, as used in the present invention, "control circuit" includes, but is not limited to, electrical circuits that have at least one discrete electrical circuit, electrical circuits that have at least one integrated circuit, electrical circuits that have at least one circuit integrated for specific application, electrical circuits that form a general purpose computing device configured by a computer program (for example, a general purpose computer configured by a computer program that at least partially executes processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially performs the processes and / or devices described here), electrical circuits that form a memory device (for example, forms of random access memory), and / or electrical circuits that form a communications device (for example, a modem, communication key, or eq optical-electrical equipment). Those skilled in the art will recognize that the subject described here can be implemented in an analog or digital way, or in some combination of these.
[0527] [0527] As used in any aspect of the present invention, the term "logical" can refer to an application, software, firmware and / or circuit configured to perform any of the aforementioned operations. The software may be incorporated as a software package, code, instructions, instruction sets and / or data recorded on the computer-readable non-transitory storage media. The firmware can be embedded as code, instructions or instruction sets and / or data that are hard-coded (for example, non-volatile) in memory devices.
[0528] [0528] As used in any aspect of the present invention, the terms "component", "system", "module" and the like may refer to a computer-related entity, be it hardware, a combination of hardware and software, software or software running.
[0529] [0529] As used here in one aspect of the present invention, an "algorithm" refers to the self-consistent sequence of steps that lead to the desired result, where a "step" refers to the manipulation of physical quantities and / or logical states that can, although they do not necessarily need to, take the form of electrical or magnetic signals that can be stored, transferred, combined, compared and manipulated in any other way. It is common use to call these signs bits, values, elements, symbols, characters, terms, numbers or the like. These terms and similar terms may be associated with the appropriate physical quantities and are merely convenient identifications applied to these quantities and / or states.
[0530] [0530] A network may include a packet-switched network. Communication devices may be able to communicate with each other using a selected packet switched network communications protocol. An exemplary communications protocol may include an Ethernet communications protocol that may be able to allow communication using a transmission control protocol / Internet protocol (TCP / IP). The protocol
[0531] [0531] Unless otherwise stated, as is evident from the foregoing disclosure, it is understood that, throughout the preceding disclosure, discussions using terms such as "processing", "computation", "calculation", "determination", "display" or similar, refers to the action and processes of a computer, or similar electronic computing device, that manipulates and transforms the data represented in the form of physical (electronic) quantities in the computer's records and memories into other data similarly represented in the form of physical quantities in the memories or records of the computer, or in other similar information storage, transmission or display devices.
[0532] [0532] One or more components in the present invention may be called "configured for", "configurable for", "operable / operational for", "adapted / adaptable for", "capable of", "conformable / conformed for", etc. Those skilled in the art will recognize that "configured for" may, in general, cover components in an active state and / or components in an inactive state and / or components in a standby state, except when the context determines otherwise.
[0533] [0533] The terms "proximal" and "distal" are used in the present invention with reference to a physician who handles the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the doctor, and the term "distal" refers to the portion located opposite the doctor. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "up" and "down" can be used in the present invention with respect to the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0534] [0534] Persons skilled in the art will recognize that, in general, the terms used here, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as "open" terms (for example, the term "including" should be interpreted as "including, but not limited to", the term "having" should be interpreted as "having, at least", the term "includes"
[0535] [0535] Furthermore, even if a specific number of an introduced claim statement is explicitly mentioned, those skilled in the art will recognize that that statement must typically be interpreted as meaning at least the number mentioned (for example, the mere mention of "two mentions ", without other modifiers, typically means at least two mentions, or two or more mentions). In addition, in cases where a convention analogous to "at least one of A, B and C, etc." is used, in general this construction is intended to have the meaning in which the convention would be understood by (for example, "a system that has at least one of A, B and C "would include, but not be limited to, systems that have A alone,
[0536] [0536] With respect to the attached claims, those skilled in the art will understand that the operations mentioned in them can, in general, be carried out in any order. In addition, although several operational flow diagrams are presented in one or more sequences, it must be understood that the various operations can be performed in other orders than those shown, or can be performed simultaneously. Examples of such alternative orderings may include overlapping, merged, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, inverse or other variant orders, unless the context otherwise requires. In addition, terms such as "responsive to", "related to" or other adjectival participles are not intended in general to exclude these variants, unless the context otherwise requires.
[0537] [0537] It is worth noting that any reference to "one (1) aspect", "one aspect", "an exemplification" or "one (1) exemplification", and the like means that a particular feature, structure or feature described in connection with the aspect is included in at least one aspect. Thus, the use of expressions such as "in one (1) aspect", "in one aspect", "in an exemplification", "in one (1) exemplification", in several places throughout this specification does not necessarily refer the same aspect. In addition, specific resources, structures or characteristics can be combined in any appropriate way in one or more aspects.
[0538] [0538] Any patent application, patent, non-patent publication or other description material mentioned in this specification and / or mentioned in any order data sheet is hereby incorporated by reference, to the extent that the materials incorporated are not inconsistent with that. Accordingly, and to the extent necessary, disclosure as explicitly presented herein replaces any conflicting material incorporated by reference to the present invention. Any material, or portion thereof, which is incorporated herein by reference, but which conflicts with the definitions, statements, or other disclosure materials contained herein, will be incorporated here only to the extent that there is no conflict between the embedded material and existing advertising material.
[0539] [0539] In summary, numerous benefits have been described that result from the use of the concepts described in this document. The previously mentioned description of one or more modalities has been presented for purposes of illustration and description. This description is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. One or more modalities were chosen and described in order to illustrate the principles and practical application to, thus, allow those skilled in the art to use the various modalities and with various modifications, as they are convenient to the specific use contemplated.
It is intended that the claims presented in the annex define the global scope.
权利要求:
Claims (20)
[1]
1. Central surgical controller configured to transmit generator data associated with a surgical procedure from a central surgical controller generator to a cloud-based system communicatively coupled to a plurality of central surgical controllers, characterized by comprising: a processor; and a memory coupled to the processor, the memory stores instructions executable by the processor to: receive data from the generator, and the data from the generator are structured in a data package that comprises at least two of the following fields: a field that indicates the data source; an exclusive timestamp; a field indicating a generator power mode; a field that indicates a power output from the generator; and a field indicating a duration of the generator's power output; encrypt the generator data; generate a message authentication code based on the generator data; generate a datagram comprising: the encrypted generator data, the generated message authentication code, a source identifier and a destination identifier; and transmitting the datagram to the cloud-based system, the datagram allowing the cloud-based system to: decrypt the encrypted generator data of the transmitted datagram; verify the integrity of the generator data based on the message authentication code;
authenticate the central surgical controller as the origin of the datagram; and validate a transmission path followed by the datagram between the central surgical controller and the cloud-based system.
[2]
2. Central surgical controller, according to claim 1, characterized in that the datagram comprises: generating a header of the datagram, the header of the datagram being structured to comprise: a field that indicates an IP address associated with the central surgical controller; and a field indicating an IP address associated with the cloud-based system; and generate a datagram payload, the datagram payload being structured to understand the encrypted generator data and the generated message authentication code.
[3]
Central surgical controller, according to claim 2, characterized in that the datagram header is additionally structured to comprise: a field that indicates a transmission path that designates at least one IP address associated with at least one intermediate network component through from which the datagram must pass as the datagram is transmitted from the IP address associated with the central surgical controller to the IP address associated with the cloud-based system.
[4]
Central surgical controller, according to claim 1, characterized in that the instructions are additionally executable by the processor to: receive a reception message from the cloud-based system in response to the transmitted datagram, the reception message indicating at least one among:
the integrity of the generator data, decrypted from the transmitted datagram, was verified by the cloud-based system; the central surgical controller has been authenticated as the origin of the datagram by the cloud-based system; or the transmission path followed by the datagram transmitted between the central surgical controller and the cloud-based system has been validated by the cloud-based system.
[5]
5. Central surgical controller, according to claim 1, characterized in that the instructions are additionally executable by the processor to: send a message to the cloud-based system, the message requesting data recommended for the generator associated with a specific surgical procedure ; receiving a response datagram from the cloud-based system, the response datagram comprising encrypted recommended data for the generator and a response message authentication code; decrypt the data recommended for the generator encrypted from the response datagram, the data recommended for the generator being structured and placed in a response data package comprising at least one of the following fields: a field indicating a power mode the generator for the specific surgical procedure; a field that indicates an energy output from the generator for the specific surgical procedure; or a field that indicates a duration of the generator's energy output for the specific surgical procedure; verify the integrity of the data recommended for the generator based on the response message authentication code; and send the recommended data for the generator to the generator for implementation, through a generator module, during the specific surgical procedure.
[6]
6. Central surgical controller, according to claim 5, characterized in that the data recommended for the generator are based on generator data associated with the specific surgical procedure as safely transmitted by the plurality of central surgical controllers for the cloud-based system over the time.
[7]
Central surgical controller, according to claim 1, characterized in that the generation of the message authentication code comprises: calculating the message authentication code based on a key, a hash function and one of the generator data received or encrypted generator data.
[8]
Central surgical controller, according to claim 7, characterized in that the key is a secret key and the hashing algorithm is a message authentication code algorithm, and the calculation of the message authentication code comprises processing the generator data encrypted using the message authentication code algorithm using the secret key.
[9]
Central surgical controller, according to claim 7, characterized in that the key is a secret key and the hashing algorithm is a message authentication code algorithm, and the message authentication code calculation comprises processing the generator data received through the message authentication code algorithm using the secret key.
[10]
10. Central surgical controller, according to claim 1, characterized in that the encryption of the generator data comprises encrypting the generator data received using a shared secret or a public key associated with the cloud-based system.
[11]
11. Central surgical controller configured to transmit generator data associated with a surgical procedure from a central surgical controller generator to a cloud-based system communicatively coupled to a plurality of central surgical controllers, characterized by comprising: a configured control circuit to: receive data from the generator, the data from the generator being structured in a data package comprising at least two of the following fields: a field that indicates the source of the data; an exclusive timestamp; a field indicating a generator power mode; a field that indicates a power output from the generator; and a field indicating a duration of the generator's power output; encrypt the generator data; generate a message authentication code based on the generator data; generate a datagram comprising the encrypted generator data, the generated message authentication code, a source identifier and a destination identifier; and transmitting the datagram to a cloud-based system, the datagram allowing the cloud-based system to: decrypt the encrypted generator data of the transmitted datagram; verify the integrity of the generator data based on the message authentication code;
authenticate the central surgical controller as the origin of the datagram; and validate a transmission path followed by the datagram between the central surgical controller and the cloud-based system.
[12]
12. Central surgical controller, according to claim 11, characterized in that the control circuit is additionally configured to: send a message to the cloud-based system, the message requesting data recommended for the generator associated with a specific surgical procedure ; receiving a response datagram from the cloud-based system, the response datagram comprising encrypted recommended data for the generator and a response message authentication code; decrypt the data recommended for the generator encrypted from the response datagram, the data recommended for the generator being structured and placed in a response data package comprising at least one of the following fields: a field indicating a power mode the generator for the specific surgical procedure; a field that indicates an energy output from the generator for the specific surgical procedure; or a field that indicates a duration of the generator's energy output for the specific surgical procedure; verify the integrity of the data recommended for the generator based on the response message authentication code; and send the recommended data for the generator to the generator for implementation, through a generator module, during the specific surgical procedure.
[13]
13. Central surgical controller, according to claim 12, characterized in that the data recommended for the generator is based on generator data associated with the specific surgical procedure as safely transmitted by the plurality of central surgical controllers for the cloud-based system over the time.
[14]
14. Central surgical controller characterized by being configured to prioritize surgical data associated with a surgical procedure from a surgical device of the central surgical controller to a cloud-based system communicatively coupled to a plurality of central surgical controllers, the central surgical controller being comprises: a processor; and a memory attached to the processor, the memory stores instructions executable by the processor to: capture surgical data, and the surgical data comprises data associated with the surgical device; apply a timestamp to the captured surgical data; identify a failure event; identify a period of time associated with the failure event; isolate surgical data from the failure event and surgical data not associated with the failure event based on the identified time period; create a chronology of the surgical data of the failure event using timestamps; encrypt the surgical data of the failure event created by chronology; generate a datagram that comprises the encrypted failure event surgical data, the datagram is structured to include a field that includes a flag that prioritizes the encrypted failure event surgical data over other encrypted data in the datagram; transmitting the datagram to the cloud-based system, the datagram allowing the cloud-based system to: decrypt the encrypted failure event surgical data; focus the analysis on the surgical data of the failure event instead of on the surgical data not associated with the failure event; and mark the surgical device associated with the failure event for at least one of: to be removed from an operating room; be returned to the manufacturer; future inoperability in the cloud-based system; or download an update to avoid failure events.
[15]
Central surgical controller according to claim 14, characterized in that the surgical device comprises an end actuator that includes a staple cartridge, the captured surgical data comprising instantaneous images captured through an endoscope of the central surgical controller during a stapling portion of a surgical procedure, and the identification of the failure event comprises comparing, through an imaging module of the central surgical controller, the instant images with images showing correctly implanted staples to capture at least one among a bad staple implanted or evidence of a poorly implanted staple.
[16]
16. Central surgical controller, according to claim 15, characterized in that the instructions are additionally executable by the processor to: download a program from the cloud-based system for execution by the surgical device, the execution of the program modifying the surgical device to prevent poorly implanted staples.
[17]
Central surgical controller, according to claim 14, characterized in that the surgical device comprises an end actuator that includes a temperature sensor, the captured surgical data comprising at least one temperature detected by the temperature sensor during a portion of tissue sealing of a surgical procedure, and the identification of the failure event comprises comparing at least one detected temperature with a temperature or a range of temperatures associated with that surgical procedure to detect an inadequate sealing temperature.
[18]
18. Central surgical controller, according to claim 17, characterized in that the instructions are additionally executable by the processor to: download a program from the cloud-based system for execution by the surgical device, the execution of the program modifying the surgical device to avoid inadequate sealing temperatures.
[19]
19. Central surgical controller according to claim 14, characterized in that the identified period of time includes a period of time before the failure event is identified.
[20]
20. Central surgical controller, according to claim 14, characterized in that the instructions are additionally executable by the processor to:
receive an action message from the cloud-based system, the action message indicating the surgical device as marked for at least one of the following: to be removed from the operating room; be returned to the manufacturer; future inoperability in the cloud-based system; or download an update to avoid failure events; and providing a notification, via at least one of a central surgical controller user interface or a surgical device user interface, to perform an action associated with the action message.
类似技术:
公开号 | 公开日 | 专利标题
BR112020012737A2|2020-12-01|interactive surgical systems with encrypted communication capabilities
BR112020013243A2|2020-12-22|PROVISIONS OF CENTRAL SURGICAL CONTROLLER
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BR112020012382A2|2020-11-24|coordination by a central surgical controller of control and communications of devices in an operating room
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BR112020012793A2|2020-12-01|cloud-based medical analysis for security and authentication trends and reactive measures
BR112020013040A2|2020-11-24|adaptive control program updates for central surgical controllers
BR112020012965A2|2020-12-01|updates of adaptive control programs for surgical devices
BR112020013225A2|2020-12-01|data handling and prioritization in a cloud-based data analysis network
BR112020013102A2|2020-12-01|cloud interface for attached surgical devices
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同族专利:
公开号 | 公开日
WO2019133056A1|2019-07-04|
CN111512392A|2020-08-07|
EP3506312A1|2019-07-03|
US10944728B2|2021-03-09|
US20210336939A1|2021-10-28|
US20190207911A1|2019-07-04|
JP2021509195A|2021-03-18|
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法律状态:
2021-12-07| B350| Update of information on the portal [chapter 15.35 patent gazette]|
优先权:
申请号 | 申请日 | 专利标题
US201762611339P| true| 2017-12-28|2017-12-28|
US201762611340P| true| 2017-12-28|2017-12-28|
US201762611341P| true| 2017-12-28|2017-12-28|
US62/611,341|2017-12-28|
US62/611,339|2017-12-28|
US62/611,340|2017-12-28|
US201862649302P| true| 2018-03-28|2018-03-28|
US62/649,302|2018-03-28|
US15/940,641|2018-03-29|
US15/940,641|US10944728B2|2017-12-28|2018-03-29|Interactive surgical systems with encrypted communication capabilities|
PCT/US2018/044138|WO2019133056A1|2017-12-28|2018-07-27|Interactive surgical systems with encrypted communication capabilities|
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