change of scale, alignment and self-organization of data based on predefined parameters within surgi

专利摘要:
The present invention relates to a system for automatically merging data from a medical procedure. The system includes a central medical controller comprising at least one processor and at least one memory. A processor is configured to access a first data set comprising sample data at a first sampling rate during a sample-sampling period, accessing a second data set comprising sample data at a second sampling rate data that is lower than the first data sampling rate and is recorded during the sampling time period, change the scale of the second set of data to correlate with the first data sampling rate, fun-dir the first set data and the second data set in a composite data set, align the first data set and the second data set in the composite data set, display the composite data set, generate a graphical overlay at the top of the display screen composite data set and transmit the composite data set to a remote server.
公开号:BR112020013199A2
申请号:R112020013199-7
申请日:2018-11-14
公开日:2020-12-01
发明作者:Frederick E. Shelton Iv；Jason L. Harris
申请人:Ethicon Llc；
IPC主号:

专利说明:

[001] [001] The present application claims the benefit of the priority of the non-provisional patent application US serial number 16 / 182.260, entitled AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN SURGICAL NETWORKS, POWERED SURGICAL TOOL WITH PREDEFINED
[002] [002] This application claims priority under 35 U.S.C. & $ 119 (e) to US provisional patent application No. 62 / 729,177, entitled AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING
[003] [003] The present application also claims priority under title 35 of the USC (United States Code), $ 119 (e), to US provisional patent application No. 62 / 692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE , filed on June 30, 2018, at the provisional patent application
[004] [004] The present application claims priority under 35 USC $ 119 (e) of US provisional patent application 62 / 659,900, entitled METHOD OF HUB COMMUNICATION, filed on April 19, 2018, the description of which is incorporated herein by way of reference, in its entirety.
[005] [005] The present application also claims priority under 35 USC $ 119 (e) of US provisional patent application 62 / 650,898 filed March 30, 2018, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, of the application for US Provisional Patent Serial No. 62 / 650,887, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPARBILITIES, filed on March 30, 2018, from US Provisional Patent Application Serial No. 62 / 650,882, entitled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed at March 30, 2018, and provisional US patent application serial number 62 / 650,877, entitled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS, filed on March 30, 2018, the description of which is incorporated herein by reference, in its entirety.
[006] [006] The present application also claims priority under 35 U.S.C. $ 119 (e) of US provisional patent application serial number 62 / 640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND
[007] [007] The present application also claims priority under 35 USC $ 119 (e) of US provisional patent application serial number 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, of the provisional US 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 which is incorporated herein by reference, in its entirety. BACKGROUND OF THE INVENTION
[008] [008] The present invention relates to various surgical systems. Surgical procedures are typically performed in theaters or surgical operating rooms in a health care facility, such as a hospital. A sterile field is typically created around the patient. The sterile field may include members of the brushing team, who are properly dressed, and all furniture and accessories in the area. Various surgical devices and systems are used to perform a surgical procedure.
[009] [009] Furthermore, in the digital and information age, medical systems and facilities are often slower to implement systems or procedures that use newer and improved technologies due to patient safety and a general desire to maintain traditional practices. However, health systems and clinics may often lack communication and knowledge shared with other neighboring or similarly located clinics as a result. To improve patient practices, it would be desirable to find ways to help better connect medical systems and clinics. SUMMARY
[0010] [0010] In several modalities, a system is described for automatically merging data obtained from a medical procedure, said system including a central medical controller that includes at least one processor and at least one memory, and a remote server attached communicatively with the central medical controller. At least one processor is configured to access a first data set comprising data sampled at a first data sampling rate over a sampling period, accessing a second data set comprising data sampled at a second data sampling rate which is slower than the first data sampling rate and is recorded during the sampling time period, change the scale of the second data set to match the first data sampling rate, merge the first data set and the second dataset in a composite dataset, align the first dataset and the second dataset in the composite dataset, display the composite dataset, generate a graphical overlay on the display of the composite dataset, and transmit the composite data set to a remote server.
[0011] [0011] In various embodiments, a method of a system for automatically merging data from a medical procedure is described, the system comprising a central medical controller comprising at least one processor and at least one memory. The method includes accessing a first data set comprising data sampled at a first data sampling rate recorded during a sampling period, accessing a second data set comprising data sampled at a second data sampling rate which is slower that the first data sampling rate and is recorded during the sampling time period, change the scale of the second data set to match the first data sampling rate, merge the first data set and the second data set into a composite dataset, align the first dataset and the second dataset in the composite dataset, so that the data from the first dataset and the second dataset are ordered sequentially into the composite dataset in one sequence in which the data was recorded, display the composite data set, generate a graphic overlay on the display of the composite data that provides an interpretation of the composite data set and transmits the composite data set to a remote server.
[0012] [0012] In various modalities, a computer-readable medium is described that does not include any transient signals and includes instructions that, when executed by a processor, cause the processor to perform operations. Operations include accessing a first data set comprising data sampled at a first data sampling rate recorded during a sampling period, accessing a second data set comprising data sampled at a second data sampling rate which is slower that the first data sampling rate and is recorded during the sampling time period, change the scale of the second data set to match the first data sampling rate, merge the first data set and the second data set into a composite dataset, align the first dataset and the second dataset in the composite dataset, so that the data from the first dataset and the second dataset are ordered sequentially into the composite dataset in one sequence in which the data was recorded, display the composite data set, generate a graphic overlay on the display of the set composite data set that provides an interpretation of the composite data set and transmits the composite data set to a remote server. FIGURES
[0013] [0013] The various aspects described here, both with regard to organization and methods of operation, together with additional objects and advantages of them, can be better understood in reference to the description presented below, considered together with the drawings in attached as follows.
[0014] [0014] Figure 1 is a block diagram of an interactive surgical system implemented by computer, according to at least one aspect of the present description.
[0015] [0015] Figure 2 illustrates a surgical system being used to perform a surgical procedure in an operating room, in accordance with at least one aspect of the present description.
[0016] [0016] Figure 3 is a central surgical controller paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present description.
[0017] [0017] Figure 4 is a partial perspective view of a central surgical controller compartment, and of a combined generator module slidably received in a drawer of the central surgical controller compartment, in accordance with at least one aspect of the present description. .
[0018] [0018] Figure 5 is a perspective view of a generator module combined with bipolar, ultrasonic and monopolar contacts and a smoke evacuation component, in accordance with at least one aspect of the present description.
[0019] [0019] 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 description.
[0020] [0020] Figure 7 illustrates a vertical modular housing configured to receive a plurality of modules, according to at least one aspect of the present description.
[0021] [0021] 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, in accordance with at least one aspect of the present description.
[0022] [0022] Figure 9 illustrates an interactive surgical system implemented by computer, in accordance with at least one aspect of the present description.
[0023] [0023] Figure 10 illustrates a central surgical controller that comprises a plurality of modules coupled to the modular control tower, in accordance with at least one aspect of the present description.
[0024] [0024] Figure 11 illustrates an aspect of a universal serial bus (USB) central network controller device, in accordance with at least one aspect of the present description.
[0025] [0025] Figure 12 is 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 least one aspect of the present description.
[0026] [0026] Figure 13 is a functional module architecture of a cloud computing system, according to at least one aspect of the present description.
[0027] [0027] Figure 14 illustrates a diagram of a surgical system with situational recognition, according to at least one aspect of the present description.
[0028] [0028] Figure 15 is a timeline that represents the situational recognition of a central surgical controller, in accordance with at least one aspect of the present description.
[0029] [0029] Figure 16 is a block diagram of a system for automated scaling, organization, merging and alignment of distinctly different data sets, in accordance with at least one aspect of the present description.
[0030] [0030] Figure 17 is a set of graphs that includes a first graph showing blood pressure measured as a function of time, a second graph showing fused blood pressure as a function of time, and a third graph showing blood pressure as a function of time time for different sampling rates, in accordance with at least one aspect of this description.
[0031] [0031] Figure 18 is a graph showing blood pressure in relation to high and low limits, according to at least one aspect of the present description.
[0032] [0032] Figure 19 is a graph showing the frequency of the ultrasonic system as a function of time, according to at least one aspect of the present description.
[0033] [0033] Figure 20 is a graph showing the expected blood pressure for different types of vessels, according to at least one aspect of the present description.
[0034] [0034] Figure 21 is a block diagram representing stratified contextual information, in accordance with at least one aspect of the present description.
[0035] [0035] Figure 22 is a block diagram representing functional configurations of the instrument, according to at least one aspect of the present description.
[0036] [0036] Figure 23 is a graph representing the force to fire (FTF) and the speed of fire for patients subject to different risk of complications. DESCRIPTION
[0037] [0037] The applicant for this application holds the following US patent applications, filed on November 6, 2018, the description of which is incorporated herein by reference in its entirety: * US patent application No. 16 / 182,224 , titled SURGICAL NETWORK, INSTRUMENT, AND CLOUD RESPONSES
[0038] [0038] The applicant for this application holds the following US patent applications filed on September 10, 2018, the description of which is incorporated herein by reference in its entirety: * US provisional patent application No. 62 / 729,183 entitled A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASED ON À SENSED SITUATION OR USAGE;
[0039] [0039] The applicant for this application holds the following US patent applications, filed on August 28, 2018, the description of each of which is incorporated herein by reference in its entirety: * US patent application No. 16 /115,214, entitled
[0040] [0040] The applicant for this application holds the following US patent applications filed on August 23, 2018, the description of which is incorporated herein by reference in its entirety for reference: * Provisional US patent application 62 / 721,995, entitled
[0041] [0041] The applicant of the present application holds the following US patent applications, filed on June 30, 2018, the description of each of which is incorporated herein, by reference, in its entirety:
[0042] [0042] The applicant for this application holds the following US patent applications, filed on June 29, 2018, the description of each of which is incorporated herein by reference in its entirety: * US patent application no. series 16 / 024.090, entitled
[0043] [0043] The applicant for this application holds the following provisional US patent applications, filed on June 28, 2018, with the description of each of which is incorporated herein by reference in its entirety: * US provisional patent application no. series 62 / 691.228, entitled A Method of using reinforced flex circuits with multiple sensors with electrosurgical devices; * US provisional patent application serial number 62 / 691.227, entitled controlling a surgical instrument according to sensed closure parameters; * US provisional patent application serial number 62 / 691.230, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE; * US provisional patent application serial number 62 / 691,219, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;
[0044] [0044] The applicant for this application holds the following provisional US patent applications, filed on April 19, 2018, with the description of each of which is incorporated herein by reference, in its entirety: * US provisional patent application. serial number 62 / 659,900, entitled METHOD OF HUB COMMUNICATION.
[0045] [0045] The applicant for this application holds the following provisional US patent applications, filed on March 30, 2018, the description of which is incorporated herein by reference in its entirety for reference: * Provisional US patent application 62 / 650,898 filed on March 30, 2018, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS; * - US provisional patent application serial number 62 / 650,887, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;
[0046] [0046] The applicant for 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: * - US patent application no. serial 15 / 940,641, entitled INTERACTIVE SURGICAL - SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; * - US patent application serial number 15 / 940,648, entitled
[0047] [0047] The applicant for this application holds the following provisional US patent applications, filed on March 28, 2018, the description of each of which is incorporated herein by reference in its entirety: * US provisional patent application 62 / 649,302, entitled INTERACTIVE - SURGICAL SYSTEMS WITH —ENCRYPTED COMMUNICATION CAPABILITIES; * US provisional patent application serial number 62 / 649,294, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD; * US provisional patent application serial number 62 / 649,300, entitled SURGICAL HUB SITUATIONAL AWARENESS; * US Provisional Patent Application Serial No. 62 / 649,309, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER; * Provisional US patent application No. 62 / 649,310, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS; * US Provisional Patent Application No. 62 / 649,291, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT; * US Provisional Patent Application No. 62 / 649,296, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;
[0048] [0048] The applicant for this application holds the following provisional US patent applications, filed on March 8, 2018, with the description of each of which is incorporated herein by reference in its entirety: * US provisional patent application no. series 62 / 640.417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR; and
[0049] [0049] The applicant for this application holds the following provisional US patent applications, filed on December 28, 2017, the description of which is incorporated herein by reference in its entirety for reference: * - Provisional US patent application serial number 62 / 611.341, entitled INTERACTIVE SURGICAL PLATFORM; * - US provisional patent application serial number 62 / 611,340, entitled CLOUD-BASED MEDICAL ANALYTICS; and * - US provisional patent application serial number 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM.
[0050] [0050] 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. Central surgical controllers
[0051] [0051] With reference to Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (for example, cloud 104 which may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one central surgical controller 106 in communication with the cloud 104 which can include a remote server 113. In one example, as illustrated in Figure 1, surgical system 102 includes a visualization system 108, a robotic system 110, a smart handheld surgical instrument 112, which are configured to communicate with one another and / or the central controller 106. In some respects, a surgical system 102 may include a number of central controllers M 106, an N number of visualization systems 108, an O number of robotic systems 110, and a P number of smart, hand-held surgical instruments 112, where M, N, O, and P are whole numbers greater than or equal to one.
[0052] [0052] Figure 2 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 part of the surgical system 102. The robotic system 110 includes a surgeon console 118, a patient carriage 120 (surgical robot), and a robotic central surgical controller 122. The patient carriage 120 can handle at least one attached surgical tool removably 117 through a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. An image of the surgical site can be obtained by a medical imaging device 124, which can be manipulated by car of patient 120 to orient imaging device 124. Robotic central surgical controller 122 can be used to process images from the surgical site for subsequent display to the surgeon through the surgeon's console 118.
[0053] [0053] 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 description 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.
[0054] [0054] Several examples of cloud-based analysis that are performed by the cloud 104, and are suitable for use with the present description, are described in US provisional patent application serial number 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.
[0055] [0055] In several aspects, 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.
[0056] [0056] 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.
[0057] [0057] 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.
[0058] [0058] 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.
[0059] [0059] In several respects, the imaging device 124 is configured for use in a minimally invasive procedure.
[0060] [0060] In one aspect, the imaging device uses multi-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 greater detail under the heading "Advanced Imaging Acquisition Module" in US provisional patent application serial number 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.
[0061] [0061] 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.
[0062] [0062] 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 visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in US provisional patent application serial number 62 / 611.341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the description of which is incorporated here reference title in its entirety.
[0063] [0063] As shown in Figure 2, a primary screen 119 is positioned in the sterile field to be visible to the operator on the operating table 114. In addition, a viewing tower 111 is positioned outside the sterile field. The display tower 111 includes a first non-sterile screen 107 and a second non-sterile screen 109, which are opposite each other. The visualization system 108, guided by the central controller 106, is configured to use screens 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the central controller 106 can have the visualization system 108 display a snapshot of a surgical site, as recorded by an imaging device 124, on a non-sterile screen 107 or 109, while maintaining a live transmission of the surgical site on main screen 119. Snapshot on non-sterile screen 107 or 109 can allow a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
[0064] [0064] In one aspect, central controller 106 is also configured to route a diagnostic input or feedback by a non-sterile operator in the display tower 111 to the primary screen 119 within the sterile field, where it can be seen by a sterile operator on the operating table. In one example, the entry may be in the form of a modification of the snapshot displayed on the non-sterile screen 107 or 109, which can be routed to main screen 119 by central controller 106.
[0065] [0065] With reference to Figure 2, a surgical instrument 112 is being used in the surgical procedure as part of the surgical system 102. The central controller 106 is also configured to coordinate the flow of information to a screen of the surgical instrument 112. For example, the flow of coordinated information is further described in US provisional patent application serial number 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the content of which is incorporated herein by reference, in its entirety. An entry or diagnostic feedback inserted by a non-sterile operator in the viewing tower 111 can be routed by the central controller 106 to the surgical instrument screen 115 in the sterile field, where it can be seen by the surgical instrument operator 112. Exemplary surgical instruments that are suitable for use with Surgical System 102 are described under the heading "Surgical Instrument Hardware" and in US provisional patent application serial number 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, for example.
[0066] [0066] Now with reference to Figure 3, a central controller 106 is shown in communication with a visualization system 108, a robotic system 110 and a smart handheld surgical instrument 112. Central controller 106 includes a central controller screen 135, an imaging module 138, a generator module 140 (which may include a monopolar generator 142, a bipolar generator 144 and / or an ultrasonic generator 143), a communication module 130, a processor module 132 and a storage matrix 134. In certain aspects, as illustrated in Figure 3, the central controller 106 additionally includes a smoke evacuation module 126, a suction / irrigation module 128 and / or an operating room mapping module 133.
[0067] [0067] 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 housing of the central controller 136 offers a unified environment for managing power, data and fluid lines, which reduces the frequency of entanglement between such lines.
[0068] [0068] Aspects of the present description feature a central surgical controller for use in a surgical procedure that involves applying energy to the tissue at a surgical site. The central surgical controller includes a central controller housing and a combination generator module received slidably at a central controller housing 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.
[0069] [0069] 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 housing. In one aspect, the central controller housing comprises a fluid interface.
[0070] [0070] 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 description present a solution in which a modular housing of central controller 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the central modular housing 136 is that it allows quick removal and / or replacement of several modules.
[0071] [0071] Aspects of the present description feature a modular surgical wrap for use in a surgical procedure that involves applying energy to the tissue. The modular surgical housing 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 energy contacts, the first module being The power generator 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.
[0072] [0072] In addition to the above, the modular surgical enclosure 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.
[0073] [0073] 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.
[0074] [0074] With reference to Figures 3 to 7, aspects of the present description are presented for a modular housing of the central controller 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction module / irrigation 128. The central modular housing 136 further facilitates interactive communication between modules 140, 126, 128. As shown in Figure 5, generator module 140 can be a generator module with integrated monopoly, bipolar and ultrasonic components, supported in a single cabinet unit 139 slidably insertable into the central modular housing 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, generator module 140 may comprise a series of monopolar, bipolar and / or ultrasonic generator modules that interact through the mod shell central ular
[0075] [0075] In one aspect, the central modular housing 136 comprises a modular power and a back communication board 149 with external and wireless communication heads to allow removable fixing of modules 140, 126, 128 and interactive communication between them.
[0076] [0076] In one aspect, the central modular housing 136 includes docking stations, or drawers, 151, here also called drawers, which are configured to receive modules 140, 126, 128 in a sliding manner. Figure 4 illustrates a view in partial perspective of a central surgical controller housing 136, and a combined generator module 145 slidably received at a docking station 151 of the central surgical controller housing 136. A docking port 152 with power and data contacts on one side The rear of the combined generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of a corresponding docking station 151 of the central controller modular housing 136 as the combined generator module 145 is slid into position at the station matching coupling 151 of the central controller 136 modular housing. In one aspect, the combined generator module 145 includes a bipolar, ultrasonic and monopolar module and a smoke evacuation module integrated in a single 139-bay unit, as shown in Figure 5.
[0077] [0077] In several respects, the smoke evacuation module 126 includes a fluid line 154 that carries captured / collected fluid fluid away from a surgical site and to, for example, the smoke evacuation module 126. Suction a vacuum that originates from the smoke evacuation module 126 can pull the smoke into an opening of a utility conduit at the surgical site. The utility conduit, coupled to the fluid line, can be in the form of a flexible tube that ends in the smoke evacuation module 126. The utility conduit and the fluid line define a fluid path that extends towards the smoke evacuation module 126 which is received in the central controller housing 136.
[0078] [0078] In several 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.
[0079] [0079] In one aspect, the surgical tool includes a drive shaft that has an end actuator at a distal end of the same and at least an energy treatment associated with the end actuator, a suction tube, and a suction tube. irrigation. The suction tube can have an inlet port at a distal end of it and the suction tube extends through the drive shaft. Similarly, an irrigation pipe can extend through the drive shaft and may have an entrance port close to the power application implement. The power application implement is configured to deliver ultrasonic and / or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the drive shaft.
[0080] [0080] The irrigation tube can be in fluid communication with a fluid source, and the suction tube can be in fluid communication with a vacuum source. The fluid source and / or the vacuum source can be housed in the suction / irrigation module 128. In one example, the fluid source and / or the vacuum source can be housed in the central controller housing 136 separately from the control module. suction / irrigation
[0081] [0081] In one aspect, modules 140, 126, 128 and / or their corresponding docking stations in the central modular housing 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 of the central modular housing
[0082] [0082] In some respects, the drawers 151 of the central modular housing 136 are the same, or substantially the same size, and the modules are adjusted in size to be received in the drawers
[0083] [0083] In addition, the contacts of a specific module can be switched to engage with the contacts of a specific drawer to avoid the insertion of a module in a drawer with unpaired contacts.
[0084] [0084] 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 housing 136. The coupling ports 150 of the central modular enclosure 136 can, alternatively or additionally, facilitate interactive wireless communication between the modules housed in the central modular enclosure
[0085] [0085] 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 160. Alternatively, modules 161 can be arranged vertically in a side modular cabinet.
[0086] [0086] 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 164. In the example in Figure 7, a screen 177 is provided to show data relevant to the operation of modules 165.
[0087] [0087] In several respects, 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.
[0088] [0088] During a surgical procedure, removing a surgical device from the surgical field and replacing it with another surgical device that includes a different camera or other light source may be inefficient. Temporarily losing sight of the surgical field can lead to undesirable consequences. The imaging device module of the present description 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.
[0089] [0089] 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.
[0090] [0090] 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.
[0091] [0091] Various image processors and imaging devices suitable for use with the present description 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.
[0092] [0092] 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 healthcare 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 central communication controller 203 comprises a central network controller 207 and / or a network switch 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 switch 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.
[0093] [0093] Modular devices 1a to 1n located in the operating room can be coupled to the modular communication center
[0094] [0094] It will be understood that the surgical data network 201 can be expanded by interconnecting multiple central network controllers 207 and / or multiple network switches 209 with multiple network routers 211. The central controller of modular communication 203 may be contained in a modular control tower configured to receive multiple devices 1a to 1n / 2a to 2m. The local computer system 210 can also be contained in a modular control tower. The modular communication 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.
[0095] [0095] In one aspect, the surgical data network 201 may comprise a combination of central network controllers,
[0096] [0096] The application of cloud computer data processing techniques to data collected by devices 1a to 1n / 2a to 2m, the surgical data network provides better surgical results, reduced costs, and better patient satisfaction. At least some of the devices 1a to 1n / 2a to 2m can be used to view tissue status to assess leakage or perfusion of sealed tissue after a tissue sealing and cutting procedure. At least some of the devices 1a to 1n / 2a to 2m can be used to identify the pathology, such as the effects of disease, with the use of cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes confirmation of the location and margin of the tissue and phenotypes. At least some of the devices 1a to 1n / 2a to 2m can be used to identify anatomical structures of the body using a variety of sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. The data collected by devices 1a to 1n / 2a to 2m, including the image data, can be transferred to the cloud 204 or the local computer system 210 or both for data processing and manipulation including image processing and manipulation. The data can be analyzed to improve the results of the surgical procedure by determining whether additional treatment, such as application of endoscopic intervention, 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.
[0097] [0097] In an implementation, devices in the operating room 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 1n on a central network controller . The central network controller 207 can be implemented, in one aspect, as a LAN 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 half-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 1n 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 having all (admit that) the information transmitted to multiple input ports can be a security risk and cause bottlenecks.
[0098] [0098] 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 switch 209 works on 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 switch 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 switch 209. Network switch 209 stores and uses MAC addresses of devices 2a to 2m to transfer data.
[0099] [0099] The central network controller 207 and / or the network switch 209 are coupled to the network router 211 for connection to the cloud
[00100] [00100] 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.
[00101] [00101] 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 (IEXE 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,
[00102] [00102] The modular communication hub 203 can serve as a central connection for one or all operating room devices 1a to 1n / 2a to 2m and handles a data type known as frames. The tables carry the data generated by the devices 1a to 1n / 2a to 2m. When a frame is received by the modular 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.
[00103] [00103] The modular communication central controller 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.
[00104] [00104] 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 interactive surgical system implemented by 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 communicating with a cloud 204 which may include a remote server
[00105] [00105] 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 central communication controller 203 includes three downstream ports and one upstream port. The central controller / network switch upstream is connected to a processor to provide a communication connection to the cloud computing resources and a local display 217. Communication with the cloud 204 can be done via a wired communication channel or wireless.
[00106] [00106] The central surgical controller 206 uses a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using non-contact measuring devices such as laser or ultrasonic. An ultrasound-based non-contact sensor module scans the operating room by transmitting an ultrasound explosion and receiving the echo when it bounces outside the perimeter of the operating room walls, as described under the heading "Surgical Hub Spatial Awareness Within an Operating Room "in US provisional patent application serial number 62 / 611,341, entitled" INTERACTIVE SURGICAL PLATFORM ", filed on December 28, 2017, which is incorporated herein by reference in its entirety, in which the sensor module is configured to determine the size of the operating room and adjust the limits of the Bluetooth pairing distance. 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 Bluetooth pairing distance limits, for example.
[00107] [00107] 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 through of a system bus. The system bus can be any of several types of bus structures, including the memory bus or memory controller, a peripheral bus or external bus, and / or a local bus that uses any variety of available bus architectures including, but not limited to, not limited to, 9-bit bus, industry standard architecture (ISA), Micro-Charmel Architecture (MSA), extended ISA (EISA), smart drive electronics (IDE), VESA local bus (VLB), component interconnection peripherals (PCI), USB, accelerated graphics port (AGP), PCMCIA bus (International Personal Computer Memory Card Association, "Personal Computer Memory Card International Association"), Small Computer Systems Interface (SCSI), or any another proprietary bus.
[00108] [00108] 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.
[00109] [00109] 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.
[00110] [00110] System memory includes volatile and non-volatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within the computer system, such as during startup, is stored in non-volatile memory. For example, non-volatile memory can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM or flash memory. Volatile memory includes random access memory (RAM), which acts as an external cache memory. In addition, RAM is available in many forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct RAM Rambus RAM (DRRAM).
[00111] [00111] Computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, for example disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive,
[00112] [00112] 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.
[00113] [00113] A user enters commands or information into the computer system 210 via the input device (s) coupled to the 1 / O interface 251. Input devices include, but are not limited to, a pointing device like a mouse, trackball, stylus,
[00114] [00114] Computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computers, or local computers. Remote cloud computers can be a personal computer, server, router, personal network computer, workstation, microprocessor-based device, peer device, or other common network node, and the like, and typically include many or all elements described in relation to the computer system. For the sake of brevity, only one memory storage device is illustrated with the remote computer. Remote computers are logically connected to the computer system via a network interface and then physically connected via a communication connection. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet / IEEE 802.3, Token ring / IEEE 802.5 and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks such as digital integrated service networks (ISDN) and variations in them, packet switching networks and digital subscriber lines (DSL).
[00115] [00115] In several respects, computer system 210 of Figure 10, imaging module 238 and / or display system 208, and / or processor module 232 of Figures 9 to 10, may comprise an image processor, image processing engine, media processor, or any specialized digital signal processor (DSP) used for processing digital images. The image processor can employ parallel computing with single multi-data instruction (SIMD) or multiple multi-data instruction (MIMD) technologies to increase speed and efficiency. The digital image processing engine can perform a number of tasks. The image processor can be an integrated circuit system with a multi-core processor architecture.
[00116] [00116] 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.
[00117] [00117] Figure 11 illustrates a functional block diagram of an aspect of a USB 300 central network controller device, in accordance with at least one aspect of the present description. In the illustrated aspect, the USB 300 central network controller device uses a TUSB2036 integrated circuit central controller available from Texas Instruments. Is the USB hub controller 300 a CMOS device that provides an upstream 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 downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including "plus" differential data outputs (DP1-DP3) paired with "minus" differential data outputs (DM1-DM3) .
[00118] [00118] 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 central network controller device can be configured in bus powered or self powered mode and includes 312 central power logic to manage power.
[00119] [00119] The USB 300 central network controller device includes a 310 series interface engine (SIE). The SIE 310 is the hardware front end of the USB 300 central network controller and handles most of the protocol described in chapter 8 of the USB specification. SIE 310 typically comprises signaling down to the transaction level. The functions it handles could include: packet recognition, transaction sequencing, SOP, EOP, RESET, and RESUME signal detection / generation, clock / data separation, data encoding / decoding non-inverted zero (NRZI ), generation and verification of CRC (token and data), generation and verification / decoding of packet ID (PID), and / or series-parallel / parallel-series conversion. The 310 receives a clock input 314 and is coupled with a suspend / resume logic circuit and frame timer 316 and a central circuit repeat loop 318 to control communication between the upstream USB transceiver port 302 and the transceiver ports Downstream USB 304, 306, 308 through the logic circuits of ports 320, 322, 324. The SIE 310 is coupled to a command decoder 326 through logic interface 328 to control the commands of a serial EEPROM via a serial interface. EEPROM in series 330.
[00120] [00120] 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 central USB network controller 300, the upstream USB transceiver port 302 is connected to a USB host controller, and the downstream USB transceiver ports 304, 306, 308 are exposed to connect USB-compatible devices, and so on.
[00121] [00121] Additional details regarding the structure and function of the central surgical controller and / or networks of central surgical controllers can be found in US provisional patent application No. 62 / 659,900, entitled METHOD OF HUB COMMUNICATION, filed on April 19, 2018 , which is incorporated herein by reference, in its entirety.
[00122] [00122] Figure 12 is a block diagram of the interactive surgical system implemented by computer, according to at least one aspect of the present description. 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. Although the cloud-based data analysis system is described as a surgical system, it is not necessarily limited with such and could be a cloud-based medical system in general. As shown in Figure 12, the cloud-based data analysis system comprises a plurality of surgical instruments 7012 (may be the same or similar to instruments 112), a plurality of central surgical controllers 7006 (may be the same or similar to central controllers 106 ) and a surgical data network 7001 (can be the same or similar to network 201) to couple central surgical controllers 7006 to cloud 7004 (can be the same or similar to cloud 204). Each of the plurality of central surgical controllers 7006 is communicatively coupled to one or more surgical instruments 7012. Central controllers 7006 are also communicably coupled to the cloud 7004 of the interactive surgical system implemented by computer over the 7001. network. 7004 is a remote centralized source of hardware and software for storing, manipulating and communicating data generated based on the operation of various surgical systems. As shown in Figure 12, access to the 7004 cloud is achieved through the 7001 network, which can be the Internet or some other suitable computer network. Central surgical controllers 7006 that are coupled to the 7004 cloud can be considered the client side of the cloud computing system (ie, cloud-based data analysis system). Surgical instruments 7012 are paired with central surgical controllers 7006 for control and implementation of various surgical operations or procedures as described here.
[00123] [00123] 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 health posts (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 12, cloud 7004 comprises central servers 7013 (which can be the same or similar to remote server 113 in Figure 1 and / or remote server 213 in Figure 9), application servers for central controllers 7002, analysis modules data 7034 and an input / output interface ("I / O") 7007. Central servers 7013 of the cloud 7004 collectively administer the cloud computing system, which includes monitoring requests by central client controllers 7006 and managing the capacity of cloud processing
[00124] [00124] Based on connections to several 7006 surgical centers through the 7001 network, the 7004 cloud can aggregate data from specific data generated by several 7012 surgical instruments and their corresponding 7006 central controllers. Such aggregate data can be stored in aggregate medical databases 7011 of cloud 7004. In particular, cloud 7004 can advantageously perform data analysis and operations on aggregate data to produce insights and / or perform functions that individual central controllers 7006 could not achieve on their own. For this purpose, as shown in Figure 12, cloud 7004 and central surgical controllers 7006 are communicatively coupled to transmit and receive information. The I / O interface 7007 is connected to the plurality of central surgical controllers 7006 over the network 7001. In this way, the I / O interface 7007 can be configured to transfer information between the central surgical controllers 7006 and the aggregated medical databases 7011. Consequently, the 7007 I / O interface can facilitate the read / write operations of the cloud-based data analysis system. Such read / write operations can be performed in response to requests from central controllers
[00125] [00125] The configuration of the specific cloud computing system described in this description 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 clinicians can control aspects of interaction between surgical instruments 7012 and the cloud 7004. Other user interfaces suitable for control, such as interfaces controlled by auditory alert, can also be used.
[00126] [00126] Figure 13 is a block diagram that illustrates the functional architecture of the interactive surgical system implemented by computer, according to at least one aspect of the present description. 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 analytical data solutions for problems that arise specifically in the medical field. As shown in Figure 13, the functions of the 7034 cloud-based data analysis modules can be supported through applications for central controllers 7014 hosted by the application servers for central controllers 7002 that can be accessed on central surgical controllers 7006. cloud computing 7008 and applications for central controllers 7014 can operate together to perform 7034 data analysis modules. 7016 application program interfaces ("API") define the set of protocols and routines that correspond to applications for central controllers 7014. In addition, APIs 7016 manage the storage and retrieval of data in / from the aggregated medical data databases 7011 for the operations of 7014 applications. 7018 cache memories also store data (for example, temporarily ) and are coupled to APIs 7016 for more efficient recovery of data the ones used by the 7014 applications. The data analysis modules 7034 in Figure 13 include modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, updating 7026 control programs, analyzing patient results 7028, recommendations 7030 and classification and prioritization of data 7032. Other suitable data analysis modules could also be implemented by the 7004 cloud, according to some aspects. In one respect, data analysis modules are used for specific recommendations based on analysis of trends, results and other data.
[00127] [00127] - For example, the data collection and aggregation module 7022 could be used to generate self-describing data (for example, metadata), including the identification of notable features or configuration (for example, trends), the management of sets of redundant data and the storage of data in paired data sets that can be grouped by surgery, but not necessarily switched to surgical dates and to actual 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 as a desirable event (for example, a successful surgical procedure) or an undesirable event (for example, a surgical instrument with failure or misuse 7012). The aggregated self-describing data can correspond to individual data received from various groups or subgroups of central surgical controllers 7006. Consequently, the 7022 data collection and aggregation module can manage aggregated metadata or other data organized based on raw data received from the central surgical controllers. 7006. For this purpose, 7008 processors can be operationally coupled with applications for central controllers 7014 and aggregated medical databases 7011 to perform data analysis modules 7034. The data collection and aggregation module 7022 can store data aggregates organized in the aggregated medical databases 2212.
[00128] [00128] The resource optimization module 7020 can be configured to analyze this aggregated data to determine an optimal use of resources for a specific group or group of health posts. For example, the resource optimization module 7020 can determine an ideal ordering point for surgical stapling instruments 7012 for a group of clinics based on the corresponding expected demand for such instruments 7012. The resource optimization module 7020 could also assess resource use or other operational settings at various health posts to determine whether resource use could be improved.
[00129] [00129] The 7028 patient results analysis module can analyze surgical results associated with currently used operating parameters of 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
[00130] [00130] The 7026 control program update module can be configured to implement various 7012 surgical instrument recommendations when the corresponding control programs are updated. For example, the Patient Results Analysis Module 7028 could identify correlations that link specific control parameters with successful (or unsuccessful) results. These correlations can be addressed 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 gathered and analyzed by the data collection and aggregation module 7022 of the 7004 cloud. Additionally, the patient results analysis module 7028 and the recommendations module 7030 could identify better methods of using 7012 instruments based on aggregated performance data.
[00131] [00131] The cloud-based data analysis system can include security features implemented by the 7004 cloud. These security features can be managed by the authorization and security module 7024. Each central surgical controller 7006 can have unique credentials associated with username , password, and other appropriate security credentials. These credentials could be stored in memory 7010 and associated with a level of access allowed to the cloud. For example, based on the provision of accurate credentials, a central surgical controller 7006 can be granted access to communicate with the cloud to a predetermined point (for example, only certain defined types of information can participate in transmitting or receiving). For this purpose, the aggregated medical databases 7011 of the cloud 7004 may comprise a database of authorized credentials to verify the accuracy of the supplied credentials. Different credentials can be associated with varying levels of permission to interact with the 7004 cloud, such as a predetermined level of access to receive data analysis generated by the 7004 cloud.
[00132] [00132] Furthermore, for security purposes, the cloud could maintain a database of 7006 central controllers, 7012 instruments and other devices that may comprise a "black list" of prohibited devices. In particular, a blacklisted central surgical controller 7006 may not be allowed to interact with the cloud, while blacklisted 7012 surgical instruments may not have functional access to a corresponding 7006 central controller and / or may be prevented from functioning fully when paired with its corresponding central controller 7006. In addition or alternatively, cloud 7004 can signal instruments 7012 based on incompatibility or other specified criteria. In this way, counterfeit medical devices and inappropriate reuse of such devices throughout the cloud-based data analysis system can be identified and addressed.
[00133] [00133] Surgical instruments 7012 can use wireless transceivers to transmit wireless signals that can represent, for example, authorization credentials to access the corresponding central controllers 7006 and the cloud 7004. Wired transceivers can also be used to transmit signals. These authorization credentials can be stored in the respective memory devices of the 7012 surgical instruments. The authorization and security module 7024 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, surgical instruments 7012 can transmit a signal to the corresponding central controllers 7006 and finally to cloud 7004 to indicate that instruments 7012 are ready to obtain and transmit medical data. In response, the 7004 cloud can transition to a state enabled to receive
[00134] [00134] The cloud-based data analysis system can allow monitoring of multiple health posts (for example, medical posts such as hospitals) to determine improved practices and recommend changes (through the 2030 recommendations module, for example) accordingly . In this way, processors 7008 from the 7004 cloud can analyze the data associated with an individual health clinic to identify the health clinic and aggregate the data with other data associated with other health clinics 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 for the entire group of health posts. The cloud-based data analysis system could also be used to improve situational recognition. For example, 7008 processors can predictively model the effects of recommendations on cost and effectiveness for a specific post (in relation to general operations and / or various medical procedures). The cost and effectiveness associated with that specific station can also be compared to a corresponding local region of other stations or any other comparable stations.
[00135] [00135] 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, unpredictability, distrust). This classification and prioritization can be used in conjunction with the functions of the other 7034 data analysis modules described above to improve the operation and cloud-based data analysis described here. For example, the 7032 data classification and prioritization module can assign a priority to the data analysis performed by the 7022 data collection and aggregation module and the 7028 patient outcome analysis module. Different levels of prioritization can result in specific responses from the 7004 cloud (corresponding to a level of urgency), such as escalation to an accelerated response, special processing, exclusion of aggregated medical databases 7011 or other appropriate responses. In addition, if necessary, the 7004 cloud can transmit a request (for example, a push message) through the application servers to central controllers for additional data from corresponding 7012 surgical instruments. The push message may result in a notification displayed on the corresponding 7006 central controllers to request support or additional data. This push message may be necessary in situations where the cloud detects an irregularity or results outside significant limits and the cloud cannot determine the cause of the irregularity. Central 7013 servers can be programmed to activate this push message in certain significant circumstances, such as when data is determined to be different from an expected value beyond a predetermined threshold or when it appears that security has been compounded, for example.
[00136] [00136] Additional details related to the cloud data analysis system can be found in US provisional patent application 62 / 659,900, entitled METHOD OF HUB COMMUNICATION, filed on April 19, 2018, which is hereby incorporated by reference , in its entirety.
[00137] [00137] Although a "smart" device, including control algorithms responsive to detected data, may be an improvement over a "stupid" device that operates without taking the detected data, some detected data may be incomplete or inconclusive when considered in isolation, that is, without the context of the type of surgical procedure being performed or the type of tissue that is undergoing the surgery. Without knowing the context of the procedure (for example, knowing the type of tissue that is undergoing surgery, or the type of procedure that is being performed), the control algorithm may control the modular device incorrectly or suboptimally, provided the detected data without specific context. For example, the ideal way for a control algorithm to control a surgical instrument in response to a particular detected parameter can vary according to the type of particular tissue being operated on. This is due to the fact that different types of tissue have different properties (for example, tear resistance) and thus respond differently to actions performed by surgical instruments. Therefore, it may be desirable for a surgical instrument to perform different actions when the same measurement is detected for a specific parameter. As a specific example, the ideal way to control a surgical stapling and cutting instrument in response to the instrument's detection of an unexpectedly high force to close its end actuator will vary depending on whether the tissue type is susceptible or resistant to tearing. For tissues that are susceptible to tearing, such as lung tissue, the instrument's control algorithm would optimally slow the engine in response to an unexpectedly high force to close to prevent tearing of the tissue. For tissues that are tear resistant, such as stomach tissue, the instrument's control algorithm would optimally accelerate the engine in response to an unexpectedly high force to close to ensure that the end actuator is properly attached to the tissue. Without knowing whether lung or stomach tissue has been trapped, the control algorithm can make a decision below what is considered ideal.
[00138] [00138] “A solution uses a central surgical controller including a system configured to derive information about the surgical procedure that is being performed based on data received from various data sources, and then control, accordingly, the paired modular devices . In other words, the central surgical controller is configured to infer information about the surgical procedure from received data and then control the modular devices paired with the central surgical controller based on the inferred context of the surgical procedure. Figure 14 illustrates a diagram of a surgical system with 5100 situational recognition, in accordance with at least one aspect of the present description. In some examples, data sources 5126 include, for example, modular devices 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular device itself), databases 5122 (for example, a base EMR data containing the patient's medical record), and 5124 monitoring devices (for example, a blood pressure monitor (BP) and an electrocardiography monitor (ECG)).
[00139] [00139] A central surgical controller 5104 that can be similar to surgical controller 106 in many ways, can be configured to derive contextual information related to the surgical procedure from data based, for example, on the combination (s) specific data (s) received or in the specific order in which data is received from data sources 5126. Contextual information inferred from data received may include, for example, the type of surgical procedure being performed, the specific stage of the surgical procedure that the surgeon is performing, the type of tissue being operated on, or the body cavity that is the object of the procedure. This ability for some aspects of the 5104 central surgical controller to derive or infer information related to the surgical procedure from received data, can be called "situational recognition". In one example, the central surgical controller 5104 can incorporate a situational recognition system, which is the hardware and / or programming associated with the central surgical controller 5104 that derives contextual information related to the surgical procedure based on the data received.
[00140] [00140] The situational recognition system of the central surgical controller 5104 can be configured to derive contextual information from data received from data sources 5126 in several ways. In one example, the situational recognition system includes a pattern recognition system, or machine learning system (for example, an artificial neural network), that has been trained in training data to correlate various inputs (for example, data from databases 5122, patient monitoring devices 5124, and / or devices - modular - 5102) to corresponding contextual information regarding a surgical procedure. In other words, a machine learning system can be trained to accurately derive contextual information regarding a surgical procedure from the inputs provided. In another example, the situational recognition system can include a look-up table that stores pre-characterized contextual information regarding a surgical procedure in association with one or more entries (or ranges of entries) corresponding to the contextual information. In response to a query with one or more entries, the lookup table can return the corresponding contextual information to the situational recognition system to control modular devices 5102. In an example, the contextual information received by the surgical controller's situational recognition system central 5104 are associated with a specific control setting or set of control settings for one or more 5102 modular devices. In another example, the situational recognition system includes an additional machine learning system, research table or other such system , generating or retrieving one or more control settings for one or more 5102 modular devices, when contextual information is provided as input.
[00141] [00141] A 5104 central surgical controller, which incorporates a situational recognition system, provides several benefits to the 5100 surgical system. One benefit includes improving the interpretation of detected and captured data, which in turn improves processing accuracy and / or the use of data during the course of a surgical procedure. To return to a previous example, a central surgical controller with situational recognition 5104, could determine what type of tissue was being operated on; therefore, when an unexpectedly high force is detected to close the end actuator of the surgical instrument, the central surgical controller with situational recognition 5104 could correctly accelerate or decelerate the surgical instrument motor for the tissue type.
[00142] [00142] As another example, the type of tissue being operated on may affect the adjustments that are made to the load and compression rate thresholds of a stapling and surgical cutting instrument for a specific span measurement. A central surgical controller with situational recognition 5104 could infer whether a surgical procedure being performed is a thoracic or abdominal procedure, allowing the central surgical controller 5104 to determine whether tissue clamped by an end actuator of the surgical cutting and stapling instrument is lung tissue (for a chest procedure) or stomach tissue (for an abdominal procedure). The central surgical controller 5104 can then properly adjust the loading and compression rate thresholds of the surgical stapling and cutting instrument for the tissue type.
[00143] [00143] As yet another example, the type of body cavity being operated during an insufflation procedure, can affect the function of a smoke evacuator. A central surgical controller with situational recognition 5104 can determine if the surgical site is under pressure (by determining that the surgical procedure is using insufflation) and determine the type of procedure. As a type of procedure is usually performed in a specific body cavity, the 5104 central surgical controller can then adequately control the speed of the smoke evacuator motor to the body cavity being operated. In this way, a central surgical controller with situational recognition 5104 can provide a consistent amount of smoke evacuation to both thoracic and abdominal procedures.
[00144] [00144] As yet another example, the type of procedure being performed can affect the ideal energy level for an ultrasonic surgical instrument or radio frequency electrosurgical instrument (RF) to operate.
[00145] [00145] - As yet another example, data can be extracted from additional data sources 5126 to improve the conclusions that the central surgical controller 5104 extracts from a data source 5126. A central surgical controller with situational recognition 5104 can augment the data that he receives from modular devices 5102 with contextual information that he has accumulated, referring to the surgical procedure, from other data sources 5126. For example, a surgical controller with situational recognition! 5104 can be configured to determine whether hemostasis has occurred (that is, if bleeding has stopped at a surgical site), according to video or image data received from a medical imaging device.
[00146] [00146] Another benefit includes proactively and automatically controlling paired modular devices 5102, according to the specific stage of the surgical procedure being performed to reduce the number of times medical personnel are required to interact with or control the 5100 surgical system during the course of a surgical procedure. For example, a central surgical controller with situational recognition 5104 can proactively activate the generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in the procedure requires the use of the instrument. Proactively activating the power source allows the instrument to be ready for use as soon as the preceding step of the procedure is complete.
[00147] [00147] As another example, a central surgical controller with situational recognition 5104 could determine whether the current or subsequent stage of the surgical procedure requires a different view or degree of magnification of the screen, according to the resource (s) on the site surgical procedure that the surgeon is expected to see. The central surgical controller 5104 could then proactively change the displayed view (provided, for example, by a Medical Imaging device to the visualization system 108), so that the screen automatically adjusts throughout the surgical procedure.
[00148] [00148] Still as another example, a central surgical controller with situational recognition 5104 could determine which stage of the surgical procedure is being performed or will be performed subsequently and whether specific data or comparisons between the data will be required for that stage of the surgical procedure. The central surgical controller 5104 can be configured to call screens automatically based on data about the stage of the surgical procedure being performed, without waiting for the surgeon to request specific information.
[00149] [00149] Another benefit includes checking for errors during the configuration of the surgical procedure or during the course of the surgical procedure. For example, a central surgical controller with situational recognition 5104 could determine whether the operating room is properly or ideally configured for the surgical procedure to be performed. The central surgical controller 5104 can be configured to determine the type of surgical procedure being performed, retrieve the corresponding checklists, product location, or configuration needs (for example, from a memory), and then compare the current operating room layout with the standard layout for the type of surgical procedure that the 5104 central surgical controller determines is being performed. In one example, the 5104 central surgical controller can be configured to compare the list of items for the procedure read by a suitable scanner, for example, and / or a list of devices paired with the 5104 central surgical controller with a list of items and / or devices recommended or expected for the given surgical procedure. If there are any discontinuities between the lists, the central surgical controller 5104 can be configured to provide an alert indicating that a specific modular device 5102, patient monitoring device 5124 and / or other surgical item is missing. In one example, the central surgical controller 5104 can be configured to determine the position or relative distance of modular devices 5102 and patient monitoring devices 5124 using proximity sensors, for example. The 5104 central surgical controller can compare the relative positions of the devices with a recommended or anticipated layout for the specific surgical procedure. If there are any discontinuities between the layouts, the 5104 central surgical controller can be configured to provide an alert indicating that the current layout for the surgical procedure deviates from the recommended layout.
[00150] [00150] As another example, the 5104 situational recognition central surgical controller could determine whether the surgeon (or other medical personnel) was making a mistake or otherwise deviating from the expected course of action during the course of a surgical procedure . For example, the central surgical controller 5104 can be configured to determine the type of surgical procedure being performed, retrieve the corresponding list of steps or order of use of the equipment (for example, from a memory), and then compare the steps being performed or equipment being used during the course of the surgical procedure with the steps or equipment expected for the type of surgical procedure that the 5104 central surgical controller determined is being performed. In one example, the central surgical controller 5104 can be configured to provide an alert indicating that an unexpected action is being taken or an unexpected device is being used at the specific stage in the surgical procedure.
[00151] [00151] In general, the situational recognition system for the central surgical controller 5104 improves the results of the surgical procedure by adjusting the surgical instruments (and other modular devices 5102) for the specific context of each surgical procedure (such as adjusting to different types tissue), and when validating actions during a surgical procedure. The situational recognition system also improves the surgeon's efficiency in performing surgical procedures by automatically suggesting the next steps, providing data, and adjusting screens and other 5102 modular devices in the operating room, according to the specific context of the procedure.
[00152] [00152] With reference now to Figure 15, a time line 5200 is shown representing the situational recognition of a central controller, such as the central surgical controller 106 or 206 (Figures 1 to 11), 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.
[00153] [00153] The central surgical controller with situational recognition 106, 206 receives data from data sources throughout the course of the surgical procedure, including the data generated each time medical personnel use a modular device that is paired with the central surgical controller 106 , 206. Central surgical controller 106, 206 can receive this data from paired modular devices and other data sources and continuously derive inferences (ie, contextual information) about the ongoing procedure as new data is received, such as which stage of the procedure. procedure is being performed at any given time. The situational recognition system of the central surgical controller 106, 206 is capable of, for example, recording data related to the procedure to generate reports, checking the steps being taken by medical personnel, providing data or warnings (for example, through a display) that may be relevant to the specific step of the procedure, adjust the modular devices based on the context (for example, activate monitors, adjust the field of view (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.
[00154] [00154] In the first step 5202, in this illustrative procedure, members of the hospital team retrieve the patient's electronic medical record (PEP) from the hospital's PEP database. Based on patient selection data in the PEP, the central surgical controller 106, 206 determines that the procedure to be performed is a thoracic procedure.
[00155] [00155] 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).
[00156] [00156] At the third step 5206, the medical staff scans the patient's band with a scanner that is communicatively connected to the central surgical controller 106, 206. The central surgical controller 106, 206 can then confirm the patient's identity based on the data scanned.
[00157] [00157] In the fourth step 5208, the medical staff 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,
[00158] [00158] 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 the central surgical controller 106, 206. As central surgical controller 106, 206 begins to receive data from patient monitoring devices, the central surgical controller 106, 206 thus confirming that the patient is in the operating room.
[00159] [00159] 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.
[00160] [00160] In the seventh step 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.
[00161] [00161] In the eighth step 5216, the medical imaging device (for example, a display device) is inserted and the video from the medical imaging device is started. Central surgical controller 106, 206 receives data from the medical imaging device (i.e., video or image data) through its connection to the medical imaging device. Upon receipt of data from the medical imaging device, the central surgical controller 106, 206 can determine that the portion of the laparoscopic surgical procedure has started. In addition, the central surgical controller 106, 206 can determine that the specific procedure being performed is a segmentectomy, rather than a lobectomy (note that a wedge procedure has already been discarded by the central surgical controller 106, 206 based on the data received in the second step 5204 of the procedure). The data received from the medical imaging device 124 (Figure 2) can be used to determine contextual information about the type of procedure being performed in several different ways, including determining the angle at which the medical imaging device is oriented in relation to viewing the image. anatomy of the patient, monitor the number or medical imaging devices being used (ie, that are activated and paired with the central surgical controller 106, 206), and monitor the types of visualization devices used.
[00162] [00162] 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.
[00163] [00163] 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.
[00164] [00164] 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.
[00165] [00165] In the twelfth step 5224, the node dissection step is then performed. The central surgical controller 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on the data received from the generator that indicates which ultrasonic or RF instrument is being fired. For this specific procedure, an RF or ultrasonic instrument being used after the parenchyma has been transected corresponds to the node dissection step, which allows the central surgical controller 106, 206 to make this inference. It should be noted that surgeons regularly switch between surgical stapling / cutting instruments and surgical energy instruments (that is, RF or ultrasonic) depending on the specific step in the procedure because different instruments are better adapted for specific tasks. Therefore, the specific sequence in which 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.
[00166] [00166] 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.
[00167] [00167] 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 communicatively coupled to the central surgical controller 106, 206.
[00168] [00168] Situational recognition is further described in US provisional patent application serial number 62 / 659,900, entitled METHOD OF HUB COMMUNICATION, filed on April 19, 2018, 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 its components and / or based on information from the cloud 104. Data manipulation, analysis and storage
[00169] [00169] In several aspects, a central surgical controller system can be configured to collect rich contextual data related to the use of surgical devices that are connected to said system, providing a perception hierarchy for the central surgical controller system. Indexing and data storage
[00170] [00170] Various techniques are described here for data transformation, validation, organization and fusion.
[00171] [00171] A question that arises in the context of the central surgical controller system is how to merge data from several different sources into a common data set that is useful. For example, what solutions are available to merge two types of data that are recorded at different sample rates Can systems be designed to be sampled at a similar rate Can a timing signal be inserted in all data to assist in the synchronization of data sets The solution selected for various applications may depend on the specific types of surgical devices that are collecting the data sets being merged and other factors.
[00172] [00172] In one aspect, the central surgical controller can be configured to automatically perform the scale change, alignment and organization of the collected data based on parameters predefined in the central surgical controller before the data is transmitted. In one respect, the predefined parameters could be set or changed by the interaction between the central surgical controller and the cloud system when configured for use. The cloud system can provide solutions obtained from other central controllers on the network that addressed a similar problem, and can also provide offline processing using various learning mechanisms to determine how to align the data. This allows data collected by the central surgical controller to be integrated directly into a larger cloud-based database for analysis purposes. In another aspect, the central surgical controller and / or the cloud system can be configured to change the sample rate of the measured systems. For example, data sets could be organized into a functional database and / or analyzed through functional data analysis. For example, the system can be configured to include computational tabulation of multiple measurements obtained from the same or different devices in a single measurement. For example, the system can be configured to include a hash function to encrypt or authenticate the source or sources of the data.
[00173] [00173] In one aspect, the central surgical controller system can be configured to perform data preparation ("data wrangling" or "data munging"), that is, the reorganization of raw data in a usable form. For example, the central surgical controller system can be configured to organize the data received from the central surgical controller and other equipment into a unified data set. Data storage and merging
[00174] [00174] A challenge with the integration and merging of data sets are the different data rates, data configurations, file formats and methods of organizing the data sources. In addition, when moving data to a single storage structure, it is useful to include the context of the conditions under which the data was recorded, any modification of the data to the expected format, and any change in data calibration to make it directly comparable, to name a few examples.
[00175] [00175] Figure 16 is a block diagram of a system for automated scaling, organization, merging and alignment of distinctly different data sets, in accordance with at least one aspect of the present description. Illustration 204000 provides an example of how data can be organized through several different stages. The automated system can be implemented in a central medical controller that receives data from several sources, such as one or more medical devices, business software and administrative software. In one aspect of the automated system, data can be extracted from a variety of data sources
[00176] [00176] In one aspect, data can be loaded into data warehouse 204015 using several different techniques. For data transfer, known techniques that preserve data formats can be used. The speed at which data can be transferred may be based, more preferably, on the means of transferring the data, such as by which physical means or whether the data is transferred wirelessly. As another example, using hardware can be much faster than relying on software.
[00177] [00177] In one aspect, the organized data can be loaded into a functional database for analysis. The data loading process may depend on the structure of the 204015 data warehouse. For example, metadata tends to be noticeably larger in size and significantly more ancillary to the primary data itself. Therefore, data could be grouped / stored in one location so that it can be consulted more quickly / during a process, and metadata could be stored in another location (for example, external) and / or in a more suitable storage medium. for long-term storage so that they can be consulted when needed or when directly requested. Consequently, the system can be configured to analyze the data and send it to the appropriate repositories. In such respects, different data sets or data types could be manipulated in the absence of each other, or the metadata could be used as a means to modify the primary data and then be put back into storage or otherwise removed from the data set. combined data to limit the size of the data set.
[00178] [00178] In another aspect, all types of data (ie primary data and / or metadata) can be stored in predefined locations and a reference database can be configured to retrieve each of the data that is necessary for the current analysis, instead of having all the data stored in a single cohesive database.
[00179] [00179] In one aspect, the 204015 data storage system can be configured to merge dissimilar data, such as high and low volume data. In one aspect, data that is received and that is in a different format or structure than that of another data set could use the metadata associated with the data point to allow the data to be merged into a format compatible with the other data . For example, data that is written at widely different data rates could be duplicated and placed in empty cells in a data storage structure. This technique can be used if, for example, the data source is a non-critical or supplementary data element or metadata for another critical data point. As another example, if the data rate is very high and the data is being integrated into a smaller and more critical data form, the average of the data points or data points methods sent (exchanged) could be used to provide a average homogeneous data flow. To illustrate, if harmonic transducer data in the kHz range (ie, transducer data sampled at a kHz rate) is being combined with or into data in the 30 Hz range based on results, the average of every 1,000 points blade impedance data could be used with the lowest sampling clamp clamping force to create a uniform time-based data flow. As another illustration, 3D imaging data could be transformed into a flatter 2D version in the plane being measured by the adjacent mechanical device. In some ways, the cloud system can make it easier to determine which data sets are more important than others, to determine how to effectively combine and align data. Using situational recognition, the cloud system can retrieve from other data sets or various medical procedures which types of data are reliable and most commonly adhered to. These data sets used by surgeons, analysts or others can provide probabilistic indications of what types of data are very useful, and then determine how to merge the data for these purposes.
[00180] [00180] In various aspects, data from one or more sources connected to a central medical controller can be sent to the data warehouse and organized, scaled and / or aligned using predefined parameters within the central controller doctor. That is, before integration or aggregation in the cloud system, data can already be processed to fit a predefined format, scale, or other alignment when it is collected at the central medical controller. In some cases, these predefined parameters can be adjusted after interacting with the cloud system. For example, the cloud system may determine that some data needs to be reviewed after adding new medical devices to your system. As another example, the cloud system can use situational recognition or other machine learning to determine a more efficient scale of certain types of data that are most useful to an end user. These types of changes can be propagated to each of the medical central controllers so that the scaling, automated alignment and organization of data in the medical central controller can provide more relevant data before being uploaded to the cloud system. Data cleaning
[00181] [00181] Data cleaning, also called data pre-processing, refers to the removal of duplicate data, reorientation of columns or rows and connection of interconnected data.
[00182] [00182] In one aspect, the 204015 data storage system can be configured to remove duplicate data. Duplication of data may result from the fact that data could be entering the 204015 data storage system from multiple sources (see block 204005), several of which could be being used together during the course of a surgical procedure. For example, a robotic central controller, a central power / display controller and a central monitor tower controller could all be interfacing in the same procedure, and each of these central controllers could generate at least some overlapping data, but that finally, it is useful to have them combined and aligned. In addition, the central controllers could be moved in and out of the operating room for portions of a surgical procedure and even moved to meet other procedures. Being able to search for duplicate data sets from different sources and then being able to remove duplicate data would prevent specific users, uses or regions from excessively influencing conclusions drawn from the overall data set resulting from merely duplicating the data. As another example, the data could be duplicated due to an interruption or loss of data in transit, initiating a second transmission of the same data. As yet another example, the data could be intentionally loaded multiple times. All of this duplicate data would affect the weighting of certain conclusions drawn from the data sets, which could interfere with trends and analyzes.
[00183] [00183] In one aspect, the 204015 data storage system can be configured to integrate separate data streams. An alternative to multiple data duplications can occur when all of a series of devices or central controllers that were used in the same procedure send their data separately to the 204015 data warehouse that groups them. This creates an unrelated problem in the sense that each device will require some form of synchronization of some continuous measure that allows the devices to be related to each other. In aspects where patient data is anonymized, then synchronizing the data received from different data sources can be even more challenging because a single synchronized real-time clock may not be an acceptable synchronizer (since real-time storage associated with data could be used to determine sensitive patient data). Additionally, if a randomized date and time were generated, then the randomizer would need to communicate that starting point to all devices to allow them to use the same time measure.
[00184] [00184] In one aspect, surgical devices are configured to use the time of their own internal clocks, instead of real time, and transmit a synchronizing signal between the devices within the same procedure. Consequently, each device records and assigns a time stamp to the data from its individualized points of view and then, after all data has been transmitted to a data warehouse (for example, the 204015 data warehouse), the data warehouse could synchronize the signals and use that synchronization to interrelate or merge the different data streams structured into a unified signal data set. This addresses the issue of patient privacy and at the same time performs data synchronization successfully. Calculation of values from independent imported data elements
[00185] [00185] In one aspect, a portion of the metadata can be used to transform primary data points into related aspect data. For example, the 204015 data storage system can be configured to use the tissue type to calculate a constant which is then multiplied by the tissue impedance to balance the collagen level and conductivity with the impedance to create a comparable impedance value. to assess a sealing resistance that is comparable between types of fabric. As another example, the 204015 data storage system can be configured to use the tissue thickness and the color of the staple cartridge of a surgical stapling instrument to calculate a constant that is then multiplied by the force to fire (FTF) to create a device-triggering performance value that is independent of tissue.
[001868] [001868] In one aspect, the generation of a specific surgical instrument or its serial number can be used to transform the instrument's behavior into a cascade that allows all devices to be compared through multiple design changes. The cloud system can propagate the change from a medical central controller that is connected to the specific surgical instrument to all other medical central controllers as far as relevant. The new changes can also be incorporated into the update of situational recognition for the medical device, noting that a new version or an updated version of the surgical instrument leads to a modification that must be taken into account. Interrelated chronological data
[00187] [00187] In one aspect, interrelated chronological data can be stored as part of a patient's electronic health record (EHR) within the privacy limits protected and controlled by HIPAA (Health Insurance Portability and Liability Law). The patient can then access a set of combined data obtained from several different data sources. If, for example, multiple medical central controllers and / or multiple medical devices have been used in surgery, the patient will be able to see in chronological order how all instruments may have interacted, based on the data merged and aligned according to the processes described here. Randomized data pairs
[00188] [00188] In one respect, pairs or groups of non-traceable and apparently unrelated data can be integrated with the results. In such an aspect, the data preparation process may include randomized data pairs and allow metadata resulting from the data to continue to be correlated to the results that exist as part of the data pair or group. Adjustment transformation and data shape
[00189] [00189] In several respects, the fit and shape of the data can be transformed so that the data has an expected format (for example, a format expected by the 204015 data storage system). In one respect, raw data can be mapped into specific functional forms in the 204010 data preparation module. For example, numerical data elements can be replaced with alphabetic data elements. In another aspect, the data can be transformed into a predefined configuration, such as a specific arrangement of rows, columns, fields, cells, and so on.
[00190] [00190] Illustration 204100 in Figure 17 shows a set of graphs that includes a first graph 204105 showing blood pressure as a function of time, a second 204110 graph showing blood pressure as a function of time, and a third graph 204115 showing blood pressure as a function of time for different sampling rates, in accordance with at least one aspect of the present description. The graphs in illustration 204100 show examples of how some of the data entering the 204015 data warehouse may contain different scales, sample rates and different measurements over time, and how the system in Figure 16 can properly merge and align the data for create a usable format. Graphs 204105 and 204110 are different data sets here, but shown on the same time scale. Graph 204105 represents a small set of blood pressure values measured over time (over the period t1). In this example, the 204125 line plot represents the actual blood pressure, although there are sampled data points that are shown mainly along the continuous line. In reality, the sampled data points contain a pair of error data points 204120. The data store 204015, through processing by one or more central medical controllers and / or the cloud system, can use techniques to take into account the error points to form the correct blood pressure curve.
[00191] [00191] This blood pressure curve measured on graph 204105 can then be merged with other sampling data to create a 204110 fused blood pressure graph. The time period is aligned as shown, along with additional data that can be collected from other data sets. For example, plot 204140 can be a set of data obtained with a lower sample rate, but recorded over the same period of time. The blood pressure plot 204135 can be generated in part by the same data points sampled in plot 204105, but also by additional data. In the merged graph 204110, due to the fact that the data warehouse 204015 would have processed the data to integrate it, the error data points like the 204120 points can be smoothed. They can be removed and plot 204135 can take an average of the last data points before and after in some cases. In other cases, only the last data point can replace error points if the rate of change of data per unit of time is greater than a predefined threshold.
[00192] [00192] Plot 204115 shows an example of scaling low frequency data. A 204155 downward slope plot sampled at 100 Hz can be overlaid with data sampled at a lower frequency, but scaled up to be aligned with the highest sampling rate. Around the plot sampled at 100 Hz 204155, two data plots 204145 and 204150 are shown, which are sampled at 10 Hz, but scaled up to 100 Hz to match the highest frequency sampled plot. Plot 204145 is an example of an error in the lower sampled plot, but which is filled in and / or replaces the error points. As shown, the points sampled at the lowest frequency are scaled only horizontally, in this example, at the highest frequency rate. In other cases, if a sufficient number of data points are shown to establish a non-horizontal slope, the 204015 data warehouse can extrapolate the lower frequency sampling to create a smoother fit, for example following the downward slope of the plotting 204155.
[00193] [00193] Illustration 204200 in Figure 18 shows a graph 204205 representing blood pressure in relation to the high and low limits, according to at least one aspect of the present description. Graph 204205 can be an example of a data analysis report that can use metadata that results from merging and aligning data from data warehouse 204200. Graph 204205 can be a more elaborate product that uses the data in Figure 17 Thus, in this example, blood pressure plotting 204210 may be the result of one or more data sets sampled from a patient that may have been merged, similar to one or more of the processes described above. Multiple data sets that were sampled at different data rates, for example, between 2 Hz and 10 Hz, may have been used to create the 204210 plot. In addition, the system according to the present description can add graphical overlays, such as the high limit line 204215 and the low limit line 204220 to illustrate the blood pressure range based on the data. Using the processes and systems described in this document, a patient or analyst may be able to obtain more comprehensive data that is more beneficial to use than if multiple data sets are analyzed independently.
[00194] [00194] Figure 19 is a graph showing the frequency of the ultrasonic system as a function of time, according to at least one aspect of the present description. Illustration 204300 can be another example of a final product report that is the result of merging and aligning data with the 204015 data warehouse and subsequent analysis using the 204020 metadata layer and / or the reporting and analysis layer
[00195] [00195] Figure 20 is a graph showing the expected blood pressure for different types of vessels, according to at least one aspect of the present description. Illustration 204400 can be another example of a final product report that is the result of merging and aligning data with the 204015 data warehouse and subsequent analysis using the 204020 metadata layer and / or the 204025 reporting and analysis layer. Here , graph 204405 shows how different types of blood vessels must have or are reported to have different blood pressures. Each data point in graph 204405 can be the result of compiling aggregated data from multiple data samples. The data may have been combined by the 204015 data warehouse on a common scale and then organized to be viewed as the graph shown. Additional overlays may have been included, such as IDs and vertical lines, to help you better visualize the data.
[00196] [00196] “As discussed above and illustrated in Figures 17 to 20, in several aspects a computer system can be configured to smooth or fuse data based, for example, on expected variations in the source data. For example, blood pressure measured in large arteries is not necessarily equivalent to blood pressure measured in smaller vessels (for example, smaller arteries, arterioles, etc.) where an energy-emitting surgical instrument (i.e., an electrosurgical instrument or an instrument ultrasonic surgery) may be in use. Consequently, the computer system can apply a scaling factor to the pressure measurement (ie, the pressure measured in large arteries) to align it with the pressure that is experienced by the device's end actuator (ie, the actual pressure in the minor arteries being dissected, sealed or otherwise manipulated by the end actuator of the surgical instrument). In addition, there may also be a delay between the arterial pulse (pressure) measured in the artery and the pressure correlated to the tissue property measured at the location of the end actuator. Consequently, the computer system can apply a delay factor to shift the pressure measurement. In addition, different types of sampled data may have widely different sample rates and bit sizes. For example, ultrasonic feedback / control data can be sampled at, for example, 100 Hz to 2 kHz (see Figure 19), whereas blood pressure can be sampled at, for example, 2 Hz to 0.25 Hz. Consequently, the computer system can be configured to pair or merge data that has different sample rates using the techniques discussed above to perform in-depth analysis of the data. Data validation
[00197] [00197] In several aspects, the computer system can be configured to validate the data sets and / or the sources of the data sets, including central controllers, individual instruments or detection systems. In addition, a computer system (for example, the central surgical controller and / or the cloud system) can be configured to validate the received data and provide reactions to Invalid data.
[00198] [00198] In one aspect, the central controller, the instrument and / or the cloud can be configured to provide specific responses based on the validation of a received data set and the authentication of its source and integrity. In addition, the response (or responses) provided by the central controller, the instrument and / or the cloud could be selected from a set of reactions corresponding to the data and / or metadata. In one aspect, the cloud can be configured to isolate data from the primary data group in response to poor data integrity, a lack of data authenticity (that is, the inability to authenticate data or the ability to determine that data data is not authentic), or user behavior. In another aspect, a computer system can be configured to provide a variety of responses, including identifying the user or facility, isolating data from other data sets, compiling the effects of the data to determine the reactions of the data warehouse, and / or provide notices of tampered instruments for procedures and their implications. In one aspect, the central controller can be configured to provide a variety of responses, including marking the data for further analysis, varying changes to associated instrument control algorithms, or preventing the use of the central controller or instruments based on validation or authenticity of data, instruments, user behavior, or linked data sources. In one respect, a local user could have the ability to override the reaction of the local central controller.
[00199] [00199] In one aspect, the computer system can be configured to check trends in the data to confirm that its behavior and therefore its data are kept unchanged.
[00200] [00200] There are sequential trends and repetitive data points that can be used in any normal surgical procedures that could not be misleading if the device was used for the work and when the said device was supposed to be used. In one respect, these points of comparison could be used to verify data integrity. This analysis of sequential trends and repetitive data points could not only be a check to verify a validation or encryption term, but it would also be a means to dynamically ensure that the data itself was not affected in any way.
[00201] [00201] In one aspect, a validation term and / or checksum encrypted by private key can be used to verify that the data received is actually from the instrument that they claim to be. For example, instead of encrypting all data and metadata, a validation term could be used, but this could be costly in terms of bandwidth, storage capacity and processor speed. Using a validation term could allow the data to be scanned in a less costly manner using a cryptographic and key algorithm so that the cloud and the central surgical controller units can verify that the data actually comes from the alleged source.
[00202] [00202] In one aspect, the cloud system can use data from other sources, such as one or more other medical central controllers, to determine whether a data set from a different medical central controller is valid. The cloud system can be configured to extract from known valid data set standards on several other medical central controllers, and / or invalid known data sets from these various sources. In other cases, the cloud system can cross-check the data to determine whether the data set is unique and whether the data set should be truly unique. For example, if the data indicates that the serial number of a medical instrument is the same as the serial number of another known medical instrument, the data set can be marked.
[00203] [00203] In one aspect, if new malicious agents are discovered, the cloud system can use situational awareness to propagate the occurrence of known fraud or malicious activity to other central controllers on the network. In general, situational recognition can be used to determine valid or invalid data patterns and can apply those patterns to new situations or new nodes (for example, central controllers) in the network in determining the validity of any data set.
[00204] [00204] In one aspect, if it is found that the data has been changed, the computer system can be configured to determine whether the data is completely artificial or has been modified.
[00205] [00205] —If it is determined that the data is completely artificial or was deliberately created, then the computer system can respond by alerting a security officer of the invasion and initiating an investigation of the data source and behavior; quarantine all data and data requests from affected central controllers, regions or system users; and / or prevent erroneous data from being added to any of the databases (for example, a storage database) or affecting or being considered as part of any analyzes.
[00206] [00206] If it is determined that the data has been changed (for example, to affect data correlation analyzes), but that the change has been made by a valid source, then the computer system can respond by marking the data and identifying the source data as a source of contaminated data. An example of this would be for a "pirate" device that knows it is being monitored to generate slightly different data with the intention of hiding the fact that it is not as effective as the original devices. Another example would be a recovered device containing a mathematical constant that is used to compensate for the aging calibration of the original device that has been affected by its uses (ie, overuse) or resterilization. These data sets could be verified by the instrument being instructed to operate in a certain way during a controlled situation. For example, an instrument can be programmed to close the claws on the first activation, activate the transducer at a known power level, and then review the blade harmonics. As another example, an energized stapler can be programmed to retract the firing member when the knife is in its fully retracted state and to monitor the force measured by the system. When programmed to operate in a certain known way in a controlled situation, the instrument can then determine whether its functioning is being altered or otherwise affected.
[00207] [00207] If the data is determined to be invalid and has invalid data characteristics that the system has previously seen, the data could be used to determine the source and purpose of the invalidation. The data can then be relayed to the central controller from which it came to inform users that the data is being affected by products or individuals that are interfering with the proper functioning and better results of their devices. Layered contextual information
[00208] [00208] In some respects, contextual information can be organized in layers on top of the data to enable contextual transformation, instead of being merely an aggregation of data sets. In other words, contextual metadata can be linked to the result and device data to allow contextual transformation of data sets.
[00209] [00209] In one aspect, a system (for example, a central surgical controller system, a cloud-based data analysis system, etc.) can be programmed to adjust device control programs based on stratified contextual data, beyond the data. Contextual data represents the circumstances surrounding the collection of data or related patient, procedure, surgeon, or facility information. Stratified analysis to determine interrelationships of influencing factors can be used to create an improved cause and effect response for the central surgical controller and updates to instrument control programs. In one respect, context stratification includes a hierarchy of influencing factors, where some may be more important or functionally interrelated at a higher priority than in other interrelations. In one respect, data pairs include the result of the instrument's operation and its functional parameters. In one respect, contextual parameters are derived from the patient's complications, other treatments, comorbidities, procedural complications, previous functional parameters of the instrument, etc. In one respect, adjustments based on these contextual limitations or influencing factors can proportionally affect the adjustments. Identification of relevant contextual cues
[00210] [00210] Figure 21 is a 204500 block diagram representing stratified contextual information, in accordance with at least one aspect of the present description. In this illustration, there are four examples of types of contextual information in layers that can be taken into account by the systems of the present description.
[00211] [00211] In example B 204510, adjustments to the control parameters of the device can be made after resolving conflicts between different levels in a non-standard way. For example, a primary data set of contextual information can contain a maximum trigger strength of 400 lbs, while a secondary data set of contextual information related to the type of medication a patient is receiving can indicate a maximum strength of only 150 lbs. . A tertiary data set of contextual information may have additional instructions for maximum force to fire based on patient parameters. In this case, the secondary contextual information may prevail over the parameters of the primary contextual information because the patient has a high body mass index (BMI), or there is some other prevailing restriction. In some cases, the primary contextual data set may include one or more exceptions to pass to different parameters, if they exist in other data sets at lower levels. In that case, the primary data set may provide an exception to use another force to trigger if the patient's medication requires it, and thus the secondary contextual data set will override that condition for this case.
[00212] [00212] In example C 204515, the settings of the control parameters can be determined by combining multiple contextual information, instead of simply making one prevail over the other.
[00213] [00213] In example D 204520, side or tertiary effects can still be used to override any predefined control parameters to which a primary contextual data set is not related. In general, secondary and tertiary contextual data sets can be based on specific parameters, and therefore lead to changes made at the time of surgery or dynamically. In some cases, new contextual information may be provided in real time, which can then cause additional adjustments to the device (s).
[00214] [00214] Figure 22 is a 204600 block diagram representing functional configurations of the instrument, according to at least one aspect of the present description. Figure 204600 in Figure 22 provides an example of how multiple sets of contextual information can be applied to the same device simultaneously, but are applied conditionally at different times or in different functions occurring at the same time. For example, different configurations may apply to an instrument's trigger system and separately to the instrument's clamping (gripping) system. The way in which control settings are applied according to any of the examples in Figure 21 can be applied in different instrument contexts, as shown in Figure 22. Therefore, multiple sets of contextual information can be applied simultaneously to a single instrument. In some cases, the result of this may be some lower level effects being applied to the instrument during a specific function, although these same lower level effects would not be applied to the instrument during a different function.
[00215] [00215] Figure 23 is a 204700 graph representing the force to fire (FTF) and the speed of fire for patients subject to different risk of complications. Illustration 204700 shows four plots, with two plots 204705 and 204720 corresponding to the vertical axis on the left that represents the firing speed, and two plots 204710 and 204715 corresponding to the vertical axis on the right that represents the force to fire. The two plots corresponding to an axis type correspond to two different patients and how the settings of an instrument can vary between two patients with different health conditions. In many respects, contextual information adjustments for a single instrument can be queued on the same instrument, to take into account different patients to whom the instrument can be applied over the course of a day. In many ways, the instrument can be configured to load contextual disease information, instrument contextual information, contextual treatment information, contextual patient information, and so on, where the combined contextual information from various data sets different types can form a specific combination that provides the optimal instrument settings for a given surgery on a specific patient. For example, for the first patient, contextual information about stage 3 emphysema can be loaded into the instrument for disease status. The force information for firing for the specific instrument can be loaded into the state of the instrument. Contextual radiation treatment information can be loaded into the treatment status, and contextual steroid dosage information can be loaded into the patient's status. Any conflicts or combinations can be resolved using the exemplifying processes described in Figures 21 and 22, which then provide the instrument with a particular set of adjustments to precisely manipulate that first patient.
[00216] [00216] Then, a second set of contextual information for dealing with a second patient can also be loaded into the instrument, but remain queued before being implemented. For example, for the second patient, contextual information about high blood pressure (for example, 165/110) can be loaded into the instrument for disease status. The force information to close for the specific instrument can be loaded into the state of the instrument. Contextual chemotherapy information can be loaded into the treatment status, and contextual anticoagulant dosage information can be loaded into the patient's condition. Any conflicts or combinations can be resolved using the exemplifying processes described in Figures 21 and 22, which then provide the instrument with a particular set of adjustments to precisely handle this second patient.
[00217] [00217] The combinations resulting from the contextual information for the first patient can result in two graphs 204705 and 204710, for example, for the settings of firing speed and force to fire over time, respectively. Similarly, combinations resulting from the contextual information for the second patient can result in two graphs 204720 and 204715, for example, for the trigger speed and force settings to fire over time, respectively.
[00218] [00218] In one aspect, the adjustments to the instrument for a single configuration can be weighted by the hierarchical level from which the proposed adjustment derives. For example, if FTF adjustments are found at all primary, secondary and tertiary levels, then the adjustment for FTF can be done according to the following example weighting structure: FTF = FTF (default) + 1.5 * FTF ( primary) + 1.0 * FTF (secondary) + 0.75 * FTF (tertiary),
[00219] [00219] Other weighting mechanisms can also be used and are not limiting.
[00220] [00220] Some non-limiting examples of contextual information that can be included for adjustments to an instrument will be discussed below. The type and number of factors described can be used in the processes described in Figures 21, 22 and 23 to create a comprehensive or combined instrument fit. Contextual indications may include non-device specific indications, device specific indications, medical indications, patient specific indications, procedure specific indications and surgeon specific indications. Non-device-specific contextual statements
[00221] [00221] Non-device-specific indications are contextual indications related to the operation of a device, but which are not specific to any particular type of device. Contextual indications not specific to the device may include, for example, tissue clamping by the device, tissue information, and instrument usage history.
[00222] [00222] Contextual indications of tissue clamping may include, for example, implications of clamping force or pressure on the tissue (i.e., the primary clamping effect (s) of the tissue), which may , in turn, include desired and adverse impacts on the tissue. Clamping the tissue can have multiple different desirable effects on the clamped tissue. For example, tissue clamping can drive fluids out of the tissue, flatten the tissue layers and flatten any interior openings. This allows the tissue layers to be in close proximity and prevent leaks from any hollow structures in the area (for example, capillaries, bronchi, gastrointestinal). Another desired effect of tissue clamping is that, as the body tissues are viscoelastic, the compressibility of the tissue depends on the type of tissue, its fluid content, the pressure level and the compression rate. Consequently, for the same amount of compression, the faster the compression, the greater the force applied. For constant pressure, the tissue will continue to grow thinner and thinner until a stable state of full compression is achieved. This continuous thinning is defined as the deformation of the tissue and is a function of the viscoelasticity of the tissue. This is important when discussing pre-compression cycles, waiting times and total instant compression. Lower levels of total compression over a longer period of time are less detrimental to the treatment of the tissue and to the pressure differential (shear) on the adjacent tissue.
[00223] [00223] Clamping the fabric can also have adverse impacts on the fabric due to compression. For example, when the fabric is clamped and fabric structures are flattened, there may be structures in the fabric that should not be retracted. This can create a microtension in the tissue or pressure differential between the adjacent non-pinched tissue and the compressed tissue. Some tissues (for example, parenchyma, parenchyma of solid organs) are not particularly tolerant of such tension or pressure without causing disruption of the tissue layers adjacent to the pPpinched tissue, which, in turn, causes unintended collateral damage to the tissue and potential additional leaks. The total amount of pressure,
[00224] [00224] Several different device control parameters influence the clamping, such as the clamping force, the clamping rate and the number of repetitive clamping. The characteristics of the clamping force can be illustrated by a clamping force versus time curve, which can indicate the rate of change in the force time, the maximum clamping force, the time of stabilization of the clamping force, the force steady-state clamping, and the difference between the maximum clamping force and the stabilized clamping force.
[00225] [00225] The clamping force can be measured directly or indirectly by means of an intermediate or substitute agent ("proxy"). Numerous substitutes can be used to measure the clamping force. For energized closing, substitutes can include the current through the motor and the difference between the intended motor speed and the actual motor speed. Strain gauges on components that are loaded during the clamping act, such as the anvil, the closing member and / or the support structure can also be used to measure the clamping force.
[00226] [00226] The clamping rate can be determined by comparing the actual clamping rate with the desired clamping rate for energized closing. The clamping rate can also be determined based on the duration of the clamping process, from start to finish.
[00227] [00227] The number of repetitive clamps may be important because manipulation of heavy tissue prior to the transection of the tissue treatment can have a cumulative effect on the tissue due to the repeated exposure of pressure to the tissue. Some devices have a maximum pressure that can be applied, as well as a minimum level of closure for the next mechanism to start its operation. In such cases, the jaws are opened and closed repeatedly to place the tissue in its minimal closed state while it is compressed repeatedly until that state is achieved. In one aspect, a robotic surgical system can signal if the clamping parameters do not fall within a threshold to ensure that the claws are properly clamped.
[00228] [00228] Contextual indications of tissue information may include, for example, placement in the claw (which can be considered, for example, a side effect of the surgical procedure), knowledge of tissue quality from other sources (for example , imaging or RME, which can indicate previous interventions, current / previous illnesses, and so on), the type, thickness or density, and impedance (which can be considered, for example, a primary effect of the surgical procedure) . The placement of the fabric within the claws may correspond to the percentage of the claws covered by the fabric, the region or locations of the claws covered by the fabric (eg, vase, etc.), and the degree of grouping or degree of uniformity of the fabric throughout the length of the claws. Any device that compresses the tissue is applying a known measurable force to the tissue inside the jaws. The amount of tissue in the claws, the positioning of the tissue (that is, in relation to the distal position to the proximal position), and the variability of its thickness affect the pressure on the tissue. Knowing the force applied to the fabric without knowing the percentage of the claws is covered by the fabric or the placement of the fabric makes it difficult to determine the pressure on the fabric. Many devices are also sensitive to the technique. For example, often only the distal tip of an ultrasonic device is used for dissection, welding and cutting, leaving most of the claw empty in many shots. As another example, surgical stapling and cutting instruments often position the heaped tissue on the proximal fork of the jaws, leaving a tissue gap between the proximal end and the distal end of the end actuator. Unless the only materially relevant information is the trends in the parameters (which may be the case in certain situations), the settings of the device control parameters will be functionally dependent on knowledge about the percentage of the claws that are loaded and the location where the claws are loaded, because these factors have implications for the measured forces.
[00229] [00229] The contextual indications of the history of use of the instrument may include, for example, the number of uses and the number of resterilizations of the devices. Device-specific contextual indications
[00230] [00230] There is a wide variety of device-specific contextual indications for surgical staplers, ultrasonic instruments, laparoscopic or endoscopic suture devices, double bipolar instruments, monopolar instruments and clip applicators.
[00231] [00231] Contextual indications for stapling devices can include indications of device identification and reloading and indications of firing speed (which can be considered, for example, a primary effect of the surgical procedure).
[00232] [00232] Device identification and refill indications may include, for example, information about the type and refill of the stapler (ie, the cartridge). Type indications may include the brand, motorized or manual, length of the drive shaft, general or specialized, hand or robotic, single-use or multipurpose, history of use, whether the device has been reprocessed (for example, reprocessing authentic or resterilized, use "off-label"), and stapler configuration (for example, linear, linear curved, or circular). Refill indications can include color, length, height of the clamp (uniform or variable), authentication (that is, if the refill is compatible and from the same brand; if the refill is compatible, but from a device of another brand or unknown brand) or if a "pirate" refill is used with the manufacturer's stapler; not compatible; or the correct generation of technology, such as one), specialty (for example, curved, reinforced, radial, absorbable staples, medicine-coated staples, or fabric thickness compensation), use and the type of reinforcement or other accessory of the staple line, or provides drug release through the accessory of the staple line.
[00233] [00233] Trigger speed indications can include, for example, the actual speed versus time over the entire firing cycle, the difference between the target speed and the actual speed, or the adaptive firing speed control (for example, initial speed, number of changes in target speed, and actual maximum and minimum speeds recorded). Firing speed has multiple direct and / or indirect implications for the function of the device. For example, firing speed can have implications for staple formation for several reasons.
[00234] [00234] “As a reason, the rate at which a beam with a profile in | or a blade actuator is cycled causes the fabric to move while the clamps are being positioned. In a circular stapler, the advance of the knife is often coupled with the advance of the staple driver. If the knife starts to cut the fabric before the staples are formed completely (as may be the case), the fabric begins to move radially outward. This flow of tissue can have implications for staple formation. In sequentially linear positioning staplers, the knife / actuator advances through the cartridge (typically from the proximal to the distal position, although it can sometimes be in the opposite direction) and cuts the fabric while progressively forming the staples, which creates the flow of direction of movement. Pre-compression and fabric stabilization features can reduce this effect, while smaller compressions of fabric and compressions at the beam site with a profile in | typically increase this effect. The effect of the movement of the fabric can create a wave in the advancement of the cutting member, which occurs in a related area where the unformed staples are advanced towards the anvil. Consequently, this flow of tissue has an effect on the formation of staples and the length of the cut line.
[00235] [00235] As another reason, the rate at which the clamp drivers are advanced has an effect on their advance and the likelihood that they will rotate or flex, causing the clamp crown to move out of the plane. For stapling and cutting surgical instruments where the diameter of the device is limited to the diameter, size or type of the trocar, the clamp actuators are often short and have an aspect ratio that allows the rotation of the actuator, in addition to perpendicular linear feed the tissue contact surface of the cartridge. This turn of the trigger can result in a switch on of the trigger so that, as the slider continues to advance, the drivers are rotated, instead of advancing outward, resulting in the destruction of the cartridge and the staple line. This rotation of the clamp actuators is a function of the sliding friction, lubrication and cartridge geometry. The connection, and therefore the turn of the actuator, is amplified by the rate at which the slide is advanced and, therefore, by the trigger rate of the actuator of the device. In addition, many staplers overload the actuators above the tissue contact surface of the cartridge. This overload exposes the driver to the tissue flows that occur between the anvil and the cartridge. The actuators have a moment of inertia and are brought into contact with the fabric, and also experience the loads of the clamps being formed. The rate at which these triggers are advanced into the tissue and the extent of the overload influence the likelihood that the trigger will remain directly under the anvil forming pocket.
[00236] [00236] As another example, the firing speed may have implications for local tissue compression. In the case of surgical stapling and cutting instruments coupled by a beam with an | profile, the advance of the firing member causes compression of local tissue around the location of the beam with an | profile, in addition to cutting the tissue and positioning the staples against the anvil pockets. This wave of compression at the location of the beam with a profile | moves from the proximal position to the distal position with the location of the beam with | profile. The viscoelastic aspect of the fabric makes the rate of this advance directly related to the local compression force applied, as well as the size of the rotating compression wave. This local gyrus compression is capable of causing tension damage to the local tissue in the treatment area, as well as collateral damage because the compression rate is probably higher than the pre-compression rate.
[00237] [00237] As yet another example, the speed of firing can have implications for the forces within the device. The loads experienced within the instrument itself are a cumulative effect of pre-compression, as well as local rotation compression. The faster the firing member is advanced, the greater the force required to advance the firing member. This is due to the dynamics of the moving structures within the device, as well as the beam forces with | The greater these forces are, the more stretching there will be in all components in the elongated pipe and the structure, which in turn results in some forces being impacted (for example, deterioration of pre-compression as the system stretches)) These losses then add more force to the firing member balance, resulting in even greater impacts on the relationship between firing speed and load.
[00238] [00238] These various examples of contextual stapler indications can be further illustrated with respect to a specific example. In this example, through the procedure plan, RME and other hospital records, several pieces of information are known: (i) this is a right upper lobectomy procedure; (ii) the patient was previously submitted to radiation to treat a tumor in this area; and (iii) the patient has interstitial lung disease. This information suggests that the lung will be more rigid than normal, healthy tissue. Based on this inference, the conservative approach would be to slow the maximum closing rate and adjust the thresholds. However, contextual information in additional layers can additionally be used to determine how the instrument is to be controlled. In the same patient, during closing, the force to close is greater than the expected value, exceeding the new thresholds (that is, the thresholds that are defined according to the procedure and the patient information noted above). As a result, the waiting time before the start of the firing sequence is increased and the initial firing speed is decelerated. Trigger algorithms will take over after the trigger is started. It should be noted that the contextual indications can influence the thresholds in the triggering algorithms.
[00239] [00239] Contextual indications for ultrasonic devices may include activation time, evaluation of tissue collagen coherence tomography, the current mix of energy modalities (for example, if the instrument uses an ultrasonic / bipolar mixture, an ultrasonic / monopolar or just ultrasonic mixture), the blade temperature and the condition of the block. The temperature of the blade increases with the duration of contact with the tissue or block of the clamping arm and the power supplied to the transducer. This temperature changes the natural frequency of the blade and has the ability to add heat when welding the fabric, which is not desirable. It can also cause unintended damage to the tissue with which it comes into contact, even between actuations of the instrument. Hot blades also cause local tissue to carbonize (which can then adhere to the blade). The blade temperature has a long-term effect on cutting / coagulation performance, but it also creates a shearing or tearing force on the fabric weld as the jaws are opened and removed (once the carbonized fabric adheres to the blade) . The condition of the block may depend on the length of active time without tissue in the jaws and / or the temperature history of the jaws. As the block is degraded, the underlying metallic resistance of the clamping arm is exposed to the blade, ultimately impacting its performance.
[00240] [00240] These various examples of contextual indications for ultrasonic devices can be further illustrated with respect to a specific example. In this example, through the procedure plan, RME and other hospital records, several information are known: (i) this is a vertical sleeve gastrectomy procedure; (ii) the patient's BMI is 40; and (iii) the patient's body composition suggests that he has a high level of visceral fat. This information suggests that the reversal of the greater curvature will have a greater volume of fatty mesentery than normal. Based on this inference, the combined algorithm tends more strongly towards the cut than the seal given the expected high fat content. The algorithm parameters can be adjusted simultaneously to ensure a robust seal.
[00241] [00241] Contextual indications for laparoscopic or endoscopic suture devices may include the suture tension (tension monitoring can be used to inform the suture technique, for example), the type of suture (for example, braided or monofilament, absorbable or non-absorbable, suture diameter / size, or needle size / type). Pattern recognition models can be used to recognize the pattern of the sutures applied depending on the tension applied during the sutures (for example, suture / tension / suture / tension or suture / suture / tension / suture / suture / tension). The pattern recognition system can be configured to provide announcements of techniques, for example, three sutures without a tension step with a braided suture can be difficult to tighten without causing injury to the tissue, while two sutures may be suitable.
[00242] [00242] Contextual indications for dual bipolar RF instruments may include the coating (which may include the coatings disclosed in US Patent No. 5,693,052 and US Patent No. 5,843,080, each of which is incorporated herein by reference in in its entirety), the design (which may include the design described in US patent no. D399,561, which is hereby incorporated by reference in its entirety), bipolar coagulation, algorithms and load curves, smoke generated, conductivity contact of the electrodes (for example, the amount of carbonization present in the electrodes or if a short circuit is detected), compression of the claw (for example, the compression force, pressure, or in the special case of bipolar scissors the localized cross section / geometry high electrode strength or greater maximum force, as described in US patent No. 9,084,606, which is incorporated here as a reference in its entirety), span the fabric (that is, if the claw is open / angled or closed / spaced), configuration of the electrodes (for example, opposite electrodes, displaced electrodes, or electrodes / isolation, as described in US Patents No. 5,100,402,
[00243] [00243] Contextual indications for monopolar instruments may include power (for example, constant voltage or current and variable control of the other given a fabric impedance), fabric impedance (for example, impedance change rate, measured total impedance, or time at a given impedance), algorithms and load curves, return path capability, blade technology (for example, the coating of the blade, such as insulation breakage or various coatings disclosed in US Patent Nos. 5,197,962, 5,697. 926,
[00244] [00244] Contextual indications for clip applicator devices may include clip size devices, first or last clip of the applicator, the timing of the detected forces (for example, overload protection mechanisms in the event that unexpectedly rigid structures are accidentally pinched by the claws , such as when cutting over another clip or when claws are closed over another instrument), clip feed monitoring (for example, loading loads or detecting the presence of clips at predefined locations or at predefined times) , side-end actuator and bending loads, or claw actuation load (for example, clip closure, maximum load in controlled displacement actuation, maximum displacement in controlled load actuation, or fabric handling loads with the claws ). Medical contextual indications
[00245] [00245] Contextual medical indications may include contextual indications associated with medical complications, disease states, medications and procedural complexity.
[00246] [00246] Contextual indications for medical complications may include functional constipation, functional diarrhea, sphincter control or resistance failure disorders, functional dyspepsia and complications affecting plans and compositional composition of the tissue, to name just a few.
[00247] [00247] Functional constipation can result from colorectal surgery including a circular anastomosis, which would suggest a longer period before intestinal motility after surgery to allow for further expansion. It could also suggest the use of an expandable clamp configuration or contraindicate the use of reinforcement or compression ring technologies that would not tolerate larger and more solid stools (which can, for example, be a side effect of the surgical procedure as an effect complicating tissue fragility).
[00248] [00248] Functional diarrhea may indicate higher acid levels and more fluid movements, which could dictate tighter clamp shapes, higher pre-compressions, and the potential need for secondary accessories applied laterally to the abdomen to minimize the likelihood of fecal introduction into the abdominal cavity (which can be defined as a tertiary effect of the surgical procedure).
[00249] [00249] “Inadequate sphincter control or other disorders of insufficient resistance can result in heartburn or acid reflux. These contextual indications may indicate, for example, that an esophageal anastomosis would benefit from stronger staples, tighter shapes and / or longer tissue pre-compression to allow for tighter staple shapes and lower tissue tension thresholds (both micro and macrotension). The macrotension of the tissue is related to a more extensive mobilization of the tissue from adjacent structures and could be measured by lateral forces applied to the stapling device. The microtension of the tissue is due to the compression rate, maximum compaction and compression gradient of the tissue between the areas directly adjacent to the treatment area and the type of staple forms in the treatment area. 3D clamps reduce microtension as well as a lower level of maximum pre-compression. Heartburn and / or acid reflux can be considered, for example, a side effect of the surgical procedure. Device or surgery suggestions could include a reinforcement treatment for the sphincter or an auxiliary therapy applied to the staple lines to increase robustness.
[00250] [00250] - Functional adispepsia can result from the sensation or inhibition of peristalsis, which could suggest rigidity of the anastomosis line (there would be an additional amplification of the effect). A lower tissue microtension would facilitate the effect (3D staples) or a line of expandable staples. Compression of the anastomosis lines or accessory material used on the staple lines would cause more problems. Functional dyspepsia can be considered, for example, a side effect as a complicating effect of auxiliary therapy.
[00251] [00251] In the case of complications affecting tissue plans and compositional composition of the tissues, the cure of a first surgery and adhesions leads to an increase in the thickness of the tissue, as well as in a disorganized remodeling of the tissue, resulting in an increase in the hardness of the fabric. To adjust these effects during stapling, the suggestion would be to implement an increased span, higher tissue load thresholds, slower performance and larger or heavier staples. These complications can be considered, for example, a side effect of the surgical procedure, as a complicating effect of the thickness / robustness of the tissue. Other such complications may include revision surgery, adhesions and altered tissue conditions resulting from medical treatments (for example, irradiated tissue or steroid-induced changes).
[00252] [00252] Contextual indications for disease states may vary for colorectal, thoracic, metabolic and cardiovascular diseases.
[00253] [00253] —Colorectal diseases, inflammatory bowel disease can be a contextual indication. All repetitive inflammatory colorectal diseases cause an increase in the thickness of the tissue, as well as its disorganized remodeling, resulting in an increase in the hardness of the tissue. Stapling adjustments could include an increased span, higher tissue load thresholds, slower performance, and larger or heavier staples. These complications can be considered, for example, a side effect of the surgical procedure, as a complicating effect of a stapling accessory. Such colorectal diseases can include Crohn's disease and diverticulitis.
[00254] [00254] For chest diseases, bronchitis, emphysema, chronic obstructive pulmonary disease (COPD), asthma and interstitial lung disease can all be contextual indications. For example, emphysema results in thicker and stiffer lung tissue that would suggest load clamping rates, lower levels of pre-compression and slower firing of the knife / beam with profile in | to avoid adjacent collateral damage around the perimeter of the anvil and the cartridge due to excessive pressure differential during treatment. These are primary effects. As another example, COPD results in arterial walls that could be more rigid and less elastic, requiring smoother manipulation of the arteries before treatment is applied. This could require the mechanical fasteners to clamp at a slower rate and potentially lower clamping pressure to minimize damage outside the treatment area and premature damage to the treatment area. These adjustments can be for both energy and stapling. These are side effects. In stapling, the suggestion of an accessory can be contraindicated to avoid additional uncontrolled remodeling and hardening. In advanced energy, the RF treatment mode is preferred and the balance between RF and ultrasonic energy for welding is greater than for cutting.
[00255] [00255] For metabolic diseases, the metabolic syndrome, obesity and type 2 diabetes mellitus can all be contextual indications.
[00256] [00256] For cardiovascular diseases, arteriosclerosis, cholesterol! high and vascular disease can all be contextual indications.
[00257] [00257] Contextual indications for medications may include blood thinning, blood clotting, steroids, radiation treatment and chemotherapy.
[00258] [00258] For example, thinning of the blood may indicate that advanced energy devices benefit from improved clotting before cutting. This is a priority and a primary effect, as a complicating effect of blood pressure. In a hybrid energy device, RF power can be increased or the application of ultrasonic energy delayed to increase clotting before cutting. In an ultrasonic only device, the algorithm could be adjusted to apply a lower level of power for a longer period of time to further denature the collagen before cutting. Additionally, in an ultrasonic-only device, the harmonic power could be adjusted to a lower value as the temperature approached a predefined optimal temperature and that temperature could be maintained for a longer period of time before increasing the energy. the transducer to start cutting. In addition, on a stapling instrument, the suggested color of the cartridge could be adjusted, suggesting shorter formed clamps, or increased closing clamping time or increased pressure before firing. This is a side effect.
[00259] [00259] For example, blood clotting may indicate that pre-compression or compression levels of advanced energy or stapling could be decreased prior to treatment to minimize accidental damage and therefore clotting outside the area of treatment. This is a side effect, like a complicating effect of increased pressure.
[00260] [00260] For example, steroids cause physiological effects that delay healing and increase blood pressure, which in turn increases preexisting complications. This is a tertiary effect, as a complicating effect of disease amplification, as well as long-term healing complications. Steroids increase blood pressure in many people who consume them. One reason is that steroids and other corticosteroids cause the body to retain fluids. Extra fluid in the circulation can cause an increase in blood pressure. In addition, anti-inflammatory corticosteroids have a significant impact on wound healing. Corticosteroids decrease levels of transforming growth factor BB (TGF-B) and factor | of insulin-like growth | (IGF-I) and tissue deposition in wounds, and retinoids stimulate the release of TGF-B and IGF-1 impaired by corticosteroids and the production of collagen.
[00261] [00261] For example, radiation treatment can result in inflammation of the organ and thickening of the tissue wall. This effect can increase the hardness, thickness and resistance of the fabric being treated. This increases the need for longer compression times and potentially higher compression thresholds, unless there are complications that inhibit this. Radiation-based treatments can also have complicating effects on blood oxygenation through the impact on the breathing system and can have a multiplicative effect on collagen vascular diseases, which could, in turn, require changes in any advanced energy, mixture of welding energies or algorithms that suggest more time to weld and a slower rate before cutting. This is a side effect, like a complicating effect of the compositional composition of a fabric.
[00262] [00262] For example, chemotherapy treatment can make the tissue thin and friable. These effects make collateral damage to tissues much more likely and more difficult to treat. The implications for any mechanical device are lower handling forces and pre-compression levels, as well as lower rate thresholds and, in general, smoother handling and lower stresses on the fabric. This is a primary effect, like complicating effects with higher tissue compressions.
[00263] [00263] Contextual indications associated with the complexity of the procedure include the location of a tumor, remaining vascularity, the challenge of accessing the surgical site, the total time under anesthesia, the amount of work required to complete the procedure, and whether there were any procedures previous ones.
[00264] [00264] For example, the remaining vascularity can be a contextual indication! because vascularization is directly related to the cure rate and tissue viability. In addition, this aspect has longer-term implications for tissue strength and recovery. This is a primary physiological impact on healing. This does not have any implications for operating the short-term instruments, but it does have implications for the strength of recovery and reinforcement, requiring additional time for the durability of the main surgical treatment. This achievement may impact the instrument's recommendations for post-surgical recovery, additional auxiliary therapies applied and necessary monitoring. This is a side effect such as an amplification of the disease state, blood sugar level and impacts of oxygenation on tissue remodeling.
[00265] [00265] For example, total time under anesthesia can be a contextual indication because time under anesthesia is a complicating effect of pre-surgery recovery levels relative to oxygenation levels and metabolic reactions. During surgery, this has an amplifying effect on lower levels of blood oxygenation. This is a time-dependent effect that is not linear; the longer the time, the greater the impact of the effects. This is a tertiary effect as a complicating effect at the lower levels of blood oxygenation.
[00266] [00266] For example, the amount of work required to complete the procedure can be a contextual indication because it is related to the number of energy cycles, the number of movements of dissectors or scissors and / or the number of shots from the stapling instrument surgical.
[00267] [00267] For example, previous procedures can be a contextual indication because they increase the likelihood of adhesions and secondary tissue remodeling. This typically creates more disorganized fabric layers and more resistant fabrics with more cover fabrics. This is a tertiary effect, such as complicating effects of disease amplification, as well as complicating effects of collagen level.
[00268] [00268] Patient-specific contextual indications may include, for example, patient parameters and physiological indications.
[00269] [00269] The patient's parameters can include age, sex, if the patient is a smoker, BMI and body composition information.
[00270] [00270] For example, age results in friable fabrics that would require lower compression and a lower compression rate of treatment devices, especially in pretreatment compressions. This is a side effect as a complicating effect of greater tissue compression.
[00271] [00271] For example, gender has deviations from threshold implications to the ideal ranges of many physiologically related measures (eg BMI, body fat composition and impacts on physiology). This is a tertiary effect on other parameters.
[00272] [00272] For example, the fact that the patient is a smoker results in thicker and more rigid lung tissue that would suggest load clamping rates, lower levels of pre-compression and slower firing of the profile knife / beam in | to avoid adjacent collateral damage around the perimeter of the anvil and the cartridge due to excessive pressure differential during treatment. These are side effects, such as emphysema and complicating effects of oxygen saturation. Oxygenation of the tissue can be, as noted later, a metric available to quantify the effect of smoking.
[00273] [00273] For example, BMI is a contextual indication because obesity tends to increase the comorbidities of many other medical complications. This is a tertiary effect, such as a complicating effect of amplification with blood sugar levels, congestive heart problems, oxygen levels and several other disease states.
[00274] [00274] For example, body composition information can be contextual indications because the percentage of body fat affects the collagen content of tissues, the compression properties of tissue types, and the metabolic implications for tissue healing and remodeling. This has effects in a very high percentage and a very low percentage with different effects at each end. Percentages of body fat above a certain level inhibit metabolic operation and increase complications around organ function. These complications will tend to amplify the complications of disease state in the functions of the mechanical device. Additionally, the percentages of body fat below a certain level will tend to have an impact on the constitution of the tissue itself. These changes in tissue constitution can impact both healing and the ability of advanced energy devices to consistently weld due to fluctuations in collagen levels, requiring more compression and longer weld times. These are tertiary effects, as amplification of the complicating effects of the disease, and also as complicating effects of the collagen level.
[00275] [00275] Physiological indications may include the time the patient last ate, the fasting blood glucose level, blood pressure, tissue macrotension, fluid levels in the tissue and tissue oxygenation.
[00276] [00276] For example, the fasting blood glucose level can be a contextual indication because blood sugar level is the main physiological factor in healing. A higher than normal blood sugar level prevents nutrients and oxygen from energizing cells and prevents the immune system from functioning efficiently. This is a side effect. Additionally, knowing the continuous fasting state, as well as changes and reactions after meals, affects the implications of a measured value. In most humans, this ranges from about 82 mg / dl to 110 mg / dl (4.4 to 6.4 mmol /]). Blood sugar levels rise to almost 140 mg / dl (7.8 mmol / l) or slightly more in normal humans after a complete meal. In humans, normal blood glucose levels around 90 mg / dl, equivalent to mM (mmol / l)
[00277] [00277] This measure also depends on time. The consumption of heavy carbohydrate foods would cause a significant increase in blood sugar, but would typically also start to decrease after about 30 minutes.
[00278] [00278] For example, blood pressure can be used as a contextual indication because advanced energy devices benefit from improved clotting before cutting. This is a priority and a primary effect. In a hybrid energy device, RF power can be increased or the application of ultrasonic energy delayed to increase clotting before cutting. In an ultrasonic only device, the algorithm could be adjusted to apply a lower level of power for a longer period of time to further denature the collagen before cutting. Additionally, in an ultrasonic-only device, the harmonic power could be adjusted to a lower value as the temperature approached a predefined optimal temperature and that temperature could be maintained for a longer period of time before increasing the energy. the transducer to start cutting. Blood pressure can be measured using different methods and in different locations. For example, the pressure at 10 minutes of rest, that is, the blood pressure measured at rest, can be very different than any blood pressure measured after physical effort. Whether this is a blood pressure measurement based on an exact measurement or whether it is considered a systemic resting pressure reading will have implications for how to respond to the measurement and whether its value exceeds the upper or lower pressure. In addition, there are differences for vascular blood pressure levels. Typical blood pressure is taken in larger arteries in one arm or other extremity. A pressure in the arteries in the 129/80 arm could be related to a micro pressure of 70/40 in the capillaries and even lower 20/10 in veins where the actual tissue treatments are being carried out. Occlusions and variations in physiology can amplify or limit differences in pressure from one part of the system to another. Knowing where the pressure is being taken and knowing any long-term measures could help to adjust the necessary effects due to changes in pressure.
[00279] [00279] For example, fluid levels in the tissue can be a contextual indication because dehydration reduces blood flow throughout the body, and although this consequently also reduces blood pressure, the wound bed can be deprived of white blood cells. blood that protect against infection, and also limits the amount of oxygen that reaches the wound site through blood flow, such as vitamins and nutrients. In general, lower fluid levels inhibit every aspect of wound healing. This is a tertiary effect, as a complicating effect of healing amplification. For superficial tissue remodeling and the potential healing of colorectal tissue in place, dehydration can delay healing in several ways. A warm, humid environment is ideal for new tissue growth, and a lack of moisture in the affected area can disrupt cell development and migration. Without adequate moisture, the epithelial cells that migrate through the wound bed to repair tissue along the way cannot properly navigate and cover the wound site. This stops the creation of new tissue and leaves the wound open and susceptible to harmful bacteria that can cause infection. Potential measures related to dehydration may include, for example, electrolytes, blood urea nitrogen, creatine, urine test, complete blood count, and urine and / or blood osmolality.
[00280] [00280] For example, tissue oxygenation can be a contextual indication because it is widely recognized for playing an important role in almost all parts of the wound healing stages. During healing, a surgical site develops an increasing need for bacterial defense, cell proliferation, collagen synthesis and angiogenesis, among other reparative functions. Collagen accumulation is a direct function of oxygen tension, and levels below 20 mm / Hg have been shown to impair this accumulation. Collagen synthesis depends on enzyme functions, which are, in turn, a function of local oxygen levels. In contrast, hyperbaric oxygen therapy is recognized for increasing cure rates by increasing oxygen concentrations above normal levels.
[00281] [00281] Contextual indications specific to the procedure may include the time of day the procedure occurred, be it an emergency or planned surgery, the duration of the procedure, the type of procedure (for example, laparoscopic, robotic or open), and whether it was a new operation or original procedure. Specific contextual indications of the surgeon
[00282] [00282] The surgeon's specific contextual indications may include: whether the surgeon is a specialist or a general practitioner (this comparison is made for each procedure to be performed), the surgeon's skill level (which can be indicated, for example, the total number of procedures performed, the total number of times that the operation in question was performed and / or his / her training level), and the surgeon's concentration and disposition (which can be indicated by, for example, the number of other procedures performed that day and the duration of the current procedure).
[00283] [00283] In several respects, metadata (for example, the contextual indications described above) can be included with the generation of general data.
[00284] [00284] In one aspect, metadata can be stored by associating metadata with primary data with the ability to filter data from metadata. In another aspect, metadata can be stored in a different location than primary data, but can be linked to it, allowing access to metadata to obtain key metadata.
[00285] [00285] Metadata accessibility can be controlled in a variety of different ways. In one aspect, the associated metadata can be transported with the original data collected. In another aspect, data can be extracted from metadata by filtering data and relevant context. Knowledge hierarchy
[00286] [00286] In several respects, contextual indications can be organized to provide data based on the necessary context. Consequently, the computer system can be configured to identify or determine the relevance of specific metadata to provide context. In addition, a computer system can be programmed to provide navigation through metadata. Methodology of use
[00287] [00287] In one respect, metadata can be used for (i) identification and association of isolated but interrelated data points or records, (ii) identification of associated occurrences, and / or (iii) algorithms can be programmed to automatically compare results (and complaints) to any / all recorded data and compare regression trends and predictive model ability to determine what factors can influence success. These data can be limited to a single device (for example, trigger speed or energy versus leakage current), or they can be combined between multiple devices to infer aspects such as trigger time in relation to the placement of trocars or the start of anesthesia ( start of surgery) or number of scissors / desiccators / energy devices activations (for example, degree of dissection / fat removal).
[00288] [00288] Various aspects of the subject described in this document are defined in the following numbered examples:
[00289] [00289] Example 1 - System for automatically merging data obtained from a medical procedure. The system comprises a medical central controller comprising at least one processor and at least one memory, and a remote server communicatively coupled to the medical central controller. At least one processor is configured to access a first data set comprising data sampled at a first data sampling rate over a sampling period, accessing a second data set comprising data sampled at a second data sampling rate which is slower than the first data sampling rate and is recorded during the sampling time period, change the scale of the second data set to match the first data sampling rate, merge the first data set and the second dataset in a composite dataset, align the first dataset and the second dataset in the composite dataset, display the composite dataset, generate a graphical overlay on the display of the composite dataset, and transmit the composite data set to a remote server.
[00290] [00290] Example 2 - System, according to Example 1, the first or the second data set comprising one or more points of error data, and the processor is additionally configured to smooth the one or more points error data.
[00291] [00291] Example 3 - System, according to Example 1 or Example 2, the graphic overlay comprising a horizontal axis and a vertical axis, and the composite data set is displayed in a graphical form according to with the horizontal and vertical axes.
[00292] [00292] “Example 4 - System, according to Example 3, and the graphic overlay additionally comprises visual contours that indicate visual limits of the composite data set.
[00293] [00293] Example 5 - System, according to Example 1 or Example 4, with the graphic overlay comprising a horizontal axis, a first vertical axis and a second vertical axis, the first data set comprising data related to a first measurement that is expressed by the first vertical axis on the horizontal axis, and the second data set comprises data related to a second measurement different from the first measurement that is expressed by the second vertical axis on the horizontal axis.
[00294] [00294] Example6 - System, according to any one of Examples 1 to 5, and the processor is additionally configured to access first metadata associated with the first data set and recorded during the sampling time period, access associated second metadata to the second data set and recorded during the sampling time period, transmit the first and second metadata to an off-site repository, and store the first and second data sets in system memory.
[00295] [00295] Example 7 - System, according to any one of Examples 1 to 6, the first data set being registered in a first format, the second data set being registered in a second format different from the first format, and the processor is additionally configured to convert the first and second data sets to a common format.
[00296] [00296] Example 8 - System, according to any one of Examples 1 to 7, the processor being additionally configured to determine duplicate data from the first and second data sets and remove all copies of the duplicate data before of merging the first and second data sets into the composite data set.
[00297] [00297] Example 9- System, according to any one of Examples 1 to 8, where the first data set is generated by a first device that has a first internal clock, the second data set is generated by a second device that has a second internal clock, and the first data set and the second data set do not have a common time period because the first and second data sets are registered by their respective internal clocks. The processor is additionally configured to access a synchronizer signal between the first and second devices and align the first data set and the second data set using the synchronizer signal to interrelate the first data set and the second data set .
[00298] [00298] “Example 10 - System, according to any one of Examples 1 to 9, and the processor is additionally configured to access first metadata associated with the first data set and recorded during the sampling time period, access seconds metadata associated with the second data set and recorded during the sampling time period, transform the first data set into first aspectual data related to the use of the first metadata, and transform the second data set into second aspectual data related to the use the second metadata, where the merging of the first data set and the merging of the second data set into the composite data set comprises merging the first related aspectual data with the second related aspectual data.
[00299] [00299] “Example 11- System, according to any one of Examples 1 to 10, the remote server being configured to access updated parameters of one or more other central medical controllers connected in a communicative way to the remote server, and propagate the updated parameters for the medical central controller, and the medical central controller is configured to adjust the composite data set according to the updated parameters.
[00300] [00300] Example 12 - Method of a system to automatically merge data from a medical procedure, the system comprising a central medical controller comprising at least one processor and at least one memory. The method comprises accessing a first data set comprising data sampled at a first data sampling rate recorded during a sampling period, accessing a second data set comprising data sampled at a second data sampling rate which is slower that the first data sampling rate and is recorded during the sampling time period, change the scale of the second data set to match the first data sampling rate, merge the first data set and the second data set into a composite dataset, align the first dataset and the second dataset in the composite dataset, so that the data from the first dataset and the second dataset are ordered sequentially into the composite dataset in one sequence in which the data was recorded, display the composite data set, generate a graphic overlay on the display of the set the composite data that provides an interpretation of the composite data set and transmits the composite data set to a remote server.
[00301] [00301] Example 13 - Method, according to Example 12, the first or second data set comprising one or more error data points, and the method additionally comprising smoothing the error data points.
[00302] [00302] Example 14 - Method, according to Example 12 or Example 13, the graphic overlay comprising a horizontal axis, a first vertical axis and a second vertical axis, the first data set comprising data related to a first measurement that is expressed by the first vertical axis on the horizontal axis, and the second data set comprises data related to a second measurement different from the first measurement that is expressed by the second vertical axis on the horizontal axis.
[00303] [00303] “Example 15 - Method, according to any one of Examples 12 to 14, with the first data set being registered in a first format, the second data set being registered in a second format different from first format, and the method additionally comprises converting the first and second data sets into a common format.
[00304] [00304] “Example 16 - Method, according to any one of Examples 12 to 15, the method further comprising determining duplicate data from the first and second data sets and removing all copies of the duplicate data before merge the first and second datasets into the composite dataset.
[00305] [00305] Example 17 - Method, according to any one of Examples 12 to 16, where the first data set is generated by a first device that has a first internal clock, the second data set is generated by a second device that has a second internal clock, and the first data set and the second data set do not have a common time period because the first and second data sets are registered by their respective internal clocks. The method further comprises accessing a synchronizer signal between the first and second devices and aligning the first data set and the second data set using the synchronizer signal to interrelate the first data set and the second data set.
[00306] [00306] Example 18 - Method, according to any of Examples 12 to 17, the method additionally comprising accessing first metadata associated with the first data set and recorded during the sampling time period, accessing second metadata associated with the second data set and recorded during the sampling time period, transform the first data set into first aspectual data related to the use of the first metadata, and transform the second data set into second aspectual data related to the use of the second metadata, wherein merging the first data set and merging the second data set into the composite data set comprises merging the first related aspectual data with the second related aspectual data.
[00307] [00307] Example 19 - Method, according to any one of Examples 12 to 18, the method additionally comprising accessing, through the remote server, updated parameters from one or more other central medical controllers connected in a communicative way to the remote server, propagate, through the remote server, the updated parameters to the medical central controller, and adjust,
[00308] [00308] “Example 20 - Computer-readable media that does not include any transient signals and comprises instructions that, when executed by a processor, cause the processor to perform operations. The operations comprise accessing a first data set comprising data sampled at a first data sampling rate recorded during a sampling period, accessing a second data set comprising data sampled at a second data sampling rate which is slower that the first data sampling rate and is recorded during the sampling time period, change the scale of the second data set to match the first data sampling rate, merge the first data set and the second data set into a composite dataset, align the first dataset and the second dataset in the composite dataset, so that the data from the first dataset and the second dataset are ordered sequentially into the composite dataset in one sequence in which the data was recorded, display the composite data set, generate a graphic overlay on the display of the data composite data set that provides an interpretation of the composite data set, and transmit the composite data set to a remote server.
[00309] [00309] Although several forms have been illustrated and described, it is not the applicant's intention to restrict or limit the scope of the attached claims to such detail. Numerous modifications,
[00310] [00310] 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.
[00311] [00311] 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 (EEPROM), cards magnetic or optical, flash memory, or a machine-readable tangible storage media used to transmit information over the Internet via an electrical, optical, acoustic cable or other forms of propagation signals (for example, carrier waves, infrared signal, digital signals, etc.). Consequently, computer-readable non-transitory media includes any type of machine-readable media suitable for storing or transmitting instructions or electronic information in a machine-readable form (for example, a computer).
[00312] [00312] 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 that includes one or more cores instruction processing units - individual, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic matrix (PLA), or field programmable port arrangement (FPGA)), state machine circuits, firmware that stores instructions executed by the programmable circuit, and any combination thereof. The control circuit can, collectively or individually, be incorporated as an electrical circuit that is part of a larger system, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), an on-chip system (SoC ), desktop computers, laptop computers, tablet computers, servers, smart headsets, etc. Consequently, as used in the present invention, "control circuit" includes, but is not limited to, electrical circuits that have at least one discrete electrical circuit, electrical circuits that have at least one integrated circuit, electrical circuits that have at least one circuit integrated for specific application, electrical circuits that form a general purpose computing device configured by a computer program (for example, a general purpose computer configured by a computer program that at least partially executes processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially performs the processes and / or devices described here), electrical circuits that form a memory device (for example, forms of random access memory), and / or electrical circuits that form a communications device (for example, a modem, communication key, or eq optical-electrical equipment). Those skilled in the art will recognize that the subject described here can be implemented in an analog or digital way, or in some combination of these.
[00313] [00313] 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.
[00314] [00314] “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.
[00315] [00315] As used here in one aspect of the present invention, an "algorithm" refers to the self-consistent sequence of steps that lead to the desired result, where a "step" refers to the manipulation of physical quantities and / or logical states that can, although they do not necessarily need to, take the form of electrical or magnetic signals that can be stored, transferred, combined, compared and manipulated in any other way. It is common use to call these signs bits, values, elements, symbols, characters, terms, numbers or the like. These terms and similar terms may be associated with adequate physical quantities and are merely convenient identifications applied to those quantities and / or states.
[00316] [00316] 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 asynchronous transfer mode ("ATM") communication protocol. 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.
[00317] [00317] Unless otherwise stated, as is evident from the preceding description, it is understood that, throughout the preceding description, discussions that use 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.
[00318] [00318] One or more components in the present invention may be called "configured for", "configurable for",
[00319] [00319] The terms "proximal" and "distal" are used in the present invention with reference to a physician who handles the handle portion of a 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.
[00320] [00320] 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 "at least one" or "one or more"); the same goes for the use of defined articles used to introduce claims.
[00321] [00321] 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 the,
[00322] [00322] “With respect to the attached claims, those skilled in the art will understand that the operations mentioned in them can, in general, be executed 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 ordering - overlapping, merging, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, inverse or other variant orders, unless the context otherwise determines. 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.
[00323] [00323] 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 resource, structure or characteristic 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 features, structures or characteristics can be combined in any appropriate way in one or more aspects.
[00324] [00324] Any patent application, patent, non-patent publication or other description material mentioned in this specification and / or mentioned in any order data sheet is hereby incorporated by reference, to the extent that the materials incorporated are not inconsistent with that. Accordingly, and to the extent necessary, 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.
[00325] [00325] 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 described.
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 (1)
[1]
1. System for automatically merging data from a medical procedure, characterized in that the system comprises: a medical central controller comprising at least one processor and at least one memory and a remote server communicatively coupled to the medical central controller, where the hair at least one processor is configured to: access a first data set comprising sample data at a first sampling frequency recorded during a sampling time period; accessing a second data set comprising sample data at a second data sampling rate that is slower than the first data sampling rate and is recorded during the sampling time period; change the scale of the second data set to be correlated to the first data sampling rate; merging the first data set and the second data set into a composite data set; align the first dataset and the second dataset in the composite dataset, so that the data from both the first dataset and the second dataset are ordered sequentially in the composite dataset in an order in which the data have been registered; display the composite data set; generate a graphic overlay at the top of the composite data set display screen that provides an interpretation of the composite data set; and transmit the composite data set to the remote server.
System according to claim 1, characterized in that the first or the second data set comprises one or more error data points, and in which the processor is further configured to smooth the one or more error data points .
System according to claim 1, characterized in that the graphic overlay comprises a horizontal axis and a vertical axis, and in which the composite data set is displayed in a graphical form according to the horizontal and vertical axis.
4, System according to claim 3, characterized in that the graphic overlay further comprises visual contours that indicate visual limits of the composite data set.
5. System according to claim 1, characterized in that the graphic overlay comprises a horizontal axis, a first vertical axis and a second vertical axis, in which the first data set comprises data related to a first measurement that is expressed by the first vertical axis along the horizontal axis, and where the second data set comprises data related to a second measurement different from the first measurement which is expressed by the second vertical axis along the horizontal axis.
6. System, according to claim 1, characterized in that the processor is further configured to: access the first metadata associated with the first data set and recorded during the sampling time period; access the second metadata associated with the second data set and recorded during the sampling time period; transmit the first and second metadata to an off-site repository; and store the first and second data sets in system memory.
7. System according to claim 1, characterized in that the first data set is registered in a first format, in which the second data set is registered in a second format different from the first format, and in which the processor is configured yet to convert the first and second data sets to a common format.
8. System according to claim 1, characterized in that the processor is further configured to: determine duplicate data from the first and second data sets; and removing all copies of the duplicate data before merging the first and second data sets into the composite data set.
9. System according to claim 1, characterized in that: the first data set is generated by a first device that has a first internal clock; the second data set is generated by a second device that has a second internal clock; and the first data set and the second data set do not have a common time period due to the first and second data sets that are recorded by their respective internal clocks.
wherein the processor is further configured to: access a synchronizer between the first signal and the second device; and aligning the first data set and the second data set with the use of the synchronizer signal to relate the first data set and the second data set.
10. System, according to claim 1, characterized in that the processor is also configured to: access the first metadata associated with the first data set and recorded during the sampling time period; access second metadata associated with the second data set and recorded during the sampling time period; transform the first data set into first aspectual data related to the use of the first metadata; and transforming the second data set into second aspectual data related to the use of the second metadata; wherein merging the first data set and merging the second data set into the composite data set comprises merging the first related aspectual data with the second related aspectual data.
11. System, according to claim 1, characterized in that the remote server is configured to: access updated parameters of one or more other medical central controllers connected in a communicative way to the remote server; and propagate the updated parameters to the central medical controller; where the medical center is configured to adjust the composite data set according to the updated parameters.
12. A system method for automatically merging data from a medical procedure, in which the system comprises a central medical controller comprising at least one processor and at least one memory, in which the method is characterized by comprising: accessing a first data set comprising sample data at a first recorded sampling frequency over a period of sampling time; accessing a second data set comprising sample data at a second data sampling rate that is slower than the first data sampling rate and is recorded during the sampling time period; change the scale of the second data set to be correlated to the first data sampling rate; merging the first data set and the second data set into a composite data set; align the first dataset and the second dataset in the composite dataset, so that the data from both the first dataset and the second dataset are ordered sequentially in the composite dataset in an order in which the data have been registered; display the composite data set; generate a graphic overlay at the top of the composite data set display screen that provides an interpretation of the composite data set; and transmit the composite data set to the remote server.
Method according to claim 12, characterized in that the first or the second data set comprises one or more error data points, and wherein the method further comprises smoothing the error data points.
Method according to claim 12, characterized in that the graphic overlay comprises a horizontal axis, a first vertical axis and a second vertical axis, wherein the first data set comprises data related to a first measurement that is expressed by the first vertical axis along the horizontal axis, and where the second data set comprises data related to a second measurement different from the first measurement which is expressed by the second vertical axis along the horizontal axis.
15. Method according to claim 12, characterized in that the first data set is recorded in a first format, in which the second data set is recorded in a second format different from the first format, and in which the method further comprises convert the first and second data sets to a common format.
16. The method of claim 12, further comprising: determining duplicate data from the first and second data sets; and removing all copies of the duplicate data before merging the first and second data sets into the composite data set.
17. Method according to claim 12, characterized in that: the first data set is generated by a first device that has a first internal clock; the second data set is generated by a second device that has a second internal clock; and the first data set and the second data set do not have a common time period due to the first and second
7I8 data sets that are registered by their respective internal clocks.
wherein the method further comprises: accessing a synchronizer between the first signal and the second device; and aligning the first data set and the second data set with the use of the synchronizer signal to relate the first data set and the second data set.
18. Method, according to claim 12, characterized by further comprising: accessing the first metadata associated with the first data set and recorded during the sampling time period; access the second metadata associated with the second data set and recorded during the sampling time period; transform the first data set into first aspectual data related to the use of the first metadata; and transforming the second data set into second aspectual data related to the use of the second metadata; wherein merging the first data set and merging the second data set into the composite data set comprises merging the first related aspectual data with the second related aspectual data.
19. Method, according to claim 12, characterized by further comprising: accessing, via the remote server, updated parameters of one or more other medical central controllers communicatively coupled to the remote server;
propagate, through the remote server, the updated parameters to the medical central controller; and adjust, through the central medical controller, the data set composed according to the updated parameters.
20. Computer-readable media characterized by understanding non-transitory signals and understanding instructions that, when executed by a processor, cause the processor to perform operations that include: accessing a first set of data that comprises sample data at a first sampling frequency recorded over a sampling time period; accessing a second data set comprising sample data at a second data sampling rate that is slower than the first data sampling rate and is recorded during the sampling time period; change the scale of the second data set to be correlated to the first data sampling rate; merging the first data set and the second data set into a composite data set; align the first dataset and the second dataset in the composite dataset, so that the data from both the first dataset and the second dataset are ordered sequentially in the composite dataset in an order in which the data have been registered; display the composite data set; generate a graphic overlay at the top of the composite data set display screen that provides an interpretation of the composite data set; and transmit the composite data set to the remote server.
SN rr o = healthy - 3 | 23 ET Ez
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AND
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UN MONITOR 135
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IMAGE 138 [| SYSTEM 140 GENERATOR MODULE DISPLAY AT 108h
144. [| 143
SYSTEM 1 | ROBOTIC EVACUATION MODULE 126 OF SMOKE 110
128 MODULE | SUCTION / IRRIGATION
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MAPPING OPERATING ROOM 133

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

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

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US16/182,260|US11056244B2|2017-12-28|2018-11-06|Automated data scaling, alignment, and organizing based on predefined parameters within surgical networks|

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PCT/US2018/060991|WO2019133146A1|2017-12-28|2018-11-14|Automated data scaling, alignment, and organizing based on predefined parameters with surgical networks|

---