updates of adaptive control programs for surgical devices

专利摘要:
The present invention relates to several analytical systems. An analytical system is configured to connect in a communicable way to the central surgical controller. The central surgical controller is configured to connect in a communicable way to a modular device that is controlled by a control program. The analytical system comprises a processor and a memory attached to the processor. The memory stores instructions that, when executed by the processor, cause the analytical system to: receive perioperative data indicative of an operational behavior of the modular device, with perioperative data comprising data detected by the modular device during a surgical procedure; receive procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operating behavior is below ideal; generate a control program update configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
公开号:BR112020012965A2
申请号:R112020012965-8
申请日:2018-07-31
公开日:2020-12-01
发明作者:Jason L. Harris；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 number 62 / 649,296, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES, filed March 28, 2018 , whose description is hereby incorporated by reference in its entirety for reference.
[0002] [0002] This application also claims priority benefit under US $ 119 (e) to US Provisional Patent Application serial number 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, with US Provisional Patent Application serial number 62 / 611.340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed on December 28, 2017, and US Provisional Patent Application serial number 62 / 611.339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, the description of each of them being incorporated here for reference in its entirety. BACKGROUND
[0003] [0003] The present invention relates to various surgical systems. In the digital and information age, the implementation of systems or procedures that use newer and improved technologies in medical systems and facilities is often slower due to patient safety and a general desire to maintain traditional practices. However, medical systems and facilities can often lack communication and knowledge shared with other neighboring or similarly located facilities as a result. To improve patient practices, it would be desirable to find ways to assist with better interconnection of medical systems and facilities. SUMMARY
[0004] [0004] In general, an analytical system is provided. The analytical system is configured to connect in a communicable way to the central surgical controller. The central surgical controller is configured to connect in a communicable way to a modular device that is controlled by a control program. The analytical system comprises a processor and a memory attached to the processor. The memory stores instructions that, when executed by the processor, cause the analytical system to: receive perioperative data indicative of an operational behavior of the modular device, with perioperative data comprising data detected by the modular device during a surgical procedure; receive procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operating behavior is below ideal; generate a control program update configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
[0005] [0005] In another general aspect, another analytical system is provided. The analytical system is configured to connect in a communicable way to the central surgical controller. The central surgical controller is configured to connect in a communicable way to a modular device that is controlled by a control program. The analytical system comprises a control circuit configured to: receive perioperative data indicative of an operational behavior of the modular device; receiving procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operational behavior is less than ideal; generate an update of control programs configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device. Perioperative data comprises data detected by the modular device during a surgical procedure.
[0006] [0006] In yet another general aspect, another analytical system is provided. The analytical system is configured to connect in a communicable way to the central surgical controller. The central surgical controller is configured to connect in a communicable way to a modular device that is controlled by a control program. Computer readable non-transitory media stores computer-readable instructions that, when executed, cause the analytical system to: receive perioperative data indicative of an operational behavior of the modular device; receive procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operating behavior is below ideal; generate a control program update configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device. Perioperative data comprises data detected by the modular device during a surgical procedure. 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 invention.
[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 invention.
[0010] [0010] Figure 3 is a central device or 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 invention.
[0011] [0011] Figure 4 is a partial perspective view of a central surgical controller compartment, and of a generator module in combination slidably received in a central surgical controller compartment, in accordance with at least one aspect of the present invention.
[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 invention.
[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 invention.
[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 invention.
[0015] [0015] Figure 8 illustrates a surgical data network comprising a modular communication center configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a utility facility especially equipped for surgical operations, to the cloud according to at least one aspect of the present invention.
[0016] [0016] Figure 9 illustrates an interactive surgical system implemented by computer, in accordance with at least one aspect of the present invention.
[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 invention.
[0018] [0018] Figure 11 illustrates an aspect of a universal serial bus (USB) central controller device, in accordance with at least one aspect of the present invention.
[0019] [0019] Figure 12 illustrates a logical diagram of a control system for an instrument or surgical tool, according to at least one aspect of the present invention.
[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 invention.
[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 invention.
[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 invention.
[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 invention.
[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 invention.
[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 invention.
[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 invention.
[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 invention.
[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 invention.
[0029] [0029] Figure 22 illustrates a block diagram of a cloud computing system that comprises a plurality of intelligent surgical instruments coupled to central surgical controllers that can connect to the cloud component of the cloud computing system, according to the least one aspect of the present invention.
[0030] [0030] Figure 23 illustrates a functional module architecture of a cloud computer system, in accordance with at least one aspect of the present invention.
[0031] [0031] Figure 24 illustrates a block diagram of an interactive surgical system implemented by computer that is configured to adaptively generate control program updates for modular devices, in accordance with at least one aspect of the present invention.
[0032] [0032] Figure 25 illustrates a logical flow chart of a process for updating the control program of a modular device, in accordance with at least one aspect of the present invention.
[0033] [0033] Figure 26 illustrates a diagram of an illustrative analytical system updating a surgical instrument control program, in accordance with at least one aspect of the present invention.
[0034] [0034] Figure 27 illustrates a diagram of an analytical system automating an update to a modular device via a central surgical controller, in accordance with at least one aspect of the present invention.
[0035] [0035] Figure 28 illustrates a diagram of an interactive surgical system implemented by computer that is configured to adaptively generate control program updates for central surgical controllers, in accordance with at least one aspect of the present invention.
[0036] [0036] Figure 29 illustrates a logical flow chart of a process for updating the control program of a central surgical controller, in accordance with at least one aspect of the present invention.
[0037] [0037] Figure 30 illustrates a logical flowchart of a process for updating the data analysis algorithm of a control program of a central surgical controller, according to at least one aspect of the present invention.
[0038] [0038] Figure 31 is a timeline representing the situational recognition of a central surgical controller, in accordance with at least one aspect of the present invention. DESCRIPTION
[0039] [0039] The applicant for this application has the following
[0040] [0040] The applicant of the present application holds the following US Patent Applications, filed on March 29, 2018, the description of each of which is incorporated herein by reference in its entirety: and Patent Application serial number, entitled INTERACTIVE —SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; Attorney document number END8499USNP / 170766; and Patent Application Serial No., entitled
[0041] [0041] The applicant of the present application holds the following US Patent Applications, filed on March 29, 2018, the description of each of which is incorporated by reference in its entirety for reference: and Patent Application serial number, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS; Attorney document number END8506USNP1 / 170773-1; and Patent Application Serial No., entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER; Attorney document number END8507USNP / 170774; and Patent Application Serial No., entitled CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL
[0042] [0042] The applicant of the present application holds the following US Patent Applications, filed on March 29, 2018, the description of each of which is incorporated by reference in its entirety for reference: and Patent Application serial number, entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8511USNP / 170778; and Patent Application Serial No., entitled COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8511USNP1 / 170778-1; and Patent Application Serial No., entitled CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8511USNP2 / 170778-2; and Patent Application serial number, entitled AUTOMATIC. TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8512USNP / 170779; and Patent Application Serial No., entitled CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8512USNP1 / 170779-1; and Patent Application Serial No., entitled COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8512USNP2 / 170779-2; and Patent Application Serial No., entitled DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8512USNP3 / 170779-3; and e Patent Application Serial No., entitled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney document number END8513USNP / 170780.
[0043] [0043] 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.
[0044] [0044] 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 and a smart handheld surgical instrument 112, which are configured to communicate with each other and / or with the central controller 106. In some respects, a surgical system 102 may include an M number of central controllers 106, a number N of display systems 108, an O number of robotic systems 110, and a P number of smart, hand-held surgical instruments 112, where M, NO, and P are whole numbers greater than or equal to one.
[0045] [0045] 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
[0046] [0046] 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 invention are described in Provisional Patent Application serial number 62 / 611.339 , entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, whose description is hereby incorporated by reference in its entirety for reference.
[0047] [0047] Several examples of cloud-based analysis that are performed by cloud 104, and are suitable for use with the present invention, are described in US Provisional Patent Application Serial No. 62 / 611.340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed on December 28, 2017, the description of which is incorporated herein by reference, in its entirety.
[0048] [0048] 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.
[0049] [0049] 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.
[0050] [0050] 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.
[0051] [0051] 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.
[0052] [0052] 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 invention 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.
[0053] [0053] In one aspect, the imaging device employs multiple spectrum monitoring to discriminate topography and underlying structures. A multi-spectral 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 more 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 description of which is incorporated herein 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.
[0054] [0054] 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.
[0055] [0055] In various 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 description of which is incorporated herein reference title in its entirety.
[0056] [0056] 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, central controller 106 can have 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 broadcast of the site surgical on main screen 119. Snapshot on non-sterile screen 107 or 109 may allow a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
[0057] [0057] In one aspect, central controller 106 is also configured to route a diagnostic input or feedback by a non-sterile operator in the viewing 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.
[0058] [0058] With reference to Figure 2, a 112 surgical instrument is being used in the surgical procedure as part of the surgical system
[0059] [0059] 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. The 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.
[0060] [0060] 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 modular compartment 136 of the central controller offers a unified environment for managing power, data and fluid lines, which reduces the frequency of entanglement between such lines.
[0061] [0061] Aspects of the present invention 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 combination 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.
[0062] [0062] 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.
[0063] [0063] 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 invention present a solution in which a modular compartment 136 of the central controller is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the modular compartment 136 of the central controller is that it allows quick removal and / or replacement of several modules.
[0064] [0064] Aspects of the present invention feature 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 and power contacts, the first being The power generator module is slidingly movable in an electric coupling with the power and data contacts, and the first power generator module is slidingly movable out of the electric coupling with the first power and data contacts.
[0065] [0065] 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.
[0066] [0066] In addition, the modular surgical cabinet also includes a communication bus between the first coupling port and the second coupling port, configured to facilitate communication between the first power generator module and the second power generator module.
[0067] [0067] With reference to Figures 3 to 7, aspects of the present invention are presented for a modular compartment 136 of the central controller 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 monopolar, bipolar and / or ultrasonic generator modules that interact through the compa central modular housing 136. The central modular compartment 136 can be configured to facilitate the insertion of multiple generators and interactive communication between generators anchored in the central modular compartment 136 so that the generators act as a single generator.
[0068] [0068] 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.
[0069] [0069] 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 compartment 136 of the central surgical controller, and a combined generator module 145 received slidably at a docking station 151 of compartment 136 of the central surgical controller. A docking port 152 with power and data contacts on a rear side of the combined generator module 145 is configured to engage a matching docking port 150 with the power and data contacts of a matching docking station 151 of the controller 136 modular bay center as the combined generator module 145 is slid into position at the corresponding docking station 151 of the central controller 136 modular compartment. In one aspect, the combined generator module 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.
[0070] [0070] In several respects, the smoke evacuation module 126 includes a fluid line 154 that carries captured / collected fluid smoke 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 compartment 136 of the central controller.
[0071] [0071] In various aspects, 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.
[0072] [0072] In one aspect, the surgical tool includes a drive shaft that has an end actuator at a distal end thereof 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.
[0073] [0073] 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 compartment 136 of the central controller 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.
[0074] [0074] 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.
[0075] [0075] 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.
[0076] [0076] In addition, the contacts of a specific module can be switched to engage with the contacts of a specific drawer to avoid inserting a module in a drawer with unpaired contacts.
[0077] [0077] As shown in Figure 4, the coupling port 150 of one 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 central modular compartment 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, such as Air Titan Bluetooth.
[0078] [0078] 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
[0079] [0079] 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
[0080] [0080] In several aspects, the 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.
[0081] [0081] 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 another light source may be inefficient. Temporarily losing sight of the surgical field can lead to undesirable consequences. The imaging device module of the present invention 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.
[0082] [0082] 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.
[0083] [0083] 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.
[0084] [0084] Various image processors and imaging devices suitable for use with the present invention 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 by reference in its entirety. In addition, US Patent No. 7,982,776, entitled SBIl 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 data of image. Such systems can be integrated with imaging module 138. In addition to these, US Patent Application Publication No. 2011/0306840, entitled CONTROLLABLE MAGNETIC. SOURCE TO FIXTURE INTRACORPOREAL APPARATUS, published on December 15, 2011, and US Patent Application Publication No. 2014/0243597, entitled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published on August 28, 2014, which are each of which are incorporated herein by reference in their entirety.
[0085] [0085] Figure 8 illustrates a surgical data network 201 comprising a modular communication center 203 configured to connect modular devices located in one or more operating rooms of a health care facility, or any environment in a utility facility 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 center 203 comprises a central network controller 207 and / or a network key 209 in communication with a network router. The modular communication center 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 controllable key. A central switching controller reads the destination address of each packet and then forwards the packet to the correct port.
[0086] [0086] Modular devices 1a to 1n located in the operating room can be coupled to the modular communication center 203. The central network controller 207 and / or the network switch 209 can be coupled to a network router 211 to connect the devices 1a to 1n to the cloud 204 or to the local computer system 210. The data associated with devices 1a to 1n can be transferred to cloud-based computers through the router for remote data processing and manipulation. The data associated with devices 1a to 1h can also be transferred to the local computer system 210 for processing and manipulation of the local data. Modular devices 2a to 2m located in the same operating room can also be attached to a network switch 209. To network switch 209 can be attached to the central network controller 207 and / or to network router 211 to connect devices 2a 2m to cloud 204. The data associated with devices 2a to 2n can be transferred to cloud 204 via network router 211 for data processing and manipulation. The data associated with devices 2a to 2m can also be transferred to the local computer system 210 for processing and manipulation of the local data.
[0087] [0087] It will be understood that the surgical data network 201 can be expanded by interconnecting multiple central network controllers 207 and / or multiple network keys 209 with multiple network routers 211. The modular communication center 203 may be contained in a modular control roaster 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 center 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 center 203 of the surgical data network 201.
[0088] [0088] 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 computing based on Internet ", in which different services - such as servers, storage and applications - are applied to the modular communication center 203 and / or computer system 210 located in the operating room (for example, a fixed, mobile, temporary room or space, or field of operation) and devices connected to the modular communication center 203 and / or computer system 210 over the 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 the data cole 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.
[0089] [0089] The application of cloud computer data processing techniques to the 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 1hn / 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, emerging technologies, targeted radiation, targeted intervention, accurate robotics at specific tissue sites and conditions, can be followed. This data analysis can additionally use analytical processing of the results, and with the use of standardized approaches they can provide beneficial standardized feedback both to confirm surgical treatments and the surgeon's behavior or to suggest changes to surgical treatments and the surgeon's behavior.
[0090] [0090] In an implementation, operating room devices 1a to 1n can be connected to the modular communication center 203 via a wired channel or a wireless channel depending on the configuration of devices 1a to 1h on a central network controller . 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 open system interconnection model ("OSI" - 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 semi-duplex mode. The central network controller 207 does not store any media / Internet protocol (MAC / IP) access control for transferring data from the device. Only one of the devices 1a to 1h at a time can send data through 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 network data through each connection and to a remote server 213 (Figure 9) in the cloud 204. The central network controller 207 can detect basic network errors, such as collisions, but the transmission of all information to multiple input ports can be a security risk and can cause bottlenecks.
[0091] [0091] 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. The network key 209 stores and uses MAC addresses of devices 2a to 2m to transfer data.
[0092] [0092] The central network controller 207 and / or the network key 209 are coupled to the network router 211 for a connection to the cloud
[0093] [0093] 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 USB port on several levels, so that more ports are available to connect the devices to the system's host computer. The central network controller 207 can include wired or wireless capabilities to receive information about a wired channel or a wireless channel. In one aspect, a wireless wireless, broadband and short-range wireless USB communication protocol can be used for communication between devices 1a to 1n and devices 2a to 2m located in the operating room.
[0094] [0094] In other examples, devices in the operating room 1a to 1n / 2a to 2m can communicate with the modular communication center 203 via standard Bluetooth wireless technology for exchanging data over short distances (using short-wavelength UHF radio waves in the 2.4 to 2.485 GHz ISM band) from fixed and mobile devices and to build personal area networks (PANs). In other respects, operating room devices 1a to 1n / 2a to 2m can communicate with the modular communication center 203 through 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), 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.
[0095] [0095] The modular communication center 203 can serve as a central connection for one or all devices in the operating room 1a to 1n / 2a to 2m and handles a type of data known as frames. The tables carry the data generated by the devices 1a to 1nN / 2a to 2m. When a frame is received by the modular communication center 203, it is amplified and transmitted to the network router 211, which transfers the data to the cloud computing resources using a series of wireless communication standards or protocols or with wire, as described in the present invention.
[0096] [0096] The modular communication center 203 can be used as a standalone device or be connected to compatible central network controllers and network switches to form a larger network. The modular communication center 203 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.
[0097] [0097] Figure 9 illustrates an interactive surgical system, implemented by computer 200. The interactive surgical system implemented by computer 200 is similar in many respects to the interactive surgical system, implemented by computer 100. For example, the surgical system, interactive, implemented 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
[0098] [0098] Figure 10 illustrates a central surgical controller 206 comprising a plurality of modules coupled to the modular control tower 236. The modular control tower 236 comprises a modular communication center 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 center 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 center 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in Figure 10, each of the central controllers / network switches in the modular communication center 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.
[0099] [0099] 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 of the laser or ultrasonic type. 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 number 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 of the 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.
[00100] [00100] 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 input / output interface 251 via 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.
[00101] [00101] —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 StellarisWareO program, read-only memory programmable and electrically erasable (EEPROM) of 2 KB, one or more pulse width modulation (PWM) modules, one or more analog quadrature encoder (QEI) inputs, one or more analog to digital converters (ADC) of 12 bits with 12 analog input channels, details of which are available for the product data sheet.
[00102] [00102] 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 by 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.
[00103] [00103] 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 like SRAM, dynamic RAM
[00104] [00104] 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 drive magnetic disk, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card or memory stick (pen-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.
[00105] [00105] 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.
[00106] [00106] A user enters commands or information into computer system 210 through the input device (s) coupled to the 1I / O 251. interface. 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.
[00107] [00107] 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,
[00108] [00108] 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 and 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.
[00109] [00109] 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.
[00110] [00110] Figure 11 illustrates a functional block diagram of an aspect of a USB 300 central network controller device, in accordance with an aspect of the present invention. 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" differential data input (DMO) paired with a "plus" differential data input (DPO). 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) .
[00111] [00111] 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 USB 300 network central controller device can be configured in bus powered or self powered mode and includes 312 central power logic to manage power.
[00112] [00112] The USB 300 network central controller device includes a 310 series interface motor (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 to a logic suspend / resume timing circuit and frame 316 and a central controller repeat circuit 318 to control communication between the upstream USB transceiver port 302 and the ports downstream USB transceiver 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 interface 330 series EEPROM.
[00113] [00113] 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.
[00114] [00114] 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 invention. 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 motor 492, operationally couples a longitudinally movable displacement member to drive the beam cutting element with | 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, a firing bar and a beam cutting element with a profile |. Additional motors can be provided at the instrument driver interface to control the firing of the beam with an | 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.
[00115] [00115] 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 StellarisWareO program, programmable memory 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.
[00116] [00116] In one aspect, the 461 microcontroller may comprise a safety controller that comprises two families based on controllers, such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also available from Texas
[00117] [00117] The 461 microcontroller can be programmed to perform various functions, such as precise control of the speed and position of the joint and knife 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 an articulation or scalpel 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 2017/0296213, entitled SYSTEMS AND METHODS FOR
[00118] [00118] 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.
[00119] [00119] 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 set releasably mounted on the handle assembly or tool compartment to provide control power to 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 706 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.
[00120] [00120] 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.
[00121] [00121] The tracking system 480 comprises a controlled motor drive circuit arrangement comprising a position sensor 472 according to an aspect of the present invention. 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 the firing bar or the beam with a | profile, each of which can be adapted and configured to include a rack of driving teeth.
[00122] [00122] The 482 electric motor may include a rotary drive shaft, which interfaces operationally with a gear set, which is mounted in coupling hitch with a set or rack of driving teeth on the driving 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 beam with | or combinations of them.
[00123] [00123] A single revolution of the sensor element associated with the position sensor is equivalent to a longitudinal linear displacement di of the displacement member, where di is the longitudinal linear distance through 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. The 472 position sensor can complete multiple revolutions for the full travel of the displacement member.
[00124] [00124] A series of keys, 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 position sensor 472. The state of the keys is transmitted back to microcontroller 461 which applies logic to determine a single position signal corresponding to the longitudinal linear displacement d1 + d2 + ... dh 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.
[00125] [00125] 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, Halli effect anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magneto impedance, magnetostrictive / piesoelectric compounds, magnetodiode, magnetic transistor, optical fiber , magneto-optics and magnetic sensors based on microelectromechanical systems, among others.
[00126] [00126] 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 an ASSOSSEQFT single integrated circuit magnetic and rotary 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 ASS055 integrated circuit supplied in a small 16-pin QFN package whose measurement corresponds to 4x4x0.85 mm.
[00127] [00127] The tracking system 480 that comprises an absolute positioning system can understand 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 into 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
[00128] [00128] 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.
[00129] [00129] “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, for example, the amplitude of the strain exerted on the anvil 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. 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 a | on a triggering stroke of the surgical system or surgical tool. The beam with profile in | it is configured to engage a wedge slide, which is configured to move the clamp drivers upward to force the clamps to deform in contact with an anvil. Beam with profile in | includes a sharp cutting edge that can be used to separate fabric as the beam with a profile | it 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.
[00130] [00130] 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 meter, which is configured to measure one or more parameters of the end actuator, for example. In one aspect, the 474 strain gauge sensor can measure the amplitude or magnitude of the mechanical stress 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
[00131] [00131] The measurements of tissue compression, tissue thickness and / or the 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.
[00132] [00132] The control system 470 of the instrument or surgical tool can also comprise wired or wireless communication circuits for communication with the modular communication center shown in Figures 8 to 11.
[00133] [00133] Figure 13 illustrates a control circuit 500 configured to control aspects of the instrument or surgical tool according to an aspect of the present invention. 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 invention.
[00134] [00134] 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 invention. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 can 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.
[00135] [00135] Figure 15 illustrates a sequential logic circuit 520 configured to control aspects of the instrument or surgical tool according to an aspect of the present invention. 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.
[00136] [00136] 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.
[00137] [00137] 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 trigger points, generated by the motor 602 to the end actuator, particularly to move the beam element with | In certain cases, the firing movements generated by the firing motor 602 can cause the staples to be positioned from the staple cartridge in the fabric captured by the end actuator and / or by the cutting edge of the beam element with profile in | to be advanced in order to cut the captured tissue, for example. The beam element with profile in | can be retracted by reversing the direction of motor 602.
[00138] [00138] 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.
[00139] [00139] 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.
[00140] [00140] As described above, the instrument or surgical 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, the closing motor 603 can be activated simultaneously with the firing motor 602 to make the closing tube or the beam element with profile in | proceed distally, as described in more detail later in this document.
[00141] [00141] In certain cases, the instrument or surgical tool may include a common control module 610 that can be used with a plurality of motors of the instrument 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 or tool motors surgical.
[00142] [00142] Just 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 603 closing motor. At least an 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.
[00143] [00143] 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.
[00144] [00144] In several cases, as illustrated 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.
[00145] [00145] 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.
[00146] [00146] 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 628 power source. In certain cases, the power source 628 power supply can be replaceable and / or rechargeable, for example.
[00147] [00147] 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.
[00148] [00148] 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 & O software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, one or more ADCs of 12 bits 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 invention should not be limited in this context.
[00149] [00149] In certain cases, memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are attachable to 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.
[00150] [00150] In certain cases, one or more mechanisms and / or sensors, such as 630 sensors, can be used to alert the 622 processor about the 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 622 processor can use the program instructions associated with firing the beam with | the end actuator upon detection, through sensors 630, for example, that key 614 is in 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.
[00151] [00151] 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 description. 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.
[00152] [00152] In one aspect, the robotic surgical instrument 700 comprises a control circuit 710 configured to control an anvil 716 and a beam portion with profile in | 714 (including a sharp cutting edge) of an end actuator 702, a removable clamp cartridge 718, a drive shaft 740 and one or more hinge members 742a, 742b through a plurality of motors 704a to 704e. A 734 position sensor can be configured to provide feedback on the beam with a profile | 714 to control circuit 710. Other sensors 738 can be configured to provide feedback to control circuit 710. A timer / counter 731 provides timing and counting information to control circuit 710. A power source 712 can be provided to operate the motors 704a to 704e and a current sensor 736 provide motor current feedback to control circuit 710. Motors 704a to 704e can be operated individually by control circuit 710 in an open loop or closed loop feedback control.
[00153] [00153] 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 the position of the beam with | 714, as determined by the position sensor 734, with the timer / counter output 731 so that the control circuit 710 can determine the position of the beam with profile in | 714 at a specific time (t) in relation to an initial position or time (t) when the beam with profile in | 714 is in a specific position in relation to an initial position. The timer / counter 731 can be configured to measure elapsed time, count external events, or measure external events.
[00154] [00154] 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 fabric 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.
[00155] [00155] In one aspect, the control circuit 710 can generate motor setpoint signals. Motor setpoint signals can be provided for various motor controllers 708a through 708e. Motor controllers 708a to 708e can comprise one or more circuits configured to provide motor drive signals for 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.
[00156] [00156] 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 member travel. 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.
[00157] [00157] In one aspect, the / 04a to 704e motors can receive power from a 712 power source. The 712 power source can be a DC power source powered by an alternating main power supply, a battery, a super capacitor, or any other suitable power source. Motors 704a to 704e can be mechanically coupled to individual mobile mechanical elements such as the beam with profile in | 714, the anvil 716, the drive shaft 740, the hinge 742a and the hinge 742b, through the respective transmissions 706a to 706e. Broadcasts
[00158] [00158] In one aspect, the control circuit 710 is configured to drive a firing member as the beam portion with profile in | 714 of end actuator 702. Control circuit 710 provides a motor setpoint to 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 beam with profile in | 714. The transmission 706a comprises moving mechanical elements, such as rotating elements, and a firing member for distally and proximally controlling the movement of the beam with profile in | 714 along a longitudinal geometric axis of the end actuator 702. In one aspect, the motor 704a can be coupled to the knife gear assembly, which includes a knife gear reduction assembly that includes a first knife drive gear and a second knife drive gear. A torque sensor 744a provides a feedback signal of the firing force to the control circuit 710. The firing force signal represents the force required to fire or move the beam with a profile | 714. A position sensor 734 can be configured to provide the position of the profiled beam at 1714 along the firing stroke or the firing member position as a feedback signal to the 710 control circuit. End actuator 702 can include additional sensors 738 configured to provide feedback signals 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 displacement member moves distally, a beam with a | 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.
[00159] [00159] 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 the 704b motor. 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 to 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 the control circuit 710. Additional sensors 738 on the end actuator 702 can provide the feedback signal of the closing force to the control circuit 710. A pivoting slide 716 is positioned opposite the staple cartridge 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.
[00160] [00160] 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 at a motor control 708c, which provides a drive signal to motor 704c. The output shaft of the 704c motor is coupled to a 744c torque sensor. The torque sensor 744c is coupled to a transmission 706c which is coupled to the shaft 740. The transmission 706c comprises moving mechanical elements, such as rotary elements, to control the rotation of the drive shaft 740 clockwise or counterclockwise until and above 360º. In one aspect, the 704c engine is coupled to the rotary drive assembly, which includes a pipe gear segment that is formed over (or attached to) the proximal end of the proximal closing tube for operable engagement by a rotational gear assembly that is supported operationally on the tool mounting plate. The torque sensor 744c provides a rotation force feedback signal to the control circuit 710. The rotation force feedback signal represents the rotation force applied to the drive shaft 740. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal to the control circuit 710. Additional sensors 738, such as a drive shaft encoder, can provide the rotational position of the drive shaft 740 to the control circuit 710.
[00161] [00161] 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 articulation elements, to control the articulation of the 702 + 65º 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 744d torque sensor provides a feedback signal from the hinge force to the control circuit
[00162] [00162] In another aspect, the articulation function of the robotic surgical system 700 can 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.
[00163] [00163] 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 operation of the physical system to deviate from a desired operation of the physical system.
[00164] [00164] In one aspect, the position sensor 734 can be implemented as an absolute positioning system. In one aspect, the position sensor 734 can comprise an absolute rotary magnetic positioning system implemented as a single integrated circuit rotary magnetic position sensor, ASSOSSEQFT, 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.
[00165] [00165] 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, control circuit 710 can detect (1) the closing load experienced by the distal closing tube and its position, (2) the trigger member on the rack and its position, (3) which portion of the staple cartridge 718 has tissue in it, and (4) the load and position on both articulation rods.
[00166] [00166] In one aspect, the one or more sensors 738 may comprise a stress meter such as, for example, a micro-stress 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.
[00167] [00167] 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.
[00168] [00168] 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 to 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.
[00169] [00169] 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 beam with a profile | 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 a beam with a profile | 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 June 29, 2017, which is hereby incorporated by reference in its entirety.
[00170] [00170] 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 invention. In one aspect, the 750 surgical instrument is programmed to control the distal translation of a displacement member, such as the beam with a | 764. The surgical instrument 750 comprises an end actuator 752 which may comprise an anvil 766, a beam with a profile in | 764 (including a sharp cutting edge), and a removable staple cartridge 768.
[00171] [00171] The position, movement, displacement and / or translation of a member of linear displacement, such as the beam with profile in | 764, can be measured by an absolute positioning system,
[00172] [00172] Control circuit 760 can generate a setpoint signal for motor 772. The setpoint signal for motor 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.
[00173] [00173] The 754 motor can receive power from an energy source
[00174] [00174] 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.
[00175] [00175] 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.
[00176] [00176] 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 may be at a point of interaction between the closing tube and the anvil 766 to detect the closing forces applied by the closing tube to the anvil 766. The forces exerted on the anvil 766 may 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 to the 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.
[00177] [00177] A current sensor 786 can be used to measure the current drained by the 754 motor. The force necessary to advance the beam with profile in | 764 corresponds to the current drained by the motor
[00178] [00178] The control circuit 760 can be configured to simulate the real system response of the instrument in the controller software. A displacement member can be actuated to move a beam with a profile | 764 on end actuator 752 at or near a target speed. The surgical instrument 750 can include a feedback controller, which can be one or any of the feedback controllers, including, but not limited to, a PID controller, state feedback, LOR, 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.
[00179] [00179] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member or beam with profile in | 764, by a brushed DC motor with gearbox and mechanical connections to an articulation and / or cutting system. 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.
[00180] [00180] Several exemplifying aspects are directed to a surgical instrument 750 that comprises an end actuator 752 with surgical implements of stapling and cutting driven by motor. For example, a motor 754 can drive a displacement member distally and proximally along a longitudinal geometry axis of end actuator 752. End actuator 752 can comprise an articulating anvil 766 and, when configured for use, an ultrasonic blade 768 positioned on the opposite side of the anvil 766. A doctor can hold the tissue between the anvil 766 and the staple cartridge 768, as described in the present invention. When ready to use the 750 instrument, the physician can provide a trigger signal, for example, by pressing a trigger on the 750 instrument. In response to the trigger signal, motor 754 can drive the displacement member distally along the geometric axis longitudinal stroke of the end actuator 752 from a proximal start position to a distal end position from the start position. As the displacement member moves distally, the beam with | 764 with a cutting element positioned at a distal end, you can cut the fabric between the staple cartridge 768 and the anvil 766.
[00181] [00181] 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 beam with profile in | 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 trigger 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 fabric is present, the control circuit 760 can be programmed to move the displacement member at a higher speed and / or with greater power.
[00182] [00182] 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 of the displacement member. 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 circuit 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 to 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.
[00183] [00183] Figure 19 is a schematic diagram of a 790 surgical instrument configured to control various functions in accordance with an aspect of the present invention. In one aspect, the 790 surgical instrument is programmed to control the distal translation of a displacement member, such as the beam with a | 764. The surgical instrument 790 comprises an end actuator 792 which may comprise an anvil 766, a beam with a profile | 764 and a removable staple cartridge 768 that can be interchanged with an RF cartridge 796 (shown in dashed line).
[00184] [00184] 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, the sensors
[00185] [00185] 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 magnetic and rotary position sensor, ASSOSSEQFT, 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.
[00186] [00186] In one aspect, the beam with | 764 can be implemented as a cutting member comprising a knife body that operationally supports a tissue cutting blade therein and may additionally include flaps or anvil engaging features and channel engaging features, or a pedal. 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 Commonly Owned US Patent Application Serial No. 15 / 628,175, entitled TECHNIQUES
[00187] [00187] The position, movement, displacement and / or translation of a linear displacement member, such as the beam with profile in 1764, can be measured by an absolute positioning system, sensor arrangement and position sensor represented as the position sensor 784. Once the beam with profile | 764 is coupled to the longitudinally movable drive member, the position of the beam with profile in | 764 can be determined by measuring the position of the longitudinally movable drive member employing the position sensor 784. Consequently, in the following description, the position, displacement and / or translation of the beam with | 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 beam with | 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 beam with profile in | 764, as described. In one aspect, a timer / counter 781 provides an output signal, such as elapsed time or a digital count, to the control circuit 760 to correlate the position of the beam with | 764 as determined by position sensor 784 with timer / counter output 781, so that control circuit 760 can determine the position of the beam with profile in | 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.
[00188] [00188] Control circuit 760 can generate a setpoint signal for motor 772. The setpoint signal for motor 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.
[00189] [00189] The 754 motor can receive power from a power source
[00190] [00190] 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.
[00191] [00191] 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.
[00192] [00192] 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 may be at a point of interaction between the closing tube and the anvil 766 to detect the closing forces applied by the closing tube to the anvil 766. The forces exerted on the anvil 766 may 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 to the 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 portion of the control circuit 760. The control circuit 760 receives sample measurements in real time to provide and analyze time-based information and evaluate , in real time, the closing forces applied to the anvil 766.
[00193] [00193] A current sensor 786 can be used to measure the current drained by the 754 motor. The force necessary to advance the beam with profile in | 764 corresponds to the current drained by the motor
[00194] [00194] 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.
[00195] [00195] 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 into reference title in its entirety. Generator hardware
[00196] [00196] Figure 20 is a simplified block diagram of a generator 800 configured to provide tuning without an inductor, among other benefits. Additional details of generator 800 are described in US Patent No. 9,060,775, entitled SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, granted on June 23, 2015, which is hereby incorporated by reference in its entirety. The generator 800 can comprise a patient isolated stage 802 in communication with a non-isolated stage 804 via a power transformer 806. A secondary winding 808 of the power transformer 806 is contained in the isolated stage 802 and can comprise a bypass configuration. (for example, a central or non-central bypass configuration) to define the trigger signal outputs 810a, 810b, 810c, in order to deliver trigger signals to different surgical instruments, such as an ultrasonic surgical device, an electrosurgical RF instrument and a multifunctional surgical instrument that includes ultrasonic and RF energy modes that can be released alone or simultaneously. In particular, the trigger signal outputs 810a, 810c can provide an ultrasonic trigger signal (for example, a 420 V mean square [RMS] trigger signal) to an ultrasonic surgical instrument, and the signal signal outputs of drive 810b, 810c can provide an electrosurgical drive signal (for example, a 100 V RMS drive signal) to an RF electrosurgical instrument, with the drive signal output 810b corresponding to the center tap of the 806 power transformer .
[00197] [00197] In certain forms, ultrasonic and electrosurgical trigger signals can be supplied simultaneously to different surgical instruments and / or to a single surgical instrument, such as the 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 electrosurgical instrument - dedicated - and by the instrument - combined electrosurgical / ultrasonic multifunctional instrument can be both a therapeutic and subtherapeutic level signal, where the subtherapeutic signal can be used, for example, to monitor tissue or the conditions of the instruments and provide feedback to the generator. For example, RF and ultrasonic signals can be supplied 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 dissect tissue while RF electrosurgical energy can be used to cauterize vessels.
[00198] [00198] 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 contain a logic device 816 to provide a digital output to a digital-to-analog converter circuit ("DAC" - digital-to-analog converter) 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), 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 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, 810c. In certain ways and as discussed below, logic device 816, in conjunction with a processor (for example, a DSP discussed below), can implement a number of control algorithms based on digital signal processing (DSP) and / or others control algorithms for control parameters of the drive signals provided by generator 800.
[00199] [00199] Power can be supplied to a power rail of the power amplifier 812 by a key mode regulator 820, for example, a power converter. In certain forms, the key mode regulator 820 may comprise an adjustable antagonistic regulator, for example. The non-isolated stage 804 can comprise,
[00200] [00200] In certain forms, the logical device 816, in conjunction with the DSP processor 822, 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)
[00201] [00201] The «non-isolated stage 804 may additionally comprise a first ADC 826 circuit and a second ADC 828 circuit coupled to the output of the power transformer 806 by means of respective isolation transformers, 830, 832, to respectively sample the voltage and the current of drive signals emitted by generator 800. In certain ways, ADC circuits 826, 828 can be configured for high speed sampling (eg, 80 mega samples per second (MSPS)) to allow over-sampling of the drive signals. In one form, for example, the sampling speed of the ADC 826, 828 circuits can allow "an oversampling of approximately 200x (depending on the frequency) of the drive signals. In certain ways, the sampling operations of the ADC 826, 828 circuit may be performed by a single ADC circuit receiving voltage and current input signals via a bidirectional multiplexer. The use of high speed sampling in the forms of the generator 800 can allow, among other things, the calculation of the complex current flowing through the motion branching (which can be used in certain ways to implement the DDS-based waveform control described above), the exact digital filtering of the sampled signals and the calculation of the actual energy consumption with a high degree of accuracy. feedback on voltage and current emitted by ADC 826, 828 circuits can be received and processed (for example, first-input-prim temporary storage floor-exit ("FIFO" - first-in-first-out), multiplexer) by logic device 816 and stored in data memory for subsequent retrieval, for example, by processor 822. As noted above, feedback data on voltage and current can be used as input to an algorithm for pre-distortion or modification of waveform samples in the LUT, in a dynamic and continuous way. In certain ways, this may require that each stored voltage and current feedback data pair be indexed based on, or otherwise associated with, a sample of the corresponding LUT that was provided by logic device 816 when the data pair of feedback on voltage and current was captured. The synchronization of the LUT samples with the feedback data about voltage and current in this way contributes to the correct timing and stability of the pre-distortion algorithm.
[00202] [00202] In certain forms, feedback data about voltage and current can be used to control the frequency and / or amplitude (for example, current amplitude) of the trigger 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 0º), 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 DSP processor 822, for example, with the frequency control signal being supplied as input to a DDS control algorithm implemented by the programmable logic device 816.
[00203] [00203] 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, current amplitude control can be implemented by the control algorithm, such as a proportional-integral-derivative control algorithm ("PID" - proportional-integral-derivative), in the DSP 822 processor. The variables controlled by the control algorithm to properly control the current amplitude of the drive signal may include, for example, scaling the LUT waveform samples stored in logic device 816 and / or the full-scale output voltage of the DAC circuit 818 (which provides input to the power amplifier 812) via a DAC 834 circuit.
[00204] [00204] The «non-isolated stage 804 may additionally comprise a second processor 836 to provide, among other things, the functionality of the user interface (" UI "- user interface). In one form, the UI 836 processor may comprise an Atmel AT91SAM9263 processor that has an ARM 926EJ-S core, available from Atmel Corporation, of San Jose, CA, USA, for example. Examples of UIL functionality supported by the UI 836 processor may include audible and visual feedback from the user, communication with peripheral devices (for example, via a universal serial bus (USB) interface, communication with the foot switch, communication with an input device (for example, a touch screen) and communication with an output device (for example, a speaker) The UIl 836 processor can communicate with the DSP 822 processor and the device logic 816 (for example, via serial peripheral interface buses ("SPI" - serial peripheral interface)). Although the UI 836 processor can primarily support UI functionality, it can also coordinate with the DSP 822 processor to implement risk mitigation in certain ways. For example, the UIl 836 processor can be programmed to monitor various aspects of inputs by the user and / or other inputs (for example, touchscreen inputs, foot switch inputs, temperature sensor inputs) and can disable the drive output of generator 800 when an error condition is detected.
[00205] [00205] In certain ways, both the DSP 822 processor and the UI 836 processor can, for example, determine and monitor the operational status of generator 800. For the DSP 822 processor, the operational state of generator 800 can determine, for example, which control and / or diagnostic processes are implemented by the DSP 822 processor. For the UI 836 processor, the operational state of generator 800 can determine, for example, which elements of a UI (for example, display screens , sounds) are presented to a user. The respective UI and DSP processors 822 and 836 can independently maintain the current operational state of generator 800, and recognize and evaluate possible transitions out of the current operational state. The DSP 822 processor can act as the master in this relationship and 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 particular transition is adequate. For example, when the DSP 822 processor instructs the UI 1090 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.
[00206] [00206] The non-isolated platform 804 may also contain an 838 controller for monitoring input devices (for example, a capacitive touch sensor used to turn the 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
[00207] [00207] 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 wake up the power supply (for example, enable one or more DC / DC voltage converters 856 from power supply 854 to operate) if activation of the "on / off" input device 145 is detected for a user. Controller 838 can therefore initiate a sequence to transition the generator 800 to an "on" state. On the other hand, controller 838 may 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 process sequence necessary 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.
[00208] [00208] In certain forms, controller 838 may 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.
[00209] [00209] In certain forms, the isolated stage 802 may comprise an instrument interface circuit 840 to, for example, offer a communication interface between a control circuit of a surgical instrument (for example, a control circuit comprising switches handle) and non-isolated stage components 804, such as logic device 816, DSP processor 822 and / or UI processor 836. Instrument interface circuit 840 can exchange information with non-stage components isolated 804 by means of a communication link that maintains an adequate degree of electrical isolation between the isolated and non-isolated stages 802, 804 such as, for example, an infrared-based communication link ("IR" - infrared). 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.
[00210] [00210] 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.
[00211] [00211] 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 ways, for example, a first data circuit may be arranged on a wire 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 800 generator. The first data circuit can be deployed in any suitable manner and can communicate with the generator in accordance with 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.
[00212] [00212] 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 interface circuit of the instrument 840 (for example, the logic circuit 842), transferred to a component of the non-isolated stage 804 (for example, to the logic device 816, DSP 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.
[00213] [00213] As previously discussed, a surgical instrument can be removable from a handle (for example, the multifunctional surgical instrument can be removable 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, design a surgical instrument so that it remains backwards compatible! with generators lacking the indispensable data reading functionality, it can 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.
[00214] [00214] - In addition, 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, the 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.
[00215] [00215] In some ways, the second data circuit can store information about the electrical and / or ultrasonic properties of an ultrasonic transducer, end actuator, or associated 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 diode (LED) indication or other visible indication) based on the received data.
[00216] [00216] 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 supply conductors for this purpose (for example, dedicated cable conductors connecting a grip 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 cable. 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.
[00217] [00217] In certain forms, the isolated stage 802 may comprise at least one blocking capacitor 850-1 connected to the output of the trigger signal 810b to prevent the passage of direct current 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, 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. Based on changes in leakage current (as indicated by the voltage samples), generator 800 can determine when at least one of the blocking capacitors 850-1, 850-2 failed, thus offering a benefit over single capacitor designs that have a single point of failure.
[00218] [00218] In certain embodiments, the non-isolated stage 804 may comprise a power supply 854 for delivering DC power at an appropriate 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 awakening of the 856 DC / DC voltage converters.
[00219] [00219] 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.
[00220] [00220] Generator 900 comprises a processor 902 coupled to a waveform generator 904. Processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a coupled memory to processor 902, not shown for clarity of description. 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 the 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 ENERGIAI and RETORNO. A second signal of a second energy modality is coupled through a capacitor 910 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. It will also be It is recognized that up to "n" return paths, RETURN can be provided without departing from the scope of the present invention.
[00221] [00221] A second voltage detection circuit 912 is coupled through the terminals identified as ENERGY and the RETURN path to measure the output voltage between them. A second voltage detection circuit 924 is connected via the terminals identified as ENERGY 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 supplied to processor 902 for further processing and computation. 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.
[00222] [00222] In one aspect, impedance can be determined by processor 902 by dividing the output of the first voltage detection circuit 912 coupled through the terminals identified as ENERGY1 / RETURN or the second voltage detection circuit 924 coupled through 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 isolating transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolating transformer 916. The digitized voltage and current detection measurements from the ADC 926 circuit are provided to processor 902 to compute the impedance. As an example, can the first ENERGY1 energy modality be ultrasonic energy and the second ENERGY energy modality it could 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 fabric impedance can be measured by dividing the output of the second circuit detection voltage 924 by current detection circuit 914.
[00223] [00223] “As shown in Figure 21, generator 900 comprising at least one output port can include a power transformer 908 with a single output and multiple taps 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.
[00224] [00224] Additional details are disclosed in US Patent Application Publication 2017/0086914 entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING
[00225] [00225] “As used throughout this description, the term" wireless "and its derivatives can be used to describe circuits, devices, systems, methods, techniques, communication channels etc.,
[00226] [00226] 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".
[00227] [00227] 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 may contain digital functions,
[00228] [00228] 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.
[00229] [00229] “As used in the present invention, the term controller or microcontroller can 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.
[00230] [00230] 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 ARM Cortex by Texas
[00231] [00231] In one aspect, the processor may comprise a safety controller that comprises two controller-based families, such as TMS570 and RM4x, known under the tradename Hercules ARM Cortex R4, also by 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.
[00232] [00232] 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, through a distributed computing architecture). In some examples, the control algorithms of the modular devices control the devices based on the data detected by the modular device itself (that is, by sensors on, over or connected to the modular device). This data can be related to the patient being operated on (for example, tissue properties or insufflation pressure) or to the modular device itself (for example, the rate at which a knife is being advanced, the motor current, or the levels of energy). For example, a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument's motor drives its knife through the fabric according to the resistance encountered by the knife as it progresses.
[00233] [00233] Figure 22 is a block diagram of the interactive surgical system implemented by computer, according to at least one aspect of the present invention. In one aspect, the computer-implemented interactive surgical system is configured to monitor and analyze data related to the operation of various surgical systems that include central surgical controllers, surgical instruments, robotic devices, and operating rooms or healthcare facilities. The computer-implemented interactive surgical system comprises a cloud-based data analysis system.
[00234] [00234] In addition, surgical instruments 7012 may comprise transceivers for transmitting data to and from their corresponding central surgical controllers 7006 (which may also comprise transceivers). Combinations of surgical instruments 7012 and corresponding central controllers 7006 can indicate specific locations, such as operating rooms in healthcare facilities (for example, hospitals), to provide medical operations. For example, the memory of a central surgical controller 7006 can store location data. As shown in Figure 22, cloud 7004 comprises central servers 7013 (can be the same or similar to remote server 7013), application servers for central controllers 7002, data analysis modules 7034, and an input / output interface ("I / O ") 7006. Central servers 7013 of the cloud 7004 collectively administer the cloud computing system, which includes monitoring orders by client 7006 central surgical controllers and managing the processing capacity of the 7004 cloud to execute orders. The central servers 7013 each comprise one or more processors 7008 coupled with suitable memory devices 7010 which may include volatile memory as random access memory (RAM) and non-volatile memory as magnetic storage devices. The 7010 memory devices can comprise machine executable instructions that, when executed, cause the 7008 processors to run the 7034 data analysis modules for analysis, operations, recommendations and other cloud-based data operations described below. In addition, processors 7008 can run data analysis modules 7034 independently or in conjunction with central controller applications independently run by central controllers 7006. Central servers 7013 also comprise aggregated medical databases 2212, which can reside in memory 2210 .
[00235] [00235] Based on connections with several central surgical controllers 7006 over the network 7001, the cloud 7004 can aggregate the specific data data generated by various surgical instruments 7012 and their corresponding central controllers 7006.
[00236] [00236] The configuration of the specific cloud computing system described in the present invention is designed specifically to address various issues raised in the context of medical operations and procedures performed using medical devices, such as surgical instruments 7012, 112. In particular, surgical instruments 7012 can be digital surgical devices configured to interact with the 7004 cloud to implement techniques to improve the performance of surgical operations. Various surgical instruments 7012 and / or central surgical controllers 7006 can comprise touch-controlled user interfaces, so that doctors can control aspects of interaction between surgical instruments 7012 and the cloud 7004. Other user interfaces suitable for control such as audibly controlled users can also be used.
[00237] [00237] —Figure23 is a block diagram that illustrates the functional architecture of the interactive surgical system implemented by computer, in accordance with at least one aspect of the present invention. The cloud-based data analysis system includes a plurality of 7034 data analysis modules that can be run by the 7008 cloud 7004 processors to provide data analysis solutions for problems that arise specifically in the medical field. As shown in Figure 23, the functions of the 7034 cloud-based data analysis modules can be aided by central controller applications 7014 hosted by application servers for central controllers 7002 that can be accessed on central surgical controllers 7006. Processors from 7008 cloud computing and 7014 central controller applications can operate together to run 7034 data analysis modules. 7016 application programming interfaces (APIs) define the set of protocols and routines that correspond to 7014 central controller applications. In addition, APIs 7016 manage the storage and retrieval of data to and from aggregated medical databases 7012 for the operations of 7014 applications. 7018 caches also store data (for example, temporarily) and are coupled to APIs 7016 for more efficient recovery of data used by applications
[00238] [00238] - For example, the 7022 data collection and aggregation module could be used to generate self-describing data (for example, metadata) including the identification of notable features or configurations (for example, trends), management of redundant data sets, and storing data in paired data sets that can be grouped by surgery, but not necessarily focused on actual surgery dates and surgeons. In particular, paired data sets generated from operations of the 7012 surgical instruments may comprise application of a binary classification, for example, a bleeding or non-bleeding event. More generally, the binary classification can be characterized either as a desirable event (for example, a successful surgical procedure) or as an undesirable event (for example, a surgical instrument used improperly or poorly triggered 7012). Aggregated self-describing data can correspond to individual data received from various groups or subgroups of central surgical controllers
[00239] [00239] The resource optimization module 7020 can be configured to analyze this aggregated data to determine an optimal use of resources for a specific health care facility or group of healthcare facilities. For example, the 7020 resource optimization module can determine an ideal ordering point for 7012 surgical stapling instruments for a group of healthcare facilities based on the corresponding expected demand for such 7012 instruments. The 7020 resource optimization module it could also assess resource use or other operational configurations of various health care facilities to determine whether resource use could be improved. Similarly, the 7030 recommendation module can be configured to analyze aggregated organized data from the 7022 data collection and aggregation module to provide recommendations. For example, the 7030 recommendations module could recommend to healthcare facilities (for example, medical providers such as hospitals) that a specific 7012 surgical instrument should be upgraded to an improved version based on an error rate of greater than expected, for example. In addition, the 7030 recommendation module and / or the 7020 resource optimization module could recommend better supply chain parameters such as product repurchase points and provide suggestions for different 7012 surgical instruments, their uses, or procedural steps to improve surgical results. Healthcare facilities can receive such recommendations through corresponding 7006 central surgical controllers. More specific recommendations related to the parameters or configurations of various 7012 surgical instruments can also be provided. Central controllers 7006 and / or surgical instruments 7012 may also have display screens that display data or recommendations provided by the 7004 cloud.
[00240] [00240] The 7028 patient results analysis module can analyze surgical results associated with currently used operating parameters of the 7012 surgical instruments. The 7028 patient results analysis module can also analyze and evaluate other potential operational parameters. In this context, the 7030 recommendations module could recommend the use of these other potential operating parameters based on producing better surgical results, such as better sealing or less bleeding. For example, the 7030 recommendations module could transmit recommendations to a 7006 surgeon about when to use a specific cartridge for a corresponding 7012 stapling surgical instrument. In this way, the cloud-based data analysis system, while controlling common variables, can be configured to analyze the large collection of raw data and provide centralized recommendations across multiple health service facilities (advantageously determined based on aggregated data). For example, the cloud-based data analysis system could analyze, evaluate and / or aggregate data based on the type of medical practice, type of patient, number of patients, geographical similarity between medical providers, which medical providers / facilities use types similar instruments, etc., in a way that no health service facility alone would be able to independently analyze. The 7026 control program update module can be configured to implement various 7012 surgical instrument recommendations when corresponding control programs are updated. For example, the 7028 patient outcome analysis module could identify correlations by linking specific control parameters to successful (or unsuccessful) results. Such correlations can be resolved when updated control programs are transmitted to 7012 surgical instruments via the 7026 control program update module. Updates to 7012 instruments that are transmitted via a corresponding central controller 7006 can incorporate aggregated performance data that has been collected and analyzed by the data collection and aggregation module 7022 from the cloud 7004. Additionally, the patient results analysis module 7028 and the recommendations module 7030 could identify improved methods of using the 7012 instruments based on aggregated performance data.
[00241] [00241] The cloud-based data analysis system can include safety features implemented by the 7004 cloud. These safety features can be managed by the authorization and safety module 7024. Each central surgical controller 7006 can have unique credentials associated with it as username, password, and other appropriate security credentials.
[00242] [00242] Surgical instruments 7012 can use wireless transceivers to transmit wireless signals that can represent, for example, credentials for authorization to access the corresponding central controllers 7006 and the cloud 7004. Wired transceivers can also be used to transmit signals. Such authorization credentials can be stored in the respective memory devices of the 7012 surgical instruments. The 7024 authorization and security module can determine whether the authorization credentials are accurate or falsified. The 7024 authorization and security module can also dynamically generate authorization credentials for increased security. Credentials could also be encrypted, such as using hash-based encryption. After transmitting the appropriate authorization, the surgical instruments 7012 can transmit a signal to the corresponding central controllers 7006 and finally to the cloud 7004, to indicate that the instruments 7012 are ready to obtain and transmit medical data. In response, the 7004 cloud can transition to a state enabled to receive medical data for storage in the aggregated medical data databases 7012. This data transmission availability could be indicated by a light indicator on the 7012 instruments, for example. The 7004 cloud can also transmit signals to the 7012 surgical instruments to update its associated control programs. The 7004 cloud can transmit signals that are targeted to a specific class of 7012 surgical instruments (for example, electrosurgical instruments) so that software updates for control programs are transmitted only to the 7012 surgical instruments. In addition, the 7004 cloud it could be used to implement system-wide solutions to address local or global problems based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 is identified as having a common manufacturing defect, the 7004 cloud can change the authorization credentials corresponding to this group to implement an operational block of the group.
[00243] [00243] The cloud-based data analysis system can allow monitoring of multiple healthcare facilities (eg, medical posts such as hospitals) to determine improved practices and recommend changes (through the 2030 recommendations module, for example) properly. In this way, cloud 7004 processors 7008 can analyze the data associated with a healthcare facility to identify the facility and aggregate the data to other data associated with other healthcare facilities in a group. Groups could be defined based on similar operating practices or geographic location, for example. In this way, the 7004 cloud can provide analysis and recommendations regarding a health service facility that covers an entire group. The cloud-based data analysis system could also be used to improve situational recognition. For example, 7008 processors can predictively demonstrate the effects of recommendations on cost and effectiveness for a specific installation (in relation to operations and / or various general medical procedures). The cost and effectiveness associated with that specific facility can also be compared to a corresponding local region of other facilities or any other comparable facility.
[00244] [00244] The 7032 data classification and prioritization module can prioritize and classify data based on severity (for example, the severity of a medical event associated with the data,
[00245] [00245] Additional exemplary details for the various functions described are provided in the following descriptions. Each of the various descriptions can use the cloud architecture as described in Figures 22 and 23 as an example of implementing hardware and software. Control program updates for surgical devices
[00246] [00246] 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. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, power generators, fans, and insufflators. Various operations of the modular devices described here can be controlled by one or more control algorithms. Control algorithms can be run 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, through a distributed computing architecture). exemplifications, the control algorithms of the modular devices control the devices based on the data detected by the modular device itself (that is, by sensors on, over or connected to the modular device). This data can be related to the patient being operated on (for example, tissue properties or insufflation pressure) or to the modular device itself (for example, the rate at which a knife is being advanced, the motor current, or the levels of energy). For example, a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument's motor drives its knife through the fabric according to the resistance encountered by the knife as it progresses.
[00247] [00247] Although a "smart" device that includes control algorithms that respond to detected data can be an improvement over "dumb" devices that operate without taking into account the captured data, if the device control program does not adapt or update over time in response to the collected data, then devices can continue to repeat the same errors or otherwise operate less than ideally.
[00248] [00248] Figure 24 illustrates a block diagram of a 9060 computer-implemented adaptive surgical system that is configured to adaptively generate control program updates for 9050 modular devices, in accordance with at least one aspect of the present invention. In one example, the surgical system includes a central surgical controller 9000, multiple modular devices 9050 coupled communicably to the central surgical controller 9000, and an analytical system 9100 coupled communicably to the central surgical controller 9000. Although a single central surgical controller 9000 be represented, it should be noted that the 9060 surgical system can include any number of 9000 central surgical controllers, which can be connected to form a network of 9000 central surgical controllers that are communicably coupled to the 9010 analytical system. In one example, the central surgical controller 9000 includes a 9010 processor coupled with a 9020 memory to execute instructions stored on it and a 9030 data retransmission interface through which data is transmitted to the analytical system 9100. In one example, the central surgical controller 9000 additionally includes te a 9090 user interface that has a 9092 input device (for example, a capacitive touchscreen or a keyboard) for receiving input from a user and a 9094 output device (for example, a display screen) to provide exits to a user. Outputs may include data from a user-entered consultation, suggestions for products or mixtures of products for use in a given procedure, and / or instructions for actions to be performed before, during or after surgical procedures. The central surgical controller 9000 additionally includes a 9040 interface for communicating the 9050 modular devices communicably with the central surgical controller 9000. In one aspect, the 9040 interface includes a transceiver that is communicably connected to the 9050 modular device via a communication protocol. wireless. 9050 modular devices may include, for example, surgical stapling and cutting instruments, electrosurgical instruments, ultrasonic instruments, insufflators, respirators, and display screens. In one example, the central surgical controller 9000 can also be connected in a communicable way to one or more 9052 patient monitoring devices, such as EKG monitors or BP monitors. In another example, the central surgical controller 9000 can be additionally coupled in a communicable manner to one or more 9054 databases or external computer systems, such as a REM database of the medical facility in which the central surgical controller 9000 is located.
[00249] [00249] “When the 9050 modular devices are connected to the central surgical controller 9000, the central surgical controller 9000 can detect or receive perioperative data from the 9050 modular devices and then associate the received perioperative data with surgical procedural result data. Perioperative data indicates how the 9050 modular devices were controlled during the course of a surgical procedure. Procedural outcome data includes data associated with a result of the surgical procedure (or a step in it), which may include the possibility of the surgical procedure (or a step in it) having a positive or negative result. For example, outcome data could include whether a patient experienced post-operative complications from a specific procedure or whether there was a leak (for example, bleeding or air leak) in a specific clamp or incision line. The central surgical controller 9000 can obtain surgical procedural result data by receiving data from an external source (for example, from an RME 9054 database), by directly detecting the result (for example, through one of the 9050 modular devices connected), or infer the occurrence of the results through a situational recognition system. For example, data on postoperative complications could be retrieved from a REM 9054 database, and data regarding leaks in the clamp or incision line could be directly detected or inferred by a situational recognition system. Surgical procedural outcome data can be inferred by a situational recognition system from data received from a variety of data sources, including the 9050 modular devices themselves, the 9052 patient monitoring device, and the databases 9054 to which the central surgical controller 9000 is connected.
[00250] [00250] The central surgical controller 9000 can transmit data and result data from the associated modular device 9050 to the analytical system 9100 for processing thereof. By transmitting both perioperative data that indicates how 9050 modular devices are controlled and procedural result data, the 9100 analytical system can correlate the different ways of controlling 9050 modular devices with surgical results for the specific type of procedure. In one example, the 9100 analytical system includes a network of 9070 analytical servers that are configured to receive data from the 9000 central surgical controllers. Each of the 9070 analytical servers can include a memory and a memory-coupled processor that is executing instructions stored in it. to analyze the data received. In some examples, 9070 analytical servers are connected in a distributed computing architecture and / or use a cloud computing architecture. Based on this paired data, the 9100 analytical system can then learn optimal or preferred operating parameters for the various types of 9050 modular devices, generate settings for the control programs of the 9050 modular devices in the field, and then transmit (or "send") ) updates to the control programs for 9050 modular devices.
[00251] [00251] Additional details regarding the interactive surgical system implemented by computer 9060, including the central surgical controller 9000 and several modular devices 9050 connectable to it, are described in connection with Figures 9 and 10.
[00252] [00252] Figure 25 illustrates a logical flow chart of a 9200 process for updating the control program of a 9050 modular device, in accordance with at least one aspect of the present invention. In the following description of process 9200, reference should also be made to Figure 24. Process 9200 can be executed, for example, by one or more processors from analytical servers 9070 of analytical system 9100. In one example, analytical system 9100 it could be a cloud computing system. For economy, the following description of process 9200 will be described as being executed by the analytical system 9100; however, it should be understood that the analytical system 9100 includes the processor (s) and / or the control circuit (s) that are performing the 9200 process steps described.
[00253] [00253] The 9100 analytical system receives 9202 perioperative data from the modular device 9050 and surgical procedural result data from one or more of the 9000 central surgical controllers that are communicably connected to the 9100 analytical system. Perioperative data includes data preoperative, intraoperative data, and / or postoperative data detected by a 9050 modular device in association with a particular surgical procedure. For 9050 modular devices or functions specific to 9050 modular devices that are manually controlled, perioperative data indicates the way in which a member of the surgical team operated the 9050 modular devices. For 9050 modular devices or specific functions of 9050 modular devices that are controlled by control programs for modular devices, perioperative data indicates the way in which control programs operated 9050 modular devices. The way in which 9050 modular devices operate under specific sets of conditions (or due to manual control or control by control programs for 9050 modular devices) may be called "operating behavior" displayed by the 9050 modular device. Perioperative data on the 9050 modular device includes data on the state of the 9050 modular device (for example, force to fire or force to close by an instru surgical stapling device and cutting instrument, or the power output for an electrosurgical or ultrasonic instrument), tissue data measured by the 9050 modular device (for example, impedance, thickness, or hardness), and other data that can be detected by a 9050 modular device. Perioperative data indicates the way in which the 9050 modular devices were programmed to operate or were manually controlled during the course of a surgical procedure because they indicate how the 9050 modular devices worked in response to various conditions detected.
[00254] [00254] Procedural outcome data includes data related to the overall outcome of a surgical procedure (for example, if there was a complication during the surgical procedure) or data related to a result of a specific step within a surgical procedure (e.g., if a certain line of staples bleed or leaked). Procedural result data can, for example, be detected directly by modular devices 9050 and / or by the central surgical controller 9000 (for example, a medical imaging device can view or detect bleeding), determined or deduced by a situational recognition system central surgical controller 9000 as described in US Patent Application serial number (attorney document number END8501USNP / 170768), or retrieved from a 9054 database (for example, an EMR database) by the central surgical controller 9000 or by the analytical system
[00255] [00255] Using the 9100 analytical system receiving 9202 data, the 9100 analytical system analyzes the 9050 modular device and process result data to determine 9204 whether the 9050 modular devices are being used less than ideally in connection with the specific procedure or the specific step of the procedure. A 9050 modular device can be suboptimally controlled if the specific way in which the 9050 modular device is being controlled is repeatedly causing an error, or if an alternative way of controlling the 9050 modular device is superior under the same conditions. The 9100 analytical system can then determine whether a 9050 modular device is being controlled less than ideally (either manually or by its control program) by comparing the rate of positive and / or negative results produced by the 9050 modular device in relation to the limits or performance of other 9050 modular devices of the same type.
[00256] [00256] For example, the 9100 analytical system can determine whether a type of modular device 9050 is being operated under ideal if the rate of negative procedural results produced by the modular device 9050 under a given set of conditions in association with a given operational behavior exceeds an average or limit. As a specific example, the analytical system 9100 can analyze 9204 if a control program for a surgical stapling instrument that determines a specific trigger force (or ranges of trigger forces) is less than ideal for a tissue thickness and type of specific tissue. If the 9100 analytical system determines that the instrument generates an abnormally high leak rate in the staple lines when fired at a specific force (for example, causing the staples to be malformed, not fully penetrate the tissue, or tear the tissue) in with respect to a mean or limit on the leakage rate of the staple line, then the 9100 analytical system can determine that the control program for the surgical stapling instrument is operating below ideal given the tissue conditions.
[00257] [00257] As another example, the analytical system 9100 can determine whether a type of modular device 9050 is being operated under ideal if the rate of positive results produced by an alternative control mode under a specific set of conditions in association with a specific operational behavior exceeds the rate of positive results generated by the control mode analyzed under the same conditions. In other words, if a subpopulation of the modular device type 9050 exhibits a first operating behavior under a given set of conditions and a second subpopulation of the same type of modular device 9050 exhibits a second operating behavior under the same set of conditions, then the system analytical 9100 can determine whether to update the control programs for 9050 modular devices according to whether the first or the second operating behavior is more highly correlated to a positive procedural result. As a specific example, the 9100 analytical system can analyze 9204 if a control program for an RF or ultrasonic electrosurgical instrument that determines a specific energy level is less than ideal for a specific tissue type and environmental conditions. If the 9100 analytical system determines that a first energy level given a set of tissue conditions and environmental conditions (for example, the instrument being located in a liquid-filled environment, as in an arthroscopic procedure) produces a lower rate of hemostasis than a second energy level, then the 9100 analytical system can determine that the control program for the electrosurgical or ultrasonic instrument dictating the first energy level is operating below ideal for the given tissue and environmental conditions.
[00258] [00258] After analyzing the data 9204, the analytical system 9100 determines 9206 whether it should update the control program. If the analytical system 9100 determines that the modular device 9050 is not being controlled less than optimally, then process 9200 continues along the NO branch and the analytical system 9100 continues to analyze 9204 the received data 9202, as described above. If the analytical system 9100 determines that the modular device 9050 is being controlled less than ideally, then process 9200 continues along the SIM branch and the analysis system 9100 generates a 9208 control program update. The generated control program update 9208 includes, for example, a new version of the control program for the specific type of modular device 9050 to replace the previous version or a patch that partially replaces or supplements the previous version.
[00259] [00259] —Optipode of update of control programs that is generated 9208 by the analytical system 9100 depends on the behavior below the specific ideal exhibited by the modular device 9050 that is identified by the analytical system 9100. For example, if the analytical system 9100 determines that a force specific triggering of a surgical stapling instrument results in a higher leakage rate in the staple line, so the analytical system 9100 can generate 9208 an update of control programs that adjusts the firing force from a first value to a second value that corresponds to a higher rate of leaking staple lines or a lower rate of leaking staple lines. As another example, if the 9100 analytical system determines that a certain energy level for an electrosurgical or ultrasonic instrument produces a low rate of hemostasis when the instrument is used in a liquid-filled environment (for example, due to the effects of energy dissipation of the liquid), then the analytical system 9100 can generate 9208 an update of control programs that adjust the energy level of the instrument when it is used in surgical procedures where the instrument will be immersed in liquid.
[00260] [00260] The type of control program update that is generated 9208 by the analytical system 9100 also depends on the possibility that the suboptimal behavior exhibited by the modular device 9050 is caused by manual control or control by the control program of the modular device 9050. If the suboptimal behavior is caused by manual control, the update of control programs can be configured to provide warnings, recommendations, or feedback to users based on the way in which they are operating 9050 modular devices. control programs can change the manually controlled operation of the 9050 modular device to an operation that is controlled by the 9050 modular device control program. Updating control programs may or may not allow the user to override the control of the function control program specific. In one example, if the 9100 analytical system determines 9204 that surgeons are manually adjusting an RF electrosurgical instrument to an energy level below ideal for a specific tissue type or procedure type, then the 9100 analytical system can generate 9208 an update control programs that provide an alert (for example, on the 9000 central surgical controller or on the RF electrosurgical instrument itself) recommending that the energy level be changed. In another example, the generated control program update 9208 can automatically set the energy level to a standard or recommended level given the specific circumstances detected, which could then be changed as desired by the clinic staff. In yet another example, the update of generated control programs 9208 can automatically set the energy level to a level determined by the 9100 analytical system and not allow medical staff to change the energy level. If the suboptimal behavior is caused by the control program for the 9050 modular device, then updating control programs may change the way the control program works under the specific set of circumstances that the control program is operating under. of the ideal.
[00261] [00261] Once the control program update was generated 9208 by the analytical system 9100, the analytical system 9100 then transmits 9210 or sends the control program update to all 9050 modular devices of the relevant type that are connected to the analytical system 9100. The 9050 modular devices can be connected to the 9100 analytical system via central surgical controllers 900, for example. In one example, surgical centers 9000 are configured to download the update control program for the various types of modular devices 9050 from the 9100 analysis system each time an update is generated 9208 like this. When the 9050 modular devices subsequently connect to or pair with a 9000 central surgical controller, the 9050 modular devices then automatically download any control program updates from it. In one example, the analytical system 9100 can then continue to receive 9202 and analyze 9204 data from modular devices 9050, as described above.
[00262] [00262] In an example, instead of the 9050 modular devices transmitting recorded data to a central surgical controller
[00263] [00263] To assist in understanding process 9200 illustrated in Figure 25 and the other concepts discussed above, Figure 26 illustrates a diagram of an illustrative analytical system 9100 that updates a surgical instrument control program, in accordance with at least one aspect of present invention. In one example, a central surgical controller 9000 or network of central surgical controllers 9000 is communicably coupled to an analytical system 9100, as illustrated above in Figure 24. The analytical system 9100 is configured to filter and analyze data from the 9050 modular device associated with surgical procedure result data to determine whether adjustments to the control programs for the 9050 modular devices are required. The 9100 analytical system can then send updates to the 9050 modular devices via the 9000 central surgical controllers as needed.
[00264] [00264] In the example shown, analytical system 9100 executing process 9200 described in connection with Figure 24 is receiving 9202 data from modular device 9050 and procedural result data. When transmitted to the 9100 analytical system, the process result data can be associated with or paired with the data from the 9050 modular device corresponding to the operation of the 9050 modular device that caused the specific procedural result. The perioperative data from the 9050 modular device and the corresponding procedural result data can be called data pairs. The data is shown to include a first group 9212 of data associated with successful process results and a second group 9214 of data associated with negative process results. For this specific example, a subset of data 9212, 9214 received 9202 by the analytical system 9100 is highlighted to further clarify the concepts discussed here.
[00265] [00265] For a first data pair 9212a, the data from the modular device 9050 includes the closing force ("FTC" - force to close) over time, the triggering force ("FTF" - force to fire) when over time, the type of tissue (parenchyma), the condition of the tissue (the tissue is from a patient suffering from emphysema and has undergone radiation), what was the number of the trigger for the instrument (third), a anonymous date and time (to protect patient confidentiality while still allowing the analytical system to calculate the time elapsed between shots and other similar metrics), and an anonymous patient identifier (002). The procedural outcome data includes data indicating that there was no bleeding, which corresponds to a successful outcome (that is, a successful firing of the surgical stapling instrument). For a second data pair 9212b, data from the modular device 9050 includes the waiting time before the instrument is triggered (which corresponds to the first trigger of the instrument), the FTC over time, the FTF over time (which indicate that there was a peak of force near the end of the firing stroke), the type of tissue (1.1 mm vessel), the condition of the tissue (the tissue was subjected to radiation), what was the firing number for the instrument (first), an anonymous timestamp, and an anonymous patient identifier (002). Procedural outcome data includes data indicating that there was a leak, which corresponds to a negative result (that is, a failure to trigger the surgical stapling instrument). For a third data pair 9212c, data from the modular device 9050 includes the waiting time before the instrument is triggered (which corresponds to the instrument's first trigger), the FTC over time, the FTF over time, the type of tissue (1.8 mm vessel), the condition of the tissue (no notable condition), what was the trigger number for the instrument (first), an anonymous timestamp, and an anonymous patient identifier (012 ). Procedural outcome data includes data indicating that there was a leak, which corresponds to a negative result (that is, a failure to trigger the surgical stapling instrument). It should be noted again that these data are intended to be used exclusively for illustrative purposes to assist in understanding the concepts discussed in the present invention and should not be interpreted to limit the data received and / or that are analyzed by the 9100 analytical system to generate updates control programs.
[00266] [00266] When the analytical system 9100 receives 9202 perioperative data from the centrally operated controllers connected in a communicable manner 9000, the analytical system 9100 proceeds to aggregate and / or store the data according to the type of procedure (or a step thereof) associated to data, the type of modular device 9050 that generated the data, and other such categories. By collecting the data properly, the 9100 analytical system can analyze the data set to identify correlations between specific ways of controlling each specific type of 9050 modular device and positive or negative procedural results. Based on whether a specific control mode for a 9050 modular device correlates with positive or negative procedural results, the analytical system 9100 can determine 9204 whether the control program for the 9050 modular device type should be updated.
[00267] [00267] For this specific example, the analytical system 9100 performs a first analysis 9216a of the data set when analyzing the peak of FTF 9213 (that is, the maximum FTF for each specific shot of a surgical stapling instrument) in relation to number of shots 9211 for each FTF peak value. In this exemplary case, the analytical system 9100 can determine that there is no specific correlation between the peak of FTF 9213 and the occurrence of positive or negative results for the specific data set. In other words, there are no distinct distributions for the FTF 9213 peak for positive and negative results. As there is no specific correlation between the FTF peak 9213 and positive or negative results, the analytical system 9100 would then determine that an update of control programs to address this variable is not necessary. In addition, the analytical system 9100 performs a second analysis 9216b of the data set by analyzing the waiting time 9215 before the instrument is triggered in relation to the number of shots 9211. For this specific analysis 9216b, the analytical system 9100 can determine that there are a clear distribution of negative result 9217 and a distribution of positive result 9219. In this example case, the distribution of negative result 9217 has an average of 4 seconds and the distribution of positive result has an average of 11 seconds. In this way, the 9100 analytical system can determine that there is a correlation between the 9215 waiting time and the type of result for this stage of the surgical procedure. That is, the 9217 negative result distribution indicates that there is a relatively high rate of negative results for waiting times of 4 seconds or less. Based on this analysis 9216b demonstrating that there is a large divergence between the distribution of negative result 9217 and the distribution of positive result 9219, analytical system 9100 can then determine 9204 that an update of control programs needs to be generated
[00268] [00268] Since the analytical system 9100 analyzes the data set and determines 9204 that an adjustment of the control program of the specific modular device 9050 that is the object of the data set would improve the performance of the 9050 modular device, the 9100 analytical system then 9208 generates a control program update accordingly. In this exemplary case, the analytical system 9100 can determine based on analysis 9216b of the data set that an update of 9218 control programs recommending a 5 second waiting time would prevent an additional 90% of the distribution of negative results with a confidence interval of 95%. Alternatively, the analytical system 9100 can determine based on analysis 9216b of the data set that an update to 9218 control programs recommending a waiting time of more than 5 seconds would result in the rate of positive results being greater than the rate of negative results. The 9100 analytical system can then determine that the specific type of surgical instrument must wait more than 5 seconds before being triggered under specific tissue conditions so that negative results are less common than positive results. Based on one or both of these restrictions to generate 9208 an update of control programs that analytical system 9100 determines are satisfied by analysis 9216b, analytical system 9100 can generate 9208 an update of control programs 9218 for the surgical instrument it makes the surgical instrument, under the given circumstances, either imposes a waiting time of 5 seconds or longer before the specific surgical instrument can be triggered, or causes the surgical instrument to present an alert or a recommendation to the user that it indicates to the user that the user must wait at least 5 seconds before firing from the instrument. Various other restrictions can be used by the 9100 analytical system to determine whether 9208 generation of a control program update is generated, such as whether a control program update would reduce the rate of negative results by a certain percentage or whether a control program update would maximize the rate of positive results.
[00269] [00269] After the 9218 control program update is generated 9208, the analytical system 9100 then transmits 9210 the control program update 9218 for the appropriate type of modular devices 9050 to the central surgical controllers 9000. In an example, when a device modular 9050 which corresponds to the update of control programs 9218 is then connected to a central surgical controller 9000 that downloaded the update of control programs 9218, the modular device 9050 then automatically downloads the update 9218. In another example, the central surgical controller 9000 controls the 9050 modular device according to the 9218 control program update, instead of the 9218 control program update being transmitted directly to the 9050 modular device itself.
[00270] [00270] In one aspect, the 9060 surgical system is configured to automatically check parameters and software updates if 9050 modular devices are detected as being outdated in the data stream of the central surgical controller 9000. Figure 27 illustrates a diagram of a system analytical 9100 automating an upgrade to a modular device 9050 via a central surgical controller 9000, in accordance with at least one aspect of the present invention. In one example, the 9000 analytical system is configured to transmit a control program update generated for a specific type of 9050 modular device to a 9000 central surgical controller. In one aspect, each time a 9050 modular device connects to a controller central surgical device 9000, the modular device 9050 determines whether there is an updated version of its control program on or otherwise accessible through the central surgical controller 9000. If the central surgical controller 9000 does have an updated control program (or Up-to-date control is otherwise available from analytical system 9100) for the specific type of modular device 9050, so the modular device 9050 downloads the control program update from it.
[00271] [00271] In one example, any data set being transmitted to the 9100 analytical systems includes a unique ID for central surgical controller 9000 and the current version of its control program or operating system. In one example, any data set being sent to the 9100 analytical systems includes a unique ID for the 9050 modular device and the current version of its control program or operating system. The unique ID of the central surgical controller 9000 and / or the modular device 9050 being associated with the uploaded data allows the analytical system 9100 to determine whether the data matches the latest version of the control program. The analytical system 9100 can, for example, choose to discount (or ignore) data generated by a modular device 9050 or central surgical controller 9000 that is being controlled by an outdated control program and / or cause the updated version of the control is sent to the modular device 9050 or central surgical controller 9000.
[00272] [00272] In one example, the operational versions of all modular devices 9050 that the central surgical controller 9000 have updated control software for could also be included in a state data block of the central surgical controller 9000 that is transmitted to the analytical system 9100 on a periodic basis. If the 9100 analytical system identifies that the operating versions of the 9100 central surgical controller control programs and / or any of the 9050 pluggable modular devices are out of date, the 9100 analytical system can send the latest revision of the relevant control program to the central surgical controller 9000.
[00273] [00273] In one example, the central surgical controller 9000 and / or modular devices 9050 can be configured to automatically download any software updates. In another example, the central surgical controller 9000 and / or modular devices 9050 can be configured to provide an alert to the user to ask in the next configuration step (for example, between surgical procedures) if the user wants to update the (s) outdated data control program (s) In another example, the 9000 central surgical controller can be user-programmable to never allow updates or allow updates only to the 9050 modular devices and not to the 9000 central surgical controller itself. Control program updates for central surgical controllers
[00274] [00274] “As with the 9050 modular devices described above, the central surgical controllers 9000 may also include control programs that control the various operations of the central surgical controller 9000 during the course of a surgical procedure. If the 9000 central surgical controllers' control programs do not adapt over time in response to the collected data, then the 9000 central surgical controllers can continue to repeat errors, fail to provide warnings or recommendations to the surgical team based on the information learned, and not adjust to the preferences of the surgical team. One solution includes transmitting operational data from the 9000 central surgical controllers that indicate how the 9000 central surgical controllers are being used or controlled during the course of a surgical procedure for a 9100 analytical system. The 9100 analytical system can then analyze aggregated data from the network of central surgical controllers 9000 connected to the 9100 analytical system to determine whether a specific operating mode of central surgical controllers
[00275] [00275] In one example, an analytical system 9100 is configured to generate and send control program updates to central surgical controllers 9000 in the field based on perioperative data related to the way in which central surgical controllers 9000 are controlled or used. In other words, the 9000 central surgical controllers can be upgraded with better decision-making skills according to the data generated from the central controller network. In one respect, external and perioperative data are collected by an analytical system. The data is then analyzed to generate a control update to improve the performance of the 9000 central surgical controllers. The 9100 analytical system can analyze the aggregated data from the 9000 central surgical controllers to determine the preferred operating mode of the 9000 central surgical controllers, under what conditions the control programs of the central surgical controllers 9000 are controlling the central surgical controllers 9000 less than ideally (that is, if there are repeated failures or errors in the control program or if an alternative algorithm operates in a superior manner), or under what conditions the medical team is using sub-optimal central surgical controllers 9000. The 9100 analytical system can then send the update to the 9000 central surgical controllers connected to it.
[00276] [00276] Figure 28 illustrates a diagram of an adaptive surgical system implemented by a 9060 computer that is configured to adaptively generate control program updates for 9000 central surgical controllers, in accordance with at least one aspect of the present invention. The 9060 surgical system includes several 9000 central surgical controllers that are communicably coupled to the 9100 analytical system. Subpopulations of 9000 central surgical controllers (each of which may include individual 9000 central surgical controllers or groups of 9000 central surgical controllers) within the population total connected to the 9100 analytical system may exhibit different operating behaviors during the course of a surgical procedure. Differences in operational behavior between groups of central surgical controllers 9000 within the population may result from central surgical controllers 9000 running different versions of their control program, through the control programs of central surgical controllers 9000 being customized or programmed differently by the team local surgical team, or by the local surgical team manually controlling the 9000 central surgical controllers differently. In the example shown, the population of central surgical controllers 9000 includes a first subpopulation 9312 that is exhibiting a first operational behavior and a second subpopulation 9314 that is exhibiting a second operational behavior for a specific task. Although 9000 central surgical controllers are divided into a pair of subpopulations 9312, 9314 in this specific example, there is no practical limit to the number of different behaviors displayed within the population of 9000 central surgical controllers. The tasks that 9000 central surgical controllers can perform include, for example, controlling a surgical instrument or analyzing a set of data in a specific way.
[00277] [00277] Central surgical controllers 9000 can be configured to transmit perioperative data regarding the operational behavior of central surgical controllers 9000 to the analytical system 9100. Perioperative data can include preoperative data, intraoperative data, and postoperative data. Preoperative data may include, for example, patient-specific information, such as demographic, health history, pre-existing conditions, preoperative procedure, medication history (that is, medications currently and previously taken), genetic data ( for example, SNPs or gene expression data), EMR data, advanced imaging data (for example, MRI, CT, or PET), metabolomics, and microbiome. Several additional types of patient-specific information that can be used by the 9100 analytical system are described in US Patent No. 9,250,172,
[00278] [00278] Intraoperative data may include, for example, the use of the 9050 modular device (for example, the number of shots by a surgical stapling instrument, the number of shots by an RF electrosurgical instrument or an ultrasonic instrument, or the number and types of staple cartridges used), operational parameter data for 9050 modular devices (for example, the FTF curve for a surgical stapling instrument, the FTC curve for a surgical stapling instrument, the power output of a generator, the internal pressure or pressure differential of a smoke evacuator), unexpected use of the 9050 modular device (ie, detection of the use of a modular device that is standardized for the type of procedure), adjunctive therapies administered to the patient, and the use of equipment other than 9050 modular devices (for example, sealants to treat leaks). Intraoperative data may also include, for example, detectable misuse of a 9050 modular device and use outside the detectable indication of a 9050 modular device.
[00279] [00279] Post-operative data may include, for example, an indication if the patient does not leave the operating room and / or is sent for standardized post-operative care (for example, a patient undergoing a routine bariatric procedure) is sent to the ICU after the procedure), a post-operative assessment of the patient related to the surgical procedure (for example, data related to spirometric performance after thoracic surgery or data related to a leak in the staple line after intestinal or bariatric procedures ), data related to complications - postoperative (for example, transfusions or air leaks), or the patient's length of stay in the medical facility after the procedure. Due to the fact that hospitals are increasingly being evaluated for readmission frequencies, complication rates, average length of stay, and other such metrics of surgical quality, postoperative data sources can be monitored by the 9100 analytical system alone or in combination with data from surgical procedural results (discussed below) to evaluate and establish updates to the control programs of the 9000 central surgical controllers and / or 9050 modular devices.
[00280] [00280] In some examples, the postoperative and / or intraoperative data include data that may additionally include data referring to the result of each surgical procedure or a stage of the surgical procedure. Data from surgical procedural results may include whether a specific procedure or a specific step in a procedure has had a negative or positive result. In some examples, data from surgical procedural results may include a procedure step and / or timestamp images of the 9050 modular device's performance, a signal indicating whether a 9050 modular device has functioned properly, notes from medical staff, or a signal for unsatisfactory, suboptimal, or unacceptable performance from the 9050 modular device. Surgical procedural outcome data can, for example, be detected directly by the 9050 modular devices and / or the 9000 central surgical controller (for example, a medical imaging can view or detect bleeding), determined or deduced by a central surgical controller 9000 situational recognition system as described in US Patent Application serial number (attorney document number END8501USNP / 170768), or retrieved from a database 9054 (for example, an EMR database) by the ce surgical controller ntral 9000 or by the analytical system
[00281] [00281] In an example, perioperative data can be assembled on a procedure-by-procedure basis and thus sent by 9000 central surgical controllers to the 9100 analytical system for analysis. Perioperative data indicates the way in which the 9000 central surgical controllers were programmed to operate or were manually controlled in association with a surgical procedure (ie, the operating behavior of the 9000 central surgical controllers) because they indicate what actions the controller central surgical 9000 took in response to several detected conditions, how central surgical controllers 9000 controlled modular devices 9050, and what inferences the situational recognition of central surgical controllers 9000 derived from the received data. The 9100 analytical system can be configured to analyze the various types and combinations of preoperative, intraoperative, and postoperative data to determine whether a control program update should be generated and then send the update to the general population or one or more subpopulations of 9000 central surgical controllers as needed.
[00282] [00282] Figure 29 illustrates a logical flow chart of a 9300 process for updating the control program of a 9000 central surgical controller, in accordance with at least one aspect of the present invention. During the description of process 9300 below, reference should also be made to Figures 24 and 28. Process 9200 can be executed, for example, by one or more processors from analytical servers 9070 of analytical system 9100. In one example, the system analytical 9100 can be a cloud computing system. For economy, the following description of the 9300 process will be described as being carried out by the 9100 analytical system; however, it should be understood that the 9100 analytical system includes the processor (s) and / or the control circuit (s) that are performing the 9300 process steps described.
[00283] [00283] The analytical system 9100 that executes the 9300 process receives 9302 perioperative data from the central surgical controllers 9000 that are communicably connected to the analytical system 9100. The perioperative data indicates the way in which the central surgical controllers 9000 are programmed to operate control programs or are controlled by the surgical team during a surgical procedure. In some respects, perioperative data may include or be transmitted to the 9100 analytical system in association with data from surgical procedural results. Procedural outcome data can include data related to the overall outcome of a surgical procedure (for example, if there was a complication during the surgical procedure) or data related to a specific step within a surgical procedure (for example, if a particular line of staples bleed or leaked).
[00284] [00284] After an analysis system 9100 running process 9300 has received 9302 perioperative data, analytical system 9100 then analyzes 9304 data to determine whether an update condition has been met. In one example, the update condition includes determining whether a limit number or percentage of 9000 central surgical controllers within the population exhibits specific operating behavior. For example, the 9100 analytical system can determine that a control program update must be generated to automatically activate an energy generator at a specific step in a type of surgical procedure when a majority of the 9000 central surgical controllers are used to activate the generator of energy at that procedural stage. In another example, the update condition includes whether the rate of positive procedural results (or lack of negative procedural results) correlated to a given operating behavior exceeds a threshold value (for example, an average rate of positive procedural results for a step in the procedure ). For example, the 9100 analytical system may determine that a control program update should be generated to recommend that the power generator be adjusted to a specific energy level when the associated rate of haemostasis (ie, lack of bleeding) at that level of energy for the specific tissue type exceeds a threshold rate. In another example, the update condition includes whether the rate of positive procedural results (or lack of negative procedural results) for a given operational behavior is higher than the rate of positive procedural results (or a lack of negative procedural results) for operational behaviors related. In other words, if a subpopulation of 9000 central surgical controllers exhibits a first operating behavior under a given set of conditions and a second subpopulation of 9000 central surgical controllers exhibits a second operating behavior under the same set of conditions, then the 9100 analytical system can determine whether the 9000 central surgical controllers control programs should be updated according to whether the first or second operating behavior is more highly correlated to a positive procedural outcome. In another example, the analytical system 9100 analyzes the data 9304 to determine whether multiple update conditions have been met.
[00285] [00285] If an update condition has not been satisfied, process 9300 continues along the NO branch and the analytical system 9100 continues to receive 9302 and analyze 9304 perioperative data from central surgical controllers 9000 to monitor the occurrence of an update condition. If an update condition has been met, process 9300 continues along the YES branch and analytical system 9100 proceeds to generate a 9308 control program update. The nature of the control program update generated 9308 corresponds to the specific operational behavior of the central surgical controller 9000 which is identified by the analytical system 9100 as activating the update condition. In other words, updating control programs adds, removes, or otherwise alters functions performed by the central surgical controller 9000 so that the central surgical controller 9000 operates differently under the conditions that gave rise to the identified operational behavior.
[00286] [00286] The 9100 analytical system then transmits 9310 the update of control programs to the general population of central surgical controllers 9000 or the subpopulations of central surgical controllers 9000 that are performing the operational behavior that is identified by the analytical system 9100 as activating the condition of update. In one example, the 9000 central surgical controllers are configured to download control program updates from the 9100 analytical system each time a 9308 update is generated in this way. In one example, analytical system 9100 can then continue process 9300 for analyzing 9304 of data received 9302 from central surgical controllers 9000, as described above.
[00287] [00287] Figure 30 illustrates a representative implementation of the 9300 process represented in Figure 29. Figure 30 illustrates a logical flowchart of a 9400 process to update the data analysis algorithm of a control program for a central surgical controller 9000, from according to at least one aspect of the present invention. As with the 9300 process shown in Figure 29, the 9400 process illustrated in Figure 30 can, in one example, be run by the 9100 analytical system. In the following description of the 9400 process, reference should also be made to Figure 28. In a exemplification of the adaptive surgical system 9060 shown in Figure 28, the first subpopulation of central surgical controllers 9312 uses a first data analysis algorithm, and the second subpopulation of central surgical controllers 9314 uses a second data analysis algorithm. For example, the first subpopulation of central surgical controllers 9312 can use a normal continuous probability distribution to analyze a specific data set, while the second subpopulation of central surgical controllers 9314 can use a bimodal distribution to analyze the specific data set. In this example, the analytical system 9100 receives 9402, 9404 perioperative data from the first and second subpopulations of central surgical controllers 9312, 9314 corresponding to the respective data analysis algorithms. The analytical system 9100 then analyzes 9406 perioperative data sets to determine whether one of the perioperative data sets meets one or more update conditions. Update conditions may include, for example, a specific analysis method being used by a percentage limit (for example, 75%) of central surgical controllers 9000 in the general population, and a specific analysis method being correlated to positive surgical procedural results in a percentage limit (for example, 50%) of cases.
[00288] [00288] In this example, the analytical system 9100 determines 9408 if one of the data analysis algorithms used by the first and second subpopulations of central surgical controllers 9312, 9314 satisfies both update conditions. If the update conditions are not met, then process 9400 proceeds along the NO branch and the analytical system 9100 continues to receive 9402, 9404 and analyze 9406 perioperative data from the first and second subpopulations of central surgical controllers 9312, 9314. If the update conditions are met, process 9400 proceeds along the YES branch and the analytical system 9100 generates 9412 an update of control programs according to which data analysis algorithms analysis 9406 determined has satisfied the update conditions.
[00289] [00289] This technique optimizes the performance of the central surgical controller 9000 by updating its control programs generated from data aggregated throughout the entire network of central surgical controllers 9000. Effectively, each central surgical controller 9000 can be adjusted according to according to knowledge shared or learned through the network of central surgical controllers 9000. This technique also allows the analytical system 9100 to determine when unexpected devices (for example, modular devices 9050) are used during the course of a surgical procedure by providing the analytical system 9100 through knowledge of the devices being used in each type of surgical procedure throughout the entire network of central surgical controllers 9000. Situational recognition
[00290] [00290] 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 that is the object of 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 provides information or contextualized suggestions to the surgeon during the course of the surgical procedure. Situational recognition can be applied to perform and / or improve any of the functions described in Figures 22 to 30, for example.
[00291] [00291] - Now with reference to Figure 31, a time line 5200 is represented representing 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.
[00292] [00292] 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 operating room 106 , 206. Central surgical controller 106, 206 can receive this data from paired modular devices and other data sources and continuously derives inferences (ie contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being carried out 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 (FOV) of the medical imaging device, or change the energy level of a ultrasonic surgical instrument or RF electrosurgical instrument), and take any other action described above.
[00293] [00293] In the first step 5202, in this illustrative procedure, the hospital team members 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.
[00294] [00294] “In the second step 5204, the team members scan the entry of 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).
[00295] [00295] In the third step 5206, the medical staff scans the patient's band 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.
[00296] [00296] In the fourth step 5208, the medical personnel 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. Once 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 over the data it subsequently receives 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.
[00297] [00297] In the fifth step 5210, the team members 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 central surgical controller 106, 206. As central surgical controller 106, 206 begins to receive data from patient monitoring devices, central surgical controller 106, 206 thus confirming that the patient is in the operating room.
[00298] [00298] In the sixth step 5212, the medical personnel induced 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.
[00299] [00299] In the seventh stage 5214, the lung of the patient being operated on is retracted (while ventilation is switched to the contralateral lung). The central surgical controller 106, 206 can infer from the ventilator data that the patient's lung has been retracted, for example. Central surgical controller 106, 206 can infer that the operative portion of the procedure 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 retraction of the patient lung is the first operative step in this specific procedure.
[00300] [00300] At the 8th 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 medical imaging device data 124 (Figure 2) can be used to determine contextual information about the type of procedure being performed in a number of different ways, including by determining the angle at which the medical imaging device is oriented in in relation to visualizing the patient's anatomy, monitoring the number or medical imaging devices being used (ie, which are activated and paired with the operating room 106, 206), and monitoring the types of visualization devices used.
[00301] [00301] In the ninth step 5218 of the procedure, the surgical team starts the dissection step. 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.
[00302] [00302] In the tenth step 5220 of the procedure, the surgical team proceeds to the connection step. 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.
[00303] [00303] 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.
[00304] [00304] “In the second 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 the 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.
[00305] [00305] 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.
[00306] [00306] Finally, in the fourteenth step 5228 is that medical personnel remove the various patient monitoring devices from the patient. 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.
[00307] [00307] Situational recognition is additionally described in US Provisional Patent Application serial number 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 herein, for example, can be controlled by the central controller 106, 206 based on its situational recognition and / or feedback from the components of the same and / or based on information from cloud 102.
[00308] [00308] Various aspects of the subject described in this document are defined in the following numbered examples.
[00309] [00309] “Example 1. An analytical system configured to connect in a communicable way to a central surgical controller, the central surgical controller configured to connect in a communicable way to a modular device that is controlled by a control program, the analytical system comprising: a processor; and a memory attached to the processor, the memory storing instructions that, when executed by the processor, cause the analytical system to: receive perioperative data indicative of an operational behavior of the modular device, and the perioperative data comprises data detected by the modular device during a surgical procedure; receive procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operating behavior is below ideal; generate a control program update configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
[00310] [00310] Example 2. The analytical system of Example 1, the memory stores instructions that, when executed by the processor, cause the analytical system to determine if the operational behavior is below ideal according to whether the operational behavior correlates with a negative procedural result.
[00311] [00311] Example 3. The analytical system of any of the
[00312] [00312] Example 4. The analytical system of any of Examples 1 to 3, with the update of control programs configured to provide an alert associated with operational behavior.
[00313] [00313] Example 5. The analytical system of any of Examples 1 to 4, with the update of control programs being configured to change a function controlled manually to a function controlled by the control program.
[00314] [00314] Example 6. The analytical system of any of Examples 1 to 5, the memory stores instructions that, when executed by the processor, cause the analytical system to receive the process result data from a database. REM data.
[00315] [00315] Example 7. The analytical system of any of Examples 1 to 6, the memory stores instructions that, when executed by the processor, cause the analytical system to receive the process result data from a surgical controller central.
[00316] [00316] Example 8. An analytical system configured to connect in a communicable way to a central surgical controller, the central surgical controller configured to connect in a communicable way to a modular device that is controlled by a control program, the analytical system comprising: a control circuit configured to: receive perioperative data indicative of an operational behavior of the modular device, with perioperative data comprising data detected by the modular device during a surgical procedure; receiving procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operational behavior is less than ideal; generate an update of control programs configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
[00317] [00317] Example 9.0 The analytical system of Example 8, with the control circuit being configured to determine if the operational behavior is below ideal according to whether the operational behavior correlates with a negative procedural result.
[00318] [00318] Example 10. The analytical system of any of Examples 8 to 9, being that: the operational behavior is a first = “operational behavior; additional perioperative data additionally indicate a second operating behavior; and the control circuit is configured to determine whether the first operating behavior is less than ideal according to whether the second operating behavior is more highly correlated to a positive procedural result than the first operating behavior.
[00319] [00319] Example 11. The analytical system of any of Examples 8 to 10, with the update of control programs configured to provide an alert associated with operational behavior.
[00320] [00320] Example 12. The analytical system of any of Examples 8 to 11, the update of control programs is configured to change a function controlled manually to a function controlled by the control program.
[00321] [00321] Example 13. The analytical system of any of Examples 8 to 12, and the control circuit is configured to make the analytical system receive the process results data from a REM database.
[00322] [00322] Example 14. The analytical system of any of Examples 8 to 13, the control circuit being configured to make the analytical system receive the process results data from the central surgical controller.
[00323] [00323] Example 15. A non-transitory, computer-readable medium that stores computer-readable instructions that, when executed, cause an analytical system configured to be communicably coupled to a central surgical controller, the central surgical controller configured to connect in a communicable way to a modular device that is controlled by a control program, to: receive perioperative data indicative of an operational behavior of the modular device, the perioperative data comprising data detected by the modular device during a surgical procedure; receiving procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operational behavior is less than ideal; generate an update of control programs configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
[00324] [00324] “Example 16.The computer-readable non-transitory media according to Example 15, the computer-readable non-transitory media stores instructions that cause the analytical system to determine if the operational behavior is below ideal according to whether operating behavior is correlated to a negative procedural outcome.
[00325] [00325] “Example 17. The computer-readable non-transitory media according to any of Examples 15 to 16, being that: the operational behavior is a first operational behavior; additional perioperative data additionally indicate a second operating behavior; and the computer-readable non-transitory media stores instructions that cause the analytical system to determine whether the first operating behavior is less than ideal according to whether the second operating behavior is more highly correlated to a positive procedural result than the first operating behavior.
[00326] [00326] Example 18. The non-transitory, computer-readable media of any of Examples 15 through 17, with the update of control programs configured to provide an alert associated with operational behavior.
[00327] [00327] Example 19. The non-transitory, computer-readable media of any of Examples 15 through 18, the update of control programs is configured to change a function controlled manually to a function controlled by the control program.
[00328] [00328] Example 20.The computer-readable non-transitory media according to any of Examples 15 to 19, the computer-readable non-transitory media stores instructions that cause the analytical system to receive the process result data from from a REM database.
[00329] [00329] “Example 21.The computer readable non-transitory media according to any of Examples 15 to 20, the computer readable non-transitory media stores instructions that make the analytical system receive the process result data from the central surgical controller.
[00330] [00330] Although several 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 the present invention. 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 are revealed for certain components, other materials can be used. It should be understood, therefore, that the preceding description and the appended claims are intended to cover all these modifications, combinations and variations that fall within the scope of the modalities presented. The attached claims are intended to cover all such modifications, variations, alterations, substitutions, modifications and equivalents.
[00331] [00331] 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, can 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 description. 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.
[00332] [00332] The instructions used to program the logic to execute various revealed 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
[00333] [00333] 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,
[00334] [00334] 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.
[00335] [00335] “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 running software.
[00336] [00336] As used 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.
[00337] [00337] 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 Ethernet protocol can conform to or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) entitled "EEE 802.3 Standard", published in December 2008 and / or later versions of this standard. Alternatively or in addition, communication devices may be able to communicate with each other using an X.25 communications protocol. The X.25 communications protocol can conform or be compatible! with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or in addition, communication devices may be able to communicate with each other using a frame-relay communications protocol. The frame-relay communications protocol can conform to or be compatible with a standard promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, transceivers may be able to communicate with each other using an ATM communication protocol ("asynchronous transfer mode"). The ATM communication protocol can conform to or be compatible with an ATM standard published by the ATM forum entitled "ATM-MPLS Network Interworking 2.0" published in August 2001, and / or later versions of that standard. Obviously, different and / or post-developed connection-oriented network communication protocols are also contemplated in the present invention.
[00338] [00338] Unless otherwise stated, as is evident from the preceding description, it is understood that, throughout the preceding description, discussions using terms such as "processing", or "computation", or "calculation", or " determination ", or" display ", or similar, refer 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 records and memories of the computer in other data represented in a similar way in the form of physical quantities in the memories or records of the computer, or in other similar devices for storing, transmitting or displaying information.
[00339] [00339] “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 dictates otherwise.
[00340] [00340] 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.
[00341] [00341] 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" should be interpreted as "includes, but is not limited to ", etc.). It will also be understood by those skilled in the art that, when a specific number of a claim statement entered is intended, that intention will be expressly mentioned in the claim and, in the absence of such mention, no intention will be present. For example, as an aid to understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim statements. However, the use of such phrases should not be interpreted as implying that the introduction of a claim statement by the indefinite articles "one, ones" or "one, ones" limits any specific claim containing the mention of the claim entered to claims that contain only such a mention, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles, such as "one, ones" or "one, ones" (for example, "one, ones" and / or "one, ones" should typically be interpreted as meaning "not one" or "one or more"); the same goes for the use of defined articles used to introduce claims.
[00342] [00342] 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, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B and C together, etc.). In cases where a convention analogous to "at least one of A, B or 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 have at least one of A, B and C "would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A , B and C together, etc.). It will be further understood by those skilled in the art that typically a disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, in the claims or in the drawings, should be understood as contemplating the possibility of including one of the terms, any of the terms or both terms,
[00343] [00343] With respect to the attached claims, those skilled in the art will understand that the operations mentioned in them can, in general, be performed 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.
[00344] [00344] 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.
[00345] [00345] “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 this. Accordingly, and to the extent necessary, the description 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 description materials contained herein, will be incorporated here only to the extent that there is no conflict between the embedded material and the existing description material.
[00346] [00346] 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 (21)
[1]
1. Analytical system configured to connect in a communicable way to a central surgical controller, the central surgical controller being configured to connect in a communicable way to a modular device that is controlled by a control program, the analytical system being characterized by comprising: a processor; and a memory attached to the processor, and the memory stores instructions that, when executed by the processor, cause the analytical system to: receive perioperative data indicative of an operational behavior of the modular device, and the perioperative data comprise data detected by the modular device during a surgical procedure; receive procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operating behavior is below ideal; generate a control program update configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
[2]
2. Analytical system, according to claim 1, characterized in that the memory stores instructions that, when executed by the processor, cause the analytical system to determine if the operational behavior is below the ideal according to the possibility of the operational behavior being correlate with a negative procedural outcome.
[3]
3. Analytical system, according to claim 1, characterized by: the operational behavior! be a first operational behavior; the additional perioperative data additionally indicate a second operational behavior; and memory storing instructions that, when executed by the processor, cause the analytical system to determine if the first operating behavior is below ideal according to the possibility that the second operating behavior is more highly correlated to a positive procedural result than the first operational behavior.
[4]
4. Analytical system, according to claim 1, characterized in that the update of control programs is configured to provide an alert associated with operational behavior.
[5]
5. Analytical system, according to claim 1, characterized in that the update of control programs is configured to change a function controlled manually to a function controlled by the control program.
[6]
6. Analytical system, according to claim 1, characterized in that the memory stores instructions that, when executed by the processor, cause the analytical system to receive the process result data from an RME database.
[7]
7. Analytical system, according to claim 1, characterized in that the memory stores instructions that, when executed by the processor, cause the analytical system to receive the process results data from the central surgical controller.
[8]
8. Analytical system configured to connect in a communicable way to a central surgical controller, the central surgical controller being configured to connect in a communicable way to a modular device that is controlled by a control program, the analytical system being characterized by comprising: a control circuit configured to: receive perioperative data indicative of an operational behavior of the modular device, with perioperative data comprising data detected by the modular device during a surgical procedure; receiving procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operational behavior is less than ideal; generate an update of control programs configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
[9]
9. Analytical system, according to claim 8, characterized in that the control circuit is configured to determine if the operational behavior is below the ideal according to the possibility of the operational behavior correlating with a negative procedural result.
[10]
10. Analytical system, according to claim 8, characterized by: the operational behavior is a first operational behavior; the additional perioperative data additionally indicate a second operational behavior; and the control circuit is configured to determine whether the first operating behavior is less than ideal according to the possibility that the second operating behavior is more highly correlated to a positive procedural result than the first operating behavior.
[11]
11. Analytical system, according to claim 8, characterized in that the update of control programs is configured to provide an alert associated with operational behavior.
[12]
12. Analytical system, according to claim 8, characterized in that the update of control programs is configured to change a function controlled manually to a function controlled by the control program.
[13]
13. Analytical system, according to claim 8, characterized in that the control circuit is configured to make the analytical system receive the process result data from an RME database.
[14]
14. Analytical system, according to claim 8, characterized in that the control circuit is configured to make the analytical system receive the process results data from the central surgical controller.
[15]
15. Non-transient, computer-readable media characterized by storing computer-readable instructions that, when executed, cause an analytical system configured to connect in a communicable way to a central surgical controller, the central surgical controller being configured to couple in a way communicable to a modular device that is controlled by a control program: receive perioperative data indicative of an operational behavior of the modular device, with perioperative data comprising data detected by the modular device during a surgical procedure; receive procedural outcome data associated with the surgical procedure; analyze perioperative data and procedural outcome data to determine if operating behavior is below ideal; generate a control program update configured to change the way in which the control program operates the modular device during the surgical procedure for operational behavior; and transmit the update of control programs to the modular device.
[16]
16. Computer-readable non-transitory media according to claim 15, characterized in that the computer-readable non-transitory media stores instructions that cause the analytical system to determine if the operational behavior is below ideal according to the possibility that the operational behavior correlates to a negative procedural result.
[17]
17. Computer readable non-transitory media, according to claim 15, characterized by: the operational behavior is a first operational behavior; the additional perioperative data additionally indicate a second operational behavior; and computer readable non-transitory media store instructions that cause the analytical system to determine whether the first operating behavior is less than ideal according to the possibility that the second operating behavior is more highly correlated to a positive procedural outcome than the first behavior operational.
[18]
18. Computer-readable non-transitory media according to claim 15, characterized in that the update of control programs is configured to provide an alert associated with operational behavior.
[19]
19. Computer readable non-transitory media according to claim 15, characterized in that the update of control programs is configured to change a function controlled manually to a function controlled by the control program.
[20]
20. Computer-readable non-transitory media according to claim 15, characterized in that the computer-readable non-transitory media stores instructions that cause the analytical system to receive process result data from an RME database.
[21]
21. Computer-readable non-transitory media according to claim 15, characterized in that the computer-readable non-transitory media stores instructions that cause the analytical system to receive process result data from the central surgical controller.

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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:

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申请号 | 申请日 | 专利标题

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US201762611339P| true| 2017-12-28|2017-12-28|

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US201762611341P| true| 2017-12-28|2017-12-28|

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US201762611340P| true| 2017-12-28|2017-12-28|

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US62/611,339|2017-12-28|

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US62/611,340|2017-12-28|

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US62/611,341|2017-12-28|

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US201862649296P| true| 2018-03-28|2018-03-28|

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US62/649,296|2018-03-28|

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US15/940,636|US20190206003A1|2017-12-28|2018-03-29|Adaptive control program updates for surgical devices|

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US15/940,636|2018-03-29|

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PCT/IB2018/055742|WO2019130075A1|2017-12-28|2018-07-31|Adaptive control program updates for surgical devices|

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