JP2021509313A - A system for adjusting end effector parameters based on perioperative information - Google Patents

Abstract

The surgical system includes a surgical instrument, an end effector, a control circuit, and a sensor configured to transmit a sensor signal indicating the closure parameter of the end effector. The control circuit is configured to adjust the closure rate of change parameter and closure threshold parameter based on the perioperative information received from one or more data sources and the sensor signal received from the sensor.

Description

(Cross-reference of related applications)
This application is filed on June 28, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACTIVE COUPLING", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the US Patent Act. Claims priority over US Provisional Patent Application No. 62 / 691,227.

This application is further filed under Article 119 (e) of the US Patent Act, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES", the entire disclosure of which is incorporated herein by reference. U.S. Provisional Patent Application No. 62 / 650,887, U.S. Provisional Patent Application No. 62 / 650,877, filing March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS" US Provisional Patent Application No. 62 / 650,882 filed on March 30, 2018, and US Provisional Patent Application No. 62 / 650,882, filed on March 30, 2018, entitled "CAPACTIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS" Claim the benefit of the priority of Nos. 62 / 650,898.

This application is further under Article 119 (e) of the United States Patent Act, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR", the entire disclosure of which is incorporated herein by reference. U.S. Provisional Patent Application Nos. 62 / 640,417 of the Japanese filing, and U.S. Provisional Patent Application No. 62 / 640,415 of the March 8, 2018 application entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTOR SYSTEM THEREFOR" Claim the interests of priority.

This application is also a US provisional patent filed on December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," in which the entire disclosure is incorporated herein by reference under Section 119 (e) of the US Patent Act. Application No. 62 / 611,341, U.S. Provisional Patent Application No. 62 / 611,340, filed December 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS", and December 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM". Claims the priority benefit of US Provisional Patent Application No. 62 / 611,339 filed on 28th May.

(Field of invention)
The present disclosure relates to various surgical systems.

Surgical systems include surgical instruments. The surgical instrument comprises an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument further comprises a motor configured to move the first jaw relative to the second jaw according to the closure rate of change parameter and the closure threshold parameter. Surgical instruments further include sensors configured to transmit sensor signals indicating end effector closure parameters. The surgical system further comprises a control circuit communicatively coupled to the sensor. The control circuit is configured to receive perioperative information including one or more of the types of perioperative disease, perioperative treatment, and surgical procedure. The control circuit is further configured to receive the sensor signal from the sensor and, based on the perioperative information and the sensor signal, determine the adjustment to the closure rate of change parameter and the closure threshold parameter.

The surgical system comprises a surgical hub configured to receive perioperative information transmitted from a remote database of cloud computing systems. The surgical hub is communicably coupled to the cloud computing system. The surgical system further comprises a surgical instrument communicatively coupled to the surgical hub. The surgical instrument comprises an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The end effector further comprises a motor configured to move the first jaw relative to the second jaw according to the closure rate of change and closure threshold parameters of the closure control program received from the surgical hub. The end effector further comprises a sensor configured to transmit a sensor signal indicating the closure parameter of the end effector. The surgical hub is further configured to receive a sensor signal from the sensor and, based on the perioperative information and the sensor signal, determine adjustments to the closure rate of change parameter and closure threshold parameter.

The features of the various aspects are described in detail within the appended claims. However, various aspects of both the mechanism and the method of operation, along with their further objectives and advantages, can be best understood by reference to the following description, in conjunction with the accompanying drawings below.
FIG. 6 is a block diagram of a computer-mounted interactive surgical system according to at least one aspect of the present disclosure. A surgical system used to perform a surgical procedure in an operating room according to at least one aspect of the present disclosure. A surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. FIG. 3 is a partial perspective view of a surgical hub housing and a combination generator module slidably acceptable within the drawer of the surgical hub housing according to at least one aspect of the present disclosure. FIG. 3 is a perspective view of a combination generator module with bipolar, ultrasonic, and unipolar contacts, and smoke exhaust components, according to at least one aspect of the present disclosure. Demonstrates the individual power bus attachments of a plurality of lateral docking ports of a laterally modular housing configured to accept a plurality of modules according to at least one aspect of the present disclosure. Demonstrates a vertically modular housing configured to accept multiple modules according to at least one aspect of the present disclosure. A modular device located in one or more operating rooms of a medical facility, or any room in a medical facility equipped with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure. Shown is a surgical data network with a modular communication hub configured to connect. A computer-mounted interactive surgical system according to at least one aspect of the present disclosure is shown. Demonstrates a surgical hub with a plurality of modules connected to a modular control tower according to at least one aspect of the present disclosure. An aspect of a universal serial bus (USB) network hub device according to at least one aspect of the present disclosure is shown. A logical diagram of a control system for a surgical instrument or tool according to at least one aspect of the present disclosure is shown. Demonstrates a control circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates a combination logic circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates an order logic circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. It is a circuit diagram of a robotic surgical instrument configured to operate the surgical tools described herein according to at least one aspect of the present disclosure. FIG. 3 shows a block diagram of a surgical instrument programmed to control the distal translation of a displacement member according to at least one aspect of the present disclosure. It is a circuit diagram of a surgical instrument configured to control various functions according to at least one aspect of the present disclosure. It is a graph of the stroke length which shows an example of the control system which corrects the stroke length of a gripping assembly based on a joint movement angle. It is a closed tube assembly positioning graph which shows an example of the control system which corrects the longitudinal position of a closed tube assembly based on a joint movement angle. It is a figure of comparison between the stapling method using controlled tissue compression, and the stapling method not using controlled tissue compression. The force graph shown in section A and the associated displacement graph shown in section B, the force graph and the displacement graph have a time-defining x-axis, and the y-axis of the displacement graph is the displacement of the launch rod. The y-axis of the force graph defines the sensed torsional force for a motor configured to advance the launch rod. It is the schematic of the tissue contact circuit which shows the completion of the circuit at the time of contact with a pair of separated contact plates. FIG. 3 is a perspective view of a surgical instrument having an interchangeable shaft assembly operably connected thereto, according to at least one aspect of the present disclosure. FIG. 5 is a view of an assembly shown in an exploded view of a portion of the surgical instrument of FIG. 25 according to at least one aspect of the present disclosure. FIG. 5 is a view of an assembly shown in an exploded view of a portion of an interchangeable shaft assembly according to at least one aspect of the present disclosure. It is an exploded view of the end effector of the surgical instrument of FIG. 25 according to at least one aspect of the present disclosure. FIG. 25 is a block diagram of a control circuit of a surgical instrument of FIG. 25, spanning two drawings, according to at least one aspect of the present disclosure. FIG. 25 is a block diagram of a control circuit of a surgical instrument of FIG. 25, spanning two drawings, according to at least one aspect of the present disclosure. A block diagram of a control circuit for a surgical instrument of FIG. 25 showing an interface between a handle assembly and a power supply assembly and between a handle assembly and a replaceable shaft assembly according to at least one aspect of the present disclosure. Is. It is a figure which depicts an example medical apparatus which may include one or more aspects of this disclosure. It is a figure which depicts the end effector of an example of the medical device which surrounds a tissue by one or more aspects of this disclosure. FIG. 5 depicts an end effector of an example of a medical device that compresses tissue according to one or more aspects of the present disclosure. FIG. 5 illustrates the force exerted by an end effector of a medical device compressing tissue according to one or more aspects of the present disclosure. This is also a diagram depicting an example force exerted by an end effector of a medical device that compresses tissue, according to one or more aspects of the present disclosure. It is a figure which draws an example tissue compression sensor system by one or more aspects of this disclosure. This is also a diagram depicting an example tissue compression sensor system according to one or more aspects of the present disclosure. This is also a diagram depicting an example tissue compression sensor system according to one or more aspects of the present disclosure. This is also a diagram depicting an example circuit diagram according to one or more aspects of the present disclosure. This is also a diagram depicting an example circuit diagram according to one or more aspects of the present disclosure. FIG. 5 is a graph depicting an example of frequency modulation according to one or more aspects of the present disclosure. It is a graph which draws the synthesized RF signal by one or more aspects of this disclosure. FIG. 5 is a graph depicting a filtered RF signal according to one or more aspects of the present disclosure. It is a perspective view of the surgical instrument provided with the interchangeable shaft which can move a joint. It is a side view of the tip part of a surgical instrument. Time-dependent changes in void size (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force. It is a graph which plots the change with time (FIG. 50). Time-dependent changes in void size (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force. It is a graph which plots the change with time (FIG. 50). Time-dependent changes in void size (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force. It is a graph which plots the change with time (FIG. 50). Time-dependent changes in void size (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force. It is a graph which plots the change with time (FIG. 50). Time-dependent changes in void size (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force. It is a graph which plots the change with time (FIG. 50). It is a graph which plots the tissue displacement with the tissue compression for a normal tissue as a function. It is a graph which plots tissue displacement as a function of tissue compression to distinguish between normal tissue and lesioned tissue. It is a figure which shows one Embodiment of the end effector which includes a 1st sensor and a 2nd sensor. FIG. 5 is a logical diagram illustrating an embodiment of a process for adjusting a measured value of a first sensor based on an input from a second sensor of the end effector shown in FIG. 53. FIG. 5 is a logical diagram illustrating an embodiment of a process for determining a look-up table for a first sensor based on inputs from a second sensor. FIG. 5 is a logical diagram illustrating an embodiment of a process for calibrating a first sensor in response to an input from a second sensor. FIG. 5 is a logical diagram illustrating an embodiment of a process for determining and displaying the thickness of a portion of tissue held between an anvil of an end effector and a staple cartridge. FIG. 5 is a logical diagram illustrating an embodiment of a process for determining and displaying the thickness of a portion of tissue held between an anvil of an end effector and a staple cartridge. It is a graph which shows the comparison between the adjusted Hall effect thickness measurement value and the uncorrected Hall effect thickness measurement value. It is a figure which shows one Embodiment of the end effector which includes a 1st sensor and a 2nd sensor. It is a figure which shows one Embodiment of the end effector which includes a 1st sensor and a plurality of 2nd sensors. It is a logical diagram which shows one Embodiment of the process for adjusting the measured value of a 1st sensor in response to a plurality of secondary sensors. It is a figure which shows one Embodiment of the circuit configured to convert the signal from a 1st sensor and a plurality of secondary sensors into a digital signal which can be received by a processor. It is a figure which shows one Embodiment of the end effector which includes a plurality of sensors. FIG. 5 is a logical diagram illustrating an embodiment of a process for determining one or more tissue characteristics based on a plurality of sensors. It is a figure which shows one Embodiment of the end effector which includes a plurality of sensors coupled to a 2nd jaw member. It is a figure which shows one Embodiment of the staple cartridge which includes a plurality of sensors integrally formed therein. FIG. 5 is a logical diagram illustrating an embodiment of a process for determining one or more parameters of a portion of tissue held within an end effector. It is a figure which shows one Embodiment of another end effector which includes a plurality of redundant sensors. It is a logical diagram which shows one Embodiment of the process for selecting the most reliable output from a plurality of redundant sensors. It is a figure which shows one Embodiment of the end effector which includes a sensor which includes a specific sampling rate which limits or excludes a pseudo signal. FIG. 5 is a logical diagram illustrating an embodiment of a process for generating a thickness measurement of a portion of tissue located between an anvil of an end effector and a staple cartridge. It is a figure which shows one Embodiment of the end effector which comprises a sensor for identifying a different type of staple cartridge. It is a figure which shows one Embodiment of the end effector which comprises a sensor for identifying a different type of staple cartridge. It is a figure which shows one aspect of the segmentation flexible circuit configured to be fixedly attached to the jaw member of an end effector according to at least one aspect of this disclosure. It is a figure which shows one aspect of the segmentation flexible circuit configured to be attached to the jaw member of an end effector by at least one aspect of this disclosure. It is a figure which shows one aspect of the end effector configured to measure the tissue gap GT by at least one aspect of this disclosure. It is a figure which shows one aspect of the end effector which comprises a segmentation flexible circuit by at least one aspect of this disclosure. FIG. 5 shows an end effector shown in FIG. 78, comprising a jaw member holding tissue between the jaw member and the staple cartridge according to at least one aspect of the present disclosure. FIG. 5 is a diagram of an absolute positioning system for a surgical instrument comprising a controlled motor drive circuit configuration with a sensor mechanism according to at least one aspect of the present disclosure. FIG. 5 is a diagram of a position sensor comprising a magnetic rotation absolute positioning system according to at least one aspect of the present disclosure. FIG. 6 is a cross-sectional view of an end effector of a surgical instrument showing a launching member stroke against tissue gripped within the end effector according to at least one aspect of the present disclosure. The first graph of two closure force (FTC) plots depicting the forces applied to the closure member to close on the thick and thin tissue during the closure phase and through the thick and thin tissue during the launch phase. 2 is a second graph of two firing force (FTF) plots illustrating the force applied to the firing member to fire. A closing force load on the closing member is desired by causing the firing member to advance distally and perform a gradual closure of the closing member during the firing stroke connecting into the gripping arm according to at least one aspect of the present disclosure. It is a graph of a control system configured to reduce the firing force load on the launching member by reducing the ratio of. It is a figure which illustrates the proportional integral calculus (PID) controller feedback control system by at least one aspect of this disclosure. It is a logical flow diagram which depicts the process of the control program or the logical composition for determining the speed of a closing member by at least one aspect of this disclosure. It is a timeline showing the situational awareness of the surgical hub according to at least one aspect of the present disclosure. FIG. 6 is a block diagram of a surgical system configured to control surgical function according to at least one aspect of the present disclosure. FIG. 6 is a block diagram of a situational awareness surgical system configured to control surgical function according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram depicting situational awareness based on an algorithm for controlling surgical function according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram depicting an algorithm for controlling surgical function according to at least one aspect of the present disclosure. FIG. 5 shows a portion of patient tissue, including a tumor, as well as a surgical margin defined for the tumor, according to at least one aspect of the present disclosure. It is a logical flow diagram which depicts the process back of the control program or the logical composition for dealing with the device selection problem by at least one aspect of this disclosure. FIG. 6 is a block diagram of a surgical system configured to determine the validity of a surgical instrument based on device parameters and sensed parameters according to at least one aspect of the present disclosure. FIG. 6 is a block diagram of a surgical instrument according to at least one aspect of the present disclosure. It is a logical flow diagram of the process for controlling a surgical instrument according to the integrity of the grasped tissue according to at least one aspect of the present disclosure. FIG. 1 is a first graph depicting the force and time of a closing end effector for exemplary launch of a surgical instrument, according to at least one aspect of the present disclosure. 2 is a second graph depicting the force and time of an end effector for exemplary launch of a surgical instrument, according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram of a process for controlling a surgical instrument according to the physiological type of grabbed tissue, according to at least one aspect of the present disclosure. FIG. 5 is a side elevation view of the end effector gripping the soft tissue, in which the end effector is in initial contact with the soft tissue, according to at least one aspect of the present disclosure. FIG. 6 is a side elevation view of an end effector gripping soft tissue, with the end effector closed, according to at least one aspect of the present disclosure. FIG. 5 is a side elevation view of an end effector gripping a blood vessel in which the end effector is in initial contact position with the blood vessel, according to at least one aspect of the present disclosure. FIG. 5 is a side view of an end effector gripping a blood vessel in which the end effector is closed, according to at least one aspect of the present disclosure. In the first and second graphs depicting the force and closing speed of the end effector to close, respectively, with respect to the exemplary launch of a surgical instrument gripping soft tissue, according to at least one aspect of the present disclosure. is there. In the third and fourth graphs depicting the force and closing speed of the end effector to close, and the time, respectively, for the exemplary launch of a surgical instrument that grips a blood vessel, according to at least one aspect of the present disclosure. is there. FIG. 5 shows a fifth graph depicting the force and closing speed and time of an end effector to close with respect to an exemplary launch of a surgical instrument according to at least one aspect of the present disclosure. FIG. 5 is a fifth graph showing the force and closing speed of the end effector to close and the time, respectively, with respect to the exemplary launch of the surgical instrument according to at least one aspect of the present disclosure. FIG. 5 is a fifth graph showing the force and closing speed of the end effector to close and the time, respectively, with respect to the exemplary launch of the surgical instrument according to at least one aspect of the present disclosure. FIG. 5 is a graph depicting impedance and time to determine when the jaw of a surgical instrument comes into contact with tissue and / or staples, according to at least one aspect of the present disclosure. FIG. 1 is a first graph depicting various tissue closure thresholds for controlling end effector closure according to at least one aspect of the present disclosure. 2 is a second graph depicting various tissue closure thresholds for controlling end effector closure according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram depicting a control program or logical configuration process for adjusting a closure speed algorithm according to at least one aspect of the present disclosure.

The applicant of the present application owns the following US patent application filed June 29, 2018, the entire disclosure of which is incorporated herein by reference.
CAPACTIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, US Patent Application No. ___________, Agent Reference Number END8542USNP / 170755,
CONTROLLING A SURGICAL INSTRUMENT ACCRDING TO SENSED CLOSED CLOSED CLOSED CLOSED CLOUSETERS, U.S. Patent Application No.
SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATION INFORMATION, US Patent Application No. ___________, Agent Reference Number END8543USNP1 / 170760-1,
SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING, US Patent Application No. ___________, Agent Reference Number END8543USNP2 / 170760-2,
SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING, US Patent Application No. ___________, Agent Reference No. END8543USNP3 / 170760-3,
SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES, US Patent Application No. ___________, Agent Reference Number END8543USNP4 / 170760-4,
US Patent Application No. ___________, Agent Reference No. END8543USNP5 / 170760-5, entitled SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE,
-US Patent Application No. ___________, Agent Reference Number, END8543USNP6 / 170760-6, entitled SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLES,
US Patent Application No. ______________, Agent Reference Number, END8543USNP7 / 170760-7-7, entitled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY,
U.S. Patent Application No. ___________, Agent Reference Number, END8544USNP / 170761, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE,
-US Patent Application No. ___________, Agent Reference Number END8544USNP1 / 170761-1, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUT,
-US Patent Application No. ___________, Agent Reference Number END8544USNP2 / 170761-2, entitled SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY,
SURGICAL SYSTEMS WITH PRIORIZED DATA TRANSMISSION CAPABILITIES, US Patent Application No. ___________, Agent Reference Number END8544USNP3 / 170761-3,
U.S. Patent Application No. ___________, Agent Reference No. END8545USNP / 170762, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL,
U.S. Patent Application No. ______________, Agent Reference Number, END8545USNP1 / 170762-1, entitled SURGICAL EVACUATION SENSOR ARRANGEMENTS,
U.S. Patent Application No. ___________, Agent Reference Number, END8545USNP2 / 170762-2, entitled SURGICAL EVACUATION FLOW PATHS,
U.S. Patent Application No. ___________, Agent Reference No. END8545USNP3 / 170762-3, entitled SURGICAL EVACUATION SENSING AND GENERATION CONTORL,
U.S. Patent Application No. ______________, Agent Reference Number END8545USNP4 / 170762-4, entitled SURGICAL EVACUATION SENSING AND DISPLAY,
COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODEL FOR FOR INTERACTIVE SURGICAL PLATFORM
U.S. Patent Application No. ___________, US Patent Application No. ________, Agent Reference No. END7856
· SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE entitled ", U.S. Patent Application No. __________ No., Attorney Docket No. END8547USNP / 170764, and entitled · DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS , U.S. Patent Application No. ___________, Agent Reference Number END8548USNP / 170765.

The applicant of the present application owns the following US provisional patent application filed June 28, 2018, the entire disclosure of which is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES",
-US Provisional Patent Application No. 62 / 691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE",
-US Provisional Patent Application No. 62 / 691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL",
・ US title "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODEL FOR FOR INTERACTIVE SURGICAL PLATFORM"
・ "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEEN A FILTER AND A SMOKE EVACUATION DEVILE Provisional Patent Application No. 62 / 691,251.

The applicant of the present application owns the following US patent application filed March 29, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application No. 15 / 940, 641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENGRYPTED COMMUNICATION CAPABILITIES",
U.S. Patent Application No. 15 / 940,648 entitled "INTERACTIVE SURGICAL SYSTEM SYSTEM WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES",
U.S. Patent Application No. 15 / 940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATION ROOM DEVICES",
U.S. Patent Application No. 15 / 940,666 entitled "SPATIAL AWARENSS OF SURGICAL HUBS IN OPERATING ROOMS",
U.S. Patent Application No. 15 / 940,670, entitled "COOPERATION UTILIZETION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS",
U.S. Patent Application No. 15 / 940,677, entitled "SURGICAL HUB CONTOROL ARRANGEMENTS",
-US Patent Application No. 15 / 940, 632, entitled "DATA STRIPPING METHOD TO INTERROGATE PAIENT RECORDS AND CREATE ANONYMIZED RECORD",
・ "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS US Pat.
US Patent Application No. 15 / 940,645, entitled "SELF DESCRIBING DATA PACKETS GENELATED AT AN ISSUING INSTRUMENT",
U.S. Patent Application No. 15 / 940,649 entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME",
U.S. Patent Application No. 15 / 940,654, entitled "SURGICAL HUB Situational Awareness",
U.S. Patent Application No. 15 / 940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING",
U.S. Patent Application No. 15 / 940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA",
U.S. Patent Application No. 15 / 940, 671, entitled "SURGICAL HUB SPARC AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER",
U.S. Patent Application No. 15 / 940,686 entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE",
U.S. Patent Application No. 15 / 940,700 entitled "STERILE FIELD INTERACTIVE CONTROLL DISPLAYS",
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U.S. Patent Application No. 15 / 940,704 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT",
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The applicant of the present application owns the following US patent application filed March 29, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application No. 15 / 940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES",
U.S. Patent Application No. 15 / 940, 653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS",
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The applicant of the present application owns the following US patent application filed March 29, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application No. 15 / 940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application No. 15 / 940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
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The applicant of the present application owns the following US provisional patent application filed March 28, 2018, the entire disclosure of which is incorporated herein by reference.
US Provisional Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENGRYPTED COMMUNICATION CAPABILITIES",
-US Provisional Patent Application No. 62 / 649,294 entitled "DATA STRIPPING METHOD TO INTERROGATE PAIENT RECORDS AND CREATE ANONYMIZED RECORD",
-US Provisional Patent Application No. 62 / 649,300, entitled "SURGICAL HUB Situational Awareness",
-US Provisional Patent Application No. 62 / 649,309, entitled "SURGICAL HUB SPARC AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER",
-US Provisional 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",
-US Provisional Patent Application No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZETION AND RECOMMENDATIONS TO A USER",
-US Provisional Patent Application No. 62 / 649,327 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES",
-US Provisional Patent Application No. 62 / 649,315 entitled "DATA HANDLING AND PRIORIZATION IN A CLOUD ANALYTICS NETWORK",
-US Provisional Patent Application No. 62 / 649,313, entitled "CLOUD Interface FOR COUPLED SURGICAL DEVICES",
-US Provisional Patent Application No. 62 / 649,320 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
-US provisional patent application No. 62 / 649,307 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and- "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED US issue.

The applicant of the present application owns the following US provisional patent application filed on April 19, 2018, of which the entire disclosure is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 659,900 entitled "METHOD OF HUB COMMUNICATION".

The applicant of the present application owns the following US provisional patent application filed on March 30, 2018, the entire disclosure of which is incorporated herein by reference.
US Provisional Patent Application No. 62 / 650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES",
-US Provisional Patent Application No. 62 / 650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTORLS",
-US Provisional Patent Application Nos. 62 / 650,882 entitled "SMOKE EVACUATION MODEL INTERACTIVE SURGICAL PLATFORM", and- "CAPACITION COUPLED RETURN PATH PAD WITH PAD WITH PAD WITH USA" US Pat.

The applicant of the present application owns the following US provisional patent application filed March 8, 2018, of which the entire disclosure is incorporated herein by reference.
-US provisional patent application No. 62 / 640,417 entitled "TEMPERATURE CONTROLL IN ULTRASONIC DEVICE AND CONTROLL SYSTEM THEREFOR", and- "ESTIMATING STATE OF ULTRASONIC END EFFECT" , 415.

The applicant of the present application owns the following US provisional patent application filed December 28, 2017, for which the entire disclosure is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM",
-US Provisional Patent Application No. 62 / 611,340 entitled "CLOUD-BASED MEDICAL ANALYTICS" and-US Provisional Patent Application No. 62 / 611,339 entitled "ROBOT ASSISTED SURGICAL PLATFORM".

Prior to elaborating on the various aspects of surgical devices and generators, the illustrated examples are not limited in application or application to the details of the structure and arrangement of the parts shown in the accompanying drawings and description. It should be noted. The exemplary examples may be implemented or incorporated in other embodiments, variants, and modifications, and may be implemented or implemented in a variety of ways. Furthermore, unless otherwise stated, the terms and expressions used herein have been selected for the convenience of the reader to illustrate exemplary examples and are not intended to limit them. .. In addition, one or more of the embodiments, embodiments, and / or examples described below, and any of the other embodiments, embodiments, and / or examples described below. It should be understood that it can be combined with one or more.

Prior to elaborating on the various aspects of surgical devices and generators, the illustrated examples are not limited in application or application to the details of the structure and arrangement of the parts shown in the accompanying drawings and description. It should be noted. The exemplary examples may be implemented or incorporated in other embodiments, variants, and modifications, and may be implemented or implemented in a variety of ways. Furthermore, unless otherwise stated, the terms and expressions used herein have been selected for the convenience of the reader to illustrate exemplary examples and are not intended to limit them. .. In addition, one or more of the embodiments, embodiments, and / or examples described below, and any of the other embodiments, embodiments, and / or examples described below. It should be understood that it can be combined with one or more.

Specific exemplary embodiments are described below to provide an overall understanding of the principles of structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. For those skilled in the art, the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the various embodiments is defined only by the claims. You will understand that. Features exemplified or described in connection with one exemplary embodiment can be combined with features of another embodiment. Such modifications and modifications shall be included within the scope of the "claims".

Referring to FIG. 1, a computer-mounted interactive surgical system 100 may include one or more surgical systems 102 and a cloud-based system (eg, a remote server 113 coupled to a storage device 105) cloud 104. ) And, including. Each surgical system 102 includes at least one surgical hub 106 that communicates with a cloud 104 that may include a remote server 113. In one embodiment, as shown in FIG. 1, the surgical system 102 comprises a visualization system 108, a robot system 110, and a handheld intelligent surgical instrument configured to communicate with each other and / or with a hub 106. 112 and. In some embodiments, the surgical system 102 may include M hubs 106, N visualization systems 108, O robot systems 110, and P handheld intelligent surgical instruments 112. Well, here M, N, O, and P are integers greater than or equal to 1.

FIG. 3 shows an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in an operating room 116. The robot system 110 is used as part of the surgical system 102 in a surgical procedure. The robot system 110 includes a surgeon's console 118, a patient-side cart 120 (surgical robot), and a surgical robot hub 122. The patient-side cart 120 can operate at least one detachably coupled surgical tool 117 during 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 the medical imaging device 124, which can be manipulated by the patient-side cart 120 to orient the imaging device 124. The robot hub 122 can be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

Other types of robotic systems can be easily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with this disclosure are entitled "ROBOT ASSISTED SURGICAL PLATFORM" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in US Provisional Patent Application No. 62 / 611,339.

Various examples of cloud-based analysis performed by Cloud 104 and suitable for use with this disclosure are described in "CLOUD-BASED MEDICAL" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in US Provisional Patent Application No. 62 / 611,340 entitled "ANALYTICS".

In various aspects, the imaging device 124 comprises at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. One or more illumination sources may be oriented to illuminate part of the surgical field. One or more image sensors may receive reflected or refracted light from the surgical field, including light reflected or refracted from tissues and / or surgical instruments.

One or more illumination sources may be configured to radiate electromagnetic energy within the visible and invisible spectra. The visible spectrum, sometimes referred to as the optical spectrum or emission spectrum, is a portion of the electromagnetic spectrum visible to the human eye (ie, detectable by the human eye) and is sometimes referred to as visible light, or simply light. The typical human eye responds to wavelengths in the air from about 380 nm to about 750 nm.

The invisible spectrum (ie, the non-emissive spectrum) is a portion of the electromagnetic spectrum located below and above the visible spectrum (ie, wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths above about 750 nm are longer than the red visible spectrum, which results in invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, which results in invisible UV, X-ray, and gamma-ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include arthroscopy, angioscope, bronchoscope, biliary tract, colonoscope, cytoscope, duodenalscope, endoscopy, esophagogastroduodenalscope (gastroscope) , Endoscope, laryngoscope, nasopharyngo-neproscope, sigmoid colonoscope, thoracoscope, and cystoscope, but not limited to these.

In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlayer structure. A multispectral image captures image data within a specific wavelength range over an electromagnetic spectrum. Wavelengths can be separated by filters or by using devices that are sensitive to light from frequencies beyond the visible light range, such as IR and ultraviolet light. Spectral imaging can allow the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is the "Advanced Imaging" of US Provisional Patent Application No. 62 / 611,341 entitled "INTERACTIVE SURGICAL PLATFORM" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is explained in detail in the section "Acquisition Module". Multispectral monitoring can be a useful tool for rearranging surgical fields to perform one or more of the above tests on treated tissue after one surgical operation has been completed.

It is self-evident that any surgical procedure requires strict sterilization of the operating room and surgical instruments. The "surgical theater", that is, the strict hygiene and sterilization conditions required for operating rooms or treatment rooms, require the highest degree of sterilization of all medical devices and equipment. Part of the sterilization process is the need to sterilize anything that comes into contact with the patient or invades the sterilization field, including the imaging device 124 and its accessories and components. The sterile field can be considered as a specific area considered to be free of microorganisms, such as in a tray or on a sterile towel, or the sterile field is considered to be the area immediately surrounding the patient prepared for the surgical procedure. It will be understood that it can be done. The sterile field may include washed team members wearing appropriate clothing, as well as all fixtures and fixtures within the area.

In various aspects, the visualization system 108 comprises one or more imaging sensors strategically placed relative to the sterile field and one or more image processing units, as shown in FIG. And one or more storage arrays and one or more displays. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. For the various components of the visualization system 108, US Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM", filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in the section "Advanced Imaging Application Module".

As shown in FIG. 2, the primary display 119 is arranged in the sterile field so that it is visible to the operator located on the operating table 114. In addition, the visualization tower 111 is located outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. The visualization system 108 guided by the hub 106 is configured to use displays 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the hub 106 causes the visualization system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109 while maintaining a live image of the surgical site on the primary display 119. Can be done. Snapshots on the non-sterile display 107 or 109 can allow, for example, a non-sterile operator to perform surgical steps related to the surgical procedure.

In one aspect, the hub 106 sends diagnostic input or feedback input by a non-sterile operator located at the visualization tower 111 to the primary display 119 within the sterilization area in the sterilization field, which is a sterilization operation located on the operating table. It is also configured so that one can see it. In one embodiment, the input may be in the form of a modification to the snapshot displayed on the non-sterile display 107 or 109, which can be sent by the hub 106 to the primary display 119.

With reference to FIG. 2, the surgical instrument 112 is used as part of the surgical system 102 in the surgical procedure. The hub 106 is also configured to coordinate the flow of information to the display of the surgical instrument 112. For example, in US Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. Diagnostic input or feedback input by the non-sterile operator at the location of the visualization tower 111 may be sent by the hub 106 to the surgical instrument display 115 in the sterile field, where the diagnostic input or feedback is on the surgical instrument 112. It may be seen by the operator. For exemplary surgical instruments suitable for use with the surgical system 102, for example, the item "Surgical Instrument Hardware", the entire disclosure of which is incorporated herein by reference, and the 2017 entitled "INTERACTIVE SURGICAL PLATFORM". It is described in US Provisional Patent Application No. 62 / 611,341 filed December 28, 2014.

With reference to FIG. 3, the hub 106 is shown communicating with the visualization system 108, the robot system 110, and the handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In a particular embodiment, as shown in FIG. 3, the hub 106 further includes a smoke exhaust module 126 and / or a suction / irrigation module 128.

During the surgical procedure, applying energy to the tissue for sealing and / or cutting generally involves flue gas, aspiration of excess fluid, and / or irrigation of the tissue. Fluids, power, and / or data lines from different sources are often entangled during the surgical procedure. Addressing this issue during a surgical procedure can result in the loss of valuable time. Untangling the lines may require pulling the lines out of their corresponding modules, which may require resetting the modules. The modular housing 136 of the hub provides a unified environment for managing power, data, and fluid lines, reducing the frequency of such line entanglements.

Aspects of the present disclosure present a surgical hub for use in surgical procedures involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module that is slidably acceptable within the docking station of the hub housing. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a unipolar RF energy generator component housed in a single unit. In one aspect, the combination generator module further comprises a smoke exhaust component, at least one energy supply cable for connecting the combination generator module to the surgical instrument, and smoke generated by the application of therapeutic energy to the tissue. Includes at least one flue gas component configured to expel fluid, and / or particulates, and a fluid line extending from the remote surgery site to the flue gas component.

In one aspect, the fluid line is the first fluid line and the second fluid line extends from the remote surgery site to the suction and irrigation module slidably received within the hub housing. In one aspect, the hub housing comprises a fluid interface.

Certain surgical procedures may require the application of more than one energy type to the tissue. One energy type can be more beneficial for cutting tissue, while another different energy type can be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal the tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which a modular enclosure 136 of a hub is configured to accommodate various generators and facilitate two-way communication between them. One of the advantages of the modular housing 136 of the hub is that it allows for rapid removal and / or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure comprises a first energy generator module configured to generate a first energy to be applied to the tissue and a first docking port containing first data and power contacts. The first energy generator module includes a first docking station and is slidably movable to electrically engage with power and data contacts, and the first energy generator module is a first. It is slidably movable so as to disengage from the electrical engagement with the power and data contacts of 1.

In addition to the above, the modular surgical enclosure has a second energy generator module configured to generate a second energy to be applied to the tissue, which is different from the first energy, and a second. A second docking station with a second docking port containing the data and power contacts of the second energy generator module is slidably moved to electrically engage the power and data contacts. It is possible and the second energy generator module is slidably movable so as to disengage from the electrical engagement with the second power and data contacts.

In addition, the modular surgical enclosure is configured to facilitate communication between the first energy generator module and the second energy generator module, with a first docking port and a second docking. It also includes a communication bus to and from the port.

Referring to FIGS. 3-7, aspects of the present disclosure relating to a modular housing 136 of a hub that allows modular integration of a generator module 140, a smoke exhaust module 126, and a suction / irrigation module 128 are presented. Will be done. The modular housing 136 of the hub further facilitates bidirectional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 is integrated into a single housing unit 139 that is slidably insertable into the modular housing 136 of the hub. It may be a generator module with sound wave components. As shown in FIG. 5, the generator module 140 may be configured to connect to a unipolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of unipolar, bipolar, and / or ultrasonic generator modules that interact via the modular housing 136 of the hub. The modular housing 136 of the hub allows multiple generators to be inserted and bidirectional between the generators docked in the modular housing 136 of the hub so that the multiple generators function as a single generator. It may be configured to facilitate communication.

In one aspect, the modular enclosure 136 of the hub comprises modular power and with external and wireless communication headers to allow removable mounting of modules 140, 126, 128 and bidirectional communication between them. A communication backplane 149 is provided.

In one aspect, the modular housing 136 of the hub includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and the combination generator module 145 slidably acceptable to the docking station 151 of the surgical hub housing 136. The docking port 152, which has power and data contacts on the rear side of the combination generator module 145, is such that when the combination generator module 145 is slid into a position within the corresponding docking station 151 of the modular housing 136 of the hub. The corresponding docking port 150 is configured to engage the power and data contacts of the corresponding docking station 151 of the modular enclosure 136 of the hub. In one aspect, the combination generator module 145 includes a bipolar, ultrasonic, and unipolar module and a smoke exhaust module integrated with a single housing unit 139, as shown in FIG.

In various aspects, the smoke exhaust module 126 includes a fluid line 154 that transports captured / recovered smoke and / or fluid away from the surgical site, eg, to the smoke exhaust module 126. The vacuum suction generated from the smoke exhaust module 126 can draw smoke into the opening of the utility conduit at the surgical site. The utility conduit connected to the fluid line may be in the form of a flexible tube terminated by a smoke exhaust module 126. Utility conduits and fluid lines define a fluid path extending towards the smoke exhaust module 126 received within the hub housing 136.

In various aspects, the suction / irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one embodiment, the suction and suction fluid line is in the form of a flexible tube extending from the surgical site towards the suction / irrigation module 128. One or more drive systems may be configured to cause fluid irrigation and inhalation into and from the surgical site.

In one aspect, the surgical tool comprises a shaft having an end effector at its distal end, at least one energy treatment section associated with the end effector, a suction tube, and an irrigation tube. The suction tube can have an inlet port at its distal end, and the suction tube extends through the shaft. Similarly, the irrigation tube can extend through the shaft and can have an inlet port in close proximity to the energy delivery device. The energy delivery device is configured to deliver ultrasonic and / or RF energy to the surgical site and is first connected to the generator module 140 by a cable that extends through the shaft.

The irrigation pipe can communicate with the fluid source, and the suction pipe can communicate with the vacuum source. The fluid source and / or vacuum source may be housed in the suction / irrigation module 128. In one embodiment, the fluid source and / or vacuum source may be housed in the hub housing 136 separately from the suction / irrigation module 128. In such an embodiment, the fluid interface may be configured to connect the suction / irrigation module 128 to a fluid source and / or a vacuum source.

In one aspect, their corresponding docking stations on modules 140, 126, 128 and / or the modular housing 136 of the hub align the docking ports of the modules to the docking stations of the modular housing 136 of the hub. It may include an alignment mechanism configured to engage these corresponding components within. For example, as shown in FIG. 4, the combination generator module 145 is configured to slidably engage the corresponding bracket 156 of the corresponding docking station 151 of the modular housing 136 of the hub. Includes 155. The brackets work together to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the modular enclosure 136 of the hub.

In some embodiments, the drawer 151 of the modular housing 136 of the hub is the same or substantially the same size, and the module is adjusted to a size that is acceptable within the drawer 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In another aspect, the drawer 151 is of different size and is designed to accommodate a particular module.

In addition, the contacts of a particular module may be locked to engage the contacts of a particular drawer to avoid inserting the module into a drawer with incompatible contacts.

As shown in FIG. 4, the docking port 150 of one drawer 151 is connected to the docking port 150 of another drawer 151 via a communication link 157, and the module is housed in the modular housing 136 of the hub. Two-way communication between them can be facilitated. Alternatively, or further, the docking port 150 of the modular housing 136 of the hub may facilitate wireless bidirectional communication between the modules housed in the modular housing 136 of the hub. For example, any suitable wireless communication such as Air Titan-Bluetooth may be used.

FIG. 6 shows the individual power bus attachments of the plurality of lateral docking ports of the laterally modular housing 160 configured to receive the plurality of modules of the surgical hub 206. The laterally modular housing 160 is configured to laterally receive and interconnect the modules 161. The module 161 is slidably inserted into the docking station 162 of the lateral modular housing 160, which includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the module 161 is arranged laterally within the laterally modular housing 160. Alternatively, the module 161 may be arranged vertically within the laterally modular housing.

FIG. 7 shows a vertical modular housing 164 configured to receive multiple modules 165 of the surgical hub 106. The module 165 is slidably inserted into the docking station or drawer 167 of the vertical modular housing 164 including the backplane for interconnecting the modules 165. Although the drawer 167 of the vertical modular housing 164 is arranged vertically, in certain cases the vertical modular housing 164 may include a drawer arranged laterally. Further, the modules 165 can interact with each other via the docking port of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 for displaying data related to the operation of module 165 is provided. In addition, the vertical modular housing 164 includes a master module 178 that houses a plurality of submodules that are slidably received within the master module 178.

In various aspects, the imaging module 138 comprises a built-in video processor and modular light source and is adapted for use with a variety of imaging devices. In one aspect, the imaging device comprises a modular housing that can be assembled with a light source module and a camera module. The housing may be a disposable housing. In at least one embodiment, the disposable housing is detachably coupled with a reusable controller, light source module, and camera module. The light source module and / or the camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes 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 deliver white light or different light depending on the surgical procedure.

During the surgical procedure, it may be inefficient to remove the surgical device from the surgical field and replace it with another surgical device containing a different camera or different light source. Temporary loss of field of view in the surgical field can have undesired consequences. The modular imaging device of the present disclosure is configured to allow replacement of a light source module or camera module intermediate (midstream) during a surgical procedure without the need to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing that includes a plurality of channels. The first channel is configured to slidably accept a camera module that may be configured to snap fit and engage with the first channel. The second channel is configured to slidably accept a light source module that may be configured to snap fit and engage with the second channel. In another embodiment, the camera module and / or light source module can be rotated to its final position within these corresponding channels. Screw engagement may be employed instead of snap fit engagement.

In various embodiments, multiple imaging devices are positioned at different locations within the surgical field to provide multiple fields of view. The imaging module 138 can be configured to switch between imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from different imaging devices.

Various image processors and imaging devices suitable for use with the present disclosure are US Pat. Nos. 6, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which are incorporated herein by reference in their entirety. It is described in No. 7,995,045. In addition, US Pat. No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, removes motion artifacts from image data. Describes various systems for doing so. Such a system can be integrated with the imaging module 138. In addition, the US Patent Application Publication No. 2011/0306840 published on December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE TO FIXTURE INTRACORPORTAL APPARATUS", and "SYSTEM FOR PERFORMING A MEMRAL 2014" Published US Patent Application Publication No. 2014/0243597, each disclosure of which is incorporated herein by reference in its entirety.

FIG. 8 shows a cloud-based system (eg, storage) of modular equipment located in one or more operating rooms of a medical facility, or in any room within a medical facility equipped with specialized equipment for surgical procedures. FIG. 6 shows a surgical data network 201 with a modular communication hub 203 configured to connect to a cloud 204) that may include a remote server 213 connected to device 205. In one aspect, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 that communicates with a network router. The modular communication hub 203 can also be coupled to the local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switchable. Passive surgical data networks act as conduits for data, allowing data to travel from one device (or segment) to another (or segment) and to cloud computing resources. The intelligent surgical data network allows traffic to pass through the monitored surgical data network and includes additional mechanisms that make up each port within the network hub 207 or network switch 209. Intelligent surgical data networks can be referred to as manageable hubs or switches. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

The modular devices 1a to 1n arranged in the operating room may be connected to the modular communication hub 203. The network hub 207 and / or the network switch 209 can be connected to the network router 211 to connect the devices 1a to 1n to the cloud 204 or the local computer system 210. The data associated with the devices 1a-1n may be transferred to a cloud-based computer via a router for remote data processing and operation. The data associated with the devices 1a-1n may also be transferred to the local computer system 210 for local data processing and operation. Modular devices 2a-2m located in the same operating room may also be connected to the network switch 209. The network switch 209 can be connected to the network hub 207 and / or the network router 211 to connect the devices 2a to 2m to the cloud 204. The data associated with the devices 2a-2n may be transferred to the cloud 204 via the network router 211 for data processing and operation. The data associated with the devices 2a-2m may also be transferred to the local computer system 210 for local data processing and operation.

It will be appreciated that the surgical data network 201 can be extended by interconnecting the plurality of network hubs 207 and / or the plurality of network switches 209 with the plurality of network routers 211. The modular communication hub 203 may be housed in a modular control tower configured to receive a plurality of devices 1a-1n / 2a-2m. The local computer system 210 may also be housed in a modular control tower. The modular communication hub 203 is connected to the display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example during a surgical procedure. In various aspects, the devices 1a-1n / 2a-2m are among the modular devices that can be connected to the modular communication hub 203 of the surgical data network 201, for example, the imaging module 138 connected to an endoscope. , Generator module 140 connected to energy-based surgical equipment, smoke exhaust module 126, suction / irrigation module 128, communication module 130, processor module 132, storage array 134, surgical equipment connected to display, and / Alternatively, various modules such as non-contact sensor modules may be mentioned.

In one aspect, the surgical data network 201 combines a network hub (s), a network switch (s), and a network router (s) that connect the devices 1a-1n / 2a-2m to the cloud. It may be included. Any one or all of the devices 1a-1n / 2a-2m connected to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and operation. .. It will be appreciated that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. The term "cloud" can be used as a metaphor for the "Internet," but the term is not so limited. Therefore, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing," in which various services such as servers, storage, and applications are referred to as surgical sites. Modular communication hub 203 and / or computer system 210 located (eg, fixed, mobile, temporary, or field operating room or space) and / or modular communication hub 203 and / or computer via the Internet. Delivered to a device connected to system 210. The cloud infrastructure can be maintained by the cloud service provider. In this context, a cloud service provider can be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services can perform a number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware allows multiple devices or connections to connect to computers that communicate with cloud computing resources and storage.

By applying cloud computer data processing technology to the data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. After the tissue sealing and cutting procedure, at least some of the devices 1a-1n / 2a-2m can be used to observe the condition of the tissue and assess leakage or perfusion of the sealed tissue. .. At least one of the devices 1a-1n / 2a-2m to use cloud-based computing to examine data containing images of body tissue samples for diagnostic purposes to identify medical conditions such as the effects of disease. Some can be used. This includes tissue and phenotypic localization and margin confirmation. Devices 1a-1n / 2a to identify the anatomical structure of the body using techniques such as overlaying images captured by multiple imaging devices and various sensors integrated with the imaging device. At least some of ~ 2 m can be used. Data collected by devices 1a-1n / 2a-2m, including image data, may be transferred to cloud 204 and / or local computer system 210 for data processing and operation, including image processing and operation. .. The data of surgical procedures by determining whether further treatments such as endoscopic interventions for tissue-specific sites and conditions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robots can be performed. It can be analyzed to improve the results. Such data analysis may further employ prognostic processing, and whether using a standardized approach confirms surgical treatment and surgeon behavior or suggests modifications to surgical treatment and surgeon behavior. Can provide useful feedback for any of the above.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via a wired or wireless channel, depending on the configuration of the devices 1a-1n with respect to the network hub. In one aspect, the network hub 207 may be implemented as a local network broadcaster acting on the physical layer of the Open Systems Interconnection (OSI) model. The network hub provides connectivity to devices 1a-1n located within the same operating room network. Network hub 207 collects data in packet form and sends them to the router in half-duplex mode. The network hub 207 does not store any medium access control / internet protocol (MAC / IP) for transferring device data. Only one of the devices 1a-1n can transmit data at a time via the network hub 207. The network hub 207 does not have a routing table or intelligence regarding the destination of information, and broadcasts all network data to the entire connection and to the remote server 213 (FIG. 9) on the cloud 204. The network hub 207 can detect basic network errors such as collisions, but broadcasting all the information to a plurality of ports poses a security risk and may cause a bottleneck.

In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via a wired or wireless channel. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operating room to the network. The network switch 209 transmits data in the form of a frame to the network router 211 and functions in full-duplex mode. The plurality of devices 2a to 2m can simultaneously transmit data via the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a to 2m to transfer data.

The network hub 207 and / or network switch 209 is connected to the network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 cloud the data packets received from the network hub 207 and / or the network switch 211 in order to further process and manipulate the data collected by any one or all of the devices 1a-1n / 2a-2m. Create a route to send to the base computer resource. The network router 211 is used to connect two or more different networks located at different locations, for example, different operating rooms in the same medical facility or different networks located in different operating rooms in different medical facilities. May be good. The network router 211 transmits packet form data to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data at the same time. The network router 211 uses an IP address to transfer data.

In one embodiment, the network hub 207 may be implemented as a USB hub that allows a plurality of USB devices to be connected to a host computer. A USB hub can extend a single USB port into several layers so that more ports are available to connect the device to the host system computer. The network hub 207 may include a wired or wireless capability for receiving information via a wired or wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in the operating room.

In another embodiment, operating room devices 1a-1n / 2a-2m exchange data over short distances from fixed and mobile devices (using short wavelength UHF radio waves in the ISM band 2.4-2.485 GHz). ), And can communicate with the modular communication hub 203 via the Bluetooth radio technology standard to build a personal area network (PAN). In another aspect, the operating room devices 1a-1n / 2a-2m are Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, Long Term Evolution (LTE), and Ev. -DO, HSPA +, HSDPA +, HSUPA +, LTE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any other radio designated as 3G, 4G, 5G, and beyond. It is possible to communicate with the modular communication hub 203 via a number of wireless or wired communication standards or protocols, including but not limited to wired protocols. The computing module may include a plurality of communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc. May be dedicated to long-range wireless communication.

The modular communication hub 203 can function as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles a data type known as a frame. The frame carries the data generated by the devices 1a-1n / 2a-2m. When the frame is received by the modular communication hub 203, the frame is amplified and transmitted to the network router 211, which uses a number of wireless or wired communication standards or protocols described herein. Transfer this data to your cloud computing resources.

The modular communication hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communication hub 203 is generally easy to install, configure, and maintain, making the modular communication hub 203 a good choice for networking operating room devices 1a-1n / 2a-2m.

FIG. 9 shows a computer-mounted interactive surgical system 200. The computer-mounted interactive surgical system 200 is, in many respects, similar to the computer-mounted interactive surgical system 100. For example, the computer-mounted interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204 that may include a remote server 213. In one aspect, the computer-mounted interactive surgical system 200 comprises a modular control tower 236 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. .. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 connected to the computer system 210. As illustrated in the embodiment of FIG. 9, the modular control tower 236 includes an imaging module 238 connected to an endoscope 239, a generator module 240 connected to an energy device 241, a smoke evacuator module 226, and suction / It is coupled to the irrigation module 228, the communication module 230, the processor module 232, the storage array 234, the smart device / appliance 235 optionally coupled to the display 237, and the non-contact sensor module 242. The operating room equipment is connected to cloud computing resources and data storage via a modular control tower 236. Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. Above all, the device / appliance 235, visualization system 208 may be connected to the modular control tower 236 via a wired or wireless communication standard or protocol described herein. The modular control tower 236 may be coupled to a hub display 215 (eg, monitor, screen) to display and overlay images received from the imaging module, device / instrument display, and / or other visualization system 208. .. The hub display may also display data received from a device connected to the modular control tower along with images and overlay images.

FIG. 10 shows a surgical hub 206 with a plurality of modules connected to a modular control tower 236. The modular control tower 236 includes, for example, a modular communication hub 203 such as a network connection device and a computer system 210 for providing, for example, local processing, visualization, and imaging. As shown in FIG. 10, the modular communication hub 203 is connected in a hierarchical configuration in order to expand the number of modules (for example, devices) that can be connected to the modular communication hub 203, and the data associated with the modules is displayed. It can be transferred to computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches in the modular communication hub 203 includes three downstream ports and one upstream port. Upstream network hubs / switches are connected to processors to provide communication connections to cloud computing resources and local displays 217. Communication to the cloud 204 can be done via either a wired or wireless communication channel.

The surgical hub 206 uses the non-contact sensor module 242 to measure the dimensions of the operating room and uses either an ultrasonic or laser non-contact measuring device to generate a map of the surgical site. "Surgical Hub Spatial Awarens With Operating Room" in US Provisional Patent Application No. 62 / 611,341 filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", which is incorporated herein by reference in its entirety. As described in the section, the ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound and receiving an echo as the burst of ultrasound reflects off the outer wall of the operating room. Here, the sensor module is configured to determine the size of the operating room and adjust the distance limit of the Bluetooth pairing. A laser-based non-contact sensor module, for example, transmits a laser light pulse, receives a laser light pulse reflected on the outer wall of the operating room, and compares the phase of the transmitted pulse to the received pulse in the operating room. The operating room is scanned by determining the size and adjusting the Pulsetooth pairing distance limit.

The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is connected to the communication module 247, the storage 248, the memory 249, the non-volatile memory 250, and the input / output interface 251 via the system bus. The system bus is a 9-bit bus, industry standard architecture (ISA), microchannel architecture (MSA), extended ISA (EISA), intelligent drive electronics (IDE), VESA local bus (VLB), peripheral device interconnection (PCI), Any, but not limited to, USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association Bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus. It may be any of several types of bus structures (s), including memory buses or memory controllers, peripheral buses or external buses, and / or local buses that use the various bus architectures of.

The processor 244 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In one aspect, the processor, for example, on-chip memory of up to 40 MHz 256 KB single cycle flash memory or other non-volatile memory, the details of which are available in the product data sheet, for improving performance above 40 MHz. Prefetch buffer, 32KB single-cycle serial random access memory (SRAM), internal read-only memory with StaticrisWare® software (ROM), 2KB electrically erasable programmable read-only memory (EEPROM), and / or One or more pulse width modulation (PWM) modules, one or more orthogonal encoder input (QEI) analogs, one or more 12-bit analog-to-digital with 12 analog input channels It may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including a converter (ADC).

In one aspect, the processor 244 may include a safety controller that includes two controller families such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory options. Good.

Examples of the system memory include volatile memory and non-volatile memory. A basic input / output system (BIOS) that includes a basic routine for transferring information between elements in a computer system, such as during startup, is stored in non-volatile memory. For example, the non-volatile memory may include a ROM, a programmable ROM (PROM), an electrically programmable ROM (EPROM), an EEPROM, or a flash memory. Examples of the volatile memory include a random access memory (RAM) that functions as an external cache memory. Further, the RAM includes SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESRAM), synclink DRAM (SLRAM), direct rambus RAM (DRRAM), and the like. It is available in many forms of.

The computer system 210 also includes removable / non-removable volatile / non-volatile computer storage media such as disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage can be a storage medium independently, or a compact disc ROM device (CD-ROM), a compact disc recordable drive (CD-R drive), a compact disc rewritable drive (CD-RW drive), and the like. Alternatively, an optical disk drive such as a digital versatile disk ROM drive (DVD-ROM) can be mentioned, but the present invention can be included in combination with other storage media not limited thereto. A removable or non-removable interface may be used to facilitate the connection of the disk storage device to the system bus.

It should be understood that the computer system 210 includes software that acts as an intermediary between the user and the basic computer resources described in the preferred operating environment. Examples of such software include operating systems. An operating system that can be stored on disk storage functions to control and allocate resources for the computer system. System applications take advantage of resource management by the operating system via program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein can be implemented in different operating systems or combinations of operating systems.

The user inputs a command or information to the computer system 210 via an input device (s) connected to the I / O interface 251. Input devices include pointing devices such as mice, trackballs, stylus, and touchpads, keyboards, microphones, joysticks, gamepads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, and webcams. However, it is not limited to these. These and other input devices connect to the processor through the system bus via the interface port (s). Examples of the interface port (s) include a serial port, a parallel port, a game port, and USB. The output device (s) use some of the same types of ports as the input device (s). Thus, for example, the USB port may be used to provide input to the computer system and output information from the computer system to the output device. Output adapters are provided to indicate the presence of some output devices, such as monitors, displays, speakers, and printers, among other output devices that require special adapters. Output adapters include, for example, but not limited to, video and sound cards that provide a means of connection between the output device and the system bus. Note that other devices and / or systems of devices, such as remote computers (s), provide both input and output functions.

The computer system 210 can operate in a networked environment that uses a logical connection to one or more remote computers or local computers, such as a cloud computer (s). The remote cloud computer (s) can be a personal computer, server, router, network PC, workstation, microprocessor-based device, peer device, or other common network node, typically a computer. Contains many or all of the elements described for the system. For brevity, only the memory storage device is shown along with the remote computer (s). The remote computer (s) are logically connected to the computer system via a network interface and then physically connected via a communication connection. Network interfaces include communication networks such as local area networks (LANs) and wide area networks (WANs). Examples of LAN technology include an optical fiber distributed data interface (FDDI), a copper wire distributed data interface (CDDI), Ethernet / IEEE802.3, Token Ring / IEEE802.5, and the like. WAN technology includes, but is not limited to, point-to-point links, integrated services digital networks (ISDN) and circuit switching networks such as and variants thereof, packet switching networks, and digital subscriber lines (DSL).

In various embodiments, the computer system 210 of FIG. 10, the imaging module 238 of FIGS. 9-10, and / or the visualization system 208, and / or the processor module 232 are image processors, image processing engines, media processors, or digital images. It may include any dedicated digital signal processor (DSP) used in the processing of. Image processors can increase speed and efficiency by using single instruction multiple data (SIMD) or parallel computing using multiple instruction multiple data (MIMD) technology. Digital image processing engines can perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

Communication connection (s) refers to the hardware / software used to connect the network interface to the bus. The communication connection is shown inside the computer system for the sake of illustration clarity, but the communication connection may be outside the computer system 210. For illustrative purposes only, the hardware / software required to connect to a network interface includes conventional telephone grade modems, cable modems, modems including DSL modems, ISDN adapters, and internal and external technologies such as Ethernet cards. Can be mentioned.

FIG. 11 shows a functional block diagram of one aspect of the USB network hub 300 device according to at least one aspect of the present disclosure. In the illustrated embodiment, the USB network hub device 300 employs a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that provides upstream USB transmission / reception ports 302 and up to three downstream USB transmission / reception ports 304, 306, and 308 that comply with the USB 2.0 standard. The upstream USB transmit / receive port 302 is a differential root data port that includes a differential data plus (DP0) input and a paired differential data minus (DM0) input. The three downstream USB transmit / receive ports 304, 306, 308 are differential data ports each containing a differential data plus (DP1 to DP3) output paired with a differential data minus (DM1 to DM3) output.

The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. A fully compliant USB transmitter / receiver is integrated into the circuits of the upstream USB transmit / receive port 302 and all downstream USB transmit / receive ports 304, 306, 308. Downstream USB transmit and receive ports 304, 306, 308 support both maximum and slow speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered mode or self-powered mode and includes hub-powered logic 312 for managing power.

The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE310 is the front end of the USB network hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. The SIE310 typically understands signaling down to the transaction level. Functions covered by this include packet recognition, transaction reordering, SOP, EOP, SETET, and RESTUME signal detection / generation, clock / data separation, non-return-to-zero reversal (NRZI) data coding / decoding and bit stuffing, CRC Generation and check (tokens and data), packet ID (PID) generation, and check / decryption, and / or serial parallel / parallel serial conversion can be mentioned. 310 receives clock input 314 and suspend / resume logic as well to control communication between upstream USB transmit / receive ports 302 and downstream USB transmit / receive ports 304, 306, 308 via port logic circuits 320, 322, 324. It is connected to the frame timer 316 circuit and the hub repeater circuit 318. The SIE 310 is connected to the command decoder 326 via an interface logic for controlling commands from the serial EEPROM via the serial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functions configured in up to 6 logical layers (hierarchies) to a single computer. In addition, the USB network hub 300 can be connected to all peripherals using four standardized wire cables that provide both communication and power distribution. The power configuration is a bus-powered mode and a self-powered mode. The USB network hub 300 is a bus power hub having either individual port power management or interlocking port power management, and a self-powered hub having either individual port power management or interlocking port power management. It may be configured to support one mode. In one aspect, using a USB cable, a USB network hub 300, the upstream USB transmit / receive port 302 is plugged into a USB host controller, and the downstream USB transmit / receive ports 304, 306, 308 connect a USB compatible device. It is exposed because of it.

Hardware of Surgical Instruments FIG. 12 shows a logical diagram of a surgical instrument or tool control system 470 according to one or more aspects of the present disclosure. System 470 includes a control circuit. The control circuit includes a microprocessor 461 with a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, and 476 provide real-time feedback to the processor 462. The motor 482, driven by the motor drive 492, operably connects to a displacement member that is movable in the longitudinal direction to drive the I-beam knife element. The tracking system 480 is configured to determine the position of a displacement member that is movable in the longitudinal direction. Positional information is provided to processor 462, which can be programmed or configured to determine the position of drive members that are longitudinally movable, as well as the positions of launch members, launch bars, and I-beam knife elements. .. Additional motors may be provided in the tool driver interface to control I-beam launch, closed tube movement, shaft rotation, and joint movement. The display 473 may display various operating conditions of the appliance and may include a touch screen function for data entry. The information displayed on the display 473 can be overlaid with the image acquired via the endoscopic imaging module.

In one aspect, the microcontroller 461 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In one aspect, the main microcontroller 461 improves performance to over 40 MHz, for example, on-chip memory of 256 KB single cycle flash memory up to 40 MHz or other non-volatile memory, the details of which are available in the product datasheet. Prefetch buffer for, 32KB single cycle SRAM, internal ROM with NonvolatilesWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, and / Alternatively, it may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including one or more 12-bit ADCs with 12 analog input channels.

In one aspect, the microcontroller 461 may include a safety controller that includes two controller families such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory options. Good.

The microcontroller 461 may be programmed to perform a variety of functions, such as precise control over the speed and position of the knife and joint movement system. In one aspect, the microcontroller 461 includes a processor 462 and memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and a mechanical connection to a joint movement or knife system. In one aspect, the motor drive 492 may be A3941 available from Allegro Microsystems, Inc. Other motor drives can be easily replaced for use in the tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system, which is incorporated herein by reference in its entirety, is entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT" published October 19, 2017 in the United States Patent Application Publication No. 2017/2017. 0296213.

The microcontroller 461 may be programmed to provide precise control over the speed and position of the displacement member and joint movement system. Microcontroller 461 may be configured to calculate the response within the software of microcontroller 461. The calculated response is compared to the measured response of the actual system to give an "observed" response, which is used to determine the actual feedback. The observed response is a suitable adjusted value that balances the smooth and continuous nature of the simulated response with the measured response, which can detect external effects on the system.

In one aspect, the motor 482 may be controlled by a motor drive 492 and may be used by a surgical instrument or tool launch system. In various forms, the motor 482 may be, for example, a brushed DC drive motor having a maximum rotational speed of about 25,000 RPM. In another configuration, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor drive 492 may include, for example, an H-bridge drive that includes a field effect transistor (FET). The motor 482 may be powered by a power assembly that is detachably mounted on the handle assembly or tool housing to supply control power to the surgical instrument or tool. The power assembly may include a battery that may include a large number of battery cells connected in series, which can be used as a power source to power a surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cell can be a lithium ion battery that can be coupled to and separable from the power assembly.

The motor drive 492 may be A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full bridge controller for use with an external N-channel power metal oxide semiconductor field effect transistor (MOSFET) specifically designed for inductive loads such as brushed DC motors. The drive 492 is equipped with a unique charge pump regulator, which provides full (> 10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive up to 5.5V. To do. A bootstrap capacitor may be used to provide the above-mentioned battery supply voltage required for the N-channel MOSFET. The internal charge pump for high-side drive enables DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation is possible with both high-side and low-side FETs. The power FET is protected from shoot-through by a register-adjustable dead time. The integrated diagnostics indicate low voltage, overtemperature, and power bridge anomalies and can be configured to protect the power MOSFET under most short circuit conditions. Other motor drives can be easily replaced for use in the tracking system 480 with an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuit configuration with a position sensor 472 according to at least one aspect of the present disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for meshing and engaging with the corresponding drive gear of the gear reducer assembly. In another aspect, the displacement member represents a launching member that can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement members represent launch bars or I-beams, each of which may be adapted and configured to include a rack of drive teeth. Accordingly, as used herein, the term displacement member refers to any movable member of the surgical instrument, such as a drive member, launch member, launch bar, I-beam, or any element that can be displaced. Is used to collectively refer to. In one aspect, longitudinally movable drive members are coupled to launch members, launch bars, and I-beams. Therefore, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of the drive member that is movable in the longitudinal direction. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, longitudinally movable drive members, launch members, launch bars, or I-beams, or combinations thereof, may be coupled to any suitable displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor. Linear displacement sensors include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), slide potentiometers, movable magnets and a series of straight lines. Magnetic sensing system with placed Hall effect sensors, magnetic sensing system with fixed magnets and Hall effect sensors placed on a series of movable straight lines, movable light sources and placed on a series of straight lines It may include an optical detection system with a magneto or photodetector, an optical detection system with a fixed light source and a reluctance or photodetector arranged on a series of movable straight lines, or any combination thereof. ..

The electric motor 482 may include a rotary shaft that operably interfaces with a gear assembly mounted in mesh engagement with a set or rack of drive teeth on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. Gearing and sensor mechanisms can be connected to linear actuators by rack and pinion mechanisms, or to rotary actuators by spur gears or other connections. The power supply powers the absolute positioning system and the output indicator can display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed on it to mesh and engage with the corresponding drive gear of the gear reducer assembly. Displacement members represent longitudinally movable launch members, launch bars, I-beams, or combinations thereof.

One rotation of the sensor element associated with the position sensor 472 corresponds to a linear displacement d1 in the longitudinal direction of the displacement member, in which case d1 is where the displacement member points after one rotation of the sensor element connected to the displacement member. It is a linear distance in the longitudinal direction that moves from "a" to the point "b". The sensor mechanism may be connected via gear deceleration resulting in the position sensor 472 completing one or more rotations for the full stroke of the displacement member. The position sensor 472 can complete a plurality of rotations with respect to the full stroke of the displacement member.

A series of switches (where n is an integer greater than 1), even when used alone, in combination with gear deceleration to provide a unique position signal for two or more rotations of the position sensor 472. May be used in. The state of the switch is fed back to the microcontroller 461, and the microcontroller 461 applies logic to linear displacement d1 + d2 + of the displacement member in the longitudinal direction. .. .. Determine the unique position signal corresponding to dn. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may include an analog rotation sensor such as a magnetic sensor, a potential difference meter, or an array of analog Hall effect elements that output a unique combination of position signals or values.

The position sensor 472 may include any number of magnetic sensing elements, such as magnetic sensors that are classified based on whether or not they measure the total magnetic field or vector component of the magnetic field. The technology used to produce both types of magnetic sensors involves many aspects of physics and electronics. Techniques used for magnetic field sensing include, among other things, probe coils, flux gates, optical pumping, nuclear precession, SQUID, Hall effect, anisotropic magnetic resistance, giant magnetic resistance, magnetic tunnel junctions, giant magnetic impedance. , Magnetic strain / piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magnetic optics, and magnetic sensors based on microelectromechanical systems.

In one aspect, the position sensor 472 of the tracking system 480 with the absolute positioning system comprises a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055 EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. The position sensor 472 cooperates with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the region of the position sensor 472 located above the magnet. In addition, a high resolution ADC and smart power management controller are provided on the chip. Digit-by-digit method and boulder to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. A coordinate rotation digital computer (CORDIC) processor, also known as a Volder's algorithm, is provided. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface such as a serial peripheral interface (SPI) interface. The position sensor 472 provides a 12-bit or 14-bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4 x 4 x 0.85 mm package.

The tracking system 480 with an absolute positioning system may include and / or may be programmed to implement a feedback controller such as a PID, state feedback, and adaptive controller. The power supply converts the signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include voltage, current, and force PWM. In addition to the position measured by the position sensor 472, other sensors (plurality) may be provided to measure the physical parameters of the physical system. In some embodiments, as the other sensor (s), the US Pat. No. 9, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety. , 345, 481, the United States Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE TISSUE TISSUE SENSOR SYSTEM," which is incorporated herein by reference in its entirety, and in its entirety. U.S. Patent Application No. 17/28 A sensor mechanism such as a thing can be mentioned. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. Absolute positioning systems use algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response to combine the calculated response with the measured response. Can be equipped. In order to predict what the state and output of the physical system will be by knowing the inputs, the calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, and induced resistance.

The absolute positioning system resets the displacement members as would be required in a conventional rotary encoder where the motor 482 simply counts the number of steps taken forward or backward to estimate the position of device actuators, drive bars, knives, etc. Provides the absolute position of the displacement member when the appliance is powered on, without retracting or advancing to the zero or home) position.

A sensor 474, such as a strain gauge or microstrain gauge, can indicate, for example, one or more end effectors such as the amplitude of strain exerted on the anvil during clamping operation, which can indicate the closing force applied to the anvil. It is configured to measure the parameters of. The measured distortion is converted into a digital signal and provided to the processor 462. Instead of, or in addition to, the sensor 474, a sensor 476, such as a load sensor, can also measure the closure force applied to the anvil by the closure drive system. For example, a sensor 476, such as a load sensor, can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument. The I-beam is configured to engage the wedge-shaped thread, which cams the staple driver upwards to push the staples into deformed contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current draw by the motor 482. The force required to advance the launching member may correspond, for example, to the current drawn by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.

In one form, the strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector. A strain gauge can be attached to the end effector to measure the force of the end effector on the tissue to be treated. The system for measuring the force applied to the tissue gripped by the end effector is, for example, a strain gauge sensor 474, such as a micro strain gauge configured to measure one or more parameters of the end effector. To be equipped. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the jaw member of the end effector during the gripping motion, which can be an indicator of tissue compression. The measured distortion is converted into a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to manipulate the knife element, for example, to cut the tissue trapped between the anvil and the staple cartridge. Magnetic field sensors can be used to measure the thickness of captured tissue. The magnetic field sensor measurements can also be converted to digital signals and provided to the processor 462.

Measures of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474 and 476, respectively, are the selected position of the launching member and /. Alternatively, it can be used by the microcontroller 461 to characterize the corresponding value of the velocity of the launching member. In one example, memory 468 can store techniques, equations and / or look-up tables that can be used by microcontroller 461 during evaluation.

The surgical instrument or tool control system 470 may also include a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 8-11.

FIG. 13 shows a control circuit 500 configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. The control circuit 500 can be configured to implement the various processes described herein. The control circuit 500 can include a microcontroller having one or more processors 502 (eg, microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions for implementing the various processes described herein. The processor 502 may be any one of a number of single or multi-core processors known in the art. The memory circuit 504 may include volatile and non-volatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

FIG. 14 shows a combination logic circuit 510 configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. The combination logic circuit 510 can be configured to implement the various processes described herein. The combination logic circuit 510 is a finite state machine containing the combination logic 512 configured to receive data associated with a surgical instrument or tool at input 514, process the data by combination logic 512, and provide output 516. May include.

FIG. 15 shows a sequence logic circuit 520 configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. The sequential logic circuit 520 or combinational logic 522 can be configured to implement the various processes described herein. The order logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, a combinatorial logic 522, at least one memory circuit 524, and a clock 529. At least one memory circuit 524 can store the current state of the finite state machine. In a particular example, the order logic circuit 520 may be synchronous or asynchronous. Combination logic 522 is configured to receive data associated with a surgical instrument or tool from input 526, process the data by combination logic 522, and provide output 528. In another aspect, the circuit may include a combination of a processor (eg, processor 502 in FIG. 13) and a finite state machine that implements the various processes herein. In another aspect, the finite state machine can include a combination of a combination logic circuit (eg, combination logic circuit 510 in FIG. 14) and a sequence logic circuit 520.

FIG. 16 shows a surgical instrument or tool with multiple motors that can be activated to perform various functions. In a particular example, the first motor can be started to perform the first function, the second motor can be started to perform the second function, and the third motor can be started. The third function can be executed, the fourth motor can be started to execute the fourth function, and so on. In certain examples, multiple motors of the robotic surgical instrument 600 can be individually activated to produce launching, closing, and / or jointing motions in the end effector. Launching motion, closing motion, and / or joint motion can be transmitted to the end effector, for example, via a shaft assembly.

In certain examples, the surgical instrument system or tool may include a launch motor 602. The launch motor 602 may be operably coupled to a launch motor drive assembly 604 that may be configured to transmit the launch motion generated by the motor 602 to the end effector, specifically to displace the I-beam element. In certain examples, the firing motion generated by the motor 602, for example, places the staples from the staple cartridge into the tissue captured by the end effector and / or advances the cutting edge of the I-beam element to capture it. The tissue may be cut. The I-beam element can also be retracted by reversing the direction of the motor 602.

In certain examples, the surgical instrument or tool may include a closure motor 603. The closing motor 603 specifically displaces the closing tube to close the anvil and transmits the closing motion generated by the motor 603 to the end effector to compress the tissue between the anvil and the staple cartridge. It may be operably coupled with a closed motor drive assembly 605 that may be configured. The closing motion allows, for example, the end effector to transition from an open configuration to an approaching configuration to capture tissue. The end effector can be transitioned to the open position by reversing the direction of the motor 603.

In certain examples, the surgical instrument or tool may include, for example, one or more joint motion motors 606a, 606b. The motors 606a, 606b may be operably coupled to the corresponding joint motion motor drive assemblies 608a, 608b, which may be configured to transmit the joint motion generated by the motors 606a, 606b to the end effector. In certain examples, articulation allows, for example, end effectors to articulate with respect to the shaft.

As mentioned above, a surgical instrument or tool may include multiple motors that may be configured to perform a variety of independent functions. In certain examples, multiple motors of a surgical instrument or tool can be activated independently or separately to perform one or more functions while the other motors remain stationary. Can be carried out. For example, the joint movement motors 606a and 606b can be activated to jointly move the end effector while the launch motor 602 is maintained in a stopped state. Alternatively, the launch motor 602 can be activated to launch a plurality of staples and / or advance the cutting edge while the joint motion motor 606 is stopped. Further, the closure motor 603 may be activated at the same time as the launch motor 602 to advance the closure tube and the I-beam element distally, as described in more detail below.

In certain examples, the surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In a particular example, the common control module 610 can accommodate one of a plurality of motors at a time. For example, the common control module 610 may be individually connectable and detachable to multiple motors of a robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, multiple motors of a surgical instrument or tool can be independently and selectively engaged with a common control module 610. In a particular example, the common control module 610 selectively works from one of the multiple motors of the surgical instrument or tool to the other of the multiple motors of the surgical instrument or tool. You can switch.

In at least one example, the common control module 610 selects between an operable engagement with the joint motion motors 606a, 606b and an operable engagement with either the launch motor 602 or the closure motor 603. Can be switched. In at least one embodiment, as shown in FIG. 16, switch 614 can move or transition between multiple positions and / or states. For example, at the first position 616, the switch 614 may electrically connect the common control module 610 to the launch motor 602, and at the second position 617, the switch 614 closes the common control module 610. It may be electrically connected to the motor 603, and at the third position 618a, the switch 614 may electrically connect the common control module 610 to the first joint motion motor 606a, at the fourth position. At 618b, the switch 614 may electrically connect the common control module 610 to the second joint motion motor 606b. In certain examples, separate common control modules 610 may be electrically connected to launch motors 602, closure motors 603, and joint motion motors 606a, 606b at the same time. In a particular example, the switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may be provided with a torque sensor for measuring the output torque on the shaft of the motor. The force on the end effector may be sensed by any conventional method, such as by a force sensor on the outside of the jaw, or by a torque sensor on the motor that actuates the jaw.

In various examples, as shown in FIG. 16, the common control module 610 may include a motor drive 626, which may include one or more H-bridge FETs. The motor drive 626 may modulate the power transmitted from the power supply 628 to the motor connected to the common control module 610, for example, based on the input from the microcontroller 620 (“controller”). In a particular example, as described above, for example, a microcontroller 620 can be used while the motor is connected to a common control module 610 to determine the current drawn by the motor.

In certain examples, the microcontroller 620 may include a microprocessor 622 (“processor”) and one or more non-transitory computer-readable media or memory units 624 (“memory”). In a particular example, memory 624 can store various program instructions that, when executed, can cause processor 622 to perform multiple functions and / or calculations described herein. it can. In a particular example, one or more of the memory units 624 may be attached to, for example, processor 622.

In certain examples, the power supply 628 may be used to power, for example, the microcontroller 620. In certain examples, the power supply 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery. In certain examples, the battery pack may be configured to be detachably attached to the handle to power the surgical instrument 600. A large number of battery cells connected in series may be used as the power source 628. In certain examples, the power supply 628 may be, for example, replaceable and / or rechargeable.

In various examples, the processor 622 can control the motor drive 626 to control the position, direction of rotation, and / or speed of the motor coupled to the common control module 610. In a particular example, the processor 622 can signal the motor drive 626 to stop and / or disable the motor coupled to the common control module 610. The term "processor", as used herein, is the function of any suitable microprocessor, microcontroller, or computer central processing unit (CPU) in one integrated circuit or up to several integrated circuits. It should be understood to include other basic computing devices integrated above. A processor is a versatile programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides the results as output. This is an example of sequential digital logic because it has internal memory. The processor operates on numbers and symbols represented in binary notation.

In one example, the processor 622 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In a particular example, the microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR features on-chip memory of up to 40 MHz 256 KB single-cycle flash memory or other non-volatile memory, with 40 MHz performance, among other characteristics readily available in the product datasheet. Prefetch buffer for super-improvement, 32KB single cycle SRAM, internal ROM with Non-volatile Memory® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs , ARM Cortex-M4F processor core containing one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with the module 4410. Therefore, this disclosure should not be limited to this context.

In a particular example, the memory 624 may include program instructions for controlling each motor of a surgical instrument 600 that can be connected to a common control module 610. For example, the memory 624 may include program instructions for controlling the launch motor 602, the closure motor 603, and the joint motion motors 606a, 606b. Such program instructions can cause the processor 622 to control firing, closing, and joint motor functions according to input from an algorithm or control program of a surgical instrument or tool.

In certain examples, one or more mechanisms and / or sensors, such as sensor 630, can be used to warn processor 622 to use program instructions that should be used in a particular setting. .. For example, sensor 630 can warn processor 622 to use program instructions related to end effector firing, closing, and joint movement. In certain examples, the sensor 630 may include, for example, a position sensor that can be used to sense the position of the switch 614. Thus, if the processor 622 detects, for example, through the sensor 630 that the switch 614 is in the first position 616, it can use the program instructions associated with the emission of the I-beam of the end effector, the processor 622. Can use the program instructions associated with the closure of the anvil, for example, when it detects that the switch 614 is in the second position 617 via the sensor 630, and the processor 622 can use, for example, via the sensor 630. When the switch 614 is detected at the third position 618a or the fourth position 618b, the program instruction associated with the joint movement of the end effector can be used.

FIG. 17 is a schematic representation of a robotic surgical instrument 700 configured to operate the surgical tools described herein, according to at least one aspect of the present disclosure. The robotic surgical instrument 700 uses either a single or multiple joint motion drive joints to provide distal / proximal translation of displacement members, distal / proximal displacement of closed tubes, shaft rotation, and joints. It may be programmed or configured to control movement. In one aspect, the surgical instrument 700 may be programmed or configured to individually control launching members, closing members, shaft members, and / or one or more joint motion members. The surgical instrument 700 includes a control circuit 710 configured to control a motor driven launching member, a closing member, a shaft member, or one or more joint motion members.

In one aspect, the robotic surgical instrument 700 has an anvil 716 and an I-beam 714 (including a sharp cutting edge) portion of the end effector 702, a removable staple cartridge 718, a shaft 740, via a plurality of motors 704a-704e. And a control circuit 710 configured to control one or more joint motion members 742a, 742b. The position sensor 734 may be configured to provide position feedback for the I-beam 714 to the control circuit 710. The other sensor 738 may be configured to provide feedback to the control circuit 710. The timer / counter 731 provides timing and count information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and the current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.

In one aspect, the control circuit 710 is one or more microcontrollers, microprocessors, or other suitable for executing instructions that cause the processor or multiple processors to perform one or more tasks. It may be equipped with a processor. In one aspect, the timer / counter circuit 731 provides an output signal such as elapsed time or digital count to the control circuit 710 and sets the position of the I-beam 714 determined by the position sensor 734 as the output of the timer / counter circuit 731. As a result, the control circuit 710 determines the position of the I-beam 714 at a specific time (t) with respect to the start position or time (t) when the I-beam 714 is at a specific position with respect to the start position. can do. The timer / counter 731 may be configured to measure elapsed time, count external events, or measure the time of external events.

In one aspect, the control circuit 710 may be programmed to control the function of the end effector 702 based on one or more tissue states. The control circuit 710 may be programmed to sense tissue conditions such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a launch control program or a closure control program based on tissue conditions. The launch control program can describe the distal motion of the displacement member. Various launch control programs can be selected to better handle different tissue conditions. For example, in the presence of thicker tissue, the control circuit 710 may be programmed to translate the displacement member at a lower speed and / or at a lower power. In the presence of thinner tissue, the control circuit 710 may be programmed to translate the displacement member at higher speed and / or higher power. The closure control program can control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and the joint motion members 742a, 742b.

In one aspect, the control circuit 710 may also generate a motor set value signal. Motor set value signals may be provided to various motor controllers 708a-708e. Motor controllers 708a-708e include one or more circuits configured to provide motor drive signals to motors 704a-704e to drive motors 704a-704e, as described herein. You may. In some embodiments, the motors 704a-704e may be brushed DC electric motors. For example, the speeds of the motors 704a to 704e may be proportional to the respective motor drive signals. In some embodiments, the motors 704a-704e may be brushless DC electric motors, the respective motor drive signal being PWM provided to one or more stator windings of the motors 704a-704e. It may include a signal. Further, in some embodiments, the motor controllers 708a to 708e may be omitted, and the control circuit 710 may directly generate a motor drive signal.

In one aspect, the control circuit 710 may first operate each of the motors 704a-704e in an open-loop configuration at the first open-loop portion of the displacement member stroke. Based on the response of the robotic surgical instrument 700 during the open loop portion of the stroke, the control circuit 710 may select a launch control program with a closed loop configuration. The response of the instrument is the translational distance of the displacement member between the open loop portions, the time elapsed between the open loop portions, the energy provided to one of the motors 704a-704e during the open loop portions, the motor. The total pulse width of the drive signal may be mentioned. After the open loop portion, the control circuit 710 may implement the selected launch control program for the second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 modulates one of the motors 704a-704e in a closed-loop fashion based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. You may let me.

In one aspect, the motors 704a-704e can receive power from the energy source 712. The energy source 712 may be a main AC power source, a battery, a supercapacitor, or a DC power source driven by any other suitable energy source. The motors 704a to 704e are mechanically connected to individual movable mechanical elements such as the I-beam 714, the anvil 716, the shaft 740, the joint movement member 742a and the joint movement member 742b via the respective transmission devices 706a to 706e. It's okay. Transmission devices 706a-706e may include one or more gears or other connecting components for connecting motors 704a-704e to mobile mechanical elements. The position sensor 734 can sense the position of the I-beam 714. The position sensor 734 may be any type of sensor capable of generating position data indicating the position of the I-beam 714, or may include it. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the I-beam 714 translates distally and proximally. The control circuit 710 may track the pulse to determine the position of the I-beam 714. Other suitable position sensors, including, for example, proximity sensors may be used. Other types of position sensors may provide other signals indicating the motion of the I-beam 714. Further, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a-704e is a step motor, the control circuit 710 may track the position of the I-beam 714 by summing the number and directions of steps instructed by the motor 704 to perform. .. The position sensor 734 may be located within the end effector 702 or at any other part of the instrument. Each output of the motors 704a-704e includes torque sensors 744a-744e for sensing force and has an encoder that senses the rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a launching member, such as the I-beam 714 portion of the end effector 702. The control circuit 710 provides the motor control unit 708a with a motor set value, and the motor control unit 708a provides a drive signal to the motor 704a. The output shaft of the motor 704a is connected to the torque sensor 744a. The torque sensor 744a is connected to the transmission device 706a connected to the I beam 714. The transmission device 706a includes movable mechanical elements such as rotating elements and launching members for controlling the movement of the distal and proximal I-beams 714 along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to launch or displace the I-beam 714. The position sensor 734 may be configured to provide the position of the I-beam 714 or the position of the firing member along the firing stroke to the control circuit 710 as a feedback signal. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor control unit 708a. In response to the launch signal, the motor 704a drives the launch member distally along the longitudinal axis of the end effector 702 from the proximal stroke start position to the stroke end position distal to the stroke start position. be able to. When the launching member translates distally, the I-beam 714 with the cutting element located at the distal end advances distally and cuts the tissue located between the staple cartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closing member such as the anvil 716 of the end effector 702. The control circuit 710 provides a motor set value to the motor control unit 708b that provides a drive signal to the motor 704b. The output shaft of the motor 704b is connected to the torque sensor 744b. The torque sensor 744b is connected to the transmission device 706b connected to the anvil 716. The transmission device 706b includes movable mechanical elements such as rotating elements and closing members for controlling the movement of the anvil 716 from the open and closed positions. In one aspect, the motor 704b is coupled to a closed gear assembly that includes a closed reduction gear set that is meshed with and supported by the closed spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal represents the closing force applied to the anvil 716. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 can provide a closing force feedback signal to the control circuit 710. The pivotable anvil 716 is located on the opposite side of the staple cartridge 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control unit 708b. In response to the closure signal, the motor 704b advances the closure member to grip the tissue between the anvil 716 and the staple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaft member, such as a shaft 740, to rotate the end effector 702. The control circuit 710 provides the motor control unit 708c with a motor set value, and the motor control unit 708c provides a drive signal to the motor 704c. The output shaft of the motor 704c is connected to the torque sensor 744c. The torque sensor 744c is connected to the transmission device 706c connected to the shaft 740. The transmission device 706c comprises a movable mechanical element such as a rotating element to control the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is formed (or to) on the proximal end of the proximal closure tube so that it is operably engaged by a rotating gear assembly operably supported on a tool mounting plate. It is connected to a rotation transmission assembly that includes a tubular gear segment (attached). The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotation position of the shaft 740 to the control circuit 710.

In one aspect, the control circuit 710 is configured to jointly move the end effector 702. The control circuit 710 provides the motor control unit 708d with a motor set value, and the motor control unit provides a drive signal to the motor 704d. The output shaft of the motor 704d is connected to the torque sensor 744d. The torque sensor 744d is connected to a transmission device 706d connected to the joint movement member 742a. The transmission device 706d includes movable mechanical elements such as a joint movement element for controlling the ± 65 ° joint movement of the end effector 702. In one aspect, the motor 704d is connected to a joint motion nut, which is rotatably pivoted on the proximal end portion of the distal spine portion and joints on the proximal end portion of the distal spine portion. It is rotatably driven by the kinetic gear assembly. The torque sensor 744d provides a joint kinetic force feedback signal to the control circuit 710. The joint kinetic force feedback signal represents the joint kinetic force applied to the end effector 702. A sensor 738, such as a joint motion encoder, may provide the joint motion position of the end effector 702 to the control circuit 710.

In another aspect, the joint motor function of the robotic surgical system 700 may include two joint motor members, or joints 742a, 742b. These joint motion members 742a, 742b are driven by separate discs on a robot interface (rack) driven by two motors 708d, 708e. A separate launch motor 704a is provided to provide resistance holding motion and load to the head when the head is not in motion, and to provide joint motion when the head is in joint motion. Each of the joint motion connecting portions 742a and 742b can be driven antagonistically with respect to the other connecting portions. The joint movement members 742a and 742b are attached to the head with a fixed radius when the head rotates. Therefore, as the head rotates, the mechanical efficiency of the push-pull connection changes. This change in mechanical efficiency can be more pronounced in the drive system of other joint motion connections.

In one aspect, one or more motors 704a-704e may include a gearbox and a brushed DC motor with a mechanical connection to a launching member, closing member, or articulating member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulated joints, closure tubes, and shafts. External effects are unmeasured and unpredictable effects, such as friction on tissues, surrounding bodies, and physical systems. Such external influences are sometimes referred to as drags that act against one of the electric motors 704a-704e. External influences, such as failures, can deviate the behavior of the physical system from the desired behavior of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a gyromagnetic absolute positioning system implemented as an AS5055 EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. The position sensor 734 can provide an absolute positioning system in cooperation with the control circuit 710. The position is located above the magnet and is provided to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. It may include multiple Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the boulder algorithm.

In one aspect, the control circuit 710 may communicate with one or more sensors 738. The sensor 738 is positioned on the end effector 702 and is adapted to work with the robotic surgical instrument 700 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. You may. The sensor 738 is one of a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an induction sensor such as a vortex current sensor, a resistance sensor, a capacitance sensor, an optical sensor, and / or an end effector 702. Alternatively, any other suitable sensor for measuring two or more parameters may be provided. Sensor 738 may include one or more sensors. The sensor 738 may be placed on the deck of the staple cartridge 718 to determine the position of the tissue using the split electrodes. Torque sensors 744a-744e may be configured to sense, among other things, forces such as firing force, closing force, and / or joint kinetic force. Therefore, the control circuit 710 has (1) the closure load received by the distal closure tube and its position, (2) the launching member and its position in the rack, and (3) which part of the staple cartridge 718 has tissue on it. And (4) can sense the load and position on both staples.

In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the anvil 716 during the gripping state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. The sensor 738 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect the impedance of a portion of the tissue located between the anvil 716 and the staple cartridge 718, which impedance is the thickness and / or integrity of the tissue located between them. Show sex.

In one aspect, the sensor 738 is mounted as, among other things, one or more limit switches, electromechanical devices, solid switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers. May be done. In other embodiments, the sensor 738 may be mounted as a solid-state switch that operates under the influence of light, such as light sensors, IR sensors, and UV sensors, among others. Further, the switch may be a solid-state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.

In one aspect, the sensor 738 may be configured to measure the force exerted on the anvil 716 by the closed drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the anvil 716 to detect the closing force applied to the anvil 716 by the closure tube. The force exerted on the anvil 716 may represent the tissue compression applied to a portion of the tissue captured between the anvil 716 and the staple cartridge 718. By positioning one or more sensors 738 at various points of interaction along the closure drive system, the closure force applied to the anvil 716 by the closure drive system can be detected. One or more sensors 738 may be sampled in real time during the clamping operation by the processor of control circuit 710. The control circuit 710 receives real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the anvil 716 in real time.

In one aspect, the current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements, such as the I-beam 714, corresponds to the current drawn by one of the motors 704a-704e. This force is converted into a digital signal and provided to the control circuit 710. The control circuit 710 may be configured to simulate the response of the actual system of the instrument with the software of the controller. The displacement member can be actuated to move the I-beam 714 in the end effector 702 at or around the target speed. The robotic surgical instrument 700 can include a feedback controller, the feedback controller being any feedback controller including, but not limited to, PID, state feedback, linear quadratic (LQR), and / or adaptive controllers. It may be any one of them. The robotic surgical instrument 700 can include a power source for converting signals from the feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force. .. Further details are disclosed in US Patent Application No. 15 / 636,829 entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT", filed June 29, 2017, which is incorporated herein by reference in its entirety. Has been done.

FIG. 18 shows a block diagram of a surgical instrument 750 programmed to control the distal translation of a displacement member according to at least one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control the distal translation of the displacement member, such as the I-beam 764. The surgical instrument 750 comprises an anvil 766, an I-beam 764 (including a sharp cutting edge), and an end effector 752 which may include a removable staple cartridge 768.

The position, movement, displacement, and / or translation of a linear displacement member such as the I-beam 764 can be measured by an absolute positioning system, sensor mechanism, and position sensor 784. Since the I-beam 764 is connected to a drive member that can move in the longitudinal direction, the position of the I-beam 764 is determined by measuring the position of the drive member that can move in the longitudinal direction using the position sensor 784. Can be done. Therefore, in the following description, the position, displacement, and / or translation of the I-beam 764 can be achieved by a position sensor 784 as described herein. The control circuit 760 may be programmed to control the translation of the displacement member, such as the I-beam 764. In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or multiple processors to control a displacement member, such as the I-beam 764, in the manner described. Other suitable processors for execution may be provided. In one aspect, the timer / counter 781 provides an output signal such as elapsed time or digital count to the control circuit 760 to correlate the position of the I-beam 764 determined by the position sensor 784 with the output of the timer / counter 781. As a result, the control circuit 760 can determine the position of the I-beam 764 at a specific time (t) with respect to the start position. The timer / counter 781 may be configured to measure elapsed time, count external events, or measure the time of external events.

The control circuit 760 may generate the motor set value signal 772. The motor set value signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide the motor 754 with a motor drive signal 774 to drive the motor 754, as described herein. In some embodiments, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor and the motor drive signal 774 may include PWM signals provided to one or more stator windings of the motor 754. Also, in some embodiments, the motor controller 758 may be omitted and the control circuit 760 may directly generate the motor drive signal 774.

The motor 754 may receive power from the energy source 762. The energy source 762 may be a battery, a supercapacitor, or any other suitable energy source, or may include it. The motor 754 may be mechanically coupled to the I-beam 764 via a transmission device 756. The transmission device 756 may include one or more gears or other connecting components for connecting the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may or may be any type of sensor capable of generating position data indicating the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the I-beam 764 translates distally and proximally. The control circuit 760 may track the pulse to determine the position of the I-beam 764. Other suitable position sensors, including, for example, proximity sensors may be used. Other types of position sensors may provide other signals indicating the motion of the I-beam 764. Further, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuit 760 may also track the position of the I-beam 764 by summing the number and directions of steps instructed by the motor 754 to perform. The position sensor 784 may be located within the end effector 752 or at any other part of the instrument.

The control circuit 760 may communicate with one or more sensors 788. The sensor 788 is positioned on the end effector 752 and can be adapted to work with the surgical instrument 750 to measure various derived parameters such as clearance distance and time, tissue compression and time, and anvil strain and time. .. The sensor 788 is one or more of induction sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or end effectors 752. Any other suitable sensor for measuring the parameter may be provided. Sensor 788 may include one or more sensors.

One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the anvil 766 during the gripped state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of a portion of the tissue located between the anvil 766 and the staple cartridge 768, which indicates the thickness and / or integrity of the tissue located between them.

The sensor 788 may be configured to measure the force exerted on the anvil 766 by the closed drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closure tube. The force exerted on the anvil 766 may represent the tissue compression received by the tissue portion captured between the anvil 766 and the staple cartridge 768. By positioning one or more sensors 788 at various points of interaction along the closure drive system, the closure force applied by the closure drive system to the anvil 766 can be detected. One or more sensors 788 may be sampled in real time during the clamping operation by the processor of control circuit 760. The control circuit 760 receives real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the anvil 766 in real time.

A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current drawn by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

The control circuit 760 may be configured to simulate the response of the actual system of the instrument with the software of the controller. The displacement member can be actuated to move the I-beam 764 in the end effector 752 at or around the target speed. The surgical instrument 750 can include a feedback controller, the feedback controller being any one of any feedback controllers including, but not limited to, for example, PID, state feedback, LQR, and / or adaptive controllers. It may be one. The surgical instrument 750 can include a power source for converting signals from the feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force.

The actual drive system for the surgical instrument 750 is such that the displacement member, cutting member, or I-beam 764 is driven by a brushed DC motor with a gearbox and a mechanical connection to the joint movement and / or knife system. It is configured in. Another example is, for example, an electric motor 754 that operates a displacement member of a replaceable shaft assembly and a joint motion driver. External effects are unmeasured and unpredictable effects, such as friction on tissues, surrounding bodies, and physical systems. Such external influences are sometimes referred to as failures acting against the electric motor 754. External influences, such as failures, can deviate the behavior of the physical system from the desired behavior of the physical system.

Various exemplary embodiments are directed to a surgical instrument 750 with an end effector 752 having motor-driven surgical staple fastening and cutting means. For example, the motor 754 may drive the displacement members distally and proximally along the longitudinal axis of the end effector 752. The end effector 752 may include a pivotable anvil 766 and a staple cartridge 768 positioned opposite the anvil 766 if configured for use. The clinician can grip the tissue between the anvil 766 and the staple cartridge 768 as described herein. When the instrument 750 is ready for use, the clinician may provide a firing signal, for example by pressing the trigger on the instrument 750. In response to the firing signal, the motor 754 drives the displacement member distally along the longitudinal axis of the end effector 752 from the proximal stroke start position to the stroke end position distal to the stroke start position. be able to. As the displacement member translates distally, an I-beam 764 with a cutting element located at the distal end can cut the tissue between the staple cartridge 768 and the anvil 766.

In various embodiments, the surgical instrument 750 provides a control circuit 760 programmed to control the distal translation of a displacement member, such as an I-beam 764, based on one or more tissue conditions. You may prepare. The control circuit 760 may be programmed to sense tissue conditions such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a launch control program based on tissue conditions. The launch control program can describe the distal motion of the displacement member. Various launch control programs can be selected to better handle different tissue conditions. For example, in the presence of thicker tissue, the control circuit 760 may be programmed to translate the displacement member at a slower speed and / or at a lower power. In the presence of thinner tissue, the control circuit 760 may be programmed to translate the displacement member faster and / or at higher power.

In some embodiments, the control circuit 760 may first operate the motor 754 in an open loop configuration at the first open loop portion of the displacement member stroke. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a launch control program. The response of the instrument is the sum of the translational distance of the displacement member between the open loop portions, the time elapsed between the open loop portions, the energy provided to the motor 754 during the open loop portions, and the pulse width of the motor drive signal. And so on. After the open loop portion, the control circuit 760 may implement the selected launch control program for the second portion of the displacement member stroke. For example, during the closed loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed loop manner based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. Further details are incorporated herein by reference in its entirety, US Patent Application No. 15 / 720,852, entitled "SYSTEM AND METHODS FOR CONTOROLRING A DISPLAY OF A SURGICAL INSTRUMENT", filed September 29, 2017. It is disclosed in.

FIG. 19 is a schematic representation of a surgical instrument 790 configured to control various functions according to at least one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of the displacement member, such as the I-beam 764. The surgical instrument 790 includes an end effector 792 that may include an anvil 766, an I-beam 764, and a removable staple cartridge 768 that can be replaced with an RF cartridge 796 (shown by a dashed line).

In one aspect, the sensor 788 may be implemented, among other things, as a limit switch, electromechanical device, solid switch, Hall effect device, MR device, GMR device, magnetometer. In other embodiments, the sensor 638 may be a solid-state switch that operates under the influence of light, especially light sensors, IR sensors, UV sensors, and the like. Further, the switch may be a solid-state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.

In one aspect, the position sensor 784 may be implemented as an absolute positioning system comprising a magnetic rotation absolute positioning system implemented as an AS5055EQFT single chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 784 can provide an absolute positioning system in cooperation with the control circuit 760. The position is located above the magnet and is provided to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. It may include multiple Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the boulder algorithm.

In one aspect, the I-beam 764 may be mounted as a knife member with a knife body operably supporting the tissue cutting blade on top, further including an anvil engaging tab or mechanism and a passage engaging mechanism or foot. It's fine. In one aspect, the staple cartridge 768 may be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, the RF cartridge 796 may be mounted as an RF cartridge. These and other sensor configurations, which are incorporated herein by reference in their entirety, are entitled "TECHNIQUES FOR ADAPTIVE CONTROL CONTOROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT", date 20 June 2017. It is described in US Patent Application No. 15 / 628,175, which has a common owner.

The position, movement, displacement, and / or translation of a linear displacement member, such as the I-beam 764, can be measured by an absolute positioning system, sensor configuration, and a position sensor represented as a position sensor 784. Since the I-beam 764 is connected to a drive member that can move in the longitudinal direction, the position of the I-beam 764 is determined by measuring the position of the drive member that can move in the longitudinal direction using the position sensor 784. Can be done. Therefore, in the following description, the position, displacement, and / or translation of the I-beam 764 can be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of the displacement member, such as the I-beam 764, as described in the present invention. In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or multiple processors to control a displacement member, such as the I-beam 764, in the manner described. Other suitable processors for execution may be provided. In one aspect, the timer / counter 781 provides an output signal such as elapsed time or digital count to the control circuit 760 to correlate the position of the I-beam 764 determined by the position sensor 784 with the output of the timer / counter 781. As a result, the control circuit 760 can determine the position of the I-beam 764 at a specific time (t) with respect to the start position. The timer / counter 781 may be configured to measure elapsed time, count external events, or measure the time of external events.

The control circuit 760 may generate the motor set value signal 772. The motor set value signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide the motor 754 with a motor drive signal 774 to drive the motor 754, as described herein. In some embodiments, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor and the motor drive signal 774 may include PWM signals provided to one or more stator windings of the motor 754. Also, in some embodiments, the motor controller 758 may be omitted and the control circuit 760 may directly generate the motor drive signal 774.

The motor 754 can receive power from the energy source 762. The energy source 762 may be a battery, a supercapacitor, or any other suitable energy source, or may include it. The motor 754 may be mechanically coupled to the I-beam 764 via a transmission device 756. The transmission device 756 may include one or more gears or other connecting components for connecting the motor 754 to the I-beam 764. The position sensor 784 can sense the position of the I-beam 764. The position sensor 784 may or may be any type of sensor capable of generating position data indicating the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the I-beam 764 translates distally and proximally. The control circuit 760 may track the pulse to determine the position of the I-beam 764. Other suitable position sensors, including, for example, proximity sensors may be used. Other types of position sensors may provide other signals indicating the motion of the I-beam 764. Further, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuit 760 may also track the position of the I-beam 764 by summing the number and directions of steps instructed by the motor to perform. The position sensor 784 may be located within the end effector 792 or at any other part of the instrument.

The control circuit 760 may communicate with one or more sensors 788. The sensor 788 is positioned on the end effector 792 and may be adapted to work with the surgical instrument 790 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. .. The sensor 788 is one or more of induction sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or end effectors 792. Any other suitable sensor for measuring the parameter may be provided. Sensor 788 may include one or more sensors.

One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the anvil 766 during the gripped state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of a portion of the tissue located between the anvil 766 and the staple cartridge 768, which indicates the thickness and / or integrity of the tissue located between them.

The sensor 788 may be configured to measure the force exerted on the anvil 766 by a closed drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closure tube. The force exerted on the anvil 766 may represent the tissue compression applied to a portion of the tissue captured between the anvil 766 and the staple cartridge 768. By positioning one or more sensors 788 at various points of interaction along the closure drive system, the closure force applied by the closure drive system to the anvil 766 can be detected. One or more sensors 788 may be sampled in real time during gripping operation by the processor portion of control circuit 760. The control circuit 760 receives real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the anvil 766 in real time.

A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current drawn by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

The RF energy source 794 is coupled to the end effector 792 and is applied to the RF cartridge 796 when the RF cartridge 796 is loaded into the end effector 792 instead of the staple cartridge 768. The control circuit 760 controls the delivery of RF energy to the RF cartridge 796.

Further details are incorporated herein by reference in their entirety, "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING US Pat. / 636,096.

FIG. 20 shows a stroke length graph 20740 showing how the control system can modify the stroke length of the closed tube assembly based on the joint motion angle θ. Such a stroke length correction is a stroke length after correcting the stroke length (eg, y) so that the joint motion angle θ increases (eg, defined along the x-axis). Includes shrinking to (defined along the axis). The length of the corrected stroke defines the length of movement of the closed tube assembly in the distal direction to close the jaw of the end effector, which length depends on the joint motion angle θ. It also prevents the closed tube assembly from moving excessively and causing damage to the surgical device.

For example, as shown in the stroke length graph 20740, the stroke length of the closed tube assembly is about 0.250 inch when the end effector is not in joint movement, and the joint movement angle θ is about 60. In degrees, the corrected stroke length is about 0.242 inches. Such measurements are provided as an example only and may include various angles and any of the corresponding stroke lengths and corrected stroke lengths without departing from the scope of the present disclosure. it can. Further, the relationship between the joint motion angle θ and the corrected stroke length is non-linear, and as the joint motion angle increases, the ratio of the corrected stroke length shortening also increases. For example, the reduction of the stroke length after correction of the joint movement of 45 to 60 degrees is larger than the reduction of the stroke length after the correction of the joint movement of zero to 15 degrees. In this technique, the control system adjusts the length of the stroke based on the joint motion angle θ to cause damage to the surgical device (eg, clog the distal end of the closed tube assembly in the distal position). Although prevented, the distal closure can still advance during joint movement, which can at least partially close the jaw.

FIG. 21 shows a closed tube assembly positioning graph 20750 showing an aspect in which the control system modifies the longitudinal position of the closed tube assembly based on the joint motion angle θ. Such a modification of the longitudinal position of the closed tube assembly allows the closed tube assembly to be jointed by the correction distance (eg, defined along the y-axis) when the end effector is jointed. For example, it involves retracting proximally based on (defined along the x-axis). The corrected distance at which the closed tube assembly is retracted proximally prevents the distal advance of the closed tube, thereby keeping the jaw in an open position during joint movement. By retracting the closed tube assembly proximally by a compensating distance during joint movement, the closed tube assembly strokes starting from a proximally retracted position to close the jaw when the closed tube assembly is activated. You can go the length of.

For example, as shown in the closed tube assembly positioning graph 20750, the correction distance when the end effector is not in joint movement is zero, and the correction distance when the joint movement angle θ is about 60 degrees is about 0. It is 008 inches. In this example, the closed tube assembly is retracted by a correction distance of 0.008 inches during joint movement. Therefore, to close the jaw, the closed tube assembly can advance the length of the stroke starting from this retracted position. Such measurements are provided, for example, for purposes only and may include any of the various angles and corresponding correction distances without departing from the scope of the present disclosure. As shown in FIG. 21, the relationship between the joint movement angle θ and the correction distance is non-linear, and as the joint movement angle θ increases, the ratio of the correction distance increasing also increases. For example, an increase in the correction distance of 45 to 60 degrees is greater than an increase in the correction distance of zero to 15 degrees.

When gripping a patient's tissue, the force exerted through the gripping device (eg, a linear stapler) can reach unacceptably high levels. For example, if a constant closing rate is adopted, the force may be large enough to cause excessive trauma to the stapled tissue, causing deformation of the stapler. Acceptable tissue gaps may not be maintained across the stapled pathway. FIG. 22 shows the power applied to the tissue during compression at a constant anvil closure rate (ie, without utilizing controlled tissue compression (CTC)) and during compression at a variable anvil closure rate (ie, by CTC). It is a graph which shows the electric power applied to an organization. The closure rate may be adjusted to control tissue compression so that the power applied to the tissue remains constant over a portion of the compression. The peak power applied to the tissue according to FIG. 22 is much lower when the variable anvil closure rate is utilized. Based on the power applied, the force exerted by the surgical device (a force-related parameter or a force-proportional parameter) can be calculated. In this regard, the power is stapled when the force exerted through a surgical device, such as the jaw of a linear stapler, is in a completely closed position due to the jaw spreading out. It may be restricted so that it does not exceed a yield force or pressure that is no longer acceptable along the entire length. For example, the jaw should be parallel or sufficiently close so that the tissue gap remains within an acceptable or target range for all staple positions along the entire length of the jaw. In addition, the power limits applied avoid, or at least minimize, trauma or damage to the tissue.

In FIG. 22, the total energy delivered in the CTC-free method is the same as the total energy delivered in the CTC-based method, i.e. the regions under the power curve in FIG. 22 are the same or substantially. It is the same. However, the difference in power profiles used is considerably larger in the examples using CTC because the peak power is much lower in the examples using CTC than in the example using CTC.

The power limit is achieved in the examples using CTC by reducing the closing speed, as indicated by line 20760. Note that the compression time B'is longer than the closure time B. As shown in FIG. 22, devices and methods that provide constant closure rates (ie, without CTC) have the same 1 mm tissue gap as devices and methods that provide variable closure rates (ie, with CTC). Achieve the same 50 lb compressive force. Devices and methods that provide a constant closing rate can achieve compressive forces in the desired tissue gap in a shorter period of time compared to devices and methods that use variable closing rates, which is shown in FIG. 22. As shown in, it will cause a spike in the power applied to the tissue. In contrast, the exemplary embodiment shown in the CTC slows down the closure rate and limits the amount of power applied to the tissue so that it does not exceed a certain level. By limiting the power applied to the tissue, tissue trauma can be minimized for CTC-free systems and methods.

FIG. 22 and additional illustrations are published August 6, 2013, entitled "DEVICE AND METHOD FOR CONTOROLRING COMPRESSION OF TISSUE", filed June 1, 2012, the entire disclosure of which is incorporated herein by reference. It is further described in US Pat. No. 8,499,992.

In some embodiments, the control system assists the control system in determining the position of the E-beam and / or the joint motion of the firing shaft and appropriately controlling at least one motor based on such determination. It can contain multiple predefined force thresholds. For example, force thresholds can vary depending on the length of movement of the launch bar configured to translate the launch shaft, and such force thresholds can be one or more that communicate with the control system. Can be compared with the measured torsional force of the motor. Comparison of the measured torsional force against the force threshold can provide a method by which the control system can rely on to determine the position of the E-beam and / or the joint movement of the end effector. This allows the control system to properly control one or more motors (eg, reduce or stop torsional loads) to ensure proper launch of the launch assembly and joint movement of the end effector. It makes it possible to do so and prevent damage to the system.

FIG. 23 shows a force and displacement graph 20800, including the measured force in section A, related to the measured displacement in section B. Both sections A and B have an x-axis that defines time (eg, seconds). The y-axis of section B defines the displacement of the launch rod (eg, in millimeters), and the y-axis of section A defines the force applied to the launch bar, thereby advancing the launch shaft. As shown in Section A, movement of the launch bar within the first joint movement range 20902 (eg, the first approximately 12 mm movement) causes the end effector to joint. For example, at a displacement position of 12 mm, the end effector is fully articulated to the right, and further articulation is mechanically impossible. As a result of full joint movement, the torsional force on the motor increases and the control system can sense a joint movement peak 20802 that exceeds the predefined joint movement threshold 20804, as shown in Section A. The control system can include two or more predefined joint movement thresholds 20804 for sensing two or more maximum joint movement directions (eg, left joint movement and right joint movement). After the control system detects a joint kinetic force peak 20802 that exceeds a predetermined joint kinetic threshold 20804, the control system can reduce or stop the operation of the motor, thereby at least protecting the motor from damage.

After the launch bar has advanced beyond the range of joint motion 20902, a shift mechanism within the surgical stapler can cause a distal movement of the launch shaft by further distally moving the launch bar. For example, as shown in Section B, a movement of about 12 mm to 70 mm of movement displacement can advance the E-beam along the firing stroke 20904 and cut the tissue captured between the jaws. Other lengths of movement are also within the scope of this disclosure. In this embodiment, the maximum firing stroke position 20906 of the E-beam occurs at a movement of 70 mm. At this point, the E-beam or knife abuts on the cartridge or the distal end of the jaw, thereby increasing the torsional force on the motor and causing the control system to sense the knife movement peak 20806 as shown in Section A. .. As shown in Section A, the control system includes a motor threshold 20808 and a knife movement threshold 20810 that branches off from the motor threshold 20808 and decreases (eg, non-linearly) as the E-beam approaches the maximum firing stroke position 20906. be able to.

The control system applies the motor torsional force sensed during at least the last portion of the E-beam's distal movement 20907 (eg, the last 10 percent of the firing stroke 904) before reaching the maximum firing stroke position 20906. It can be configured to monitor. While monitoring along such a last portion of the distal movement 20907, the control system can reduce the torsional force on the motor, thereby reducing the load on the E-beam. This can prevent damage to the surgical stapler containing the E-beam by reducing the load on the E-beam as it approaches the maximum firing stroke position 20906, thereby distant from the cartridge or jaw. The impact of the E-beam on the position edge is reduced. As mentioned above, such an impact causes a knife movement peak 20806, which may exceed the knife movement threshold 20810 but does not exceed the motor threshold 20808 and thus does not damage the motor. .. Therefore, the control system shuts down the motor before the knife movement peak 20806 exceeds the knife movement threshold 20810 and the knife movement peak 20806 exceeds the motor threshold 20808, thereby protecting the motor from damage. Further, increasing the reduction of the knife movement threshold 20810 prevents the control system from inferring in advance that the E-beam has reached the maximum firing stroke position 20906.

After the control system detects the knife movement peak 20806 above the knife movement threshold 20810, the control system can confirm the position of the E-beam (eg, 70 mm displacement and / or the end of the firing stroke 20904), as such. The launch bar can be retracted based on knowing the displacement position to reset the E-beam at the most proximal position 20908 (eg, 0 mm displacement). At the most proximal position 20908, a knife retreat peak 20812 above the predefined knife retreat threshold 20814 can be sensed by the control system as shown in Section A. At this point, the control system can be recalibrated as needed, with subsequent advancement of the firing rod in the distal direction (eg, approximately 12 mm in length) of the shifter from the firing bar to the E-beam. The position of the E-beam can be associated so that it is in the home position to disengage. When disengaged, the launch bar moves within the joint motion range 20902, causing the end effector joint motion again.

Therefore, the control system controls the movement of the launch bar and compares such perceived torsional forces to multiple thresholds to determine the position of the E-beam or the joint motion angle of the end effector, thereby causing the motor. It can be properly controlled to prevent damage to the motor, and the position of the firing bar and / or E-beam can be confirmed.

As described above, the tissue contact sensor or pressure sensor determines when the jaw member first contacts the tissue "T". This allows the surgeon to determine the initial thickness of the tissue "T" and / or the thickness of the tissue "T" before grasping. In any of the aspects of the surgical instrument described above, as shown in FIG. 24, the contact of the jaw member with the tissue "T" is with the pair of opposing plates "P1, P2" provided on the jaw member. By establishing contact with, the otherwise open sensing circuit "SC" is closed. The contact sensor may also include a force sensitive transducer that determines the amount of force applied to the sensor, which can be assumed to be the same as the amount of force applied to the tissue "T". .. After such force is applied to the tissue, it may be converted into the amount of tissue compression. The force sensor measures the amount of compression the tissue receives and provides the surgeon with information about the force applied to the tissue "T". Excessive tissue compression can adversely affect the tissue "T" being operated on. For example, excessive compression of tissue "T" can result in tissue necrosis and, with certain treatments, staple line breakage. Information about the pressure applied to the tissue "T" can better determine that the surgeon is not applying excessive pressure to the tissue "T".

Any contact sensor disclosed herein is located on the inner surface of the jaw, which closes, but is not limited to, a sensing circuit that is otherwise open when in contact with tissue. Can include electrical contacts. The contact sensor may also include a force sensitive transducer that detects when the tissue being held resists compression. The force converter is not limited to this, but is used to drive a piezoelectric element, a piezoresistive element, a metal film or semiconductor strain gauge, an induced pressure sensor, a capacitive pressure sensor, and a wiper arm on the resistance element. Can be mentioned as a potential differential pressure converter using a Bourdon tube, capsule or fugo.

In one aspect, any one of the surgical instruments described above may include one or more piezoelectric elements for detecting changes in pressure occurring on the jaw member. A piezoelectric element is a bidirectional converter that converts stress into an electric potential. The element may be composed of metallized quartz or ceramic. When stress is applied to the crystal during operation, the charge distribution of the material changes and a voltage is generated throughout the material. Piezoelectric elements may be used to indicate the amount of pressure exerted on the tissue "T" after any one or both of the jaw members have contacted the tissue "T" and the contact has been established.

In one aspect, any one of the surgical instruments described above may include, or comprises, one or more metal strain gauges located within or on a portion of the body thereof. You may. Metal strain gauges operate on the principle that the resistance of the material depends on the length, width, and thickness. Therefore, when the material of the metal strain gauge is strained, the resistance of the material changes. Therefore, a resistor built into the circuit, made of this material, converts the distortion into a change in the electrical signal. Desirably, the strain gauge may be placed on the surgical instrument so that the pressure applied to the tissue affects the strain gauge.

Alternatively, in another aspect, one or more semiconductor strain gauges may be used in the same manner as the metal strain gauges described above, but with different modes of conversion. During operation, as the crystal lattice structure of the semiconductor strain gauge deforms as a result of the applied stress, the resistance of the material changes. The observed phenomenon is sometimes referred to as the "piezoresistive effect".

In yet another aspect, any one of the surgical instruments described above may include one or more inductive pressure sensors to convert pressure or force into motion of the inductive elements relative to each other. It may or may be provided. The movement of these inductive elements relative to each other changes the overall inductance or inductive coupling. Capacitive pressure transducers likewise convert pressure or force into the motion of a capacitive element that changes the overall capacitance.

In yet another aspect, any one of the surgical instruments described above may be one or two to convert pressure or force into the motion of a capacitive element that changes the overall capacitance. The above capacitance type pressure converter may be included or may be provided.

In one aspect, any one of the surgical instruments described above may include, or comprises, one or more mechanical pressure transducers for converting pressure or force into motion. May be good. During use, the movement of mechanical elements is used to deflect the pointer or dial on the gauge. This movement of the pointer or dial can represent the pressure or force exerted on the tissue "T". Examples of mechanical elements include, but are not limited to, Bourdon tubes, capsules or bellows. As an example, the mechanical element may be coupled with other measuring and / or sensing elements such as potentiometer pressure transducers. In this embodiment, the mechanical element is coupled with a wiper on a variable resistor. During use, the pressure or force is converted into a mechanical motion that deflects the wiper on the potentiometer to reflect the applied pressure or force, thereby varying the resistance and reflecting the applied pressure or force. May be good.

The combination of the above embodiments, in particular the gap and tissue contact sensor, provides the surgeon with feedback and / or real-time information regarding the condition of the surgical site and / or the target tissue "T". For example, information about the initial thickness of tissue "T" could guide the surgeon in choosing the appropriate staple size, and information about the grasped thickness of tissue "T" was selected. The surgeon can be informed if the staples are properly formed and the amount of compression or strain on the tissue "T" using information about the initial thickness of the tissue "T" and the thickness grasped. And the information related to the strain on the tissue "T" can also be used to avoid staping to the tissue that has been subjected to excessive strain values and / or excessive strain.

In addition, force sensors may be used to provide the surgeon with the amount of pressure exerted on the tissue. The surgeon may use this information to avoid applying excessive pressure to the tissue "T" that has experienced excessive strain.

FIG. 24 and additional illustrations were filed on June 27, 2011, the entire disclosure of which is incorporated herein by reference, entitled "SURGICAL INSTRUMENT EMPLOYING SENSORS" and published May 5, 2012. It is further described in US Patent Application No. 8,181,839.

Specific embodiments are presented and described to provide an understanding of the structure, function, manufacture, and use of the disclosed devices and methods. The features shown or described in one embodiment may be combined with the features of another embodiment, and modified and modified forms are within the scope of the present disclosure.

The terms "proximal" and "distal" are for clinicians who operate the handles of surgical instruments, "proximal" refers to the part closer to the clinician, and "distal" is more from the clinician. Refers to the distant part. For convenience, the spatial terms "vertical," "horizontal," "top," and "bottom" used with respect to drawings are limited and / or absolute, as surgical instruments can be used in a variety of orientations and positions. Not intended to be.

Illustrative devices and methods for performing laparoscopic and minimally invasive surgical procedures are provided. However, such devices and methods can be used for other surgical procedures and applications, including, for example, open surgery. Surgical instruments can be inserted through natural openings or through incisions or puncture holes formed within the tissue. The working part of the instrument, the end effector part, can be inserted directly into the body or through an access device with a working passage that allows the end effector and elongated shaft of the surgical instrument to be advanced. it can.

25-28 depict motor-driven surgical instruments 150010 for cutting and fastening that may or may not be reused. In the illustrated embodiment, the surgical instrument 150010 includes a housing 15012 with a handle assembly 150014 configured to be grasped, operated, and actuated by a clinician. The housing 150012 is configured to be operably attached to a replaceable shaft assembly 150200 in which an end effector 150300 configured to perform one or more surgical tasks or procedures is operably coupled. There is. According to the present disclosure, various forms of interchangeable shaft assemblies can be effectively used in connection with robotic controlled surgical systems. Thus, the term "housing" accommodates or operably supports at least one drive system configured to generate and add at least one control motion available to actuate an interchangeable shaft assembly. , The housing of the robot system or similar parts can be included. The term "frame" may refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robot-controlled surgical instrument and / or a portion of a robotic system that can be used to operably control a surgical instrument. The interchangeable shaft assembly is a variety of robots disclosed in US Pat. No. 9,072,535, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," which is incorporated herein by reference in its entirety. It may be used with systems, instruments, components, and methods.

FIG. 25 is a perspective view of a surgical instrument 150010 having an operably connected interchangeable shaft assembly 150200 according to at least one aspect of the present disclosure. Housing 15012 includes an end effector 150300 with a surgical cutting and fastening device configured to operably support the surgical staple cartridge 150304 therein. Housing 150012 includes end effectors adapted to support staple cartridges of various sizes and types for use in connection with replaceable shaft assemblies of various shaft lengths, sizes and types. It may be configured in. The housing 150012 is an end effector configuration adapted to use other motions and other forms of energy such as radio frequency (RF) energy, ultrasonic energy and / or motion in connection with various surgical applications and procedures. May be used with a variety of interchangeable shaft assemblies, including assemblies configured to apply to. End effectors, shaft assemblies, handles, surgical instruments, and / or surgical instrument systems can utilize any suitable fastener to fasten the tissue. For example, a fastener cartridge with a plurality of fasteners detachably stored therein can be detachably inserted and / or mounted on an end effector of a shaft assembly.

The handle assembly 15014 may include a pair of interconnectable handle housing segments 15001, 150018 that may be interconnected with screws, snap mechanisms, adhesives, and the like. The handle housing segments 150016 and 150018 work together to form a pistol grip portion 150019 that can be grasped and manipulated by the clinician. The handle assembly 150014 operably supports a plurality of drive systems configured to generate a control motion and add it to the corresponding portion of the replaceable shaft assembly operably attached to the handle assembly. ing. The display may be provided below the cover 150045.

FIG. 26 is an exploded view of a portion of the surgical instrument 150010 of FIG. 25 according to at least one aspect of the present disclosure. The handle assembly 150014 may include a frame 150020 that operably supports a plurality of drive systems. The frame 150020 can operably support a "first", i.e., closed drive system 150030, which can apply closing and opening motions to the interchangeable shaft assembly 150200. The closed drive system 150030 may include an actuator such as a closed trigger 150032 that is pivotally supported by the frame 150020. The closure trigger 150032 allows the closure trigger 150032 to be operated by the clinician by being pivotally coupled to the handle assembly 150014 by a pivot pin 150033. When the clinician grips the pistol grip portion 150019 of the handle assembly 15001, the closure trigger 150032 is placed in the starting position or the "non-actuated" position to the "actuated" position, more specifically in a fully compressed position or. It can be pivoted to a fully activated position.

The handle assembly 150014 and frame 150020 may operably support a launch drive system 150080 configured to apply launch motion to the corresponding parts of the interchangeable shaft assembly attached to them. The launch drive system 150080 may utilize an electric motor 150082 installed in the pistol grip portion 150019 of the handle assembly 150014. The electric motor 150082 may be, for example, a brushed DC motor having a maximum rotation speed of about 25,000 RPM. In other configurations, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The electric motor 150082 may be powered by a power source 150090 that may include a removable power pack 150092. The removable power pack 150092 may include a proximal housing portion 150094 configured to attach to the distal housing portion 150096. The proximal housing portion 150094 and the distal housing portion 150096 are configured to operably support a plurality of batteries 150098 therein. Each battery 150098 may include, for example, lithium ion (LI) or other suitable battery. The distal housing portion 150096 is configured to be removable and operably attached to the control circuit board 150100, which is operably coupled to the electric motor 150082. Several batteries 150098 connected in series can power the surgical instrument 150010. The power supply 150090 may be replaceable and / or rechargeable. The display 150043, located below the cover 150045, is electrically coupled to the control circuit board 150100. The cover 15004 may be removed to expose the display 15004.

The electric motor 150082 is a rotary shaft (not shown) that operably cooperates with a gear reducer assembly 150084 mounted in mesh engagement with a set or rack of drive teeth 150122 on a drive member 150120 that is movable in the longitudinal direction. ) Can be included. The longitudinally movable drive member 150120 has a rack of drive teeth 150122 formed on it to mesh and engage with the corresponding drive gear 150086 of the gear reducer assembly 150084.

In use, the voltage polarity provided by the power supply 150090 can cause the electric motor 150082 to operate clockwise, but the voltage polarity applied to the electric motor by the battery causes the electric motor 150082 to operate counterclockwise. It can also be inverted to. When the electric motor 150082 is rotated in one direction, the drive member 150120, which is movable in the longitudinal direction, is driven axially in the distal direction "DD". When the electric motor 150082 is driven in the opposite rotational direction, the drive member 150120, which is movable in the longitudinal direction, is driven axially in the proximal direction "PD". The handle assembly 150014 can include a switch that can be configured to reverse the polarity applied to the electric motor 150082 by the power supply 150090. The handle assembly 150014 may include a sensor configured to detect the position of the longitudinally movable drive member 150120 and / or the direction in which the longitudinally movable drive member 150120 is moved.

The operation of the electric motor 150082 may be controlled by a firing trigger 150130 pivotally supported on the handle assembly 150014. The firing trigger 150130 may be pivoted between the non-actuated position and the actuated position.

Returning to FIG. 25, the replaceable shaft assembly 150200 includes an end effector 150300, which includes an elongated channel 150302 configured to operably support the surgical staple cartridge 150304 therein. The end effector 150300 may include an anvil 150306 that is pivotally supported for an elongated channel 150302. The replaceable shaft assembly 150200 may include a joint joint 150270. The configuration and operation of the end effector 150300 and joint joint 150270 is described in US Patent Application Publication No. 2014/0263541, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK", which is incorporated herein by reference in its entirety. ing. The replaceable shaft assembly 150200 may include a proximal housing or nozzle 150201 composed of nozzle portions 150202, 150203. The replaceable shaft assembly 150200 may include a closing tube 150260 extending along the shaft shaft SA, which can be used to close and / or open the anvil 150306 of the end effector 150300.

Returning to FIG. 25, the method described in U.S. Patent Application Publication No. 2014/0263541, which is the above-mentioned reference, causes the closure tube 150260 to be distally oriented (direction “DD”, for example, in response to the activation of the closure trigger 150032. ”) To translate and close the anvil 150306. The anvil 150306 is opened by translating the closing tube 150260 in the proximal direction. In the open position of the anvil, the closing tube 150260 is moved to its proximal position.

FIG. 27 is a diagram of an assembly shown in another exploded view of a portion of the interchangeable shaft assembly 150200 according to at least one aspect of the present disclosure. The replaceable shaft assembly 150200 may include a launching member 150220 supported to move axially within the spine 150210. The launch member 150220 includes an intermediate launch shaft 150222 configured to attach to a distal cut or knife bar 150280. The launching member 150220 is sometimes referred to as a "second shaft" or "second shaft assembly". The intermediate launch shaft 150222 may include, at its distal end, a longitudinal slot 150223 configured to receive a tab 150284 at the proximal end 150282 of the knife bar 150280. The longitudinal slot 150223 and the proximal end 150282 may be configured to allow relative movement between them and may include a slip joint 150286. The slip joint 150286 may allow the intermediate launch shaft 150222 of the launch member 150220 to joint the end effector 150300 around the joint 150270 without moving the knife bar 150280, or at least substantially. Once the end effector 150300 is properly oriented, the intermediate launch shaft 150222 is advanced distally to advance the knife bar 150280 into the channel 150302 until the proximal side wall of the longitudinal slot 150223 contacts the tab 150284. Positioned staple cartridges can be fired. The spine 150210 has an elongated opening or window 150213 inside to facilitate assembly and insertion of the intermediate launch shaft 150222 into the spine 150210. Once the intermediate launch shaft 150222 is inserted there, the top frame segment 150215 can be engaged with the shaft frame 150212 to enclose the intermediate launch shaft 150222 and the knife bar 150280 inside. The operation of the launching member 150220 can be found in US Patent Application Publication No. 2014/0263541. The spine 150210 may be configured to slidably support the launching member 150220 and the closing tube 150260 extending around the spine 150210. The spine 150210 may slidably support the joint motion driver 150230.

The replaceable shaft assembly 150200 may include a clutch assembly 150400 configured to selectively and removably connect the joint motion drive 150230 to the launch member 150220. The clutch assembly 150400 includes a lock collar or lock sleeve 150402 located around the launch member 150220, the lock sleeve 150402 is an engaging position where the lock sleeve 150402 engages the joint motion drive 150230 to the launch member 150220. The joint motion drive 150230 can be rotated to and from an disengaged position that is not operably coupled to the launching member 150220. When the lock sleeve 150402 is in its engaging position, the distal movement of the launching member 150220 allows the joint motion drive 150230 to be moved distally and correspondingly to the launching member 150220. Proximal movement allows the joint motion drive 150230 to be moved proximally. When the lock sleeve 150402 is in its disengaged position, the movement of the launching member 150220 is not transmitted to the joint motion drive 150230, resulting in the launching member 150220 moving independently of the joint motion drive 150230. Can be made to. Nozzle 150201 can be used to operably engage and disengage a joint drive system and a launch drive system in various manners described in U.S. Patent Application Publication No. 2014/0263541. it can.

The replaceable shaft assembly 150200 may comprise a slip ring assembly 150600, which may, for example, transfer power to and / or end effector 150300 to and / or end effector 150300. / Or can be configured to communicate signals from the end effector 150300. The slip ring assembly 150600 can include a proximal connector flange 150604 and a distal connector flange 150601 arranged inside a slot defined within nozzle portions 150202, 150203. The proximal connector flange 150604 can comprise a first surface and the distal connector flange 150601 is located adjacent to the first surface and has a second surface that is movable relative to the first surface. Can be prepared. The distal connector flange 150601 can rotate about the shaft axis SA-SA (FIG. 25) with respect to the proximal connector flange 150604. The proximal connector flange 150604 can comprise a plurality of concentric, or at least substantially concentric, conductors 150602 defined on its first surface. The connector 150607 can be mounted proximal to the distal connector flange 150601 and may have multiple contacts, each of which corresponds to one of the conductors 150602 and is in electrical contact with it. are doing. Such a configuration allows the proximal connector flange 150604 and the distal connector flange 150601 to rotate relative to each other while maintaining electrical contact between them. Proximal connector flange 150604 may include, for example, an electrical connector 150606 capable of communicating conductor 150602 with a shaft circuit board. In at least one case, a wiring harness with a plurality of conductors may extend between the electrical connector 150606 and the shaft circuit board. The electrical connector 150606 may extend proximally through a connector opening defined within the chassis mounting flange. US Patent Application Publication No. 2014/0263551, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM", is incorporated herein by reference in its entirety. US Patent Application Publication No. 2014/0263552, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM", is incorporated herein by reference in its entirety. Further details regarding the slip ring assembly 150600 may be found in US Patent Application Publication No. 2014/0263541.

The replaceable shaft assembly 150200 may include a proximal portion fixably attached to the handle assembly 150014 and a distal portion that is rotatable about a longitudinal axis. The rotatable distal shaft portion can be rotated relative to the proximal portion about the slip ring assembly 150600. The distal connector flange 150601 of the slip ring assembly 150600 can be positioned within a rotatable distal shaft portion.

FIG. 28 is an exploded view of one aspect of the end effector 150300 of the surgical instrument 150010 of FIG. 25 according to at least one aspect of the present disclosure. The end effector 150300 may include an anvil 150306 and a surgical staple cartridge 150304. The anvil 150306 may be coupled to an elongated channel 150302. By defining an opening 150199 in an elongated channel 150302 to receive a pin 150152 extending from the anvil 150306, the anvil 150306 is pivoted from an open position to a closed position with respect to the elongated channel 150302 and the surgical staple cartridge 150304. Can be made possible. The launch bar 150172 is configured to translate longitudinally into the end effector 150300. The launch bar 150172 may be constructed from one solid piece or may include a laminated material containing a stack of steel plates. The launch bar 150172 comprises an I-beam 150178 and a cutting edge 150182 at its distal end. A distally projecting end of the launch bar 150172 is attached to the I-beam 150178 to allow space from the surgical staple cartridge 150304 located within the elongated channel 150302 when the anvil 150306 is in the closed position. It can assist in arranging 150306. The I-beam 150178 may include a sharp cutting edge 150182 to cut tissue as the I-beam 150178 is advanced distally by the launch bar 150172. During operation, the I-beam 150178 may or fires a surgical staple cartridge 150304. The surgical staple cartridge 150304 may include a molded cartridge body 150194 that holds a plurality of staples 150191 mounted on the staple driver 150192 into staple recesses 150195 that are opened upwards, respectively. The wedge-shaped thread 150190 is driven distally by the I-beam 150178 and slides onto the cartridge tray 150196 of the surgical staple cartridge 150304. The wedge-shaped thread 150190 cams the staple driver 150192 upward while the cutting edge 150182 of the I-beam 150178 cuts the gripped tissue, pushing out the staple 150191 and deforming contact with the anvil 150306.

The I-beam 150178 can include an upper pin 150180 that engages the anvil 150306 during firing. The I-beam 150178 may include a central pin 150184 and a bottom foot 150186 to engage a portion of the cartridge body 150194, cartridge tray 150196, and elongated channel 150302. When the surgical staple cartridge 150304 was placed in the elongated channel 150302, the slot 150193 defined in the cartridge body 150194 was defined in the longitudinal slot 150197 defined in the cartridge tray 150196, and in the elongated channel 150302. It can be aligned with slot 150189. In use, the I-beam 150178 can slide through the aligned longitudinal slots 150193, 150197, and 150189, and as shown in FIG. 28, the bottom foot 150186 of the I-beam 150178 has a slot 150189. Can be engaged in a groove running along the bottom surface of the elongated channel 150302 along the length of the central pin 150184, which engages the top surface of the cartridge tray 150196 along the length of the longitudinal slot 150197. The top pin 150180 can engage the anvil 150306. I-beam 150178 when the firing bar 150172 advances distally to launch staples from the surgical staple cartridge 150304 and / or when incising the tissue captured between the anvil 150306 and the surgical staple cartridge 150304. Can be spaced between the anvil 150306 and the surgical staple cartridge 150304, or their relative movement can be restricted. The launch bar 150172 and the I-beam 150178 are retracted proximally, which allows the anvil 150306 to be opened and release the two stapled and amputated tissue sections.

29A and 29B are block diagrams of the control circuit 150700 of the surgical instrument 150010 of FIG. 25, spanning two drawings, according to at least one aspect of the present disclosure. Primarily with reference to FIGS. 29A and 29B, the handle assembly 150702 may include a motor 150714, which motor can be controlled by a motor drive 150715 and is utilized by the launch system of the surgical instrument 150010. can do. In various embodiments, the motor 150714 may be a brushed DC drive motor with a maximum rotational speed of approximately 25,000 RPM. In another configuration, the motor 150714 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor drive 150715 may include, for example, an H-bridge driver that includes a field effect transistor (FET) 150719. The motor 150714 may be powered by a power assembly 150706 releasably attached to the handle assembly 150200 to supply control power to the surgical instrument 150010. The power assembly 150706 may include multiple batteries connected in series that can be used as a power source to power the surgical instrument 150010. Under certain circumstances, the battery cells of the power supply assembly 150706 may be replaceable and / or rechargeable. In at least one example, the battery cell may be a lithium ion battery that may be separately connectable to the power supply assembly 150706.

The shaft assembly 150704 includes a shaft assembly controller 150722 capable of communicating with the safety controller and the power management controller 150716 via an interface while the shaft assembly 150704 and the power supply assembly 150706 are connected to the handle assembly 150702. be able to. For example, the interface corresponds to allow telecommunications between the shaft assembly controller 150722 and the power management controller 150716 while the shaft assembly 150704 and the power supply assembly 150706 are connected to the handle assembly 150702. 1 for the connection engagement of the first interface portion 150725, which may include one or more electrical connectors for the connection engagement with the shaft assembly electrical connector, and the corresponding power supply assembly electrical connector. It may include a second interface portion 150727, which may include one or more electrical connectors. One or more communication signals can be transmitted through the interface to convey one or more power requirements of the attached interchangeable shaft assembly 150704 to the power management controller 150716. Accordingly, the power management controller may modulate the power output of the battery of the power assembly 150706 according to the power requirements of the attached shaft assembly 150704, as described in more detail below. The connector is actuated after a mechanically connected engagement of the handle assembly 150702 with the shaft assembly 150704 and / or the power assembly 150706 to provide electrical communication between the shaft assembly controller 150722 and the power management controller 150716. Equipped with a switch to enable.

The interface is one or more communication signals between the power management controller 150716 and the shaft assembly controller 150722 by, for example, routing the communication signals through the main controller 150717 in the handle assembly 150702. Can be facilitated. Under other circumstances, the interface is between the power management controller 150716 and the shaft assembly controller 150722 via the handle assembly 150702 while the shaft assembly 150704 and the power supply assembly 150706 are connected to the handle assembly 150702. In some cases, it facilitates direct line communication.

The main controller 150717 may be any single-core or multi-core processor, such as that known as Texas Instruments brand name ARM Cortex. In one aspect, the main controller 150717 improves on-chip memory, performance of up to 40 MHz 256 KB single cycle flash memory or other non-volatile memory, the details of which are available in the product datasheet, to over 40 MHz. Prefetch buffer for, 32KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StaticisWare® software, 2KB electrically erasable programmable read-only memory (EEPROM), 1 Or two or more pulse width modulation (PWM) modules, one or more orthogonal encoder input (QEI) analogs, one or more 12-bit analog-to-digital converters with 12 analog input channels. It may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including (ADC).

The safety controller may be a safety controller platform with two controller-based families, such as the TMS570 and RM4x, also known as Texas Instruments brand name Hercules ARM Cortex R4. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory options. Good.

The power assembly 150706 may include a power management circuit that may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. While the shaft assembly 150704 and the power supply assembly 150706 are connected to the handle assembly 150702, the power management circuit may be configured to modulate the power output of the battery based on the power requirements of the shaft assembly 150704. The power management controller 150716 can be programmed to control the power modulator 150738 of the power output of the power assembly 150706 and utilizes the current sensing circuit 150736 to monitor the power output of the power assembly 150706. By providing the power management controller 150716 with feedback on the power output of the battery, the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. The power management controller 150716 and / or the shaft assembly controller 150722 may each include one or more processors and / or memory units capable of storing a large number of software modules.

The surgical instrument 150010 (FIGS. 25-28) may include an output device 150742 that may include a device for providing sensory feedback to the user. Such devices may include, for example, a visual feedback device (eg, LCD display screen, LED indicator), an audible feedback device (eg, speaker, buzzer) or a tactile feedback device (eg, tactile activator). Under certain circumstances, the output device 150742 may include a display 150743 that may be included in the handle assembly 150702. The shaft assembly controller 150722 and / or the power management controller 150716 can provide feedback to the user of the surgical instrument 150010 via the output device 150742. The interface can be configured to connect the shaft assembly controller 150722 and / or the power management controller 150716 to the output device 150742. The output device 150742 may instead be integrated with the power supply assembly 150706. Under such circumstances, communication between the output device 150742 and the shaft assembly controller 150722 may be accomplished via an interface while the shaft assembly 150704 is coupled to the handle assembly 150702.

The control circuit 150700 includes a circuit segment configured to control the operation of the electrosurgical instrument 150010. The safety controller segment (segment 1) includes a safety controller and a main controller 150717 segment (segment 2). The safety controller and / or main controller 150717 is configured to interact with one or more additional circuit segments such as acceleration segment, display segment, shaft segment, encoder segment, motor segment, and power segment. There is. Each of the circuit segments may be connected to the safety controller and / or the main controller 150717. The main controller 150717 is also connected to the flash memory. The main controller 150717 also includes a serial communication interface. The main controller 150717 comprises, for example, one or more circuit segments, batteries, and / or a plurality of inputs coupled to a plurality of switches. The segmented circuit may be implemented by any suitable circuit, such as, for example, a printed circuit board assembly (PCBA) in an electrosurgical instrument 150010. The term processor, as used herein, combines the functionality of any microprocessor, processor, one or more controllers, or the central processing unit (CPU) of a computer into an integrated circuit or maximum. It should be understood to include other basic computing devices embedded on several integrated circuits in. The main controller 150717 is a versatile programmable device that receives digital data as input, processes the data according to instructions stored in memory, and provides the result as output. This is an example of sequential digital logic because it has internal memory. The control circuit 150700 may be configured to implement one or more of the processes described herein.

The acceleration segment (segment 3) includes an accelerometer. The accelerometer is configured to detect the movement or acceleration of the electrosurgical instrument 150010. Inputs from the accelerometer may be used to identify the transition to and from sleep mode, the orientation of the electrosurgical instrument, and / or when the surgical instrument has fallen. In some examples, the acceleration segment is coupled to the safety controller and / or the main controller 150717.

The display segment (segment 4) includes a display connector connected to the main controller 150717. The display connector connects the main controller 150717 to the display through one or more integrated circuit drivers of the display. The integrated circuit driver for the display may be integrated with the display and / or may be located separately from the display. The display may include any suitable display, such as, for example, an organic light emitting diode (OLED) display, a liquid crystal display (LCD), and / or any other suitable display. In some examples, the display segment is attached to the safety controller.

The shaft segment (segment 5) is a control unit for the replaceable shaft assembly 150200 (FIGS. 25 and 27) connected to a surgical instrument 15001 (FIGS. 25-28) and / or the interchangeable shaft assembly. It comprises one or more control units for the end effector 150300 connected to the 150200. The shaft segment comprises a shaft connector configured to connect the main controller 150717 to the shaft PCBA. The shaft PCBA comprises a ferroelectric random access memory (FRAM), a joint motion switch, a shaft release hole effect switch, and a low power microcontroller having a shaft PCBA EEPROM. The shaft PCBA EEPROM contains one or more parameters, routines, and / or programs specific to the interchangeable shaft assembly 150200 and / or the shaft PCBA. The shaft PCBA may be coupled to the replaceable shaft assembly 150200 and / or may be integral with the surgical instrument 150010. In some examples, the shaft segment comprises a second shaft EEPROM. The second shaft EEPROM is a plurality of algorithms, routines, parameters, and / or other data corresponding to one or more shaft assemblies 150200 and / or end effectors 150300 that may be associated with the electrosurgical instrument 150010. including.

The position encoder segment (segment 6) comprises one or more magnetic angular rotation position encoders. One or more magnetic angular rotation position encoders are the motor 150714 of the surgical instrument 15001 (FIGS. 25-28), the interchangeable shaft assembly 150200 (FIGS. 25 and 27), and / or the end effector 150300. It is configured to identify the rotational position of. In some examples, the magnetic angular rotation position encoder may be coupled to the safety controller and / or the main controller 150717.

The motor circuit segment (segment 7) comprises a motor 150714 configured to control the movement of the electrosurgical instrument 150010 (FIGS. 25-28). The motor 150714 is coupled to the main microcontroller processor 150717 by an H-bridge driver comprising one or more H-bridge field effect transistors (FETs) and a motor controller. The H-bridge driver is also coupled to the safety controller. The motor current sensor is connected in series with the motor in order to measure the withdrawal current of the motor. The motor current sensor is in signal communication with the main controller 150717 and / or the safety controller. In some examples, the motor 150714 is coupled to a motor electromagnetic interference (EMI) filter.

The motor controller controls the first motor flag and the second motor flag to indicate the status and position of the motor 150714 to the main controller 150717. The main controller 150717 provides the motor controller with a pulse width modulation (PWM) high signal, a PWM low signal, a directional signal, a synchronization signal and a motor reset signal via a buffer. The power segment is configured to provide a segment voltage to each of the circuit segments.

The power segment (segment 8) comprises a safety controller, a main controller 150717, and batteries coupled to additional circuit segments. The battery is connected to the segmented circuit by a battery connector and a current sensor. The current sensor is configured to measure the total draw current of the segmented circuit. In some examples, one or more voltage converters are configured to provide a given voltage value to one or more circuit segments. For example, in some examples, the segmented circuit may include a 3.3V voltage converter and / or a 5V voltage converter. The boost transducer is configured to provide a boost voltage up to a predetermined amount, for example up to 13V. Boost transducers are configured to provide additional voltage and / or current during power intensive operation to prevent voltage drops or low power conditions.

A plurality of switches are coupled to the safety controller and / or the main controller 150717. The switch may be configured to control the operation of the surgical instrument 150010 (FIGS. 25-28) of the segmented circuit and / or to indicate the status of the surgical instrument 150010. The emergency exit door switch and the Hall effect switch for emergency exit are configured to indicate the status of the emergency exit door. Multiple joint movement switches, such as left joint movement left switch, left joint movement right switch, left joint movement center switch, right joint movement left switch, right joint movement right switch, and right joint movement center switch, are interchangeable shafts. It is configured to control the joint movement of the assembly 150200 (FIGS. 25 and 27) and / or the end effector 150300 (FIGS. 25 and 28). The left reversing switch and the right reversing switch are coupled to the main controller 150717. A left switch with a left joint movement left switch, a left joint movement right switch, a left joint movement center switch, and a left reversing switch is coupled to the main controller 150717 by a left flexible connector. A right switch with a right joint movement left switch, a right joint movement right switch, a right joint movement center switch, and a right reversing switch is coupled to the main controller 150717 by a right flexible connector. A firing switch, a grip release switch, and a shaft engagement switch are coupled to the main controller 150717.

A plurality of switches may be implemented in any combination using any suitable mechanical switch, electromechanical switch, or solid-state switch. For example, the switch may be a surgical instrument 150010 (FIGS. 25-28) or a limiting switch actuated by the movement of a component associated with the presence of an object. Such switches can be used to control various functions associated with the surgical instrument 150010. A limit switch is an electromechanical device consisting of an actuator mechanically connected to a set of contacts. When the object comes into contact with the actuator, the device manipulates the contact to create or break an electrical connection. Due to its robustness, ease of installation, and reliability of operation, limit switches are used in a variety of applications and environments. The limit switch can determine the presence / absence of an object, passage, placement, and end of movement. In other embodiments, the switch is a solid-state switch that operates under the influence of a magnetic field, such as a Hall effect device, a magnetoresistive (MR) device, a giant magnetoresistive (GMR) device, a magnetometer, etc. You may. In other implementations, the switch may be a solid-state switch that operates under the influence of light, especially light sensors, infrared sensors, UV sensors, and the like. Further, the switch may be a solid-state device such as a transistor (for example, FET, junction FET, metal oxide semiconductor FET (MOSFET), bipolar, etc.). Other switches may include, among other things, wireless switches, ultrasonic switches, accelerometers, inertial sensors.

FIG. 30 shows the interface between the handle assembly 150702 and the power supply assembly 150706 and the interface between the handle assembly 150702 and the replaceable shaft assembly 150704 according to at least one aspect of the present disclosure. It is another block diagram of the control circuit 150700 of a surgical instrument. The handle assembly 150702 may include a main controller 150717, a shaft assembly connector 150726, and a power supply assembly connector 150730. The power assembly 150706 may include a power assembly connector 150732 and a power management circuit 150734 that may include a power management controller 150716, a power modulator 150738 and a current sensing circuit 150736. The shaft assembly connectors 150730, 150732 form the interface 150727. While the replaceable shaft assembly 150704 and the power supply assembly 150706 are connected to the handle assembly 150702, the power management circuit 150734 may modulate the power output of the battery 150707 based on the power requirements of the replaceable shaft assembly 150704. Can be configured in. For example, the power management controller 150716 can be programmed to control the power modulator 150738 of the power output of the power assembly 150706, and the current sensing circuit 150736 monitors the power output of the power assembly 150706 and the battery. By utilizing it to provide feedback on the power output of 150707 to the power management controller 150716, the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. The shaft assembly 150704 includes a shaft processor 150720 that is connected to the non-volatile memory 150721 and the shaft assembly connector 150728 to electrically connect the shaft assembly 150704 to the handle assembly 150702. The shaft assembly connectors 150726, 150728 form the interface 150725. The main controller 150717, the shaft processor 150720 and / or the power management controller 150716 can be configured to implement one or more of the processes described herein.

The surgical instrument 150010 (FIGS. 25-28) may include an output device 150742 that sends sensory feedback to the user. Such devices may include visual feedback devices (eg, LCD display screens, LED indicators), audible feedback devices (eg, speakers, buzzers) or tactile feedback devices (eg, tactile activators). Under certain circumstances, the output device 150742 may include a display 150743 that may be included in the handle assembly 150702. The shaft assembly controller 150722 and / or the power management controller 150716 may provide feedback to the user of the surgical instrument 150010 via the output device 150742. The interface 150727 may be configured to connect the shaft assembly controller 150722 and / or the power management controller 150716 to the output device 150742. The output device 150742 may be integrated with the power supply assembly 150706. Communication between the output device 150742 and the shaft assembly controller 150722 may be accomplished via interface 150725 while the interchangeable shaft assembly 150704 is connected to the handle assembly 150702. A control circuit 150700 (FIGS. 29A and 29B and FIG. 6) for controlling the operation of the surgical instrument 150010 (FIGS. 25-28) has been described, but the present disclosure is here from the surgical instrument 150010 (FIGS. 25-28). 28) and various configurations of the control circuit 150700.

With reference to FIG. 31, the surgical stapler 151000 may include a handle component 151002, a shaft component 151004 and an end effector component 151006. The surgical stapler 151000 is constructed and equipped similarly to the motor driven surgical cutting and fastening instrument 150010 described in connection with FIG. 25. Therefore, for the sake of brevity and clarity, the details of operation and structure are not repeated here. The end effector 151006 may be used to compress, cut, or staple the tissue. Next, referring to FIG. 32, the end effector 151030 may be positioned by the physician to surround the tissue 15132 prior to compression, cutting, or stapling. As shown in FIG. 32, no compression may be applied to the tissue while preparing to use the end effector. Next, referring to FIG. 33, the physician may use the end effector 151030 to compress the tissue 15132 by engaging the handle of the surgical stapler (eg, handle 151002). In one aspect, tissue 15132 may be compressed to its maximum threshold, as shown in FIG.

With reference to FIG. 34, various forces may be applied to the tissue 151032 by the end effector 151030. For example, when tissue 151032 is compressed between the anvil 15103 of the end effector 151030 and the channel frame 151036, normal forces F1 and F2 may be applied to the anvil 151304 and the channel frame 151036. Next, referring to FIG. 35, various oblique and / or lateral forces may be applied to the tissue 15132 when compressed by the end effector 151030. For example, force F3 may be applied. For the purpose of operating a medical device such as a surgical stapler 151000, it may be desirable to sense or calculate the various forms of compression applied to the tissue by the end effector. For example, knowing the vertical or lateral compression can allow the end effector to apply the staple movement more precisely or more accurately, or to use the surgical stapler more appropriately or more safely. In some cases, the operator is informed of the surgical stapler information so that the stapler can be used.

The compression in the direction of penetrating the structure 151032 may be determined from the impedance of the structure 151032. At various compression levels, the impedance Z of the structure 15132 can increase or decrease. By applying voltage V and current I to tissue 151032, the impedance Z of tissue 151032 may be determined at various compression levels of compression. For example, the impedance Z can be calculated by dividing the applied voltage V by the current I.

Next, referring to FIG. 36, in one embodiment, the RF electrode 151038 may be positioned on the end effector 151030 (eg, on the staple cartridge, knife, or channel frame of the end effector 151030). In addition, the electrical contacts 151040 may be positioned above the anvil 151534 of the end effector 151030. In one aspect, the electrical contacts can be located on the channel frame of the end effector. When the structure 15132 is compressed between the anvil 151534 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the structure 151032 changes. The vertical tissue compression 151042 produced by the end effector 151030 may be measured as a function of the impedance Z of the tissue 151332.

Next, referring to FIG. 37, in one aspect, when the RF electrode 151038 is positioned, the electrical contact 151444 may be positioned at the opposite end of the end effector 151030, anvil 151534. When the tissue 151032 is compressed between the anvil 151534 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. The lateral tissue compression 15146 produced by the end effector 151030 may be measured as a function of the impedance Z of the structure 151332.

Next, referring to FIG. 38, in one aspect, the electrical contacts 151050 may be positioned above the anvil 151534, and the electrical contacts 151052 may be positioned above the opposite end of the end effector 151030 in the channel frame 151036. Good. The RF electrode 151048 may be laterally located in the center of the end effector 151030. When the tissue 151032 is compressed between the anvil 151534 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. Lateral compression 151054 or angled compression 151056 on either side of the RF electrode 151048 may be caused by the end effector 151030, which is a variety of tissue 15132 based on the relative positioning of the RF electrode 151048, electrical contacts 151050 and 151052. It may be measured as a function of impedance Z.

As shown in FIG. 39, the frequency generator 151222 may receive power or current from the power source 151221 and may supply one or more RF signals to one or more RF electrodes 151224. .. As discussed above, one or more RF electrodes may be located at various locations or components on the end effector or surgical stapler, such as staple cartridges or channel frames. One or more electrical contacts, such as electrical contacts 151226 or 151228, may be located on the channel frame or anvil of the end effector. In addition, one or more filters, such as filters 151230 or 151232, may be communicably coupled with electrical contacts 151226 or 151228. The filters 151230 and 151232 may filter one or more RF signals supplied by the frequency generator 151222 before merging into a single return path 151234. The voltage V and current I associated with one or more RF signals can be compressed between one or more RF electrodes 151224 and the electrical contacts 151226 or 151228 and / or communicable. It may be used to calculate the impedance Z associated with the tissue that can be coupled.

Further referring to FIG. 39, various components of the tissue compression sensor system described herein may be located within the handle 151236 of the surgical stapler. For example, as shown in schematic 151220a, the frequency generator 151222 is located within the handle 151236 and is capable of receiving power from the power supply 151221. Also, current I1 and current I2 can be measured on the return path corresponding to the electrical contacts 151228 and 151226. Impedances Z1 and Z2 can be calculated using the voltage V applied between the supply and return paths. Z1 may correspond to the impedance of the tissue compressed and / or communicably coupled between one or more of the RF electrodes 151224 and the electrical contacts 151228. In addition, Z2 may correspond to the impedance of the tissue that is compressed and / or communicably coupled between one or more of the RF electrodes 151224 and the electrical contacts 151226. Applying the formulas Z1 = V / I1 and Z2 = V / I2, impedances Z1 and Z2 corresponding to various compression levels of the tissue compressed by the end effector can be calculated.

Next, with reference to FIG. 40, one or more aspects of the present disclosure are described in schematic 151250. In one implementation, the power supply at the handle 151252 of the surgical stapler may power the frequency generator 151254. The frequency generator 151254 may generate one or more RF signals. One or more RF signals may be multiplexed or superposed in the multiplexer 151256, which may be within the shaft 151258 of the surgical stapler. In this way, two or more RF signals can be superposed (or, for example, both nested or modulated) and transmitted to the end effector. One or more RF signals may energize one or more RF electrodes 151260 (eg, located within a staple cartridge) in the surgical stapler end effector 151262. Tissues (not shown) can be compressed and / or communicably coupled between one or more RF electrodes 151260 and one or more electrical contacts. For example, tissue is compressed between one or more RF electrodes 151260 and electrical contacts 151264 located within the channel frame of end effector 151262 or electrical contacts 151266 located within the anvil of end effector 151262. And / or can be communicatively combined. The filter 151268 may be communicably coupled to the electrical contact 151264 and the filter 151270 may be communicably coupled to the electrical contact 151266.

The voltage V and current I associated with one or more RF signals can be communicably coupled to a staple cartridge (and one or more RF electrodes 151260) and a channel frame or anvil (electrical contacts). It can be used to calculate the impedance Z associated with a tissue that can be compressed with one or more of 151264 or 151266).

In one aspect, the various components of the tissue compression sensor system described herein may be located within the shaft 151258 of a surgical stapler. For example, as shown in schematic 151250 (and in addition to the frequency generator 151254), an impedance calculator 151272, a controller 151274, a non-volatile memory 151276, and a communication channel 151278 may be located within the shaft 151258. In one embodiment, the frequency generator 151254, impedance calculator 151272, controller 151274, non-volatile memory 151276, and communication channel 151278 may be located on a circuit board within the shaft 151258.

Two or more RF signals may be returned on a common path via electrical contacts. In addition, the two or more RF signals are filtered before the RF signals merge on a common path to differentiate the separate tissue impedances represented by the two or more RF signals. Can be done. Current I1 and current I2 can be measured on the return path corresponding to the electrical contacts 151264 and 151266. Impedances Z1 and Z2 can be calculated using the voltage V applied between the supply and return paths. Z1 may correspond to the impedance of the tissue compressed and / or communicably coupled between one or more of the RF electrodes 151260 and the electrical contacts 151264. In addition, Z2 may correspond to the impedance of the tissue compressed and / or communicably coupled between one or more of the RF electrodes 151260 and the electrical contacts 151266. Applying the formulas Z1 = V / I1 and Z2 = V / I2, impedances Z1 and Z2 corresponding to various compressions of the tissue compressed by the end effector 151262 can be calculated. In the embodiment, the impedances Z1 and Z2 can be calculated by the impedance calculator 151272. Impedances Z1 and Z2 can be used to calculate various compression levels of tissue.

Next, referring to FIG. 41, a frequency graph 151290 is shown. Frequency graph 151290 shows frequency modulation that nests two RF signals. The two RF signals can be nested before reaching the RF electrodes in the end effector, as described above. For example, an RF signal having frequency 1 and an RF signal having frequency 2 can both be nested. Next, referring to FIG. 42, the resulting nested RF signal is shown in frequency graph 151300. The composite signal shown in the frequency graph 151300 includes two combined RF signals of the frequency graph 151290. Next, referring to FIG. 43, a frequency graph 151400 is shown. Frequency graph 151400 shows RF signals having frequency 1 and frequency 2 after being filtered (eg, by filters 151268 and 151270). The resulting RF signal can be used to make separate impedance calculations or measurements on the return path, as described above.

In one aspect, the filters 151268 and 151270 can be high Q filters such that the filter range can be narrowed (eg, Q = 10). Q can be defined by center frequency (Wo) / bandwidth (BW) and Q = Wo / BW. In one embodiment, frequency 1 can be 150 kHz and frequency 2 can be 300 kHz. The viable impedance measurement range can be 100 kHz to 20 MHz. In various embodiments, other advanced techniques such as correlation, orthogonal detection, etc. may be used to separate the RF signals.

Using one or more of the techniques and features described herein, a single energizing electrode on an end effector staple cartridge or isolated knife can simultaneously perform multiple tissue compression measurements. Can be used to do. If two or more RF signals are superimposed, multiplexed (or nested, or modulated), they can be transmitted to the single power supply side of the end effector, which can be transmitted to the end effector. Can wrap over either the channel frame or the anvil. The tissue impedance represented by both paths can be differentiated if filters are incorporated at the anvil and channel contacts before they merge into the common return path. This may provide a measurement of vertical tissue compression vs. lateral tissue compression. This method may also provide proximal and distal tissue compression depending on the placement of the filter and the location of the metal return pathway. The frequency generator and signal processor may be located on one or more chips on a circuit board or sub-board (which may already be present in the surgical stapler).

In one aspect, the present disclosure provides an instrument 150010 (described in connection with FIGS. 25-30) composed of various sensing systems. Therefore, for the sake of brevity and clarity, the details of operation and structure are not repeated here. In one aspect, the detection system includes a viscoelastic / rate of change detection system to monitor knife acceleration, rate of change in impedance, and rate of change in tissue contact. In one embodiment, the rate of change in knife acceleration can be used as a measure of tissue type. In another embodiment, the rate of change of impedance can be measured by a pulse sensor and can be used as a measure of compressibility. Finally, the rate of change in tissue contact can be measured by a sensor that measures tissue flow based on the knife firing rate.

The rate of change of the detected parameter, or otherwise defined, how long it takes for the tissue parameter to reach an asymptotic steady-state value, is itself a separate measurement and the detection of the derivation source. Can be more valuable than the parameters given. To improve the measurement of tissue parameters, such as waiting for a predetermined time before making the measurement, the present disclosure provides a novel technique for using the differential coefficients of the measurement, such as the rate of change of the tissue parameters.

Derivative techniques or rate of change measurements are most useful, with the understanding that there is no single measurement that can be used alone to dramatically improve staple formation. It is a combination of measurements that make the measurements valid. In the case of tissue gaps, it is useful to know how much the jaw is covered with tissue to make the relevant gap measurements. Impedance rate of change measurements may be combined with strain measurements in anvils to relate the forces and compressions applied to the tissue gripped between the jaw members of end effectors such as anvils and staple cartridges. The rate of change measurement can be used by an in-vivo surgical device to determine tissue type as well as tissue compression. Gastric and lung tissue sometimes have similar thicknesses, and even similar compressive properties when lung tissue is calcified, but the device has gaps, compression, applied force, tissue contact area. , And a combination of measurements such as the rate of change in compression or the rate of change in the gap may be used to distinguish between these tissue types. When any of these measurements are used alone, it can be difficult for an in-vivo surgical device to distinguish tissue types. The rate of change in compression can also help the device to determine if the tissue is "normal" or if anomalies are present. Measuring not only the elapsed time, but also the variation of the sensor signal and determining the derivative of the signal will provide another measurement that allows the internal surgical device to measure that signal. The rate of change information can also be used to determine when steady state is reached and signal the next step in the process. For example, after gripping tissue between jaw members of end effectors such as anvils and staple cartridges, when tissue compression reaches steady state (eg, about 15 seconds), an indicator or trigger is available to initiate the launch of the device. Can be.

Also provided herein are methods, devices, and systems for time-dependent assessment of sensor data that determine the stability, creep, and viscoelastic properties of tissue during surgical instrument operation. Surgical instruments such as staplers shown in FIG. 25 measure motion parameters such as jaw gap size or distance, firing current, tissue compression, amount of jaw covered by tissue, anvil strain, and trigger force. Can include a variety of sensors to do so. These detected measurements are important for automatic control of surgical instruments and for providing feedback to the clinician.

The examples shown in connection with FIGS. 30-49 can be used to measure various derived parameters such as gap distance vs. time, tissue compression vs. time, and anvil strain vs. time. The motor current may be monitored using a current sensor in series with the battery 2308.

Moving on to FIG. 44, a motor-driven surgical cutting and fastening instrument 151310, which may or may not be reused, is depicted. The motor-driven surgical cutting and fastening instrument 151310 is constructed and equipped in the same manner as the motor-driven surgical cutting and fastening instrument 150010 described in connection with FIGS. 25-30. In the embodiment shown in FIG. 44, the instrument 151310 includes a housing 151312 comprising a handle assembly 151314 configured to be grasped, operated and actuated by a clinician. The housing 151312 is configured to be operably attached to a replaceable shaft assembly 151500 to which a surgical end effector 151600 configured to perform one or more surgical tasks or procedures is operably coupled. Has been done. The motor-driven surgical cutting and fastening instrument 151310 is constructed and equipped in the same manner as the motor-driven surgical cutting and fastening instrument 150010 described in connection with FIGS. 25-30, for the sake of brevity and clarity. , Here we do not repeat the details of operation and structure.

The housing 151312 depicted in FIG. 44 is connected to a replaceable shaft assembly 151500 that includes an end effector 151600 with a surgical cutting and fastening device configured to operably support the surgical staple cartridge 151304 therein. Is shown. Housing 151312 includes end effectors adapted to support staple cartridges of various sizes and types, and is used in connection with replaceable shaft assemblies of various shaft lengths, sizes, types, etc. It may be configured as follows. In addition, housing 151312 is also adapted to use other forms of motion, as well as other forms of energy such as radio frequency (RF) energy, ultrasonic energy and / or motion, in connection with various surgical applications and procedures. May be used with a variety of other replaceable shaft assemblies, including assemblies configured to apply to end effector configurations. In addition, end effectors, shaft assemblies, handles, surgical instruments, and / or surgical instrument systems can utilize any suitable fastener to fasten the tissue. For example, a fastener cartridge with a plurality of fasteners detachably stored therein can be detachably inserted and / or mounted on an end effector of a shaft assembly.

FIG. 44 shows a surgical instrument 151310 to which a replaceable shaft assembly 151500 is operably connected. In the illustrated configuration, the handle housing forms a pistol grip portion 151319 that can be grasped and manipulated by the clinician. The handle assembly 151314 is capable of operating multiple drive systems configured to generate various control movements and add to the corresponding parts of the replaceable shaft assembly operably attached to the handle assembly. Supports. The trigger 151332 is operably associated with the pistol grip to control a variety of these control movements.

Subsequently referring to FIG. 44, the interchangeable shaft assembly 151500 includes a surgical end effector 151600 with an elongated channel 151302 configured to operably support the staple cartridge 151304 therein. The end effector 151600 may further include an anvil 151306 that is pivotally supported by the elongated channel 151302.

We find that the derived parameters may be more useful in controlling surgical instruments, such as the instruments illustrated in FIG. 44, than the perceived parameters underlying the derived parameters. I found. Non-limiting examples of the derived parameters include the rate of change of the detected parameters (eg, jaw gap distance) and the elapsed time for the tissue parameters to reach a close steady-state value (eg, 15 seconds). ). Derived parameters, such as the rate of change, are particularly useful because they dramatically improve measurement accuracy and also provide information that is not directly apparent from the parameters detected in other ways. For example, the rate of change of impedance (eg, tissue compression) can be combined with anvil strain to relate compression and force, which allows the microcontroller to determine the tissue type as well as the amount of tissue compression. Will be possible. This example is only an example, and any derived parameter can be combined with one or more detected parameters for tissue type (eg, stomach and lung), tissue health (calcification). And normal), and more accurate information about the operating state of the surgical device (eg, grab completed) can be provided. Different tissues have their own viscoelastic properties and their own rate of change, so these and other parameters described herein are useful signs for monitoring and automatically adjusting the surgical procedure. It becomes.

FIG. 46 is an exemplary graph showing the time course of the gap distance, where the gap is the space occupied by the grabbed tissue between the jaws. The vertical (y) axis is distance and the horizontal (x) axis is time. Specifically, referring to FIGS. 44 and 45, the gap distance 151340 is the distance between the end effector anvil 151306 and the elongated channel 151302. In the open jaw position, at time 0, the gap 151340 between the anvil 151306 and the elongated member is at its maximum distance. The width of the gap 151340 decreases as the anvil 151306 closes, such as while holding tissue. Since the tissue has non-uniform elasticity, the rate of change in interstitial distance can fluctuate. For example, some tissue types initially exhibit rapid compression, resulting in faster rate of change. However, when the tissue is continuously compressed, the viscoelastic properties of the tissue can reduce the rate of change until the tissue can no longer be compressed, after which the gap distance remains substantially constant. become. The gap decreases over time as the tissue is crushed between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. For example, magnetic field sensors, strain gauges, pressure sensors, force sensors such as induction sensors such as eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other suitable sensor, as shown in FIGS. 31-43. One or more sensors described in association measure the gap distance "d" between the anvil 151306 and the staple cartridge 151304 over time "t", as shown graphically in FIG. It may be adapted and configured as such. The rate of change of the gap distance "d" over time "t" is the slope of the curve shown in FIG. 46, where the slope = Δd / Δt.

FIG. 47 is an exemplary graph showing the firing current of the jaw of the end effector. The vertical (y) axis is the current and the horizontal (x) axis is the time. As discussed herein, surgical instruments and / or their microcontrollers, as shown and described in connection with FIG. 25, are undergoing various operations such as tissue grasping, cutting, and / or stapling. It may include a current sensor that detects the current utilized in. For example, as the resistance of the tissue increases, the electric motor of the appliance may require more current to grab, cut, and / or staple the tissue. Conversely, as resistance decreases, the electric motor may require less current to grab, cut, and / or staple the tissue. As a result, the firing current can be used as an approximation of tissue resistance. The detected current can be used alone or more preferably in combination with other measurements to provide feedback on the target tissue. Still referring to FIG. 47, during some operations, such as stapling, the firing current is initially high at time 0 but decreases over time. If the motor draws more current to overcome the increasing mechanical load during the operation of other devices, the current can increase over time. In addition, the rate of change of firing current can be used as an indicator that the tissue is transitioning from one state to another. Therefore, the firing current and, above all, the rate of change of the firing current can be used to monitor device operation. As the knife cuts through the tissue, the firing current decreases over time. If the cut tissue results in greater or lesser resistance due to the properties of the tissue or the sharpness of the knife 151305 (FIG. 45), the rate of change of firing current can fluctuate. As the cutting conditions fluctuate, the work done by the motor fluctuates, and as a result, the firing current fluctuates over time. A current sensor may be utilized to measure the firing current over time while the knife 151305 is firing, as shown graphically in FIG. For example, the motor current may be monitored using a current sensor. The current sensor may be adapted and configured to measure the motor firing current "i" over time "t", as shown graphically in FIG. 47. The rate of change of the firing current “i” over time “t” is the gradient of the curve shown in FIG. 47, where gradient = Δi / Δt.

FIG. 48 is an exemplary graph of changes in impedance over time. The vertical (y) axis is impedance and the horizontal (x) axis is time. Impedance is low at time 0, but increases over time as tissue pressure increases due to manipulation (eg, gripping and stapling). The tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304 is cut with a knife or sealed using RF energy between the electrodes located between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. Therefore, the rate of change fluctuates with time. For example, as the tissue is cut, the electrical impedance rises and reaches infinity when the tissue is completely cut off by a knife. Also, when the end effector 151340 includes an electrode connected to an RF energy source, the electrical impedance of the tissue increases when energy is delivered through the tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. .. The electrical impedance rises as the energy passing through the tissue dries the tissue by evaporating the water in the tissue. Ultimately, when a suitable amount of energy is delivered to the tissue, the impedance rises to a very high value, or to infinity if the tissue is disrupted. In addition, as shown in FIG. 48, different tissues may have unique compression properties that distinguish the tissues, such as compression ratio. Tissue impedance can be measured by driving a paratherapeutic RF current through the tissue gripped between the first jaw member 9014 and the second jaw member 9016. One or more electrodes may be positioned on either or both of the anvil 151306 and the staple cartridge 151304. The tissue compression / impedance of the tissue between the anvil 151306 and the staple cartridge 151304 can be measured over time as shown graphically in FIG. For example, magnetic field sensors, strain gauges, pressure sensors, force sensors such as induction sensors such as eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other suitable sensor, as shown in FIGS. 31-43. The sensors described in association may be adapted and configured to measure tissue compression / impedance. The sensor may be adapted and configured to measure tissue impedance "Z" over time "t", as shown graphically in FIG. 48.

FIG. 49 is an exemplary graph of changes in strain of anvil 151306 (FIGS. 44, 45) over time. The vertical (y) axis is distortion and the horizontal (x) axis is time. For example, during staple fastening, the strain of the anvil 151306 is initially large, but decreases as the tissue reaches steady state and the pressure exerted on the anvil 151306 decreases. The rate of change in strain of the anvil 151306 is either the anvil 151306 or the staple cartridge 151304 (FIGS. 44, 45) to measure the pressure or strain applied to the tissue gripped between the anvil 151306 and the staple cartridge 151304. It can be measured by a pressure sensor or strain gauge located on or both. The strain of the anvil 151306 can be measured over time as shown graphically in FIG. The rate of change of the strain “S” over time “t” is the gradient of the curve shown in FIG. 49, where gradient = ΔS / Δt.

FIG. 50 is an exemplary graph of changes in trigger force over time. The vertical (y) axis is the trigger force and the horizontal (x) axis is the time. In certain embodiments, the triggering force is gradual and provides tactile feedback to the clinician. Thus, at time 0, the pressure of the trigger 151320 (FIG. 44) may be at its lowest value and the trigger pressure may increase until the operation (eg, gripping, cutting, or stapling) is complete. The rate of change of the trigger force is the instrument 151310 (FIG. 45) to measure the force required to drive the knife 151305 (FIG. 45) to penetrate the tissue gripped between the anvil 151306 and the staple cartridge 151304. It can be measured by a pressure sensor or strain gauge located on the trigger 151302 of the handle 151319 of 44). The trigger 151332 force can be measured over time as shown graphically in FIG. The rate of change of the strain trigger force “F” over time “t” is the gradient of the curve shown in FIG. 50, and the gradient = ΔF / Δt.

For example, gastric and lung tissues can be distinguished even if they may have similar thicknesses and may have similar compressive properties when the lung tissue is calcified. Gastric and lung tissues can be identified by analyzing jaw gap distance, tissue compression, applied force, tissue contact area, rate of change in compression, and rate of change in jaw gap. For example, FIG. 51 shows a graph of tissue pressure “P” of various tissues and tissue displacement of various tissues. The vertical (y) axis is the tissue pressure and the horizontal (x) axis is the tissue displacement. Distinguishing tissue using the amount of tissue displacement, as well as the rate of tissue displacement before reaching the threshold, when tissue pressure reaches a predetermined threshold, such as 0.50 to 100 pounds per square (psi). Can be done. For example, vascular tissue reaches a predetermined pressure threshold with less tissue displacement and faster rate of change than tissue in the colon, lung, or stomach. In addition, the rate of change of vascular tissue (tissue pressure relative to displacement) is nearly asymmetric at a threshold of 50-100 psi, while the colon, lung, and stomach are not aximate at a threshold of 50-100 psi. As will be appreciated, any pressure threshold can be used, for example 1 to 1000 psi, more preferably 10 to 500 psi, and even more preferably an additional 50 to 100 psi. In addition, multiple thresholds or gradual thresholds may be used to provide a further solution for tissue types with similar viscoelastic properties.

The rate of change in compression may also allow the microcontroller to determine if the tissue is "normal" or if there are anomalies such as calcification. For example, referring to FIG. 52, compression of calcified lung tissue follows a different curve than compression of normal lung tissue. Therefore, tissue displacement and rate of change in tissue displacement can be used to diagnose calcified lung tissue and / or distinguish it from normal lung tissue.

In addition, certain detected measurements may benefit from additional perceptual inputs. For example, in the case of the jaw gap, knowing how much the jaw is covered by tissue can make the gap measurement more useful and accurate. If a small portion of the jaw is covered with tissue, tissue compression may appear less than if the entire jaw is covered with tissue. Therefore, jaw coverage can be taken into account by the microcontroller when analyzing tissue compression and other detected parameters.

In certain situations, elapsed time can also be an important parameter. Measuring elapsed time with the detected parameters and derivative parameters (eg, rate of change) provide additional useful information. For example, if the rate of change in the jaw gap remains constant after a set period (eg, 5 seconds), this parameter may have reached an asymptotic value.

The rate of change information is also useful for determining when steady state is reached and signaling the next step in the process. For example, if tissue compression reaches a steady state during grasping, for example, if no significant rate of change occurs after a set period, the microcontroller warns the clinician to start the next step of operation, such as staple firing. Can send a signal to the display. Alternatively, the microcontroller may be programmed to automatically initiate the next step of operation (eg, staple firing) once steady state is reached.

Similarly, the rate of change of impedance can be combined with anvil distortion to relate force and compression. The rate of change will allow the device to determine the tissue type rather than simply being able to measure the compression value. For example, the stomach and lungs sometimes have similar thicknesses, and even similar compressive properties when the lungs are calcified.

The combination of one or more detected and derived parameters provides a more reliable and accurate assessment of tissue type and tissue health, resulting in more effective device monitoring, control, and clinician. Allows feedback to.

FIG. 53 shows an embodiment of an end effector 152000 comprising a first sensor 152008a and a second sensor 152008b. The end effector 152000 is similar to the end effector 150300 described above. The end effector 152000 comprises a first jaw member, i.e. anvil 152002, pivotally coupled to a second jaw member 152004. The second jaw member 152004 is configured to receive the staple cartridge 152006 inside. The staple cartridge 152006 includes a plurality of staples (not shown). Multiple staples can be deployed from staple cartridge 152006 during surgery. The end effector 152000 includes a first sensor 152008a. The first sensor 152008a is configured to measure one or more parameters of the end effector 152000. For example, in one embodiment, the first sensor 152008a is configured to measure the gap 152010 between the anvil 152002 and the second jaw member 152004. The first sensor 152008a may include, for example, a Hall effect sensor configured to detect the magnetic field generated by the magnet 152012 embedded in the second jaw member 152004 and / or the staple cartridge 152006. As another example, in one embodiment, the first sensor 152008a is attached to the anvil 152002 by a second jaw member 152004 and / or by a tissue gripped between the anvil 152002 and the second jaw member 152004. It is configured to measure one or more forces exerted.

The end effector 152000 includes a second sensor 152008b. The second sensor 152008b is configured to measure one or more parameters of the end effector 152000. For example, in various embodiments, the second sensor 152008b may include a strain gauge configured to measure the magnitude of strain in the anvil 152002 during the gripped state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. In various embodiments, for example, the first sensor 152008a and / or the second sensor 152008b is a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure sensor, a force sensor, such as an induction sensor such as a vortex current sensor. It may include a resistance sensor, a capacitance sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 152000. The first sensor 152008a and the second sensor 152008b may be arranged in a series configuration and / or a parallel configuration. In a series configuration, the second sensor 152008b may be configured to directly affect the output of the first sensor 152008a. In a parallel configuration, the second sensor 152008b may be configured to indirectly affect the output of the first sensor 152008a.

In one embodiment, the one or more parameters measured by the first sensor 152008a are associated with the one or more parameters measured by the second sensor 152008b. For example, in one embodiment, the first sensor 152008a is configured to measure the gap 152010 between the anvil 152002 and the second jaw member 152004. The gap 152010 represents the thickness and / or compressibility of a portion of the tissue gripped between the anvil 152002 and the staple cartridge 152006. The first sensor 152008a may include, for example, a Hall effect sensor configured to detect the magnetic field generated by the magnet 152012 coupled to the second jaw member 152004 and / or the staple cartridge 152006. The single point measurement accurately represents the thickness of the compressed tissue in the case of a calibrated full mesh of tissue, but the partial mesh of tissue is with the anvil 152002 and the second jaw member 152004. If it is located between, it may give inaccurate results. Partial meshing of tissue, either proximal partial meshing or distal partial meshing, alters the geometry of the grip of the anvil 152002.

In some embodiments, the second sensor 152008b indicates one or two types of tissue meshing, such as full meshing, partial proximal meshing, and / or partial distal meshing. It is configured to detect one or more parameters. The readings of the second sensor 152008b adjust the readings of the first sensor 152008a so as to accurately represent the thickness of the true compressed tissue in the partial meshing located proximally or distally. May be used for. For example, in one embodiment, the second sensor 152008b comprises a strain gauge, such as a micro strain gauge, configured to monitor the magnitude of strain in the anvil during the gripped state. The magnitude of the strain in the anvil 152002 is the output of the first sensor 152008a, eg, the Hall effect sensor, so as to accurately represent the thickness of the true compressed tissue in the partial meshing located proximally or distally. Used to fix. The first sensor 152008a and the second sensor 152008b may be measured in real time during the gripping operation. Real-time measurements allow time-based information to be analyzed, for example, by a primary processor (eg, processor 462 (FIG. 12)), and also recognize tissue characteristics and grip position for tissue thickness. It can be used to select one or more algorithms and / or lookup tables to dynamically adjust the measurements.

In some embodiments, the thickness measurement of the first sensor 152008a may be provided to the output device of the surgical instrument 150010 coupled to the end effector 152000. For example, in one embodiment, the end effector 152000 is connected to a surgical instrument 150010 comprising a display (eg, display 473 (FIG. 12)). The measurements of the first sensor 152008a are provided to the processor, eg, the primary processor. The primary processor adjusts the readings of the first sensor 152008a based on the readings of the second sensor 152008b to determine the true tissue of the portion of the tissue held between the anvil 152002 and the staple cartridge 152006. Reflect the thickness. The primary processor outputs adjusted tissue thickness measurements and instructions for full or partial meshing to the display. The operator may decide whether or not to deploy the staples in the staple cartridge 152006 based on the displayed value.

In some embodiments, the first sensor 152008a and the second sensor 152008b, for example, the first sensor 152008a is placed at a treatment site inside the patient and the second sensor 152008b is placed outside the patient's body. It may be placed in a different environment. The second sensor 152008b may be configured to calibrate and / or modify the output of the first sensor 152008a. The first sensor 152008a and / or the second sensor 152008b may include, for example, an environmental sensor. The environmental sensor may include, for example, a temperature sensor, a humidity sensor, a pressure sensor, and / or any other suitable environmental sensor.

FIG. 54 is a logical diagram showing an embodiment of the process 152020 that adjusts the measured value of the first sensor 152008a based on the input from the second sensor 152008b. The first signal 152022a is captured by the first sensor 152008a. The first signal 152022a may be tuned based on one or more predetermined parameters, such as, for example, a smoothing function, a look-up table, and / or any other suitable tuning parameter. The second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be tuned based on one or more predetermined tuning parameters. The first signal 152022a and the second signal 152022b are provided to a processor such as a primary processor. The processor adjusts the measurements of the first sensor 152008a, as represented by the first signal 152022a, based on the second signal 152022b from the second sensor. For example, in one embodiment, the first sensor 152008a comprises a Hall effect sensor and the second sensor 152008b comprises a strain gauge. The distance measurement of the first sensor 152008a is adjusted by the magnitude of the strain measured by the second sensor 152008b to determine the integrity of the tissue meshing in the end effector 152000. The adjusted measurements are displayed to the operator, for example, by a display embedded in a surgical instrument 150010.

FIG. 55 is a logical diagram showing an embodiment of process 152030 that determines a look-up table for the first sensor 152008a based on input from the second sensor 152008b. The first sensor 152008a captures a signal 152022a indicating one or more parameters of the end effector 152000. The first signal 152022a may be tuned based on one or more predetermined parameters, such as, for example, a smoothing function, a look-up table, and / or any other suitable tuning parameter. The second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be tuned based on one or more predetermined tuning parameters. The first signal 152022a and the second signal 152022b are provided to a processor such as a primary processor. The processor selects a look-up table from one or more available look-up tables 152034a, 152034b based on the value of the second signal. The selected look-up table is used to convert the first signal into a measure of tissue thickness located between the anvil 152002 and the staple cartridge 152006. The adjusted measurements are displayed to the operator, for example, by a display embedded in a surgical instrument 150010.

FIG. 56 is a logical diagram showing an embodiment of the process 152040 that calibrates the first sensor 152008a in response to an input from the second sensor 152008b. The first sensor 152008a is configured to capture the signal 152022a indicating one or more parameters of the end effector 152000. The first signal 152022a may be tuned based on one or more predetermined parameters, such as, for example, a smoothing function, a look-up table, and / or any other suitable tuning parameter. The second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be tuned based on one or more predetermined tuning parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as a primary processor. The primary processor calibrates the first signal 152022a in response to the second signal 152022b. The first signal 152022a is calibrated to reflect the integrity of tissue meshing in the end effector 152000. The calibrated signal is displayed to the operator, for example, by a display embedded in a surgical instrument 150010.

FIG. 57 is a logical diagram showing an embodiment of a process 152050 that determines and displays the thickness of a portion of the tissue held between the anvil 152002 of the end effector 152000 and the staple cartridge 152006. Process 152050 involves acquiring the Hall effect voltage 152052, for example, through a Hall effect sensor located at the distal tip of the anvil 152002. The Hall effect voltage 152052 is provided to the analog-to-digital converter 152504 and converted into a digital signal. The digital signal is provided to a processor, such as a primary processor. The primary processor calibrates the curve input of the Hall effect voltage 152052 signal 152056. For example, a strain gauge 152058, such as a microstrain gauge, is configured to measure one or more parameters of the end effector 152000, for example, the magnitude of strain exerted on the anvil 152002 during the gripping motion. ing. The measured distortion is converted into a digital signal and provided to a processor such as 152060, for example a primary processor. The primary processor uses one or more algorithms and / or a look-up table to adjust the Hall effect voltage 152052 in response to the strain measured by the strain gauge 152058 to anvil 152002 and staple cartridge 152006. Reflects the true thickness of the tissue grasped by and the integrity of its meshing. The adjusted thickness is displayed to the operator, for example, by a display embedded in the surgical instrument 150010.

In some embodiments, the surgical instrument may further comprise a load cell or load sensor 152802. The load sensor 152082 can be located, for example, in the shaft assembly 150200 described above, or also in the housing 150012 described above. FIG. 58 is a logical diagram showing an embodiment of a process 152070 that determines and displays the thickness of a portion of the tissue held between the anvil 152002 of the end effector 152000 and the staple cartridge 152006. The process involves acquiring the Hall effect voltage 152072, for example, through a Hall effect sensor located at the distal tip of the anvil 152002. The Hall effect voltage 152072 is provided to the analog-to-digital converter 152074 and is converted into a digital signal. The digital signal is provided to a processor, such as a primary processor. The primary processor calibrates the curve input of the Hall effect voltage 152072 signal 152076. A strain gauge 152078, such as a microstrain gauge, is configured to measure one or more parameters of the end effector 152000, for example, the magnitude of strain exerted on the anvil 152002 during gripping operation. .. The measured distortion is converted into a digital signal and provided to a processor such as 152080, for example a primary processor. The load sensor 152082 measures the gripping force of the anvil 152002 with respect to the staple cartridge 152006. The measured grip force is converted into a digital signal and provided to a processor such as a 15284, for example a primary processor. The primary processor uses one or more algorithms and / or look-up tables to respond to the strain measured by the strain gauge 152078 and the gripping force measured by the load sensor 152082, and the Hall effect voltage. Adjusting 152072 reflects the true thickness of the tissue gripped by the anvil 152002 and the staple cartridge 152006 and the completeness of their meshing. The adjusted thickness is displayed to the operator, for example, by a display embedded in the surgical instrument 150010.

FIG. 59 is a graph 152090 showing a comparison between the adjusted Hall effect thickness measurement 152092 and the uncorrected Hall effect thickness measurement 152094. Uncorrected, as shown in FIG. 59, because a single sensor cannot correct distal / proximal partial occlusion, resulting in inaccurate thickness measurements. The Hall effect thickness measurement 152094 indicates a thicker tissue measurement. The adjusted thickness measurement 152092 is produced, for example, by the process 152050 shown in FIG. The Hall effect thickness measurement 152092 is calibrated based on inputs from one or more additional sensors, such as strain gauges. The adjusted Hall effect thickness 152092 reflects the true thickness of the tissue located between the anvil 152002 and the staple cartridge 152006.

FIG. 60 shows an embodiment of an end effector 152100 including a first sensor 152108a and a second sensor 152108b. The end effector 152100 is similar to the end effector 152000 shown in FIG. The end effector 152100 comprises a first jaw member pivotally coupled to a second jaw member 152104, i.e. anvil 152102. The second jaw member 152104 is configured to receive the staple cartridge 152106 therein. The end effector 152100 includes a first sensor 152108a coupled to the anvil 152102. The first sensor 152108a is configured to measure one or more parameters of the end effector 152100, such as the gap 152110 between the anvil 152102 and the staple cartridge 152106. The gap 152110 may correspond, for example, to the thickness of the tissue held between the anvil 152102 and the staple cartridge 152106. The first sensor 152108a may include any suitable sensor that measures one or more parameters of the end effector. For example, in various embodiments, the first sensor 152108a is a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure sensor, an induction sensor such as a vortex current sensor, a resistance sensor, a capacitance sensor, an optical sensor and / or any of them. Other suitable sensors may be provided.

In some embodiments, the end effector 152100 comprises a second sensor 152108b. The second sensor 152108b is coupled to the second jaw member 152104 and / or the staple cartridge 152106. The second sensor 152108b is configured to detect one or more parameters of the end effector 152100. For example, in some embodiments, the second sensor 152108b is, for example, the color of the staple cartridge 152106 coupled to the second jaw member 152104, the length of the staple cartridge 152106, the gripping state of the end effector 152100, the end. It is configured to detect one or more instrument states, such as effector 152100 and / or staple cartridge 152106, number of uses / remaining number of uses, and / or any other suitable instrument state. The second sensor 152108b includes magnetic sensors such as Hall effect sensors, induction sensors such as strain gauges, pressure sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other suitable sensor. Any suitable sensor that detects the state of one or more instruments may be provided.

The end effector 152100 may be used in conjunction with any of the processes shown in FIGS. 54-57. For example, in one embodiment, the input from the second sensor 152108b may be used to calibrate the input from the first sensor 152108a. The second sensor 152108b may be configured to detect one or more parameters of the staple cartridge 152106, such as, for example, the color and / or length of the staple cartridge 152106. The detected parameters, such as the color and / or length of the staple cartridge 152106, are, for example, the height of the cartridge deck, the optimum tissue thickness available for the staple cartridge, and / or the pattern of staples within the staple cartridge 152106. Etc., which may correspond to one or more characteristics of the cartridge. Known parameters of the staple cartridge 152106 may be used to adjust the thickness measurements provided by the first sensor 152108a. For example, if the staple cartridge 152106 has a higher deck height, the thickness measurements provided by the first sensor 152108a may be reduced to compensate for the additional deck height. The adjusted thickness may be displayed to the operator, for example, through a display coupled to the surgical instrument 150010.

FIG. 61 shows an embodiment of an end effector 152150 including a first sensor 152158 and a plurality of second sensors 152160a, 152160b. The end effector 152150 includes a first jaw member, that is, anvil 152152, and a second jaw member 152154. The second jaw member 152154 is configured to receive the staple cartridge 152156. The anvil 152152 is pivotally movable with respect to the second jaw member 152154 in order to grip the tissue between the anvil 152152 and the staple cartridge 152156. The anvil comprises a first sensor 152158. The first sensor 152158 is configured to detect one or more parameters of the end effector 152150, such as the gap 152110 between the anvil 152152 and the staple cartridge 152156. The gap 152110 may correspond, for example, to the thickness of the tissue held between the anvil 152152 and the staple cartridge 152156. The first sensor 152158 may include any suitable sensor that measures one or more parameters of the end effector. For example, in various embodiments, the first sensor 152158 is a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure sensor, an induction sensor such as a vortex current sensor, a resistance sensor, a capacitance sensor, an optical sensor, and / or any. Other suitable sensors may be provided.

In some embodiments, the end effector 152150 comprises a plurality of secondary sensors 152160a, 152160b. The secondary sensors 152160a, 152160b are configured to detect one or more parameters of the end effector 152150. For example, in some embodiments, the secondary sensors 152160a, 152160b are configured to measure the amount of strain exerted on the anvil 152152 during the gripping procedure. In various embodiments, the secondary sensors 152160a, 152160b are magnetic sensors such as Hall effect sensors, induction sensors such as strain gauges, pressure sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any of them. Other suitable sensors may be provided. Secondary sensors 152160a, 152160b are such that they measure one or more identical parameters at different locations on the anvil 152152, different parameters at the same location on the anvil 152152, and / or different parameters at different locations on the anvil 152152. It may be configured in.

FIG. 62 is a logical diagram showing an embodiment of the process 152170 that adjusts the measured value of the first sensor 152158 in response to the plurality of secondary sensors 152160a and 152160b. In one embodiment, the Hall effect voltage is obtained, for example, by a Hall effect sensor 152172. The Hall effect voltage is 152174 converted by an analog-to-digital converter. 152176 where the converted Hall effect voltage signal is calibrated. The calibrated curve represents the thickness of a portion of the tissue located between the anvil 152152 and the staple cartridge 152156. 152178a, 152178b where a plurality of secondary measurements are acquired by a plurality of secondary sensors, such as a plurality of strain gauges. The input of the strain gauge is, for example, 152180a, 152180b, which is converted into one or more digital signals by a plurality of electron μ strain conversion circuits. The calibrated Hall effect voltage and multiple secondary measurements are provided to a processor, such as a primary processor. The primary processor utilizes secondary measurements to adjust the Hall effect voltage, eg, by applying algorithms and / or applying one or more look-up tables. The adjusted Hall effect voltage represents the true thickness of the tissue gripped between the anvil 152152 and the staple cartridge 152156 and the integrity of its meshing. The adjusted thickness is displayed to the operator, for example, by a display embedded in the surgical instrument 150010.

FIG. 63 illustrates an embodiment of circuit 152190 configured to convert signals from the first sensor 152158 and a plurality of secondary sensors 152160a, 152160b into digital signals receivable by a processor such as a primary processor. It shows. Circuit 152190 includes an analog-to-digital converter 152194. In some embodiments, the analog-to-digital converter 152194 comprises a 4-channel 18-bit analog-to-digital converter. It will be appreciated by those skilled in the art that the analog-to-digital converter 152194 may be provided with any suitable number of channels and / or bits for converting one or more inputs from an analog signal to a digital signal. There will be. Circuit 152190 includes one or more level shift resistors 152196 configured to receive input from a first sensor 152158, such as a Hall effect sensor. The level shift resistor 152196 adjusts the input from the first sensor to shift the value to a higher voltage or a lower voltage depending on the input. The level shift resistor 152196 provides a level shifted input from the first sensor 152158 to the analog-to-digital converter.

In some embodiments, the plurality of secondary sensors 152160a, 152160b are coupled to the plurality of bridges 152192a, 152192b in the circuit 152190. The plurality of bridges 152192a, 152192b may provide filtering of inputs from the plurality of secondary sensors 152160a, 152160b. After filtering the input signal, the plurality of bridges 152192a, 152192b provide inputs from the plurality of secondary sensors 152160a, 152160b to the analog-to-digital converter 152194. In some embodiments, the switch 152198 coupled to one or more level shift resistors may be coupled to the analog-to-digital converter 152194. The switch 152198 is configured to calibrate one or more input signals, such as an input from a Hall effect sensor. The switch 152198 may be engaged to provide one or more level shift signals to adjust one or more input signals of the sensor, eg, calibrate the inputs of the Hall effect sensor. Good. In some embodiments, adjustment is not mandatory and the switch 152198 is left in the open position to disconnect the level shift resistor. Switch 152198 is coupled to analog-to-digital converter 152194. The analog-to-digital converter 152194 provides output to one or more processors, such as a primary processor. The primary processor calculates one or more parameters of the end effector 152150 based on the input from the analog-to-digital converter 152194. For example, in one embodiment, the primary processor calculates the thickness of tissue located between the anvil 152152 and the staple cartridge 152156 based on inputs from one or more sensors 152158, 152160a, 152160b. ..

FIG. 64 shows an embodiment of the end effector 152200 including a plurality of sensors 152208a to 152208d. The end effector 152200 comprises an anvil 152202 pivotally coupled to a second jaw member 152204. The second jaw member 152204 is configured to receive the staple cartridge 152206 therein. The anvil 152202 includes a plurality of sensors 152208a to 152208d on the anvil 152202. The plurality of sensors 152208a-152208d are configured to detect one or more parameters of the end effector 152200, for example anvil 152202. The plurality of sensors 152208a to 152208d may include one or more identical sensors and / or different sensors. The plurality of sensors 152208a-152208d may include, for example, magnetic sensors such as Hall effect sensors, strain gauges, pressure sensors, guidance sensors such as eddy current sensors, resistance sensors, capacitive sensors, optical sensors, and / or any other suitable. It may be equipped with a sensor or a combination thereof. For example, in one embodiment, the plurality of sensors 152208a to 152208d may include a plurality of strain gauges.

In one embodiment, the plurality of sensors 152208a-152208d makes it possible to realize a robust tissue thickness sensing process. By detecting various parameters along the length of the anvil 152202, the plurality of sensors 152208a-152208d can be surgically operated, for example, with a surgical instrument 150010, regardless of meshing, such as partial meshing or full meshing. The device will be able to calculate the thickness of the tissue in the jaw. In some embodiments, the plurality of sensors 152208a-152208d comprises a plurality of strain gauges. A plurality of strain gauges are configured to measure strain at various points on the anvil 152202. The magnitude and / or gradient of strain at each of the various points on the anvil 152202 can be used to determine the thickness of the tissue between the anvil 152202 and the staple cartridge 152206. Multiple strain gauges are configured to optimize the maximum difference in size and / or gradient based on gripping mechanics to determine tissue thickness, tissue placement, and / or material properties. You may. By time-based monitoring of multiple sensors 152208a-152208d during gripping, a processor, such as a primary processor, utilizes algorithms and look-up tables to recognize tissue features and gripping positions, and end effectors 152200, And / or the tissue gripped between the anvil 152202 and the staple cartridge 152206 can be dynamically adjusted.

FIG. 65 is a logical diagram showing an embodiment of process 152220 that determines the characteristics of one or more tissues based on a plurality of sensors 152208a-152208d. In one embodiment, the plurality of sensors 152208a-152208d generate a plurality of signals indicating one or more parameters of the end effector 152200 152222a-152222d. The plurality of generated signals are converted into digital signals and provided to the processor from 152224a to 152224d. For example, in one embodiment including a plurality of strain gauges, a plurality of electron μ strain (micro distortion) conversion circuits convert the strain gauge signal into a digital signal 152224a to 152224d. The digital signal is provided to a processor, such as a primary processor. The primary processor determines the characteristics of one or more tissues based on multiple signals 152226. The processor may determine the characteristics of one or more organizations by applying algorithms and / or look-up tables. One or more tissue features are displayed to the operator, for example, by a display embedded in a surgical instrument 150010.

FIG. 66 shows an embodiment of an end effector 152250 comprising a plurality of sensors 152260a to 152260d coupled to a second jaw member 3254. The end effector 152250 comprises an anvil 152252 pivotally coupled to a second jaw member 152254. The anvil 152252 is movable with respect to the second jaw member 152254 so as to hold one or more substances in between, for example a portion of tissue 152264. The second jaw member 152254 is configured to receive the staple cartridge 152256. The first sensor 152258 is coupled to the anvil 152252. The first sensor is configured to detect one or more parameters of the end effector 152150, such as the gap 152110 between the anvil 152252 and the staple cartridge 152256. The gap 152110 may correspond, for example, to the thickness of the tissue held between the anvil 152252 and the staple cartridge 152256. The first sensor 152258 may include any suitable sensor that measures one or more parameters of the end effector. For example, in various embodiments, the first sensor 152258 is a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure sensor, an induction sensor such as a vortex current sensor, a resistance sensor, a capacitance sensor, an optical sensor, and / or optional. Other suitable sensors may be provided.

A plurality of secondary sensors 152260a to 152260d are coupled to the second jaw member 152254. The plurality of secondary sensors 152260a to 152260d may be integrally formed with the second jaw member 152254 and / or the staple cartridge 152256. For example, in one embodiment, the plurality of secondary sensors 152260a to 152260d are disposed on the outer row of staple cartridges 152256 (see FIG. 67). The plurality of secondary sensors 152260a to 152260d are configured to detect one or more parameters of the end effector 152250 and / or the portion of the tissue 152264 held between the anvil 152252 and the staple cartridge 152256. Has been done. The plurality of secondary sensors 152260a to 152260d may include, for example, magnetic sensors such as Hall effect sensors, induction sensors such as strain gauges, pressure sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other. Any suitable sensor that detects one or more parameters of the end effector 152250 and / or part of the tissue 152264, such as a suitable sensor, or a combination thereof, may be provided. The plurality of secondary sensors 152260a to 152260d may include the same sensor and / or different sensors.

In some embodiments, the plurality of secondary sensors 152260a-152260d comprises a dual purpose sensor and a tissue stabilizing element. The plurality of secondary sensors 152260a to 152260d are electrodes and electrodes configured to create a stable tissue state when the plurality of secondary sensors 152260a to 152260d are engaged with a portion of tissue 152264, for example during a gripping operation. / Or has a sensing shape. In some embodiments, one or more of the plurality of secondary sensors 152260a-152260d may be replaced with non-sensing tissue stabilizing elements. Secondary sensors 152260a-152260d create a stable tissue condition by controlling tissue flow, staple formation, and / or other conditions during gripping, stapling, and / or other treatment processes.

FIG. 67 shows an embodiment of a staple cartridge 152270 including a plurality of sensors 152272a to 152272h integrally formed therein. The staple cartridge 152270 comprises a plurality of rows including a plurality of holes for storing the staples therein. One or more of the holes in the outer row 152278 are replaced with one of the plurality of sensors 152272a to 152272h. A notch is shown to show the sensor 152272f coupled to the sensor wire 152276b. The sensor wires 152276a, 152276b may include a plurality of wires for connecting the plurality of sensors 152272a to 152272h to one or more circuits of the surgical instrument, such as the surgical instrument 150010. In some embodiments, one or more of the plurality of sensors 152272a to 152272h have dual objectives having electrodes and / or sensing shapes configured to provide tissue stabilization. It is equipped with sensors and tissue stabilizing elements. In some embodiments, the plurality of sensors 152272a to 152272h may be replaced and / or co-installed with the plurality of tissue stabilizing elements. Tissue stabilization may be provided, for example, by controlling tissue flow and / or staple formation during the gripping and / or stapling process. The plurality of sensors 152272a to 152272h provide signals to one or more circuits of the surgical instrument 150010 to improve stapling performance and / or feedback of tissue thickness sensing.

FIG. 68 is a logical diagram illustrating an embodiment of the process 152280 for determining one or more parameters of a portion of tissue 152264 held within an end effector, such as the end effector 152250 shown in FIG. is there. In one embodiment, the first sensor 152258 is configured to detect one or more parameters of the end effector 152250 and / or part of the tissue 152264 located between the anvil 152252 and the staple cartridge 152256. Has been done. The first signal is 1522282 generated by the first sensor 152258. The first signal indicates one or more parameters detected by the first sensor 152258. The one or more secondary sensors 152260 are configured to detect one or more parameters of the end effector 152250 and / or part of the tissue 152264. The secondary sensor 152260 may be configured to detect the same parameters as the first sensor 152258, additional parameters, or different parameters. The secondary signal 152284 is generated by the secondary sensor 152260. The secondary signal 152284 indicates one or more parameters detected by the secondary sensor 152260. The first signal and the secondary signal are provided to a processor such as a primary processor. The processor adjusts the first signal generated by the first sensor 152258 based on the input generated by the secondary sensor 152260. The tuned signal may indicate, for example, the thickness of a portion of tissue 152264 and the integrity of meshing. The tuned signal is displayed to the operator, for example, by a display embedded in the surgical instrument 150010.

FIG. 69 shows an embodiment of the end effector 152300 including a plurality of redundant sensors 152308a and 152308b. The end effector 152300 comprises a first jaw member pivotally coupled to a second jaw member 152304, i.e. anvil 152302. The second jaw member 152304 is configured to receive the staple cartridge 152306 therein. The anvil 152302 is movable between the anvil 152302 and the staple cartridge 152306 with respect to the staple cartridge 152306 to grip a substance, such as a portion of tissue. A plurality of sensors 152308a and 152308b are coupled to the anvil. The plurality of sensors 152308a, 152308b are configured to detect one or more parameters of a portion of tissue located between the end effector 152300 and / or the anvil 152302 and the staple cartridge 152306. In some embodiments, the plurality of sensors 152308a, 152308b are configured to detect the gap 152310 between the anvil 152302 and the staple cartridge 152306. The gap 152310 may correspond, for example, to the thickness of the tissue located between the anvil 152302 and the staple cartridge 152306. The plurality of sensors 152308a, 152308b may detect the gap 152310, for example, by detecting the magnetic field generated by the magnet 152312 coupled to the second jaw member 152304.

In some embodiments, the plurality of sensors 152308a, 152308b include redundant sensors. The redundant sensor is configured to detect the same characteristics of a portion of tissue located between the end effector 152300 and / or the anvil 152302 and the staple cartridge 152306. The redundant sensor may include, for example, a Hall effect sensor configured to detect the gap 152310 between the anvil 152302 and the staple cartridge 152306. The redundant sensor provides a signal representing one or more parameters that allows a processor, such as a primary processor, to evaluate multiple inputs and determine the most reliable input. In some embodiments, redundant sensors are used to reduce noise, pseudo signals, and / or drift. Each redundant sensor is measured in real time during grabbing to analyze time-based information and allow algorithms and / or look-up tables to dynamically recognize organizational features and grabbing positioning. You may. One or more inputs of the redundant sensor are adjusted and / or selected to provide true tissue thickness and meshing of a portion of the tissue located between the anvil 152302 and the staple cartridge 152306. May be identified.

FIG. 70 is a logical diagram illustrating an embodiment of process 152320 that selects the most reliable output from a plurality of redundant sensors, such as the plurality of sensors 152308a, 152308b shown in FIG. 69. In one embodiment, the first signal is generated by the first sensor 152308a. The first signal is 152322a, which is converted by an analog-to-digital converter. One or more additional signals are generated by one or more redundant sensors 152308b. One or more additional signals are converted by an analog-to-digital converter 152322b. The converted signal is provided to a processor such as a primary processor. The primary processor evaluates the redundant inputs to determine the most reliable output 152324. The most reliable output may be selected based on one or more parameters, such as, for example, algorithms, look-up tables, inputs from additional sensors, and / or instrument status. After selecting the most reliable output, the processor, for example, one or more to reflect the true thickness and meshing of a portion of the tissue located between the anvil 152302 and the staple cartridge 152306. The output may be adjusted based on the additional sensor of. The most reliable regulated output is shown to the operator, for example, by a display embedded in a surgical instrument 150010.

FIG. 71 shows an embodiment of an end effector 152350 comprising a sensor 152358 with a unique sampling rate that limits or eliminates pseudo signals. The end effector 152350 comprises a first jaw member, i.e. anvil 152352, pivotally coupled to a second jaw member 152354. The second jaw member 152354 is configured to receive a staple cartridge 152356 therein. The staple cartridge 152356 contains a plurality of staples that can be delivered to a portion of the tissue located between the anvil 152352 and the staple cartridge 152356. The sensor 152358 is coupled to the anvil 152352. The sensor 152358 is configured to detect one or more parameters of the end effector 152350, such as the gap 152364 between the anvil 152352 and the staple cartridge 152356. The gap 152364 may correspond to the thickness of the material, such as a portion of the tissue, and / or the integrity of the material meshing between the anvil 152352 and the staple cartridge 152356. The sensor 152358 may include, for example, a magnetic sensor such as a Hall effect sensor, an induction sensor such as a strain gauge, a pressure sensor, a vortex current sensor, a resistance sensor, a capacitance sensor, an optical sensor, and / or any other suitable sensor. Any suitable sensor that detects one or more parameters of the effector 152350 may be provided.

In one embodiment, the sensor 152358 comprises a magnetic sensor configured to detect a magnetic field generated by an electromagnetic wave source 152360 coupled to a second jaw member 152354 and / or staple cartridge 152356. The electromagnetic wave source 152360 generates a magnetic field detected by the sensor 152358. The strength of the detected magnetic field may correspond, for example, to the thickness of the tissue located between the anvil 152352 and the staple cartridge 152356 and / or the integrity of the mesh. In some embodiments, the electromagnetic source 152360 produces a signal at a known frequency, for example 1 MHz. In other embodiments, the signal generated by the electromagnetic source 152360 is, for example, a type of staple cartridge 152356 mounted on a second jaw member 152354, one or more additional sensors, algorithms, and / or one. It may be adjustable based on one or more parameters.

In one embodiment, the signal processor 152362 is coupled to an end effector 152350, for example anvil 152352. The signal processor 152362 is configured to process the signal generated by the sensor 152358 to eliminate the pseudo signal and boost the input from the sensor 152358. In some embodiments, the signal processor 152362 may be disposed separately from the end effector 152350, for example in the handle 150014 of the surgical instrument 150010. In some embodiments, the signal processor 152362 comprises an algorithm that is integrally formed with a general purpose processor, such as a primary processor, and / or is executed by the general purpose processor. The signal processor 152362 is configured to process the signal of the sensor 152358 at a frequency substantially equal to the frequency of the signal generated by the electromagnetic wave source 152360. For example, in one embodiment, the electromagnetic wave source 152360 produces a signal at a frequency of 1 MHz. The signal is detected by sensor 152358. The sensor 152358 produces a signal indicating the detected magnetic field provided to the signal processor 152362. The signal is processed by the signal processor 152362 at a frequency of 1 MHz to eliminate the pseudo signal. The processed signal is provided to a processor, such as a primary processor. The primary processor correlates the received signal with one or more parameters of the end effector 152350, such as the gap 152364 between the anvil 152352 and the staple cartridge 152356.

FIG. 72 illustrates an embodiment of process 152370 for generating a thickness measurement of a portion of tissue located between an anvil of an end effector and a staple cartridge, such as the end effector 152350 shown in FIG. 71. It is a figure. In one embodiment of process 152370, the signal is generated by a modulated electromagnetic source 152360. 152372. The generated signal may include, for example, a 1 MHz signal. The magnetic sensor 152358 is configured to detect a signal generated by the electromagnetic wave source 152360. The magnetic sensor 152358 generates a signal indicating the detected magnetic field and provides the signal to the signal processor 152362. The signal processor 152362 processes the signal to perform 152376, noise removal, pseudo signal removal, and / or signal boosting. The processed signal is provided to an analog-to-digital converter at 152378 for conversion to a digital signal. The digital signal may be calibrated, for example, by applying a calibration curve input algorithm and / or a look-up table. Signal processing 152376, conversion 152378, and calibration 152380 may be performed by one or more circuits. The calibrated signal is displayed to the user, for example, by a display integrally formed with the surgical instrument 150010.

73 and 74 show an embodiment of an end effector 152400 with a sensor 152408 that identifies different types of staple cartridges 152406. The end effector 152400 comprises a first jaw member or anvil 152402 pivotally coupled to a second jaw member or elongated channel 152404. The elongated channel 152404 is configured to operably support the staple cartridge 152406 therein. The end effector 152400 further comprises a sensor 152408 located in the proximal region. The sensor 152408 can be either an optical sensor, a magnetic sensor, an electrical sensor, or any other suitable sensor.

The sensor 152408 may be capable of detecting the characteristics of the staple cartridge 152406 and thereby identifying the type of staple cartridge 152406. FIG. 74 shows an example in which the sensor 152408 is an optical emitter / detector 152410. The body of the staple cartridge 152406 may be a different color so that the color identifies the type of staple cartridge 152406. The light emitter / detector 152410 may be operational to query the color of the staple cartridge 152406 body. In an exemplary example, the light emitter / detector 152410 is capable of detecting white by receiving reflected light of equal intensity red, green, and blue spectra. The light emitter / detector 152410 is capable of detecting red by receiving light in the higher intensity red spectrum while receiving very little reflected light in the green and blue spectra.

Alternatively, or in addition, the light emitter / detector 152410, or another suitable sensor 152408, can query and identify any other symbol or marking on the staple cartridge 152406. The symbol or mark can be any one of barcodes, shapes or letters, color-coded patterns, or any other suitable mark. The information read by the sensor 152408 can be communicated to the microcontroller of the surgical device 150010, such as a microcontroller (eg, microcontroller 461 (FIG. 12)). The microcontroller can be configured to communicate information about the staple cartridge 152406 to the operator of the instrument. For example, the identified staple cartridge 152406 may not be suitable for a given application, in which case the operator of the instrument can be notified and / or the instrument is improperly functioning. .. In such an example, the microcontroller can optionally be configured to disable the functionality of the surgical instrument. Alternatively, or in addition, the microcontroller tells the operator of the surgical instrument 150010 the parameters of the type of staple cartridge 152406 identified, such as the length of the staple cartridge 152406, or the height and length, etc. , Information about staples can be configured to be notified.

FIG. 75 illustrates an aspect of the segmented flexible circuit 153430 configured to be fixedly attached to the jaw member 153434 of the end effector. The segmented flexible circuit 153430 includes a distal segment 153432a and lateral segments 153432b, 153432c that include individually addressable sensors to provide detection of the presence of local tissue. Segments 153432a, 153432b, 153432c can be individually addressed to detect tissue and measure tissue parameters based on individual sensors located within each of the segments 153432a, 153432b, 153432c. Segments 153432a, 153432b, 153432c of the segmented flexible circuit 153430 are attached to the jaw member 153434 and are electrically coupled to an energy source such as an electrical circuit via a conductive element 153436. A Hall effect sensor 153438 or any suitable magnetic sensor is placed at the distal end of the jaw member 153434. The Hall effect sensor 153438 works with a magnet to provide a measurement of the opening defined by the jaw member 153434, which is separately shown in detail in FIG. 77, otherwise referred to as the tissue gap. The segmented flexible circuit 153430 may be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue location within the end effector.

FIG. 76 illustrates an aspect of the segmented flexible circuit 153440 configured to be attached to the jaw member 153444 of the end effector. The segmented flexible circuit 153440 comprises a distal segment 153442a containing individually addressable sensors and lateral segments 153442b, 153442c for tissue control. Segments 153442a, 153442b, 153442c can be individually addressed to treat tissue and to read individual sensors located within each of segments 153442a, 153442b, 153442c. Segments 153442a, 153442b, 153442c of the segmented flexible circuit 153440 are attached to the jaw member 153444 and electrically coupled to the energy source via the conductive element 153446. A Hall effect sensor 153448 or other suitable magnetic sensor is provided at the distal end of the jaw member 153444. The Hall effect sensor 153448 works with a magnet to provide measurements of the aperture or tissue gap defined by the end effector jaw member 153444, which is detailed in FIG. 77. In addition, a plurality of lateral asymmetric temperature sensors 153450a, 153450b are mounted on or formally integrated with the segmented flexible circuit 153440 to provide tissue temperature feedback to the control circuit. The segmented flexible circuit 153440 may be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue location within the end effector.

Figure 77 illustrates one embodiment of an end effector 153 460 configured to measure tissue gap _{G T.} The end effector 153460 includes a jaw member 153462 and a jaw member 153444. The flexible circuit 153440 described in FIG. 76 is attached to the jaw member 153444. The flexible circuit 153 440, in order to measure the tissue gap _{G T,} comprises a Hall effect sensor 153 448 to work with the magnets 153,464, which is attached to the jaw members 153,462. Such techniques can be used to measure the opening defined between the jaw member 153444 and the jaw member 153462. The jaw member 153462 may be a staple cartridge.

FIG. 78 illustrates one aspect of the end effector 153470, including the segmented flexible circuit 153468. The end effector 153470 includes a jaw member 153472 and a staple cartridge 153474. The segmented flexible circuit 153468 is attached to the jaw member 153472. Each of the sensors disposed inside segments 1-5 is configured to detect the presence of tissue located between the jaw member 153472 and the staple cartridge 153474 and represent tissue areas 1-5. .. In the configuration shown in FIG. 78, the end effector 153470 is shown in an open position ready to receive or grip tissue between the jaw member 153472 and the staple cartridge 153474. The segmented flexible circuit 153468 may be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue location within the end effector 153470.

FIG. 79 illustrates the end effector 153470 shown in FIG. 78, in which the jaw member 153472 holds the jaw member 153472, eg, tissue 153476 between the anvil and the staple cartridge. As shown in FIG. 79, tissue 153476 is positioned between segments 1-3 and represents tissue areas 1-3. Thus, tissue 153476 is detected by sensors in segments 1-3, and tissue absence (empty state) is detected in section 153469 by segments 4-5. Information about the presence and absence of tissues 153476 positioned within specific segments 1-3 and 4-5 is transmitted to control circuits as described herein, eg, via interface circuits, respectively. The control circuit is configured to detect tissues located within segments 1-3. Segments 1-5 include any suitable temperature, force / pressure, and / or Hall effect magnetic sensor for measuring tissue parameters of tissues located within certain segments 1-5, and certain segments 1 It will be appreciated that electrodes and electrodes for delivering energy to tissues located within ~ 5 may be accommodated. The segmented flexible circuit 153468 may be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue location within the end effector 153470.

FIG. 80 is a diagram of an absolute positioning system 153100 that can be used with a surgical instrument or system according to the present disclosure. The absolute positioning system 153100 comprises a controlled motor drive circuit configuration with a sensor mechanism 153102 according to at least one aspect of the present disclosure. The sensor mechanism 153102 for the absolute positioning system 153100 provides a unique position signal corresponding to the position of the displacement member 153111. In one aspect, the displacement member 153111 represents a longitudinally movable drive member connected to a cutting instrument or knife (eg, cutting instrument, I-beam, and / or I-beam 153514 (FIG. 82)). In another aspect, the displacement member 153111 represents a launching member connected to a cutting tool or knife that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member 153111 represents a firing bar or I-beam, each of which may be adapted and configured to include a rack of drive teeth.

Thus, as used herein, the term displacement member refers to surgical instruments such as drive members, launch members, launch bars, cutting instruments, knives, and / or I-beams, or any element that can be displaced. Or used to collectively refer to any moving member of the system. Therefore, the absolute positioning system 153100 can actually track the displacement of the I-beam 153514 (FIG. 82) by tracking the displacement of the drive member that is movable in the longitudinal direction. In various other embodiments, the displacement member 153111 may be coupled to any sensor suitable for measuring the displacement. Thus, longitudinally movable drive members, launch members, launch bars, or I-beams, or combinations thereof, may be coupled to any suitable displacement sensor. Displacement sensors may include contact or non-contact displacement sensors. Displacement sensors are arranged on a series of linear variable differential transformers (LVDT), differential variable reluctance transducers (DVRT), slide potentiometers, movable magnets and a series of straight lines. Magnetic sensing system with Hall effect sensors, fixed magnets and magnetic sensing system with Hall effect sensors arranged on a series of movable straight lines, movable light sources and light arranged on a series of linear lines It may include an optical detection system with a diode or photodetector, or an optical detection system with a fixed light source and a photodetector or photodetector arranged on a series of movable straight lines, or any combination thereof. ..

The electric motor 153120 may include a rotary shaft 153116 that operably cooperates with a gear assembly 153114 mounted in mesh engagement with a set or rack of drive teeth on the displacement member 153111. The sensor element 153126 may be operably coupled to the gear assembly 153114 such that one rotation of the sensor element 153126 corresponds to some linear longitudinal translation of the displacement member 153111. The gearing and sensor 153118 configuration can be connected to a linear actuator by rack and pinion configuration, or to a rotary actuator by spur gear or other connection. The power supply 153129 supplies power to the absolute positioning system 153100, and the output indicator 153128 can display the output of the absolute positioning system 153100.

One rotation of the sensor element 153126 associated with the position sensor 153112 _{corresponds to the longitudinal displacement d 1} of the displacement member 153111, where d ₁ is the displacement member after one rotation of the sensor element 153126 connected to the displacement member 153111. 153111 is the longitudinal distance from point "a" to point "b". The sensor mechanism 153102 may be connected via gear deceleration that results in the position sensor 153112 completing one or more rotations for the full stroke of the displacement member 153111. The position sensor 153112 can complete a plurality of rotations with respect to the full stroke of the displacement member 153111.

A series of switches 153122a to 153122n (where n is an integer greater than 1) may be used alone or gear deceleration to provide a unique position signal for two or more rotations of the position sensor 153112. It may be used in combination with. The states of the switches 153122a to 153122n are fed back to the controller 153110, and the controller applies logic to the longitudinal displacement of the displacement member 153111 d ₁ + d ₂ +. .. .. Determine the unique position signal corresponding to d _n. The output 153124 of the position sensor 153112 is provided to the controller 153110. The position sensor 153112 of the sensor mechanism 153102 may include a magnetic sensor, an analog rotation sensor such as a potential difference meter, and an array of analog Hall effect elements, which output a unique combination of position signals or values. The controller 153110 may be housed within the master controller or within the instrument mounting housing of the surgical instrument or system according to the present disclosure.

The absolute positioning system 153100 provides a displacement member 153111, which may be required in conventional rotary encoders where the motor 153120 simply counts the number of steps taken forward or backward to estimate the position of device actuators, drive bars, knives, etc. It provides the absolute position of the displacement member 153111 when the surgical instrument or system is powered on, without retracting or advancing to the reset (zero or home) position.

Controller 153110 may be programmed to perform a variety of functions, such as precise control over the speed and position of the knife and joint movement system. In one aspect, controller 153110 includes processor 153108 and memory 153106. The electric motor 153120 may be a brushed DC motor with a gearbox and a mechanical connection to a joint movement or knife system. In one aspect, the motor drive 153110 may be A3941 available from Allegro Microsystems, Inc. Other motor drives can be easily replaced for use in the absolute positioning system 153100.

Controller 153110 may be programmed to provide precise control over the speed and position of the displacement member 153111 and the joint movement system. Controller 153110 may be configured to calculate the response within the software of controller 153110. The calculated response is compared to the measured response of the actual system to give an "observed" response, which is used to determine the actual feedback. The observed response is a suitable tuned value that balances the smooth and continuous nature of the simulated response with the measured response, which can detect external effects on the system.

The absolute positioning system 153100 may include and / or may be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. The power supply 153129 converts the signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include voltage, current, and force pulse width modulation (PWM). In addition to the position measured by the position sensor 153112, another sensor (s) 153118 may be provided to measure the physical parameters of the physical system. In a digital signal processing system, an absolute positioning system 153100 is coupled to a digital data acquisition system, where the output of the absolute positioning system 153100 has a finite resolution and sampling frequency. The absolute positioning system 153100 compares and combines the calculated response with the measured response using algorithms such as weighted average and theoretical control loops that drive the calculated response towards the measured response. Can be equipped with a circuit. In order to predict what the state and output of the physical system will be by knowing the inputs, the calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, and induced resistance.

The motor drive 153110 may be A3941 available from Allegro Microsystems, Inc. The A3941 drive 153110 is a full bridge controller for use with an external N-channel power metal oxide semiconductor field effect transistor (MOSFET) specifically designed for inductive loads such as brushed DC motors. Drive 153110 is equipped with a unique charge pump regulator, which provides full (> 10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive up to 5.5V. To do. A bootstrap capacitor may be used to provide the battery supply voltage required for the N-channel MOSFET. The internal charge pump for high-side drive enables DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation is possible with both high-side and low-side FETs. The power FET is protected from shoot-through by a resistor adjustable dead time. The integrated diagnostics indicate low voltage, overtemperature, and power bridge anomalies and can be configured to protect the power MOSFET under most short circuit conditions. Other motor drives can be easily replaced for use in the absolute positioning system 153100.

FIG. 81 is a diagram of a position sensor 153200 for an absolute positioning system 153100', comprising a magnetic rotation absolute positioning system according to at least one aspect of the present disclosure. The absolute positioning system 153100'is similar to the absolute positioning system 153100 in many respects. The position sensor 153200 may be implemented as an AS5055 EQFT single chip gyromagnetic position sensor available from Austria Microsystems, AG. The position sensor 153200 provides an absolute positioning system 153100'in cooperation with the controller 153110. The position sensor 153200 is a low voltage, low power component, eg, a position sensor 153200 located above a magnet positioned on a rotating element associated with a displacement member such as a knife drive gear and / or a closed drive gear. Region 153230 includes four Hall effect elements 153228A, 153228B, 153228C, 153228D, which allow precise tracking of displacement of the launching member and / or closing member. A high resolution ADC 153232 and a smart power management controller 153238 are also provided on the chip. As a digit-by-digit method and Volder's algorithm to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. Also known, a CORDIC processor 153236 (abbreviation for coordinate rotation digital computer) is provided. The angular position, alarm bits, and magnetic field information are transmitted to the controller 153110 via a standard serial communication interface such as SPI interface 153234. The position sensor 153200 provides 12-bit or 14-bit resolution. The position sensor 153200 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

The Hall effect elements 153228A, 153228B, 153228C, and 153228D are installed directly above the rotating magnet. The Hall effect is a well-known effect and is not described in detail herein for convenience, but in general, the Hall effect is the voltage difference between an electrical conductor that traverses a current in a conductor and a magnetic field that is orthogonal to the current. Generates (Hall voltage). The Hall coefficient is defined as the ratio of the induced electric field to the current density multiplied by the applied magnetic field. The Hall coefficient is characteristic of the material that makes up the conductor, as its value depends on the type, number, and properties of the charge carriers that make up the current. In the AS5055 position sensor 153200, the Hall effect elements 153228A, 153228B, 153228C, 153228D can generate a voltage signal indicating the absolute position of the magnet at an angle over one rotation of the magnet. This angle value is a unique position signal, calculated by the CORDIC processor 153236 and stored in a register or memory onboard the AS5055 position sensor 153200. Angle values indicating the position of the magnet over one revolution are provided to the controller 153110 in various techniques, for example at power up or when requested by the controller 153110.

The AS5055 position sensor 153200, when connected to the controller 153110, requires only a few external components to operate. A simple application using a single power supply requires 6 wires, 2 wires for power and 4 wires 153240 for SPI interface 153234 with controller 153110. A seventh connection may be added to send an interrupt to controller 153110 to signal that a new valid angle may be read. Upon power-on, the AS5055 position sensor 153200 performs the entire power-on sequence, including one angle measurement. Completion of this cycle is indicated as INT output 153242 and the angle value is stored in an internal register. When this output is set, the AS5055 position sensor 153200 pauses and goes into sleep mode. The controller 153110 can respond to an INT request at the INT output 153242 by reading the angle value from the AS5055 position sensor 153200 via the SPI interface 153234. When the angle value is read by the controller 153110, the INT output 153242 is cleared again. Further, when the "angle reading" command is transmitted to the position sensor 153200 by the SPI interface 153234 by the controller 153110, the chip is automatically turned on and another angle measurement is started. Immediately after the controller 153110 completes reading the angle value, the INT output 153242 is cleared and a new result is stored in the angle register. Completion of the angle measurement is indicated again by setting the corresponding flag in the INT output 153242 and the status register.

Due to the measurement principle of the AS5055 position sensor 153200, only a single angle measurement is performed in a very short time (~ 600 μs) after each power-on sequence. As soon as the measurement of one angle is completed, the AS5055 position sensor 153200 pauses and transitions to the power off state. On-chip filtering of angle values by digital averaging is not performed because it requires multiple angle measurements, resulting in longer power-on times and is not desirable for low power applications. Angle jitter can be reduced by averaging several angle samples within controller 153110. For example, averaging four samples reduces jitter by 6 dB (50%).

FIG. 82 is a cross-sectional view of the end effector 153502 showing the firing stroke of the I-beam 153514 with respect to the tissue 153526 gripped within the end effector 153502 according to at least one aspect of the present disclosure. The end effector 153502 is configured to work with either the surgical instrument or system according to the present disclosure. The end effector 153502 includes an anvil 153516 and an elongated channel 153503, with the staple cartridge 153518 positioned within the elongated channel 153503. The launch bar 153520 can be translated distally and proximally along the longitudinal axis 153515 of the end effector 153502. When the end effector 153502 is not in joint motion, the end effector 153502 is in line with the shaft of the instrument. An I-beam 153514 including a cutting edge 153509 is illustrated in the distal portion of the launch bar 153520. The wedge thread 153513 is located within the staple cartridge 153518. As the I-beam 153514 translates distally, the cutting edge 153509 can contact and cut the tissue 153526 positioned between the anvil 153516 and the staple cartridge 153518. The I-beam 153514 also contacts the wedge thread 153513 and pushes it distally to bring the wedge thread 153513 into contact with the staple driver 153511. The staple driver 153511 is pushed up into the table 153505 and advances the staple 153505 through the tissue into a pocket 153507 defined within the anvil 153516, which pocket forms the staple 153505.

The firing stroke of an exemplary I-beam 153514 is illustrated by chart 153259, aligned with the end effector 153502. An exemplary tissue 153526 is also shown aligned with the end effector 153502. The stroke of the launching member may include a stroke start position 153527 and a stroke end position 153528. During the firing stroke of the I-beam 153514, the I-beam 153514 may advance distally from the stroke start position 153527 to the stroke end position 153528. The I-beam 153514 is shown at one exemplary location of stroke start position 153527. The launch member stroke chart 153259 of the I-beam 153514 illustrates five launch member stroke regions 153517, 153519, 153521, 153523, 153525. In the first firing stroke region 153517, the I-beam 153514 may begin to advance distally. In the first firing stroke region 153517, the I-beam 153514 may contact the wedge thread 153513 and begin to move it distally. However, while in the first region, the cutting edge 153509 may not contact the tissue and the wedge thread 153513 may not contact the staple driver 153511. After overcoming the static friction, the force driving the I-beam 153514 within the first region 153517 can be substantially constant.

In the second launch member stroke region 153519, the cutting edge 153509 may come into contact with the tissue 153526 and begin to cut. Also, the wedge thread 153513 may begin to contact the staple driver 153511 to drive the staple 153505. The force driving the I-beam 153514 may begin to rise. As shown, the first bumped tissue may be compressed and / or thinner due to the manner in which the anvil 153516 is pivoted relative to the staple cartridge 153518. In the third launch member stroke region 153521, the cutting edge 153509 may continuously contact and cut the tissue 153526, and the wedge thread 153513 may repeatedly contact the staple driver 153511. The force driving the I-beam 153514 may be flat within the third region 153521. With the fourth firing stroke region 153523, the force driving the I-beam 153514 may begin to decline. For example, the tissue at the portion of the end effector 153502 corresponding to the fourth launch region 153523 may not be compressed as much as the tissue closer to the pivot point of the anvil 153516 and may require less force to cut. Also, the cutting edge 153509 and the wedge-shaped thread 153513 may reach the end of the tissue 153526 while in the fourth region 153523. When the I-beam 153514 reaches the fifth region 153525, the tissue 153526 may be completely cut. The wedge thread 153513 may contact one or more staple drivers 153511 at or near the edge of the tissue. The force that advances the I-beam 153514 to pass through the fifth region 153525 may be reduced and, in some examples, may be comparable to the force driving the I-beam 153514 in the first region 153517. .. At the end of the stroke of the launching member, the I-beam 153514 may reach the stroke end position 153528. The positioning of the stroke regions 153517, 153519, 153521, 153523, 153525 of the launching member in FIG. 82 is merely an example. In some examples, different regions may start at different positions along the longitudinal axis 153515 of the end effector, for example, based on the position of the tissue between the anvil 153516 and the staple cartridge 153518.

As discussed above, and here with reference to FIGS. 80-82, the tissue captured within the end effector 153502 was positioned within the master controller of the surgical instrument for stapling and / or incision. The electric motor 153120 can be used to advance and / or retract the launch system of the shaft assembly, including the I-beam 153514, with respect to the end effector 153502 of the shaft assembly. The I-beam 153514 may be advanced or retracted at a desired speed or within a desired speed range. Controller 153110 may be configured to control the speed of the I-beam 153514. The controller 153110 of the I-beam 153514 is based on various parameters of power supplied to the electric motor 153120, such as voltage and / or current, and / or other operating parameters of the electric motor 153120 or external influences. It can be configured to predict speed. The controller 153110 also bases the current value of the current and / or voltage supplied to the electric motor 153120, and / or the current state of the I-beam 153514, such as velocity, acceleration, and / or position. It can be configured to predict speed. Controller 153110 may be configured to sense the velocity of the I-beam 153514 using the absolute positioning sensor system described herein. Whether the controller should increase the power to the electric motor 153120 to increase the speed of the I-beam 153514 by comparing the predicted speed of the I-beam 153514 with the perceived speed of the I-beam 153514. And / or may be configured to determine if the I-beam 153514 should be reduced to slow it down.

The force acting on the I-beam 153514 can be determined using a variety of techniques. The force of the I-beam 153514 may be determined by measuring the current of the motor 153120, and the current of the motor 153120 is based on the load received by the I-beam 153514 as it advances distally. The force of the I-beam 153514 can be determined by positioning the strain gauge on the drive member, launch member, I-beam 153514, launch bar and / or on the proximal end of the cutting edge 153509. The power of I-beam 153 514 monitors the actual position of the I-beam 153 514 moving at the predicted rate based on the current set speed of the motor 153 120 after a predetermined elapsed time period _{T 1,} the actual position of the I-beam 153,514 it may be determined by comparing the predicted position of the I-beam 153 514 based on the current set speed period _{T 1} at the end of the motor 153,120. Therefore, if the actual position of the I-beam 153514 is less than the predicted position of the I-beam 153514, the force on the I-beam 153514 is greater than the nominal force. Conversely, if the actual position of the I-beam 153514 exceeds the expected position of the I-beam 153514, the force on the I-beam 153514 is less than the nominal force. The difference between the actual position of the I-beam 153514 and the expected position is proportional to the deviation of the force on the I-beam 153514 from the nominal force.

Before referring to the description of the closed loop control technique of the closed tube and the launching member, the description will briefly refer to FIG. 83. FIG. 83 shows two closure force (FTC) plots 153606, 153608 depicting the forces applied to the closing member to close on the thick and thin tissue during the closure phase, and the thick and thin tissue during the launch phase. It is a graph 153601 drawing two firing force (FTF) plots 153622 and 153624 which draw the force applied to the firing member to fire through the tissue. Referring to FIG. 83, graph 153600 shows the force exerted on thick and thin tissue during the closing stroke to close the end effector 153502 against the tissue gripped between the anvil 153516 and the staple cartridge 153518. An example is drawn, in which the closing force is plotted as a function of time. Closing force plots 153606, 153608 are plotted on two axes. The vertical axis 153602 indicates the closing force (FTC) of the end effector 153502 in Newton (N) units. The horizontal axis 153604 indicates the time in seconds and is labeled with _{t 0 to t 13 for clarity.} The first closing force plot 153606 is an example of the force applied to the thick tissue during the closing stroke to close the end effector 153502 against the tissue gripped between the anvil 153516 and the staple cartridge 153518. Plot 153608 of 2 is an example of the force applied to the thin tissue during the closing stroke to close the end effector 153502 against the tissue gripped between the anvil 153516 and the staple cartridge 153518. The first closing force plot 153606 and the second closing force plot 153608 are divided into three stages: a closing stroke (closing), a waiting interval (standby), and a firing stroke (launching). During the closure stroke, the closure tube is translated distally (direction "DD") to move the anvil 153516 with respect to, for example, the staple cartridge 153518, in response to the activation of the closure stroke by the closure motor. In another example, the closure stroke involves moving the staple cartridge 153518 with respect to the anvil 153516 in response to the activation of the closure motor, in another example the closure stroke in response to the activation of the closure motor. , Accompanied by moving the staple cartridge 153518 and the anvil 153516. With reference to the first closing force plot 153606, the closing force 153610 in the closing stroke increases _{from 0 to the maximum force F 1} in time t _{0 to t 1.} Referring to the second closing force graph 153608, closing force 153 616 in the closing stroke, from 0 to the maximum force _{F 3,} increases at time _t 0 ~t _1. The relative difference between the maximum force F ₁ and F ₃ is due to the difference in closing force required for thick tissue for thin tissue, with respect to thin tissue, the order to close the anvil on thick tissue Great power is required.

The first closure force plot 153606 and the second closure force plot 153608 show that the closure force within the end effector 153502 increases during the initial grip period ending in _{time (t 1).} The closing force reaches the maximum force (F ₁ , F _{3 ) in time (t 1).} The initial gripping period can be, for example, about 1 second. The waiting interval may be applied before the launch stroke begins. The waiting interval allows fluid drainage from the tissue compressed by the end effector 153502, which reduces the thickness of the compressed tissue and the smaller gap and waiting interval between the anvil 153516 and the staple cartridge 153518. Provides a lower closing force at the end. With reference to the first closing force plot 153606, there is a slight decrease in the closing force 153612 from F _{1 to F 2} during the waiting interval _{from t 1 to t 4.} Similarly, referring to the second closing force plot 153608, the closing force 153618 drops slightly from F _{3 to F 4} during the waiting interval _{from t 1 to t 4. In some embodiments, a waiting interval (t 1 to t 4} ) selected from the range of about 10 seconds to about 20 seconds is typically used. In the example of the first closing force plot 153606 and the second closing force plot 153608, a period of about 15 seconds is used. After the waiting interval is a firing stroke, which lasts for a period selected from, for example, from about 3 seconds to, for example, about 5 seconds. The closing force is reduced as the I-beam 153514 is advanced relative to the end effector during the firing stroke. As indicated by a first closing force plot 153 606 and closing force 153614,153620 the second closing force plots 153,608, closing force 153614,153620 exerted on closure tube sharply until _{t 5} approximately time _{t 4} ~ about time Decreases to. Time t ₄ represents the moment when the I-beam 153514 couples into the anvil 153516 and begins to receive a closed load. Therefore, the closing force decreases as the firing force increases, as indicated by the first firing force plot 153622 and the second firing force plot 153624.

FIG. 83 is also graph 153601 of a first firing force plot 153622 and a second firing force plot 153624 plotting the forces applied to advance the I-beam 153514 during the firing stroke of the surgical instrument or system according to the present disclosure. Is illustrated. The firing force plots 153622 and 153624 are plotted on two axes. The vertical axis 153626 indicates the firing force in Newton (N) units applied to advance the I-beam 153514 during the firing stroke. The I-beam 153514 is configured to advance the knife or cutting element and propel the driver to deploy the staples during the firing stroke. The horizontal axis 153605 indicates the time in seconds on the same time scale as the horizontal axis 153604 of the graph 153600 above.

As mentioned earlier, the closed tube force _{drops sharply at time t 4} to approximately time t ₅ , as this time is indicated by the first firing force plot 153622 and the second firing force plot 153624. , The I-beam 153514 couples into the anvil 153516, begins to receive a load, and represents the moment when the closing force decreases as the firing force increases. I-beam 153 514 from the stroke start position at time _{t 4,} is advanced to the stroke end position of the _{t 13} of the firing force plot 153 622 for _t 8 ~t _9, and thick tissue firing force plot 153 624 for thin tissue. When the I-beam 153514 is advanced distally during the firing stroke, the closing assembly relinquishes control of the staple cartridge 153518 and anvil 153516 over the firing assembly, thereby increasing firing power and reducing closing power. Let me.

In the launch force plot 153622 of thick tissue during the launch section (launch), the plot 153622 is divided into three separate segments. The first segment 153 628 shows the firing force when increases from 0 at _{t 4} to peak force F _'1 just prior to _{t 5.} The first segment 153628 is the firing force in the early stages of the firing stroke, in which the I-beam 153514 advances distally from the top of the closed ramp until the I-beam 153514 touches the tissue. The second segment 153630 shows the firing force in the second stage of the firing stroke, where the I-beam 153514 advances distally, deploys staples and cuts tissue. In the second stage of the firing stroke, the firing force decreases 'from ₁ F' F up to ₂ at approximately _{t 12.} The third segment 153632 indicates the firing force at the third or final stage of the firing stroke, and the I-beam 153514 leaves the tissue and advances to the end of the stroke within the tissue-free area. In the third stage of the firing stroke, the firing force, I-beam 153,514 has reached the end of the stroke, is reduced from F _'2 at approximately _{t 13} to zero (0). In summary, during the firing stroke, the firing force increased dramatically as the I-beam 153514 entered the tissue area, gradually decreased within the tissue area during the stapling and cutting operation, and the I-beam 153514 It drops dramatically when exiting and entering an area where there is no tissue at the end of the stroke.

The thin tissue firing force plot 153624 follows a pattern similar to the thick tissue firing force plot 153622. Accordingly, in a first stage of the firing stroke, firing force 153634 it is dramatically increased from 0 at about _{t 5} to F _'3. In the second stage of the firing stroke, firing force 153636 is 'from _3, F at approximately _{t 8'} F decreases uniformly until _4. Firing force 153,638 in the final stage of the firing stroke _decreases dramatically at t 8 ~t ₉ from F _'4 to 0.

As shown in the first firing force plot 153622 and the second firing force plot 153624, the moment when the I-beam 153514 joins within the anvil 153516 and begins to be loaded and the closing force decreases as the firing force increases. To overcome the sharp drop in closing force at time t ₄ to approximately time t ₅ , the closing tube is moved distally while the launching member, such as the I-beam 153514, is being moved distally. May be done. The closing tube is represented as a transmission element that exerts a closing force on the anvil 153516. As described herein, the control circuit applies the motor set value to the motor control unit, which applies the motor control signal to the motor to drive the transmission element and advance the closure tube distally. Then, a closing force is applied to the anvil 153516. A torque sensor coupled to the output shaft of the motor can be used to measure the force applied to the closed tube. In other embodiments, the closing force can be measured with a strain gauge, load cell, or other suitable force sensor.

FIG. 84 shows a closing member (eg, closure) when the launching member (eg, I-beam 153514) according to at least one aspect of the present disclosure advances distally and couples into a gripping arm (eg, anvil 153516). FIG. 5 is a diagram of a control system 153950 configured to reduce the closing force load on a closing member by a desired ratio and reduce the firing force load on the launching member by performing a gradual closure to the tube). In one aspect, the control system 153950 may be implemented as a nested PID feedback controller. The PID controller is a control loop feedback mechanism (controller) for continuously calculating the error value as the difference between the desired set point and the measured process variable, and is a proportional, integral, and derivative term (P, respectively). , I, and D). The nested PID controller feedback control system 153950 includes a primary controller 153952 in a primary (outer) feedback loop 153954 and a secondary controller 153955 in a secondary (inner) feedback loop 153965. The primary controller 153952 may be a PID controller 153972 as shown in FIG. 84, and the secondary controller 153955 may also be a PID controller 153972 as shown in FIG. 85. The primary controller 153952 controls the primary process 153958 and the secondary controller 153955 controls the secondary process 153960. The output 153966 (output) of the primary process 153958 is subtracted from the _{primary set value SP 1 by the first adder 153962.} The first adder 153962 produces a single sum output signal applied to the primary controller 153952. The output of the primary controller 153952 is the secondary set value SP ₂ . The output 153966 of the secondary process 153960 is subtracted from the _{secondary set value SP 2 by the second adder 153964.}

In the context of controlling the displacement of the closed tube, the control system 153950 has a primary set value SP ₁ of the desired closing force value and the primary controller 153952 receives the closing force from the torque sensor coupled to the output of the closing motor. , May be configured to determine the motor speed of the closed motor set value SP _2. In other embodiments, the closing force can be measured with a strain gauge, load cell, or other suitable force sensor. The speed set value SP ₂ of the closed motor is compared with the actual speed of the closed tube as determined by the secondary controller 153955. The actual velocity of the closed tube can be measured by comparing the measurement of the displacement of the closed tube with a position sensor to the measurement of the elapsed time with a timer / counter. Other techniques, such as linear encoders or rotary encoders, can be used to measure the displacement of the closed tube. The output 153966 of the secondary process 153960 is the actual speed of the closed tube. The velocity output of the closed tube 153968 is provided to the primary process 153958 to determine the force acting on the closed tube and is fed back to the adder 153962 which subtracts the _{measured closing force from the primary set value SP 1.} The primary set value SP ₁ may be an upper threshold value or a lower limit threshold value. Based on the output of the adder 153962, the primary controller 153952 controls the speed and direction of the closed tube motor. The secondary controller 153955 is based on the actual velocity of the closed tube measured by the secondary process 153960 and the secondary set value SP ₂ based on the comparison between the actual firing force and the upper and lower thresholds of the firing force. To control the speed of the closed motor.

FIG. 85 illustrates a PID feedback control system 153970 according to at least one aspect of the present disclosure. The primary controller 153952 and / or secondary controller 153955 may be implemented as PID controller 153972. In one aspect, the PID controller 153972 may include a proportional element 153974 (P), an integrating element 153976 (I), and a differential element 153978 (D). The outputs of the P element 153974, the I element 153976, and the D element 153978 are added by the adder 153896, which provides the control variable u (t) to process 153980. The output of process 153980 is the process variable y (t). The adder 153984 calculates the difference between the desired set value r (t) and the measured process variable y (t). The PID controller 153972 has an error value e (t) as a difference between the desired set value r (t) (for example, the closing force threshold) and the measured process variable y (t) (for example, the velocity and direction of the closed tube). ) (For example, the difference between the closing force threshold and the measured closing force) was continuously calculated and calculated by the proportional element 153974 (P), the integrating element 153976 (I), and the differential element 153978 (D), respectively. Apply corrections based on proportional, integral, and derivative terms. The PID controller 153972 attempts to minimize the error e (t) over time by adjusting the control variable u (t) (eg, the velocity and direction of the closed tube).

According to the PID algorithm, the "P" element 153974 corresponds to the current value of the error. For example, when the error is large and positive, the control output is also large and positive. According to the present disclosure, the error term e (t) differs between the desired closing force of the closed tube and the measured closing force. The "I" element 153976 corresponds to the past value of the error. For example, if the current output is not strong enough, the error integral accumulates over time and the controller responds by applying stronger motion. The "D" element 153978 corresponds to an error-prone future trend based on its current rate of change. For example, returning to the example of P above, if a large positive control output succeeds in bringing the error close to zero, it also puts the process on the path to a large negative error in the near future. In this case, the derivative becomes negative and the D module reduces the strength of motion to prevent this overshoot.

It will be appreciated that other variables and settings may be monitored and controlled according to the feedback control systems 153950, 153970. For example, the adaptive closure member velocity control algorithms described herein include, among other things, the parameters of launch member stroke position, launch member load, cutting element displacement, cutting element velocity, closure tube stroke position, closure tube load. At least two of them can be measured.

FIG. 86 is a logical flow diagram depicting a control program or logical configuration process 153990 for determining the speed of a closing member according to at least one aspect of the present disclosure. The control circuit of a surgical instrument or system according to the present disclosure is configured to determine the actual closing force of a closing member. The control circuit compares the actual closing force with the threshold closing force 153994, and based on this comparison determines the set value velocity for displacing the closing member 153996. The control circuit controls the actual speed of the closing member based on the set value speed 153998.

Also with reference to FIGS. 84 and 85, in one aspect, the control circuit comprises proportional, integral, and derivative (PID) feedback control systems 153950, 153970. The PID feedback control systems 153950 and 153970 include a primary PID feedback loop 153954 and a secondary PID feedback loop 153956. The primary feedback loop 153954 determines the first error between the actual closing force of the closing member and the threshold closing force SP _1, and sets the closing member speed set value SP ₂ based on the first error. The secondary feedback loop 153956 determines a second error between the actual speed of the closing member and the set value speed, and controls the closing member speed based on the second error.

In one aspect, the threshold closing force SP ₁ includes an upper threshold and a lower threshold. The set point velocity SP ₂ is configured to advance the closing member distally when the actual closing force is less than the lower threshold, and the set point velocity is such that the actual closing force is greater than the lower threshold. Occasionally, the closing member is configured to retract proximally. In one aspect, the set point velocity is configured to hold the closing member in place when the actual closing force is between the upper and lower thresholds.

In one aspect, the control system further comprises a force sensor coupled to the control circuit (eg, any of sensors 472, 474, 476 (FIG. 12)). The force sensor is configured to measure the closing force. In one aspect, the force sensor comprises a torque sensor coupled to the output shaft of the motor coupled to the closing member. In one aspect, the force sensor comprises a strain gauge connected to a closing member. In one aspect, the force sensor comprises a load cell connected to a closing member. In one aspect, the control system includes a position sensor connected to the closing member, which is configured to measure the position of the closing member.

In one aspect, the control system comprises a first motor configured to couple to the closure member, and the control circuit is configured to advance the closure member in at least a portion of the firing stroke.

The function or process 153990 described herein may be performed by any of the processing circuits described herein. Aspects of electrosurgical instruments may be performed without the specific details disclosed herein. Some aspects are shown as block diagrams rather than details.

A part of the present disclosure may be expressed as an instruction that operates on data stored in computer memory. An algorithm refers to a self-consistent sequence of steps that leads to a desired result, and a "step" takes the form of an electrical or magnetic signal that can be stored, transmitted, coupled, compared and otherwise manipulated. Refers to the manipulation of physical quantities that can be done. These signals can be referred to as bits, values, elements, symbols, letters, terms, numbers. These and similar terms may be associated with appropriate physical quantities and are only convenient labels applied to these quantities.

In general, the various aspects described herein, which can be implemented individually and / or collectively by a wide range of hardware, software, firmware, or any combination thereof, of various types of "electricity". It can be regarded as composed of "circuits". As a result, an "electric circuit" is composed of an electric circuit having at least one individual electric circuit, an electric circuit having at least one integrated circuit, an electric circuit having at least one application-specific integrated circuit, and a computer program. It forms electrical circuits and memory devices that form general purpose computing devices (eg, general purpose computers or processors composed of computer programs that at least partially execute the processes and / or devices described herein). For example, it includes an electric circuit (in the form of a random access memory) and / or an electric circuit forming a communication device (for example, a modem, a communication switch, or an optical electric device). These embodiments can be implemented in analog or digital form, or a combination thereof.

The above description describes aspects of an apparatus and / or process by use of block diagrams, flowcharts, and / or embodiments that may include one or more functions and / or operations. Each function and / or operation in such a block diagram, flowchart, or embodiment is implemented individually and / or collectively by a wide range of hardware, software, firmware, or virtually any combination thereof. be able to. In one aspect, some parts of the subject matter described herein are application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), programmable logic devices (PLDs), It may be implemented via a combination of circuits, registers and / or software components such as programs, subroutines, logic and / or hardware and software components. Logic gates, or other integrated form. Some aspects of the embodiments disclosed herein, all or part of them, are as one or more computer programs running on one or more computers (eg, 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 (eg, one) Or as one or more programs running on more than one microprocessor), as firmware, or as virtually any combination thereof, can be implemented equivalently in an integrated circuit and also. It will be appreciated by those skilled in the art that designing circuits and / or writing software and / or firmware code is within the skill of those skilled in the art in light of the present disclosure.

The disclosed subject matter mechanisms can be distributed as program products in a variety of forms, and exemplary aspects of the subject matter described herein are specifics used to make the actual distribution. It is used regardless of the type of signal carrier. Examples of signal transport media include: recordable media, floppy disks, hard disk drives, compact discs (CDs), digital video discs (DVDs), digital tapes, computer memories, and transmission media such as digital. And / or analog communication media (eg, optical fiber cables, waveguides, wired communication links, wireless communication links (eg, transmitters, receivers, transmission logic, reception logic, etc.)).

The above description of these embodiments is presented for the purpose of description and description. It is not intended to be inclusive or limited to the exact form disclosed. In view of the above teachings, modifications or modifications are possible. These embodiments are selected and described to illustrate the principles and practical applications, thereby making various embodiments available to those skilled in the art, along with various modifications, as suitable for the particular application conceived. Is to be done. The claims presented with this specification are intended to define the overall scope.

Situational awareness Situational awareness is the ability of some aspects of a surgical system to determine or estimate surgical procedure-related information from data received from databases and / or instruments. The information can include the type of procedure performed, the type of tissue being operated on, or the body cavity that is the subject of the procedure. With contextual information related to the surgical procedure, the surgical system controls, for example, a modular device connected to it (eg, a robot arm and / or a robotic surgical tool) and applies to the surgeon during the surgical procedure. The way information or suggestions are provided can be improved.

Here, with reference to FIG. 87, a timeline 5200 showing situational awareness of a hub, such as a surgical hub 106 or 206, is drawn. Timeline 5200 is an exemplary surgical procedure and contextual information that the surgical hubs 106, 206 can derive from data received from a data source at each step of the surgical procedure. Timeline 5200 is taken by nurses, surgeons, and other healthcare professionals in the process of lung segment resection surgery, which begins with the establishment of an operating room and ends with the transfer of the patient to the postoperative recovery room. Here is a typical process that would be.

Situation Aware Surgical Hubs 106, 206 are data sources that include data generated each time a healthcare professional uses a modular device paired with Surgical Hubs 106, 206 throughout the course of the surgical procedure. Receive from. Surgical hubs 106, 206 receive this data from paired modular devices and other data sources to receive new data such as which step of the procedure is being performed at any given time. Then, inferences about ongoing actions (ie, contextual information) can be continuously derived. The situation-aware system of surgical hubs 106, 206, for example, records data about the procedure to generate a report, validates the steps taken by healthcare professionals, data that may be associated with a particular procedure step, or Providing a prompt (eg, via a display screen), adjusting a modular device based on context (eg, activating a monitor, adjusting the visibility (FOV) of a medical imaging device, or for ultrasound surgery It is possible to perform any of the above operations, such as changing the energy level of the instrument or RF electrosurgical instrument).

As a first step 5202 in this exemplary procedure, the hospital staff reads the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, surgical hubs 106, 206 determine that the procedure performed is a thoracic procedure.

In the second step 5204, the staff scans incoming medical supplies for treatment. Surgical hubs 106, 206 cross-reference the scanned supplies with a list of supplies used in various types of procedures to ensure that the mix of supplies corresponds to the thoracic procedure. In addition, the surgical hubs 106, 206 can also determine that the procedure is not a wedge-shaped procedure (the incoming supplies do not contain the specific supplies required for the thoracic wedge-shaped procedure, or otherwise the thoracic Either because it does not support wedge-shaped treatment).

In step 5206, the healthcare professional scans the patient's band via a scanner communicatively connected to the surgical hubs 106, 206. Subsequently, the surgical hubs 106, 206 can confirm the patient's identification information based on the scanned data.

In step 4 5208, the medical staff turns on the assistive device. Auxiliary devices utilized may vary depending on the type of surgical procedure and the technique used by the surgeon, but in this exemplary case, these include smoke evacuators, inhalers, and medical imaging devices. Upon activation, the modular device, the auxiliary device, can be automatically paired with surgical hubs 106, 206 located within a particular neighborhood of the modular device as part of its initialization process. .. The surgical hubs 106, 206 can then derive contextual information about the surgical procedure by detecting the type of modular device paired with it before or during this initialization phase. In this particular embodiment, surgical hubs 106, 206 determine that the surgical procedure is VATS surgery based on this particular combination of paired modular devices. Based on the combination of data from the patient's EMR, the list of medical supplies used in the surgery, and the type of modular device connected to the hub, the surgical hubs 106, 206 generally describe the specific procedure performed by the surgical team. Can be estimated. When the surgical hubs 106, 206 know what specific procedure is being performed, the surgical hubs 106, 206 are subsequently connected, reading the procedure steps from memory or from the cloud. Data subsequently received from other data sources (eg, modular and patient monitoring devices) can be cross-referenced to estimate which step of the surgical procedure is being performed by the surgical team.

In the fifth step 5210, the staff attaches the EKG electrode and other patient monitoring device to the patient. EKG electrodes and other patient monitoring devices can be paired with surgical hubs 106, 206. When the surgical hubs 106, 206 start receiving data from the patient monitoring device, the surgical hubs 106, 206 confirm that the patient is in the operating room.

In step 5212, the healthcare professional induces anesthesia in the patient. Surgical hubs 106, 206 indicate that the patient is under anesthesia, based on data from modular and / or patient monitoring devices, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Can be estimated. When the sixth step 5212 is completed, the preoperative part of the lung segment resection surgery is completed and the surgical part is started.

In step 5214, the operated patient's lungs are collapsed (while ventilation is switched to the contralateral lungs). Surgical hubs 106, 206 can, for example, estimate from ventilator data that the patient's lungs have collapsed. Surgical hubs 106, 206 can compare the detection of collapse of the patient's lungs with the expected steps of the procedure (which can be pre-accessed or read) so that the surgical portion of the procedure It can be presumed that it has begun, thereby collapsing the lungs, which can be determined to be the first surgical step in this particular procedure.

In the eighth step 5216, a medical imaging device (eg, a scope) is inserted and a video image from the medical imaging device is started. Surgical hubs 106, 206 receive medical imaging device data (ie, video or image data) through a connection to a medical imaging device. Upon receiving the medical imaging device data, the surgical hubs 106, 206 can determine that the laparoscopic portion of the surgical procedure has begun. In addition, surgical hubs 106, 206 can determine that the particular procedure being performed is a segmental resection as opposed to a lobectomy (in the data received in the second step 5204 of the procedure). Note that the wedge procedure has already been discounted by the surgical hubs 106, 206). The data from the medical imaging device 124 (FIG. 2) has been used (ie, activated) by determining the angle of the medical imaging device that is oriented with respect to the visualization of the patient's anatomy. Of many different methods, including by monitoring the number or medical imaging device (paired with surgical hubs 106, 206) and by monitoring the type of visualization device used. Can be used to determine contextual information about the type of treatment being performed from. For example, one technique for performing a VATS lobectomy is to place the camera above the diaphragm in the anterior inferior corner of the patient's chest cavity, while one technique for performing a VATS segmental resection is a camera. Is placed at the anterior intercostal position with respect to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situation recognition system can be trained to recognize the location of a medical imaging device based on a visualization of the patient's anatomical structure. As another example, one technique for performing VATS lobectomy utilizes a single medical imaging device, while another technique for performing VATS segmental resection utilizes multiple cameras. As yet another example, one technique for performing VATS segmental resection uses an infrared light source (which can be communicatively linked to a surgical hub as part of a visualization system) to visualize segmental fissures. , This is not used in VATS lobectomy. By tracking any or all of this data from a medical imaging device, surgical hubs 106, 206 are used for a particular type of surgical procedure in progress and / or a particular type of surgical procedure. You can determine which technology you have.

In step 5218, the surgical team initiates the procedure incision step. The surgical hubs 106, 206 are presumed to be in the process of the surgeon incising and separating the patient's lungs to receive data from the RF or ultrasound generator indicating that the energy device is being fired. Can be done. Surgical hubs 106, 206 cross-reference the received data with the read process of the surgical procedure and the energy fired at this point in the process (ie, after the procedure of the procedure described above is complete). It can be determined that the instrument is compatible with the incision process. In certain examples, the energy instrument can be an energy tool attached to the robot arm of a robotic surgical system.

In step 10 5220, the surgical team proceeds to the procedure ligation step. Since the surgical hubs 106, 206 receive data from surgical staples and cutting instruments indicating that the instrument is being fired, it can be presumed that the surgeon is ligating the arteries and veins. Similar to the previous step, surgical hubs 106, 206 can derive this estimate by cross-referencing the reception of data from surgical staples and cutting instruments with the steps in the read process. .. In certain examples, the surgical instrument can be a surgical tool attached to the robot arm of a robotic surgical system.

In step 5222, a segmental excision portion of the procedure is performed. Surgical hubs 106, 206 can be presumed that the surgeon is making a transverse incision in parenchymal tissue based on data from surgical staples and cutting instruments, including data from the cartridge. The data in the cartridge can correspond, for example, to the size or type of staple fired by the instrument. Since different types of staples are utilized for different types of tissue, the cartridge data can indicate the type of tissue that is stapled and / or traversed. In this case, the type of staple fired is used for parenchymal tissue (or other similar tissue type), thereby presuming that surgical hubs 106, 206 are performing a segmental resection of the procedure. Can be done.

Subsequently, in the twelfth step 5224, a nodule incision step is performed. Surgical hubs 106, 206 are presumed to have a surgical team incising a nodule and performing a leak test based on data received from a generator indicating that an RF or ultrasonic instrument is being fired. Can be done. For this particular procedure, the RF or ultrasound instrument used after the parenchymal tissue has been transversely incised corresponds to a nodular incision process that allows the surgical hubs 106, 206 to make this estimate. It will be possible. Surgeons regularly staple / cut instruments and surgical energy (ie, RF or ultrasound), depending on the particular step during the procedure, because different instruments better fit to a particular task. ) Note that it alternates between the instrument and the device. Thus, the particular sequence in which stapled / cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. In addition, in certain cases, robotic tools can be used for one or more steps during a surgical procedure and / or handheld surgical instruments for one or more steps during a surgical procedure. Can be used. The surgeon (s) can, for example, alternate between robotic tools and handheld surgical instruments in sequence and / or, for example, the devices can be used simultaneously. Upon completion of the twelfth step 5224, the incision is closed and the postoperative portion of the procedure begins.

In step 5226, the patient's anesthesia is reversed. Surgical hubs 106, 206 can be estimated, for example, based on ventilator data (ie, the patient's respiratory rate begins to increase) that the patient is awakening from anesthesia.

Finally, the fourteenth step 5228 is for the healthcare professional to remove various patient monitoring devices from the patient. Therefore, surgical hubs 106, 206 can presume that the patient is being transferred to the recovery room when the hub loses other data from the EKG, BP, and patient monitoring device. As can be seen from the description of this exemplary procedure, the surgical hubs 106, 206 are given a given surgical procedure, based on data received from various data sources communicatively linked to the surgical hubs 106, 206. It is possible to determine or estimate when each step of is occurring.

Situational awareness is further described in US Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety. In certain examples, the operation of a robotic surgical system, including, for example, the various robotic surgical systems disclosed herein, is based on its situational awareness and / or feedback from its components and / or from the cloud 104. Can be controlled by hubs 106, 206 based on the information in.

Safety System for Smart Electric Surgical Staple Closure Various aspects of the disclosure are internal drive of a surgical instrument in response to tissue parameters detected via one or more sensors of the surgical instrument. It targets improved safety systems that are capable of adapting, controlling, and / or synchronizing movements. According to at least one aspect, in the jaw of the end effector, the force detected through one or more sensors is performed by one or more subsequent / additional functions of the end effector. It may be large enough to prevent it from being done. According to another aspect, it prevents one or more subsequent / additional functions of the end effector from being performed, such as in the jaw of the end effector, via one or more sensors. Metal objects may also be detected. FIG. 88 shows a surgical system 23000 with a surgical instrument 23002, a surgical hub 23004, and a user interface 23006. In such an embodiment, the surgical instrument 23002 may comprise one or more sensors 23008, and the parameters detected by the one or more sensors 23008 of the surgical instrument 23002 are the surgical hub. It may be transmitted / communicated (eg, wirelessly) to the control circuit 23010 of 23004. Further, in such an embodiment, the surgical hub 23004 is associated with a surgical function (eg, incision, gripping, coagulation, stapling, cutting) associated with a component of the surgical instrument 23002 (eg, end effector, shaft, etc.). , Rotation, joint movement, etc.) may be configured to determine if it can be safely performed based on the parameters detected by one or more sensors 23008 of the surgical instrument 23002. In particular, in such an embodiment, the surgical hub 23004 provides the result (s) associated with the determination (ie, warnings related to surgical function, reasons why surgical function is blocked, etc.) in user interface 23006. May be configured to transmit / communicate with. Moreover, according to various aspects, the various user interfaces disclosed herein can be selected to advance surgical function, despite reasons to support any warning and / or blocking. A user interface feature (eg, override element 23012) may be included. In particular, in such aspects, such user interface features (eg, override element 23012) may not be visible (eg, performing a surgical function may endanger the patient).

With reference to FIG. 89 according to various aspects of the present disclosure, the surgical system 23100 is a control circuit and (23112, 23122, 23132 and / or 23142, eg, in a virtual line to indicate an arbitrary position (s)). ), And the user interface (23118, 23128, 23138, 23148 and / or 23158, eg, in virtual lines to indicate any position), eg, handle assembly 23110, shaft assembly 23120, and end effector assembly. It may be equipped with a surgical instrument 23102 including 23130. In such an embodiment, the control circuit is incorporated into one or more components of the surgical instrument 23102 (eg, handle assembly 23110, shaft assembly 23120 and / or end effector assembly 23130, etc.). Often (eg, 23112, 23122 and / or 23132) and / or may be incorporated into a surgical hub 23140 (eg, wirelessly) paired with a surgical instrument 23102 (eg, 23142). In particular, according to various aspects, the surgical instrument 23102 and / or the surgical hub 23140 may be a situational awareness surgical instrument and / or a situational awareness surgical hub. Situation awareness is surgical from data received from a database (eg, historical data related to a surgical procedure, eg 23149 and / or 23150) and / or data received from a surgical instrument (eg, sensor data during a surgical procedure). Refers to the ability of a surgical system, eg, 23100, to determine or estimate information about a procedure. For example, the determined or estimated information can include the type of procedure performed, the type of tissue to be operated on, the body cavity to be treated, and the like. Based on such contextual information associated with the surgical procedure, the surgical system can control, for example, the paired surgical instrument 23102 or its components (eg, 23110, 23120 and / or 23130). It can and / or can provide the surgeon with relevant information or suggestions throughout the surgical procedure (eg, via user interfaces 23118, 23128, 23138, 23148 and / or 23158). Further details regarding situational awareness can be found, for example, under the heading "Situational awareness".

Also, in FIG. 89 according to one aspect, the situational awareness surgical hub 23140 is paired (eg, wirelessly) with a surgical instrument 23102 used to perform a surgical procedure. In such an embodiment, the surgical instrument 23102 features a first jaw, a second jaw pivotally coupled to the first jaw, and the function of the end effector 23130 (eg, incision, grip). End effector assembly 23130 including a sensor 23134 configured to detect parameters associated with holding, coagulation, cutting, staple fastening, etc.) and transmit the detected parameters to the control circuit 23142 of the surgical hub 23140. May be equipped.

Further, in such an embodiment, the surgical instrument 23102 detects parameters associated with the function of the shaft assembly 23120 (eg, rotation, joint movement, etc.) and transfers the detected parameters to the control circuit 23142 of the surgical hub 23140. A shaft assembly 23120 may further include a sensor 23124 configured to transmit. In particular, the sensors referenced herein and in other disclosed embodiments are configured to detect multiple parameters associated with multiple end effector assemblies and / or shaft assembly functions. Please understand that it may be provided. Thus, in such an embodiment, the surgical hub control circuit 23142 is configured to receive parameters (eg, sensor data) detected from such sensors 23134 and / or 23124 throughout the course of the surgical procedure. May be done.

The detected parameters are the function of the associated end effector assembly 23130 (eg, incision, gripping, coagulation, cutting, staple fastening, etc.) and / or the function of the associated shaft assembly 23120 (eg, rotation, joints, etc.). Can be received each time an exercise, etc.) is performed. The surgical hub control circuit 23142 may be further configured to receive data from an internal database (eg, surgical hub database 23149) and / or an external database (eg, from cloud database 23150). According to various aspects, the data received from the internal and / or external database is based on treatment data (eg, the process of performing the surgical procedure) and / or historical data (eg, historical data associated with the surgical procedure). Data indicating the predicted parameters) may be included.

In various aspects, the treatment data may include current / recognized standard treatment procedures for the surgical procedure, and the historical data may be historical data associated with the surgical procedure (eg, system-defined constraints). May include preferred / ideal parameters and / or preferred / ideal parameter ranges based on. Based on the data received (eg, sensor data, internal and / or external data, etc.), the surgical hub control circuit 23142 is to continuously derive inferences (eg, contextual information) about the ongoing surgical procedure. May be configured in. That is, a situation-aware surgical hub, for example, records data about a surgical procedure to generate a report, validates the steps a surgeon takes to perform a surgical procedure, and data that may be relevant to a particular procedure step or. Providing prompts (eg, via a surgical hub and / or user interface associated with the surgical instrument, eg, through 23148, 23158, 23118, 23128 and / or 23138), controlling the function of the surgical instrument, etc. May be configured in. According to various aspects, the context-aware surgical hub 23140 (eg, after the first surgical function of the end effector assembly 23130 or shaft assembly 23120 has been performed) is from the internal database 23149 and / or the external database 23150. The next surgical function performed may be estimated based on the treatment data received.

Further, in such an embodiment, the context-aware surgical hub 23140 has detected parameters (eg, preferred / ideal parameters) based on historical data (eg, preferred / ideal parameters) received from the internal database 23149 and / or the external database 23150. , Received from sensors 23134 and / or 23124 in response to the initial surgical function) can be evaluated. Here, if the detected parameters do not exceed the preferred / ideal parameters and / or are within their respective preferred / ideal parameter ranges, the situation-aware surgical hub 23140 performs the following surgical functions: It may be possible and / or may not prevent / control the performance of the next surgical function. Alternatively, if the detected parameters exceed the preferred / ideal parameters and / or are not within their respective preferred / ideal parameter ranges, the situational awareness surgical hub 23140 is to perform the following surgical functions: Can be prevented first.

According to another aspect of the disclosure, the situational awareness surgical hub 23140 communicates that a particular surgical function is being tested / required / performed (eg, surgical instrument 23102). Can be received (from components such as 23130 and / or 23120). In such an embodiment, the situational awareness surgical hub 23140 is the next surgical function in which a particular surgical function has been inferred to ensure adherence to current / recognized standard treatment procedures. It may be compared with the function. In that case, the situational awareness surgical hub 23140 then sets the detected parameters (as described) before allowing the particular surgical function (eg, as described) to proceed. Can be evaluated. Otherwise, the situation-aware surgical hub 23140 may prevent a particular surgical function from being performed, or even if it prevents a particular surgical function from being performed until an override is received. Good (see, eg, via user interface 23 158, 23148, 23138, 23128 and / or 23118, eg, selectable user interface element 23012 in FIG. 88). In such an embodiment, when the override is received, the situational awareness surgical hub 23140 can then evaluate the detected parameters before allowing the particular surgical function to proceed.

With reference to FIG. 89 according to another aspect again, the surgical procedure may be performed using the situational awareness surgical instrument 23102. In such an embodiment, the surgical instrument 23102 may include a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. The end effector assembly 23130 has a first jaw, a second jaw motivated to be coupled to the first jaw, and the function of the end effector assembly 23130 (eg, incision, gripping, coagulation). , Cutting, stapled, etc.) and the detected parameters to the control circuit (23112, 23122, 23132 and / or 23142, eg, virtual line to indicate any position (s) It may include a sensor 23134 configured to transmit to).

For example, in such an embodiment, the detected parameters may be transmitted to the control circuit 23132 of the end effector assembly 23130. Here, the end effector assembly control circuit 23132 may be configured to receive parameters (eg, sensor data) detected from the sensor 23134 during the course of the surgical procedure. The detected parameters may be received each time the function of the associated end effector assembly 23130 (eg, incision, gripping, coagulation, cutting, stapling, etc.) is performed.

The end effector assembly 23130 provides internal database (eg, end effector memory 23136) and / or external database (eg, from surgical hub database 23149 to cloud database 23150 via surgical hub 23140) throughout the course of the surgical procedure. May be further configured to receive. According to various aspects, the data received from the internal and / or external database is the staple cartridge data (eg, the size and / or type of staple associated with the staple cartridge located within the end effector assembly) and /. Alternatively, it may include historical data (eg, data indicating the type of stapled tissue having such size and / or type based on the predicted tissue and / or historical data). In various aspects, the data received will be staples of such size and / or type, or such predicted tissue and / or type of tissue, based on historical data (eg, system-defined constraints). Can include preferred / ideal parameters and / or preferred / ideal parameter ranges associated with. Based on the received data (eg, sensor data, internal and / or external data, etc.), the end effector control circuit 23132 is configured to continuously derive inferences (eg, contextual information) about the ongoing surgical procedure. May be done. In particular, according to an alternative aspect, the sensor 23134 of the end effector assembly 23130 associates the detected parameters with another surgical instrument 23102 component, such as the handle assembly 23110 and / or the shaft assembly 23120. It may be transmitted to a control circuit (for example, 23112 and / or 23122). In such an embodiment, the control circuits of other surgical instrument components (eg, 23112 and / or 23122) may be similarly configured to perform various aspects of the end effector control circuit 23132 described above. Good. Further, according to various aspects, the shaft assembly 23120 of the surgical instrument 23102 detects parameters associated with the function of the shaft assembly 23120 (eg, rotation, joint movement, etc.) and obtains the detected parameters. It may include a sensor 23124 configured to transmit to a control circuit (eg, 23112) similarly configured to perform various aspects of the end effector control circuit 23132 described above. Finally, the context-aware surgical instrument 23102 may be configured, for example, to warn the user of a discrepancy (eg, the configuration of another surgical instrument 23102 via the user interface 23138 of the end effector assembly 23130). A user interface via a user interface (eg 23128 and / or 23118) of an element such as a shaft assembly 23120 and / or a handle assembly 23110 and / or associated with a surgical hub 23140 coupled to a surgical instrument 23102. Through 23148 and / or 23158). For example, for discrepancies, the detected parameters are the preferred / ideal parameters associated with these size and / or type of staples, or their expected tissue and / or tissue type, and / or preferred. / Exceeding the ideal parameter range may be included. As a further example, the situational awareness surgical instrument 23102 may be configured to control the function of the surgical instrument 23102 based on a discrepancy. According to at least one aspect, the situational awareness surgical instrument 23102 can block surgical function based on discrepancies.

Situation Awareness Functional Control As highlighted herein, various aspects of the disclosure perform a function (eg, grab), detect parameters associated with that function, and utilize the situational awareness aspect. Then, via the control circuit, the detected parameter is less than or greater than a predefined parameter (eg, considered ideal / preferred), or a predefined range for that parameter (eg, normal). Evaluate if it is less than or greater than (considered) and take action in response that the detected parameters are outside the predefined parameters and / or predefined parameter ranges. (Ie, stop functioning (s), warn the user, inform the user of possible causes, etc.). For example, FIG. 90 shows 23204, where the control circuit receives the detected parameters (s) associated with the surgical function performed by the surgical instrument and retrieves situational awareness data from internal and / or external databases 23204. 23200, an algorithm that implements such an embodiment. The control circuit then evaluates the detected parameters in consideration of the situational awareness data 23206 and takes action based on the evaluation 23208.

According to various aspects of the present disclosure, the force detected at the jaw of the end effector assembly (eg, via one or more sensors) is one or more of the end effector assembly. May be large enough to prevent subsequent / further functions from being performed. For example, with reference back to FIG. 12, forces may be detected via sensors 474, 476 and / or 478. In such an embodiment, the sensor 474 may be a strain gauge coupled to the end effector, where the strain gauge indicates the closing force exerted on the jaw (s) of the end effector jaw (s). It is configured to measure the magnitude / amplitude of strain in (s). Further, in such an embodiment, the sensor 476 may be a load sensor configured to measure the closing force applied to the jaw by the closing drive system. Further, in such an embodiment, the sensor 478 may be a current sensor configured to measure the current drawn by the motor, which correlates with the closing force applied to the jaw. In addition to this, or as a further example, with reference back to FIG. 17, the force may be detected via sensors 744a and / or 744b. In such an embodiment, the sensors 744a and / or 744b may be torque sensors configured to provide a firing force feedback signal representing the closing force applied to the jaw by the closure drive system.

In one aspect, with reference back to FIG. 58, the load sensor 152802 (eg, located within the shaft assembly or handle assembly) is configured to detect the load after attaching the shaft assembly to the handle assembly. May be done. In such an embodiment, the detected load may exceed a predefined load and / or a predetermined load range. In such an embodiment, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or combined surgical operation. 23142) built into the hub evaluates the detected load and uses situational awareness (eg, based on historical data) to damage the shaft assembly and / or end effector assembly. / Can determine that it must have been damaged. In such an embodiment, the control circuit records a unique identifier associated with the shaft assembly 23120 and / or the end effector assembly 23130 and further use and / or to the handle assembly 23110. It may be configured to be designated as prohibited from mounting.

In another aspect, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or a combined surgical hub. 23142) incorporated into the jaw evaluates the force detected / sensed (eg, via one or more sensors as described) and the firing function / cycle of the end effector assembly. May be configured to determine to prevent. Specifically, the control circuit uses situational awareness (eg, based on historical data) to detect / sense force in the jaw (eg, detected before the launch function / cycle begins). May be determined to exceed the range of predefined forces and / or predefined forces. In such an embodiment, the control circuit may be configured to prevent the launch function / cycle from starting. Further, in such an embodiment, referring again to FIG. 89, the control circuit (eg, the user interfaces 23138, 23128 and / or 23118 of the components of the surgical instrument, and / or the user interface associated with the surgical hub). It may be configured to warn the user that the firing function / cycle cannot be performed (via 23148 and / or 23158) and / or inform the user of possible causes. According to various aspects, the control circuit is capable of firing function / cycle when the force detected / sensed at the jaw drops to a predefined force and / or falls within a range of predefined forces. It can be configured to allow the start.

In another aspect, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or a combined surgical hub. 23142) incorporated in 23142) evaluates the force detected / sensed at the jaw (eg, via one or more sensors, such as a load sensor, torque sensor, etc., as described). , The end effector assembly may be initially determined to allow firing function / cycle. However, after initiating the launch function / cycle, the control circuit uses situational awareness (eg, based on historical data) to provide the force to launch (eg, detected during the launch function / cycle). , The predefined firing force and / or the predefined firing force may be determined to be exceeded. In such an embodiment, the control circuit may be configured to stop the firing function / cycle (eg, prevent the firing function / cycle from continuing). Further, in such an embodiment, again referring to FIG. 89, the control circuit warns the surgeon about the range of forces to fire beyond the limit or the range of forces to fire beyond the limit (eg, surgery). It may be configured (via the user interfaces 23138, 23128 and / or 23118 of the instrument components, and / or the user interfaces 23148 and / or 23158 associated with the surgical hub). According to various aspects, the control circuit receives an override command (see, eg, through the user interface (s), FIG. 88, selectable user interface element 23012) and launches a function / cycle. May be further configured to allow the continuation. In such an embodiment, the control circuit uses situational awareness (eg, based on historical data) to generate a second firing force (eg, detected during a continuous firing function / cycle). It may be determined that the range of 2 predetermined firing power and / or 2nd predetermined firing power (eg, higher threshold) is exceeded. In such an embodiment, the control circuit may be configured to stop the firing function / cycle again, warn the surgeon, and / or receive an override command as described.

In another aspect, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or a combined surgical hub. 23142) incorporated in may evaluate the force detected / sensed at the jaw (eg, via one or more sensors as described). In addition, the control circuit may further evaluate the detected / sensed force within the shaft assembly (ie, via one or more sensors as described). Here, according to various aspects, the control circuits reciprocally detect / sense the force in the jaw and / or the force detected / sensed in the shaft assembly while the surgical procedure is being performed. You may refer to it. According to such an embodiment, the control circuit uses situational awareness (eg, based on treatment data and / or historical data) to allow the force detected / sensed within the shaft assembly to be a predefined shaft force and / or / Or it may be determined to exceed the predefined shaft force range. In one embodiment, the shaft assembly may comprise a special shaft assembly configured for use with a particular tissue type in a particular surgical procedure. In such an embodiment, the control circuit uses situational awareness (eg, based on treatment data and / or historical data) to have too high a force detected / sensed within the special shaft assembly (eg, prior). The defined shaft force and / or beyond the range of the predefined shaft force associated with the special shaft assembly) and / or the force detected / sensed at the jaw is not a predefined force and / or It may be determined that it is not within the predefined range (eg, the predicted force historically associated with the surgical procedure being performed). In such an embodiment, the control circuit may be configured to stop the firing function / cycle (eg, prevent the firing function / cycle from starting and / or continuing). Further, in such an embodiment, with reference to FIG. 89 again, the control circuit warns the surgeon about the range of shaft force and / or shaft force beyond the limit (eg, the user interface of the components of the surgical instrument). It may be configured (via 23138, 23128 and / or 23118, and / or the user interface 23148 and / or 23158 associated with the surgical hub). In various aspects, the warning gives the surgeon, for example, to remove the special shaft assembly 23120 from the handle assembly 23110 and attach it to the handle assembly 23110 of another shaft assembly (eg, detected / sensed force and). It may also inform the surgeon of a regular reload configured for the tissue encountered. In such an embodiment, the control circuit may be configured to allow the launch function / cycle to start and / or continue when the appropriate shaft assembly is installed.

In another aspect, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or a combined surgical hub. 23142) incorporated in may evaluate the force detected / sensed in the jaw during the surgical procedure (eg, via one or more sensors as described). According to such an embodiment, the control circuit uses situational awareness (eg, based on treatment and / or historical data) to ensure that tissue creep latency is held during the surgical procedure. It may also be determined to be below the predefined creep latency and / or predefined creep latency associated with a particular organization. In other words, considering FIGS. 83 and 84 herein, the initial closing force decays faster than expected and creep stability is reached with a lower closing force. obtain. In such an embodiment, the control circuit may be configured to stop the firing function / cycle (eg, prevent the firing function / cycle from starting and / or continuing). Further, in such an embodiment, referring again to FIG. 89, the control circuit (eg, the user interfaces 23138, 23128 and / or 23118 of the components of the surgical instrument, and / or the user interface associated with the surgical hub). It may be configured to warn the surgeon about reduced creep latency (via 23148 and / or 23158). In various embodiments, the warning prompts the surgeon to remove the end effector assembly, eg 23130, from the handle assembly, eg, and process another end effector assembly (eg, tissue with detected creep latency). The surgeon may be informed that the constructed end effector assembly) will be attached to the handle assembly 23110. In such an embodiment, the control circuit may be configured to allow the launch function / cycle to start and / or continue when the appropriate end effector assembly is installed.

In another aspect, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or a combined surgical hub. 23142) incorporated into the components of may evaluate the force detected / sensed at the jaw (eg, via one or more sensors as described). In addition, the control circuit can further evaluate the detected / sensed position with respect to the joint motion member (ie, via one or more sensors). For example, with reference back to FIG. 12, the position can be detected / sensed by a sensor 472 coupled to the articulated member. In one aspect, the sensor 472 may be a position sensor configured to measure linear displacement, with a single rotation of the sensor element corresponding to a particular linear displacement of the joint motion member. In another embodiment, with reference back to FIG. 17, the position may be sensed / detected by a position sensor 734 located within the end effector. Here, the position sensor 734 may be a sensor configured to provide a series of pulses traceable by a control circuit to determine the position of the joint motion member. Here, according to various aspects, the control circuitry reciprocally refers to the force detected / sensed in the jaw and / or the position detected / sensed with respect to the joint movement member undergoing the surgical procedure. May be good. According to such an aspect, the control circuit uses situational awareness (eg, based on treatment data and / or historical data) to allow the articulated member to move into a predetermined forward position and / or a range of predetermined forward positions. It may be determined (eg, within the shaft assembly) that it has advanced beyond. In various aspects, a predetermined forward position and / or range of predetermined forward positions may correlate with the closing force detected / sensed in the chin. In such an embodiment, the control circuit prevents the launch function / cycle from stopping (eg, starting and / or continuing) beyond a designated predetermined forward position. ) Can be configured. Further, in such an embodiment, referring again to FIG. 89, the control circuit (eg, the user interfaces 23138, 23128 and / or 23118 of the components of the surgical instrument, and / or the user interface associated with the surgical hub). It may be configured to warn the surgeon about the range of forward position and / or forward position beyond the limit (via 23148 and / or 23158). In various aspects, the warning can inform the surgeon to consider retracting the articulating member to and / or within a predetermined advance position. Here, in one embodiment, the predetermined forward position and / or range of predetermined forward positions has the desired and / or successful firing function / cycle realized by history with respect to the corresponding closing force. Can be done. In such an embodiment, the control circuit may be configured to allow the launch function / cycle to start and / or continue when the appropriate forward position is achieved.

In another aspect, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or a combined surgical hub. 23142) incorporated in may evaluate the force detected / sensed in the jaw during a surgical procedure (eg, via one or more sensors as described). According to such an embodiment, the control circuit uses situational awareness (eg, based on treatment and / or historical data) to identify that the force to close is seized during the surgical procedure. It may be determined that the predefined closing force and / or the predefined closing force associated with the tissue is exceeded. In other words, in light of FIGS. 83 and 84 herein, the detected / sensed closing force is expected to allow the firing function / cycle to proceed. Higher than. In such an embodiment, the control circuit may be configured to stop the firing function / cycle (eg, prevent the firing function / cycle from starting and / or continuing). Further, in such an embodiment, referring again to FIG. 89, the control circuit warns the surgeon about the elevated closing force (eg, the user interfaces 23138, 23128 and / of the components of the surgical instrument). Or 23118, and / or via the user interface 23148 and / or 23158 associated with the surgical hub). In various aspects, the warning may inform the surgeon to consider adjusting the launch motor speed. In one embodiment, if the particular tissue is hard tissue, the warning may suggest that the surgeon slow down the launch motor to avoid tearing the rigid tissue. In such embodiments, the downward adjustment may be based on historical data associated with the surgical procedure being performed. In another embodiment, if the particular tissue is soft tissue with weak shear strength, the warning suggests that the surgeon adjust the launch motor velocity to ensure that the tissue is properly gripped. obtain. In such an embodiment, the upregulation may be based on historical data associated with the surgical procedure being performed. In such an embodiment, the control circuit may be configured to allow the launch function / cycle to start and / or continue when the appropriate launch motor speed is set.

In another aspect, for example, with reference to FIG. 89, a control circuit associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into a component of the surgical instrument, or a combined surgical hub. 23142) incorporated in may evaluate the force detected / sensed in the jaw during a surgical procedure (eg, via one or more sensors as described). According to such an embodiment, the control circuit uses situational awareness (eg, based on treatment and / or historical data) to allow periodic forces on the launch system to be predefined during the surgical procedure. It can be determined that the periodic force and / or the predefined periodic force range is exceeded. In other words, the detected / sensed periodic force may be higher than expected, indicating that a motor failure is imminent based on historical data. In such an embodiment, the control circuit may be configured to stop the firing function / cycle (eg, prevent the firing function / cycle start and / or continuous advance). Further, in such an embodiment, again referring to FIG. 89, the control circuit warns the surgeon about increased periodic forces and possible motor failures (eg, the user interface of the components of the surgical instrument). It may be configured (via 23138, 23128 and / or 23118, and / or the user interface 23148 and / or 23158 associated with the surgical hub). According to various aspects, the control circuit receives the override command (eg, see FIG. 88, selectable user interface element 23012 via the user interface) and the firing function / cycle continues. It may be further configured to allow this. In such an embodiment, the control circuit continues to monitor during the surgical procedure whether the periodic force on the launch system exceeds the range of the predefined periodic force and / or the predefined periodic force. be able to. In such an embodiment, the control circuit may be configured to stop the firing function / cycle again, warn the surgeon, and / or receive an override command as described.

According to another aspect of the present disclosure, for example, with reference to FIG. 89, control circuits associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into the components of the surgical instrument, or coupled. 23142) incorporated into a surgical hub may evaluate the force detected / sensed at the jaw (eg, via one or more sensors as described). In addition, the control circuit may further evaluate the force / torque for articulating the end effector assembly 23130. In such an embodiment, the joint kinetic force / torque drives one or more sensors (eg, a force sensor associated with the joint kinetic member, a torque sensor associated with the joint kinetic member, a joint kinetic member). It may be detected via a current sensor associated with a motor configured as such). For example, with reference back to FIG. 17, the joint motion force / torque can be detected / sensed by the torque sensors 744d and / or 744e coupled to the joint motion drive system. In addition to this and / or as an alternative, with reference to FIG. 17 again, the joint kinetic force / torque may be correlated with the current drawn by the motors 704d and / or 704e as measured by the sensor 736. Here, according to various aspects, the control circuit mutually references the force detected / sensed in the jaw and / or the joint motion force / torque detected with respect to the joint motion member undergoing the surgical procedure. You may. According to such an embodiment, the control circuit uses situational awareness (eg, based on treatment and / or historical data) to detect joint kinetic force / torque with respect to the joint kinetic member for a predefined joint. It may be determined that the kinetic force / torque and / or the predefined joint kinetic force / torque range is exceeded. In various aspects, the predefined joint force / torque and / or the predefined joint force / torque range can correlate with the force detected / sensed in the jaw. In such an embodiment, the control circuit is configured to stop the joint movement of the end effector assembly (eg, prevent the joint movement from continuing) when the specified joint movement force / torque is exceeded. You may. Further, in such an embodiment, again referring to FIG. 89, the control circuit warns the surgeon regarding the ultrasonic force / torque and / or the joint kinetic force / torque range (eg, the user of the components of the surgical instrument). It may be configured (via the interfaces 23138, 23128 and / or 23118, and / or the user interface 23148 and / or 23158 associated with the surgical hub). According to various aspects, the control circuit receives the override command (eg, via the user interface, see, eg, FIG. 88, selectable user interface element 23012) and the firing function / cycle continues. It may be further configured to allow this to be done. In such an embodiment, the control circuit may continue to monitor whether the joint force / torque exceeds the predefined joint force / torque and / or the predefined joint force / torque range during the surgical procedure. it can. In such an embodiment, the control circuit may be configured to stop joint movement, warn the surgeon, and / or receive an override command as described.

According to yet another aspect of the present disclosure, for example, with reference to FIG. 89, control circuits associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into the components of the surgical instrument, or coupling. 23142) incorporated into the surgical hub, may evaluate the force detected / sensed at the jaw (eg, via one or more sensors as described). In addition, the control circuit may further evaluate the force / torque for rotating the shaft assembly 23120 (eg, shaft member). In such an embodiment, the rotational force / torque refers to one or more sensors (eg, a force sensor associated with a rotational / shaft member, a torque sensor associated with a rotational / shaft member, a rotational / shaft member). It may be detected via a current sensor associated with a motor configured to rotate). For example, referring back to FIG. 17, the torque sensor 744c connected to the rotation / shaft member drive system may detect / sense the rotational force / torque. In addition to this and / or as an alternative, with reference to FIG. 17 again, the rotational force / torque may be correlated with the current drawn by the motor 704c as measured by the sensor 736. Here, according to various aspects, the control circuit mutually references the force detected / sensed at the jaw and / or the rotational force / torque detected with respect to the rotational / shaft member undergoing the surgical procedure. You may. According to such an aspect, the control circuit uses situational awareness (eg, based on treatment data and / or historical data) to rotate the rotational force / torque detected with respect to the rotational / shaft member in a predefined rotation. It may be determined that the force / torque and / or the predefined rotational force / torque range is exceeded. In various aspects, the predefined rotational force / torque and / or the predefined rotational force / torque range may correlate with the force detected / sensed at the jaw. In other embodiments, the predefined rotational force / torque and / or the predefined rotational force / torque range may correspond to the force / twist that the rotational / shaft member itself can withstand. In such an embodiment, the control circuit is configured to stop the rotation of the shaft assembly (eg, prevent the rotation / shaft member from continuing to rotate) when the specified rotational force / torque is exceeded. May be done. Further, in such an embodiment, again referring to FIG. 89, the control circuit warns the surgeon about the excess rotational force / torque and / or rotational force / torque range (eg, the user of the components of the surgical instrument). It may be configured (via the interfaces 23138, 23128 and / or 23118, and / or the user interface 23148 and / or 23158 associated with the surgical hub). According to various aspects, the control circuit receives an override command (eg, via the user interface, see, eg, FIG. 88, selectable user interface element 23012) and continues to rotate. It may be further configured to allow it. In such an embodiment, the control circuit can continue to monitor whether the rotational force / torque exceeds the predefined rotational force / torque and / or the predefined rotational force / torque range during the surgical procedure. .. In such an embodiment, the control circuit may be configured to stop rotation again, warn the surgeon, and / or receive an override command as described.

According to yet another aspect of the present disclosure, for example, with reference to FIG. 89, control circuits associated with the surgical instrument (eg, 23132, 23122 and / or 23112 incorporated into the components of the surgical instrument, and / or 23112, and / Or incorporated into a combined surgical hub 23142) assesses the open force detected / sensed at the jaw (eg, via one or more sensors as described) and the jaw It may be configured to determine to prevent opening. Specifically, the control circuit uses situational awareness (eg, based on historical data) to determine that the open force detected / sensed at the jaw is a predefined open force and / or a predefined open force. It may be determined that the range is exceeded. In such an embodiment, the control circuit may be configured to maintain the jaw in a gripped position or some gripped position. Further, in such an embodiment, referring again to FIG. 89, the control circuit (eg, the user interfaces 23138, 23128 and / or 23118 of the components of the surgical instrument, and / or the user interface associated with the surgical hub). To warn the user that the jaw cannot be opened (via 23148 and / or 23158) and / or inform the user of possible causes (eg, the user detects in the jaw / It may be configured so that attempts can be made to reduce the perceived opening force). According to various aspects, the control circuit will open the jaw if the open force detected / sensed at the jaw is reduced within the range of the predefined open force and / or the predefined open force. It may be configured to allow.

Short Circuit Detection and Functional Control According to various other aspects of the disclosure, the functionality of surgical instruments may be controlled based on one or more sensors configured to detect short circuits. Good. That is, when a metal object is detected in the jaw, the function / operation of at least one surgical instrument (eg, cutting, coagulation, etc.) can be blocked / prohibited. For example, FIG. 91 shows 23302, where the control circuit receives a detected parameter (s) indicating a short circuit, and algorithm 23300 for implementing such an embodiment. The control circuit may also retrieve internal and / or external database data 23304. The control circuit then evaluates the detected parameters (s) and / or database data 23306 and takes action based on the evaluation 23308.

With reference to FIG. 89 according to aspects of the present disclosure again, the surgical system 23100 is a control circuit and (23112, 23122, 23132 and / or 23142, eg, in a virtual line to indicate an arbitrary position (s)). , Includes user interfaces and (23118, 23128, 23138, 23148 and / or 23158, eg, in virtual lines to indicate arbitrary positions), such as handle assembly 23110, shaft assembly 23120, and end effector assembly 23130. It may be equipped with a surgical instrument 23100. In such an embodiment, the control circuit is one or more components of the surgical instrument 23102 (eg, 23112, 23122 and / or 23132) (eg, handle assembly 23110, shaft assembly 23120 and / or). It may be incorporated into an end effector assembly (such as 23130) and / or into a surgical hub 23140 (eg, 23142) paired with a surgical instrument 23102 (eg, wirelessly). In such an embodiment, the end effector assembly 23130 is a function of the first jaw, the second jaw motivated to be coupled to the first jaw, and the end effector assembly 23130 (eg, the function of the end effector assembly 23130). It was configured to detect parameters associated with incision, gripping, coagulation, cutting, stapling, etc. and transmit the detected parameters to control circuits (eg, 23112, 23122, 23132 and / or 23142). It may include a sensor 23134 and the like. In various embodiments, the first jaw may include anvil and the second jaw may include elongated channels configured to receive staple cartridges. Further, in such an embodiment, the surgical instrument 23102 detects parameters associated with the function of the shaft assembly 23120 (eg, rotation, joint movement, etc.) and controls the detected parameters in a control circuit (eg, 23112, etc.). A shaft assembly 23120 may further include a sensor 23124 configured to transmit to 23122, 23132 and / or 23142). In such an embodiment, the control circuit may be configured to receive parameters (eg, sensor data) detected from such sensors, eg, 23134 and / or 23124, throughout the course of the surgical procedure. The detected parameters are the function of the relevant end effector assembly 23130 (eg, incision, gripping, coagulation, cutting, stapling, etc.) and / or the function of the related shaft assembly 23120 (eg, rotation, joint movement, etc.). ) Can be received each time it is executed. The control circuit is from an internal database (eg, in memory of components of surgical instruments 23136, 23126 and / or 23116, or surgical hub database 23149) and / or an external database (eg, surgical hub database 23149, cloud database). It may be further configured to receive data (from 23150, etc.). According to various aspects, the data received from the internal and / or external database is based on treatment data (eg, the process of performing the surgical procedure) and / or historical data (eg, historical data related to the surgical procedure). Data indicating expected parameters) may be included. In various aspects, the procedure data may include current / recognized standard treatment procedures for the surgical procedure, and the historical data may be in the historical data associated with the surgical procedure (eg, system-defined constraints). It may include preferred / ideal parameters and / or preferred / ideal parameter ranges based on it. Based on received data (eg, sensor data, internal and / or external data, etc.), control circuits (eg, 23112, 23122, 23132 and / or 23142) make inferences about ongoing actions (eg, contextual information). May be configured to continuously derive. That is, the surgical instrument, for example, records data about the surgical procedure to generate a report, validates the steps the surgeon takes to perform the surgical procedure, and provides data or prompts that may be relevant to a particular procedure step. Provided (eg, via the user interfaces 23148 and / or 23158 associated with the surgical hub, and / or the user interfaces 23138, 23128 and / or 23118 associated with the surgical instrument) and the function of the surgical instrument 23102. It may be configured to control.

In one aspect, referring again to FIG. 89, the control circuits (23112, 23122, 23132 and / or 23142) during and / or after gripping the target tissue between the jaws of the end effector assembly , May be configured to check the continuity between the jaws before enabling subsequent functions (eg, firing, coagulation, etc.). Here, according to various aspects, the surgical instrument comprises an electrosurgical instrument having electrodes on at least one of the jaws (eg, integrated with anvil and / or staple cartridges). Good. In such an embodiment, the presence of short circuits between the electrodes can make it difficult to treat the tissue gripped between the jaws with electrosurgical energy (eg, RF energy). In one embodiment, conductive objects between the electrodes (eg, clips, staples, metal elements, etc.) can provide continuity between the jaws. In another embodiment, if there is not enough space between the jaws (eg, after grasping the target tissue), the electrodes may come into contact to provide continuity between the jaws. With reference to FIG. 53 again, for example, in one aspect of the present disclosure, the sensor 152008a is configured to measure the gap between the jaws of the end effector. In such an embodiment, the first jaw sensor 152008a was generated by a second jaw magnet 152012 to measure the gap between the first jaw and the second jaw. A Hall effect sensor configured to detect a magnetic field may be provided. In particular, the gap can represent the thickness of tissue gripped between the first jaw and the second jaw. Here, the presence of continuity between the jaws can lead to undesired surgical consequences (eg, treatment of incomplete tissue, excessive heating of conductive objects, etc.).

According to one aspect (eg, bipolar mode), the first jaw may include anvil and the second jaw is an elongated channel configured to receive a staple cartridge as shown in FIG. May be provided. In one embodiment, the staple cartridge may include an active electrode for delivering electrosurgical energy (eg, RF energy) to the grasped tissue, and at least a portion of the anvil may act as a return electrode. In another example, the anvil may include an active electrode for delivering electrosurgical energy (eg, RF energy) to the grasped tissue, and at least a portion of the elongated channel may act as a return electrode. According to another aspect (eg, unipolar mode), the first jaw may include anvil and the second jaw may include elongated channels configured to receive staple cartridges. .. In one embodiment, the staple cartridge may include an active electrode for delivering electrosurgical energy (eg, RF energy) to the grasped tissue, and a return electrode (eg, ground pad) may be placed on the patient's body. They may be arranged separately. In another example, the anvil may include an active electrode for delivering electrosurgical energy (eg, RF energy) to the grasped tissue, and a return electrode (eg, ground pad) is separate on the patient's body. May be placed in. Various configurations for detecting short circuits are described in US Pat. No. 9,554,854, entitled "DETECTING SHORT CIRCUITS IN ELECTROSURGICAL MEDICAL DEVICES," the entire disclosure of which is incorporated herein by reference. ing.

With reference to FIG. 89 in various aspects again, the control circuits (23112, 23122, 23132 and / or 23142) may be configured to confirm continuity in many ways. In one aspect, a sensor incorporated in a generator and / or surgical instrument that produces electrosurgical energy, such as 23134, causes the impedance between the electrodes to drop below the threshold over a period of time (ie, short circuit). It may be configured to detect the indicated decrease in impedance). Now, with reference back to FIG. 48, the sensor, eg 23134, may be configured to measure impedance over time. In one embodiment, when the electrode hits a line of conductive staples, the current can spike, while the impedance and voltage drop sharply. In another embodiment, continuity may exist as a current sink with minimal changes in voltage. See various alternatives for confirming continuity / detecting short circuits, such as those described in US Pat. No. 9,554,854, entitled "DETECTING SHORT CIRCUITS IN ELECTROSURGICAL MEDICAL DEVICES". Explicitly incorporated herein by (eg, comparing impedance values at different positions within a series of pulses).

In such an embodiment, when continuity is detected, conductive objects (eg, clips, staples, staple lines, metal elements, etc.) are present / exposed in the tissue gripped between the jaws. There may be. In particular, such conductive objects may be from current and / or previous surgical procedures. In such an embodiment, the control circuit warns the surgeon regarding the detection of conductive objects (eg, the user interfaces 23138, 23128 and / or 23118 of the components of the surgical instrument, and / or the detection of conductive objects. It may be configured (via the user interface 23148 and / or 23158) associated with the surgical hub for. For example, the warning suggests that the surgeon reposition the end effector assembly 23130 so that the electrodes are not in contact with any conductive object and / or remove the conductive object that causes the short circuit. You may. According to various aspects, the control circuit receives an override command, eg, via the user interface, eg, see FIG. 88, selectable user interface element 23012), a conductive object (eg, a clip). , Staples, staple lines, metal elements, etc.) may be further configured to allow subsequent functions (eg, cutting, solidification, etc.).

According to one aspect, the control circuitry (23112, 23122, 23132 and / or 23142) may be configured to check continuity to avoid lateral incisions in the clip. In such an embodiment, after a short circuit is detected, the control circuit warns the surgeon regarding the detection of conductive objects between the jaws (eg, user interfaces 23138, 23128 and / or of surgical instrument components). It may be configured to (via 23118 and / or the user interface 23148 and / or 23158 associated with a surgical hub). In one aspect, the surgeon can adjust the sensitivity of the control circuit through a user interface (eg, an interactive user interface element on a surgical instrument, a surgical hub, a generator, etc.). In such an embodiment, based on the adjustment, the control circuit may be configured to block firing if a conductive object is detected between the jaws.

Referring again to FIG. 89 according to another embodiment, the control circuit 23142 may be incorporated into a surgical hub 23140 paired (eg, wirelessly) with an electrosurgical instrument 23102. In such an embodiment, the surgical hub 23140 may be preloaded with the surgeon / user settings for detecting conductive objects between the jaws. In one embodiment, the surgeon / user settings include blocking firing if a conductive object is detected between the jaws. In another embodiment, the surgeon / user setting comprises warning if a conductive object is detected between the jaws before allowing firing. In yet another aspect, the surgeon / user configuration comprises allowing the surgeon / user to override the warning. In yet another aspect, the surgeon / user settings include a temporary reset, where the surgeon / user improves the situation (eg, moves the jaw, removes conductive objects) before rechecking continuity. Includes a temporary reset that allows you to.

With reference to FIG. 89 in yet another embodiment, the control circuit (23112, 23122, 23132 and / or 23142) may be configured to check continuity to intentionally cross the staple line. .. Here, in some surgical procedures, it may be beneficial to have intersecting staple lines to ensure continuous transverse incisions (eg, lung resection, especially wedges from multiple angles, sleeve procedures, etc.). There is. In such an embodiment, after continuity is detected, the control circuit warns the surgeon regarding the detection of conductive objects between the jaws (eg, existing staple lines) (eg, audible and / or visual cues). ) (Eg through the user interfaces 23138, 23128 and / or 23118 of the components of the surgical instrument and / or via the user interfaces 23148 and / or 23158 associated with the surgical hub). It may be configured.

With reference to FIG. 89 according to another aspect again, the control circuit (23112, 23122, 23132 and / or 23142) has an internal database (eg, memory 23136, 23126 and of the components of the surgical instrument) throughout the course of the surgical procedure. / Or 23116 or surgical hub database 23149), and / or external databases (eg, surgical hub database 23149, cloud database 23150, etc.) may be configured to receive data. According to various aspects, the data received from the internal and / or external database may be surgical history data (eg, data on previous surgical procedures performed on the patient, data on current surgical procedures, etc.). Can include. In one example, surgical history data may indicate that the staples were used in previous surgery and / or where the staples were used, and current surgical procedure data may be used to apply clips. It may indicate whether pliers have been used. Based on the received data (eg, surgical history data, etc.), the control circuitry (23112, 23122, 23132 and / or 23142) is to continuously derive inferences (eg, contextual information) about the ongoing procedure. It may be configured in. That is, the surgical instrument 23120 may be contextually recognizable, for example, presuming that the detected continuity may be a staple line from a previous surgical procedure or a clip from a current surgical procedure. / May be configured to determine. As another example, control if the patient has never undergone surgery, the clip applier has not been used in the current surgery, and the staple cartridge has been fired in the current surgery. The circuit may be configured to presume / determine that the conductive object detected between the jaws is the previous staple line. As yet another example, control if the patient has never undergone a surgical procedure, a clip applier is used in the current procedure, and the staple cartridge has not yet been fired in the current surgical procedure. The circuit may be configured to infer / determine that the conductive object detected between the jaws is a clip.

(Example)
Various aspects of the subject matter described herein under the heading "Safety System for Smart Electrosurgical Staple Closure" are described in the following examples.

Example 1-The surgical system comprises a control circuit and a surgical instrument. The surgical instrument comprises a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly connected to the distal end of the shaft assembly. The end effector assembly comprises a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor. The sensor is configured to detect the parameters associated with the function of the end effector and send the detected parameters to the control circuit. The control circuit is configured to analyze the detected parameters based on system-defined constraints and block at least one function of the surgical instrument based on the results of the analysis. The surgical system further comprises a user interface configured to provide the current state of at least one blocked function of the surgical instrument.

Example 2-A system-defined constraint comprises at least one of a predefined parameter or a predefined parameter range based on historical data associated with the surgical procedure performed by the surgical system. The surgical system according to Example 1.

Example 3-The current state has a first message that at least one function of the surgical instrument is blocked and a second message that indicates why at least one function of the surgical instrument is blocked. The surgical system according to Example 1 or 2, which comprises.

Example 4-The surgery according to Example 1, 2 or 3, wherein the user interface comprises a user interface element that can be selected to override the control circuit to enable at least one function of the surgical instrument. System for.

Example 5-The sensor comprises a force sensor coupled to an end effector, the detected parameter exerting a force applied to at least one of the first or second jaws of the end effector. At least one function, including and blocked through the control circuit, is to prevent the use of the attached shaft, to prevent the firing cycle from starting, to prevent the end effector joint movement, and to prevent the shaft from moving. Example 1 comprising blocking rotation or blocking one or more of one or more of the first or second jaws from opening. 2, 3 or 4 according to the surgical system.

Example 6-The function of the end effector associated with the detected parameters includes the gripping function, and at least one function of the surgical instrument blocked via the control circuit is incision function, coagulation function, staple fastening function. The surgical system according to Example 1, 2, 3, 4 or 5, comprising one or more of functions, or cutting functions.

Example 7-The surgical system according to Example 1, 2, 3, 4, 5 or 6, further comprising a surgical hub communicatively coupled to a surgical instrument, wherein the surgical hub comprises a control circuit.

Example 8-The surgical system of Example 7, wherein one of the handle assemblies or surgical hubs comprises a user interface.

Example 9-One of a surgical instrument handle assembly, shaft assembly, or end effector assembly comprises a control circuit, Example 1, 2, 3, 4, 5, 6, 7 or 8. The surgical system described in.

Example 10-The shaft assembly comprises sensors configured to detect shaft parameters associated with shaft function and transmit the detected shaft parameters to a control circuit, Examples 1, 2, 3; 4, 5, 6, 7, 8 or 9 for a surgical system. The control circuit is further configured to block at least one function of the surgical instrument, further based on the detected shaft parameters.

Example 11-The surgical system comprises a surgical hub and a surgical instrument communicatively coupled to the surgical hub. The surgical instrument comprises a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly connected to the distal end of the shaft assembly. The end effector assembly comprises a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor. The sensor is configured to detect the parameters associated with the function of the end effector and send the detected parameters to the surgical hub. The surgical hub comprises a processor and memory coupled to the processor. The memory analyzes the detected parameters based on system-defined constraints and stores instructions that can be executed by the processor to block at least one function of the surgical instrument based on the results of the analysis. The surgical system further comprises a user interface configured to provide the current state of at least one blocked function of the surgical instrument.

Example 12-System-defined constraints include at least one of a predefined parameter or a predefined parameter range, based on historical data associated with the surgical procedure performed by the surgical system. The surgical system according to Example 11.

Example 13-The current state has a first message that at least one function of the surgical instrument is blocked and a second message that indicates why at least one function of the surgical instrument is blocked. The surgical system according to Example 11 or 12, including.

Example 14-described in Example 11, 12 or 13, wherein the user interface comprises a user interface element that can be selected to override the surgical hub to enable at least one function of the surgical instrument. Surgical system.

Example 15-The sensor comprises a force sensor coupled to an end effector and the detected parameters include a force applied to at least one of the first or second jaws of the end effector. At least one function that is blocked through the surgical hub is to prevent the use of the attached shaft, to prevent the firing cycle from starting, to prevent the joint movement of the end effector, to prevent the shaft from moving. Example 11 comprising blocking rotation or preventing one or more of the first jaw or the second jaw from opening. , 12, 13 or 14.

Example 16-End effector function associated with detected parameters includes gripping function, and at least one function of the surgical instrument blocked via the surgical hub is incision function, coagulation function, staple function. The surgical system according to Example 11, 12, 13, 14 or 15, comprising one or more of a fastening function, or a cutting function.

Example 17-The surgical system according to Example 11, 12, 13, 14, 15 or 16, wherein at least one of the handle assemblies or surgical hubs comprises a user interface.

Example 18-Shaft assembly comprises sensors configured to detect shaft parameters associated with shaft function and transmit the detected shaft parameters to a surgical hub, Examples 11, 12, 13 , 14, 15, 16 or 17. The memory further stores instructions that can be executed by the processor to further block at least one function of the surgical instrument based on the detected shaft parameters.

Example 19-A non-temporary computer-readable medium stores a computer-readable instruction, which, when executed, associates the machine with the function of the end effector of the surgical system, based on system-defined constraints. By analyzing the detected parameters, the surgical system was coupled to the handle assembly, the shaft assembly extending distally from the handle assembly, and the distal end of the shaft assembly. Have the end effector assembly and include. The end effector assembly detects the first jaw, the second jaw pivotally coupled to the first jaw, and the detected parameters and sends the detected parameters to the machine. A sensor configured as described above is provided. When executed, the instruction causes the machine to further block at least one function of the surgical system and generate a user interface based on the results of the analysis. The user interface provides the current state of at least one blocked function of the surgical system.

The non-transitory computer-readable medium of Example 20-Example 19 further comprises an instruction to cause the machine to generate an override element on the user interface when executed. Override elements can be selected to enable at least one function of the surgical system.

Safety system for smart electrosurgical staple fastening Safety system for evaluating operating parameters Various aspects of the disclosure respond to tissue parameters detected via one or more sensors in surgical instruments. Thus, an improved safety system capable of adapting, controlling, and / or synchronizing the internal driving movements of surgical instruments is intended. More specifically, various aspects are aimed at sensing tissue parameters and justifying the current device parameters with respect to the sensed tissue parameters.

For example, the sensed tissue parameters may include tissue type, tissue thickness, tissue stiffness, tissue position on the patient's anatomical structure, tissue angiogenesis, etc., and current device parameters. May include the color of the cartridge, the type of cartridge, the auxiliary part, the gripping load, the gap, the rate of fire, and the like. Therefore, according to aspects of the present disclosure, physiological sensing may indicate improper use of the device or its components and / or improper positioning of the device.

In one embodiment, improper use of the surgical instrument or its components and / or improper positioning of the surgical instrument is detected via one or more sensors in the jaw of the end effector. It may be determined via an associated control circuit based on the physiological perception. In such an embodiment, after determining improper use and / or improper positioning, the associated control circuit performs one or more functions of the end effector (eg, stapling). It can be prevented from being done. Further, in such an embodiment, the associated control circuit determines that the associated control circuit has modified the positioning of the surgical instrument or its components and / or the surgical instrument (eg, inappropriate). Replacement of staple cartridges, repositioning of surgical instruments, etc.) or overrides received (eg, on surgical instruments, on surgical hubs attached to surgical instruments, through the user interface in the operating room) If determined, the associated control circuit may enable one or more functions of the end effector.

With reference to FIG. 94 in various aspects of the present disclosure, the surgical system 24200 is a control circuit and (in a virtual line to indicate 24212, 24222, 24232 and / or 24242, eg, any location. , User interface (24214, 24224, 22234, 24244 and / or 24254, eg, on a virtual line to indicate any location (s)), surgical instrument 24202. The surgical instrument 24202 comprises the components A-24216 to N 24218 of the end effector assembly 24210, as well as the shaft assembly 24220 and the handle assembly 24230, respectively, in omitted form for illustration purposes. Includes a plurality of components such as element-A (CA) to component-N (CN). In various embodiments, each component of the surgical instrument 24202 may include at least one device parameter. For example, component A-24216 of the end effector assembly 24210 can include the parameter PAa-PAN24217, component-N 24218 of the end effector assembly 24210 can include the parameter PNa-PNn24219, and so on. .. As another example, each of CA-C-N of the shaft assembly 24220 and CA-C-N of the handle assembly 24230 can also include at least one device parameter. Each component can be configured to transmit its corresponding device parameters to the control circuit. Surgical instrument 24202 further includes sensors (24213, 24223 and / or 24233) configured to detect tissue parameters associated with the function of the surgical instrument and transmit the detected tissue parameters to the control circuit. .. The control circuit may be configured to analyze the detected tissue parameters in conjunction with each respective device parameter, based on system-defined constraints.

With reference to FIG. 94 again, the control circuits 24212 and 24222 and / or 24232 (eg, shown as elements of the end effector assembly 24210, shaft assembly 24220 and handle assembly 24230, respectively) are surgical in various embodiments. One or more of a plurality of components of the appliance 24202 (eg, handle of handle assembly 24230, shaft of shaft assembly 24220, end effector assembly 24210 end effector, staple cartridge of end effector assembly, etc. ), Or may be incorporated into a surgical hub 24240 (eg, wirelessly) paired with a surgical instrument 24202 (eg, 24242). Similarly, sensors (s) 24213, 24223 and / or 24233, user interfaces 24214, 24224 and / or 24234 and memories 24215, 24225 and / or 24235 (eg, end effector assembly 24210, shaft assembly 24220 and, respectively). The handle assembly (shown as an element of 24230) may be incorporated into one or more of the plurality of components in various embodiments. In particular, according to various aspects, the surgical instrument 24202 and / or the surgical hub 24240 may be a situational awareness surgical instrument and / or a situational awareness surgical hub. Situation awareness determines surgical procedure-related information from data received from a database (eg, historical data associated with a surgical procedure) and / or data received from a surgical instrument (eg, sensor data during a surgical procedure). Or refers to the ability of the estimated surgical system (eg 24200). For example, the determined or inferred information can include the type of treatment performed, the type of tissue manipulated, the body cavity to be treated, and the like. Based on such contextual information related to the surgical procedure, the surgical system can, for example, control the paired surgical instrument or its components and / or to the surgeon throughout the surgical procedure. We can provide information or suggestions that apply to the situation.

According to one aspect, a situational awareness surgical hub (eg, 24240) is paired (eg, wirelessly) with a surgical instrument 24202 used to perform a surgical procedure. In such an embodiment, the surgical instrument 24202 may include a plurality of components including an end effector (eg, component A-24216). The end effector 24216 is a first jaw, a second jaw pivotally coupled to the first jaw, a cutting blade, and the function of the end effector 24216 (eg, incision, gripping, coagulation). An integrated sensor 24213 configured to detect tissue parameters associated with (cutting, staple fastening, etc.) and transmit the detected tissue parameters to the control circuit 24242 of the surgical hub 24240. .. Multiple components of the surgical instrument 24202, including the end effector 24216 (eg, component-N 24218, eg staple cartridge, etc.), transmit their respective device parameters (eg, 24219 and 24217, respectively) to the surgical hub 24240. It is configured as follows. In particular, sensors as referred to herein and in other disclosed embodiments (eg, 24213) are configured to detect multiple tissue parameters associated with the plurality of end effectors 24216. Please understand that you may have. Thus, further, in such an embodiment, the surgical hub control circuit 24242, through the course of the surgical procedure, each component including such parameter data (eg, detected tissue parameters (s), end effectors). It may be configured to receive device parameters, etc.). The detected tissue parameters may be received each time the associated end effector function (eg, incision, gripping, coagulation, cutting, stapling, etc.) is performed. The surgical hub control circuit 24242 may be further configured to receive data from an internal database (eg, surgical hub database 24249) and / or an external database (eg, from cloud database 24269). According to various aspects, the data received from the internal database 24249 and / or the external database 24269 may be treatment data (eg, data indicating the process of performing the surgical procedure, the respective device parameters associated with the surgical procedure) and /. Alternatively, historical data (eg, data indicating tissue parameters predicted based on historical data related to the surgical procedure, patient's surgical history data, etc.) may be included. In various aspects, the procedure data may include current / recognized standard treatment procedures for the surgical procedure, and the historical data may be in the historical data associated with the surgical procedure (eg, system-defined constraints). It may include a preferred / ideal tissue parameter range for each received device parameter based on it. Based on the data received (eg, parameter data, internal and / or external data, etc.), the surgical hub control circuit 24242 is to continuously derive inferences (eg, contextual information) about the ongoing surgical procedure. It may be configured in. That is, a situation-aware surgical hub, for example, records data about a surgical procedure to generate a report, validates the steps a surgeon takes to perform a surgical procedure, and data that may be relevant to a particular procedure step or. Prompt (eg, via the user interfaces 24244 and / or 24254 associated with the surgical hub, and / or the user interfaces 24214, 24224 and / or 24234 associated with the surgical instrument) and of the surgical instrument. It may be configured to control the function.

According to another aspect, situational awareness surgical instruments (eg, 24202) may be utilized to perform a surgical procedure. In such an embodiment, as described herein, the surgical instrument 24202 may include a plurality of components including an end effector 24216. The end effector includes a first jaw, a second jaw pivotally coupled to the first jaw, a cutting blade, and the function of the end effector 24216 (eg, incision, gripping, coagulation, etc.) It may include an integrated sensor 24213 configured to detect tissue parameters associated with (cutting, stapling, etc.) and transmit the detected tissue parameters to the control circuit. In particular, in such an embodiment, the detected tissue parameters may be transmitted to the integrated control circuit 24212 of the end effector 24216. Each of the multiple components of the surgical instrument, including the end effector 24216 (eg, component-N 24218, such as a staple cartridge), is configured to transmit its respective device parameters to the integrated end effector control circuit 24212. ing. In such an embodiment, the integrated end effector control circuit 24212 is a device of each component including such parameter data (eg, detected tissue parameters (s), end effector) throughout the course of the surgical procedure. It may be configured to receive parameters (s)). The detected tissue parameters may be received each time the relevant end effector function (eg, incision, gripping, coagulation, cutting, stapling, etc.) is performed. The integrated end effector control circuit 24212 provides an internal database (eg, end effector memory 24215) and / or an external database (eg, surgical hub database 24249 to cloud database 24269 via surgical hub 24240) throughout the surgical procedure. It may be further configured to receive data (from). According to various aspects, the data received from the internal database and / or the external database is transferred to the staple cartridge data (eg, the staple cartridge (eg 24218) for which the device parameters (s) have been received by the end effector control circuit 24212). The size and / or type of staples associated) and / or historical data (eg, the expected tissue and / or type of tissue to be stapled with such size and / or type based on historical data. The pointing data) may be included. In various embodiments, the internal and / or external data provide a preferred / ideal tissue parameter range for each received device parameter, based on historical data associated with the surgical procedure (eg, system-defined constraints). Can include. In one embodiment, the internal and / or external data are preferred / ideal tissue parameters and / or preferred / ideal tissue parameter ranges for the expected tissue and / or tissue type, or historical data. Based on (eg, system-defined constraints), it may include a preferred / ideal tissue parameter range for the size and / or type of staple associated with the device parameters of the staple cartridge (eg, 24218). Based on the received data (eg, parameter data, internal data and / or external data, etc.), the end effector control circuit 24212 is configured to continuously derive inferences (eg, contextual information) about ongoing actions. May be done. In particular, according to an alternative embodiment, the integrated sensor 24213 of the end effector 24216 associates the detected tissue parameters (s) with components of another surgical instrument, such as the handle of the handle assembly 24230. It may be transmitted to the control circuit (for example, 24222 and / or 24232). In such an embodiment, the control circuits of other surgical instrument components (eg, 24222 and / or 24232) are similarly configured to perform various aspects of the end effector control circuit 24212 as described above. You may. Finally, a situation-aware surgical instrument (eg, 24202) warns its user of a discrepancy (eg, through the user interface of the end effector 24214, of another surgical instrument component, eg, a handrel assembly 24230 It may be configured via the handrel user interface 24224 and / or 24234, or via the user interface 24244 associated with the surgical hub 24240 coupled to the surgical instrument 24202). For example, in the discrepancy, the detected tissue parameters are staples of these sizes and / or types, or the preferred / ideal tissue parameters associated with their expected tissue and / or tissue type, and / Alternatively, it may include exceeding the preferred / ideal tissue parameter range. As a further example, situational awareness surgical instruments (eg, 24202) may be configured to control the function of the surgical instrument based on discrepancies. According to at least one aspect, situational awareness surgical instruments (eg, 24202) can block surgical function based on discrepancies.

Inappropriate device placement According to various aspects of the disclosure, physiological sensing (eg, detected via one or more sensors) may indicate device placement concerns. More specifically, according to such an embodiment, there may be physiological incompatibility within / between the first jaw and the second jaw of the end effector (eg, after grasping). Further functions of the end effector (eg, coagulation, cutting, stapling, etc.) can be prohibited / blocked.

According to various aspects, the surgical procedure may include excision of the target tissue (eg, tumor). Referring to FIG. 92, for example, a portion of patient tissue 24000 may contain tumor 24002. In such an embodiment, the surgical margin 24004 may be defined to surround the tumor 24002. Ideally, the removal of healthy tissue surrounding the tumor should be avoided and / or minimized, especially during surgery. However, to ensure complete removal of the tumor, the current / recognized standard treatment procedure associated with the surgical procedure is a predetermined surgical margin defined by the distance surrounding the tumor, and / or Resection of a given surgical margin defined by the range of distance surrounding the tumor may be approved. In one aspect, the approved surgical margin may be tumor dependent (eg, based on tumor type, tumor size, etc.). In another aspect, the approved surgical margin may depend on the degree of microinfiltration of the tumor into the surrounding tissue. In other embodiments, the approved surgical margin may be correlated with improved long-term survival based on historical data associated with the tumor and / or surgical procedure. In yet another aspect, the associated control circuit (eg, 24212, 24222, 24232, within the surgical instrument, within the components of the surgical instrument, in view of FIG. 94, surgically coupled to the surgical instrument. In-hub 24242) is data received from internal 24215, 24225 and / or 24235, and / or from external databases 24249 and / or 24269 (eg, patient surgical history data from the cloud, from a surgical hub, etc., patient's). Surgical margins approved based on history data, standard treatment procedures for recurrent tumors) may be adjusted in advance. In such an embodiment, with reference back to FIG. 92, the usual final surgical margin (eg 24004) is relative to the surgical margin adjusted based on such received data (eg 24012). The amount / distance determined (eg, 24010) may be changed (eg, the patient's surgical and / or medical history data suggests that the tumor may further slightly affect the surrounding tissue. It may suggest that the patient may already have a case such as a recurrent tumor).

Moreover, in various embodiments, after a targeted surgical margin (eg, 24004 and / or 24012) has been established for the surgical procedure, the surgical margin of the tumor and / or its target is efficiently and / or accurate during the surgical procedure. It can be difficult to identify and excise. With reference to FIG. 94 in various aspects of the present disclosure again, the end effector of the surgical instrument 24202 (eg, 24216) measures the first signal and is associated with a control circuit (eg, in a surgical instrument, surgically. A first sensor (eg, 24213) configured to transmit a first signal to 24212, 24222 and / or 24232 in the instrument component, 24242 in the surgical hub coupled to the surgical instrument). May be equipped. In such an embodiment, the second sensor, configured to measure the second signal and send the second signal to the associated control circuit, uses a surgical instrument to resect the tumor. It may be previously placed on / in the tumor (see FIG. 92, eg 24006, central position relative to the tumor). Here, according to various aspects, the second sensor may be separate from the surgical instrument. In addition, and / or alternative, in such an embodiment, the second sensor may include a sensor located around the tumor prior to using a surgical instrument to resect the tumor. (See FIG. 92, eg, 2408). According to another aspect, a plurality of second sensors may be placed around the periphery of the tumor. Here, in such an embodiment, the control circuit is configured to dynamically calculate the distance between the first sensor and the second sensor based on the first signal and the second signal. You may. According to various aspects, the first sensor may be located on / near the cutting blade of the end effector. A further exemplary method for detecting targeted surgical margins is the US Patent Application Publication No. 1 entitled "SYSTEM AND METHOD FOR A TISSUE RESECTION MARGIN MEASUREMENT DEVICE", the entire disclosure of which is incorporated herein by reference. It is described in 2016/01/92960.

In one embodiment, if the second sensor is located on / within the tumor (eg, central position 24006), the control circuit will be with the second sensor established for the surgical procedure and the surgical margin of the target. It may be further configured to determine the margin distance between. In such an example, the control circuit compares the dynamically calculated distance (eg, between the first sensor and the second sensor) with its determined margin distance to the end effector (eg,). The end effector is properly placed when, for example, a cutting blade) can be efficiently and accurately placed in the target surgical margin (eg, when the dynamically calculated distance is equal to or substantially equal to the determined margin distance. Positioned). The control circuit may be configured to utilize such techniques to efficiently and accurately place end effectors (eg, cutting blades) around the target surgical margin (eg, during resection).

In another example, if the second sensor is located around the tumor, or if multiple second sensors are located around the tumor, eg, around 24008, the control circuit is the second sensor. It may be further configured to determine the margin distance between and the targeted surgical margin established for the surgical procedure. In such an example, the control circuit determines the end effector by comparing the dynamically calculated distance (eg, between the first sensor and the second sensor) with its determined margin distance. It can be placed efficiently and accurately in the target surgical margin (eg, the end effector is properly positioned when the dynamically calculated distance is equal to or substantially equal to the determined margin distance). The control circuit may be configured to utilize such techniques to efficiently and accurately place end effectors (eg, cutting blades) around the target surgical margin (eg, during resection). Such an embodiment can be beneficial when the tumor is in an abnormal shape.

With reference to FIG. 94 again, according to various aspects, the control circuit is such that the end effector (eg, or its cutting blade) is properly positioned with respect to the target surgical margin (eg 24004 and / or 24012). When positioned, it may be configured to inform the surgeon (eg, user interface 24244 on a surgical hub coupled to the surgical instrument via user interface 24214, 24224 and / or 24234 on the surgical instrument. , And / or in real time via the operating room user interface 24254 and the like). For example, the user interface i) visually confirms that the end effector (eg, 24216) is positioned in the target surgery margin and / or the end effector (eg, or its cutting blade) the target surgery margin. Video image of the surgical site with a digital overlay showing the target surgical margin to the surgeon to move against, ii) Surgical instruments to show that the cutting blade of the end effector was positioned in the target surgical margin It may include at least one of tactile feedback on the 24202 itself and / or iii) audible feedback indicating that the cutting blade of the end effector has been positioned in the target surgical margin.

Revisiting FIG. 94 for a further aspect, the control circuit is such that the end effector (eg, cutting blade) is inside the cancer margin (eg, inside the target surgery margin and close to the surrounding tissue slightly affected by the tumor). If it is too close to and / or within its range, it may be configured to prevent the surgical instrument 24202 from firing. According to such an embodiment, the control circuit receives an override command (eg, user interface 24214, 24224 and / or 24234 on the surgical instrument, user interface on the surgical hub coupled to the surgical instrument. 24244, and / or via the operating room user interface 24254, etc.), may be further configured to allow continued firing. In one embodiment, such a user interface may include a user interface element that can be selected to allow firing to continue, such as 24251. In such an embodiment, the control circuit can continue to monitor the end effector (eg, its cutting blade) against the cancer margin. Further, in such an embodiment, the control circuit may be configured to stop firing again, warn the surgeon, and / or receive an override command as described. According to another aspect, the control circuit is configured to block firing until a reset event occurs (eg, opening the end effector jaw and rearranging the end effector jaw relative to the cancer margin). May be done.

With reference to FIG. 94 according to another aspect of the present disclosure, one or more sensors of the surgical system 24200 are the first jaw and the second jaw of an end effector (eg, 24216). Blood flow through the tissue held in between can be detected (eg, 24216). For example, a Doppler imaging detector (eg, 24213 incorporated on an end effector connected to a surgical hub, eg, a parameter sensing component 24253 with a Doppler imaging detector) is otherwise at the surgical site (eg, for example). Blood flow through such vessels may be configured to identify and identify invisible blood vessels (via red, green, and / or blue laser light) and perform Doppler contrast analysis. The amount and / or speed of can be determined. In particular, in one example, it may be desirable to seal some blood vessels (eg, associated with a tumor) but not others (eg, associated with a healthy tissue / organ). Thus, the associated control circuit (eg, in a surgical instrument, 24212, 24, 222 and / or 24232 within a component of the surgical instrument, 24242 within a surgical hub coupled to the surgical instrument, etc.) Can be configured to prevent the surgical instrument 24202 from firing if it exceeds a predetermined amount and / or velocity of blood flow. According to such an embodiment, the control circuit issues override commands (eg, user interface on surgical instruments 24214, 24224 and / or 24234, user interface 24244 on surgical hub coupled to surgical instruments, and / Alternatively, it may be further configured to receive (eg, via user 24254 in the operating room) and allow continued firing (eg, when blood flow is associated with the tumor). In one embodiment, such a user interface may include a user interface element that can be selected to allow firing to continue, such as 24251. In such an embodiment, the control circuit can continue to monitor the tissue held for blood flow. Further, in such an embodiment, the control circuit may be configured to stop firing again, warn the surgeon, and / or receive an override command as described. According to another aspect, the control circuit causes a reset event (eg, the end effector's jaw is opened and the end effector's for a blood vessel having blood flow that exceeds a predetermined amount and / or velocity of blood flow. It may be configured to block firing until the jaw is rearranged).

Referring again to FIG. 94 according to another aspect of the present disclosure, one or more sensors of the surgical system 24200 are the first jaw and the second jaw of an end effector (eg, 24216). An increase in blood pressure can be detected at the same time as and / or shortly after grasping the tissue in between. For example, a blood pressure monitor (eg, a parameter sensing component 24253 coupled to a surgical hub, eg, a parameter sensing component with a blood pressure monitor) can detect an increase in blood pressure upon grasping. According to various aspects, the surgical system 24200 speculates that the situation-aware and detected increase in blood pressure was caused by gripping tissue between / within the jaws of the end effector. obtain. For example, blood vessels containing critical blood flow may be trapped between the jaws / within the jaw, resulting in narrowed blood flow. Thus, according to various aspects, the associated control circuit (eg, in a surgical instrument, 24212, 24, 222 and / or 24232 within a component of the surgical instrument, a surgical hub coupled with the surgical instrument. In 24242, etc.), the surgical instrument 24202 may be configured to prevent firing if the increase in blood pressure exceeds a predetermined amount and / or a predetermined range. According to such an embodiment, the control circuit issues override commands (eg, user interfaces 24214, 24224 and / or 24234 on surgical instruments, and / or user interfaces on surgical hubs coupled to surgical instruments. 24244, as well as via the operating room user interface 24254, etc.) may be further configured to allow continued firing. (For example, the surgeon observes that the blood pressure has dropped while the tissue is still being grasped, and in some circumstances the surgical system recognizes that the rise in blood pressure causes another cause). In one embodiment, such a user interface may include a user interface element that can be selected to allow firing to continue, such as 24251. In such an embodiment, the control circuit can continue to monitor the patient's blood pressure. Further, in such an embodiment, the control circuit may be configured to stop firing again, warn the surgeon, and / or receive an override command as described. According to another aspect, the control circuit is configured to block firing until a reset event occurs (eg, the jaw is opened and the end effector jaw is repositioned with respect to the grabbed tissue). May be done.

With reference to FIG. 94 according to another aspect of the present disclosure, one or more sensors of the surgical system are located between the first jaw and the second jaw of an end effector (eg, 24216). It is possible to detect important nerve bundles in the tissue held by the jaw. For example, a heart rate monitor (eg, 24213 integrated on an end effector coupled to a surgical hub, a parameter sensing component 24253 including a heart rate monitor, etc.) may have a first jaw and a second jaw. An increase in heart rate may be detected at the same time as and / or immediately after grasping the tissue between and. According to various aspects, the surgical system 24200 is context-aware and data received from internal 24215, 24225, 24235, 24249 and / or external databases 24249 and / or 24269 (eg, surgery of the surgical procedure being performed). In the context of site-related anatomical information), it is presumed that the detected increase in heart rate is caused by grasping tissue between / within the jaws of the end effector. Good. According to such an embodiment, the associated control circuit (eg, in a surgical instrument, 24212, 24222 and / or 24232 within a component of the surgical instrument, within a surgical hub coupled to the surgical instrument. 24242, etc.) may be configured to prevent the surgical instrument 24202 from firing on reason. Further according to such an embodiment, the control circuit issues an override command (eg, user interface 24214, 24224 and / or 24234 on the surgical instrument, user interface 24244 on the surgical hub coupled to the surgical instrument, And / or receive and allow the firing to continue (eg, operating room user interface 24254) (eg, the surgeon observes that the patient's heart rate has decreased while the tissue is still being grasped). However, the surgical system may be configured to recognize the situation that the heart rate is attributed to another cause). In one embodiment, such a user interface may include a user interface element that can be selected to allow firing to continue, such as 24251. In such an embodiment, the control circuit can continue to monitor the patient's heart rate. Further, in such an embodiment, the control circuit may be configured to stop firing again, warn the surgeon, and / or receive an override command as described. According to another aspect, the control circuit is configured to block firing until a reset event occurs (eg, the jaw is opened and the end effector jaw is repositioned with respect to the grabbed tissue). It may be configured to be.

Referring again to FIG. 94 according to another aspect of the present disclosure, one or more sensors of the surgical system 24200 are in contact with an energized device (eg, an RF instrument / device) of the surgical instrument 24202. Can be detected. In one embodiment, the surgical instrument and the energized device may be communicatively coupled to the surgical hub 24240 within the surgical system 24200. For example, with reference back to FIG. 9, the device / instrument 235 and the energy device 241 may be coupled to the modular control tower 236 of the surgical hub 206. In such an embodiment, the generator 240 that produces electrosurgical energy in the energized device 241 and / or the sensor incorporated in the energized device has a threshold value of impedance associated with the energized device. It may be configured to detect below a threshold over a period of time (eg, a drop in impedance indicating a short circuit). Similar to FIG. 48, the integrated sensor of the energized device may be configured to measure impedance over time. Various alternative methods for detecting short circuits, such as those described in US Pat. No. 9,554,854, entitled DETECTING SHORT CIRCUITS IN ELECTROSURGICAL MEDICAL DEVICES, which detect short circuits in electrosurgical medical devices, are available. Explicitly incorporated herein by reference (eg, comparing impedance values at different positions within a series of pulses). According to various aspects, the surgical system 24200 is configured with data (eg, surgical procedure) in which context-aware and detected short circuits are received from internal 24215, 24225, 24235, 24249 and / or external databases 24249 and / or 24269. Related to the use of separate surgical instruments in the context of specific steps and / or current steps in the context of separate surgical instruments (eg, procedure data indicating that they involve the use of separate surgical instruments / devices). (For example, the conductive surface of a surgical instrument may come into contact with an energizer, causing a short circuit). According to such an embodiment, the associated control circuit is coupled to the surgical instrument (eg, in a surgical instrument, 24212, 24, 222 and / or 24232 within the components of the surgical instrument and the energized device. (Such as 24242 in a surgical hub), surgical instruments 24202 may be configured to prevent inference-based firing. In the presence of short circuits, it can be difficult to treat (eg, coagulate) tissue with electrosurgical energy (eg, RF energy) and undesired surgical consequences (eg, incomplete tissue treatment, conductive objects). Excessive heating, etc.) may occur. In such context, the control circuit (eg, via the user interface 24214, 24224 and / or 24234 on the surgical hub coupled to the surgical instrument 24244, and / or the user interface of the operating room 24254, etc. It may be configured to notify (in real time). May be configured to inform the surgeon that a short circuit has existed and the launch of surgical instrument 24202 has been interrupted. Further according to such an embodiment, the control circuit issues an override command (eg, user interface 24214, 24224 and / or 24234 on the surgical instrument, user interface 24244 on the surgical hub connected to the surgical instrument, And / or receiving (via the operating room user interface 24254, etc.) to allow the launch to continue (eg, the surgeon verifies that there are no short circuits and the target tissue contains low impedance). Etc.). In one embodiment, such a user interface may include a user interface element that can be selected to allow firing to continue, such as 24251. In such an embodiment, the control circuit can continue to monitor the short circuit. Further, in such an embodiment, the control circuit may be configured to stop firing again, warn the surgeon, and / or receive an override command as described. According to another aspect, the control circuit blocks firing until a reset event occurs (eg, it is relocated to an energized device so that the relocated surgical instrument no longer contacts). It may be configured as follows.

Inappropriate Device Selection / Proposed Use According to various aspects of the disclosure, physiological sensing (eg, detected via one or more sensors) is a surgical instrument / device. Can indicate concerns about choice. More specifically, according to such aspects, there may be incompatibility between the surgical instrument and the tissue, prohibiting / blocking further functions of the end effector (eg, coagulation, cutting, stapling, etc.). May occur.

Further referring to FIG. 94 according to one aspect of the present disclosure, the control circuit within the surgical hub connected to the surgical instrument 24242 (eg, within the components of the surgical instrument 24212, 24, 222 and / or 24232). , Tissue-specific staplers (eg, vascular staplers), and any combination of sensed information (eg, detected via one or more sensors), target tissue is tissue-specific. It may be configured to provide a warning if it suggests that the stapler may be inappropriate (eg, indicating the opposite).

FIG. 93 shows an exemplary safety process 24100 for addressing device selection concerns in various aspects of the present disclosure. According to at least one aspect, the safety process 24100 is performed / performed by a control circuit associated with a situational awareness surgical hub (eg, 24242 in FIG. 94) of the surgical system (eg, 24200 in FIG. 94). May (eg, during surgical procedures). According to another aspect, the safety process 24100 is provided by a control circuit associated with a situational awareness surgical instrument (eg, 24212, 24222 and / or 24232) of the surgical system (eg, 24200 of FIG. 94). It may be performed / performed (eg, during a surgical procedure).

With reference to FIG. 93, the tissue identification process 24108 is suitable for device selection 24102 (eg, stapler selection, eg, stapler suitable for firing into soft tissue, stapler suitable for firing into blood vessels, bronchial firing. Various device measurements detected by one or more sensors (eg, stapler, etc.) 24104 (eg, end effector closure angle, length of tissue in contact with end effector, proximity / compression curve, etc.), And input including situational awareness information 24106 (eg, surgical information, surgeon tendencies, etc.) may be received.

Considering FIG. 93, in device selection 24102, the control circuit that executes / implements the safety process 24100 is the device parameters from the selected stapler / device and / or each component of the selected stapler / device (eg, for example. It may be configured to receive the device parameters associated with the staple cartridge) and direct device selection. For example, device parameters associated with staple cartridges may include cartridge type, cartridge color, auxiliary parts to the cartridge, cartridge gripping load limit, cartridge clearance range, cartridge rate of fire, and the like. According to one aspect, the device parameters may be transmitted to the control circuit by the stapler / device when coupled to the surgical system. According to an alternative embodiment, device selection may be entered via a user interface (eg, 24244 and / or 24254 in FIG. 94, associated with a surgical hub and / or operating room). And / or may be received from internal and / or external databases (eg, data on surgical procedures being performed and / or surgical instruments available, such as 24249 and / or 24269 in FIG. 94).

Further considering FIG. 93, the device measurement 24104 may be an end effector (eg, component-A, 24216 of FIG. 94) and / or other components of the surgical instrument (eg, component-N of FIG. 94). It may be detected via one or more sensors associated with 24218, eg, a staple cartridge) (eg, as described in the present invention in FIGS. 17, 18, 53, 78, etc.). .. For example, one or more tissue sensors check continuity along the length of the end effector and / or tissue impedance to assess the length of tissue in contact with the end effector. It may be positioned and configured to measure (eg, the sensor (s) 738 of FIG. 17 that determine the position of the tissue using a split electrode, and / or the tissue along the length of the end effector. Sensor 153468 of FIG. 78, which measures tissue impedance to determine its presence). As a further example, one or more sensors may be positioned and configured to detect / estimate the jaw / end effector closure angle (eg, grip actuator / drive member variability). The displacement sensor to be detected, for example, the position sensor 734 in FIG. 17, and the gap sensor for detecting the gap between the first jaw portion and the second jaw portion of the end effector, for example, the sensor 152008a in FIG. 53). As a further example, one or more sensors may be positioned and configured to detect a force that compresses / closes tissue between the first jaw and the second jaw. (For example, sensor 738, sensor 738 of FIG. 17, comprising a force sensor, eg, a force sensor, on the tissue surface of the first jaw and / or the second jaw to detect the force when the tissue is gripped. A sensor that detects the current draw of the drive member that correlates with the force applied to, eg, the current sensor 736 in FIG. 17, and a torque sensor that measures the force to close, eg, 744b in FIG. 17). Various additional aspects for detecting the end effector closure angle, the length of tissue in contact with the end effector, and the closing / compressing force are described elsewhere herein.

Next, considering FIG. 93, the surgical recognition information 24106 is provided to the surgical instrument 24202 via the internal database 24249 and / or the external database 24269 associated with the surgical hub 24242 in the light of FIG. 94. It may be received via the associated internal 24215, 24225, 24235 and / or external databases 24249, 24269.

Returning to FIG. 93, the tissue identification process 24108 is configured to determine the tissue type encountered by surgical instruments (eg, soft tissues, blood vessels, blood vessels, bronchi, etc.). In one embodiment, the tissue identification process 24108 involves various inputs (eg, when the jaw is fully open, the tissue contact, closure and opening curves detected along the length of the jaw, but the tissue It may be determined that the type of tissue is soft tissue based on (for example, suggesting that it matches soft tissue). In another example, the tissue identification process 24108 was detected at various inputs (eg, tissue contact detected almost immediately during closure, only on a small area of the stapler, and separated distally. Tissue contact, the initially detected closure force, may determine that the tissue type is blood vessel (eg, PA / PV) based on suggesting that the tissue structure is consistent with blood vessels, etc.). In yet another example, the tissue identification process 24108 is detected at various inputs (eg, tissue contact detected almost immediately during closure, only on a small area of the stapler, and both distally and proximally. The type of tissue may be determined to be bronchial, based on demarcated tissue contact, early detection of closure, suggesting that the tissue structure is consistent with the bronchi, etc.). According to various aspects, such tissue type determinations are the thickness of the tissue, the firmness of the tissue, the location of the tissue (eg, with respect to the patient), and one or two as described herein. It may be further based on tissue parameters including angiogenesis in the tissue detected and / or derived from the measurements obtained by the above sensors. In particular, the tissue identification process 24108 makes such an initial tissue determination in relation to further inputs (eg, stapler selection, surgical information, surgeon's tendency, etc.) before reaching the tissue identification output / result. May be further evaluated. Such situational awareness ultimately results in organizational identification output / results. Here, various aspects for identifying the tissue encountered are further discussed elsewhere in the specification (eg, chest surgery example).

Returning to FIG. 93, the output / result of tissue identification is that the selected stapler / device and / or each component of the selected stapler / device (eg, staple cartridge, shaft, etc.) is used for surgery. It may be used to determine whether it is optimal or not. In such an embodiment, the control circuit is an internal and / or external database (eg, with reference to FIG. 94, an internal 24249 and / or an external database 24269 associated with the surgical hub 24242, and / or a surgical instrument 24202. Further information 24112 can be received from the internal 24215, 24225, 24235 and / or the external databases 24249, 24269) associated with. More specifically, the additional information 24112 may include other available staplers, other available energy devices, other stapler components (eg, staple cartridges, shafts, etc.). According to at least one aspect, availability may depend on the current inventory status at the surgical site. In particular, further information 24112 also includes each other available stapler, each other available energy device, each other stapler component available for use with the selected stapler / device, and the like. May include.

According to various aspects, the control circuit that executes / implements the safety process 24100 when assessing whether the selected stapler / device is optimal 24110, the stapler / device selected based on system-defined constraints. Each detected tissue parameter (eg, detected via one or more sensors described in the present invention) is analyzed in conjunction with each received device parameter associated with device 24102. It may be configured as follows. In addition, according to such an embodiment, the control circuit is utilized with each other available stapler, each other available energy device, and a selected stapler / device, subject to system-defined constraints. With the received device parameters associated with each other possible stapler component, each detected tissue parameter (eg, detected via one or more sensors described herein). ) May be analyzed. According to such an embodiment, the control circuit is to be used with other available staplers, other available energy devices, and / or selected staplers / devices based on the detected tissue parameters. To determine if one or more of the other stapler components available are more optimal than the components of the selected stapler / device 24102 and / or the selected stapler / device 24102. It may be configured.

In various embodiments, the detected tissue parameters (s) may include, for example, tissue type, tissue thickness, tissue stiffness, tissue location, angiogenesis within the tissue, and are received. Device parameters may include, for example, the type of staple cartridge, the color of the staple cartridge, the auxiliary part to the staple cartridge, the gripping load limit of the staple cartridge, the gap range of the staple cartridge, the firing speed of the staple cartridge, and the like. According to various aspects, system-defined constraints (eg, based on historical and / or treatment data accessed in context-aware surgical systems) are preferred / ideal tissue parameters for each received device parameter. And / or preferred / ideal tissue parameter ranges may be included. For example, a preferred / ideal tissue thickness and / or a preferred / ideal tissue thickness range may be associated with the color of each staple cartridge. In such an example, the color of each staple cartridge may indicate the type and / or size of staples within the staple cartridge. Here, staple cartridges containing short staples may not be optimal for thick tissues. According to a further aspect, system-defined constraints (eg, based on historical and / or treatment data accessed in situational awareness surgical systems) are preferred / ideal for each detected tissue type. Grip load limits and / or preferred / ideal grip load limit ranges may be included. For example, each staple cartridge associated with each grip load limit may indicate the type of tissue in which the staples can be optimally stapled. Here, received device parameters (eg, type of staple cartridge, color of staple cartridge, auxiliary part for staple cartridge, gripping load limit of staple cartridge, gap range of staple cartridge, firing speed of staple cartridge, etc.), and detection. Tissue parameters (eg, tissue type, tissue thickness, tissue stiffness, tissue position, angiogenesis within tissue, etc.), and established system-defined constraints (eg, in context-aware surgical systems). (Associated with received device parameters and / or detected tissue parameters) based on accessed historical data and / or treatment data) is contemplated by the present disclosure.

Referencing FIG. 93 again, if the selected device 24102 is determined to be optimal, the control circuit performing / performing the safety process 24100 does nothing at first (eg, recommended later) and / or 24114 may be configured to demonstrate that the analysis has been performed. Alternatively, if the selected device 24102 is determined to be suboptimal, the control circuit may be configured to determine if a safety issue exists 24116. According to various aspects, when assessing whether there are safety issues with respect to the stapler / device 24102 selected, the control circuit is associated with the stapler / device 24102 selected based on system-defined constraints. It may be configured to analyze each detected tissue parameter in conjunction with each received device parameter.

Similar to the above, the detected tissue parameters may include, for example, tissue type, tissue thickness, tissue stiffness, tissue position, angiogenesis within the tissue, and the received device parameters may include, for example. , The type of staple cartridge, the color of the staple cartridge, the auxiliary part for the staple cartridge, the gripping load limit of the staple cartridge, the gap range of the staple cartridge, the firing speed of the staple cartridge, and the like may be included. According to various aspects, system-defined constraints (eg, based on historical and / or treatment data accessed in a situation-aware surgical system) are preferred / ideal tissue parameters and / or ideal tissue parameters for each received device parameter. / Or may include a preferred / ideal tissue parameter range. For example, a preferred / ideal tissue thickness and / or a preferred / ideal tissue thickness range may be associated with the color of each staple cartridge. In such an example, the color of each staple cartridge may indicate the type and / or size of staples within the staple cartridge. Continuing with the embodiment, the device parameters received by the selected stapler / device 24102 include the staple cartridge color (eg, indicating short staples) and the detected tissue parameters are the selected stapler / device. A staple / device of choice if it indicates a preferred / ideal tissue thickness associated with the color of the staple cartridge of 24102 and / or a tissue thickness that exceeds the preferred / ideal tissue thickness range. There is a safety issue with 24102. The use of improper staple cartridges can lead to inadequate and / or undesired consequences (eg, stapling, exudation, bleeding, etc.). In such an example, the control circuit warns the surgeon of a safety issue via 24118 (eg, see FIG. 94, user interface 24214, 24224 and / or 24234 on the selected stapler / device). It may be configured via the user interface 24244 associated with the surgical hub, via the operating room user interface 24254, etc.). In such an embodiment, the control circuit receives the override command 24120 and (eg, via the user interface 24214, 24224 and / or 24234 on the selected stapler / device, the user associated with the surgical hub. It may be further configured to allow the surgical procedure to proceed, such as through interface 24244 and via operating room user interface 24254. In one embodiment, referring to FIG. 94, such a user interface may include, for example, a user interface element that can be selected to allow continuation, such as 24251. In an alternative embodiment, in response to the warning, the surgeon can correct the notified safety issue (eg, replace the improper staple cartridge with another staple cartridge) at this point. , The device selection safety process 24100 can be performed / implemented again.

Similar to the above, according to a further aspect, system-defined constraints (eg, based on historical and / or treatment data accessed in a situational awareness surgical system) are for each tissue type detected. It may include a preferred / ideal grip load limit and / or a preferred / ideal grip load limit range. For example, each staple cartridge associated with each grip load limit may indicate the type of tissue in which the staples can be optimally stapled. Continuing with the embodiment, the device parameters received by the selected stapler / device 24102 include its staple cartridge grip load limit, and the tissue identified by the tissue identification process 24108 has a higher grip load limit. There is a safety issue with the stapler / device 24102 selected when indicating the type of tissue that requires a staple cartridge with. The use of improper staple cartridges can lead to inadequate and / or undesired consequences (eg, stapling, exudation, bleeding, etc.). In such an example, the control circuit warns the surgeon of a safety issue via 24118 (eg, see FIG. 94, user interface 24214, 24224 and / or 24234 on the selected stapler / device). It may be configured via the user interface 24244 associated with the surgical hub, via the operating room user interface 24254, etc.). In such an embodiment, the control circuit receives the override command 24120 (eg, via the user interface 24214, 24224 and / or 24234 on the selected stapler / device, the user interface associated with the surgical hub. It may be further configured to allow the surgical procedure to proceed via 24244, such as via the operating room user interface 24254). In one embodiment, referring to FIG. 94, such a user interface may include selectable user interface elements, such as 24251, to allow the procedure to continue. In an alternative embodiment, in response to the warning, the surgeon can (eg, replace the improper staple cartridge with another staple cartridge), at which point the device selection safety process 24100 is performed / performed again. Can be done. Again, the device parameters received (eg, staple cartridge type, staple cartridge color, auxiliary part to the staple cartridge, staple cartridge gripping load limit, staple cartridge clearance range, staple cartridge firing speed, etc.), and Detected tissue parameters (eg, tissue type, tissue thickness, tissue stiffness, tissue position, angiogenesis within tissue, etc.), and established system-defined constraints (eg, situation-aware surgical systems). (Associated with received device parameters and / or detected tissue parameters) based on historical data and / or treatment data accessed in.

Referencing FIG. 93 again, if it is determined that there are no safety issues with the stapler / device selected 24116, the control circuit that executes / implements the safety process 24100 is configured to provide recommendations to the surgeon 24122. May be done. According to at least one aspect of the present disclosure, another stapler, another available energy device, and / or another stapler component (eg, available for use with a selected stapler / device). If the stapler cartridge, shaft, etc.) 24112 is more optimal or optional, the control circuit makes the surgeon aware of its availability (eg, see FIG. 94, on the stapler / device of choice). User interface 24214, 24224 and / or 24234, via user interface 24244 associated with the surgical hub, via operating room user interface 24254, etc.), recommended for its use in current surgical procedures. It may be configured to do so. In such an embodiment, the control circuit is operated (eg, via the user interface 24214, 24224 and / or 24234 on the selected stapler / device, and via the user interface 24244 associated with the surgical hub, in the operating room. It may be further configured to receive recommended acceptance (eg, via the user interface 24254). If accepted, the control circuit will be more optimal with other available staplers, other available energy devices, and / or other stapler components 24112 (eg, components A to N in FIG. 94, eg. , Staple cartridges available for use with selected staplers / devices, shafts, etc.) may be configured to present information about 24124. If rejected, the control circuit may be configured to perform 24126 and / or subsequent processes to terminate the device selection safety algorithm.

Although various other aspects are specifically discussed with respect to staplers / devices herein, the present disclosure should not be so limited. More specifically, the disclosed aspects are energy devices (eg, RF instruments and / or ultrasonic surgical instruments) and / or their respective components and / or endoscopic devices and / or their respective. The same applies to other surgical instruments containing the components of.

(Example)
Various aspects of the subject matter described herein, "safety systems for stapling for smart electrosurgery," are set under the headings in the following examples.

Example 1-The surgical system comprises a control circuit and a surgical instrument. Surgical instruments include a plurality of components and sensors. Each of the multiple components of the surgical instrument contains device parameters. Each component is configured to transmit its respective device parameters to the control circuit. The sensor is configured to detect tissue parameters associated with the proposed function of the surgical instrument and send the detected tissue parameters to the control circuit. The control circuit is configured to analyze the detected tissue parameters in cooperation with each respective device parameter based on system-defined constraints. Surgical systems further include a user interface configured to indicate whether a surgical instrument containing multiple components is suitable for performing the proposed function.

Example 2-Surgery according to Example 1, wherein the tissue parameters detected include at least one of tissue type, tissue thickness, tissue stiffness, tissue location, or tissue angiogenesis. System for.

Example 3-The components of the surgical instrument include staple cartridges, and the device parameters include staple cartridge type, staple cartridge color, auxiliary parts for staple cartridges, staple cartridge gripping load limit, staple cartridge clearance range, The surgical system according to Example 1 or 2, comprising at least one of a staple cartridge firing rate.

Example 4-The components of the surgical instrument include an end effector, and the tissue parameters detected are the closing angle of the end effector on the tissue, the length of the tissue in contact with the tissue contact surface of the end effector, and within the end effector. The surgical system according to Example 1, 2 or 3, which comprises at least one of the forces for compressing the tissue.

Example 5-The surgical system according to Example 4, wherein the control circuit is further configured to identify tissue as soft tissue, blood vessels or bronchi based on at least one detected tissue parameter.

Example 6-The control circuit is further configured to recommend at least one alternative component for use with surgical instruments to perform the proposed function, Examples 1, 2, 3, The surgical system according to 4 or 5.

Example 7-System-defined constraints include at least one of a predetermined tissue parameter or a predetermined tissue parameter range associated with each transmitted device parameter, Examples 1, 2, 3, 4, 5 Or the surgical system according to 6.

Example 8-Ibid. Surgical system.

Example 9-The surgical system according to Example 8, wherein the user interface comprises a user interface element that can be selected to override the control circuit to enable the proposed function of the surgical instrument.

Example 10-The proposed function of the surgical instrument is one or more of grasping the tissue, coagulating the tissue, cutting the tissue, and stapling the tissue. The surgical system according to Example 1, 2, 3, 4, 5, 6, 7, 8 or 9, which comprises.

Example 11-Additional surgical hub communicatively coupled to the surgical instrument, the surgical hub comprising a control circuit, Example 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10. The surgical system according to 10.

Example 12-The surgical system according to Example 11, wherein one of the surgical instruments or surgical hubs comprises a user interface.

Example 13-The surgical system comprises a surgical hub and a surgical instrument communicatively linked to the surgical hub. Surgical instruments include a plurality of components and sensors. Each of the multiple components of a surgical instrument contains device parameters. Each component is configured to send its respective device parameters to the surgical hub. The sensor is configured to detect tissue parameters associated with the proposed function of the surgical instrument and send the detected tissue parameters to the surgical hub. The surgical hub comprises a processor and memory coupled to the processor. The memory stores instructions that can be executed by the processor to analyze the detected tissue parameters in cooperation with each respective device parameter, based on system-defined constraints. Surgical systems further include a user interface configured to indicate whether a surgical instrument containing multiple components is suitable for performing the proposed function.

Example 14-Surgical use according to Example 13, wherein the detected tissue parameters include at least one of tissue type, tissue thickness, tissue stiffness, tissue location, or tissue angiogenesis. system.

Example 15-The components of the surgical instrument include staple cartridges, and the device parameters include staple cartridge type, staple cartridge color, auxiliary parts for staple cartridges, staple cartridge gripping load limit, staple cartridge clearance range, And the surgical system according to Example 13 or 14, comprising at least one of the staple cartridge firing rates.

Example 16-The components of the surgical instrument include an end effector, and the tissue parameters detected are the closing angle of the end effector on the tissue, the length of the tissue in contact with the tissue contact surface of the end effector, and within the end effector. 13. The surgical system according to Example 13, 14 or 15, comprising at least one of the forces for compressing the tissue.

Example 17-The instruction is further executable by the processor of the surgical hub to recommend at least one alternative component for use with the surgical instrument to perform the proposed function. 13, 14, 15 or 16 according to the surgical system.

Example 18-In Examples 13, 14, 15, 16 or 17, the instructions can be further executed by the processor of the surgical hub to block the proposed function when the system-defined constraints are exceeded. The surgical system described.

Example 19-A non-temporary computer-readable medium stores computer-readable instructions, and when the computer-readable instructions are executed, the machine has multiple surgical instruments of the surgical system, based on system-defined constraints. Coordinating with each device parameter of the component is to analyze the detected tissue parameters, causing the detected tissue parameters to be associated with the proposed function of the surgical instrument. Surgical systems include surgical instruments that include multiple components. Each component is configured to send its respective device parameters to the machine. The surgical system further includes a sensor configured to detect the detected tissue parameters and send the detected tissue parameters to the machine. When executed, the instruction causes the machine to generate a user interface that further provides instructions on whether a surgical instrument containing multiple components is appropriate to perform the proposed function of the surgical system. ..

Example 20-Described in Example 19, when executed, the instruction causes the machine to further generate on the user interface an override element that can be selected to enable the proposed function of the surgical instrument. Non-temporary computer-readable medium.

Control of surgical instruments by sensed closure parameters Compressibility for determining tissue integrity In various embodiments, surgical instruments have a variety of different variables or parameters associated with surgical instrument jaw closure. Can be detected and used to adjust or influence various operating parameters that determine how surgical instruments work. The rate at which the jaws of a surgical instrument transition from an open position to a closed position to grip the tissue between them can be defined as the grip or closure speed. In various embodiments, the closure rate can be variable or constant in the course of the jaw closure example. The threshold at which the specific parameters associated with jaw closure are compared can be defined as the closure threshold.

Gripping tissue at an improper closure rate or at an improper closure threshold can result in damage to the tissue (eg, due to excessive force applied to the tissue). The tissue may be torn) and / or may cause dysfunction with surgical instruments (eg, due to the tissue not being fixed and held by the jaw when the staples are fired). And may deform the staples). Thus, in some embodiments, the surgical instrument detects the features of the tissue held by the surgical instrument and accordingly the closure rate (s), closure threshold (s), and other movements. It is configured to adjust the parameters. In addition, each surgical procedure may include multiple different tissue types and / or tissues with different characteristics. Thus, in some embodiments, the surgical instrument is used each time the tissue is grabbed and the closure rate (s), closure threshold (s), and other operating parameters are adjusted accordingly. It is configured to dynamically detect the characteristics of.

The present disclosure provides at least one solution, in which surgical instruments are configured to detect parameters associated with compression of tissue held by an end effector. Surgical instruments may be further configured to distinguish tissues that exhibit different consistency according to the characteristics of tissue compression detected. The motor can then be controlled to affect the jaw closure rate and / or to provide feedback to the user according to tissue integrity. Auxiliary reinforcement, for example, if the detected tissue compression features indicate that the tissue is stiff, reduce the rate of jaw closure, and / or if the tissue compression features indicate that the tissue has low shear strength. Can be configured to provide suggestions to the user to utilize.

FIG. 95 shows a perspective view of the surgical instrument 21000 according to at least one aspect of the present disclosure. In one aspect, the surgical instrument 21000 includes a control circuit 21002 coupled to a motor 21006, a user interface 21010, and a sensor (s) 21004. The motor 21006 is such that the motor 21006 has a first open configuration with the jaw of the end effector 21008 (eg, anvil 150306 and / or channel 150302 of the surgical instrument 150010 shown in FIG. 25) as discussed with respect to FIG. It is coupled to the end effector 21008 so that it transitions to and from the second closed configuration. The sensor (s) 21004 may be communicably coupled to control circuit 21002 so that control circuit 21002 receives data and / or signals. The control circuit 21002 may be communicably coupled to the motor 21006 so that the control circuit 21002 controls the operation of the motor 21006 according to, for example, the data and / or the signal received from the sensor (s) 21004. The user interface 21010 includes a device configured to provide feedback to the user of a surgical instrument such as a display or speaker.

In various aspects, the sensor (s) 21004 may be configured to detect compression parameters of tissue gripped by the end effector. In one aspect, the sensor (s) 21004 detect a force (FTC) for closing the jaw of the end effector 21008, i.e., a force applied to transition the jaw from an open configuration to a closed configuration. Can be configured as For example, the sensor (s) 21004 may include a motor current sensor configured to detect the current drawn by the motor, as discussed with respect to FIG. 12, FIG. 18 or FIG. In the case of a DC motor, the current drawn by the motor corresponds to the motor torque (eg, the torque of the output shaft of the motor 21006), which is typical of the FTC of the end effector 21008. When the end effector 21008 closes on the tissue, the FTC of the end effector 21008 represents the force transmitted from the end effector 21008 to the grabbed tissue, so that the FTC corresponds to the tissue compression of the grabbed tissue. are doing. The greater the force applied to the tissue, the more compressed the tissue will be. In another aspect, the sensor (s) 21004 are configured to receive an RF signal from the corresponding second electrode, as described in connection with FIGS. 36-38, on the end effector 21008. Includes a first electrode located in. The electrical impedance of the tissue can correspond to the thickness of the tissue, and the thickness of the tissue can correspond to the tissue compression of the seized tissue. In yet another embodiment, the sensor (s) 21004 includes a force-reactive transducer configured to determine the amount of force applied to the sensor (s) 21004 as discussed with respect to FIG. .. Similar to the above discussion with respect to FTC, when the end effector 21008 closes on the tissue, the force detected by the transducer represents the force transmitted from the end effector 21008 to the seized tissue. The greater the force applied to the tissue, the more compressed the tissue will be. The user interface 21010 includes a device configured to provide feedback to the user of a surgical instrument such as a display or speaker. In yet another aspect, the sensor (s) 21004 are a variety of sensors described above and other such sensors capable of detecting compression parameters associated with tissue gripped by the end effector. May include combinations. For example, an end effector such as the end effector 15200 shown in FIG. 53 can include a first sensor 152008a with a force-reactive transducer and a second sensor 152008b with an impedance sensor.

The control circuit 21002 may be configured to adjust the jaw closure rate of the end effector 21008 to accommodate different tissue types. The control circuit 21002 monitors the compressive force exerted on the tissue (eg, FTC) or another parameter associated with tissue compression (eg, tissue impedance) over the initial compression period (eg, tissue impedance) and tissue compression. It may be configured to appropriately adjust the closing rate or time of the jaw based on the rate of change of the parameters. For example, as discussed above with respect to FIG. 22, instead of applying the total compressive force in a short period of time, in the case of more viscoelastic tissue, slowing the closing rate or increasing the closing time. Can be beneficial.

FIG. 96 shows a logical flow diagram of process 21050 for controlling surgical instruments according to the integrity of the grasped tissue, according to at least one aspect of the present disclosure. See also FIG. 95 in the following description of process 21050. The illustrated process can be performed, for example, by the control circuit 21002 of the surgical instrument 21000. Therefore, the control circuit 21002 that executes the process receives data and / or signals (eg, digital or analog) from the sensor (s) 21004 associated with the tissue compression parameters sensed thereby 21052. In various aspects, the tissue compression parameters are the parameters associated with the characteristics, types, characteristics and / or conditions of the tissue being operated on, the internal movements and / or the parameters associated with the characteristics of the surgical instrument 21000 or the parameters thereof. It can contain constituents. In one aspect, the tissue compression parameters may include, for example, the FTC of the end effector 21008. In another aspect, the tissue compression parameters may include, for example, the thickness of the gripped tissue. The control circuit 21002 can subsequently correlate data on tissue compression parameters as one or more discrete values, associated values (s) transmitted by the sensor (s) 21004. Possible) 21052 capable of receiving the signal transmitted by 21004.

Therefore, the control circuit 21002 compares the value of the sensed tissue compression parameter with one or more thresholds and then determines how to generate a response accordingly. In one aspect, the control circuit 21002 determines the value of the sensed tissue compression parameter against a first threshold 21054. For example, control circuit 21002 can determine whether the sensed tissue compression parameter is greater than or greater than the first or upper threshold. 21054. In one aspect, if the sensed tissue compression parameter exceeds the first threshold, process 21050 proceeds along the branch of yes and control circuit 21002 controls motor 21006 to 21056, jaw of end effector 21008. Increase the length of time to close. The control circuit 21002 may, for example, reduce the rate at which the jaw is closed, increase the length of time that jaw movement is paused after initial gripping of tissue (ie, tissue creep latency), or 21056 can control the motor 21006 to increase the jaw closure time by lowering the stabilization threshold for ending the gripping step. If the sensed tissue compression parameters do not exceed the first threshold, then process 21050 proceeds along a no-branch, and in various embodiments, process 21050 can be terminated or process 21050 continues. The control circuit 21002 can also compare the sensed tissue compression value with one or more additional thresholds or 21052 to continue receiving tissue parameter data and / or signals.

In another aspect, control circuit 21002 further determines the value of the sensed tissue compression parameter against a second threshold 21058. For example, control circuit 21002 can determine if the sensed tissue compression parameter is less than or less than the second threshold 21058. In one aspect, if the sensed tissue parameters are below the second threshold, process 21050 proceeds along the yes branch and control circuit 21002 provides corresponding feedback, eg, via user interface 21010. The 21060 feedback provided can include, for example, visual feedback provided via display or audio feedback provided by speakers. In one aspect, feedback may suggest that the user takes one or more corrective actions to improve the situation where the sensed tissue compression parameters are unexpectedly low. Such corrective action is, for example, an auxiliary reinforcement as disclosed in US Patent Application No. 8,657,176, entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER", which is incorporated herein by reference. It may include the use of materials (ie, tissue thickness correctors). Auxiliary reinforcements are configured to apply and / or apply additional compressive forces to the tissue trapped between the anvil 150306 (FIG. 25) and the staple cartridge 150304 (FIG. 25) in various embodiments. It can include a layer of compressible material or a series of layers.

The thresholds discussed above are, for example, the differential values of the parameters (s) 21004 sensed by the sensor (s) 21004 and / or the parameters (s) sensed by the sensor (s) 21004 (eg,). The rate of change of the sensed parameter over time) can be included. In embodiments where the tissue compression parameters include the FTC of the end effector 21008, the first threshold may indicate that the seized tissue is considered to be rigid above it. Hard tissue may be relatively susceptible to tearing, either by mechanical action of the jaw on the tissue or due to lung tissue undergoing re-expansion. In addition, the second threshold can indicate a description in which the gripped tissue is considered to have a weak shear strength (ie, soft). Tissues with low shear strength are held firmly in place by the end effector 21008 or another during stapling and / or firing of the cutting member (ie, the I-beam 150178 with the cutting edge 150182). It can be relatively difficult to hold in a way.

The steps of a particular embodiment of process 21050 in FIG. 96 are shown as occurring in a particular order or sequence, but such depictions are for illustrative purposes only and a particular sequence of particular steps. Note that no particular sequence of processes 21050 is intended unless is explicitly required from the above description. For example, in another aspect of process 21050, the control circuit 21002 has a second tissue compression parameter sensed before 21054 determines whether the sensed tissue compression parameter exceeds the first or upper threshold. , Or may determine if it falls below a lower threshold 21058.

FIG. 97 shows a first graph 21100 showing end effector FTC 21104 and time 21102 for exemplary launch of surgical instrument 21000 according to at least one aspect of the present disclosure. See also FIGS. 95-96 in the following description of the first graph 21100. The first graph 21100 shows the first launch 21110 and the second launch 21114 which are exemplary launches by the surgical instrument 21000 controlled by the control circuit 21002 performing the process 21050 described above with respect to FIG. In this exemplary example, the first threshold 21106 comprises a particular time change rate of FTC (ie, ΔFTC) and the second threshold 21108 comprises a particular FTC. In various aspects, the thresholds 21106, 21108 may be defined for one or more other variables, or programmed or set by the user of the surgical instrument 21000.

In the first firing 21110, the control circuit executes a process shown in FIG. 96 21002 determines that the tissue compression parameter data and / or receive signals 21052, FTC is below a second threshold value 21108 at time _{t 1} 21058. Therefore, the control circuit 21002 includes suggestions for the user to take a particular action and / or provides feedback to the user indicating that the end effector 21008 is gripping a tissue with low shear strength. In one aspect, the feedback 21060 provided is provided in a tissue corrector (eg, US Patent Application No. 8,657,176) added to the end effector 21008 to reinforce and / or correct low shear strength tissue. The tissue corrector described) can suggest that the user release the surgical instrument 21000 and re-launch it. In one aspect, the control circuit 21002 may be further configured to cause the motor 21006 to stop closing the jaw of the end effector 21008 if the FTC falls below a second threshold. In another aspect, the control circuit 21002 may be configured to suggest that the user ceases to close the jaw of the end effector 21008 if the FTC falls below a second threshold. The 21060 feedback provided is provided, for example, via a prompt displayed on the operating room display 107, 109, 119 (FIG. 2) and / or the surgical instrument display, a speaker located in the operating room and / or the surgical instrument. It can take various forms, including audible messages emitted, tactile feedback via surgical instruments, or combinations thereof.

For the second launch 21114 (which may be a launch that utilizes a tissue corrector after the first launch 21110), the control circuit 21002 that performs the process 21050 shown in FIG. 96 has tissue compression parameter data and /. Alternatively, it does not determine that the signal is received 21052, the FTC falls below the second threshold, or exceeds the first threshold at any point in the process of closing the end effector 21008. Therefore, the control circuit 21002 does not affect the closing speed of the jaw and provides feedback to the user or performs any other such operation.

FIG. 98 shows a second graph 21116 showing the berth time 21104 of the end effector FTC 21102 for exemplary launch of the surgical instrument 21000 according to at least one aspect of the present disclosure. See also FIGS. 95-96 in the following description of the second graph 21116. The second graph 21116 shows a third launch 21118, which is an exemplary launch by a surgical instrument 21000 controlled by a control circuit 21002 that performs the process 21050 described above with respect to FIG. In this exemplary embodiment, the first threshold 21106 comprises the rate of change of FTC over time (ie, ΔFTC).

In the third firing 21116, the control circuit 21002 to execute the process shown in FIG. 96, receives the tissue compression parameter data and / or signal 21052, DerutaFTC determines that exceeds a first threshold value 21106 at time _{t 2} 21058. Therefore, the control circuit 21002 controls the motor 21006 so as to increase the jaw closing time by, for example, reducing the jaw closing speed, 21056, and accordingly, the rate at which the FTC 21102 increases is also reduced. Increasing the jaw closure time may be beneficial to avoid causing damage to hard tissue, for example by preventing greater amounts of force from being applied to the tissue over a short period of time. In one aspect, the first threshold 21106 is the _{rate of change of the defined value of FTC (ΔFTC D} ), i.e., surgical instrument 21000 without any modification to FTC by control algorithms according to tissue type and other such parameters. Can include the specified value of or the baseline FTC ratio. In this aspect, if the FTC received by the surgical instrument 21000 _{exceeds FTC D} during the surgical procedure, the control circuit 21002 performing process 21050 may control the motor 21006 to increase the 21056 jaw closure time. it can.

During the firing stroke of the surgical instrument 21000, the time it takes for the control circuit 21002 to execute the algorithm or process described above to compare the parameters sensed by the sensor (s) 21004 with one or more thresholds is the firing stroke. It can include a series of separate examples in and / or consecutive time intervals during the firing stroke. The tissue compression parameters monitored by the control circuit 21002 and compared to the thresholds are, for example, the FTC value (eg, the second threshold 21108 shown in FIG. 97) or the ΔFTC value (eg, the second threshold shown in FIGS. 97-98). The threshold value of 1 106) can be included.

In one aspect, the control circuit 21002 stores data related to the launch of the surgical instrument 21000 and then optionally utilizes the data from the previous launch to align the tissue of the seized tissue. It may be further configured to adjust the algorithm for determining sex. For example, data from previous launches can be used to adjust the first and / or second thresholds for process 21050 shown in FIG. In one aspect, as described above under the heading "Situation Awareness", and in its entirety is incorporated herein by reference, entitled "SURGICAL HUB Situational AWARENSS", filed March 29, 2018. As described in U.S. Patent Application No. 15 / 940, 654, the surgical instrument 21000 is configured to be paired with a surgical hub 106 (FIGS. 1-3) that implements a situational awareness system. In some cases. In this aspect, the situational awareness system can adjust the algorithm for determining the type of tissue being operated on during the surgical procedure and accordingly determining the integrity of the tissue to be grasped. In another aspect, the surgical instrument 21000 may be configured to receive user input indicating the type of tissue being operated on and to adjust algorithms to determine tissue integrity accordingly. .. For example, the surgical instrument 21000 may be configured to adjust the first and / or second thresholds of process 21050 shown in FIG. 96 from defined values, depending on the type of tissue entered by the user.

With the techniques described above, the surgical instrument 21000 avoids damage to the tissue to be grasped and results from a jaw closure rate that is inappropriate or non-ideal for certain features of the tissue being operated on. It makes it possible to prevent malfunction (for example, molding failure staples). In addition, the techniques described herein improve the ability of surgical instruments to respond appropriately to the tissue features encountered during the course of the surgical procedure.

Initial contact with tissue to determine tissue type Gripping tissue at an improper closure rate or at an improper closure threshold results in damage to the tissue (eg, excessive tissue). Tissue may be torn by applying strong force to the staples and / or impaired movement by surgical instruments (eg, staples because the tissue is not fixed and held by the jaw when the staples are fired) Can be deformed). Thus, in some embodiments, the surgical instrument detects the features of the tissue held by the surgical instrument and accordingly the closure rate (s), closure threshold (s), and other movements. It is configured to adjust the parameters. In addition, each surgical procedure may include multiple different tissue types and / or tissues with different characteristics. Thus, in some embodiments, the surgical instrument is used each time the tissue is grabbed and the closure rate (s), closure threshold (s), and other operating parameters are adjusted accordingly. It is configured to dynamically detect the characteristics of.

The present disclosure provides at least one solution, in which the surgical instrument is gripped according to the degree of tissue contact with the surface of the jaw and the relative position of the jaw at the first point of contact with the tissue. It is structured to characterize the tissue type of the tissue. Jaw closure rates and thresholds for adjusting jaw closure rates are then set to appropriate levels for the type of tissue characterized by the degree of tissue contact detected and the position of the jaw detected. can do. For example, surgical instruments are configured to distinguish between soft tissue and blood vessels because the soft tissue contacts the surface of the jaw to a greater degree and the jaw at a larger angle at the initial contact point compared to the blood vessels. Can be done. The surgical instrument can then control the motor to affect the jaw closure rate and adjustment threshold, depending on the type of tissue detected.

With reference to FIG. 95 again, in one aspect, the surgical instrument 21000 includes a motor 21006, a user interface 21010, and a control circuit 21002 connected to a sensor 21004. The motor 21006 views the jaw of the end effector 21008 (eg, the anvil 150306 and / or the channel 150302 of the surgical instrument 150010 shown in FIG. 25) in a first, i.e., open configuration, as discussed with respect to FIG. The motor 21006 is coupled to the end effector 21008 so that it transitions to and from the second, ie closed configuration. The sensor (s) 21004 may be communicably coupled to control circuit 21002 so that control circuit 21002 receives data and / or signals. The control circuit 21002 controls the operation of the motor 21006 according to, for example, the data and / or signal received from the sensor (s) 21004, and the control circuit 21002 according to, for example, the data and / or signal received from the sensor load 21004. Can be communicably coupled to the motor 21006.

In various aspects, the sensor (s) 21004 may be configured to detect physical contact of tissue with the surface of the jaw of the end effector 21008. In one aspect, the sensor (s) 21004 can include one or more tissue contact sensors arranged along the tissue contact surface of the end effector 21008 such as anvils and cartridges or channels. The tissue contact sensors are, for example, along the surface of the jaw, each configured to determine if the tissue is positioned to hit it, as discussed above in connection with FIGS. 75-79. Can include multiple sensors or segments of segmented circuits arranged in succession. In one aspect, the sensor (s) 21004 are each configured to receive RF signals from corresponding electrodes located on opposite jaws, as discussed with respect to FIGS. 36-head 38. including. Therefore, the control circuit 21002 performs a continuity test along the length of the end effector 21008 so that the tissue is at a position corresponding to each electrode capable of receiving a signal from its corresponding electrode. It can be determined (because the signal transmission medium, i.e., the tissue must be placed between the electrodes in order to receive the signal from its corresponding electrode). In another aspect, the sensor (s) 21004 are each configured to determine the amount of force applied to the sensor (s) 21004, as described with reference to FIG. 24. Includes reactive transducer. Therefore, the control circuit 21002 can determine that the tissue is at a position corresponding to each force-reactive transducer that detects a non-zero force against it. In another aspect, the sensor (s) 21004 include a plurality of load cells, pressure sensors, and / or other sensors configured to detect physical contact with them. Similar to the above discussion of force-reactive transducers, the control circuit 21002 determines that the tissue is in a position corresponding to each load cell, pressure sensor, and / or other sensor that detects a non-zero force against it. can do. In yet another aspect, the sensor (s) 21004 include a current sensor configured to detect the amount of current drawn by the motor 21006, as discussed with respect to FIGS. 12, 18 or 19. Thus, the control circuit 21002 is described with respect to FIG. 83 (ie, FTC increases as the jaw grips tissue, 153610, 153616, FTC corresponds to motor current), motor 21006. The jaw of the end effector 21008 first compensates for the increased gripping load that the motor 21006 incurs when the jaw comes into contact with the tissue as the current drawn by it increases and begins to exert gripping force on it. The point of contact with the tissue can be determined. The various embodiments described above are individually or in combination with other embodiments to determine the initial point of contact between the end effector 21008 and the tissue being gripped and / or the degree of contact between the tissue and the end effector 21008. It can be used in combination.

FIG. 99 shows a logical flow diagram of Process 21200 for controlling surgical instruments according to the physiological type of grabbed tissue, according to at least one aspect of the present disclosure. See also FIG. 95 in the description of Process 21200 below. The illustrated process can be performed, for example, by the control circuit 21002 of the surgical instrument 21000. Therefore, the control circuit 21002 that executes the illustrated process 21200 receives tissue contact data and / or signals from sensors (s) 21004, such as the tissue contact sensors discussed above and depicted in FIGS. 100A-101B. 21202 to do. The 21202 tissue contact data and / or signal received indicates whether the tissue is in contact with at least one of the sensors 21004. Therefore, the control circuit 21002 can determine the initial contact point between the end effector 21008 and the held tissue 21204. In one aspect, the control circuit 21002 determines when initial tissue contact occurs by detecting when at least one of the sensors 21004 located on each of the jaws detects tissue contact hitting it 21204. ..

Therefore, the control circuit 21002 determines the position of the jaw at the initial tissue contact point 21206. In one aspect, the control circuit 21002 is configured to detect the relative position of a corresponding magnetic element disposed on the opposing jaw, as discussed with reference to FIG. 77, of the jaw of the end effector 21008. It is communicably coupled to a Hall effect sensor located above one of them. Therefore, the control circuit 21002 can determine the position of the jaw according to the sensed distance or the gap between them 21206. In another aspect, the control circuit 21002 is driven from a first position or proximal position to a second or distal position, as discussed with respect to FIGS. 20-21 and 25. It is communicably coupled to a position sensor configured to detect the absolute or relative position of a closed tube configured to close the jaw. Therefore, the control circuit 21002 can determine the position of the jaw according to the sensed position of the closed tube 21206. In yet another embodiment, the control circuit 21002 is communicably coupled to an angle sensor such as the TLE5012B 360 ° angle sensor from Infineon Technologies configured to detect the angle at which at least one of the jaws is oriented. .. Therefore, the control circuit 21002 can determine the position of the jaw according to the sensed angle at which the jaw (s) are oriented 21206.

Therefore, the control circuit 21002 determines the degree of contact between the gripped tissue and the tissue contact surface of the jaw 21208. The degree of tissue contact can correspond to the number or proportion of sensors 21004 that have detected the presence (or absence) of tissue as discussed with respect to FIG. 79. In one aspect, the control circuit 21002 can determine the degree of tissue contact according to the ratio of the sensor (s) 21004 that detected the presence of tissue to the sensor (s) 21004 that did not detect the presence of tissue. ..

Therefore, the control circuit 21002 sets control parameters for the motor 21006 according to the determined jaw 21206 position and the determined tissue contact degree 21208. Motor control parameters can include, for example, the time and / or closing threshold for closing the jaw. In one aspect, the control circuit 21002 sets motor control parameters (eg, jaw closure rate and closure threshold) associated with a particular position of the jaw and a particular degree of tissue contact sensed through various sensors. It can be configured to access memory (eg, a lookup table) to retrieve. In various embodiments, the control circuit 21002 adjusts the rate at which the jaw transitions from the open position to the closed position, eg, after the initial grip of the tissue (ie, tissue creep latency). The motor 21006 can be controlled to adjust the jaw closure time by adjusting the length of time that the chin is rested and / or by adjusting the stabilization threshold to finish the gripping step. In various embodiments, the closure threshold (s) can be, for example, the control circuit 21002 stopping the motor 21006 driving jaw closure, or, for example, the "compression factor for determining tissue integrity". As discussed above under the heading, it may include the maximum acceptable FTC end effector 21008 or rate of change for FTC (ie, ΔFTC) that takes other actions. The control circuit 21002 can then control the motor 21206 according to the motor control parameter set 21210 by process 21200.

The position of the jaw at the initial point of contact with the tissue and the degree of contact with the tissue correspond to the thickness or geometry of the tissue to be grasped, which corresponds to the physiological type of tissue. There is. Therefore, the control circuit 21002 may be configured to distinguish between tissue types and then appropriately set control parameters for motor 21006. For example, the control circuit 21002 may be configured to determine if soft or vascular tissue is gripped by the end effector 21008 and then set motor control parameters appropriate for the type of tissue detected 21210.

In some embodiments, the jaw closure rate can be selected for each tissue type to maintain maximum FTC and / or ΔFTC below specific closure thresholds, specific closure. Thresholds can also be selected for each tissue type. In one aspect, the control circuit 21002 may be configured to set a minimum grip ratio so that the jaw closure movement is not permanently stopped. In one aspect, the control circuit 21002 may be configured to control the maximum rest time to ensure that jaw closure proceeds at at least a defined rate. In one aspect, the control circuit 21002 shuts down the motor 21006 and / or provides feedback to the user if the closure threshold (s) is exceeded or otherwise stuck during use of the surgical instrument 21000. Can be configured to.

The steps of a particular embodiment of process 21200 of FIG. 99 are shown as occurring in a particular order or sequence, but such depictions are for illustrative purposes only and the particular sequence of the particular steps It should be noted that no particular sequence of processes 21200 is intended unless explicitly required from the above description. For example, in another aspect of process 21200, control circuit 21002 can determine the degree of tissue contact before 21206 that determines the position of the jaw at the initial contact point.

100A-101B show various side elevations of the end effector 21008 gripping the soft tissue 21030 and the blood vessel 21032, both in the initial contact position with the tissue and in the closed position, according to at least one aspect of the present disclosure. Shown. In the illustrated embodiment, the end effector 21008 includes a plurality of tissue contact sensors 21016 arranged along the tissue contact surface of the jaw, including anvil 21012 and channels 21014. In another aspect, the tissue contact sensor 21016 may be placed along the channel 21014 of the surgical instrument 21000, or instead, along the cartridge 150304 (FIG. 25). For brevity, the tissue contact sensor 21016 is discussed as being arranged along channel 21014 in the following description. However, it should be noted that the concepts discussed herein apply similarly to aspects in which the tissue contact sensor 21016 is placed along the cartridge 150304. Tissue contact sensors 21016 can include, for example, impedance sensors, load cells, force-reactive transducers, and combinations thereof, as discussed above. The tissue contact sensor 21016 is used as an actuating sensor 21018 (ie, a sensor that senses the presence of tissue) and a non-actuating sensor 21020 (ie, a sensor that does not sense the presence of tissue) when using the surgical instrument 21000 in a surgical procedure. Can be shown visually.

100A and 101A show the initial contact points of the end effector 21008 with substantially soft tissue 21030 and blood vessel 21032, respectively. In one aspect, the initial point of contact between the end effector 21008 and the tissue can be defined as the presence of at least one actuation sensor 21018 on both the anvil 21012 and the channel 21014. As mentioned above, the type of tissue can be distinguished according to the location of the jaw (ie, anvil 21012 and / or channel 21014) and the degree of contact with the jaw at the initial contact point between the tissue and the tissue. For example, FIGS. 100A and 101A show how soft tissue 21030 and blood vessel 21032 can be distinguished based on the proportion of actuation sensor 21018 at the initial tissue contact point. That is, gripping the blood vessel 21032 results in a smaller number of sensors 21018 being activated, whereas gripping the soft tissue 21030. It should be further noted that the number of activated tissue sensors 21018 on the anvil 21012 and the number of activated tissue sensors 21018 on the channel 21014 do not have to be equal at the initial tissue contact point. As a further example, FIGS. 100A and 101A show how soft tissue 21030 and blood vessel 21032 can be distinguished based on the angle at which anvil 21012 is oriented with respect to channel 21014 at the initial tissue contact point. .. That is, the anvil 21012 is oriented at a first angle θ _{1 at the initial contact point with the soft tissue 21030 and at a second angle θ 2} at the initial contact point with the blood vessel 21032. The difference in the proportion of the sensors 21018 activated and the difference in the angle at which the anvil 21012 is oriented can be used individually or in combination (eg, by process 21200 shown in FIG. 99) of the tissue being gripped. Physiological types can be characterized, and then appropriate jaw closure rates, closure thresholds, and other motor control parameters for tissue type can be set.

100B and 101B show the positions where the end effector 21008 completely grips the soft tissue 21030 and the blood vessel 21032, respectively. As can be seen there, the type of tissue and / or the physics of the tissue also utilizes changes in the number or proportion of working and non-working sensors 21018 as the end effector 21008 grips the tissue. The characteristics, the degree to which the tissue is compressed, and / or the distance between the anvil 21012 and the channel 21014, and various other parameters can be determined. For example, the blood vessel 21032 deforms more than the soft tissue 21030 when fully gripped, whereby the number of sensors 21018 activated when the end effector 21008 grips the blood vessel 21032 is relatively large. It will change. In some embodiments, the control circuit depends on the change or rate of change in the number of sensors 21018 that is activated when gripping the end effector 21008, the type of tissue (ie, the type of physiological tissue or a particular physical feature). Can carry out the process of determining (the organization that has). In some embodiments, the control circuit performs a process of determining the degree to which the tissue is compressed and / or deformed according to a change or rate of change in the number of sensors 21018 that is activated when gripping the end effector 21008. Can be done.

In some embodiments, the surgical instrument 21000 includes a control circuit 21002 that performs the process 21200 described in FIG. 99, when the control circuit 21002 determines that the jaw 21013 is first in contact with the tissue. Circuit 21002 may be configured to detect or measure the distance θ between the jaws and the length or degree L of tissue contact between the tissue and the jaw. The closure threshold (eg, FTC threshold or ΔFTC threshold), initial closure rate, and adjusted closure rate (s) (ie, closure rate at which jaw 21013 is closed after exceeding the closure threshold (s)) It can be a function of θ and L, respectively. As shown in FIGS. 100A-100B, at the initial contact point with the first tissue (eg, soft tissue 21030), the jaw gap _{can be defined as θ 1,} and the degree of tissue contact is L. It can be defined as _1. As shown in FIG 101A～B, second tissue (e.g., vascular 21032) at the initial point of contact with, separation of the jaws may be defined as theta _2, the degree of tissue contact, _{L 2} Can be defined as. Therefore, in _{some embodiments of θ 1} > θ ₂ and L ₁ > L ₂ , the soft tissue FTC threshold FTC _p > vascular FTC threshold FTC _v , and the soft tissue ΔFTC threshold ΔFTC _p > vascular gradient threshold ΔFTC _v , And blood vessel initial closure rate v _V1 > soft tissue initial closure rate v _P1 . Functional differences between these thresholds are discussed in more detail below with respect to FIGS. 102-103.

FIG. 102 shows the end effectors FTC 21304 and closure speed 21306, respectively, and the first graph 21300 and time 21308 for exemplary launch of a surgical instrument 21000 gripping soft tissue 21030, according to at least one aspect of the present disclosure. The second graph 21302 is shown. In the following description of the first graph 21300 and the second graph 21302, reference should be made to FIGS. 95 and 99-100B. The exemplary launches described herein are for the purpose of demonstrating the concepts discussed above in connection with FIGS. 95 and 99-100B and are to be construed as limiting in any way. Should not be.

The first launch of the surgical instrument 21000 can be represented by a first FTC curve 21310 and a corresponding first velocity curve 21310 showing changes in FTC and closure speed over time during the process of the first launch. .. The first launch can represent, for example, a defined launch of the surgical instrument 21000, or a surgical instrument 21000 that does not include a control circuit 21002 that performs the process 21200 shown in FIG. When the launch of the surgical instrument 21000 is started, the control circuit 21002 controls the motor 21006 to start driving the anvil 21014 from its open position and sets the closing speed of the anvil 21012 to the initial or specified closing speed v _d1. 21318 to surge to. When the anvil 21012 is driven from the open position, it contacts the gripped tissue, which is the soft tissue 21030 for this particular launch. When the anvil 21012 comes into contact with the tissue being held at _{time t 0 , the FTC increases at time t 1 from} the initial FTC (eg, zero) to peak 21314 21312. At time _{t 1,} the control circuit 21002 of the surgical instrument 21000, determines that the FTC FTC threshold (e.g., possible an independent prescribed value threshold of the type of tissue) are to has been reached or exceeded, the motor 21320 controls the 21006 to stop the movement of the anvil 21012, reducing the closing speed to zero. Movement of the anvil 21012 may be paused for the duration _{p 1,} 21322 while the closing speed will be maintained at zero. During rest, FTC gradually decreases as the seized tissue relaxes 21316.

The second launch of the surgical instrument 21000 is represented by a second FTC curve 21324 and a corresponding first velocity curve 21324'showing changes in FTC and closure speed over time during the process of the second launch. be able to. In contrast to the first launch, the second launch can represent, for example, the launch of a surgical instrument 21000 that includes a control circuit 21002 that performs the process shown in FIG. When the launch of the surgical instrument 21000 is initiated, the control circuit 21002 controls the motor 21006 to start driving the anvil 21014 from its open position, rapidly increasing the closing speed of the anvil 21014. Due to the relative thickness and / or geometry of the soft tissue 21030, the initial contact point between the tissue (ie, the soft tissue 21030) and the jaw 21013 occurs shortly after the anvil 21012 begins to be driven by the motor 21006. Therefore, the control circuit 21002 that executes the process 21200 shown in FIG. 99 determines almost immediately that the soft tissue 21030 is being gripped, and correspondingly, the time for closing the jaw, the closing threshold ( Multiple), and other closure parameters can be set relatively early in the closure process. Therefore, the control circuit 21002 controls the motor 21006, the closing speed of the anvil 21014, is rapidly soft tissue 21320 to specific initial closing speed _{v p1} 21336.

When the anvil 21012 is driven from the open position, it contacts the gripped tissue, which is the soft tissue 21030 for this particular launch. When the anvil 21012 comes into contact with the tissue _{held at time t 0} , the FTC increases from the first FTC (eg, zero) to the first peak 21328 at _{time t 2 21326.} The FTC increases over time in the second launch compared to the first launch, which is 21326, which means that the control circuit 21002 that executes process 21200 is grabbed in the second launch. This is to select a first, i.e., initial closure velocity v _p1 , suitable for the type of tissue present, which reduces the amount of force exerted on the tissue compared to the unmodified launch of the surgical instrument 21000. Please note that. At time _{t 2} set, the control circuit 21002 of the surgical instrument 21000, FTC is the FTC threshold FTC _p (control circuit 21002, when soft tissue 21030 was determined to be gripped, or after _{t 0,} the control circuit 21002 It is determined that the result has been reached or has been exceeded. The soft tissue FTC threshold FTC _p can represent, for example, the maximum force that can be safely or desirablely exerted on the soft tissue 21030. Therefore, the control circuit 21002 controls the motor 21006 to stop the movement of the anvil 21012 and reduce the closing speed to zero 21338. Movement of the anvil 21012 may be paused for the duration _{p 2,} 21340 while the closing speed will be maintained at zero. During rest, FTC gradually decreases as the seized tissue relaxes 21330. The rest duration p ₂ can be equal to the default rest duration (eg, p ₁ ) or closure parameter selected by control circuit 21002 for soft tissue 21030.

After the pause duration p ₂ elapses at time t ₃ , control circuit 21002 re-engages motor 21006 and resumes closing anvil 21012. Therefore, the closing speed, the 21342 to increase to a second closing speed _{v p2.} In some embodiments, after the soft tissue FTC threshold FTC _p is first exceeded, the control circuit 21002 reduces the closing rate at which the anvil 21012 is closed to a second closing rate v _p2 specific for the soft tissue 21030. In this case, v _p2 <v _p1 . The control circuit 21002 can be configured to close the anvil 21012 at a lower rate after the soft tissue FTC threshold FTC _p is exceeded, because it is more than predicted for the type of tissue detected. This is because the tissue may be thicker or otherwise more resistant to the closing force from the anvil 21012. Therefore, it may be desirable to reduce the closing rate in an attempt to reduce the amount of closing force subsequently exerted on the tissue being held.

The anvil 21012 resumes the closure at time _{t 3,} FTC begins to increase again until a time _{t 4} reaches 21332, reaches or exceeds it again soft tissue threshold FTC _p. At time _{t 4,} the control circuit 21002 of the surgical instrument 21000, determines that the FTC is greater than or has reached the FTC threshold FTC _p. Therefore, the control circuit 21002 causes the motor 21006 to stop the movement of the anvil 21012 and reduce the closing speed to zero 21346. Movement of the anvil 21012 may be paused for the duration _{p 3,} 21348 while the closing speed will be maintained at zero. During rest, FTC gradually decreases as the seized tissue relaxes 21334.

FIG. 103 shows the end effectors FTC 21354 and closure speed 21356 for exemplary launch of a surgical instrument 21000 gripping blood vessel 21032, and a third graph 21350 and 4 showing time 21358, respectively, according to at least one aspect of the present disclosure. Graph 21352 is shown. 95, 99, 101A-101B should also be referred to in the following description of the third graph 21350 and the second graph 21352. The exemplary launches described herein are for the purpose of demonstrating the concepts discussed above with respect to FIGS. 95, 99, 101A-101B and should be construed as limiting in any way. is not it.

The third launch of the surgical instrument 21000 is represented by a third FTC curve 21360 and a corresponding first velocity curve 21360', which indicates changes in FTC and closure speed over time during the process of the third launch. be able to. The third launch can represent, for example, a defined value launch of the surgical instrument 21000, or a launch of the surgical instrument 21000 that does not include a control circuit 21002 that performs the process depicted in FIG. When the launch of the surgical instrument 21000 is started, the control circuit 21002 controls the motor 21006 to start driving the anvil 21014 from its open position and sets the closing speed of the anvil 21012 to the initial or specified closing speed v _d2. 21370 to surge to. The initial closing speed v _d2 may or may not be equal to or not equal to the initial closing speed v _{d1 in FIG.} When the anvil 21012 is driven from the open position, it moves for a period of time prior to contact with the seized tissue, which is the blood vessel 21032 for this particular launch. Note that this is in contrast to the firing of the surgical instrument 21000 holding the soft tissue 21030, as depicted in FIG. Since the vessel 21032 is relatively thin, the anvil 21012 generally needs to travel a certain distance before making initial contact with the vessel 21032, while the soft tissue 21032 is generally thicker than the vessel 21032 and therefore anvil. 21012 makes contact with blood vessel 21032 almost immediately. Therefore, the FTC is initially flat 21362 because the anvil 21012 moves for a period of time without contacting the tissue. When the anvil 21012 _{contacts the tissue at time t 0} , the FTC increases from the initial or flat 21376 FTC (eg zero) to a peak 21366 at _{time t 2 21364.} At time _{t 2,} the control circuit 21002 of the surgical instrument 21000, determines that the FTC FTC threshold (e.g., the tissue type possible in separate predetermined value threshold) are in has been reached or exceeded, the motor 21006 Stops the movement of the anvil 21012 and reduces the closing speed to zero 21372. 21374 movement of anvil 21012 for the duration _{p 4,} may be paused while the closing speed will be maintained at zero. During rest, FTC gradually decreases as the seized tissue relaxes 21368.

The fourth launch of the surgical instrument 21000 is represented by a second FTC curve 21375 and a corresponding first velocity curve 21375'showing changes in FTC and closure speed over time during the process of the second launch. Can be done. In contrast to the first launch, the fourth launch can represent, for example, the launch of a surgical instrument 21000 that includes a control circuit 21002 that performs process 21200 shown in FIG. When the launch of the surgical instrument 21000 is initiated, the control circuit 21002 controls the motor 21006 to start driving the anvil 21014 from its open position, rapidly increasing the closing speed of the anvil 21014. Due to the relative thinness and / or geometry of blood vessel 21032 (eg, compared to soft tissue 21030), the initial contact point between tissue (ie, blood vessel 21032) and jaw 21013 is that the anvil 21012 is motored 21006. Does not occur until driven for a certain period of time. Therefore, the control circuit 21002 that executes the process 21200 shown in FIG. 99 determines that the blood vessel 21032 is held until the closure process is performed over a period of time, and the jaw correspondingly. It is not possible to set the closure time, closure threshold (s), and other appropriate closure parameters. Since the anvil 21012 does not contact the thinner tissue of the blood vessel 21032 for a period of time, and thus the control circuit 21002 is unable to detect the type of tissue being held, the control circuit 21002 is anvil 21014. to surge the closing speed prescribed value velocity _{v d} like to control the 21386 motor 21006.

When the anvil 21012 is driven from the open position, the FTC is initially flat 21376 as the anvil 21012 moves over a period of time without contacting the tissue. The anvil 21012 contacts the tissue at the time _{t 0,} FTC increases from an initial FTC (e.g., zero) 21378. After contacting the blood vessel 21032, the control circuit 21002 performing the process 21200 shown in FIG. 99 can determine that the blood vessel 21032 is grasped, and correspondingly the jaw closure, closure threshold, and so on. And other closure parameters at that time in the closure process can be set. At time _{t 1,} the control circuit 21002 is, DerutaFTC is (when the control circuit 21002 determines that vessels 21032 is gripped, _{t 0} or subsequently set by the control circuit 21002) DerutaFTC threshold DerutaFTC _v in It is determined that the value has been reached or exceeded. The blood vessel ΔFTC threshold ΔFTC _v can represent, for example, the maximum rate of change of force that can be safely or desirablely exerted on the tissue of blood vessel 21032. Therefore, the control circuit 21002 controls the motor 21006 to reduce the closing rate to _{a vessel closing rate v v1 specific for the vessel 2032 tissue, 21388, in this case v v1} <v _d .

The anvil 21012 is advanced in the lower vessel closure rate _{v v1,} FTC is 21,382 to peak at time _{t 3,} increased than ever 21380. At time _{t 3,} the control circuit 21002 is, FTC is (when the control circuit 21002 determines that vessels 21032 is gripped, _{t 0} or thereafter, is being set by the control circuit 21002) FTC threshold FTC _v in It is determined that the value has been reached or exceeded. The vascular FTC threshold FTC _v can represent, for example, the maximum force that can be safely or desirablely applied to the tissue of blood vessel 21032. Therefore, in the control circuit 21002, the motor 21006 stops the movement of the anvil 21012 and reduces the closing speed to zero 21932. 21394 movement of anvil 21012 for the duration _{p 5,} may be paused while the closing speed will be maintained at zero. During rest, FTC gradually decreases as the seized tissue relaxes 21384. The rest duration p ₅ may be equal to a defined value of rest duration (eg, p ₁ ) or closure parameter selected by control circuit 21002 for vessel 21032 tissue.

In summary, FIGS. 102-103 highlight how the surgical instrument 21000 works with and without the control circuit 21002 performing the process 21200 shown in FIG. 99.

FIG. 104 shows the end effectors FTC 21402 and closure speed 21404 for exemplary launch of surgical instruments, respectively, and a fifth graph 21400 showing time 21406, according to at least one aspect of the present disclosure. See also FIGS. 95 and 99-101B in the following description of the fifth graph 21400. The exemplary launches described herein are for the purpose of demonstrating the concepts discussed above in connection with FIGS. 95 and 99-101B and are to be construed as limiting in any way. Should not be.

The fifth launch of the surgical instrument 21000 is by a fifth FTC curve 21408 and a corresponding fifth velocity curve 21408', which indicates changes in FTC and closure speed over time during the process of the fifth launch. Can be represented. The fifth launch can represent, for example, the launch of a surgical instrument 21000 that includes a control circuit 21002 that performs the process depicted in FIG. When the launch of the surgical instrument 21000 is initiated, the control circuit 21002 controls the motor 21006 to start driving the anvil 21014 from its open position, the closing speed of the anvil 21014, which is at a particular closing speed. 21416 surges 21418 until flat. When the anvil 21012 closes, the FTC increases 21410 until it peaks at a peak 21412 at a particular time. From peak 21412, the FTC decreases until the tissue is fully seized 21414, at which point control circuit 21002 controls motor 21006 to stop the closure of the anvil 21012 and reduce the closure speed to zero 21420. ..

Thus, the fifth launch represents the launch of a surgical instrument 21000 that does not reach or exceed the FTC threshold, ΔFTC threshold, or any other closure threshold during closure of jaw 21013. In other words, the fifth launch remains within all control parameters during closure of jaw 21013. Therefore, the control circuit 21002 causes the anvil 21012 to adjust the closing speed of the anvil 21012 or perform any other corrective action during the closure of the jaw 21013.

FIG. 105 shows a sixth graph 21422 showing end effectors FTC 21402 and time 21406 and closure speeds 21404 and time 21406 for exemplary launch of surgical instruments, according to at least one aspect of the present disclosure. See also FIGS. 95 and 99-101B in the following description of the sixth graph 21422. The exemplary launches described herein are for the purpose of demonstrating the concepts discussed above in connection with FIGS. 95 and 99-101B and are to be construed as limiting in any way. Should not be.

The sixth launch of the surgical instrument 21000 is represented by a sixth FTC curve 21424 and a corresponding sixth velocity curve 21424', which indicate changes in FTC and closure speed over time during the process of the sixth launch. be able to. The sixth launch can represent, for example, the launch of a surgical instrument 21000 that includes a control circuit 21002 that performs the process 21200 depicted in FIG. When the launch of the surgical instrument 21000 is initiated, the control circuit 21002 controls the motor 21006 to start driving the anvil 21014 from its open position, reaching the closing speed of the anvil 21014, which reaches a particular closing speed. 21432 to surge to. When the anvil 21012 closes, the FTC increases until it reaches a peak of 21428 at a particular time 21426. In this particular example, the operator of the surgical instrument 21000 chooses to open the jaw 21013 of the surgical instrument 21000 in order to readjust the tissue therein. Therefore, the closure rate is reduced until it reaches a negative closure rate, 21434, which means that the jaw 21013 is opened, eg, to facilitate the tissue being re-adjusted within the jaw 21013. Indicates that The closing speed then returns to zero, 21436, and the jaw 21013 stops. Correspondingly, when the jaw 21013 is released from the tissue, the FTC decreases to 21430.

FIG. 106 shows a seventh graph 21438 showing end effectors FTC 21402 and time 21406 and closure speeds 21404 and time 21406 for exemplary launch of surgical instruments, according to at least one aspect of the present disclosure. See also FIGS. 95 and 99-101B in the following description of the seventh graph 21438. The exemplary launches described herein are for the purpose of demonstrating the concepts discussed above in connection with FIGS. 95 and 99-101B and are to be construed as limiting in any way. Should not be.

The seventh launch of the surgical instrument 21000 is by a seventh FTC curve 21440 and a corresponding seventh velocity curve 21440', which indicates changes in FTC and closure speed over time during the process of the seventh launch. Can be represented. The seventh launch can represent, for example, the launch of a surgical instrument 21000 that includes a control circuit 21002 that performs the process 21200 depicted in FIG. When the firing of the surgical instrument 21000 is started, the control circuit 21002 controls the motor 21006 started to drive the anvil 21014 from its open position, the closing speed of the anvil 21014, to a first closing speed _{v 1} 21450 to surge. The anvil 21012 is closed, FTC is increased until the time _{t 1} 21442. At time _{t 1,} the control circuit 21002 includes, for particular physiological tissue type detected by the control circuit 21002 in accordance with the process 21200 depicted in Figure 99, DerutaFTC threshold DerutaFTC which may be either DerutaFTC threshold or DerutaFTC defined threshold value _{It is determined that the T} threshold is reached or exceeded. As another example, DerutaFTC _T, according to other sensed parameters, or in accordance with another algorithm, set by another process that is executed by another control circuit of the control circuit 21002 and / or surgical instrument 2100 You can also do it. For example, jaw closure proceeds within the operating parameters of process 21200 illustrated in FIG. 99, but another sensor and / or another process of surgical instrument 21000 is nevertheless held tissue. If it is determined in some way to deviate from the expected parameters (eg, the tissue is thicker or thinner than expected for a given tissue type), then the time to close jaw 21013 , Closing threshold, and other control parameters accordingly. In one embodiment, the second sensor detects thinner than tissue is expected at time t _1. Therefore, the control circuit 21002 (in this example, lower than the previous ΔFTC _T) new DerutaFTC _T Set, the control circuit 21002 determines subsequently reached at that time _{t 1,} or beyond which the ..

Therefore, the control circuit 21002 controls the motor 21006, 21452 reduces the closing speed of the anvil 21012 to the second closing speed _{v 2,} in this case _v 1> _{v 2.} From t ₁ , the decrease in closure rate will increase the FTC at a slower rate 21444. FTC increases until it reaches a peak of 21446 below the FTC threshold FTC _{T, then decreases after 21444.} Firing the seventh, since remains in all closed within the parameters after t _1, the closing rate, the tissue until is completely gripped, the second closing speed v ₂ is maintained at 21454, the control circuit 21002 is 21456, which controls the motor 21006 to stop the closure of the anvil 21012 and reduce the closure speed to zero.

FIG. 107 shows graph 21500 depicting impedance 21502 and time 21504 for determining when the jaw of a surgical instrument contacts tissue and / or staples, according to at least one aspect of the present disclosure. See also FIG. 95 in the description of the seventh graph 21438. As discussed above, sensors configured to detect the degree of compression of the tissue held by the end effector 21008 and / or to detect initial contact with the tissue (s). 21004 can include, for example, an impedance sensor. The impedance of the tissue impedance and / or the rate of change of the impedance detected by the impedance sensor (s) can be used to determine the state of the tissue being held. For example, it was detected impedance, if the impedance Z _OC indicating an open circuit condition with a plateau 21506, the control circuit 21002 that is coupled to the impedance sensor is in contact with the and / or tissue jaws are open It can be determined that there is no such thing. As another example, 21508 when a detected impedance decreases initially from the open-circuit impedance Z _OC, the control circuit 21002 that is coupled to the impedance sensor can be determined that the initial contact with the tissue is made. As another example, _{21510 when the detected impedance decreases from the open circuit impedance Z OC} , the shape of the impedance curve and time, and / or the rate of change of the detected impedance, the control circuit 21002 coupled to the impedance sensor. Can be used to determine the rate of tissue compression and / or the degree to which the tissue is compressed. As yet another example, when the detected impedance drops to zero 21512, the control circuit 21002 coupled to the impedance sensor states that the jaw of the end effector 21008 is in contact with a staple that shorts the impedance detection system. It can be determined.

(Example)
Various aspects of the subject matter described herein under the heading "Controlling surgical instruments according to perceived closure parameters" are described in the following examples.

Example 1-Surgical instruments include an end effector with a jaw that can transition between open and closed configurations. Surgical instruments further include a motor operably connected to the jaw. The motor is configured to transition the jaw between the open and closed configurations. Surgical instruments further include sensors configured to transmit at least one signal indicating tissue compression parameters associated with the tissue between the jaws. Surgical instruments further include control circuits connected to sensors and motors. The control circuit receives at least one signal, and when the jaw transitions from the open configuration to the closed configuration, determines the value of the tissue compression parameter based on at least one signal, and the value of the tissue compression parameter is the first. Increases the time for the motor to transition the jaw to the closed configuration, depending on whether it exceeds the threshold of, and provides feedback depending on whether the value of the tissue compression parameter falls below the second threshold. It is configured to do.

Example 2-The surgical instrument according to Example 1, wherein the tissue compression parameter comprises a force exerted by a motor to transition the jaw to a closed configuration.

Example 3-The surgical instrument according to Example 1, wherein the tissue compression parameters include the rate of change over time of the force exerted by the motor to transition the jaw to a closed configuration.

Example 4-The surgical instrument according to Example 1, 2 or 3, wherein the feedback comprises a proposal for an auxiliary reinforcement.

Example 5-The control circuit is configured to increase the time it takes for the jaw to transition to the closed configuration by reducing the speed at which the motor transitions the jaw to the closed configuration. The surgical instrument according to 3 or 4.

Example 6-The control circuit is configured to increase the time it takes to transition the jaw to the closed configuration by increasing the length of time the motor is paused when transitioning the jaw to the closed configuration. The surgical instrument according to Example 1, 2, 3 or 4.

Example 7-The control circuit is configured to increase the time it takes for the motor to transition to the closed configuration by lowering the stabilization threshold for stopping the transition of the jaw to the closed configuration. The surgical instrument according to Example 1, 2, 3 or 4.

Example 8-The surgical instrument comprises an end effector. The end effector comprises a jaw that can transition between open and closed configurations and one or more sensors that are located along the respective tissue contact surfaces of the jaw. One or more sensors are configured to detect contact with tissue. Surgical instruments further include a motor operably connected to the jaw. The motor is configured to transition the jaw between the open and closed configurations. Surgical instruments further include a control circuit connected to one or more sensors and a motor. The control circuit determines the initial contact point where the tissue contacts the tissue contact surface of the jaw, determines the distance between the jaws at the initial contact point, and determines the degree of contact between the tissue contact surface and the tissue. In order to make the motor transition the jaw to the closed configuration and the jaw to the closed configuration at a speed corresponding to the distance between the jaws at the initial contact point and the degree of contact between the tissue contact surface and the tissue. The motor is configured to adjust the speed at which the jaw transitions to the closed configuration, depending on whether the force exerted by the motor exceeds the threshold. The threshold corresponds to the distance between the jaws at the initial contact point and the degree of contact between the tissue contact surface and the tissue.

Example 9-1 The surgical instrument according to Example 8, wherein one or more sensors comprises a pressure sensor.

Example 10-1 The surgical instrument according to Example 8, wherein one or more sensors comprises an impedance sensor.

The surgical instrument according to Example 8, 9 or 10, wherein the distance between Example 11 and the jaw includes an angle between the jaws.

The surgical instrument according to Example 8, 9 or 10, wherein the distance between Example 12-jaw includes a gap between the jaws.

Example 13-Surgical instruments include end effectors. The end effector comprises a jaw configured to grip the tissue by transitioning between an open configuration and a closed configuration, and a contact sensor assembly configured to sense the tissue in contact therewith. Surgical instruments further include a position sensor configured to sense jaw configuration and a motor connected to the jaw. The motor is configured to transition the jaw between the open and closed configurations. Surgical instruments further include a contact sensor assembly, a position sensor, and a control circuit connected to a motor. The control circuit determines the initial contact point where the tissue contacts the jaw, determines the jaw configuration via the position sensor at the initial contact point, and the tissue and jaw at the initial contact point via the contact sensor assembly. The amount of tissue contact between the jaw and the jaw is determined, and the closing speed at which the motor transitions the jaw to the closed configuration is set according to the jaw configuration and the amount of tissue contact at the initial contact point. The closure threshold is set according to the configuration and the amount of tissue contact, and the motor is controlled according to the force exerted by the motor so as to transition the jaw to the closure configuration relative to the threshold.

Example 14-The surgical instrument according to Example 13, wherein the sensor assembly comprises a compression sensor.

Example 15-The surgical instrument according to Example 13, wherein the sensor assembly comprises an impedance sensor.

Example 16-The surgical instrument according to Example 13, 14, or 15, wherein the jaw configuration corresponds to an angle between the jaws.

Example 17-The surgical instrument according to Example 13, 14, or 15, wherein the jaw configuration corresponds to the gap between the jaws.

System for Adjusting End Effector Parameters Based on Preoperative Information Aspects of the present disclosure are presented for the adjustment of closure thresholds and closure rates performed by closure control programs performed by the control circuits of surgical instruments. , This adjustment is based on preoperative information. Adjustment of the closure threshold involves computer-mounted interactive surgical systems (one or more surgical systems 102 and cloud-based analytical medical systems such as Cloud 104, 204, which are referred to as Cloud 104 for clarity. It can be an example of execution of situation recognition by (including). For example, the closure threshold can be adjusted to a patient-specific closure threshold based on perioperative information received from the cloud 104 or determined by a surgical hub or surgical instrument. As used herein, perioperative information includes preoperative information, intraoperative information, and postoperative information.

Preoperative information refers to information received prior to performing surgery with surgical instruments, and intraoperative information is received during surgery (eg, while one step of surgery is being performed). Refers to information. Specifically, a computer-mounted interactive surgical system can determine or estimate end effector closure parameters such as appropriate end effector closure threshold and closure rate algorithms, especially for handheld intelligent surgical instruments. Such inferences can be based on contextual information related to the surgical procedure being performed and associated with the corresponding patient. The context information may include perioperative information or be determined based on that information. The surgical instrument may be any suitable surgical instrument described in the present disclosure, such as surgical instruments 112, 600, 700, 750, 790, 150010. For clarity, surgical instrument 112 is referenced.

Perioperative information, such as diseases and treatments diagnosed during the perioperative period, can affect the properties or characteristics of the tissue being treated by the surgical instrument 112. For example, a patient may have been previously diagnosed with cancer and may be receiving radiation therapy to treat the cancer. Therefore, this perioperative information indicates that the patient's tissue may have features of increased stiffness. However, currently applied closure control programs may not address this increased stiffness. Therefore, by using a closure control program to perform a surgical procedure according to a general closure rate algorithm, excessive compression of the patient's tissue can result in unnecessary trauma or damage to the tissue. In addition, intraoperative information may be analyzed during surgery, such as by identifying which of the multiple potential tissue types is being treated. Different types of tissue may also have different tissue characteristics, such as tissue stiffness. Therefore, changes in perioperative information may be used in place of or in addition to perioperative adjustment to perform intraoperative adjustment. In short, the closure control program does not believe that different closure rate thresholds should be applied depending on perioperative information such as tissue type, surgical procedure, and surgical steps already performed. ..

Surgical instruments may want to take into account the type of tissue in which the surgery is performed on the surgical instrument 112, as well as the various characteristics of such different tissue types. Specifically, the surgical instrument 112 effectively determines the type of tissue and the characteristics of that tissue type before and during the surgical operation by the clinician with the surgical instrument. May be desirable.

Thus, in some embodiments, a cloud-based analytical medical system (eg, computer-mounted interactive surgical system 100) is provided, in which perioperative information is treated according to the type of tissue to be treated and prior to treatment. It may be considered to determine the characteristics of the tissue. For example, the surgical procedure to be performed and other patient information can be an example of perioperative information obtained prior to the surgical procedure being performed. So far performed steps of surgery, other surgical histories, and changes in tissue type are examples of perioperative information that can be considered. In general, this perioperative information may be used with sensor signals indicating closure parameters for determining, estimating or adjusting end effector parameters (eg, closure rate of change and closure threshold) of surgical instrument 112. The end effector may be any end effector described in the present disclosure, such as end effectors 702, 151600, 150300, 151340, 152000, 152100, 152150, 152200, 152300, 152350, 152400, 153460, 153470, 153502. .. End effector 702 is referenced for clarity.

Analyzing perioperative information for situational awareness related to closure rate can be achieved in many ways. Based on perioperative information, control circuits such as surgical instrument control circuits 500, 710, 760, 150700 (discussed above in connection with FIGS. 12, 15, 17, and 29A-29B) , The closure rate of change and closure threshold input used in the selected closure control program can be adjusted. For clarity, control circuit 500 is referenced. The control circuit 500 can also select different control programs based on perioperative information. Additional or alternative, surgical hubs such as surgical hubs 106, 206 (referred to as surgical hub 106 for clarity) receive perioperative information from the cloud 104 or surgical instrument 112. You may. For example, the surgical hub 106 is from a cloud 104, or an initial tissue thickness measurement that is determined based on a tissue contact or pressure sensor (eg, as shown in FIG. 24) of the surgical instrument 112. The patient's electronic medical record (EMR) may be received.

The surgical hub 106 can then analyze the received perioperative information. Based on this analysis, the surgical hub 106 can then signal the surgical instrument 112 to adjust the closure rate of change and closure threshold inputs used in the selected closure control program. The surgical hub 106 can also instruct the surgical instrument 112 to select a different closure control program, such as by having the control circuit select a different control program. The choice of different control program may be based on the signal received from the hub 106 or the signal received by the surgical instrument 112 receiving the updated control program from the hub 106. Cloud 104 can also perform analyzes to adjust the closure rate and maximum threshold used. Specifically, the cloud 104 processor analyzes perioperative information to provide different suitable closure control programs that should be implemented, for example, to change inputs to the closure control program or by surgical instruments. The type and characteristics of the tissue can be determined for selection.

In this way, the surgical instrument 112 may be instructed by the cloud 104 (eg, via the hub 106) to apply a suitable closure rate algorithm and closure maximum threshold. Tissue types and characteristics may be further determined based on sensor signals indicating closure parameters. The sensor may be a tissue contact or pressure sensor, a force sensor, a motor current sensor, a position sensor, a load sensor, or the above-mentioned sensors 472, 474, 476, 630, 734, 736, 738, 744a to 744e, 784, 788, 152408, Other suitable sensors such as 153102, 153112, 153118, 153126, 153200, 153438, 153448, 153450a, 153450b, 153474 may be used. Reference is made to sensor 474 for clarity. The sensor 474 is configured to transmit a sensor signal indicating the parameters of the surgical instrument 112. Some types of perioperative information can be stored in the cloud 104 before determining the type and characteristics of the tissue. For example, the patient EMR can be stored in the memory of the cloud 104 (eg, a cloud database). In general, the surgical instrument 112, hub 106 or cloud 104 can analyze perioperative information to determine tissue type and situational awareness features.

Therefore, tissue types and characteristics determined based on perioperative information may be used to proactively adjust the closure rate and maximum threshold used. That is, the perioperative information can be used to predict more effective closure parameters (eg, end effector 702 parameters) so that the closure control program applied by the surgical instrument 112 can be applied to the tissue being treated. Closing rates and thresholds will be used that take into account patient-specific tissue characteristics and types. Therefore, by using the closure rate and threshold situational awareness described herein, the surgical instrument 112 applies the adjusted closure rate and threshold without overcompressing the tissue to be treated. Can be advantageously enabled. Excessive compression may also be due to the first and second jaw members of the end effector 702. The first and second jaw members may be, for example, the first jaw members 152002, 152152, 152154 and the second jaw members 152204, 152254, 152304. The first and second jaw members may also refer to anvils 716, 766 and staple cartridges 718, 768. For clarity, the first jaw member is referred to as 152002, while the second jaw member is referred to as 152204. The first jaw member 152002 and the second jaw member 152004 may define an opening in the end effector 702, which is defined as the distance between the first jaw member 152002 and the second jaw member 152004.

For example, if the opening of the end effector 702 is unnecessarily small, unnecessary tissue damage or trauma from overcompression can occur. Reducing or preventing such overcompression may be achieved by adjusting using perioperative information and / or sensor signals from sensor 474. Also, the compression applied during the initial closure parameter measurement is based on the load sensor 474 (measuring the closing force) and the position sensor 474 (measuring the position of the first jaw member 152002 and the second jaw member 152004). It can also be kept to a minimum. In general, the sensor 474 may be configured to measure the closing force exerted by the end effector 702 of the surgical instrument 112. In addition to proactively estimating tissue characteristics and types from perioperative information, one or more of the surgical instruments 112, hub 106 and cloud 104 are sensors (as shown in FIG. 12). The sensed measurements from 474 may be used to verify or make further adjustments to the closure force, closure rate, and closure threshold applied as needed. Specifically, a contact sensor can be used to determine the thickness of undeformed tissue. Also used by the load sensor 474 in combination with the position sensor 474 to determine the thickness of the tissue based on the closing forces applied to the respective positions of the first jaw member 152002 and the second jaw member 152004. May be done. These verifications or further adjustments can be performed preoperatively or intraoperatively.

Closed parameter situational awareness may be performed continuously. Therefore, the clinician or surgeon continuously provides perioperative information in order to properly adjust the closure parameters of the end effector 702 (eg, the closure control program) (eg, when the surgical procedure is performed). You may use it. Based on the clinician's history (eg, the surgeon's daily routine), for example, if the next step of the surgical procedure being performed is determined to involve vascular tissue, the perioperative information is used to determine the end effector. The closure parameters of 702 may be adjusted. In such situations, the situational awareness surgical instrument 112 may apply a closing force at a constant closing rate of change. Such perioperative information may also be used in conjunction with sensor signals indicating the closure parameters of the surgical instrument 112 to adjust the closure parameters of the end effector 702 (eg, control program closure rate of change and closure threshold). Good. Perioperative information, such as intraoperative information, may indicate that the patient has been previously treated with radiation therapy.

Based on this information, the control circuit 500 can estimate the increase in tissue stiffness, which is a characteristic of tissue that can be considered throughout the surgical procedure. In one embodiment, this increased tissue stiffness is used to supplement the sensor signal indicating tissue thickness so that adjustments to the more appropriate end effector 702 closure parameter values can be achieved. It may be period information. Perioperative information may also indicate that the surgical procedure applied is a lobectomy procedure, which can be determined from the data stored in the cloud 104. Based on the knowledge of lobectomy procedures, it may be specified that the types of tissue that can be treated (eg, stapled) include blood vessels, bronchial tissue, and soft tissue.

Therefore, based on perioperative information, the specific tissue type and characteristics of the tissue currently being treated by the surgical instrument 112 can be predicted or estimated prior to the initiation of therapeutic treatment of the tissue. For example, considering the initial tissue thickness (measured when the tissue currently being treated first contacts the end effector 702), along with treatment information, diagnostic information, and patient information, so far It may be possible to infer that the irradiated soft tissue is being treated. Since the type and characteristics of the tissue being treated can be contextually determined prior to the initiation of the surgical procedure, the closure control program implemented by the control circuit 500 of the surgical instrument 112 is prior to the initiation of the therapeutic procedure. Can be adjusted advantageously (eg, by changing the input parameters according to the estimated tissue type or characteristics) or (eg, by choosing a different control program). Specifically, the maximum tissue closure threshold may be lowered to address the stiffness and fragility of the irradiated soft tissue being treated. The maximum threshold can refer to the maximum closing force that can be applied, or the maximum closing rate of change. In addition, the closure algorithm of the closure control program may also be adjusted to apply a slower, more conservative closure rate based on the identification of the irradiated soft tissue.

It can also be determined whether the surgical instrument 112 is, for example, a staple fastening surgical instrument 112 suitable for irradiated soft tissue. A warning can be generated if the perioperative information indicates that the selected surgical instrument 112 is not suitable for its intended use. For example, if the tissue currently being treated is bronchial tissue and it can be estimated based on perioperative information that the inappropriate vascular stapled surgical instrument 112 has been selected, a warning will be given to the clinician. Will be generated. In general, the surgical instrument 112 may generate a warning based on a determined, predicted or estimated discrepancy between the surgical instrument type, perioperative information, and sensor signals. Moreover, as discussed above, intraoperative information can also be used for regulation throughout the surgical procedure. For example, the current process in total procedural surgery may treat hard bronchial tissue, which will typically result in a slower closing rate. Further adjustments can be made after the initial adjustment. Specifically, when additional intraoperative information (eg, perceived information) is analyzed and it is estimated that the closing force applied to the currently applied closure algorithm should be modified or adjusted. Further adjustments can be made during surgery to adjust the slower closure rate to the faster closure rate. Such adjustments may also be made post-surgery in certain circumstances.

Therefore, the closure rate and threshold can be beneficially adjusted based on the determined tissue type, tissue characteristics, and perioperative information before the initiation of the therapeutic procedure or during the therapeutic procedure. Therefore, this adjustment can advantageously avoid or minimize tissue damage due to excessive strain and facilitate proper formation of staples from the stapled surgical instrument 112.

108 and 109 show Graph 22000 showing various end effector closure threshold functions that can be used based on perioperative information and Graph 22100 showing a regulated end effector closure control algorithm according to various aspects of the present disclosure. Is. Graph 22100 has been enlarged in consideration of Graph 22000. In FIGS. 108 and 109, the gripping or closing force (FTC), which can be understood as the gripping force applied to the end effector 702, is on the y-axis 22002, 22102 of graphs 22000, 22100. It is shown. The elapsed time of the surgical cycle or the time spanning it is shown on the x-axis 2204, 22104. The x-axis 22004 in FIG. 108 shows, for example, that the cycle spans 13 seconds. In contrast, the x-axis 22104 in FIG. 109 is less than 2 seconds. As shown in FIG. 108, a defined value universal tissue closure threshold function ( _{denoted as FTC d} 22006) controls the closure of the end effector 702 of the surgical instrument 112 used in common surgical procedures. May be applied to.

Other thresholds that are more conservative than the default FTC _d 22006 are also shown in Graphs 22000, 22100. However, less conservative thresholds can be used. As _{represented by FTC L1} 22008 and FTC _L2 22010, a more conservative closure threshold can be used to reduce the closure force of the surgical instrument against a defined closure force function. FTC _L1 22008 and FTC _L2 22010 can be thresholds stored in the memory of the surgical instrument 112, hub 106 or cloud 104. Additional or alternative, FTC _d2 22006 can be dynamically regulated at a suitable time during the surgical cycle. The dynamic adjustment may be performed by control circuit 500, corresponding hub 106 or cloud 104. Also, graphs 22000, 22100 show the corresponding gradients of the different closure threshold functions FTC _d , FTC _L1 , and FTC _{L2 22006, 20108, 22010.} Since the closure threshold can change as a function of time in the corresponding surgical cycle, the gradient of the closure threshold may be constant throughout the surgical cycle or may change as needed.

In other words, the rate of change defined by a particular closure threshold function may vary between different time ranges in the surgical cycle. For example, a particular closure threshold function may define a relatively slow rate of increase at the beginning of the surgical cycle and a relatively fast rate of increase around the middle of the surgical cycle. The closed threshold functions ΔFTC _d 22106, ΔFTC _{L1 22108 and ΔFTC L2} 22110 are scaled in the figures of the functions FTC _d 22006, _L1 2208 and FTC _L2 22010 to illustrate the corresponding gradients of the closed threshold functions. In the aspect of FIG. 109, it can be seen that the gradient is constant, but the gradient can change as appropriate. The rate of change in closure can be adjusted according to the selected closure threshold function. An example of the adjustment is illustrated by the "x" in FIGS. 108 and 109 and is shown in a larger size scaled in view of graph 22100. In this example, the rate of change in closure as represented by lines 22012, 22112 is adjusted so that it does not exceed _{ΔFTC L2 22110.}

In one aspect, motors such as motors 482, 704a-704e, 754, 150082, 150714 of the surgical instrument 112 may move the first jaw member 152002 relative to the second jaw member 152004 of the end effector 702. it can. Motor 482 is referenced for clarity. The motor 482 may move or close the end effector 702 according to the rate of change in closure as represented by lines 22012, 22112 and according to the selected closure threshold. For this purpose, the control circuit 500 may adjust the current drawn by the motor 482 to change the speed or torque of the motor 482 based on a selected threshold. For example, in graphs 22000, 22100, the control circuit 500 has a time point "x" (as shown in the graph) so that the closure rate parameter of the surgical instrument 112 is varied _{to remain within the selected threshold FTC L2 22010.} Shows how the motor 482 can be adjusted. _{FTC L2} 22010, which may be a patient-specific threshold, may be selected and determined based on perioperative information.

The FTC thresholds 22006, 22008, 22010 shown in graphs 22000, 22100 may be parameters of different or identical closed control programs executed by control circuit 500. These closure control programs may be stored locally in the memory of the surgical instrument 112 or remotely on the hub 106 or cloud 104. In general, the closure threshold function defines how the closure threshold changes as a function of time in the cycle so that an instantaneously applicable closure threshold is indicated for any time point in the cycle. The closure threshold can define, for example, the maximum closure force that can be applied to close the jaw of the end effector, or the maximum rate of change of the closure force used. FIG. 108 shows that the threshold is used as the maximum rate of change of the closing force used. At selected time points on graphs 22000, 22100, lines 22012, 22112 plotted against time on x-axis 2204, 22104 and FTC on y-axis 2202, 22102 are jaws 152002 at that time in time. , Shows the momentary force applied to close 152004.

As indicated by line 22012, the applied force is increased with time from time zero to time t _1, then the increase rate is zero, then it reaches a constant ratio to reduce the force. A little before the time t _2, the reduction rate is very steep. After time t _2, the force applied to close the jaws begin to transition to zero ratios, then decreasing at a ratio of non-zero. As shown by line 22112 in graph 22100, the applied closing force for closing jaws 152002, 152004 increases from time zero to slightly before 0.5 seconds (shown on the x-axis 22104). ). At the time corresponding to the "x" on the graph 22100, the control circuit 500 may adjust the motor 482 to adjust the selected closure algorithm such that the rate of increase in closure is reduced. In this way, the motor 482 can be controlled by the control circuit 500 to remain within _{the selected patient-specific threshold ΔFTC L2 22110.} In addition, as shown in Graph 22100, after the time corresponding to the "x", the slower rate of increase in the applied closing force is at a constant rate.

In one aspect, the same total amount of FTC applied may be applied during the surgical cycle. However, the force applied to close the end effector may be applied in a more gradual or immediate manner, as needed. This is indicated by the rate of change represented by the rate of change in closure of lines 22012, 22112, etc. FIG. 109 shows that each of the three illustrated thresholds ΔFTC _d 22106, ΔFTC _{L1 22108 and ΔFTC L2} 22110 is scaled in the figures of _{FTC d} 22006, FTC _L1 2208 and FTC _L2 22010, in part. In the aspect of, ΔFTC _d 22106, ΔFTC _L1 22108 and ΔFTC _L2 22110 represent different closing threshold functions. In other words, the control circuit 500 may _{adjust from any one of the thresholds FTC d} 22006, FTC _L1 2208 and FTC _L2 22010 to the thresholds ΔFTC _d 22106, ΔFTC _L1 22108 and ΔFTC _L2 22110, which are in this situation. Is a completely different threshold.

As mentioned above, the gradient of the closure threshold function can change during a single surgical cycle. In such situations, the dynamic gradient can be adjusted consistently or individually throughout the surgical cycle. In general, the adjustment of the closure threshold parameter modifies the parameters of the current closure control program (eg, by the control circuit 500 that directly modifies the closure threshold function implemented by the control circuit 500) or an overall new closure. It can be achieved by switching to the control program. Switching or adjustment may be performed by control circuit 500, hub 106 or cloud 104 based on perioperative information. For example, the control circuit 500 can switch from the current control program to a second closed control program received from the cloud 104. The second closure control program may also be transmitted from the cloud 104 to the hub 106.

As mentioned above, one or more of the surgical instruments 112 used to treat tissue are used to determine and estimate the type and characteristics of tissue currently being treated therapeutically. Or, to predict, the corresponding hub 106 and cloud 104 can be used to receive, estimate or determine perioperative information. These closed situational awareness inferences and predictions are useful in adjusting the closed rate of change threshold. Thus, _{in addition to FTC d} 22006, ΔFTC _d 22106, graphs 22000 and 21000 can be shown, for example, in the closure algorithm used by the surgical instrument 112, eg, a second tissue closure rate of change threshold. The functions FTC _L1 2208 and ΔFTC _L1 22108 are also shown. That is, the surgical instrument 112 can adjust the input to the current closure control program or to a different control program executed by the control circuit 500. For example, the situational awareness surgical hub 106 can determine that the surgical procedure currently being applied is a lung surgical procedure based on a target area within the thoracic cavity. The thoracic cavity can then be estimated as the target area, for example, based on the aeration output from another device used in the operating room. Therefore, the type of tissue to be treated is determined to be lung tissue. Thus, the surgical instrument 112 can be adjusted to use the defined value closure threshold functions FTC _{L1 22008, 22108 for lung tissue from the thresholds FTC d 22006, 22106 previously used.} Such adjustments may be made during the surgical cycle spanning the y-axis 2204, 22104.

For example, a situational awareness surgical hub 106 can predict that a patient's lungs will contain relatively fragile tissue. Therefore, as shown in FIGS. 108 and 109, the closed threshold function can be adjusted to a lower FTC threshold function. The closure threshold can be, for example, the maximum permissible FTC value applied by the end effector, or the maximum permissible FTC rate of change. Inferences about the relatively high stiffness of lung tissue may be confirmed by other perioperative information. For example, the patient's EMR stored in the cloud 104 may be analyzed to determine that the patient has previously been diagnosed with cancer and is receiving radiation therapy. Using this type of preoperative information, it can be estimated that the tissue characteristics of lung tissue include relatively high firmness and significant fluid content (eg, the proportion of water in the tissue).

In addition to confirming initial predictions, perioperative information can also be used to adapt to inaccurate initial predictions. For example, the surgical instrument 112 may apply a suboptimal optimal closure algorithm based on the false assumption that the tissue is more flexible than it really is. In such situations, preoperative information in the patient history may be used as part of the correction for false assumptions. In general, perioperative information may be used in conjunction with sensor signals indicating closure parameters. Advantageously, the perioperative information can confirm the initial closure algorithm determined based on the sensor signal, or may be used to adjust the initial closure algorithm to a different and more suitable closure algorithm. .. For example, the sensor signal can indicate the relationship between the sensed applied closing force and the opening position of the end effector 702 (eg, the position of the first jaw 152002 with respect to the second jaw 152004). Such signals can be used to determine tissue stiffness and are used in conjunction with other perioperative information to adjust the closure algorithm before or during surgery. In some cases.

Therefore, graphs 22000, 22100 of FIGS. 108 and 109 show that the defined lung tissue threshold function FTC _L1 can be further adjusted based on patient-specific tissue characteristics. As shown in FIGS. 108 and 109, the surgical instrument can be further adjusted _{from the threshold function FTC L1} 22008 to FTC _L2 22010 or FTC _d 22006, for example, based on the patient's unique perioperative information. .. Therefore, adjustments may be made before or during the surgical procedure. Further, the adjustment may be made from FTC _d 22006 to FTC _L2 22010, or the threshold function FTCL2 22010, or the threshold function FTC _L2 22010 may simply be implemented directly. Adjustments in any of the available closure threshold functions are possible based on perioperative information.

108 and 109 can be adjusted to a lower threshold and can be adjusted to a higher threshold. The threshold functions shown in FIGS. 108 and 109 may correspond to a particular control process that may be implemented by a particular closure control program. Alternatively, the control process can accommodate different closure control programs. The control circuit 500 may, for example, directly modify the selected closure control algorithm itself or switch to a different closure control algorithm. That is, the closure threshold function of a particular closure control algorithm, or the closure threshold function for a particular applied closure rate of change represented by lines 22012, 22112, may be modified. Modification of the closure threshold function can be performed during the surgical procedure based on perioperative information. Also, the threshold function may be a function of some other parameter of time, or some other parameter in addition to time, such as the staple size used.

Additional or alternative, the regulation of closure may simply adjust the input to the closure threshold function. For example, if a tissue feature, such as tissue thickness, is an input to the closure threshold function, the perioperative information is used to modify the output closure threshold according to the input of the predicted or estimated tissue thickness. As such, the input may be corrected by prediction or by reasoning. Therefore, the applied closure threshold function can be modified based on perioperative information. As discussed above, the closed threshold function applied is defined by the closed control algorithm applied. Also, the applied FTC or closure force lines 22012, 22112 can be adjusted based on perioperative information.

In one aspect, the FTC or closure force lines 22012, 22112 represent the closure rate of change parameter of the corresponding closure control program executed by the control circuit 500. FTC lines 22012, 22112 are also defined by the closed control algorithm applied. In one aspect, the closing force applied can be dynamically adjusted during the cycle of surgical procedure performed, as indicated by the "x" in FIGS. 108 and 109. This dynamic regulation may also be a situational awareness application. In other words, perioperative information may be incorporated to estimate or predict adjustments to thresholds or threshold functions in surgical procedures. In this way, as shown in FIGS. 108 and 109, at the time or time corresponding to the "x" displayed in FIGS. 108 and 109, the applied FTC has a corresponding momentary closure. Adjusted or modified to stay within the threshold. In short, the closure control algorithm applied can include both the closure threshold function and the rate of change in closure, both of which can be adjusted based on perioperative information.

In general, adjustments to different closure thresholds or different closure threshold functions may be performed based on the determined, estimated or predicted characteristics or types of tissue being treated. As discussed above, tissue characteristics or types can be determined, estimated, or predicted based on perioperative information. Adjustments to another closure threshold can be understood as adjusting the maximum threshold relative to the maximum torque produced by the motor 482 of the surgical instrument 112, or the rate of change of the motor speed. Various examples of perioperative information can be used to determine, estimate or predict tissue type or tissue characteristics. For example, tissue water content, muscle properties, and vascular structure can affect applied closure rate algorithms, including closure thresholds. In one aspect, these properties, as well as other tissue types and tissue characteristic properties, are _{used to determine a defined closure threshold FTC D} 22006 or any other initial closure control program parameter.

Therefore, advanced vascular structure can be a characteristic of tissue used to estimate a defined value closure threshold function with a relatively low gradient. In addition to determining initial control program parameters, preoperative information such as applied surgical procedure and surgical history (eg, the typical routine of a clinician performing the procedure for the surgical process of the procedure) is used. If it is estimated that vascular tissue with a high hemoglobin content is targeted, then the rate of closure applied by the surgical instrument can be adjusted to be slower. Therefore, these properties can be used to determine control program parameters preoperatively and intraoperatively. Perioperative information may also be used to confirm that suitable vascular staplers are being used to treat vascular tissue.

FIG. 110 is a flow diagram 22200 of one aspect of adjusting the closure rate algorithm by the computer-mounted interactive surgical system 100 according to one aspect of the present disclosure. At step 22202, the current closure algorithm is determined. This may refer to determining the closure control program currently being executed by the control circuit 500 of the surgical instrument 112. As mentioned above in connection with FIGS. 108 and 109, current closure algorithms or control programs include closure threshold functions (eg, closure threshold parameters) and applied closure force (FTC) functions (eg, closure rate of change parameters). ) May be included. Flow FIG. 22200 proceeds to step 22204, where preoperative information is received and analyzed. As discussed above, preoperative information is on patient information EMR records stored in the hub or cloud, including initial tissue thickness based on tissue contact sensor 474, previous diagnosis and treatment. (Listed in), clinician history such as a surgeon's typical surgical routine, identified surgical instruments, and associated materials, as well as identified current surgical procedures. This preoperative information can be used in step 22206 to determine, estimate or predict tissue type or tissue characteristics.

For example, the initial tissue thickness before deformation as measured by the tissue contact sensor 474 can be used to determine the initial closure algorithm. Preoperative information, such as patient history of lung problems, may be used to determine that the current surgical procedure being performed is a chest procedure and the tissue type is lung tissue. This preoperative information can be further used to determine adjustments to the initial closure algorithm. Additional or alternative, non-therapeutic (or quasi-non-therapeutic) initial tissue compression measurements and closure member position measurements (eg, end effector first and second jaw positions) It can also be used in conjunction with previous information. The preoperative information of ventilation received from the ventilator in the operating room can be further used to infer that the current procedure is the thorax. Other preoperative information can also be used to further predict the particular chest procedure to be performed. For example, based on patient EMR records in the cloud indicating that the patient has cancer, it can be estimated in step 22206 that the chest procedure is lobectomy and the cancerous tissue in the lobe can be resected.

In addition, patient EMR records can further indicate that patient history indicates that the patient has previously received radiation therapy for cancer. In such situations, the irradiated lung tissue may be stiff, but it can be presumed or predicted, for example, to be susceptible to the application of unipolar RF energy by the surgical instrument 112. This is an example of presumed tissue characteristics. Inference that lobectomy is being performed may also determine that the tissue that can be stapled with the surgical instrument 112 includes blood vessels (PA / PV), bronchi, and soft tissue. At step 22208, adjustments to the current closure algorithm are determined and applied based on preoperative information. As discussed above, the closure threshold and applied FTC may be adjusted based on tissue type and tissue characteristics. For example, high tissue stiffness generally outputs a more conservative rate of change in the applied FTC (eg, as represented by FTC lines 22012, 22112) as well as a lower maximum threshold (eg FTC _L2). (As represented by 22010 and ΔFTC _L2 22110) may be required.

The maximum threshold may indicate a threshold at which the first and second jaw members 152002, 152004 are sufficiently positioned with respect to the surgical instrument 112 for firing the staples. Relatively thick tissue may, for example, correspond to a slower rate of change in closing force, and may, for example, generally correspond to a higher maximum closing threshold. The tissue type or structure may also be estimated based on the surgical procedure and clinician history determined in step 22208 to identify the regulation of other closure algorithms. For example, the clinician history of the treating surgeon may provide an example of treating a blood vessel first. The type and structure of the tissue can be presumed to be vascular lung tissue with a high blood content (ie, high vascular structure). Based on this estimated tissue type and characteristic information, it can be determined that adjustments to the slower applied FTC rate of change are beneficial. In summary, adjustments to the current closure algorithm are determined based on estimated information and applied in step 22208. Therefore, current surgery can be performed by a surgical instrument 112 that uses a regulated current closure algorithm.

The flow diagram 22200 then proceeds to determination operation 22210, in which determination operation 22210 determines whether any step of the identified surgical procedure remains. If there are no steps left (ie, the answer to determination action 22210 is no), flow diagram 22200 ends in some embodiments. However, if the answer to Judgment Action Operation 22210 is yes, further steps of surgical procedure remain. Therefore, the current state of Flow Figure 22200 is during surgery. In this case, the flow chart can proceed to step 22212 to receive and analyze intraoperative information. For example, intraoperative information may indicate that the type of tissue treated in this step of the surgical procedure is soft tissue. Specifically, the tissue can be presumed to be soft tissue, for example, based on the clinician's history. This inference can be made in conjunction with the measurements of the tissue contact sensor 474 and the measurements of the load sensor 474 and the closing member position. In addition, the clinician's history is that after an incision is made using a unipolar RF energy surgical instrument, the treating surgeon molds a lung fissure (a double fold of visceral folds that folds inward to cover the soft tissue of the lungs). It may indicate that it is completed as it is. In such situations, it may be presumed that the current process of surgery is soft tissue of the lung, based on a previously completed unipolar RF incision.

In addition, the surgical hub 106 may determine if the surgical instrument 112 used is, for example, a suitable stapler for firing into soft tissue. The measurements of the initial tissue contact sensor 474 are based on the tissue in contact with the lengths of the first and second jaw members 152002, 152004 when the end effector 702 is fully open (at the maximum jaw opening). , May indicate that the tissue is relatively thick, which can be consistent with soft tissue. In addition, the load sensor 474 for a closed member position measurement as represented by the closed portion as compared to the jaw opening curve may indicate a relatively high tissue stiffness. Such stiffness characteristics can be consistent with the irradiated soft tissue, a prediction that can be confirmed by reference to patient EMR data in the cloud. In this way, for example, in step 22212, the sensor signal and the perioperative information can be used together.

Based on this received and analyzed intraoperative information, it can be determined that further adjustment is required in the determination operation 22214. On the other hand, if the answer is no in the determination operation 22214, the flow chart returns to the determination operation 22210. When the answer in the determination operation 22214 is yes, it is presumed that the type of tissue and the characteristics of the tissue determine the characteristics of the tissue structure and hardness of the soft tissue in the same manner as described above in step 22206. The adjustment of the closure algorithm currently applied can then be determined and applied in step 22208. Specifically, the inference that hard and brittle soft tissues are being treated can result in a slower, more conservative adjustment of the closing force applied.

Therefore, the current closure algorithm can be adjusted to an algorithm that minimizes the closure threshold and rate of change. That is, the adjusted threshold may have a reduction in the maximum closing force threshold, a slower rate of change in the closing force, a reduction in the rate of change in the closing force threshold, or some combination or partial combination of the above. In situations where the clinician inadvertently exceeds the closure threshold, a waiting time can be provided, for example. Exceeding the closure threshold may require this waiting time, which may indicate that the tissue or compressed material is, for example, too thick to fire the staples. Therefore, the waiting time may allow some tissue material or fluid in the end effector 702 to drain or exit. During a suitable latency, it is determined that the tissue is properly compressed to achieve the proper end effector 702 configuration so that the stapled surgical instrument 112 can fire the staples. Adjusted closure algorithms are more conservative, so longer wait times can be used. However, it may be possible for the clinician to override this long waiting time or conservative regulated closure algorithm by manually choosing to use the faster gripping protocol on the surgical instrument 112. ..

When this modified closure algorithm is applied to soft tissue in step 22208, the flow diagram proceeds again to determination operation 22210. Here, the answer may be yes again, as there are remaining steps of the surgical procedure. For example, the lobectomy procedure can then proceed to the vascular stapling step. Again, in step 22212, intraoperative information is received and analyzed. For example, a surgical hub can determine that a clinician has selected a vascular stapler surgical instrument. Also, initial measurements from tissue contact sensor 474 may indicate that tissue contact occurs almost immediately during closure. In addition, tissue contact may be determined to cover a small area of the vascular stapler 112 or may be defined distal to the stapler 112. The measurements of the load sensor 474 may also indicate a conforming tissue structure. In addition, it can be presumed that the tissue may have a relatively low stiffness that can match the pulmonary vessels. In addition, the clinician's history may indicate that the treating surgeon uses the vascular stapler 112 for blood vessels as a step after completing the lung fissure. Thus, intraoperative information may be used, for example, along with closure parameter sensor signals to estimate tissue type and tissue characteristics. In particular, vascular tissue can be predicted to be treated based on the specific characteristics of the selected vascular stapler 112. The measured values of the initial tissue contact and load sensor 474 can confirm this initial prediction, for example.

As a result, it can be determined by the determination operation 22214 that further adjustment is necessary, whereby the flow diagram 22200 proceeds to step 22206. In step 22206, the tissue can be presumed to be vascular tissue with a relatively low tissue thickness and stiffness. Therefore, flow diagram 22200 proceeds to step 22208, where the previously applied conservative closure algorithm is adjusted to the normal closure algorithm. A normal closure algorithm may include a constant closure rate of change. Also, the closure threshold may be higher than the threshold used in the soft tissue control algorithm. In other words, conventional closure algorithms can reach higher maximum applied closure forces, and the rate of change in closure may be faster than for soft tissues. Surgical instruments can also notify the clinician of adjustments to the usual closure algorithm via suitable indicators such as light emitting diode (LED) indicators that display a particular color. In another example, step 22206 can determine that the patient has a complete lung fissure. Therefore, there is no soft tissue staple firing yet performed in the surgical procedure. In response to this determination, the surgical instrument can prompt the clinician to confirm that this inference is correct via the surgical instrument display. The clinician can then manually select the appropriate closure control algorithm for this step or stage of the surgical procedure. Additional or alternative, the surgical instrument 112 may be the default value for a conservative closure algorithm, as the inference performed in step 22206 does not have to be final. In either case, the regulated closure algorithm is applied in step 22208.

Continuing the description of the lobectomy procedure example, the flow chart proceeds to the determination operation 22210. In the determination operation 22210, it may be determined that the remaining steps of the surgical procedure are present. Therefore, in step 22212, intraoperative information is received and analyzed. Based on intraoperative information, it can be inferred that the type of tissue being treated is bronchial tissue. Further, the measurements of the initial tissue contact sensor 474 are such that the tissue gripped between the end effectors 702 contacts the first and second jaw members 152002, 152004 almost immediately during the initial closure of the end effector 702. It can be shown that the contact corresponds to a small area of the stapled surgical instrument 112. Further, such contact portions are defined on both sides of the jaw members 152002 and 152004.

As a result, this tissue contact scenario can be expected to correspond to bronchial tissue. As discussed above, the measurements of these initial tissue contact sensors 474 may be non-therapeutic or quasi-non-therapeutic. In addition, measurements of the closure load sensor 474 represented by closure as compared to the closure curve may indicate a rigid tissue structure consistent with bronchial tissue. The surgical procedure history indication that the vascular stapler 112 has already been used in the surgical procedure also indicates that soft tissue staple firing has already taken place and is likely to result in significant unipolar RF energy use. May mean. This surgical procedure history may be used, for example, to predict that a physician will treat bronchial tissue. This prediction would be consistent with the usual work of a surgeon to staple the bronchi as the final step in a lobectomy procedure. Based on analyzing this type of and other suitable intraoperative information in step 22212, it can be determined in determination operation 22214 that further adjustment is required. Since the answer to the determination action 22214 is yes, the flow chart proceeds to step 22206 and it is presumed that the treated tissue is bronchial tissue with normal tissue stiffness and thickness.

In one aspect, it may be easier to conclude that the treated tissue is bronchial tissue, since the surgical instrument 112 is configured only for a particular tissue type. For example, the surgical instrument 112 may be adaptable to fire staples used for the bronchi. Conversely, the surgical instrument 112 may be adaptable to fire staples used for soft tissue. In that scenario, the surgical instrument 112 can raise a warning as the surgeon attempts to treat the bronchial tissue with staples used for soft tissue. This warning can be auditory, visual, or any other suitable warning. In another example, the vascular stapler 112 may provide a warning if the vascular stapler 112 is selected for use with bronchial tissue. As discussed above, it can be determined based on perioperative information that the tissue being treated is bronchial tissue and vascular staplers are contraindicated. Similarly, other perioperative information such as closure load and stapler cartridge selection is used to provide a warning when the surgical instrument 112 is used for tissue types or features to which it does not apply. May be done. As discussed above, inferences made using perioperative information may be made in conjunction with closure parameter sensor signals. In all situations, a safety check may be performed to ensure that the surgical instrument 112 in use is safe for the tissue to be treated.

Adjustments are made to the current closure algorithm in step 22208 according to the estimated tissue type and characteristics. A constant closure rate may be determined to be preferred, but the closure rate may be adjusted to be faster or slower, for example, depending on the estimated tissue characteristics of the bronchi. The closure threshold can be modified in the same or similar manner. In addition, if the surgical instrument 112 exceeds the immediate applicable closure threshold, the longer waiting time can be automatically enabled or the current chain algorithm can be adjusted as suggested. For example, this waiting time for bronchial tissue may be longer than the waiting time used for soft tissue. As discussed above, the surgeon notifies the closure algorithm of the selected adjustment, for example, via an LED indicator. The clinician can also override the clinician for longer waiting times so that the surgeon can be allowed to launch the stapler surgical instrument 112 in the appropriate circumstances. Flow FIG. 22200 may then proceed to step 22212 to determine that no further steps of surgical procedure remain.

In one aspect, the flow diagram 22200 may be implemented by a control circuit. However, in other embodiments, the flow diagram 22200 may be implemented by a surgical hub 106 or cloud 104. In addition, steps 22204 and 22212 are described with respect to preoperative and intraoperative information, respectively, but are not limited thereto. Specifically, the perioperative information may be received and analyzed as a whole rather than specific preoperative or intraoperative information. As discussed above, perioperative information includes preoperative information, intraoperative information, and postoperative information. In addition, sensor signals may be used in conjunction with perioperative information for contextual and reference closure algorithm adjustments.

(Example)
Various aspects of the subject matter described herein under the heading "Systems for Adjusting End Effector Parameters Based on Preoperative Information" are presented in the following examples.

Example 1-The surgical system comprises surgical instruments. The surgical instrument comprises an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument further comprises a motor configured to move the first jaw relative to the second jaw according to the closure rate of change parameter and the closure threshold parameter. Surgical instruments further include sensors configured to transmit sensor signals indicating end effector closure parameters. The surgical system further comprises a control circuit communicatively coupled to the sensor. The control circuit is configured to receive perioperative information including one or more of the types of perioperative disease, perioperative treatment, and surgical procedure. The control circuit is further configured to receive the sensor signal from the sensor and, based on the perioperative information and the sensor signal, determine the adjustment to the closure rate of change parameter and the closure threshold parameter.

Example 2-The control circuit is further configured to determine the characteristics of the tissue to be treated by the surgical instrument based on one or more of the perioperative information and sensor signals. The surgical system according to Example 1.

Example 3-Tissue characteristics include one or more of tissue type characteristics, muscle characteristics, vascular structure characteristics, water content characteristics, firmness characteristics, and thickness characteristics. The surgical system according to Example 2.

Example 4-The control circuit is further configured to change the speed of the motor based on the adjustments determined for the closure rate of change parameter and the closure threshold parameter, according to Example 1, 2 or 3. Surgical system.

Example 5-The control circuit is further configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and sensor signals. The surgical system according to Example 1, 2, 3 or 4.

Example 6-Perioperative information is one or two of the types of tissue to be treated with surgical instruments, tissue characteristics, clinician history, and types of staple cartridges for use with surgical instruments. The surgical system according to Example 1, 2, 3, 4 or 5, further comprising one or more.

Example 7-The closure threshold parameter is the maximum closure force threshold, and the control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closure force threshold. 2, 3, 4, 5 or 6 for a surgical system.

Example 8-The surgical system comprises a surgical hub configured to receive perioperative information transmitted from a remote database of cloud computing systems. The surgical hub is communicably coupled to the cloud computing system. The surgical system further comprises a surgical instrument communicatively coupled to the surgical hub. The surgical instrument comprises an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The end effector further comprises a motor configured to move the first jaw relative to the second jaw according to the closure rate of change and closure threshold parameters of the closure control program received from the surgical hub. .. The end effector further comprises a sensor configured to transmit a sensor signal indicating the closure parameter of the end effector. The surgical hub is further configured to receive a sensor signal from the sensor and, based on the perioperative information and the sensor signal, determine adjustments to the closure rate of change parameter and closure threshold parameter.

Example 9-The closure control program is a first closure control program, the surgical hub is further configured to transmit a second closure control program to the surgical instrument, and a second closure control program. 8 is a surgical system according to Example 8, wherein the regulation for the closure rate of change parameter and the regulation for the closure threshold parameter is defined.

Example 10-The cloud computing system is configured to send a second closure control program to a surgical hub, where adjustments to the closure rate of change parameter and adjustments to the closure threshold parameter of the second control program are perioperative. The surgical system according to Example 9, which is adjusted based on the period information.

Example 11-The surgical instrument is configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and sensor signals. The surgical system according to Example 8, 9 or 10.

Example 12-The closure threshold parameter is the maximum closure force threshold, and the surgical hub is further configured to disable the motor for a predetermined period of time based on reaching the maximum closure force threshold. 8, 9, 10 or 11 for a surgical system.

Example 13-Perioperative information provides perioperative disease, perioperative treatment, type of surgical procedure, clinician history, type of surgical instrument, type of tissue treated by the surgical instrument, and tissue characteristics. The surgical system according to Example 8, 9, 10, 11, or 12, comprising one or more of the two or more.

Example 14-Surgical hub according to Example 9, wherein the surgical hub is further configured to change the speed of the motor based on the adjustments determined for the closure rate of change parameter and the closure threshold parameter. system.

Example 15-The surgical instrument comprises an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument is a motor configured to move the first jaw relative to the second jaw according to the closure rate of change and closure threshold parameters of the first closure control program received from the surgical hub. Further prepare. Surgical instruments further include a sensor configured to transmit a sensor signal indicating a closing parameter of the end effector, and a control circuit communicatively coupled to the sensor and motor. The control circuit is configured to receive the sensor signal from the sensor and determine the adjustment to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal.

Example 16-Surgical instruments are configured to generate alerts based on discrepancies between the type of surgical instrument and one or more of the perioperative information and sensor signals. The surgical system according to Example 15.

Example 17-The control circuit switches from the first closure control program to the second closure control program received from the cloud computing system and further changes the speed of the motor based on the second closure control program. The surgical system according to Example 15 or 16, which is configured.

Example 18-The control circuit is further configured to determine the characteristics and type of tissue to be treated with surgical instruments based on one or more of the perioperative information and sensor signals. The surgical system according to Example 15, 16 or 17.

Example 19-The surgical system according to Example 15, 16, 17 or 18, wherein the closure threshold parameter is the maximum closure force threshold.

Example 20-The surgical system according to Example 19, wherein the closure threshold parameter is the maximum closure force threshold.

In various aspects, sensors with a particular sensor array can be placed on staple cartridges in accordance with the present disclosure. The adhesive mask may embed the sensor in place. In various aspects, the sensor is mounted on a ridge on the staple cartridge so that the sensor is positioned higher than the cartridge deck of the staple cartridge to ensure contact with the tissue. Adhesive masks can be collectively formed on polyester substrates using, for example, screen printing techniques. Conductive pads can be printed in a common place.

In various examples, in addition to close detection of cancer tissue, the end effectors of the present disclosure may also be configured to target a particular cancer type within a particular tissue. Genomics 84 (2004) pp., Published by Altenberg Band Gruich KO, which is incorporated by reference in its entirety into the present invention. As pointed out in 104-1020, certain cancers are characterized by overexpression of glycolytic genes, whereas other cancers are not characterized by overexpression of glycolytic genes. Therefore, the end effectors of the present disclosure can be equipped with a sensor sequence having high specificity for cancer tissues characterized by overexpression of glycolytic genes such as lung cancer or liver cancer.

In various aspects, sensor readings of the sensor sequences according to the present disclosure are transmitted by surgical instruments to surgical hubs (eg, surgical hubs 106, 206) for additional analysis and / or situational awareness.

The above detailed description has described various forms of equipment and / or processes using block diagrams, flowcharts, and / or examples. As long as such block diagrams, flowcharts, and / or embodiments include one or more functions and / or operations, it is appreciated by those skilled in the art that such block diagrams, flowcharts, and / or Each function and / or operation included in the embodiments can be implemented individually and / or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. To those skilled in the art, all or part of some of the embodiments disclosed herein may be as one or more computer programs running on one or more computers (eg, 1). As one or more programs running on one or more computer systems (as one or more programs running on one or more computer systems) (eg, as one or more programs running on one or more processors) Can be equivalently implemented on an integrated circuit as one or more programs running on a microprocessor, as firmware, or as virtually any combination thereof, and designing the circuit. And / or writing code for software and / or firmware will be understood to be within the skill of those skilled in the art in light of the present disclosure. Further, as will be appreciated by those skilled in the art, the mechanisms of subject matter described herein can be distributed in a variety of forms as one or more program products, which are described herein. The specific forms of the described subject matter are used regardless of the particular type of signal carrier used in the actual distribution.

Instructions used to program logic to perform various disclosed aspects can be stored in in-system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage. In addition, instructions can be distributed over the network or by other computer-readable media. Therefore, the machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (for example, a computer), such as a floppy diskette, an optical disk, a compact disk, or a read-only memory (CD). -ROM), as well as magnetic optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, Tangible machine readable used to transmit information over the Internet via flash memory or electrical, optical, acoustic, or other forms of propagating signals (eg, carriers, infrared signals, digital signals, etc.) Not limited to storage. Thus, non-transitory computer-readable media include any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used in any aspect of the specification, the term "control circuit" refers, for example, to a hard-wired circuit, a programmable circuit (eg, a computer processor containing one or more individual instruction processing cores, a processing unit). By a processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic mechanism (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state mechanical circuit, programmable circuit. It can refer to a firmware that stores the instructions to be executed, and any combination thereof. Control circuits can be collectively or individually, for example, integrated circuits (ICs), application-specific integrated circuits (ASICs), system-on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. , Can be embodied as a circuit that forms part of a larger system. Therefore, as used herein, the "control circuit" is an electric circuit having at least one individual electric circuit, an electric circuit having at least one integrated circuit, and an electric circuit having at least one integrated circuit for a specific application. A circuit, a general-purpose computing device composed of a computer program (for example, a general-purpose computer composed of a computer program that executes at least a part of the process and / or the device described in the present specification, or a process described in the present specification. And / or electrical circuits that form a computer program that at least partially executes the device, electrical circuits that form a memory device (eg, in the form of a random access memory), and / or a communication device (eg, a communication device). Examples include, but are not limited to, electrical circuits that form modems, communication switches, or optical-electrical equipment. Those skilled in the art will recognize that the subjects described herein may be realized in analog or digital forms or some combination thereof.

As used in any aspect of the specification, the term "logic" may refer to an application, software, firmware, and / or circuit configured to perform any of the aforementioned operations. The software may be embodied as software packages, codes, instructions, instruction sets, and / or data recorded on non-temporary computer-readable storage media. Firmware may be embodied as code, instructions, or instruction sets in a memory device, and / or as hard-coded (eg, non-volatile) data.

As used in any aspect of the specification, the terms "component", "system", "module", etc. are either hardware, a combination of hardware and software, software, or running software. Can point to a computer-related entity.

As used in any aspect of the specification, an "algorithm" refers to a self-consistent sequence of steps that leads to a desired result, and a "step" is, but is not necessarily necessary, a memory, transfer, combination, Refers to the manipulation of physical quantities and / or logical states that can be in the form of electrical or magnetic signals that can be compared and manipulated differently. It is common practice to refer to these signals as bits, values, elements, symbols, letters, terms, numbers, and so on. These and similar terms may be associated with appropriate physical quantities and are simply convenient labels that apply to these quantities and / or conditions.

The network may include a packet switching network. Communication devices can communicate with each other using selected packet-switched network communication protocols. One exemplary communication protocol includes an Ethernet communication protocol that can enable communication using a transmission control protocol / Internet Protocol (TCP / IP). The Ethernet protocol conforms to or is compatible with the title "IEEE802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008, and / or later versions of the Ethernet standard. There can be. Alternatively or additionally, the communication device is X.I. Twenty-five communication protocols can be used to communicate with each other. X. The 25 communication protocols may conform to or be compatible with the standards promulgated by the International Telecommunication Union-Telecommunication Standardization Detector (ITU-T). Alternatively or additionally, the communication devices can communicate with each other using the Frame Relay communication protocol. The Frame Relay communication protocol conforms to or is compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transmitters and receivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published in August 2001 under the title "ATM-MPLS Network Interworking 2.0" by the ATM Forum and / or later versions of this standard. .. Not surprisingly, connection-oriented network communication protocols developed differently and / or later are equally contemplated herein.

Unless otherwise stated, as is clear from the above disclosure, throughout the above disclosure, "process," "calculate," "calculate," "determine," "display," etc. Discussions that use the term manipulate data expressed as physical (electronic) quantities in the memory or memory of a computer system and in the memory or register of the computer system or such information storage, transmission, or display device. It will be appreciated that it refers to the operation and processing of a computer system or similar electronic computing device that transforms it into other data that is similarly represented as physical quantity.

One or more components are "configured to", "configurable to", and "operable / as" herein. "Operaable / operative to", "adapted / adaptive", "able to", "conformable / conformable" to) ”and so on. Those skilled in the art will generally appreciate that "configured as" is an active component and / or an inactive component and / or a standby component, unless the context should be interpreted in other ways. You will understand that it can contain elements.

The terms "proximal" and "distal" are used herein with reference to the clinician operating the handle portion of the surgical instrument. The term "proximal" refers to the part closest to the clinician, and the term "distal" refers to the part located away from the clinician. For convenience and clarity, it will be further understood that spatial terms such as "vertical", "horizontal", "top", and "bottom" can be used with respect to the drawings herein. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limited and / or absolute.

Those skilled in the art generally intend that the terms used herein, and in particular in the appended claims (eg, the text of the appended claims), are generally "open" terms. The term "including" should be interpreted as "including but not limited to" and the term "having". Should be interpreted as "having at least" and the term "includes" should be interpreted as "includes but is not limited to" You will understand that it should be done, etc.). In addition, if a particular number is intended in the introduced claim recitation, such intent is clearly stated in the claim, and in the absence of such intent, such intent may not exist. , Will be understood by those skilled in the art. For example, as an aid to understanding, the following claims introduce the introductory phrases "at least one" and "one or more" and the claims. May be included to do. However, the use of such a phrase is an introductory phrase such as "one or more" or "at least one" in the same claim, even if the claim description is introduced by the indefinite definite article "a" or "an". And any particular claim, including such an introduced claim statement, is limited to a claim that includes only one such claim, even if it contains the indefinite definite "a" or "an". Should not be construed as suggesting (eg, "a" and / or "an" should usually be construed as meaning "at least one" or "one or more". ). The same is true when introducing claims using definite articles.

The terms "comprise" (any form of comprise, such as "comprises" and "comprising"), "have" (any form of have, such as "has" and "having"), "include ( ”(Any word form of include, such as“ includes ”and“ inclusion ”), and“ contain ”(any word form of content, such as“ context ”and“ contouring ”) are open concatenations. It is a verb. As a result, a surgical system, device, or device that "includes," "has," "contains," or "contains" one or more elements has one or more of them, but one of them. Not limited to having only one or more. Similarly, an element of a system, device, or device that "includes", "has", "contains", or "contains" one or more features has one or more of these features, but one of them. It is not limited to having only the above characteristics.

Moreover, even if a particular number is specified in the introduced claims, such statement should typically be construed to mean at least the number stated. , Will be recognized by those skilled in the art (eg, if there is a mere "two entries" with no other modifiers, then generally at least two entries, or two or more statements. Means matter). Further, when a notation similar to "at least one of A, B, C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art will understand the notation (eg, for example. , "A system having at least one of A, B, and C", but is not limited to, A only, B only, C only, both A and B, both A and C, B and Includes systems with both C and / or all of A, B and C, etc.). When a notation similar to "at least one of A, B, C, etc." is used, such syntax is generally intended to mean that one of ordinary skill in the art will understand the notation (eg, "" A system having at least one of A, B, or C "is, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C. Includes systems with both and / or all of A, B and C, etc.). Moreover, typically any selective word and / or phrase representing two or more selective terms is used in the specification unless the context requires other meanings. It is understood that it is intended to include one of those terms, any of those terms, or both, whether in the claims, in the claims, or in the drawings. Those skilled in the art will understand that it should be. For example, the phrase "A or B" will typically be understood to include the possibility of "A" or "B" or "A and B".

With respect to the appended claims, one of ordinary skill in the art will appreciate that the actions cited herein can generally be performed in any order. In addition, although the flow charts of various operations are shown in a sequence (s), it is understood that the various operations may be performed in an order other than those illustrated, or may be performed at the same time. It should be. Examples of such alternative ordering are duplicates, alternations, interrupts, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different ordering, unless the context requires other meanings. May include. In addition, terms such as "responding to", "related to", or other past tense adjectives may generally exclude such variants unless they should be interpreted in other ways in the context. Not intended.

Any reference to "one aspect", "aspect", "exemplification", "one example", etc. includes a particular mechanism, structure, or property described in connection with that aspect in at least one aspect. It is worth noting that it means. Thus, the terms "in one aspect", "in an embodiment", "in an example", and "in an example" found in various places throughout the specification do not necessarily all refer to the same aspect. Moreover, certain features, structures, or properties can be combined in any suitable manner in one or more embodiments.

Any patent application, patent, non-patent publication, or other disclosed material referenced herein and / or listed in any application datasheet is to the extent that the material incorporated is consistent with this specification. , Incorporated herein by reference. As such, and to the extent necessary, the disclosures expressly set forth herein shall supersede any contradictory statements incorporated herein by reference. Any content that conflicts with current definitions, views, or other disclosures described herein, or parts thereof, shall be incorporated herein by reference, but with reference and current disclosure. It shall be referred to only to the extent that there is no contradiction with.

In summary, many benefits have been described as a result of using the concepts described herein. The above description in one or more forms is presented for purposes of illustration and explanation. It is not intended to be inclusive or limited to the exact form disclosed. In view of the above teachings, modifications or modifications are possible. One or more forms exemplify the principles and practical applications, thereby making various forms available to those skilled in the art as suitable for the particular application conceived, along with various modifications. Therefore, it has been selected and described. The claims presented with this specification are intended to define the overall scope.

[Implementation mode]
(1) A surgical system
It ’s a surgical instrument,
It ’s an end effector,
The first jaw and
An end effector comprising a second jaw, wherein the first jaw is configured to move relative to the second jaw.
A motor configured to move the first jaw with respect to the second jaw according to the closure rate of change parameter and the closure threshold parameter.
A surgical instrument comprising a sensor configured to transmit a sensor signal indicating a closure parameter of the end effector.
A control circuit communicatively coupled to the sensor.
Receives perioperative information, including one or more of the types of perioperative disease, perioperative treatment, and surgery.
Upon receiving the sensor signal from the sensor,
A surgical system comprising a control circuit configured to determine adjustments to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal.
(2) The control circuit is further configured to determine the characteristics of the tissue to be treated by the surgical instrument based on the perioperative information and one or more of the sensor signals. The surgical system according to embodiment 1.
(3) The tissue characteristics include one or more of tissue type characteristics, muscle characteristics, vascular structure characteristics, water content characteristics, firmness characteristics, and thickness characteristics. 2. The surgical system according to embodiment 2.
(4) The control circuit is further configured to change the speed of the motor based on the adjustments determined for the closure rate of change parameter and the closure threshold parameter, according to embodiment 1. Surgical system.
(5) The control circuit is further configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and the sensor signal. The surgical system according to embodiment 1.

(6) The perioperative information is one of the type of tissue to be treated by the surgical instrument, the characteristics of the tissue, the history of the clinician, and the type of staple cartridge for use with the surgical instrument. The surgical system according to embodiment 1, further comprising one or more.
(7) The closing threshold parameter is the maximum closing force threshold.
The surgical system according to embodiment 1, wherein the control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closing force threshold.
(8) A surgical system
A surgical hub configured to receive perioperative information transmitted from a remote database of a cloud computing system and communicatively coupled to said cloud computing system.
A surgical instrument communicatively coupled to the surgical hub.
It ’s an end effector,
The first jaw and
An end effector comprising a second jaw, wherein the first jaw is configured to move relative to the second jaw.
A motor configured to move the first jaw relative to the second jaw according to the closure rate of change parameter and the closure threshold parameter of the closure control program received from the surgical hub.
A surgical instrument comprising a sensor configured to transmit a sensor signal indicating a closure parameter of the end effector.
The surgical hub
Upon receiving the sensor signal from the sensor,
A surgical system further configured to determine adjustments to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal.
(9) The closure control program is the first closure control program.
The surgical hub is further configured to transmit a second closure control program to the surgical instrument.
The surgical system according to embodiment 8, wherein the second closure control program defines said adjustments to the closure rate of change parameter and said adjustments to the closure threshold parameter.
(10) The cloud computing system is configured to transmit the second closure control program to the surgical hub.
The surgical system according to embodiment 9, wherein the adjustment to the closure rate of change parameter and the adjustment to the closure threshold parameter of the second control program are adjusted based on perioperative information.

(11) The surgical instrument is configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and the sensor signal. The surgical system according to embodiment 8.
(12) The closing threshold parameter is the maximum closing force threshold.
The surgical system according to embodiment 8, wherein the surgical hub is further configured to disable the motor for a predetermined period of time based on reaching the maximum closing force threshold.
(13) The perioperative information includes perioperative disease, perioperative treatment, type of surgical procedure, history of a clinician, type of surgical instrument, type of tissue treated by the surgical instrument, and the like. The surgical system according to embodiment 12, which comprises one or more of the features of the tissue.
(14) The 9th embodiment, wherein the surgical hub is further configured to change the speed of the motor based on the adjustments determined for the closure rate of change parameter and the closure threshold parameter. Surgical system.
(15) Surgical instruments
It ’s an end effector,
The first jaw and
An end effector comprising a second jaw, wherein the first jaw is configured to move relative to the second jaw.
A motor configured to move the first jaw relative to the second jaw according to the closure rate of change and closure threshold parameters of the first closure control program received from the surgical hub.
A sensor configured to transmit a sensor signal indicating the closure parameter of the end effector, and
A control circuit communicatively coupled to the sensor and the motor.
Upon receiving the sensor signal from the sensor,
A surgical instrument comprising a control circuit configured to determine adjustments to the closure rate of change parameter and the closure threshold parameter based on perioperative information and the sensor signal.

(16) The surgical instrument is configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and the sensor signal. The surgical instrument according to embodiment 15.
(17) The control circuit is
Switching from the first closure control program to the second closure control program received from the cloud computing system,
The surgical instrument according to embodiment 15, further configured to change the speed of the motor based on the second closure control program.
(18) The control circuit further determines the characteristics and type of tissue to be treated by the surgical instrument based on the perioperative information and one or more of the sensor signals. The surgical instrument according to embodiment 15, which is configured.
(19) The surgical instrument according to embodiment 15, wherein the closure threshold parameter is the maximum closure force threshold.
(20) The surgical instrument according to embodiment 19, wherein the control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closing force threshold.

Claims (20)

It ’s a surgical system,
It ’s a surgical instrument,
It ’s an end effector,
The first jaw and
An end effector comprising a second jaw, wherein the first jaw is configured to move relative to the second jaw.
A motor configured to move the first jaw with respect to the second jaw according to the closure rate of change parameter and the closure threshold parameter.
A surgical instrument comprising a sensor configured to transmit a sensor signal indicating a closure parameter of the end effector.
A control circuit communicatively coupled to the sensor.
Receives perioperative information, including one or more of the types of perioperative disease, perioperative treatment, and surgery.
Upon receiving the sensor signal from the sensor,
A surgical system comprising a control circuit configured to determine adjustments to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal. The control circuit is further configured to determine the characteristics of the tissue to be treated by the surgical instrument based on the perioperative information and one or more of the sensor signals. The surgical system according to claim 1. Claimed that the tissue characteristics include one or more of tissue type characteristics, muscle characteristics, vascular structure characteristics, water content characteristics, firmness characteristics, and thickness characteristics. Item 2. The surgical system according to item 2. The surgical system according to claim 1, wherein the control circuit is further configured to change the speed of the motor based on the adjustments determined for the closure rate of change parameter and the closure threshold parameter. .. The control circuit is further configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and the sensor signal. Item 1. The surgical system according to item 1. The perioperative information is one or two of the type of tissue to be treated by the surgical instrument, the characteristics of the tissue, the history of the clinician, and the type of staple cartridge for use with the surgical instrument. The surgical system according to claim 1, further comprising one or more. The closure threshold parameter is the maximum closure force threshold.
The surgical system according to claim 1, wherein the control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closing force threshold. It ’s a surgical system,
A surgical hub configured to receive perioperative information transmitted from a remote database of a cloud computing system and communicatively coupled to said cloud computing system.
A surgical instrument communicatively coupled to the surgical hub.
It ’s an end effector,
The first jaw and
An end effector comprising a second jaw, wherein the first jaw is configured to move relative to the second jaw.
A motor configured to move the first jaw relative to the second jaw according to the closure rate of change parameter and the closure threshold parameter of the closure control program received from the surgical hub.
A surgical instrument comprising a sensor configured to transmit a sensor signal indicating a closure parameter of the end effector.
The surgical hub
Upon receiving the sensor signal from the sensor,
A surgical system further configured to determine adjustments to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal. The closure control program is a first closure control program.
The surgical hub is further configured to transmit a second closure control program to the surgical instrument.
The surgical system of claim 8, wherein the second closure control program defines said adjustments to the closure rate of change parameter and said adjustments to the closure threshold parameter. The cloud computing system is configured to transmit the second closure control program to the surgical hub.
The surgical system of claim 9, wherein the adjustment to the closure rate of change parameter and the adjustment to the closure threshold parameter of the second control program are adjusted based on perioperative information. The surgical instrument is configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and the sensor signal. Item 8. The surgical system according to item 8. The closure threshold parameter is the maximum closure force threshold.
The surgical system of claim 8, wherein the surgical hub is further configured to disable the motor for a predetermined period of time based on reaching the maximum closing force threshold. The perioperative information includes perioperative disease, perioperative treatment, type of surgical procedure, history of a clinician, type of surgical instrument, type of tissue treated by the surgical instrument, and the tissue. 12. The surgical system of claim 12, comprising one or more of the features of. The surgical hub of claim 9, wherein the surgical hub is further configured to change the speed of the motor based on the adjustments determined for the closure rate of change parameter and the closure threshold parameter. system. It ’s a surgical instrument,
It ’s an end effector,
The first jaw and
An end effector comprising a second jaw, wherein the first jaw is configured to move relative to the second jaw.
A motor configured to move the first jaw relative to the second jaw according to the closure rate of change and closure threshold parameters of the first closure control program received from the surgical hub.
A sensor configured to transmit a sensor signal indicating the closure parameter of the end effector, and
A control circuit communicatively coupled to the sensor and the motor.
Upon receiving the sensor signal from the sensor,
A surgical instrument comprising a control circuit configured to determine adjustments to the closure rate of change parameter and the closure threshold parameter based on perioperative information and the sensor signal. The surgical instrument is configured to generate a warning based on a discrepancy between the type of surgical instrument and one or more of the perioperative information and the sensor signal. Item 15. The surgical instrument according to item 15. The control circuit
Switching from the first closure control program to the second closure control program received from the cloud computing system,
The surgical instrument of claim 15, further configured to alter the speed of the motor based on the second closure control program. The control circuit is further configured to determine the characteristics and type of tissue to be treated by the surgical instrument based on the perioperative information and one or more of the sensor signals. The surgical instrument according to claim 15. The surgical instrument according to claim 15, wherein the closure threshold parameter is the maximum closure force threshold. 19. The surgical instrument of claim 19, wherein the control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closing force threshold.

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