JP2021509043A - Surgical system for detecting irregularities in the tissue distribution of end effectors - Google Patents

Abstract

Surgical staple fasteners include an end effector, which is a first jaw and a second jaw to grip tissue between the first and second jaws. A second jaw and anvil that are movable relative to the first jaw between the open and closed configurations, and a staple cartridge that has staples that are deployable within the organization and deformable by the anvil. Be prepared. Surgical staple fasteners further include a control circuit that determines the tissue impedance in a given zone and detects irregularities in the tissue distribution within the end effector based on the tissue impedance. It is configured to adjust and perform end effector closure parameters according to irregularities.

Description

(Cross-reference of related applications)
This application is filed June 28, 2018, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCRDING TO SENSED CLOSED CLOSE PARAMETERS", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the US Patent Act. Claims the benefit of priority to US Provisional Patent Application No. 62 / 691,227.

This application is filed in the United States on March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the United States Patent Act. Tentative Patent Application No. 62 / 650,887, US Tentative Patent Application No. 62 / 650,887, "SMOKE EVACUATION SENSING AND CONTROLS", filed March 30, 2018, "SMOKE EVACUATION SENSING AND CONTROL" US Provisional Patent Application No. 62 / 650,882, filed March 30, 2018, and US Provisional Patent Application No. 62, filed March 30, 2018, entitled "CAPACTIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS". Claim the benefit of priority over / 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. Against US Provisional Patent Application Nos. 62 / 640,417 filed in Japan and US Provisional Patent Application No. 62 / 640,415 filed on March 8, 2018 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.

The present disclosure relates to various surgical systems.

In various aspects, surgical staple fasteners with end effectors are disclosed. The end effector is a first jaw and a second jaw, the first between the open and closed configurations to grip the tissue between the first and second jaws. It has a second jaw that can be moved with respect to the jaw. The end effector further comprises an anvil and a staple cartridge. Staple cartridges include staples that are deployable within the tissue and deformable by anvil. The surgical staple system further comprises a control circuit. The control circuit determines the tissue impedance in a given zone, detects the irregularity of the tissue distribution in the end effector based on the tissue impedance, and adjusts the end effector closure parameters according to the irregularity. It is configured to do and do.

In various aspects, surgical stapling instruments for stapling previously stapled tissue are disclosed. Surgical staple fasteners include a shaft that defines a longitudinal axis that extends through the interior and an end effector that extends from the shaft. The end effector is a first jaw and a second jaw, the first between the open and closed configurations to grip the tissue between the first and second jaws. It has a second jaw that can be moved with respect to the jaw. The end effector further comprises an anvil and a staple cartridge. Staple cartridges include staples that can be deployed within previously stapled tissue and are deformable by anvils. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. Surgical staple fasteners further comprise a circuit. The circuit measures the tissue impedance in a given zone, compares the measured tissue impedance to a given tissue impedance signature in a given zone, and from that comparison, the previously stapled tissue in the end effector. It is configured to detect and perform irregularities in at least one of the positions and orientations of.

In various aspects, surgical staple fasteners with end effectors are disclosed. The end effector is a first jaw and a second jaw, the first between the open and closed configurations to grip the tissue between the first and second jaws. It has a second jaw that can be moved with respect to the jaw. The end effector further comprises an anvil and a staple cartridge. Staple cartridges include staples that are deployable within the tissue and deformable by anvil. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. Surgical staple fasteners further include a control circuit. The control circuit determines the electrical parameters of the tissue in each of the predetermined zones, detects the irregularities of the tissue distribution in the end effector based on the determined electrical parameters, and the irregularities. It is configured to adjust and perform end effector closure parameters according to gender.

The features of the various aspects are described in detail in 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. FIG. 6 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 stroke length graph which shows an example of the control system which changes the stroke length of a clamp assembly based on a joint movement angle. It is a closed tube assembly positioning graph which shows an example of the control system which changes the longitudinal position of a closed tube assembly based on a joint movement angle. This is a comparison between the staple fastening method using controlled tissue compression and the staple fastening method without controlled tissue compression. The force graph shown in section A and the related displacement graph shown in section B, the force graph and the displacement graph have an x-axis showing time, and the y-axis of the displacement graph shows the moving displacement of the launch rod. , The y-axis of the force graph indicates the detected torsional force applied to the motor configured to advance the launch rod. It is the schematic of the tissue contact circuit which shows that the circuit is completed when a pair of separated contact plates come into contact with a tissue. FIG. 3 is a perspective view of a surgical instrument having an operably coupled interchangeable shaft assembly according to at least one aspect of the present disclosure. FIG. 5 is an exploded view of a portion of the surgical instrument of FIG. 25 according to at least one aspect of the present disclosure. FIG. 3 is an exploded view of a portion of an interchangeable shaft assembly according to at least one aspect of the present disclosure. FIG. 5 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. FIG. 25 is a block diagram of a surgical instrument control circuit of FIG. 25 showing an interface between a handle assembly and a power supply assembly and an interface between a handle assembly and a replaceable shaft assembly according to at least one aspect of the present disclosure. .. Shown is an exemplary medical device that may include one or more aspects of the present disclosure. Shown is an exemplary end effector of a medical device surrounding a tissue according to one or more aspects of the present disclosure. Shown is an exemplary end effector of a medical device that compresses tissue according to one or more aspects of the present disclosure. Demonstrates exemplary forces exerted by end effectors of medical devices that compress tissue, according to one or more aspects of the present disclosure. The exemplary forces exerted by the end effectors of medical devices that compress tissue according to one or more aspects of the present disclosure are further illustrated. An exemplary tissue compression sensor system according to one or more aspects of the present disclosure is shown. An exemplary tissue compression sensor system according to one or more aspects of the present disclosure is further shown. An exemplary tissue compression sensor system according to one or more aspects of the present disclosure is further shown. Similarly, it is an exemplary circuit diagram according to one or more aspects of the present disclosure. Similarly, it is an exemplary circuit diagram according to one or more aspects of the present disclosure. FIG. 5 is a graph showing exemplary frequency modulation according to one or more aspects of the present disclosure. It is a graph which showed the synthesized RF signal by one or more aspects of this disclosure. FIG. 5 is a graph showing filtered RF signals 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 of a surgical instrument. Gap size over time (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force over time (Fig. 49). It is a graph which plotted 50). Gap size over time (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force over time (Fig. 49). It is a graph which plotted 50). Gap size over time (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force over time (Fig. 49). It is a graph which plotted 50). Gap size over time (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force over time (Fig. 49). It is a graph which plotted 50). Gap size over time (Fig. 46), firing current over time (Fig. 47), tissue compression over time (Fig. 48), anvil strain over time (Fig. 49), and trigger force over time (Fig. 49). It is a graph which plotted 50). It is a graph which plotted the tissue displacement as a function of tissue compression for normal tissue. It is a graph which plotted tissue displacement as a function of tissue compression in order to distinguish between normal tissue and lesion tissue. An embodiment of an end effector including a first sensor and a second sensor is shown. FIG. 5 is a logical diagram illustrating an embodiment of a process of 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 of 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 of calibrating a first sensor in response to input from a second sensor. FIG. 5 is a logical diagram illustrating an embodiment of a process of determining and displaying the thickness of a tissue section clamped between an anvil of an end effector and a staple cartridge. FIG. 5 is a logical diagram illustrating an embodiment of a process of determining and displaying the thickness of a tissue section clamped 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. An embodiment of an end effector including a first sensor and a second sensor is shown. An embodiment of an end effector including a first sensor and a plurality of second sensors is shown. It is a logical diagram which shows one Embodiment of the process which adjusts the measured value of a 1st sensor in response to a plurality of secondary sensors. An embodiment of a circuit configured to convert signals from a first sensor and a plurality of secondary sensors into receivable digital signals by a processor is shown. An embodiment of an end effector including a plurality of sensors is shown. FIG. 5 is a logical diagram illustrating an embodiment of a process of determining one or more tissue characteristics based on a plurality of sensors. An embodiment of an end effector including a plurality of sensors connected to a second jaw member is shown. An embodiment of a staple cartridge including a plurality of sensors integrally formed inside is shown. FIG. 5 is a logical diagram illustrating an embodiment of the process of determining one or more parameters of a clamped tissue section within an end effector. An embodiment of an end effector including a plurality of redundant sensors is shown. It is a logical diagram which shows one Embodiment of the process which selects the most reliable output from a plurality of redundant sensors. An embodiment of an end effector comprising a sensor having a unique sampling rate for limiting or eliminating pseudo-signals is shown. FIG. 5 is a logical diagram illustrating an embodiment of a process of generating a thickness measurement of a tissue section located between an anvil of an end effector and a staple cartridge. An embodiment of an end effector comprising a sensor that identifies different types of staple cartridges is shown. An embodiment of an end effector comprising a sensor that identifies different types of staple cartridges is shown. Shown is an aspect of a segmented flexible circuit configured to be fixedly attached to a jaw member of an end effector according to at least one aspect of the present disclosure. Shows one aspect of a segmented flexible circuit configured to be mounted on a jaw member of an end effector according to at least one aspect of the present disclosure. Shown is an aspect of an end effector configured to measure tissue gap GT according to at least one aspect of the present disclosure. An aspect of an end effector comprising a segmented flexible circuit according to at least one aspect of the present disclosure is shown. Shown is an end effector shown in FIG. 78, in which the jaw member clamps 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, wherein the absolute positioning system according to at least one aspect of the present disclosure comprises a controlled motor drive circuit configuration with a sensor mechanism. 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 showing the force applied to the closure member to close against thick and thin tissue during the closure phase, as well as thick and thin tissue during the launch phase. 2 is a second graph of two firing force (FTF) plots showing the forces applied to a launching member to fire through tissue. According to at least one aspect of the present disclosure, when the launching member advances distally and is coupled into the clamp arm, it provides a gradual closure of the closing member during the launching stroke and desires a closing force load applied to the closing member. It is a graph of a control system configured to reduce the firing force load applied to the launching member by reducing the speed of. A proportional-integral-derivative (PID) controller feedback control system according to at least one aspect of the present disclosure is shown. FIG. 5 is a logical flow diagram illustrating a control program or logical configuration process for determining the speed of a closing member according to at least one aspect of the present disclosure. It is a timeline showing the situational awareness of the surgical hub according to at least one aspect of the present disclosure. FIG. 3 is a perspective view of a curved surgical staple fastening and cutting instrument end effector containing a predetermined zone, according to at least one aspect of the present disclosure. FIG. 88 is a straight partial cross section of the end effector of a curved surgical staple and cutting instrument of FIG. 88 having tissue gripped by the end effector according to at least one aspect of the present disclosure. FIG. 3 is a perspective view of an end effector of a surgical stapler and cutting instrument, including a predetermined zone, according to at least one aspect of the present disclosure, according to at least one aspect of the present disclosure. FIG. 8 is a straight partial cut of the end effector of a curved surgical staple and cutting instrument of FIG. 88, wherein the tissue is located between the jaws of the end effector according to at least one aspect of the present disclosure. FIG. 8 is a straight partial cut of the end effector of a curved surgical staple and cutting instrument of FIG. 88, wherein the tissue is located between the jaws of the end effector according to at least one aspect of the present disclosure. FIG. 8 is a straight partial cut of the end effector of a curved surgical staple and cutting instrument of FIG. 88, wherein the tissue is located between the jaws of the end effector according to at least one aspect of the present disclosure. Shown is the tissue of FIG. 91 gripped by the end effector of FIG. 88 according to at least one aspect of the present disclosure. Shown is the tissue of FIG. 92 gripped by the end effector of FIG. 88 according to at least one aspect of the present disclosure. Shown is the tissue of FIG. 93 gripped by the end effector of FIG. 88 according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for identifying irregularities in tissue distribution within an end effector of a surgical instrument according to at least one aspect of the present disclosure. FIG. 5 is a graph showing over time three predetermined tissue impedance measurements of the end effector of FIG. 88 according to at least one aspect of the present disclosure. FIG. 5 is a graph showing the closing force of the end effector of FIG. 88 around the tissue of FIG. 91 and the motor speed of the motor resulting in the end effector closure, plotted against time, according to at least one aspect of the present disclosure. FIG. 6 is a graph showing the closing force of the end effector of FIG. 88 around the tissue of FIG. 92 and the motor speed of the motor resulting in the end effector closure, plotted against time, according to at least one aspect of the present disclosure. FIG. 5 is a graph showing the closing force of the end effector of FIG. 88 around the tissue of FIG. 93 and the motor speed of the motor resulting in the end effector closure, plotted against time, according to at least one aspect of the present disclosure. A control system for surgical instruments according to at least one aspect of the present disclosure is shown. FIG. 5 is a diagram of a surgical instrument centered on a linear staple transverse incision line using the benefits of centering tools and techniques described in connection with FIGS. 104-106, according to at least one aspect of the present disclosure. The process of aligning an anvil trocar of a circular stapler with the staple overlap of a straight staple line created by a double staple fastening technique according to at least one aspect of the present disclosure. Shows the anvil trocar of a circular stapler that is not aligned with the staple overlap of a straight staple line created by double staple fastening technology. The process of aligning an anvil trocar of a circular stapler with the staple overlap of a straight staple line created by a double staple fastening technique according to at least one aspect of the present disclosure. Shows the anvil trocar of a circular stapler aligned with the center of the staple overlap of a straight staple line created by double staple fastening technology. The process of aligning an anvil trocar of a circular stapler with the staple overlap of a straight staple line created by a double staple fastening technique according to at least one aspect of the present disclosure. Shows a centering tool displayed on a surgical hub display showing the staple overlap of a straight staple line created by double staple fastening technology, cut by a circular stapler, in which the anvil trocar is shown in FIG. 104. As such, it is not aligned with the staple overlapping portion of the double staple line. The images before and after the centering tool according to at least one aspect of the present disclosure are shown. On the image of the table overlap presented on the surgical hub display, the projected cutting path of the anvil trocar and circular knife before being aligned with the target alignment ring that surrounds the image of the straight staple line. It is an image. The images before and after the centering tool according to at least one aspect of the present disclosure are shown. Anvil trocar and circular knife projected cutting path after alignment with the target alignment ring surrounding the image of the straight staple line on the image of the staple overlap presented on the surgical hub display. It is an image. The process of aligning the anvil trocar of a circular stapler to the center of a straight staple line according to at least one aspect of the present disclosure is shown. Shows anvil trocars that are not aligned with the center of the straight staple line. The process of aligning the anvil trocar of a circular stapler to the center of a straight staple line according to at least one aspect of the present disclosure is shown. Shows an anvil trocar aligned with the center of a straight staple line. The process of aligning the anvil trocar of a circular stapler to the center of a straight staple line according to at least one aspect of the present disclosure is shown. Shows the centering tool of a straight staple line displayed on a surgical hub display, in which the anvil trocar is not aligned with the staple overlap of the double staple line, as shown in FIG. 109. It is an image of a standard reticle field of view of a linear staple line transverse incision of surgery viewed through a laparoscope displayed on a surgical hub display according to at least one aspect of the present disclosure. A laser-aided reticle field image of the surgical site shown in FIG. 112, before the anvil trocar and circular knife of the circular stapler are aligned with respect to the center of the straight staple line, according to at least one aspect of the present disclosure. Is. An image of a laser-based reticle field of operation at the surgical site shown in FIG. 113 after an anvil trocar of a circular stapler and a circular knife have been aligned to the center of a straight staple line, according to at least one aspect of the present disclosure. FIG. 3 is a partial perspective view of a circular stapler showing a circular stapler trocar including a staple cartridge having four predetermined zones according to at least one aspect of the present disclosure. FIG. 3 is a partial perspective view of a circular stapler showing a circular stapler trocar including a staple cartridge having eight predetermined zones according to at least one aspect of the present disclosure. According to at least one aspect of the present disclosure, the two tissues containing the previously deployed staples are properly placed on the staple cartridge of FIG. 115 on the left side, and the two tissues containing the previously deployed staples. Is properly placed on the staple cartridge of FIG. 115, as shown on the right. According to at least one aspect of the present disclosure, the previously deployed staple-containing tissue is properly placed on the staple cartridge of FIG. 115 on the left side, and the previously deployed staple-containing tissue is shown in FIG. 115. It is shown on the right side where it is properly placed on the staple cartridge. It shows that, according to at least one aspect of the present disclosure, two tissues, including previously deployed staples, are properly placed on the staple cartridge of FIG. 116. It shows that, according to at least one aspect of the present disclosure, two tissues, including previously deployed staples, are improperly placed on the staple cartridge of FIG. 116. FIG. 6 is a graph showing the tissue impedance signature of a well-placed tissue of FIG. 119 according to at least one aspect of the present disclosure. It is a graph which shows the tissue impedance signature of the improperly arranged tissue of FIG. 120 according to at least one aspect of this disclosure. Shown is a properly placed, previously deployed staple-containing tissue on the staple cartridge of FIG. 116, according to at least one aspect of the present disclosure. Shown is an improperly placed, previously deployed staple-containing tissue on the staple cartridge of FIG. 116, according to at least one aspect of the present disclosure. FIG. 6 is a graph showing the tissue impedance signature of a well-placed tissue in FIG. 123 according to at least one aspect of the present disclosure. It is a graph which shows the tissue impedance signature of the improperly arranged tissue of FIG. 124 by at least one aspect of this disclosure. FIG. 5 is a logical flow diagram of Process 25600 showing a control program or logical configuration for properly positioning a previously stapled tissue within an end effector, according to at least one aspect of the present disclosure. An end effector extending from the shaft of a surgical instrument in an open configuration is shown according to at least one aspect of the present disclosure. FIG. 128 shows an end effector of FIG. 128 having a blood vessel (BV) extending between the end effector jaws according to at least one aspect of the present disclosure. Shown is the end effector of FIG. 128 in a tissueless closed configuration according to at least one aspect of the present disclosure. The end effector of FIG. 128 having a tissue gripped between the jaws of the end effector according to at least one aspect of the present disclosure. An end effector extending from the shaft of a surgical instrument in an open configuration is shown according to at least one aspect of the present disclosure. Shown is the end effector of FIG. 128 in a tissueless closed configuration according to at least one aspect of the present disclosure. The end effector of FIG. 128 having a tissue gripped between the jaws of the end effector 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.
U.S. Patent Application No. ___________, title of invention "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", agent reference number END8542USNP / 170755;
U.S. Patent Application No. ___________, title of invention "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS", agent reference number END8543USNP / 170760;
-US Patent Application No. ___________, title of invention "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATION INFORMATION", agent reference number END8543USNP1 / 170760-1;
U.S. Patent Application No. ___________, title of invention "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", agent reference number END8543USNP2 / 170760-2;
U.S. Patent Application No. ___________, title of invention "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", agent reference number END8543USNP3 / 170760-3;
U.S. Patent Application No. ___________, title of invention "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES", agent reference number END8543USNP4 / 170760-4;
-US Patent Application No. ___________, title of invention "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE", agent reference number END8543USNP5 / 170760-5;
U.S. Patent Application No. ___________, title of invention "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLES", agent reference number END8543USNP6 / 170760-6;
U.S. Patent Application No. ___________, title of invention "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", agent reference number END8543USNP7 / 170760-7;
U.S. Patent Application No. ___________, title of invention "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", agent reference number END8544USNP / 170761;
U.S. Patent Application No. ___________, title of invention "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT", agent reference number END8544USNP1 / 170761-1;
U.S. Patent Application No. ___________, title of invention "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY", agent reference number END8544USNP2 / 170761-2;
U.S. Patent Application No. ___________, title of invention "SURGICAL SYSTEMS WITH PRIORIZED DATA TRANSMISSION CAPABILITIES", agent reference number END8544USNP3 / 170761-3;
U.S. Patent Application No. ___________, title of invention "SURGICAL EVACUATION SENSING AND MOTOR CONTROL", agent reference number END8545USNP / 170762;
-US Patent Application No. ___________, title of invention "SURGICAL EVACUATION SENSOR ARRANGEMENTS", agent reference number END8545USNP1 / 170762-1;
U.S. Patent Application No. ___________, title of invention "SURGICAL EVACUATION FLOW PATHS", agent reference number END8545USNP2 / 170762-2;
U.S. Patent Application No. ___________, title of invention "SURGICAL EVACUATION SENSING AND GENERATION CONTORL", agent reference number END8545USNP3 / 170762-3;
-US Patent Application No. ___________, title of invention "SURGICAL EVACUATION SENSING AND DISPLAY", agent reference number END8545USNP4 / 170762-4;
U.S. Patent Application No. ___________, title of invention "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODELEMENT
U.S. Patent Application No. ___________, title of invention "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM;
-US Patent Application No. ___________, title of invention "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEEN A FILTER AND A SIMOKE Name "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS", 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, title of invention "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES";
-US Provisional Patent Application No. 62 / 691,230, title of invention "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
-US Provisional Patent Application No. 62 / 691,219, title of invention "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
-US provisional patent application No. 62 / 691,257, title of invention "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODEL FOR INTERITION"
U.S. provisional patent application No. 62 / 691,262, title of invention "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEEN A FILTER AND A SMOKE The title of the invention "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS".

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, title of invention "INTERACTIVE SURGICAL SYSTEMS WITH ENGRYPTED COMMUNICATION CAPABILITIES";
U.S. Patent Application No. 15 / 940,648, title of invention "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES";
U.S. Patent Application No. 15 / 940,656, title of invention "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATION ROOM DEVICES";
U.S. Patent Application No. 15 / 940,666, title of invention "SPATIAL AWARENSS OF SURGICAL HUBS IN OPERATING ROOMS";
U.S. Patent Application No. 15 / 940,670, title of invention "COOPERATION UTILIZATION OF DATA DELIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS";
U.S. Patent Application No. 15 / 940,677, title of invention "SURGICAL HUB CONTOROL ARRANGEMENTS";
U.S. Patent Application No. 15 / 940,632, title of invention "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. Patent Application No. 15 / 940,640, the title of the invention "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STARTUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BA"
U.S. Patent Application No. 15 / 940,645, title of invention "SELF DESCRIBING DATA PACKETS GENELATED AT AN ISSUING INSTRUMENT";
-US Patent Application No. 15 / 940,649, title of invention "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
U.S. Patent Application No. 15 / 940,654, Invention Title "SURGICAL HUB Situational AWARENESS";
U.S. Patent Application No. 15 / 940,663, title of invention "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
U.S. Patent Application No. 15 / 940,668, title of invention "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
U.S. Patent Application No. 15 / 940,671, title of invention "SURGICAL HUB SPARC AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
U.S. Patent Application No. 15 / 940,686, title of invention "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE";
U.S. Patent Application No. 15 / 940,700, title of invention "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
U.S. Patent Application No. 15 / 940,629, title of invention "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
-US Patent Application No. 15 / 940,704, title of invention "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
U.S. Patent Application No. 15 / 940,722, Invention Title "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY"; and U.S. Patent Application No. 15/940, 74D ARRAY IMAGING ".

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, title of invention "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. Patent Application No. 15 / 940,653, title of invention "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;
U.S. Patent Application No. 15 / 940,660, title of invention "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZETION AND RECOMMENDATIONS TO A USER";
-US Patent Application No. 15 / 940,679, title of invention "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGE"
U.S. Patent Application No. 15 / 940,694, title of invention "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION";
U.S. Patent Application No. 15 / 940,634, title of invention "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. Patent Application No. 15 / 940,706, Invention Name "DATA HANDLING AND PRIORIZATION IN A CLOUD ANALYTICS NETWORK";".

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, title of invention "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15 / 940,637, title of invention "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15 / 940,642, title of invention "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15 / 940,676, title of invention "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15 / 940,680, title of invention "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15 / 940,683, title of invention "COOPERATION SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15 / 940,690, Invention Name "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and U.S. Patent Application No. 15 / 940,711, Invention Name "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; PLATFORMS ".

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, title of invention "INTERACTIVE SURGICAL SYSTEMS WITH ENGRYPTED COMMUNICATION CAPABILITIES";
-US Provisional Patent Application No. 62 / 649,294, title of invention "DATA STRIPPING METHOD TO INTERROGATE PATION RECORDS AND CREATE ANONYMIZED RECORD";
-US Provisional Patent Application No. 62 / 649,300, title of invention "SURGICAL HUB Situational AWARENSS";
-US Provisional Patent Application No. 62 / 649,309, title of invention "SURGICAL HUB SPARC AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
-US Provisional Patent Application No. 62 / 649,310, title of invention "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
-US Provisional Patent Application No. 62 / 649,291, title of invention "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
-US Provisional Patent Application No. 62 / 649,296, title of invention "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
-US Provisional Patent Application No. 62 / 649,333, title of invention "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZETION AND RECOMMENDATIONS TO A USER";
-US Provisional Patent Application No. 62 / 649,327, title of the invention "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
-US Provisional Patent Application No. 62 / 649,315, title of invention "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";
-US Provisional Patent Application No. 62 / 649,313, title of invention "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES";
-US Provisional Patent Application No. 62 / 649,320, title of invention "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
-US provisional patent application No. 62 / 649,307, title of invention "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; -ASSISTED SURGICAL PLATFORMS ".

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, title of invention "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, title of invention "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES";
-US Provisional Patent Application No. 62 / 650,877, title of invention "SURGICAL SMOKE EVACUATION SENSING AND CONTORLS";
-US provisional patent application No. 62 / 650,882, title of invention "SMOKE EVACUATION MODEL FOR INTERACTIVE SURGICAL PLATFORM"; and-US provisional patent application No. 62 / 650,898, title of invention "CAPACITION SEPARABLE ARRAY ELEMENTS ".

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, title of invention "TEMPERATURE CONTOROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR"; and-US provisional patent application No. 62 / 640,415, title of invention "ESTIMATATING STATOR". END EFFECTOR AND CONTROL SYSTEM THE REFOR ".

The applicant of the present application owns the following US provisional patent application filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 611,341, title of invention "INTERACTIVE SURGICAL PLATFORM";
-US Provisional Patent Application No. 62 / 611,340, Invention Name "CLOUD-BASED MEDICAL ANALYTICS"; and-US Provisional Patent Application No. 62 / 611,339, Invention Name "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 in or incorporated into 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.

Referring to FIG. 1, a computer-mounted interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (eg, a cloud 104 that may include a remote server 113 attached to a storage device 105). ,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 is configured to communicate with each other and / or with the hub 106, a visualization system 108, a robot system 110, and a handheld intelligent surgical instrument 112. And, including. 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. , Where 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 robot 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 analyzes 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, vasoscope, 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 surgery requires strict sterilization of the operating room and surgical instruments. The "surgical theater", the strict hygiene and sterilization conditions required for operating rooms or treatment rooms, require the highest degree of sterilization of all medical devices and instruments. 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 seen as 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 devices, as shown in FIG. And one or more storage array 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 a 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 to the surgical instrument display 115 by the hub 106 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 section "Surgical Instrument Hardware", the entire disclosure of which is incorporated herein by reference, and the year 2017 entitled "INTERACTIVE SURGICAL PLATFORM". It is described in US Provisional Patent Application No. 62 / 611,341 filed December 28.

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 a surgical procedure, applying energy to tissue for sealing and / or cutting is generally associated with flue gas, aspiration of excess fluid, and / or tissue irrigation. 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. A first docking station, including a first docking station, the first energy generator module is slidably movable to electrically engage with power and data contacts, and the first energy generator module is: It is slidable and movable so as to disengage from the electrical engagement with the first power and data contacts.

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 may 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 may be configured to switch between imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 may 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 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 in 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 / Or various modules such as non-contact sensor modules may be mentioned.

In one aspect, the surgical data network 201 includes a combination of 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. 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 word "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 case various services such as servers, storage devices, and applications are used. Modular communication hub 203 and / or computer system 210 located at the surgical site (eg, fixed, mobile, temporary, or field operating room or space) and / or via the Internet. Alternatively, it is delivered to a device connected to the computer 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 devices.

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, including 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. It may be dedicated to long-distance 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 device 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 equipment 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 Bluetooth 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 device 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 or external buses, and / or local buses, using a variety of available bus architectures. ..

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 choices. 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 devices include, but are 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 disc storage device can store the storage medium independently, or a compact disc ROM device (CD-ROM), a compact disc recordable drive (CD-R drive), or a compact disc rewritable drive (CD-RW drive). Alternatively, an optical disk drive such as a digital versatile disc ROM drive (DVD-ROM) can be included, but the combination with other storage media is 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 a 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 memory storage devices are 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 with 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, and 308 are differential data ports that include differential data plus (DP1 to DP3) outputs, each of which is 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 for 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 driver 492, operably connects displacement members that are 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 a processor 462 that may be programmed or configured to determine the location of drive members that are longitudinally movable, as well as the location 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 choices. 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 driver 492 may be A3941 available from Allegro Microsystems, Inc. Other motor drivers may be readily substituted 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. It is described in 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 driver 492 and may be used by a surgical instrument or tool launch system. In various embodiments, the motor 482 may be a brushed DC drive motor with a maximum rotational speed of approximately 25,000 RPM. In other configurations, 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 driver 492 may include, for example, an H-bridge driver that includes a field effect transistor (FET). The motor 482 can be powered by a power assembly that is releasably mounted in 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 in the power assembly may be replaceable and / or rechargeable. In at least one embodiment, the battery cell can be a lithium ion battery that can be coupled to and separable from the power assembly.

The motor driver 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 driver 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. .. 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 drivers may be readily substituted 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 member 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 any movable member of a surgical instrument or tool, such as a drive member, launch member, launch bar, I-beam, or any element that can be displaced. Used generically to refer. 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 linear 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 detection system with arranged Hall effect sensors, magnetic detection system with fixed magnets and Hall effect sensors arranged on a series of movable straight lines, movable light sources and arranged on a series of straight lines An optical detection system with a light diode or photodetector, an optical detection system with a fixed light source and a light diode or photodetector arranged on a series of movable straight lines, or any combination thereof may be included. ..

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. Gear ring 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, where 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 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 more than one rotation 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, potentiometer, or an array of analog Hall effect elements that outputs 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 according to whether they measure the total magnetic field or vector component of the magnetic field. The techniques used to manufacture both types of magnetic sensors include many aspects of physics and electronics. Techniques used to detect magnetic fields 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 interfaces 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 member, as would be required in a conventional rotary encoder where the motor 482 simply counts the number of steps taken forward or backward to infer the position of the device actuator, drive bar, knife, 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 strain 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 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 a surgical instrument or tool. 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 separate 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 embodiment, a 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 exerted by 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 such as a micro strain gauge configured to measure one or more parameters of the end effector. 474 is provided. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the end effector jaw material during clamping operation, which can indicate tissue compression. The measured strain 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 can 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 device 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 order logic circuit 520 or combination 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 combination 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. Good. In certain examples, the firing motion generated by the motor 602, for example, deploys 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. The captured tissue may be cut. The I-beam element may 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 to 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 detailed herein 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 embodiment, the common control module 610 is 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. It can be switched selectively. 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 applied to the end effector may be detected by any conventional method, such as by a force sensor on the outside of the jaw, or by a torque sensor of the motor that operates the jaw.

In various examples, as shown in FIG. 16, the common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. The motor driver 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 batteries (or "battery packs" or "power packs"), such as lithium-ion batteries. In certain examples, the battery pack may be configured to be releasably 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 driver 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 driver 626 to stop and / or disable the motor coupled to the common control module 610. The term "processor" as used herein integrates the functionality of any suitable microprocessor, microcontroller, or computer central processing unit (CPU) into an integrated circuit or up to several integrated circuits. It should be understood to include other basic computing devices integrated on the circuit. 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 is an 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 mechanisms 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 the sensor 630, can be used to warn the processor 622 of program instructions to be used in a particular setting. For example, sensor 630 can warn processor 622 to use program instructions associated with 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 detect the position of the switch 614. Thus, the processor 622 can use the program instructions associated with the emission of the I-beam of the end effector when it detects, for example, through the sensor 630 that the switch 614 is in the first position 616, 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 circuit diagram 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 a launching member, a closing member, a shaft member, or one or more joint motion members. The surgical instrument 700 includes a control circuit 710 configured to control motor-driven launching members, closing members, shaft members, and / or one or more joint motion members.

In one aspect, the robotic surgical instrument 700 is an end effector 702 anvil 716 and I-beam 714 (including sharp cutting edge) portion, removable staple cartridge 718, shaft 740, via multiple motors 704a-704e. In addition, a control circuit 710 configured to control one or more joint movement members 742a, 742b is provided. 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 instructions for causing a 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 correlates the position of the I-beam 714 determined by the position sensor 734 with 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. be able to. 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 detect 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 slower 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 faster and / or with 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 can generate a motor set value signal. Motor set value signals may be provided to various motor controllers 708a-708e. Motor controllers 708a-708e provide one or more circuits configured to provide motor drive signals to motors 704a-704e to drive motors 704a-704e, as described herein. You may prepare. 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 to 704e 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. 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 portion 742a, and the joint movement portion 742b via the respective transmission devices 706a to 706e. May be done. 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 detect 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 embodiments, 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 can provide other signals indicating the motion of the I-beam 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a-704e is a stepper 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. it can. The position sensor 734 can be located within the end effector 702 or at any other part of the instrument. Each output of the motors 704a to 704e includes torque sensors 744a to 744e for detecting force, and has an encoder that detects 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 I-beam 714 distally and proximally 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 launch 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 along the firing stroke, or the position of the firing member, 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. As 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 an anvil 716 portion 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. Transmission device 706b includes movable mechanical elements such as rotating elements and closing members to control the movement of the anvil 716 from open and closed positions. In one aspect, the motor 704b is coupled to a closure gear assembly that includes a closure reduction gear set that is meshed with and supported by the closure 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 a motor set value to the motor control unit 708c that 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 includes 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 rotary 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 a motor set value to the motor control unit 708d that 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 a movable mechanical element 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, a closing member, or a joint motion member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, joint motion connections, 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 conjunction 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 locate the tissue using the split electrodes. Torque sensors 744a-744e may be configured to detect, 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 and its position facing the distal closure tube, (2) the launcher and its position in the rack, and (3) which part of the staple cartridge 718 has tissue on it. It can detect whether it has or (4) the load and position on both staples.

In one aspect, the one or more sensors 738 may include strain gauges, such as microstrain gauges, configured to measure the magnitude of strain in the anvil 716 during the clamped state. Strain gauges provide 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 the tissue section located between the anvil 716 and the staple cartridge 718, which impedance is the thickness and / or fullness of the tissue located between them. Is shown.

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 exerted on the anvil 716 by the closure tube. The force exerted on the anvil 716 may represent the tissue compression faced by the tissue section captured between the anvil 716 and the staple cartridge 718. One or more sensors 738 can be positioned at various points of interaction along the closure drive system to detect the closure force that the closure drive system exerts on the anvil 716. 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 clamp arm 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. The 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 near the target velocity. 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 cut edge), and an end effector 752 that 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 is movable in the longitudinal direction, the position of the I-beam 764 is determined by measuring the position of the drive member that is movable in the longitudinal direction that employs 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. 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 particular time (t) with respect to the starting 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 embodiments, 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 detect the position of the I-beam 764. The position sensor 784 may be any type of sensor capable of generating position data indicating the position of the I-beam 764, or may include it. In some embodiments, 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 can provide other signals indicating the motion of the I-beam 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 760 can 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 can be located within the end effector 752 or at any other part of the instrument.

The control circuit 760 can 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 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 752. It may include any other suitable sensor for measuring parameters. Sensor 788 may include one or more sensors.

One or more sensors 788 may include strain gauges, such as microstrain gauges, configured to measure the magnitude of strain in the anvil 766 during the clamped state. Strain gauges provide 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 the tissue section located between the anvil 766 and the staple cartridge 768, which impedance is the thickness and / or fullness of the tissue located between them. Is shown.

The sensor 788 may be configured to measure the force exerted by the closed drive system on the anvil 766. For example, one or more sensors 788 may be located at the point of interaction between the closed tube and the anvil 766 to detect the closing force that the closed tube exerts on the anvil 766. The force exerted on the anvil 766 may represent the tissue compression faced by the tissue section captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 can be positioned along the closure drive system at various points of interaction to detect the closure force that the closure drive system exerts on the anvil 766. 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 near the target velocity. 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 a 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 embodiment is an electric motor 754 that operates an interchangeable shaft assembly, eg, a displacement member 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 a motor-driven surgical staple fastening and cutting device. 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, if configured for use, a staple cartridge 768 located opposite the anvil 766. The clinician may grip the tissue between the anvil 766 and the staple cartridge 768 as described herein. When ready to use the instrument 750, 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, the I-beam 764 with the 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, for example, one or more tissue conditions. You may prepare. The control circuit 760 may be programmed to detect 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, control circuit 760 may be programmed to translate the displacement member faster and / or with higher power.

In some embodiments, the control circuit 760 may first operate the motor 754 in an open loop configuration with respect to 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 circuit diagram 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 anvil 766, an I-beam 764, and an end effector 792 that may include 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 conjunction 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, with anvil engagement tabs or features and channel engagement features or feet. Further may be included. 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 are incorporated herein by reference in their entirety, U.S. Patent Application No. 15 / 628,175 by the same applicant, the title of the invention "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING. It is described in "AND CUTTING INSTRUMENT" (filed on June 20, 2017).

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, a sensor mechanism, and a position sensor represented as a position sensor 784. Since the I-beam 764 is connected to a longitudinally movable drive member, the position of the I-beam 764 should be determined by measuring the position of the longitudinally movable drive member 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 herein. 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 particular time (t) with respect to the starting 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 embodiments, 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 detect the position of the I-beam 764. The position sensor 784 may be any type of sensor capable of generating position data indicating the position of the I-beam 764, or may include it. In some embodiments, 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 can provide other signals indicating the motion of the I-beam 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 760 can 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 can be located within the end effector 792 or at any other part of the instrument.

The control circuit 760 can 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 parameters may be provided. Sensor 788 may include one or more sensors.

One or more sensors 788 may include strain gauges, such as microstrain gauges, configured to measure the magnitude of strain in the anvil 766 during the clamped state. Strain gauges provide 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 the tissue section located between the anvil 766 and the staple cartridge 768, which impedance is the thickness and / or fullness of the tissue located between them. Is shown.

The sensor 788 may be configured to measure the force exerted by the closed drive system on the anvil 766. For example, one or more sensors 788 may be located at the point of interaction between the closed tube and the anvil 766 to detect the closing force that the closed tube exerts on the anvil 766. The force exerted on the anvil 766 may represent the tissue compression faced by the tissue section captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 can be positioned along the closure drive system at various points of interaction to detect the closure force that the closure drive system exerts on the anvil 766. One or more sensors 788 may be sampled in real time during clamping 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 change the stroke length of the closed tube assembly based on the joint motion angle θ. Such a change in stroke length shortens the stroke length to the compensating stroke length (eg, along the y-axis) as the joint motion angle θ increases (eg, along the x-axis). Including doing. The compensatory stroke length defines the length by which the closed tube assembly moves distally to close the end effector jaws, which depends on the joint motion angle θ and the closed tube assembly overmoves. To prevent damage to surgical equipment.

For example, as shown in the stroke length graph 20740, when the end effector is not in joint movement, the stroke length of the closing tube assembly for closing the jaws is about 0.250 inches and the joint movement angle θ is about. At 60 degrees, the compensating stroke length is about 0.242 inches. Such measurements are provided by way of example and can include any of various angles and corresponding stroke lengths and compensating stroke lengths without departing from the scope of the present disclosure. Furthermore, the relationship between the joint movement angle θ and the compensating stroke length is non-linear, and the rate at which the compensating stroke length becomes shorter increases as the joint movement angle increases. For example, the reduction in compensatory stroke length between a 45 degree joint movement and a 60 degree joint movement is greater than the reduction in the compensatory stroke length between a zero degree joint movement and a 15 degree joint movement. In this approach, the control system adjusts the stroke length based on the joint motion angle θ to prevent damage to the surgical device (eg, clog the distal end of the closed tube assembly in the distal position). However, the distal closure can still advance during joint movement, which can at least partially close the jaws.

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 change in the longitudinal position of the closed tube assembly compensates for the closed tube assembly when the end effector is in joint motion and based on the joint motion angle θ (eg, shown along the x-axis). For example, it involves retracting proximally (shown along the y-axis). The compensatory distance for the closure tube assembly to retract proximally prevents the distal closure tube from advancing distally, thereby keeping the jaws in the open position during joint movement. By retracting the closure tube assembly proximally by a compensating distance during joint movement, the closure tube assembly can move the stroke length starting from the proximally retracted position to close the jaws when the closure assembly is activated. it can.

For example, as shown in the closed tube assembly positioning graph 20750, the compensation distance is zero when the end effector is not in joint movement, and the compensation distance is about 0.008 when the joint movement angle θ is about 60 degrees. In inches. In this embodiment, the closed tube assembly is retracted by a compensation distance of 0.008 inches during joint movement. Therefore, to close the jaws, the closed tube assembly can advance the stalk length starting from this retracted position. Such measurements are provided for illustrative purposes only and may include any of the various angles and corresponding compensation 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 compensation distance is non-linear, and the rate at which the compensation distance increases increases as the joint movement angle θ increases. For example, the increase in compensation distance between 45 degrees and 60 degrees is greater than the increase in compensation distance between zero degrees and 15 degrees.

When clamping patient tissue, the clamping device (eg, linear stapler), and the forces applied through the tissue can reach unacceptably high levels. For example, if a constant closure speed is adopted, this force may be high enough to cause excessive trauma to the clamped tissue and cause deformation of the clamping device, which is acceptable. Possible 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 controlled tissue compression (CTC)) and compression at a variable anvil closure rate (ie, with CTC). ) Is a graph showing a comparison with the electric power applied to the tissue. The closure rate may be adjusted to control tissue compression so that the power applied within the tissue remains constant over a portion of the compression. According to FIG. 22, the peak power applied to the tissue is much lower when the variable anvil closure rate is utilized. Based on the applied power, the force exerted by the surgical device (or a force-related or force-proportional parameter) can be calculated. In this regard, power is acceptable along the entire staple fastening length when the force exerted through the surgical device (eg, through the jaws of the linear stapler) is in a fully closed position. It may be limited so that it does not exceed the yield force or pressure that results in the spread of the jaws that are out of range. For example, the jaws should be parallel or close enough so that the tissue gap remains within an acceptable or target range at all staple positions along the entire length of the jaw. In addition, limiting the power applied avoids or at least minimizes trauma or damage to the tissue.

In FIG. 22, the total energy applied in the method without CTC is the same as the total energy applied in the method with CTC. That is, the areas under the power curve in FIG. 22 are the same or substantially the same. However, since the peak power is much lower in the examples with CTC compared to the examples without CTC, the difference in power profiles utilized is quite large.

The power limit is achieved in the embodiment with 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 a constant closing rate (ie, without CTC) have the same compression force of 50 lb as devices and methods that provide variable closing rates (ie, with CTC). , Achieved with the same 1 mm tissue gap. 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 utilize variable closing rates, which is shown in FIG. 22. As shown in, there is a spike in the power applied to the tissue. In contrast, the exemplary embodiment shown with CTC slows the rate of closure and limits the amount of power applied to the tissue below a certain level. By limiting the power applied to the tissue, tissue trauma can be minimized as compared to systems and methods that do not use CTC.

FIG. 22 and additional illustrations are US Pat. No. 8,499,992 issued August 6, 2013, entitled "DEVICE AND METHOD FOR CONTROLLING COMPRESSION OF TISSUE", the entire disclosure of which is incorporated herein by reference. , (Applied June 1, 2012).

In some embodiments, the control system assists the control system in determining the position of the E-beam and / or the joint motion angle of the firing shaft and appropriately controlling at least one motor based on such determination. , Can include multiple predetermined force thresholds. For example, the force threshold can vary depending on the length of movement of the launch bar configured to translate the launch shaft, and such force threshold can be one or more motors that communicate with the control system. Can be compared with the measured torsional force of. By comparing the measured torsional force to the force threshold, a reliable method can be provided for the control system to determine the position of the end effector's E-beam and / or joint motion. This allows the control system to properly control one or more motors (eg, reduce or stop the torsional load) to properly launch and launch the launch assembly, as described in more detail below. It is possible to ensure proper joint movement of the end effector and prevent damage to the system.

FIG. 23 shows a force and displacement graph 20800, including the measured force of section A related to the measured displacement of section B. Both sections A and B have an x-axis indicating time (eg, seconds). The y-axis of section B indicates the displacement of the launch rod (eg, in millimeters), and the y-axis of section A represents the force applied to the launch bar, thereby advancing the launch shaft. As shown in Section A, the end effector is articulated by moving the launch bar within the first articulation range 20902 (eg, the first approximately 12 mm movement). For example, at a displacement position of 12 mm, the end effector is fully articulated to the right, further articulation is mechanically impossible. As a result of full joint movement, the torsional force applied to the motor increases and the control system can detect a joint movement peak 20802 that exceeds a predetermined joint movement threshold 20804, as shown in Section A. The control system can include more than one predetermined joint movement threshold 20804 to detect more than one maximum joint movement direction (eg, left and right joint movements). 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, the shift mechanism within the surgical stapler can cause further distal movement of the launch bar, causing distal movement of the launch shaft. For example, as shown in Section B, a movement of movement displacement of about 12 mm to 70 mm can advance the E-beam along the firing stroke 20904 and cut the tissue captured between the jaws, but other The moving length is within the scope of the present disclosure. In this embodiment, the maximum firing stroke position 20906 of the E-beam occurs with a movement of 70 mm. At this point, the E-beam or knife abuts on the distal end of the cartridge or jaw, thereby increasing the torsional force on the motor and causing the control system to detect the knife movement peak 20806 as shown in Section A. As shown in Section A, the control system branches from the motor threshold 20808 and the motor threshold 20808 and decreases (eg, non-linearly) as the E-beam approaches the maximum firing stroke position 20906. Can include ends.

The control system monitors the motor torsional force detected during at least the last portion of the distal movement of the E-beam 20907 (eg, the last 10 percent of the launch stroke 904) before reaching the maximum launch stroke position 20906. Can be configured as While monitoring along such a last portion of distal movement 20907, the control system can reduce the torsional force on the motor, thereby reducing the load on the E-beam. This allows the surgical stapler containing the E-beam to be protected from damage by reducing the load on the E-beam as it approaches the maximum firing stroke position 20906, whereby the E-beam can be cartridge or jawed. Reduces the impact on the distal end of the stapler. As mentioned above, such an impact can give rise to a knife movement peak 20806, which can exceed the knife movement threshold 20810 but not the motor threshold 20808 to the motor. Does not damage. Therefore, the control system shuts down the motor after the knife movement peak 20806 exceeds the knife movement threshold 20810 and before the knife movement peak 20806 exceeds the motor threshold 20808, thereby damaging the motor. Can be protected from. Further, the increased decrease in the knife movement threshold 20810 prevents the control system from predicting 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 firing bar can be retracted based on a known displacement position to return the E-beam to the nearest position 20908 (eg, 0 mm displacement). At the nearest position 20908, a knife retreat peak 20812 above the predetermined knife retreat threshold 20814 can be detected by the control system, as shown in Section A. At this point, the control system can be recalibrated as needed and the E-beam position can be associated as being in the home position. This home position is where the shifter will disengage the E-beam from the launch bar the next time the firing rod advances distally (eg, about 12 mm in length). After disengagement, the launch bar moves within the joint motion range 20902, causing the end effector joint motion again.

Therefore, the control system detects the torsional force on the motor that controls the movement of the launch bar and compares the detected torsional force with a plurality of threshold values to determine the position of the E-beam or the joint motion angle of the end effector. Thereby, the motor can be appropriately controlled to prevent damage to the motor, and at the same time, the positioning of the firing bar and / or the E-beam can be confirmed.

As mentioned above, the tissue contact or pressure sensor determines when the jaw member first contacts the tissue "T". This allows the surgeon to determine the initial thickness of tissue "T" and / or the thickness of tissue "T" before clamping. In any of the aspects of the surgical instrument described above, as shown in FIG. 24, the contact between the jaw member and the tissue "T" is with a pair of opposing plates "P1, P2" provided on the jaw member. By establishing contact with, the detection circuit "SC", which would normally be open, is closed. The contact sensor may also include a sensing force transducer that determines the amount of force applied to the sensor. It can be assumed that the amount of force applied to the sensor is the same as the amount of force applied to the tissue "T". And such force applied to the tissue can be rephrased as the amount of tissue compression. The force sensor measures the amount of compression the tissue is receiving and provides the surgeon with information about the force applied to the tissue "T". Excessive tissue compression can adversely affect the tissue "T" being manipulated. For example, excessive compression of tissue "T" can result in tissue necrosis and, with certain treatments, staple line breakage. The information about the pressure exerted on the tissue "T" allows the surgeon to better determine that the tissue "T" is not under excessive pressure.

Any contact sensor disclosed herein is, but is not limited to, electricity mounted on the inner surface of a jaw that normally closes an open detection circuit when in contact with tissue. The contacts can be mentioned. Contact sensors can also include sensing force transducers that detect when the clamped tissue first resists compression. The force converter drives, but is not limited to, 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. For this purpose, potential differential pressure converters using Bourdon tubes, capsules or bellows can be mentioned.

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

In one aspect, any one of the aforementioned surgical instruments may include, or is equipped with, one or more metal strain gauges located within or on a portion of the body. You may be doing it. Metal strain gauges operate on the principle that the resistance of a material depends on its length, width, and thickness. Therefore, when the material of the metal strain gauge is strained, the resistance of the material changes. For this reason, a resistor made of this material incorporated into the circuit converts the strain into a change in the electrical signal. Desirably, the strain gauge can be placed on the surgical instrument so that the pressure applied to the tissue affects the strain gauge.

Alternatively, in another embodiment, 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, the resistance of the material changes as the crystal lattice structure of the semiconductor strain gauge deforms as a result of the applied stress. This phenomenon is called the piezoresistive effect.

In yet another aspect, any one of the surgical instruments described above may include one or more inductive pressure sensors for converting pressure or force into movement of the inducible elements relative to each other. , Or may be equipped with it. The movement of the inductive elements relative to each other changes the overall inductance or inductive coupling. Capacitive pressure transducers likewise convert pressure or force into the movement of capacitive elements relative to each other, changing the overall capacitance.

In yet another aspect, any one of the surgical instruments described above is one or two for converting pressure or force into movement of the capacitive elements relative to each other and varying the overall capacitance. It may include or be equipped with one or more capacitive pressure transducers.

In one aspect, any one of the surgical instruments described above may include, or be equipped with, one or more mechanical pressure transducers for converting pressure or force into motion. You may be. During use, the movement of mechanical elements is used to shift the pointer or dial of 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 may be converted into a mechanical motion that shifts the wiper of the potentiometer to change the resistance that reflects the applied pressure or force.

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" can guide the surgeon in choosing the appropriate staple size. Information about the clamped thickness of the tissue "T" can inform the surgeon if the selected staples are properly formed. Information about the initial thickness of the structure "T" and the clamp thickness can be used to determine the amount of compression or strain of the structure "T". In addition, information about the strain of the tissue "T" can be used to compress the tissue to an excessive strain value and / or avoid stapling to the tissue subjected to the excessive strain.

In addition, force sensors can be used to provide the surgeon with the amount of pressure applied to the tissue. The surgeon can use this information to avoid applying excessive pressure to the tissue "T" or stapling to the tissue "T" in the face of excessive strain.

FIG. 24 and additional illustrations are US Pat. No. 8,181,839, issued May 5, 2012, entitled "SURGICAL INSTRUMENT EMPLOYING SENSORS," the entire disclosure of which is incorporated herein by reference. It is further described in (filed on June 27).

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 show motor-driven surgical instruments 150010 for cutting and fastening that can or cannot be reused. In the illustrated embodiment, the surgical instrument 150010 includes a housing 150012 with a handle assembly 150014 that is configured to be gripped, operated, and actuated by the clinician. Housing 15012 is configured to be operably attached to a replaceable shaft assembly 150200, to which end effectors 150300 configured to perform one or more surgical tasks or procedures are operably connected. Has been done. According to the present disclosure, various forms of interchangeable shaft assemblies can be effectively used in connection with robotic controlled surgical systems. The term "housing" is a robotic system that accommodates or operably supports at least one drive system configured to generate and add at least one control motion that can be used to actuate an interchangeable shaft assembly. Housing 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 robotic systems 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 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 internally. The housing 150012 may be configured for use in connection with a replaceable shaft assembly, which includes an end effector adapted to support staple cartridges of various sizes and types. And it has various shaft lengths, sizes and types. The housing 150012 has high frequency (RF) energy, ultrasonic energy, and / or for various interchangeable shaft assemblies, such as end effector configurations adapted for use in connection with various surgical applications and procedures. It may be used with other motions such as motion and assemblies configured to apply energy forms and the like. End effectors, shaft assemblies, handles, surgical instruments, and / or surgical instrument systems can utilize any suitable fastener for fastening tissue. For example, a fastener cartridge with a plurality of fasteners removably stored therein may be removably 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 150016, 15001 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 gripped and manipulated by the clinician. The handle assembly 150014 operably supports multiple drive systems so that these drive systems generate a control motion and apply this control motion to the corresponding portion of the replaceable shaft assembly operably attached to the handle assembly. It is configured in. 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 the "first", i.e., the closed drive system 150030, which can apply the closed and open motion 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 is pivotally coupled to the handle assembly 150014 by a pivot pin 15003, allowing the closure trigger 150032 to be operated by a clinician. When the clinician grasps the pistol grip portion 150019 of the handle assembly 150014, the closure trigger 150032 pivots from the starting position or "non-actuated" position to the "actuated" position, more specifically to the fully compressed or fully actuated position. I can move.

The handle assembly 150014 and frame 150020 may operably support the launch drive system 150080, the launch drive system 150080 being configured to apply launch motion to the corresponding portion of the attached interchangeable shaft assembly. Has been done. The launch drive system 150080 may use an electric motor 150082 located at 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 supply 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 internally. 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 connected 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 connected to the control circuit board 150100. The cover 15004 may be removed to expose the display 15004.

The electric motor 150082 operably interfaces with a gear reducer assembly 150084 mounted by engaging and engaging a set or rack of drive teeth 150122 on a drive member 150120 that is movable in the longitudinal direction (FIG. Not shown) can be included. The drive member 150120, which is movable in the longitudinal direction, has a rack of drive teeth 150122 formed on the drive member 150120 for meshing and engaging 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, while the voltage polarity applied to the electric motor by the battery causes the electric motor 150082 to operate counterclockwise. Can be flipped to make it. 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 being 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 activated position.

Returning to FIG. 25, the replaceable shaft assembly 150200 includes an end effector 150300 with an elongated channel 150302 configured to operably support the surgical staple cartridge 150304 internally. 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 the 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. .. 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 utilized to close and / or open the anvil 150306 of the end effector 150300.

Returning to FIG. 25, the closed tube 150260 is, for example. Translated distally (direction "DD") to close anvil 150306 in response to activation of closure trigger 150032 by the method described in US Patent Application Publication No. 2014/0263541, which is the aforementioned reference. To. The anvil 150306 is opened by translating the closing tube 150260 proximally. In the anvil open position, the closing tube 150260 is moved to its proximal position.

FIG. 27 is 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 that is 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 and the knife bar 150280 is advanced and positioned within channel 150302 until the proximal side wall of longitudinal slot 150223 contacts tab 150284. The staple cartridge 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, the top frame segment 150215 may be engaged with the shaft frame 150212 to enclose the intermediate launch shaft 150222 and the knife bar 150280 internally. 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 interchangeable shaft assembly 150200 may include a clutch assembly 150400 configured to selectively and releasably connect the joint motion driver 150230 to the launching member 150220. The clutch assembly 150400 includes a lock collar or lock sleeve 150402 that is positioned around the launch member 150220, the lock sleeve 150402 is an engaging position where the lock sleeve 150402 connects the joint motion driver 150230 to the launch member 150220 and a joint motion driver. The 150230 may be rotated to and from a disengagement 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 launch member 150220 can move the joint movement driver 150230 distally, and the corresponding proximal movement of the launch member 150220 causes joint movement. The driver 150230 can 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 driver 150230, so that the launching member 150220 can move independently of the joint motion driver 150230. Nozzle 150201 can be used to operably engage and disengage a joint drive system and a launch drive system in a variety of manners as described in US Patent Application Publication No. 2014/0263541.

The replaceable shaft assembly 150200 may include a slip ring assembly 150600, which, for example, directs power to and / or from the end effector 150300 and / or extends to the end effector 150300. / Or may be configured to communicate signals from the end effector 150300. The slip ring assembly 150600 may include a proximal connector flange 150604 and a distal connector flange 150601 located 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 has a second surface that is located adjacent to the first surface and 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. Proximal connector flange 150604 may include a plurality of concentric, or at least substantially 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 contact corresponding to one of the conductors 150602 and electrically with it. Are in contact. 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. The proximal connector flange 150604 may include, for example, an electrical connector 150606 in which the conductor 150602 can be placed in signal communication with the shaft circuit board. In at least one case, a wire harness containing the 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 in 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 by reference in its entirety. Further details regarding the slip ring assembly 150600 can 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 may 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 connected to an elongated channel 150302. An opening 150199 may be defined within the elongated channel 150302, which receives the pin 150152 extending from the anvil 150306 so that the anvil 150306 is open to the elongated channel 150302 and the surgical staple cartridge 150304 from an open position. Allows you to pivot to a closed position. The launch bar 150172 is configured to translate longitudinally into the end effector 150300. The launch bar 150172 may be constructed from one solid portion or may include a laminate material containing a laminate of steel plates. The launch bar 150172 comprises an I-beam 150178 and a cutting edge 150182 at its distal end. The distally projecting end of the launch bar 150172 is attached to the I-beam 150178 and anvils spaced 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 for separating tissue while advancing the I-beam 150178 distally by a firing bar 150172. During operation, the I-beam 150178 can fire the surgical staple cartridge 150304. The surgical staple cartridge 150304 can include a molded cartridge body 150194 that holds a plurality of staples 150191 mounted on the staple driver 150192 in the corresponding upwardly open staple cavities 150195. The wedge thread 150190 is driven distally by the I-beam 150178 and slides over the cartridge tray 150196 of the surgical staple cartridge 150304. While the cutting edge 150182 of the I-beam 150178 cuts off the clamped tissue, the wedge-shaped thread 150190 cams the staple driver 150192 upward to push out the staple 150191 into deformation 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 is positioned within the elongated channel 150302, the slot 150193 defined in the cartridge body 150194, the longitudinal slot 150197 defined in the cartridge tray 150196, and the slot defined in the elongated channel 150302. It can be aligned with 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 is a slot. A groove extending along the bottom surface of the elongated channel 150302 along the length of 150189 can be engaged, and the central pin 150184 engages the top surface of the cartridge tray 150196 along the length of the longitudinal slot 150197. The upper pin 150180 can be engaged with the anvil 150306. When the launch bar 150172 is advanced distally to launch staples from the surgical staple cartridge 150304 and / or incision the tissue trapped between the anvil 150306 and the surgical staple cartridge 150304, the I-beam 150178 , The anvil 150306 and the surgical staple cartridge 150304 can be spaced apart or the relative movement between them can be restricted. The launch bar 150172 and I-beam 150178 can be retracted proximally, thereby opening the anvil 150306 and releasing the two stapled and detached 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 the motor driver 150715 and can be used by the launch system of the surgical instrument 150010. In various embodiments, the motor 150714 may be a brushed DC drive motor with a maximum rotational speed of approximately 25,000 RPM. In other configurations, 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 driver 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 mounted on the handle assembly 150200 to supply control power to the surgical instrument 150010. The power assembly 150706 may include multiple battery cells connected in series that can be used as a power source to power the surgical instrument 150010. Under certain circumstances, the battery cells in power assembly 150706 may be replaceable and / or rechargeable. In at least one embodiment, the battery cell may be a lithium ion battery that may be separately connectable to the power assembly 150706.

The shaft assembly 150704 can include a shaft assembly controller 150722 that can communicate with the safety controller and 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. .. For example, the interface corresponds to the shaft assembly electrical to allow telecommunications between the shaft assembly controller 150722 and the power management controller 150716 while the shaft assembly 150704 and power supply assembly 150706 are connected to the handle assembly 150702. A first interface portion 150725 that may include one or more electrical connectors for connection engagement with the connector and one or more for connection engagement with the corresponding power assembly electrical connector. It may include a second interface portion 150727, which may include an electrical connector. One or more communication signals can be transmitted through the interface to transmit one or more of the power requirements of the attached interchangeable shaft assembly 150704 to the power management controller 150716. Accordingly, the power management controller can 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 activated after the handle assembly 150702 and the shaft assembly 150704 and / or the power supply assembly 150706 are mechanically coupled and engaged to allow telecommunications between the shaft assembly controller 150722 and the power management controller 150716. Can be equipped with a switch that can be used.

The interface is one or two between the power management controller 150716 and the shaft assembly controller 150722 by, for example, routing such communication signals via the main controller 150717 housed in the handle assembly 150702. The transmission of one or more communication signals can be facilitated. Under other circumstances, the interface provides direct line communication between the power management controller 150716 and the shaft assembly controller 150722 via the handle assembly 150702 while the shaft assembly 150704 and power supply assembly 150706 are connected to the handle assembly 150702. Can be facilitated.

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 choices. Good.

The power assembly 150706 may include a power management circuit, which may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. 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 while the shaft assembly 150704 and the power supply assembly 150706 are connected to the handle assembly 150702. The power management controller 150716 may 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 provides feedback on the power output of the battery. As it can be used to provide 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 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) can 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 which 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 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 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 achieved via the interface while the shaft assembly 150704 is connected 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 accepts 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 embodiments, 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 via 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 embodiments, the display segment is coupled to a safety controller.

The shaft segment (segment 5) is attached to the control unit for the replaceable shaft assembly 150200 (FIGS. 25 and 27) connected to the surgical instrument 15001 (FIGS. 25-28) and / or to the interchangeable shaft assembly 150200. It comprises one or more controls for the connected end effector 150300. 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 connected to the replaceable shaft assembly 150200 and / or may be integrated with the surgical instrument 150010. In some embodiments, the shaft segment comprises a second shaft EEPROM. The second shaft EEPROM contains multiple algorithms, routines, parameters, and / or other data corresponding to one or more shaft assemblies 150200 and / or end effectors 150300 that can interface 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 rotation position. In some embodiments, 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 connected 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 connected to the safety controller. The motor current sensor is connected in series with the motor in order to measure the current drawn in by the motor. The motor current sensor is in signal communication with the main controller 150717 and / or the safety controller. In some embodiments, 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 supplies a pulse width modulation (PWM) high signal, a PWM low signal, a direction signal, a synchronization signal, and a motor reset signal to the motor controller 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 embodiments, one or more voltage converters are configured to provide a predetermined voltage value to one or more circuit segments. For example, in some embodiments, 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. The boost transducer is configured to provide additional voltage and / or current during power intensive operation to prevent voltage drops or low power conditions.

The plurality of switches are connected 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), control the operation of the segmented circuit, and / or 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 connected 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 connected 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 connected to the main controller 150717 by a right flexible connector. The firing switch, clamp release switch, and shaft engagement switch are connected 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 limiting switch operated by the movement of components associated with the surgical instrument 150010 (FIGS. 25-28) or by 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. Limit switches are used in a variety of applications and environments due to their robustness, ease of installation, and reliability of operation. 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. May be good. In other embodiments, 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. The handle assembly 150702 can include a main controller 150717, a shaft assembly connector 150726, and a power assembly connector 150730. The power assembly 150706 can 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 detection circuit 150736. The shaft assembly connectors 150730, 150732 form the interface 150727. While the interchangeable shaft assembly 150704 and the power supply assembly 150706 are connected to the handle assembly 150702, the power management circuit 150734 may be configured to modulate the power output of the battery 150707 based on the power requirements of the interchangeable shaft assembly 150704. .. The power management controller 150716 may 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 power output of the battery 150707. It may be used to provide feedback to the power management controller 150716, which allows the power management controller 150716 to adjust the power output of the power assembly 150706 to maintain the desired output. The shaft assembly 150704 comprises a shaft processor 150720, which is connected to the non-volatile memory 150721 and the shaft assembly connector 150728, and electrically connects 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 may be configured to implement one or more of the processes described herein.

The surgical instrument 150010 (FIGS. 25-28) can 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 which 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. 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 achieved via interface 150725 while the interchangeable shaft assembly 150704 is connected to the handle assembly 150702. Although the control circuit 150700 (FIGS. 29A-29B, and 6) for controlling the operation of the surgical instrument 150010 (FIGS. 25 and 28) has been described, the present disclosure is here for the surgical instrument 150010 (FIGS. 25 and 28). 25 to FIG. 28) and various configurations of the control circuit 150700 will be described.

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, compression does not have to be applied to the tissue while preparing to use the end effector. Next, referring to FIG. 33, by engaging the handle of the surgical stapler (eg, handle 151002), the physician can use the end effector 151030 to compress the tissue 151332. 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 15132 by the end effector 151030. For example, when tissue 151032 is compressed between anvil 15103 of end effector 151030 and channel frame 151036, normal forces F1 and F2 can be applied by the anvil 151304 and channel frame 151036. Next, referring to FIG. 35, various oblique and / or lateral forces may also be applied to the tissue 15132 when compressed by the end effector 151030. For example, force F3 may be applied. In order to operate medical devices such as the surgical stapler 151000, it may be desirable to detect or calculate the various forms of compression applied to the tissue by the end effector. For example, an understanding of vertical or lateral compression may allow end effectors to apply staple movements more precisely or accurately, or surgical staplers may be used more appropriately or safely. Information on surgical staplers can be given to the operator.

The compression in the direction through the structure 151032 can be determined from the impedance of the structure 151032. At various compression levels, the impedance Z of tissue 15132 can increase or decrease. By applying voltage V and current I to tissue 151032, the impedance Z of tissue 151032 can be determined at various 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 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 vertical tissue compression 151042 produced by the end effector 151030 can be measured as a function of the impedance Z of the structure 151332.

Next, referring to FIG. 37, in one aspect, when the RF electrode 151038 is positioned, the electrical contact 151444 can be positioned at the opposite end of the anvil 151534 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. The lateral tissue compression 15146 produced by the end effector 151030 can be measured as a function of the impedance Z of the structure 151332.

Next, referring to FIG. 38, in one aspect, the electrical contact 151050 may be positioned above the anvil 151534 and the electrical contact 151052 may be located at the opposite end of the end effector 151030 in the channel frame 151036. The RF electrode 151048 may be positioned laterally to 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 or angular compression 151054 and 151056 on either side of the RF electrode 151048 can be triggered by the end effector 151030 and vary in structure 15132 based on the relative positioning of the RF electrode 151048 and electrical contacts 151050 and 151052. Can be measured as a function of impedance Z.

Next, referring to FIG. 39, the frequency generator 151222 can receive power or current from the power source 151221 and supply one or more RF signals to one or more RF electrodes 151224. Can be done. As mentioned above, one or more RF electrodes can be positioned 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 can 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 and / or communicably linked between one or more RF electrodes 151224 and the electrical contacts 151226 or 151228. It can be used to calculate the impedance Z associated with a tissue that can be.

Further referring to FIG. 39, various components of the tissue compression sensor system described herein can be located within the handle 151236 of a surgical stapler. For example, as shown in schematic 151220a, the frequency generator 151222 may be located within the handle 151236 and receives 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 linked 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 compressed and / or communicably linked 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 some implementations, the power supply on 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 a 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 end effector 151262 of the surgical stapler. Tissues (not shown) can be compressed and / or communicatively linked between one or more of the 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 communicably linked. 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 are communicably coupled to a staple cartridge (which is communicatively coupled to 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. obtain. 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 compressively and / or communicably linked between one or more of the RF electrodes 151260 and the electrical contacts 151264. In addition, the Z2 may correspond to the impedance of the tissue compressed and / or communicably linked 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 may be high Q filters such that the filter range may 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 disclosure provides an instrument 150010 (described in connection with FIGS. 25-30) composed of various detection 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 viscoelasticity / 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. For tissue gaps, it is useful to know how much the jaws are covered by the 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. If any of these measurements were used alone, it could be difficult for the internal surgical device to distinguish the tissue type. The rate of change in compression can also help to allow 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 differential coefficient of the signal will provide another measurement that allows the in-vivo surgical device to measure the 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 clamping 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 done.

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 include the size or distance of the jaw gap, firing current, tissue compression, amount of jaw covered by tissue, anvil strain, and triggering force, to name a few. Various sensors can be included to measure operating parameters such as. 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.

A motor-driven surgical cutting and fastening instrument 151310, which may or may not be reused, is then shown with reference to FIG. The motor-driven surgical cutting and fastening instrument 151310 is constructed and equipped similarly to 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 an interchangeable 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 similarly to the motor-driven surgical cutting and fastening instrument 150010 described in connection with FIGS. 25-30, so that it is concise and clear. In order to do so, the details of operation and structure are not repeated here.

Housing 151312, shown in FIG. 44, is connected to a replaceable shaft assembly 151500, including an end effector 151600 with a surgical cutting and fastening device configured to operably support the surgical staple cartridge 151304 internally. Is shown. Housing 151312 includes end effectors adapted to support staple cartridges of various sizes and types, and is used in connection with interchangeable shaft assemblies having various shaft lengths, sizes, types, etc. It may be configured in. In addition, the housing 151312 may also be effectively used with a variety of other interchangeable shaft assemblies, such as interchangeable shaft assemblies with other motion and form energies such as radio frequency (RF). Examples include assemblies configured to apply energy, ultrasonic energy and / or motion to end effector configurations adapted for use in connection with various surgical applications and procedures. 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 removably stored internally may be removably inserted and / or attached to 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 gripped and manipulated by the clinician. The handle assembly 151314 operably supports multiple drive systems internally, which generate various control movements and control this to the corresponding portion of the replaceable shaft assembly operably attached to the handle assembly. It is configured to apply exercise. 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 internally. The end effector 151600 may further include an anvil 151306 that is pivotally supported for the elongated channel 151302.

We find that the derived parameters may be even more useful than the detected parameters underlying the derived parameters for controlling surgical instruments such as the instruments illustrated in FIG. I found. Non-limiting examples of derived parameters include the rate of change of the detected parameter (eg, jaw clearance distance) and the elapsed time for the tissue parameter to reach an asymptotic steady-state value (eg, 15 seconds). Can be mentioned. 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 in impedance (ie, tissue compression) can be combined with strain in the anvil to relate compression and force, which allows the microcontroller to determine the amount of tissue compression as well as the tissue type. It becomes possible to do. 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, clamp completion) 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 gap distance over time, where the gap is the space between the jaws occupied by the clamped tissue. 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 clamping tissue. Since the tissue has non-uniform elasticity, the rate of change in interstitial distance can fluctuate. For example, some tissue types may 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. As the tissue is squeezed between the anvil 151306 of the end effector 151340 and the staple cartridge 151304, the gap diminishes over time. 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. Can 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, and the slope = Δd / Δt.

FIG. 47 is an exemplary graph showing the firing current of the end effector jaws. The vertical (y) axis is the current and the horizontal (x) axis is the time. As discussed herein, the surgical instruments and / or their microcontrollers illustrated and described in connection with FIG. 25 are utilized during various operations such as tissue clamping, cutting, and / or stapling. It may include a current sensor that detects the current to be generated. For example, as the resistance of the tissue increases, the electric motor of the appliance may require more current to clamp, cut, and / or staple the tissue. Similarly, as resistance decreases, the electric motor may require less current to clamp, 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. Further 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. The rate of change of firing current can fluctuate if the cut tissue results in more resistance due to the properties of the tissue or the sharpness of the knife 151305 (FIG. 45). As the cutting conditions fluctuate, the work done by the motor fluctuates, and as a result, the firing current fluctuates over time. The current sensor can be used to measure the firing current over time while the knife 151305 is firing, as shown graphically in FIG. 47. For example, a current sensor can be used to monitor the motor current. 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 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 under manipulation (eg, clamping and stapling). The tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304 is separated by 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 over 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 rises 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 graphically represented in FIG.

FIG. 49 is an exemplary graph of the strain of anvil 151306 (FIGS. 44, 45). The vertical (y) axis is strain and the horizontal (x) axis is time. For example, the strain on the anvil 151306 during stapling is large initially but decreases as the tissue reaches steady state and exerts less pressure on the anvil 151306. 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. Or it can be measured by a pressure sensor or strain gauge located on 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 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) can be at its lowest value and the trigger pressure can increase until the operation (eg, clamping, cutting, or stapling) is complete. The rate of change of the trigger force is such that the handle of the instrument 151310 (FIG. 44) measures the force required to drive the knife 151305 (FIG. 45) through 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 151319. The trigger force 51332 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” vs. tissue displacement for various tissues. The vertical (y) axis is the tissue pressure and the horizontal (x) axis is the tissue displacement. When tissue pressure reaches a predetermined threshold, such as 50-100 pounds per square inch (psi), tissue displacement can be used as well as tissue displacement before reaching the threshold to distinguish tissue. 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 with respect to displacement) is nearly asymmetric at a threshold of 50-100 psi, while the rate of change of colon, lung, and stomach is not asymmetric 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, even more preferably 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 jaw gaps, knowing how much the jaws are covered by tissue can make gap measurements more useful and accurate. If a small portion of the jaw is covered with tissue, the 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 of 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, when tissue compression reaches steady state during clamping, for example, if no significant rate of change occurs after a set period, the microcontroller warns the clinician to begin the next step of operation, such as staple firing. The signal can be sent 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 the strain of the anvil 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 pivotally coupled to a second jaw member 152004, i.e. anvil 152002. The second jaw member 152004 is configured to internally receive the staple cartridge 152006. The staple cartridge 152006 includes a plurality of staples (not shown). Multiple staples can be deployed from the staple cartridge 152006 during surgical operation. 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 embodiment, in one embodiment, the first sensor 152008a is anvil 152002 by a second jaw member 152004 and / or by a structure clamped between the anvil 152002 and the second jaw member 152004. It is configured to measure one or more forces exerted on.

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 strain gauges configured to measure the magnitude of strain on the anvil 152002 during the clamped state. Strain gauges provide an electrical signal whose amplitude fluctuates with the magnitude of the strain. In various embodiments, 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, eg, an induction sensor such as a vortex current sensor, and the like. 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 the tissue section clamped between the anvil 152002 and the staple cartridge 152006. The first sensor 152008a may include, for example, a Hall effect sensor configured to detect a magnetic field generated by a magnet 152012 coupled to a second jaw member 152004 and / or a staple cartridge 152006. Measurements at a single site accurately explain the compressed tissue thickness for a full bit of calibrated tissue, but partial tissue pinching is between the anvil 152002 and the second jaw member 152004. If placed, it can lead to inaccurate results. Partial tissue pinching, either proximal or distal pinching, alters the geometry of the clamp in the anvil 152002.

In some embodiments, the second sensor 152008b indicates one or two types of tissue pinch, eg, full pinch, partial proximal pinch, and / or partial distal pinch. It is configured to detect one or more parameters. The readings of the second sensor 152008b are for adjusting the readings of the first sensor 152008a so as to accurately represent the true compressed tissue thickness in the partial entrapment located proximally or distally. May be used for. For example, in one embodiment, the second sensor 152008b comprises a strain gauge, such as a microstrain gauge, configured to monitor the magnitude of strain in the anvil during the post-clamped state. The strain magnitude of the anvil 152002 outputs the output of a first sensor 152008, such as a Hall effect sensor, to accurately represent the true compressed tissue thickness in a partial entrapment located proximally or distally. Used to fix. The first sensor 152008a and the second sensor 152008b may be measured in real time during the clamping operation. Real-time measurements allow time-based information to be analyzed, for example, by a primary processor (eg, processor 462 (FIG. 12), eg), as well as recognizing tissue and clamp position adjustments and tissue thickness. It can be used to select one or more algorithms and / or lookup tables for dynamically adjusting 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), eg). The measurements of the first sensor 152008a are provided to a processor, eg, a primary processor. The primary processor adjusts the readings of the first sensor 152008a based on the readings of the second sensor 152008b to reflect the true tissue thickness of the tissue section clamped between the anvil 152002 and the staple cartridge 152006. Let me. The primary processor outputs a adjusted tissue thickness measurement and a complete or partial pinch display 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 located at the treatment site inside the patient and the second sensor 152008b is located outside the patient's body. It may be located 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. Environmental sensors may include, for example, temperature sensors, humidity sensors, pressure sensors, and / or any other suitable environmental sensor.

FIG. 54 is a logical diagram showing an embodiment of 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, for example. 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 includes a Hall effect sensor and the second sensor 152008b includes 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 degree of tissue entrapment fullness in the end effector 152000. The adjusted measurements are displayed to the operator, for example, by a display embedded in the surgical instrument 150010 (152026).

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, for example. Processor 2006 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 tissue thickness measurement 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 the surgical instrument 150010 (152026).

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, for example. The primary processor calibrates the first signal 152022a in response to the second signal 152022b (152042). The first signal 152022a is calibrated to reflect the degree of tissue entrapment filling in the end effector 152000 (152042). The calibrated signal is displayed to the operator, for example, by a display 2026 embedded in a surgical instrument 150010 (152026).

FIG. 57 is a logical diagram illustrating an embodiment of the process 152050 that determines and displays the thickness of the tissue section clamped 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 clamping operation. There is. The measured strain is converted into a digital signal (152060) and provided to a processor such as a primary processor. The primary processor adjusts the Hall effect voltage 152052 using one or more algorithms and / or lookup tables in response to the strain measured by the strain gauge 152058 to adjust the Hall effect voltage 152052 to the anvil 152002 and staple cartridge 152006. Reflects the true thickness of the tissue clamped by and the fullness of its entrapment. The adjusted thickness is shown to the operator, for example, by a display embedded in the surgical instrument 150010 (152026).

In some embodiments, the surgical instrument may further comprise a load cell or 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 illustrating an embodiment of process 152070 that determines and displays the thickness of the tissue section clamped 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 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). For example, strain gauges 152078, such as microstrain gauges, are configured to measure one or more parameters of the end effector 152000, for example, the magnitude of strain exerted on the anvil 152002 during clamping operation. There is. The measured strain is converted into a digital signal (152080) and provided to a processor such as a primary processor. The load sensor 152082 measures the clamping force of the anvil 152002 with respect to the staple cartridge 152006. The measured clamping force is converted into a digital signal (152804) and provided to a processor, such as a primary processor. The primary processor uses one or more algorithms and / or a look-up table to generate the Hall effect voltage 152072 in response to the strain measured by the strain gauge 152078 and the clamping force measured by the load sensor 152082. Adjust to reflect the true thickness of the tissue clamped by the anvil 152002 and the staple cartridge 152006 and the fullness of the pinch thereof. The adjusted thickness is shown to the operator, for example, by a display embedded in the surgical instrument 150010 (152026).

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. An uncorrected Hall, as shown in FIG. 59, because a single sensor cannot compensate for distal / proximal partial pinching, resulting in inaccurate thickness measurements. The effect thickness measurement value 152094 indicates a measurement value of a thicker tissue. The adjusted thickness measurement 152092 is produced, for example, by the process 152050 shown in FIG. The adjusted 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, i.e. anvil 152102, pivotally coupled to a second jaw member 152104. The second jaw member 152104 is configured to internally receive the staple cartridge 152106. The end effector 152100 includes a first sensor 152108a connected 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 clamped 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. Other suitable sensors may be included.

In some embodiments, the end effector 152100 comprises a second sensor 152108b. The second sensor 152108b is connected 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 clamped state of the end effector 152100, the end effector. It is configured to detect one or more instrument states, such as the number of uses / remaining uses of the 152100 and / or staple cartridge 152106, and / or any other suitable instrument state. The second sensor 152108b is, 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. Such as, any suitable sensor that detects the state of one or more instruments may be included.

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. 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 / optimal for the staple cartridge, and / or the pattern of staples within the staple cartridge 152106. It may correspond to one or more characteristics of the cartridge, such as. 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, via a display 2026 connected to a 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 can move pivotally with respect to the second jaw member 152154 to clamp 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 clamped 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 optional. Other suitable sensors may be included.

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 magnitude of strain exerted on the anvil 152152 during the clamping 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 measure one or more identical parameters at different positions on the anvil 152152, different parameters at the same position on the anvil 152152, and / or different parameters at different positions on the anvil 152152. It may be configured to do so.

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 converted by an analog-to-digital converter (152174). The converted Hall effect voltage signal is calibrated (152176). The calibrated curve represents the thickness of the tissue section located between the anvil 152152 and the staple cartridge 152156. The plurality of secondary measurements are obtained by a plurality of secondary sensors, such as a plurality of strain gauges (152178a, 152178b). The input of the strain gauge is converted into one or more digital signals by, for example, a plurality of electron μ strain conversion circuits (152180a, 152180b). The calibrated Hall effect voltage and the plurality of 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 using one or more look-up tables (152182). The adjusted Hall effect voltage represents the true thickness of the tissue clamped by the anvil 152152 and the staple cartridge 152156 and the filling of its sandwiches. The adjusted thickness is shown to the operator, for example, by a display embedded in the surgical instrument 150010 (152026).

FIG. 63 is 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. Shows the morphology. The 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. Those skilled in the art recognize that the analog-to-digital converter 152194 may include any suitable number of channels and / or bits that convert one or more inputs from an analog signal to a digital signal. Will be done. Circuit 152190 comprises 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 a 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, switch 152198 coupled to one or more level shift resistors may be coupled to analog-to-digital converter 152194. Switch 152198 is configured to calibrate one or more of the input signals, such as the input from a Hall effect sensor. Switch 152198 may be engaged to provide one or more level shift signals to adjust one or more inputs of the sensor, eg, calibrate the inputs of the Hall effect sensor. .. In some embodiments, adjustment is not mandatory and the switch 152198 is left in the open position to disconnect the level shift resistor. The switch 152198 is connected to the 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 that is pivotally coupled to a second jaw member 152204. The second jaw member 152204 is configured to internally receive the staple cartridge 152206. 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 (eg, anvil 152202, etc.). The plurality of sensors 152208a-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 include sensors, or a combination thereof. For example, in one embodiment, the plurality of sensors 152208a-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 detection process. By detecting various parameters along the length of the anvil 152202, the plurality of sensors 152208a-152208d may be pinched by a surgical instrument, such as a surgical instrument 150010, regardless of pinching, eg, partial or complete pinching. , Allows the calculation of tissue thickness within 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 the dynamics of the clamp to determine tissue thickness, tissue placement, and / or material properties. May be good. By time-based monitoring of multiple sensors 152208a-152208d in the clamp, a processor, such as a primary processor, utilizes algorithms and look-up tables to recognize tissue characteristics and clamp positions, end effectors 152200, and /. Alternatively, the tissue clamped 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 (152224a to 152224d) and provided to the processor. For example, in one embodiment involving a plurality of strain gauges, a plurality of electron μ strain (microstrain) 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 one or more tissue characteristics based on multiple signals (152226). The processor may determine one or more tissue characteristics by applying algorithms and / or look-up tables. One or more tissue properties are shown to the operator, for example, by a display embedded in a surgical instrument 150010 (152026).

FIG. 66 shows an embodiment of an end effector 152250 including a plurality of sensors 152260a to 152260d connected 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 to clamp one or more materials, such as tissue section 152264, between them. The second jaw member 152254 is configured to receive the staple cartridge 152256. The first sensor 152258 is connected 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 clamped 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 included.

The plurality of secondary sensors 152260a to 152260d are connected 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 tissue section 152264 clamped between the end effector 152250 and / or the anvil 152252 and the staple cartridge 152256. There is. 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 tissue section 152264, such as a suitable sensor, or a combination thereof, may be included. 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 include a dual purpose sensor and a tissue stabilizing element. The plurality of secondary sensors 152260a to 152260d are configured to create a stabilized tissue state when the plurality of secondary sensors 152260a to 152260d are engaged with the tissue section 152264, for example during clamping operation. It has electrodes and / or detection shapes. In some embodiments, one or more of the plurality of secondary sensors 152260a-152260d may be replaced with non-detective tissue stabilizing elements. Secondary sensors 152260a-152260d create a stabilized tissue condition by controlling tissue flow, staple formation, and / or other tissue conditions during clamping, 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 inside. The staple cartridge 152270 includes a plurality of rows including a plurality of holes for accommodating the staples inside. 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 connected to the sensor wire 152276b. The sensor wires 152276a, 152276b may include a plurality of wires connecting the plurality of sensors 152272a to 152272h to one or more circuits of a surgical instrument such as, for example, a surgical instrument 150010. In some embodiments, one or more of the plurality of sensors 152272a to 152272h are dual purpose sensors and tissue stabilization having electrodes and / or detection shapes configured to provide tissue stabilization. Includes 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 clamping and / or staple 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 detection.

FIG. 68 is a logical diagram illustrating an embodiment of the process 152280 in which one or more parameters of the tissue section 152264 clamped within an end effector, such as the end effector 152250 shown in FIG. 66, are determined. .. In one embodiment, the first sensor 152258 is configured to detect one or more parameters of tissue section 152264 located between the end effector 152250 and / or the anvil 152252 and the staple cartridge 152256. ing. The first signal is generated by the first sensor 152258 (152228). The first signal indicates one or more parameters detected by the first sensor 152258. One or more secondary sensors 152260 are configured to detect one or more parameters of the end effector 152250 and / or tissue section 152264. The secondary sensor 152260 may be configured to detect the same parameters, additional parameters, or different parameters as the first sensor 152258. 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 (152286). The tuned signal may indicate, for example, the true thickness of tissue section 152264 and the filling of the pinch. The tuned signal is displayed to the operator, for example, by a display embedded in the surgical instrument 150010 (152026).

FIG. 69 shows an embodiment of the end effector 152300 including a plurality of redundant sensors 152308a and 152308b. The end effector 152300 includes a first jaw member pivotally coupled to a second jaw member 152304, i.e. anvil 152302. The second jaw member 152304 is configured to internally receive the staple cartridge 152306. The anvil 152302 is movable with respect to the staple cartridge 152306 to grip material, such as a tissue section, between the anvil 152302 and the staple cartridge 152306. The plurality of sensors 152308a and 152308b are connected to the anvil. The plurality of sensors 152308a, 152308b are configured to detect one or more parameters of the tissue section 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 connected 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 the tissue section 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 the primary processor 2006, to evaluate multiple inputs to 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 the clamp to analyze time-based information and allow algorithms and / or look-up tables to dynamically recognize tissue characteristics and clamp position. Good. One or more inputs of the redundant sensor may be adjusted and / or selected to identify the true tissue thickness and pinch of the tissue section located between the anvil 152302 and the staple cartridge 152306.

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, for example. In one embodiment, the first signal is generated by the first sensor 152308a. The first signal is converted by an analog-to-digital converter (152322a). 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 so as to reflect the true thickness and pinch of the tissue section located between the anvil 152302 and the staple cartridge 152306. The output may be adjusted based on additional sensors. The regulated and most reliable output is shown to the operator, for example, by a display embedded in the surgical instrument 150010 (152026).

FIG. 71 shows an embodiment of an end effector 152350 comprising a sensor 152358 with a unique sampling rate for limiting or eliminating pseudo-signals. The end effector 152350 comprises a first jaw member pivotally coupled to a second jaw member 152354, i.e. anvil 152352. The second jaw member 152354 is configured to internally receive the staple cartridge 152356. The staple cartridge 152356 contains a plurality of staples that may be delivered to a tissue section located between the anvil 152352 and the staple cartridge 152356. The sensor 152358 is connected 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, for example, to the thickness of the material, such as a tissue section, and / or the filling of the material sandwiched between the anvil 152352 and the staple cartridge 152356. Sensor 152358 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 suitable sensor. Any suitable sensor that detects one or more parameters of the end effector 152350 may be included.

In one embodiment, the sensor 152358 includes 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 filling degree of the pinch. In some embodiments, the electromagnetic source 152360 produces a signal at a known frequency (eg, 1 MHz). In other embodiments, the signal generated by the electromagnetic source 152360 is, for example, a type of staple cartridge 152356 installed within a second jaw member 152354, one or more additional sensors, algorithms, and / or It may be adjustable based on one or more parameters.

In one embodiment, the signal processor 152362 is coupled to an end effector 152350 (eg, 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 includes an algorithm that is integrally formed with and / or executed by a general processor, such as a primary processor. The signal processor 152362 is configured to process the signal from the sensor 152358 at a frequency substantially equal to the frequency of the signal produced 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 generates a signal indicating the detected magnetic field, and this signal is 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 is a logical diagram illustrating an embodiment of a process 152370 that produces a thickness measurement of a tissue section located between an anvil of an end effector, such as the end effector 152350 shown in FIG. 71, and a staple cartridge. is there. 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 (152374). 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 (152376) to remove noise, remove pseudo-signals, and / or boost the signal. The processed signal is provided to an analog-to-digital converter for conversion to a digital signal (152378). The digital signal may be calibrated, for example, by applying a calibration curve input algorithm and / or a look-up table (152380). 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 (152026).

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 internally. 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 embodiment in which the sensor 152408 is a light emitter and detector 152410. The body of the staple cartridge 152406 may be of a different color so that the color identifies the type of staple cartridge 152406. The light emitter and detector 152410 may be operational to obtain color data for the staple cartridge 152406 body. In an exemplary embodiment, the light emitter / detector 152410 can detect white 152412 by receiving reflected light of equal intensity red, green, and blue spectra. The light emitter and detector 152410 can detect red 152414 by receiving very little reflected light in the green and blue spectra and by receiving light in a higher intensity red spectrum.

Alternatively or additionally, the light emitter and detector 152410, or another suitable sensor 152408, can obtain and identify data of some other symbol or mark 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 may be communicated to a microcontroller of surgical device 150010, such as a microcontroller (eg, microcontroller 461 (FIG. 12), eg). The microcontroller may 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 function of the instrument is inappropriate. In such an example, the microcontroller may optionally be configured to disable the functionality of the surgical instrument. Alternatively or additionally, the microcontroller provides information about the identified staple cartridge 152406 type parameters, such as the length of the staple cartridge 152406, or staples such as height and length, surgical instrument 150010. Can be configured to notify the operator of.

FIG. 75 shows 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 comprises a distal segment 153432a and side segments 153432b, 153432c that include individually addressable sensors to provide local tissue presence detection. Segments 153432a, 153432b, 153432c can be individually addressed to detect tissue based on individual sensors located within each of the segments 153432a, 153432b, 153432c, and to measure tissue parameters. The segments 153432a, 153432b, and 153432c of the segmented flexible circuit 153430 are mounted on the jaw member 153434 and are electrically connected to an energy source such as an electric circuit via a conductive element 153436. A Hall effect sensor 153438 or any suitable magnetic sensor is located 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 can also be referred to as the tissue gap, as detailed in FIG. 77. The segmented flexible circuit 153430 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector.

FIG. 76 shows one aspect of the segmented flexible circuit 153440 configured to be mounted on the jaw member 153444 of the end effector. The segmented flexible circuit 153440 comprises a distal segment 153442a containing individually addressable sensors for tissue control and side segments 153442b, 153442c. Segments 153442a, 153442b, 153442c can be individually addressed to treat tissue and to read individual sensors located within each of segments 153442a, 153442b, 153442. Segments 153442a, 153442b, 153442c of the segmented flexible circuit 153440 are mounted on the jaw member 153444 and are electrically connected 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 a measurement of the opening, or tissue gap, defined by the end effector jaw member 153444 as detailed in FIG. 77. In addition, a plurality of side asymmetric temperature sensors 153450a, 153450b are mounted on or formally integrally with the segmented flexible circuit 153440 to provide tissue temperature feedback to the control circuit. The segmented flexible circuit 153440 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector.

Figure 77 shows an 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 mounted on a jaw member 153444. The flexible circuit 153 440, in order to measure the tissue gap _{G T,} comprises a Hall effect sensor 153 448 operating with magnets 153,464 which are mounted to the jaw members 153,462. This technique may 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 shows one aspect of an end effector 153470 with a segmented flexible circuit 153468. The end effector 153470 includes a jaw member 153472 and a staple cartridge 153474. The segmented flexible circuit 153468 is mounted on the jaw member 153472. Each of the sensors disposed inside the segments 1 to 5 is configured to detect the presence of tissue located between the jaw member 153472 and the staple cartridge 153474 and represent tissue zones 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 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector 153470.

FIG. 79 shows the end effector 153470 shown in FIG. 78, in which the jaw member 153472 clamps the jaw member 153472, eg, the 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 zones 1-3. Thus, tissue 153476 is detected by sensors within segments 1-3, and tissue absence (empty) is detected by segments 4-5 in portion 153469. Information about the presence and absence of tissues 153476, located within specific segments 1-3 and 4-5, is transmitted, for example, via an interface circuit to the control circuits described herein, 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 may be accommodated to deliver energy to tissues located within ~ 5. The segmented flexible circuit 153468 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position 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 generally refers to any movable member of the surgical instrument or system described herein, such as a drive member, launch member, launch bar, cutting. Used to refer to instruments, knives, and / or I-beams, or any element that can be displaced. Therefore, the absolute positioning system 153100 can actually track the displacement of the cutting instrument 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 detection system with fixed Hall effect sensors, magnetic detection system with fixed magnets and Hall effect sensors arranged on a series of movable straight lines, movable light sources and light arranged on a series of straight 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 shaft 153116 that operably interfaces with the gear assembly 153114, which is mounted in mesh engagement with a set of drive teeth or rack 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 configuration of the gear ring and sensor 153118 may be connected to the linear actuator by rack and pinion configuration, or to the 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 a longitudinal displacement d 1} of the displacement member 153111, where d ₁ is the displacement member 153111 after one rotation of the sensor element 153126 connected to the displacement member 153111. Is the longitudinal distance from the point "a" to the point "b". The sensor mechanism 153102 may be connected via a gear reducer 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 more than one rotation of the position sensor 153112. May be used with the machine. The states of the switches 153122a to 153122n are fed back to the controller 153110, and the controller 153110 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 an array of magnetic sensors, analog rotation sensors such as potentiometers, and analog Hall effect elements that output unique combinations of position signals or values. The controller 153110 may be housed in a master controller or in a tool-mounted portion housing of a surgical instrument or system according to the present disclosure.

The absolute positioning system 153100 resets (zero or) as may be required in conventional rotary encoders where the motor 153120 simply counts the number of steps taken forward or backward to infer the position of device actuators, drive bars, knives, etc. The absolute position of the displacement member 153111 is provided at the time of powering on the surgical instrument or system, without retracting or advancing the displacement member 153111 to the 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 having a gearbox and a mechanical connection to a joint movement or knife system. In one aspect, the motor driver 153110 is described by Allegro Microsystems, Inc. It may be A3941 available from. Other motor drivers may be readily substituted 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, the 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.

Motor drivers 153110 are available from Allegro Microsystems, Inc. It may be A3941 available from. The A3941 driver 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. The driver 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. .. The 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 drivers may be readily substituted for use in the absolute positioning system 153100.

FIG. 81 is a position sensor 153200 for an absolute positioning system 153100'with 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 interfaces with the controller 153110 to provide an absolute positioning system 153100'. The position sensor 153200 is a low voltage and low power component, for example, a position sensor located above a magnet located on a rotating element associated with a displacement member such as a knife drive gear and / or a closed drive gear. Within the region 153230 of 153200, four Hall effect elements 153228A, 153228B, 153228C, 153228D are included, whereby the displacement of the launching member and / or the closing member can be precisely tracked. A high resolution ADC 153232 and a smart power management controller 153238 are also provided on the chip. Digit-by-digit methods and Volder's algorithms to implement concise and efficient algorithms for computing hyperbolic and trigonometric functions that require only addition, subtraction, bitshift, and table reference operations. A known CORDIC (short for coordinate rotation digital computer) processor 153236 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 a 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 arranged 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 directed to an electrical conductor perpendicular to the current in the electrical conductor and the magnetic field perpendicular to that current. Such a voltage difference (Hall voltage) is generated. 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 onboard in the AS5055 position sensor 153200 in a register or memory. An angular value indicating the position of the magnet over one revolution is given to the controller 153110 by various techniques, for example, at power-on 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 read" 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 INT output 153242 and the corresponding flags in 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 (about 600 μs) after each power-on sequence. Immediately after the measurement of one angle is completed, the AS5055 position sensor 153200 pauses and shifts 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 comprises 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 articulating, the end effector 153502 is in line with the shaft of the instrument. The I-beam 153514, including the cutting edge 153509, is shown in the distal portion of the launch bar 153520. The wedge thread 153513 is located within the staple cartridge 153518. When the I-beam 153514 translates distally, the cutting edge 153509 can contact and cut the tissue 153526 located 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 staple 153505, which allows the staple 153505 to advance through the tissue into the pocket 153507 defined in the anvil 153516 forming the staple 153505.

The firing stroke of an exemplary I-beam 153514 is illustrated by chart 153529 alongside the end effector 153502. An exemplary tissue 153526 is also shown side by side with the end effector 153502. The launching member stroke 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 can be advanced 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 the static friction is overcome, the force driving the I-beam 153514 within the first region 153517 can be substantially constant.

In the second launch member stroke region 153518, the cutting edge 153509 may come into contact with the tissue 153526 and begin to cut it. 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 can begin to rise. As shown, the first encountered tissue can 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 can continuously contact and cut the tissue 153526, and the wedge thread 153513 can repeatedly contact the staple driver 153511. The force driving the I-beam 153514 can reach 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 within the portion of the end effector 153502 corresponding to the fourth launch region 153523 may be less compressed than the tissue closer to the pivot point of the anvil 153516, requiring 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 can be completely detached. 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 through the fifth region 153525 can be reduced and, in some embodiments, can be similar to the force that drives the I-beam 153514 within 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 positions of the launch member stroke regions 153517, 153519, 153521, 153523, 153525 in FIG. 82 are merely examples. In some embodiments, different regions may start at different locations along the longitudinal axis of the end effector, for example, based on the location of the tissue between the anvil 153516 and the staple cartridge 153518.

As mentioned above, and here with reference to FIGS. 80-82, an electric motor positioned within the master controller of the surgical instrument to staple and / or incis the tissue trapped within the end effector 153502. By utilizing 153120, the launch system of the shaft assembly including the I-beam 153514 can be advanced and / or retracted with respect to the end effector 153502 of the shaft assembly. The I-beam 153514 can 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 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. Can be configured to predict the speed of. The controller 153110 is based on the previous values of the current and / or voltage supplied to the electric motor 153120 and / or the previous state of the system such as velocity, acceleration, and / or position, the current I-beam 153514. Can be configured to predict the speed of. Controller 153110 may be configured to detect the velocity of the I-beam 153514 using the absolute positioning sensor system described herein. The controller compares the predicted speed of the I-beam 153514 with the detection speed of the I-beam 153514 and whether or not the power to the electric motor 153120 should be increased to increase the speed of the I-beam 153514 and / Alternatively, it may be configured to determine whether to reduce the speed of the I-beam 153514 to reduce it.

The force acting on the I-beam 153514 can be determined using a variety of techniques. The force of the I-beam 153514 can be determined by measuring the current of the motor 153120, and the current of the motor 153120 is based on the load that the I-beam 153514 receives as it advances distally. The force of the I-beam 153514 can be determined by placing strain gauges 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 move 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, the period T _It may be determined by comparing with the predicted position of the I-beam 153514 based on the current set speed of the motor 153120 at the end of 1. Therefore, if the actual position of the I-beam 153514 is smaller than the predicted position of the I-beam 153514, the force applied to the I-beam 153514 is greater than the nominal force. Conversely, if the actual position of the I-beam 153514 is greater than the predicted position of the I-beam 153514, the force applied to the I-beam 153514 is less than the nominal force. The difference between the actual position of the I-beam 153514 and the predicted position is proportional to the deviation of the force applied to the I-beam 153514 from the nominal force.

Before starting the description of the closed loop control technique of the closed tube and the launching member, FIG. 83 will be briefly described. FIG. 83 shows two closure force (FTC) plots 153606, graph 153600 of 153608, showing the forces applied to the closure member to close against thick and thin tissue during the closure phase, as well as thick tissue during the launch phase. And graph 153601 of two firing force (FTF) plots 153622, 153624 showing the forces applied to the launching member to launch through thin tissue. Referring to FIG. 83, graph 153600 shows the force applied to 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. 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. The second plot 153608 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 phases: closing stroke (closing), waiting period (waiting), and 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. , With the movement of staple cartridges 153518 and anvil 153516. With reference to the first closing force plot 153606, the closing force 153610 during 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 clamping 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. A waiting period may be applied before the launch stroke begins. The waiting period allows fluid drainage from the tissue compressed by the end effector 153502, which reduces the thickness of the compressed tissue and reduces the gap between the anvil 153516 and the staple cartridge 153518. , Reduces the closing force at the end of the waiting period. With reference to the first closing force plot 153606, there is a slight decrease in closing force 153612 from F _{1 to F 2} during the waiting period _{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 period _{from t 1 to t 4. In some embodiments, a waiting period (t 1 to t 4} ) selected from the range of about 10 seconds to about 20 seconds is typically used. In the first closed force plot 153606 and the second closed force plot 153608 embodiment, a period of about 15 seconds is used. After the waiting period is a firing stroke, which typically lasts for a period selected from the range, for example, from about 3 seconds to, for example, about 5 seconds. The closing force is reduced as the I-beam 153514 is advanced with respect to the end effector by the firing stroke. As indicated, respectively, by closing force 153614,153620 the first and second closure force plot 153606,153608, closing force 153614,153620 exerted in the closed tube is abruptly approximately the time _{t 4} to approximately time _{t 5} Decreases to. Time t ₄ represents the moment when the I-beam 153514 connects into the anvil 153516 and begins to receive a closing load. Therefore, the closing force decreases as the firing force increases as shown by the first firing force plot 153622 and the second firing force plot 153624.

FIG. 83 is also a graph 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. 153601 is shown. 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 allow the driver to deploy 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 described above, closure tube force rapidly decreases in the time _{t 4} to approximately time _{t 5,} which is started under load by I-beam 153,514 is coupled to the anvil 153 516, and, first firing It represents the moment when the closing force decreases as the firing force increases, as shown by the force plot 153622 and the second firing force plot 153624. I-beam 153 514 from the stroke start position at time _{t 4,} the thin tissue to the stroke end position of the _{t 13} of the firing force plot 153622 in _t 8 ~t _9, and thick tissue of firing force plot 153 624, it is advanced. When the I-beam 153514 is advanced distally during the launch stroke, the closure assembly transfers control of the staple cartridge 153518 and the anvil 153516 to the launch assembly. This increases the firing force and decreases the closing force.

In the thick tissue firing force plot 153622, the plot 153622 during the firing period (launching) 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} of the previous _{t 5} '. The first segment 153628 is the firing force during the initial phase of the firing stroke, in which the I-beam 153514 advances distally from the top of the closure lamp until the I-beam 153514 touches the tissue. The second segment 153630 indicates the firing force during the second phase of the firing stroke, in which the I-beam 153514 advances distally to deploy staples and cut tissue. During a second phase of the firing stroke, the firing force decreases 'from _{F 2' F 1} until at approximately _{t 12.} The third segment 153632 indicates the firing force during the third and final phase of the firing stroke as the I-beam 153514 leaves the tissue and advances to the end of the stroke in the tissue-free zone. During the third phase of the firing stroke, firing force from _{F 2} ', it drops to zero (0) at approximately _{t 13} to I-beam 153,514 reaches the stroke end. In summary, during the firing stroke, the firing force increased dramatically as the I-beam 153514 entered the tissue zone and gradually decreased within the tissue zone during the stapling and cutting operation, and the I-beam 153514 moved through the tissue zone. Dramatically reduced when exiting and entering a zone 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. Thus, during the first phase of the firing stroke, firing force 153634 dramatically increases from 0 at approximately _{t 5} to _{F 3} '. During a second phase of the firing stroke, firing force 153636 is 'from, _{F 4} in approximately _{t 8' F 3} decreases gradually to. During the last phase of the firing stroke, firing force 153638 _dramatically reduced from _{F 4} 'to 0 at t 8 ~t _9.

The I-beam 153514 connects within the anvil 153516 and begins to be loaded, and the closing force decreases as the firing force increases, as shown in the first firing force plot 153622 and the second firing force plot 153624. It represents a moment, in order to overcome a steep reduction in closing force from time t ₄ to approximately time t _5, a closed tube, while the firing member, such as I beams 153,514 are advanced distally, the far You may be advanced to the position. The closure 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 distal the closed tube. To apply a closing force to the anvil 153516. A torque sensor connected 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) according to at least one aspect of the present disclosure, when the launching member (eg, I-beam 153514) advances distally and connects into a clamp arm (eg, anvil 153516). FIG. 5 is a diagram of a control system 153950 configured to provide gradual closure of a tube) to reduce the closing force load applied to the closing member at a desired rate and reduce the firing force load applied to the launching member. 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 value 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 analog adder 153962.} The first analog 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 analog adder 153964.}

In the situation of controlling the displacement of the closing 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 connected to the output of the closing motor. It 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 closed motor speed set value SP ₂ 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 displacement of the closed tube with a position sensor and measuring 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 closure tube velocity output 153,968 are provided on the primary process 153,958 for determining the forces acting on the closure tube and fed back to the adder 153 962 for subtracting the measured closing force from the primary set point 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 as described herein. The secondary controller 153955 is based on the actual velocity of the closed tube measured by the secondary process 153960, as well as the secondary set value SP ₂ based on the comparison of the actual firing force with the upper and lower thresholds of the firing force. Control the speed of the closed motor.

FIG. 85 shows 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 analog adder 153896, which provides the control variable u (t) to process 153980. The output of process 153980 is the process variable y (t). The analog adder 153984 calculates the difference between the desired set value r (t) and the measured process variable y (t). The PID controller 153972 sets the error value e (eg, the closing force threshold) as the difference between the desired set value r (t) and the measured process variable y (t) (eg, the velocity and direction of the closing tube). t) (eg, the difference between the closing force threshold and the measured closing force) is 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 describes 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 describes the historical 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 describes future trends in possible error 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 illustrating process 153990 of a control program or logical configuration 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 the closing member (153992). The control circuit compares the actual closing force with the threshold closing force (153994) and determines the set value velocity to displace the closing member based on this comparison (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 a first error between the actual closing force of the closing member and the threshold closing force SP ₁ and sets the closing member velocity set value SP ₂ based on the first error. The secondary feedback loop 153956 determines a second error between the actual velocity of the closing member and the set value velocity of the closing member and sets the closing member velocity based on the second error.

In one aspect, the threshold closing force SP ₁ includes an upper threshold and a lower threshold. The set value 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 value 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 value 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 connect to the closure member, and the control circuit is configured to advance the closure member during 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" is in 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 considered to consist of a "circuit". 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 by circuits, registers and / or software components (eg, a combination of programs, subroutines, logic and / or hardware and software components), logic gates, or other integrated formats. 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 such as floppy disks, hard disk drives, compact discs (CDs), digital video discs (DVDs), digital tapes, computer memories, and transmission media such as transmission media. , Digital and / or analog communication media (eg, fiber optic 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 infer information related to a surgical procedure from data received from databases and / or instruments. The information can include the type of treatment being performed, the type of tissue being manipulated, or the body cavity being treated. With contextual information related to the surgical procedure, the surgical system improves, for example, how to control modular devices (eg, robotic arms and / or robotic surgical tools) connected to the system. And it is possible to provide the surgeon with contextualized information or suggestions in the course of the surgical procedure.

Here, with reference to FIG. 87, a timeline 5200 is shown showing situational awareness of the hub, such as the surgical hub 106 or 206. 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 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 (ie, contextual information) about the ongoing procedure 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 relevant to 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 inferred. 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 infer 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 inferred. 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 be inferred from ventilator data, for example, 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 inferred 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 anatomical structure. Among 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 thoracic 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. Infer that the surgical hubs 106, 206 are in the process of 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 inferred that the surgeon is ligating arteries and veins. Similar to the previous steps, surgical hubs 106, 206 can derive this inference 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 mounted on 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 inferred that the surgeon is excising 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 excised. In this case, the type of staple fired is used for parenchymal tissue (or other similar tissue type), thereby inferring that surgical hubs 106, 206 are performing segmental resections of the procedure. Can be done.

Subsequently, in the twelfth step 5224, a nodule incision step is performed. Surgical hubs 106, 206 infer that the surgical team is incising the nodule and conducting a leak test based on the data received from the generator indicating that the RF or ultrasound device is being fired. Can be done. For this particular procedure, the RF or ultrasound instrument used after the parenchymal tissue has been resected corresponds to a nodular incision process, which allows surgical hubs 106, 206 to make this inference. It becomes. 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 the robot tool and the handheld surgical instrument in sequence and / or use the device at the same time. 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 inferred, 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 be inferred 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 infer when each step of is occurring.

Situational awareness is further described in US Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, which is incorporated herein by reference in its entirety. In certain examples, the behavior 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.

Irregularity of Tissue Distribution Typically, in surgical stapling procedures, the user places end effector jaws around the tissue to clamp and staple the tissue. In some cases, most of the tissue clamped between the jaws of the surgical stapler can be concentrated in one part of the gap between the jaws, while the rest of the gap remains unoccupied. Or slightly occupied. The irregular distribution of tissue located between the jaws of the surgical stapler can reduce the consistency of the stapled result. For example, irregular tissue distribution causes excessive tissue compression in some parts of the clamped tissue and inadequate tissue compression in other parts of the clamped tissue, which adversely affect the tissue being manipulated. Can exert. For example, excessive compression of tissue can result in tissue necrosis and, with certain treatments, staple line breakage. Inadequate tissue compression can also adversely affect the deployment and formation of staples, causing improper leakage or healing of stapled tissue.

Aspects of the present disclosure present a surgical staple fastening device comprising an end effector configured to staple the tissue clamped between the first and second jaws of the end effector. Surgical staple fasteners are configured to detect and indicate irregularities in tissue distribution within an end effector with respect to some predetermined zone between a first jaw and a second jaw. Surgical staples are further configured to detect and indicate irregularities in the amount and location of tissue between predetermined zones.

In one aspect, the surgical stapler is configured to provide feedback on the most appropriate position and placement of tissue in situations where tissue irregularities are detected.

Absolute measurements of tissue impedance in a given zone can be significantly affected by the environment in which the end effector is immersed. For example, an end effector immersed in a fluid such as blood results in a different tissue impedance measurement than, for example, an end effector not immersed in blood. Also, an end effector that clamps around a previously stapled tissue results in a different tissue impedance measurement than an end effector that clamps around a non-stapled tissue. The present disclosure addresses such discrepancies by comparing and evaluating tissue impedance measurements in these different predetermined zones when assessing the tissue distribution in different predetermined zones.

In one aspect, the irregularity of the tissue clamped between the jaws of the surgical stapler results in different tissue compression in a given zone. Aspects of the present disclosure include a tissue distribution evaluation circuit configured to detect and indicate irregularities in tissue compression between predetermined zones by measuring the impedance between the jaws of the end effectors in each of the predetermined zones. Present a surgical staple fastening device.

In one aspect, the tissue distribution evaluation circuit of the surgical staple fastening instrument comprises one or more tissue contact circuits configured to measure tissue impedance and evaluate the position and amount of clamped tissue. , Prepare for each of the predetermined zones.

For brevity, one or more of the embodiments of the present disclosure will be described in the context of a particular type of surgical instrument. However, this should not be construed as limiting. The embodiments of the present disclosure are applicable to various types of surgical staples such as linear surgical staples, curved surgical staples, and / or circular staples. The embodiments of the present disclosure are also similarly applicable to surgical instruments that apply therapeutic energy, such as ultrasound or radio frequency (RF) energy, to tissue.

With reference to FIG. 88, an end effector 25002 extending from the shaft 25004 of a curved surgical staple fastener is shown. The end effector 25002 includes a first jaw 25006 defining the anvil 25007 and a second jaw 25008 including a staple cartridge 25009. The staple cartridge 25009 and the anvil 25007 have an arcuate shape in a cross-sectional plane. The staple cartridge 25009 is removed from the rest of the end effector 25002 and mounted in a cartridge holder slidably mounted in the guide portion. The arm 250010 that supports the anvil is tightly connected to one end of the guide portion and extends parallel to the longitudinal axis L defined by the shaft 25004.

Tissue is clamped between the anvil 25007 and the staple cartridge 25009 by moving the staple cartridge 25009 distally towards the anvil 25007. In certain embodiments, the anvil 25007 moves proximally towards the staple cartridge 25009 and clamps tissue between them. In another aspect, the anvil and staple cartridges move relative to each other and clamp the tissue between them. As shown in FIG. 88, the anvil 25007 and the staple cartridge 25009 define a staple fastening plane perpendicular to the longitudinal axis L. The staples are deployed from the staple cartridge 25009 in a curved row within the tissue clamped between the staple cartridge 25009 and the anvil 25007.

With reference to FIG. 88 again, the three tissue distribution evaluation zones (zone 1, zone 2, zone 3) are defined along the curved length of the anvil 25007. Each of the three zones extends along a portion of the curved length of the anvil 25007. Tissue impedance is measured in each of the three zones to assess the irregularity of the tissue distribution between the anvil 25007 and the staple cartridge 25009. Zone 1, also referred to herein as the crotch zone, is the innermost zone closest to the arm 25010. On the other hand, the zone 3 is an outer zone and is farther from the arm 25010 than the zone 1. Zone 2 is an intermediate zone extending between Zone 1 and Zone 3. Zones 1 and 3 each extend along approximately 1/4 of the curved length of the anvil 25007. In contrast, Zone 2 extends between Zone 1 and Zone 3 along about 1/2 of the curved length of the anvil.

FIG. 89 is a partial cross-sectional view of the end effector of FIG. 88, showing tissue gripped between its jaws in three tissue distribution evaluation zones (zone 1, zone 2, zone 3). FIG. 90 is a surgical staple containing a tissue distribution assessment zone (zone 1, zone 2, zone 3) that is in many respects similar to the tissue distribution assessment zone (zone 1, zone 2, zone 3) of the end effector 25002. A perspective view of the end effector 25020 of the stapler and cutting instrument is shown.

In the embodiment of FIG. 88, the anvil 25007 has a tissue contact surface 25012 divided into three zones (zones 1, zone 2, zone 3). The tissue impedance measurements in the three zones are end effectors 25002. Represents the tissue distribution within. In various embodiments, the number of zones may be greater than or less than three. In one embodiment, the surgical staple fastener is shown in FIG. 103. As such, it may include four zones. In another embodiment, the surgical staple fastener may include eight zones, as shown in FIG. 104. Zone sizes are the same or at least substantial. Alternatively, the size of the zones may vary, as shown in FIG. 88.

The preferred number, size, and location of zones may be selected depending on the type of surgical instrument. For example, linear surgical staple fasteners are one or more intermediate zones between the medial or proximal zone closest to the shaft, the lateral or distal zone farthest from the shaft, and the medial and lateral zones. And may be included.

The three zones of the embodiment of FIG. 88 are defined with respect to the tissue contact surface 25012 of the anvil 25007. However, in other embodiments, the tissue distribution assessment zone may be defined with respect to the tissue contact surface of the staple cartridge. In other words, the tissue contact surface of the staple cartridge can be divided into predetermined zones for the purpose of assessing the tissue distribution within the end effector.

Each of the three zones of the embodiment of FIG. 88 comprises one or more tissue contact circuits configured to measure the impedance of a tissue portion present in a predetermined zone. An exemplary tissue contact circuit is shown in FIG. The tissue "T" in contact with the anvil 25007 and the staple cartridge 25009 in the predetermined zone simultaneously establishes contact with the pair of opposing plates "P1, P2" provided in the predetermined zone on the anvil 25007 and the staple cartridge 25009. Closes the detection circuit "SC" in a predetermined zone that is normally open.

Any of the contact circuits disclosed herein are mounted on the inner surface of a jaw that closes, but is not limited to, a normally open detection circuit when in contact with tissue. May include electrical contacts.

The contact circuit may also include a sensing force transducer that determines the amount of force applied to the sensor, the amount of force applied to this sensor being the same as the amount of force applied to the tissue "T". Can be assumed. Such a force applied to the tissue "T" can then be converted into a compression amount of the tissue. The force sensor measures the amount of compression received by the tissue "T" and provides the surgeon with information about the force applied to the tissue "T".

As mentioned above, excessive tissue compression can adversely affect the tissue "T" being manipulated. For example, excessive compression of tissue "T" can result in tissue necrosis and, with certain treatments, staple line breakage. The information about the pressure applied to the tissue "T" allows the surgeon to better determine that the tissue "T" is not under excessive pressure.

The force converter of the contact circuit is not limited, but is limited to a piezoelectric element, a piezo resistance element, a metal film or semiconductor strain gauge, an induction pressure sensor, a capacitance type pressure sensor, and a wiper arm on the resistance element. A potential differential pressure converter that uses a Bourdon tube, capsule or bellows to drive the

In various embodiments, the predetermined zone within the end effector 25002 may comprise one or more segmented flexible circuits configured to be fixedly attached to at least one jaw member of the end effector 25002. .. Examples of suitable segmented flexible circuits are described in connection with FIG. 75 of the present disclosure. To measure tissue impedance, segmented flexible circuitry passes electrical signals below therapeutic levels through the tissue in each of the predetermined zones.

FIGS. 91 to 96 show three examples of tissue distribution (T1, T2, T3) in the end effector 25002. A straight cross-sectional view of the end effector 25002 of FIGS. 91-93 shows the initial distribution of tissue between the three zones (zone 1, zone 2, zone 3) within the end effector 25002 according to each of the three embodiments. .. The straight cross-sections of the end effectors of FIGS. 94-96 show the tissues of the three embodiments undergoing initial compression to close the sensing contact circuit between the tissue contact surface of the anvil 25007 and the staple cartridge 25009. Shown.

As described above, when the contact between the tissue "T" and the tissue contact surface of the anvil 25007 and the staple cartridge 25009 is established in the predetermined zone, the detection circuit of the predetermined zone is closed. When the detection circuit is closed, the current passes through the tissue "T" in the predetermined zone and the detection circuit, as shown in FIG. 89. The impedance of the structure "T" in the predetermined zone can be calculated from the following equation.

式中、Ｚ_組織は組織インピーダンスであり、Ｖは電圧であり、Ｉは電流であり、Ｚ_検知回路は、検知回路のインピーダンスである。

In the equation, the Z _structure is the tissue impedance, V is the voltage, I is the current, and the Z _{detection circuit} is the impedance of the detection circuit.

As shown in FIG. 89, the insulating element 25014 can be placed between the adjacent plates (p) to separate the adjacent detection circuits. Although three detection circuits are shown in FIG. 89, the number of detection circuits may be different from three. In various embodiments, the end effector may include "n" detection circuits corresponding to "n" predetermined zones, where "n" is an integer of three or more numbers.

FIG. 97 shows a logical flow diagram of process 25030 showing a control program or logical configuration for identifying irregularities in tissue distribution within the end effector 25002 of a surgical instrument according to at least one aspect of the present disclosure. In one aspect, process 25030 is performed by control circuit 500 (FIG. 13). In another aspect, process 25030 may be performed by combination logic 510 (FIG. 14). In yet another aspect, process 25030 may be performed by sequential logic circuit 520 (FIG. 15).

Process 25030 receives a sensor signal from the sensor circuit of the detection circuit assembly 25471 corresponding to a predetermined zone (eg, zone 1, zone 2, and zone 3) in the end effector 25002 (25032) and is based on the received sensor signal. _{Includes determining the tissue impedance Z structure} of the tissue portion in such a zone (25034). _{FIG. 98 shows the tissue impedance Z structure} curves 25001, 25003, 25005 corresponding to the tissue examples T1, T2, and T3, respectively.

Process 25030 further comprises conditional steps 25036, 25038. If it is determined that the average tissue impedance of the inner zone (eg, zone 1) and the outer zone (eg, zone 3) is greater than the tissue impedance of the intermediate zone (eg, zone 2), then the tissue distribution is determined. Deemed inappropriate and given instructions to release the gripped tissue and reposition the end effector 25002, as shown by the examples in FIGS. 92, 95, 98, 100 (. 25040). In certain examples, during the release cycle, the grasped tissue is only released to the minimum threshold and then re-clamped to prevent the tissue from slipping out of the end effector 25002.

However, the average tissue impedance of the outer zone (eg, zone 1) and the inner zone (eg, zone 3) is less than or equal to the tissue impedance of the intermediate zone (eg, zone 2), and the tissue impedance of the inner zone is that of the outer zone. If it is below the tissue impedance, then the tissue distribution is considered appropriate and a predetermined closing force (Force-To-Close), as shown by the examples in FIGS. 91, 94, 98 and 99. , FTC) Continue to close the end effector while maintaining the threshold velocity (25042).

However, the average tissue impedance of the outer zone (eg, zone 1) and the inner zone (eg, zone 3) is less than or equal to the tissue impedance of the intermediate zone (eg, zone 2), and the tissue impedance of the inner zone is that of the outer zone. If greater than the tissue impedance, then the tissue distribution is considered appropriate, but the FTC threshold rate is reduced to a slower rate, as shown by the examples in FIGS. 93, 96, 98, 101. Is done (25044).

FIG. 102 shows a logical diagram of the control system 25470 that can be used to perform the process of FIG. 97. The control system 25470 is similar to the control system 470 (FIG. 12) in many respects. In addition, the control system 96/25470 includes a detection circuit assembly 25471 that includes "n" number of sensing circuits _S 1 to S _n, where "n" is an integer greater than 2. Detection circuit S ₁ to S _n, as described above, to define a predetermined zone in the end effector.

In various embodiments, the detection circuit assembly 25471 includes "n" continuous sensors, where "n" is an integer greater than 2. The continuous sensor defines a predetermined zone within the end effector, as described above.

In various embodiments, the detection circuit S ₁ to S _n may be configured to provide a sensor signal indicative of compression of the tissue using impedance measurements. Continuous sensor S ₁ to S _n are sufficient tissue may be used to notify whether extends within the end effector 25002. In addition, the FTC sensor can be used in assessing the tissue creep rate to determine the tissue distribution within the end effector 25002.

In various embodiments, the detection circuit S ₁ to S _n may be configured to measure tissue impedance by driving the RF currents below therapeutic levels through tissue grasped by the end effector 25002. One or more electrodes may be positioned on one or both jaws of the end effector 25002. The tissue compression / impedance of the gripped tissue may be measured over time.

In various embodiments, various sensors such as magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other suitable sensor. Can be adapted and configured to measure tissue compression / impedance of a given zone within an end effector.

In various aspects, if more tissue is detected in the inner zone than in the outer zone of the end effector 25002, the closure system advance speed is modified by the microcontroller 461. The closure rate is reduced to improve tissue distribution by allowing the tissue within the inner zone to creep outward within the end effector 25002.

In various embodiments, monitoring of changes in impedance as the closed gap changes may be used to similarly inform tissue properties and arrangements.

FIG. 99 shows a graph 25400 showing an end effector FTC 25402 and a closure rate 25404 vs. time 25406 for an exemplary launch of a surgical instrument end effector 25002 according to at least one aspect of the present disclosure. See also FIGS. 91, 94 and 97 in the following description of Graph 25400. The exemplary launches described herein are intended to demonstrate the concepts described above in connection with FIGS. 91, 94, 97 and should be construed as limiting in any way. Absent.

The launch of the end effector 25002 can be represented by the FTC curve 25408 and the corresponding velocity curve 25408', as shown in FIGS. 91 and 94, which curve over time the FTC and closure rate during the firing process. Changes are shown respectively. The launch can represent, for example, the launch of the end effector 25002 of a surgical instrument with a control circuit that performs the process 25030 shown in FIG. When the launch of the end effector 25002 is initiated, the processor 462 controls the motor 482 to start driving the anvil 25007 from its open position, reaching the plateau of the anvil 25007 closing speed at a particular closing speed (25418). ) To soar (25416). When the anvil 25007 closes, the FTC increases until it peaks at a particular time (25412) (25410). From the peak (25412), the FTC decreased until the tissue "T1" was fully clamped (25414), at which point the processor 462 controlled the motor 482 to stop the closure of the anvil 25007, and the closure rate was It descends to zero (25420).

The launches of FIGS. 91 and 94 therefore represent the launch of the end effector 25002, and the tissue distribution between Joe 25006 and Joe 25008 is within acceptable limits. In other words, the launches of FIGS. 91 and 94 remain within all control parameters during the process of jaw closure. Therefore, processor 462 does not suspend the anvil 25007, but adjusts the closing speed of the anvil 25007 or performs any other corrective action during the process of jaw closure.

FIG. 14 shows a graph 25422 showing the end effector FTC 25402 and closure speed 25404 vs. time 25406 for an exemplary launch of the surgical instrument end effector 25007 according to at least one aspect of the present disclosure. See also FIGS. 92, 95 and 97 in the following description of Graph 25422. The exemplary launches described herein are intended to demonstrate the concepts described above in connection with FIGS. 92, 95, 97 and should be construed as limiting in any way. Absent.

The launch of the end effector 25002 can be represented by the FTC curve 25424 and the corresponding velocity curve 25424', as shown in FIGS. 92, 95 and 97, which are the FTC and closure in the process of launch. The changes in speed over time are shown respectively. The launches of FIGS. 92 and 95 can represent, for example, the launch of the end effector 25007 of a surgical instrument with a control circuit that performs the process 25030 shown in FIG. 97. When the launch of the end effector 25007 is initiated, the processor 462 controls the motor 482 to start driving the anvil 25007 from its open position, causing the closure speed of the anvil 25007 to spike until a certain closure speed is reached ( 25432). When the anvil 25012 closes, the FTC increases to a peak (25428) at a particular time (25426). In this case, processor 462 is from the detection circuit assembly 25471, indicating that the tissue distribution between jaw 25006 and jaw 2008 is distorted towards the third zone, as shown in FIGS. 92 and 95. Receives the input of.

In response, as outlined in process 25030, processor 462 jaws the operator of the surgical instrument end effector 25007 to readjust the internal tissue "T2" via display 473. Instruct to open 25006, 25008. Therefore, the closing rate is reduced until a negative closing rate is reached (25434), eg, Joe 25006, 25008 is opened to allow the tissue "T2" to be easily readjusted within Joe 25006, 25008. Indicates that it has been done. The closing speed then returns to zero (25436) and Joe 25006, 25008 stops. Correspondingly, when Joe 25006, 25008 is released from the tissue "T2", the FTC is reduced to zero (25430).

FIG. 101 shows a graph 25438 showing an end effector FTC 25402 and a closure rate 25404 vs. time 25406 for an exemplary launch of a surgical instrument end effector 25002 according to at least one aspect of the present disclosure. See also FIGS. 93, 96, 97 in the following description of the seventh graph 25438. The exemplary launches described herein are intended to demonstrate the concepts described above in connection with FIGS. 93, 96, 97 and should be construed as limiting in any way. Absent.

The launch of the end effector 25002 can be represented by the FTC curve 21440 and the corresponding velocity curve 25440'as shown in FIGS. 93, 96, 97, which are the FTC and closure during the firing process. The changes in speed over time are shown respectively. The launches of FIGS. 93 and 96 can represent, for example, the end effector 25002 of a surgical instrument with a control circuit that performs the process 25030 shown in FIG. When the launch of the end effector 25002 is initiated, the processor 462 controls the motor 482 to start driving the anvil 25007 from its open position, spikes the closing speed of the anvil 25007 to the first closing speed v1 (25450). ). When the anvil 25007 closes, the FTC increases to time t1 (21442). At time t1, the control circuit 21002 determines that the tissue distribution is distorted towards zone 1, as shown in FIGS. 93 and 96. In response, processor 462 regulates the speed of motor 482, sufficient for tissue "T3" to creep outward towards Zone 2 and / or Zone 3, as indicated by Process 25030. You can give time.

FIG. 103 shows FIG. 6000 of a surgical instrument 6002 centered on staple line 6003 using the benefits of centering tools and techniques described in connection with FIGS. 104-114 according to at least one aspect of the present disclosure. Is shown. When used in the following description of FIGS. 104-114, the staple line may include multiple rows of staggered staples and typically, without limitation, two or three rows of staggered staples. Including. The staple line may be a double staple line 6004 formed using the double-stapling technique described in relation to FIGS. 104-108, or 109-109. It may be a linear staple line 6052 formed using the linear transection technique described in connection with FIG. 114. Using the centering tools and techniques described herein, either an instrument 6002 located in one part of the anatomy, a staple line 6003, or another instrument located in another part of the anatomy. It is possible to align without benefiting from the line of sight. Centering tools and techniques include displaying the current alignment of instrument 6002 adjacent to previous movements. Centering tools are useful, for example, during laparoscopic rectal surgery using a double stapled technique, also known as an overlapping stapling technique. In an exemplary example, during laparoscopic rectal surgery, the circular stapler 6002 is positioned within the patient's rectum 6006 within the pelvic cavity 6008 and the laparoscope is located intraperitoneally.

During laparoscopic rectal surgery, the colon is excised and sealed with staple lines 6003 having a length of "l". The double stapler technique uses a circular stapler 6002 to form an end anastomosis and is currently widely used in laparoscopic rectal surgery. To successfully form an anastomosis using the circular stapler 6002, the anvil trocar 6010 of the circular stapler 6002 is punctured through the center "l / 2" of the staple line 6003 and / or the tissue completely. After clamping, the circular stapler 6002 should be fired to cut the staple overlap 6012 and align with the center "l / 2" of the staple line 6003 transverse incision before forming an anastomosis. Misalignment between the anvil trocar 6010 and the center of the staple line 6003 transverse incision can increase the probability of anastomotic insufficiency. This technique may be applied to a combination of ultrasonic instruments, electrosurgical instruments, combined ultrasonic / electrosurgical instruments, and / or combined surgical staplers / electrosurgical instruments. Here, some techniques for aligning the anvil trocar 6010 of the circular stapler 6002 to the center "l / 2" of the staple line 6003 will be described.

In one aspect, as set forth in FIGS. 104-106 and also with reference to FIGS. 1-11, the present disclosure is made to show interaction with an interactive surgical system 100 environment, including surgical hubs 106, 206. Provides equipment and methods for detecting overlapping portions of double staple lines 6004 using double staple fastening techniques in colorectal transverse incisions in laparoscopic rectal surgery. The overlapping portion of the double staple line 6004 is detected and the current position of the anvil trocar 6010 of the circular stapler 6002 is displayed on the surgical hub display 215 connected to the surgical hub 206. The surgical hub display 215 displays the alignment of the circular stapler 6002 cartridge with respect to the overlap of the double staple line 6004 located at the center of the double staple line 6004. The surgical hub display 215 displays a circular image centered around the overlapping double staple line 6004 area, with the overlap of the double staple line 6004 included inside the knife of the circular stapler 6002. Therefore, ensure that it is removed after the circular launch. Using the display, the surgeon aligns the anvil trocar 6010 with the center of the double staple line 6004, then punctures the center of the double staple line 6004 and / or completely clamps the tissue and then the circular stapler. 6002 is fired to cut the staple overlap 6012 to form an anastomosis.

104-108 show the process of aligning the anvil trocar 6010 of the circular stapler 6022 with the staple overlap 6012 of the double staple line 6004 produced by the double staple fastening technique according to at least one aspect of the present disclosure. Shown. The staple overlapping portion 6012 is at the center of the double staple line 6004 formed by the double staple fastening technique. A circular stapler 60022 is inserted into the colon 6020 below the double staple line 6004 and a laparoscope 6014 is inserted through the abdomen above the double staple line 6004. A laparoscope 6014 and a non-contact sensor 6022 are used to determine the position of the anvil trocar 6010 with respect to the staple overlapping portion 6012 of the double staple line 6004. The laparoscope 6014 includes an image sensor for generating an image of the double staple line 6004. The image of the image sensor is transmitted to the surgical hub 206 via the imaging module 238. Sensor 6022 uses inductive or capacitive metal detection technology to generate a signal 6024 to detect metal staples. The signal 6024 changes based on the position of the anvil trocar 6010 with respect to the staple overlap portion 6004. The centering tool 6030 is a target alignment ring 6032 that surrounds the image 6038 of the double staple line 6004 and the image 6038 of the double staple line 6004 centered on the image 6040 of the staple overlap 6012 on the surgical hub display 215. And present. The centering tool 6030 also presents a projected cutting path 6034 for the anvil knife of the circular stapler 6002. The alignment process involves targeting the image 6038 of the double staple line 6004 and the image 6038 of the double staple line 6004 centered on the image 6040 of the staple overlap 6012, cut by the circular knife of the circular stapler 6002. Includes displaying the staples 6032. In addition, the image of the cross line 6036 (X) with respect to the image 6040 of the staple overlapping portion 6012 is also displayed.

FIG. 104 shows the anvil trocar 6010 of the circular stapler 6002 not aligned with the staple overlapping portion 6012 of the double staple line 6004 produced by the double stapler fastening technique. The double staple line 6004 has a length "l" and the staple overlapping portion 6012 is located in the middle "l / 2" position of the double staple line 6004. As shown in FIG. 104, the circular stapler 6002 is inserted into the colon 6020 portion and positioned just below the double staple line 6004 transverse incision. The laparoscope 6014 is positioned above the double staple line 6004 transverse incision and sends an image of the double staple line 6004 and the staple overlap 6012 within the field of view 6016 of the laparoscope 6014 to the surgical hub display 215. The position of the anvil trocar 6010 with respect to the staple overlap 6012 is detected by a sensor 6022 located on the circular stapler 6002. Sensor 6022 also provides the position of the anvil trocar 6010 with respect to the staple overlap 6012 on the surgical hub display 215.

As shown in FIG. 104, the projected path 6018 of the anvil trocar 6010 is shown along the dashed line at the position marked by the X. As shown in FIG. 104, the projected path 6018 of the anvil trocar 6010 is not aligned with the staple overlap portion 6012. Puncture of the anvil trocar 6010 through the double staple line 6044 at a point off the staple overlap 6012 can lead to anastomotic insufficiency. Using the anvil trocar 6010 centering tool 6030 described in FIG. 106, the surgeon can use the image displayed by the centering tool 6030 to align the anvil trocar 6010 with the staple overlap portion 6012. For example, in one implementation, the sensor 6022 is an inductive sensor. Since the staple overlap portion 6012 contains more metal than the rest of the lateral portion of the double staple line 6004, the signal 6024 is close to the staple overlap portion 6012 with the sensor 6022 aligned with the staple overlap portion 6012. When you are, it becomes the maximum. Sensor 6022 provides the surgical hub 206 with a signal indicating the position of the anvil trocar 6010 with respect to the staple overlap 6012. The output signal is converted into a visualization of the position of the anvil trocar 6010 with respect to the staple overlap 6012 displayed on the surgical hub display 215.

As shown in FIG. 105, the anvil trocar 6010 is aligned with the staple overlap portion 6012 at the center of the double staple line 6004 created by the double staple fastening technique. The surgeon can now puncture the anvil trocar 6010 through the staple overlap 6012 of the double staple line 6004 and / or completely clamp the tissue and then fire the circular stapler 6002 to the staple overlap 6012. Is cut out to form an anastomosis.

FIG. 106 shows the centering tool 6030 displayed on the surgical hub display 215, which is a display of the staple overlapping portion 6012 of the double staple line 6004 formed by the double-staling technique. I will provide a. In the figure, the anvil trocar 6010 is not aligned with the staple overlapping portion 6012 of the double staple line 6004, as shown in FIG. 104. The centering tool 6030 presents image 6038 of the double staple line 6004 and image 6040 of the staple overlap 6012 received from the laparoscope 6014 on the surgical hub display 215. The target alignment ring 6032 centered on the image 6040 of the staple overlap 6012 ensures that the staple overlap 6012 is of the circular stapler 6002 knife when the projected cutting path 6034 is aligned with the target alignment ring 6032. It surrounds image 6038 of the double staple line 6004 so that it is located inside the circumference of the projected cutting path 6034. The cross line 6036 (X) represents the position of the anvil trocar 6010 with respect to the staple overlapping portion 6012. Crosshair 6036 (X) indicates a point through the double staple line 6004 that would be punctured if the anvil trocar 6010 was advanced from its current position.

As shown in FIG. 106, the anvil trocar 6010 is not aligned with the desired penetration position specified by image 6040 of the staple overlap portion 6012. To align the anvil trocar 6010 with the staple overlap 6012, the surgeon said that the projected cutting path 6034 overlaps the target alignment ring 6032 and the crosshair 6036 (X) is centered on image 6040 of the staple overlap 6012. Operate the circular stapler 6002 until it becomes. When the alignment is complete, the surgeon punctures the anvil trocar 6010 through the staple overlap 6012 of the double staple line 6004 and / or clamps the tissue completely and then fires the circular stapler 6002 to release the staple overlap 6012. Cut out and form an anastomosis.

As described above, the sensor 6022 is configured to detect the position of the anvil trocar 6010 with respect to the staple overlapping portion 6012. Therefore, the position of the crosshair 6036 (X) presented on the surgical hub display 215 is determined by the surgical stapler sensor 6022. In another aspect, the sensor 6022 may be placed on the laparoscope 6014, in which case the sensor 6022 is configured to detect the tip of the anvil trocar 6010. In another aspect, the sensor 6022 is placed on either or both of the circular stapler 6022 and the laparoscope 6014 to determine the position of the anvil trocar 6010 with respect to the staple overlap 6012 and is surgical via a surgical hub 206. The information may be provided to the hub display 215.

107 and 108 show an image 6042 before and an image 6043 after the centering tool 6030 according to at least one aspect of the present disclosure. FIG. 107 is an anvil above the image 6040 of the table overlap 6040 presented on the surgical hub display 215, before being aligned with the target alignment ring 6032 surrounding the image 6038 of the double staple line 6004. An image of the projected cutting path 6034 of the trocar 6010 and the round knife is shown. FIG. 108 shows the anvil after being aligned with the target alignment ring 6032 surrounding the image 6038 of the double staple line 6004 on the image 6040 of the table overlap 6040 presented on the surgical hub display 215. An image of the projected cutting path 6034 of the trocar 6010 and the round knife is shown. The current position of the anvil trocar 6010 is marked by a crosshair 6036 (X) located at the lower left of the center of the image 6040 of the staple overlapping portion 6040, as shown in FIG. As shown in FIG. 108, when the surgeon moves the anvil trocar 6010 along the projected path 6046, the projected cutting path 6034 aligns with the target alignment ring 6032. The target alignment ring 6032 may be displayed, for example, as a grayed out alignment circle overlaid on the current position of the anvil trocar 6010 relative to the center of the double staple line 6004. The image may include an indication mark as to which direction to move. The target alignment ring 6032 may be shown in bold, in different colors, or highlighted when located within a predetermined center distance within acceptable limits.

In another aspect, the sensor 6022 may be configured to detect the start and end points of a straight staple line within a colorectal transverse incision and provide the current location of the anvil trocar 6010 of the circular stapler 6002. In another aspect, the present disclosure presents a circular stapler 6002 centered on a straight staple line, which may form uniform suture end skin deformities, and provides the current position of the anvil trocar 6010. , Surgical hub display 215. This allows the surgeon to center or align the anvil trocar 6010 as desired and then puncture and / or completely clamp the tissue prior to launching the circular stapler 6002.

In another aspect, as set forth in FIGS. 109-111, and also with reference to FIGS. 11-11, laparoscopic rectal surgery using linear staple fastening techniques In colonic rectal incisions, the starting point of the straight staple line 6052. And the end point are detected and the current position of the anvil trocar 6010 of the circular stapler 6002 is displayed on the surgical hub display 215 connected to the surgical hub 206. The surgical hub display 215 displays a circular image centered on the double staple line 6004, which may form uniform suture end skin deformities, and displays the current position of the anvil trocar 6002, which is displayed. The surgeon centers or aligns the anvil trocar 6010, then punctures through the straight staple line 6052 and / or completely clamps the tissue and then fires the circular stapler 6002 to center the straight staple line 6052. The 6050 can be cut out to form an anastomosis.

FIGS. 109-112 show the process of aligning the anvil trocar 6010 of the circular stapler 6022 to the center 6050 of the linear staple line 6052 produced by the linear stapler fastening technique according to at least one aspect of the present disclosure. FIGS. 109 and 110 show a laparoscope 6014 and a sensor 6022 located on a circular stapler 6022 for determining the position of the anvil trocar 6010 with respect to the center 6050 of the straight staple line 6052. The anvil trocar 6010 and sensor 6022 are inserted into the colon 6020 below the straight staple line 6052, and the laparoscope 6014 is inserted through the abdomen above the straight staple line 6052.

FIG. 109 shows an anvil trocar 6010 not aligned with the center 6050 of the straight staple line 6052, and FIG. 110 shows an anvil trocar 6010 aligned with the center 6050 of the straight staple line 6052. Sensor 6022 is used to detect the center 6050 of the straight staple line 6052 and align the anvil trocar 6010 with the center of the staple line 6052. In one aspect, the center 6050 of the straight staple line 6052 may be located by moving the circular stapler 6002 until one end of the straight staple line 6052 is detected. The end may be detected when the staple is no longer present in the path of the sensor 6022. Upon reaching one of the ends, the circular stapler 6002 is moved along the straight staple line 6053 until the opposite end is detected. The length "l" of the straight staple line 6052 is determined by measurement or by counting the individual staples by the sensor 6022. Once the length of the straight staple line 6052 is determined, the center 6050 of the straight staple line 6052 can be determined by dividing the length by 2 (“l / 2”).

FIG. 111 shows a centering tool 6054 displayed on the surgical hub display 215, which centering tool provides a display of straight staple lines 6052. In the figure, the anvil trocar 6010 is not aligned with the staple overlapping portion 6012 of the double staple line 6004, as shown in FIG. 109. The surgical hub display 215 presents a standard reticle field of view 6056 of a laparoscopic field of view 6016 with a straight staple line 6052, and a portion of the colon 6020. The surgical hub display 215 also presents a target ring 6062 that surrounds the image center of the straight staple line, as well as a projected cutting path 6064 for anvil trocars and circular knives. The cross line 6066 represents the position of the anvil trocar 6010 with respect to the center 6050 of the straight staple line 6052. The cross line 6036 (X) indicates a point through a straight staple line 6052 that would be punctured if the anvil trocar 6010 was advanced from its current position.

As shown in FIG. 111, the anvil trocar 6010 is not aligned with the desired penetration position specified by the offset between the target ring 6062 and the projected cutting path 6064. To align the anvil trocar 6010 with the center 6050 of the straight staple line 6052, the surgeon said that the projected cutting path 6064 overlaps the target alignment ring 6062 and the crosshair 6066 is centered on the image 6040 of the staple overlap portion 6012. Operate the circular stapler 6002 until it becomes. When the alignment is complete, the surgeon pierces the anvil trocar 6010 through the center 6050 of the straight staple line 6052 and / or after fully clamping the tissue, fires a circular stapler 6002 to cut out the staple overlap 6012 and anastomose. To form.

In one aspect, the present disclosure uses a linear transverse incision technique and an alignment ring or bullet positioned as if the anvil trocar 6010 of the circular stapler 6022 was properly centered along a straight staple line 6052. , A device and a method for displaying an image of a straight staple line 6052. The instrument displays a grayed out alignment ring overlaid on the current position of the anvil trocar 6010 relative to the center 6050 of the straight staple line 6052. The image may include an instruction mark to assist the alignment process by instructing in which direction the anvil trocar 6010 should move. The target alignment ring 6032 may be shown in bold, in different colors, or highlighted when located within a predetermined center distance within acceptable limits.

Referring now to FIGS. 109-112, FIG. 112 is a standard for a linear staple line 6052 transverse incision of surgery as viewed through a laparoscope 6014, displayed on a surgical hub display 215, according to at least one aspect of the present disclosure. It is an image 6080 of a typical reticle field of view 6080. In standard reticle diagram 6080, it is difficult to see the straight staple line 6052 within the standard reticle field of view 6056. Further, there is no alignment aid to assist in the alignment and introduction of the anvil trocar 6010 with respect to the center 6050 of the straight staple line. This figure does not show an alignment circle or alignment mark indicating whether the circular stapler was properly centered, nor does it show the projected trocar path. In this figure, it is difficult to see the staples because there is no contrast with the background image.

With reference to FIGS. 109-113, FIG. 113 shows that the anvil trocar 6010 and the circular knife of the circular stapler 6002 are aligned with respect to the center 6050 of the straight staple line 6052 according to at least one aspect of the present disclosure. The previous image 6082 of the reticle field of view 6072 using the laser at the surgical site shown in FIG. 112. The laser-aided reticle field of view 6072 indicates a projected path of the anvil trocar 6010 to assist in the placement of the anvil trocar 6010, or a alignment mark currently located in the lower left of the center of the straight staple line 6052. A crosshair 6066 (X) is provided. In addition to the projected paths marked by the crosshairs 6066 of the anvil trocar 6010, image 6082 displays the staples of the straight staple line 6052 in contrasting colors to make them more visible in contrast to the background. .. The straight staple line 6052 is highlighted and the bullseye target 6070 is displayed above the center 6050 of the straight staple line 6052. Image 6082 is an anvil trocar 6010 relative to the center 6050 of the straight staple line 6052, marked by a condition warning box 6068, a proposal box 6074, a target ring 6062, and a crosshair 6066, outside the laser-powered reticle field of view 6072. Display the current alignment position. As shown in FIG. 113, the status warning box 6068 indicates that the trocar is "misaligned" and the proposed box 6074 presents "adjust the trocar towards the center of the staple line".

With reference to FIGS. 109-114, FIG. 114 shows, according to at least one aspect of the present disclosure, after the circular knives of the anvil trocar 6010 and the circular stapler 6002 have been aligned to the center 6050 of the straight staple line 6052. FIG. 6084 is an image 6084 of a reticle field of view 6072 using a laser at the surgical site shown in FIG. 113. The laser-aided reticle field of view 6072 indicates a projected path of the anvil trocar 6010 to assist in the placement of the anvil trocar 6010, or a alignment mark currently located in the lower left of the center of the straight staple line 6052. A crosshair 6066 (X) is provided. In addition to the projected paths marked by the crosshairs 6066 of the anvil trocar 6010, image 6082 displays the staples of the straight staple line 6052 in contrasting colors to make them more visible in contrast to the background. .. The straight staple line 6052 is highlighted and the bullseye target 6070 is displayed above the center 6050 of the straight staple line 6052. Image 6082 is an anvil trocar 6010 relative to the center 6050 of the straight staple line 6052, marked by a condition warning box 6068, a proposal box 6074, a target ring 6062, and a crosshair 6066, outside the laser-powered reticle field of view 6072. Display the current alignment position. As shown in FIG. 113, the status warning box 6068 indicates that the trocar is "misaligned" and the proposed box 6074 presents "adjust the trocar towards the center of the staple line".

FIG. 114 is a view using a laser at the surgical site shown in FIG. 113 after the anvil trocar 6010 and the circular knife have been aligned to the center of the staple line 6052. In this figure, inside the laser-powered reticle field of view 6072, the alignment mark cross 6066 (X) is located at the center of the staple line 6052 and above the highlighted bullseye target, with the trocar It shows that it is aligned with the center of the staple line. Outside the laser-powered reticle field of view 6072, a condition warning box indicates that the trocar has been "aligned" and the proposal is to "promote the introduction of the trocar."

With reference to FIGS. 115-119, it is not only the amount and location of the tissue that can affect the stapled result, but also the nature, type, or condition of the tissue that affects the stapled result. obtain. For example, irregular tissue distribution is also present in situations involving previously stapled tissue, such as the J-pouch method, also known as ileal sac anal anastomosis, and end-to-end anastomosis. It becomes apparent. Inadequate placement and distribution of previously stapled tissue within the end effector of a staple cartridge causes previously fired staple lines to concentrate within one zone rather than another zone within the end effector. In some cases, this adversely affects the outcome of such treatment.

Aspects of the present disclosure present a surgical staple fastening device comprising an end effector configured to staple the tissue clamped between the first and second jaws of the end effector. In one aspect, the placement and orientation of previously stapled tissue within the end effector is determined by measuring and comparing tissue impedance in several predetermined zones within the end effector. In various embodiments, tissue impedance measurements can also be used to identify overlapping layers of tissue and their location within the end effector.

115, 117 and 118 show the end effector 25500 of a circular stapler containing a staple cartridge 25502 and anvil 25504 configured to grip the tissue in between. The anvil 25504 and staple cavity 25505 of the staple cartridge 25502 have been removed from FIG. 115 to highlight other features of the end effector 25500. The staple cartridge 25502 includes, according to the present disclosure, four predetermined zones (zone 1, zone 2, zone 3, zone 4) defined by _{detection circuits (S 1} , S ₂ , S ₃ , S _4).

FIG. 116 shows another end effector 25510 of a circular stapler containing a staple cartridge 25512 and an anvil configured to grip the tissue in between. The anvils and staple cavities of the staple cartridge 25512 have been removed to highlight other features of the end effector 25510. The staple cartridge 25512 includes, according to the present disclosure, eight predetermined zones (zones 1 to 8) defined by _{detection circuits (S 1 to} S _8). The zones defined in each of the circular staplers of FIGS. 115 and 116 are equal or at least substantially equal in size, circumferentially around a longitudinal axis extending longitudinally through the shaft of the circular stapler. Placed in.

As mentioned above, a previously stapled organization is one that contains previously deployed staples within the organization. Circular staplers are often used when stapled previously stapled tissue to non-stapled tissue (eg, the J-pouch method), and as shown in FIG. 117, as shown in FIG. 118. As such, it is used to staple previously stapled tissue to other previously stapled tissue (eg, end-to-end anastomosis).

The presence of staples in the tissue affects the tissue impedance because the staples usually have different conductivity than the tissue. The present disclosure monitors and compares the tissue impedance of a circular stapler end effector (eg, end effectors 25500, 25510) in a given zone to determine the optimal placement and orientation of previously stapled tissue with respect to the end effector. We present various tools and techniques for this purpose.

The left embodiment of FIGS. 117, 118 shows a previously stapled structure that is properly placed and oriented with respect to a predetermined zone of the circular stapler. The previously stapled tissue properly extends through the center of the staple cartridge 25502 and intersects the predetermined zone only once. The lower left side of FIGS. 117, 118 shows that the staples 25508 of the staple cartridge 25502 are deployed within a properly placed and oriented previously stapled tissue.

The example on the right side of FIGS. 117, 118 shows a previously stapled structure that is poorly placed and oriented. Previously stapled tissue is off-center or overlapping in one or more predetermined zones (FIG. 118). The lower right side of FIGS. 117, 118 shows that the staples 25508 of the staple cartridge 25502 are deployed within a previously poorly placed and oriented previously stapled tissue.

When used in connection with FIGS. 115-119, the staple line may include multiple rows of staggered staples and typically includes, without limitation, two or three rows of staggered staples. .. In the embodiment of FIG. 117, the circular stapler of FIG. 115 is used to staple two previously deployed tissues, including the previously deployed staple lines SL1 and SL2. In the example on the left side of FIG. 117 representing properly arranged and oriented staple lines SL1 and SL2, each of Zones 1 to 4 receives a separate portion of one of the staple lines SL1 and SL2. .. The first staple line SL1 extends across zones 2 and 4, while the second staple line SL2, which intersects the first staple line SL1 at the center point, extends across zones 1 and 3. Therefore, the measured impedances within the four zones are equal to each other, or at least substantially equal to each other, less than the impedance of the non-stapled tissue.

In contrast, in the right-hand embodiment of FIG. 117 representing improperly placed and oriented staple lines SL1 and SL2, the staple lines SL1 and SL2 overlap or overlap over zone 1 and zone 3. Due to the substantially overlapping and extending, the impedance measurements are lower in Zone 1 and Zone 3 compared to Zone 2 and Zone 4.

FIG. 119 and FIG. 120, as described above, is carried out by the eight detection circuits _S 1 to S ₈ end effector 25510 circular stapler of Figure 116 comprising eight predetermined zone defined (Zone 1 Zone 8) by The staple lines SL1 and SL2 in the end-end anastomosis are shown. The anvil of the end effector 25510 and the staple cavities of the staple cartridge 25512 have been removed from FIGS. 119 and 120 to highlight other features of the end effector 25510.

FIG. 121 and FIG 122 shows the measured tissue impedance based on the sensor signal from the detection circuit _S 1 to S _8. The individual measurements define the tissue impedance signature. The vertical axis 25520, 25520'represents the angle of orientation (θ), and the vertical axis 25522, 25522' enumerates the corresponding predetermined zones (zones 1 to 8). The tissue impedance (Z) is drawn on the horizontal axis 25524, 25524'.

In the embodiments of FIGS. 119 and 121, the impedance measurements represent properly arranged and oriented staple lines SL1, SL2. As shown in FIG. 119, the staple lines SL1 and SL2 extend through Zone 1, Zone 3, Zone 5, and Zone 7 and overlap only at the center point of the staple cartridge 25512. Since the previously stapled tissue is evenly distributed among Zone 1, Zone 3, Zone 5, and Zone 7, the tissue impedance measurements in such zones are of the same or greater magnitude. At least substantially the same, it is significantly smaller than the tissue impedance measurements in Zone 2, Zone 4, Zone 6, and Zone 8 that did not accept previously stapled tissue.

Conversely, in the embodiments of FIGS. 120 and 122, the impedance measurements represent improperly arranged and oriented staple lines SL1 and SL2. As shown in FIG. 120, the staple lines SL1 and SL2 extend only through zone 1 and zone 5 and overlap each other vertically. Therefore, the magnitude of the tissue impedance measurements in Zones 1 and 5 is significantly lower than in the remaining zones that did not accept previously stapled tissue.

Figure 123 and Figure 124, as described above, is carried out by the eight detection circuits _S 1 to S ₈ end effector 25510 circular stapler of Figure 116 comprising eight predetermined zone defined (Zone 1 Zone 8) by The staple line SL3 in the J pouch method is shown. The anvil of the end effector 25510 and the staple cavities of the staple cartridge 25512 have been removed from FIGS. 123 and 124 to highlight other features of the end effector 25510.

FIG. 125 and FIG 126 shows the measured tissue impedance based on the sensor signal from the detection circuit _S 1 to S _8. The individual measurements define the tissue impedance signature. The vertical axis 25526, 25526'represents the angle of orientation (θ), and the vertical axis 25528, 25528' lists the corresponding predetermined zones (zones 1 to 8). The tissue impedance (Z) is drawn on the horizontal axis 25530, 25530'.

In the embodiments of FIGS. 123 and 125, the impedance measurements are represented by a properly arranged and oriented staple line SL3. As shown in FIG. 123, the staple line SL3 extends only through Zones 1 and 5. Since the previously stapled tissue is evenly distributed between Zones 1 and 5, the size of the tissue impedance measurements in such zones is the same, or at least substantially the same. Significantly smaller than the tissue impedance measurements in the remaining zones that did not previously accept stapled tissue.

Conversely, in the examples of FIGS. 124 and 126, the impedance measurements represent improperly placed and oriented staple line SL3. As shown in FIG. 124, the staple line SL3 extends through Zone 4, Zone 5, and Zone 6, all of which are on one side of the staple cartridge 25510. Therefore, the magnitude of tissue impedance measurements in Zone 4, Zone 5, and Zone 6 is significantly lower than in the remaining zones that did not previously accept stapled tissue.

In various aspects, the circular stapler (eg, the circular stapler of FIG. 115 and the circular stapler of FIG. 116) further comprises a control system 25470 (FIG. 102), wherein the control system 25470 receives a sensor signal from the detection circuit of the circular stapler. It may be configured to further analyze the impedance measurements determined from. In a particular embodiment, the control system 25470 shown in FIG. 102 determines the geometric parameters of one or more previously deployed staple lines, as shown in connection with FIGS. 115-126. Includes a microcontroller 461 that can be configured as such. In a particular example, the microcontroller 461 may also be configured to determine the alignment mode of the circular stapler, as shown in connection with FIGS. 103-114. In a particular example, the microcontroller 461 also indicates the position of the circular trocar of the circular staple, the length and centerline of the existing staple line, and / or two contiguous lines, as shown in connection with FIGS. 103-114. It can be configured to determine the central intersection of lines.

Microcontroller 461 can, for example, warn the surgical surgeon via display 473 about the detected improper placement and / or orientation of previously stapled tissue. Other audio, tactile, and / or visual means can also be employed. Microcontroller 461 may also take steps to prevent tissue stapling. For example, the microcontroller 461 may send a signal to the motor driver 492 to stop the motor 482. In certain examples, the microcontroller 461 may recommend a new position and / or orientation to the surgeon.

In various aspects, the circular stapler of the present disclosure is communicably connected to surgical hubs 106 (FIGS. 3, 4) and 206 (FIG. 206) via wired and / or wireless communication channels. The data collected by such a circular stapler can be transmitted to surgical hubs 106, 206, which will send this data to cloud-based system 104, for further analysis. Further transmission to 204 can be made.

FIG. 127 shows a logical flow diagram of Process 25600 showing a control program or logical configuration for properly positioning previously stapled tissue within the end effectors of a surgical stapler (eg, end effectors 25500, 25510). In one aspect, process 25600 is performed by control circuit 500 (FIG. 13). In another aspect, process 25600 may be performed by combination logic 510 (FIG. 14). In yet another embodiment, process 25600 may be performed by sequential logic circuit 520 (FIG. 15).

For illustrative purposes, the following description illustrates process 25600 that can be performed by a control circuit that includes a controller 461 that includes a processor 461. Memory 468 stores program instructions that can be executed by processor 461 to execute process 25600.

Process 25600 determines the type of surgical procedure performed by the surgical stapler (25602). The type of surgical procedure can be determined using the various techniques described in the heading "Situational Awareness". Processor 25600 then selects a tissue impedance signature for properly placed, previously stapled tissue based on the type of surgical procedure determined (25604). As mentioned above, for example, previously stapled tissue properly placed in the J-pouch method has a different tissue impedance signature than, for example, in end-to-end anastomosis.

Process 25600 then determines if the measured tissue impedance within a predetermined zone corresponds to the selected tissue impedance signature (25606). If not, processor 461 may warn the user (25608) and / or override tissue action (25610). In one aspect, processor 461 can alert the user via display 473 (25608). In addition, processor 461 can override tissue treatment by preventing the end effector from completing its launch (25610). Prevention of launch completion can be achieved, for example, by having the motor driver 492 stop the motor 482 (FIG. 102).

However, if the measured tissue impedance within a predetermined zone corresponds to the selected tissue impedance signature, the processor 461 allows the end effector to proceed with tissue treatment (25612).

Generally referring to FIGS. 128-134, tissue overhangs extend beyond the optimal treatment area of the end effector, for example, tissue such as a blood vessel (BV) gripped between the jaws of the surgical end effector. It is a phenomenon that sometimes occurs. Therefore, overhanging tissue may not receive the treatment applied by the end effector. If the tissue contains blood vessels and the procedure involves sealing and cutting the blood vessels (BV), the unsealed overhangs of the blood vessels can leak, with undesired consequences.

Aspects of the present disclosure present a surgical instrument comprising a circuit configured to detect overhanging tissue within the surgical instrument end effector. Aspects of the present disclosure also present a surgical instrument comprising a circuit configured to detect tissue extending beyond a predetermined treatment area within the end effector of the surgical instrument.

In various embodiments, the end effector 25700 of the surgical instrument 25701 includes a first jaw 25702 and a second jaw 25704. 25701 is in many respects similar to the disclosure of other surgical instruments elsewhere herein, eg, surgical instrument 150010. At least one of the first jaw 25702 and the second jaw 25704 has the end effector 25700 in an open configuration (FIG. 128, 129, 132) and a closed configuration (FIGS. 130, 131, 133, 134). It can be moved to move between and. In the embodiment of FIGS. 128-134, the end effector 25700 includes a staple cartridge 25708 that includes staples that are deployable within the tissue gripped between the jaws 25702 and 25704 and that are deformable by the anvil 25710. In another embodiment, the end effectors according to the present disclosure can treat tissue by applying ultrasonic and / or high frequency energy.

The end effector 25700 further includes a flex circuit 25706 with a continuous sensor for detecting overhanging tissue. The overhanging tissue establishes an electrical path that causes the flow of current through the flex circuit 25706 when in contact with the continuous sensor as shown in FIGS. 131, 134. The current flow indicates the presence of overhanging tissue.

Jaw 25702, 25704 defines a treatment area 25714 between them when tissue treatment is applied in a closed configuration, as shown in FIGS. 131, 134.

The flexion tip or nose 25716, 25718 is defined distal to the treatment area 25714 within the jaws 25702, 25704. The stepped feature 25720 maintains a minimum distance or gap between the jaw 25702 and the jaw 25704 in the curved nose 25716, 25718 in a closed configuration.

The flex circuit 25706 is nested within the nose 25716 of the first jaw 25702 so that the gap 25724 is maintained above the flex circuit 25706 by the stepped feature 25720 in the absence of tissue.

In the embodiment of FIGS. 128-134, the end effector 25700 includes a treatment area 25714 that exists between the anvil 25710 and the staple cartridge 25708. To staple the tissue gripped by the end effector 25700 in the treatment area 25714, the staples are deployed into the tissue from the staple cartridge 25708 and deformed by the anvil 25710. In another embodiment, the treated area of the end effector 25700 can seal the tissue by applying high frequency and / or ultrasonic energy to the tissue in the treated area.

In the embodiment of FIGS. 128-134, the continuous sensor is located on the distal portion of the staple cartridge 25708 and is defined by an insulated flex circuit 25706, which flex circuit 25706 receives the staple cartridge. The first jaw 25702 is routed through a contact coupled to a corresponding contact in channel 25726 of the first jaw 25702. Sensor signals indicating the presence of overhanging tissue pass through these contacts, for example, to a control system such as control system 470 (FIG. 12).

The flex circuit 25706 extends distally from the flat or substantially flat portion 25728 of the staple cartridge 25708 between the stepped feature 25720 and the flex nose 25716. The flex circuit 25706 is further located below the ramp 25730 defined by the flex nose 25716 and extending from the distal edge of the flat portion 25728. The tissue extending beyond the stepped feature 25720 to the flat 25728 and / or the inclined surface 25730 triggers a continuous sensor and a sensor signal is transmitted to the control system 470 (FIG. 12).

The distal end of the bent nose includes a corresponding alignment feature 25722, 25732 located distal to the continuous sensor. In the embodiments of FIGS. 128-134, the alignment feature 25722 comprises a raised surface and the alignment feature 25732 includes a corresponding concave surface configured to receive the raised surface of the alignment feature 25722.

The continuous sensor is located on the staple cartridge 25708, but this should not be construed as a limitation. For example, in certain cases, the continuous sensor may be disposed on the distal nose 25718 of the anvil 25710.

In various aspects, the surgical instrument with the end effector 25700 as shown in FIGS. 128-134 may be a handheld surgical instrument. Alternatively, the end effector 25700 may be incorporated into the robot system as a component of the robot arm. Further details of the robotic system are disclosed in US Patent Provisional Application No. 62 / 611,339, filed December 28, 2017, which is incorporated herein by reference in its entirety.

In a particular example, a surgical instrument 25701 with an end effector 25700 as shown in FIGS. 128-134 is wired and / or wirelessly communicated, as described in more detail in connection with FIGS. 1-11. It may be communicably connected to a surgical hub (eg, surgical hub 106 (FIGS. 3, 4), 206 (FIG. 206)) via a channel.

In various embodiments, when a tissue overhang is detected, the display 473 may show at least a partial view of the end effector 25700, for example, the cartridge deck of the staple cartridge 25708 in which the tissue is overhanging. Further, impedance or another tissue compression estimation detection means, or three-dimensional stacking or another visualization means may be adopted to further indicate the amount of overhang structure detected between the bent nose 25716 and the nose 25718. Good.

Various aspects of the subject matter described herein are described in the following examples:
Example 1-Surgical staple fastening device with an end effector. The end effector is a first jaw and a second jaw, the first between the open and closed configurations to grip the tissue between the first and second jaws. It has a second jaw that can be moved with respect to the jaw. The end effector further comprises an anvil and a staple cartridge. Staple cartridges include staples that are deployable within the tissue and deformable by anvil. The surgical staple system further comprises a control circuit. The control circuit determines the tissue impedance in a given zone, detects the irregularity of the tissue distribution in the end effector based on the tissue impedance, and adjusts the end effector closure parameters according to the irregularity. It is configured to do and do.

Example 2-The surgical staple fastening device according to Example 1, wherein the end effector comprises a detection circuit in a predetermined zone.

Example 3-The surgical staple fastening instrument according to Example 1 or 2, wherein the predetermined zones are separated by insulating elements.

Example 4-Surgical operation according to Example 1, 2 or 3, wherein the predetermined zone includes an inner predetermined zone, an outer predetermined zone, and an intermediate predetermined zone between the inner predetermined zone and the outer predetermined zone. Staple fastener.

Example 5-Detecting irregularities in the tissue distribution within the end effector comprises determining that the average tissue impedance in the inner and outer predetermined zones is greater than the tissue impedance in the intermediate predetermined zones. The surgical staple fastening device according to Example 4.

Example 6-By detecting irregularities in the tissue distribution within the end effector, the control circuit alerts the user to release and rearrange the tissue gripped by the end effector, Examples 1, 2, 3, 4, or 5 surgical staple fastening device.

Example 7-Detecting irregularities in the tissue distribution within the end effector comprises determining that the average tissue impedance in the inner and outer predetermined zones is less than or equal to the tissue impedance in the intermediate predetermined zone. The surgical staple fastening device according to Example 4. Detecting irregularities in the tissue distribution within the end effector further includes determining that the tissue impedance of the inner predetermined zone is greater than the tissue impedance of the outer predetermined zone.

Example 8-A motor further configured to guide the end effector into a closed configuration is provided to reduce the speed of the motor in the control circuit by detecting irregularities in the tissue distribution within the end effector. , The surgical staple fastening device according to Example 1, 2, 3, 4, 5, 6, or 7.

Example 9-The surgical staple fastening device according to Example 1, 2, 3, 4, 5, 6, 7, or 8, wherein the closure parameter is the closure rate.

Example 10-The control circuit is configured to pass at least one treatment signal through the tissue in each of the predetermined zones to determine the tissue impedance, Examples 1, 2, 3, 4, 5,. 6, 7, 8, or 9 surgical staple fastening device.

Example 11-A surgical stapler for stapling previously stapled tissue comprises a shaft defining a longitudinal axis extending through the interior and an end effector extending from the shaft. Be prepared. The end effector is a first jaw and a second jaw, the first between the open and closed configurations to grip the tissue between the first and second jaws. It has a second jaw that can be moved with respect to the jaw. The end effector further comprises an anvil and a staple cartridge. Staple cartridges include staples that can be deployed within previously stapled tissue and are deformable by anvils. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. The surgical staple system further comprises a circuit. The circuit measures the tissue impedance in a given zone, compares the measured tissue impedance to a given tissue impedance signature in a given zone, and from that comparison, the previously stapled tissue in the end effector. It is configured to detect and perform irregularities in at least one of the positions and orientations of.

Example 12-The surgical staple fastening device according to Example 11, wherein the end effector comprises a detection circuit in a predetermined zone.

Example 13-The surgical staple fastening device according to Example 11 or 12, wherein the predetermined zones are separated by insulating elements.

Example 14-Surgical staple fastening device according to Example 11, 12, or 13, wherein a predetermined zone is arranged circumferentially around a longitudinal axis.

Example 15-The surgical staple fastening device according to Example 11, 12, 13, or 14, which causes the control circuit to warn the user by detecting irregularities.

Example 16-Examples 11, 12, 13, 14, or 15 the control circuit is configured to pass at least one treatment signal through the tissue in each of the predetermined zones to determine the tissue impedance. Surgical staple fastening device described in.

Example 17-The surgical staple fastening device comprises an end effector. The end effector is a first jaw and a second jaw, the first between the open and closed configurations to grip the tissue between the first and second jaws. It has a second jaw that can be moved with respect to the jaw. The end effector further comprises an anvil and a staple cartridge. Staple cartridges include staples that are deployable within the tissue and deformable by anvil. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. Surgical staple fasteners further include a control circuit. The control circuit determines the electrical parameters of the tissue in each of the predetermined zones, detects the irregularity of the tissue distribution in the end effector based on the determined electrical parameters, and the irregularity. It is configured to adjust and do the closing parameters of the end effector according to.

Example 18-The surgical staple fastening device of Example 17, wherein the end effector comprises a detection circuit in a predetermined zone.

Example 19-The surgical staple fastening device according to Example 17 or 18, wherein the predetermined zones are separated by insulating elements.

Example 20-The surgical staple fastening device according to Example 17, 18, or 19, wherein the closure parameter is the closure rate.

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 devices. .. 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 memory 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.) It is not limited to the device. 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. Thus, as used herein, a "control circuit" includes an electric circuit having at least one individual electric circuit, an electric circuit having at least one integrated circuit, and at least one application-specific integrated circuit. Electrical circuits, general purpose computing devices configured by computer programs (eg, general purpose computers configured by computer programs that at least partially execute the processes and / or devices described herein, or described herein. Electrical circuits forming electrical circuits (microprocessors composed of computer programs that execute processes and / or devices at least partially), electrical circuits forming memory devices (eg, in the form of random access memory), and / or communication devices (e.g.) 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. The 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" and the like are either hardware, a combination of hardware and software, software, or running software. Can refer to a computer-related entity that is.

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, or 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 manipulated, compared, and otherwise manipulated. 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 may include 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 December 2008 title "IEEE 802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE) 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 Sector (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 an 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 refer to data expressed as a physical (electronic) quantity in a computer system's memory or memory as a physical quantity in the computer's memory or register or such information storage, transmission, or display. It will be appreciated that it refers to the operation and processing of a computer system or similar electronic computing device that manipulates and transforms into other similarly represented data.

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. It will be further understood that for convenience and clarity, spatial terms such as "vertical", "horizontal", "top", and "bottom" may be used for 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 does not exist. However, those skilled in the art will understand. 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.

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. Therefore, 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 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. 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) Surgical staple fastening device
It ’s an end effector,
With the first Joe
A second jaw that is movable relative to the first jaw between the open and closed configurations to grip the tissue between the first jaw and the second jaw. , With the second Joe,
Anvil and
An end effector comprising a staple cartridge comprising staples that can be deployed within the tissue and that can be deformed by the anvil.
It ’s a control circuit,
Determining the tissue impedance in a given zone
To detect irregularities in the tissue distribution in the end effector based on the tissue impedance,
A surgical staple fastening device comprising a control circuit, which is configured to adjust the closure parameters of the end effector according to the irregularity.
(2) The surgical staple fastening device according to the first embodiment, wherein the end effector includes a detection circuit in the predetermined zone.
(3) The surgical staple fastening device according to the second embodiment, wherein the predetermined zone is separated by an insulating element.
(4) The predetermined zone in front is
Inside predetermined zone and
Outer predetermined zone and
The surgical staple fastening device according to embodiment 2, comprising an intermediate predetermined zone between the inner predetermined zone and the outer predetermined zone.
(5) Detecting the irregularity of the tissue distribution in the end effector means that the average of the tissue impedances in the inner predetermined zone and the outer predetermined zone is larger than the tissue impedance in the intermediate predetermined zone. The surgical staple fastening device according to embodiment 4, which comprises determining.

(6) An embodiment in which the control circuit is warned by detecting the irregularity of the tissue distribution in the end effector to release and rearrange the tissue gripped by the end effector. The surgical staple fastening device according to 5.
(7) Detecting the irregularity of the tissue distribution in the end effector is
It is determined that the average of the tissue impedances in the inner predetermined zone and the outer predetermined zone is equal to or less than the tissue impedance in the intermediate predetermined zone.
The surgical staple fastening device according to embodiment 4, wherein the tissue impedance of the inner predetermined zone is determined to be larger than the tissue impedance of the outer predetermined zone.
(8) The motor is further provided with a motor configured to induce the end effector to shift to the closed configuration, and by detecting the irregularity of the tissue distribution in the end effector, the motor is connected to the control circuit. The surgical staple fastening device according to embodiment 7, which reduces the speed of the surgical stapler.
(9) The surgical staple fastening device according to the first embodiment, wherein the closing parameter is the closing speed.
(10) The surgical staple fastening according to embodiment 1, wherein the control circuit is configured to pass at least one therapeutic signal through the tissue in each of the predetermined zones to determine the tissue impedance. Instrument.

(11) A surgical stapler for stapling previously stapled tissue.
A shaft that defines a longitudinal axis that extends through the interior,
An end effector extending from the shaft.
With the first Joe
A second jaw that is movable relative to the first jaw between the open and closed configurations to grip the tissue between the first jaw and the second jaw. , With the second Joe,
Anvil and
A staple cartridge containing staples that can be deployed within the previously stapled tissue and that can be deformed by the anvil.
An end effector comprising a predetermined zone between the anvil and the staple cartridge.
It ’s a circuit,
Measuring the tissue impedance in the predetermined zone and
Comparing the measured tissue impedance with a predetermined tissue impedance signature in the predetermined zone,
The comparison comprises a circuit configured to detect and perform irregularities in at least one of the positions and orientations of the previously stapled tissue within the end effector. , Surgical staple fasteners.
(12) The surgical staple fastening device according to embodiment 11, wherein the end effector includes a detection circuit in the predetermined zone.
(13) The surgical staple fastening device according to embodiment 12, wherein the predetermined zone is separated by an insulating element.
(14) The surgical staple fastening device according to embodiment 13, wherein the predetermined zone is arranged in the circumferential direction around the longitudinal axis.
(15) The surgical staple fastening device according to embodiment 11, which causes the control circuit to warn the user by detecting the irregularity.

(16) The surgical staple fastening according to embodiment 11, wherein the control circuit is configured to pass at least one therapeutic signal through the tissue in each of the predetermined zones to determine the tissue impedance. Instrument.
(17) Surgical staple fastening device
It ’s an end effector,
With the first Joe
A second jaw that is movable relative to the first jaw between the open and closed configurations to grip the tissue between the first jaw and the second jaw. , With the second Joe,
Anvil and
A staple cartridge containing staples that can be deployed within the tissue and that can be deformed by the anvil.
An end effector comprising a predetermined zone between the anvil and the staple cartridge.
It ’s a control circuit,
Determining the electrical parameters of the tissue in each of the predetermined zones
Detecting irregularities in the tissue distribution within the end effector based on the determined electrical parameters
A surgical staple fastening device comprising a control circuit, which is configured to adjust the closure parameters of the end effector according to the irregularity.
(18) The surgical staple fastening device according to embodiment 17, wherein the end effector includes a detection circuit in the predetermined zone.
(19) The surgical staple fastening device according to embodiment 18, wherein the predetermined zone is separated by an insulating element.
(20) The surgical staple fastening device according to embodiment 17, wherein the closing parameter is the closing rate.

Claims (20)

Surgical staple fastening device
It ’s an end effector,
With the first Joe
A second jaw that is movable relative to the first jaw between the open and closed configurations to grip the tissue between the first jaw and the second jaw. , With the second Joe,
Anvil and
An end effector comprising a staple cartridge comprising staples that can be deployed within the tissue and that can be deformed by the anvil.
It ’s a control circuit,
Determining the tissue impedance in a given zone
To detect irregularities in the tissue distribution in the end effector based on the tissue impedance,
A surgical staple fastening device comprising a control circuit, which is configured to adjust the closure parameters of the end effector according to the irregularity. The surgical staple fastening device according to claim 1, wherein the end effector includes a detection circuit in the predetermined zone. The surgical staple fastening device according to claim 2, wherein the predetermined zone is separated by an insulating element. The above-mentioned predetermined zone is
Inside predetermined zone and
Outer predetermined zone and
The surgical staple fastening device according to claim 2, further comprising an intermediate predetermined zone between the inner predetermined zone and the outer predetermined zone. Detecting the irregularity of the tissue distribution in the end effector determines that the average of the tissue impedances in the inner predetermined zone and the outer predetermined zone is larger than the tissue impedance in the intermediate predetermined zone. 4. The surgical staple fastening device according to claim 4. 5. The fifth aspect of the present invention, which warns the user to release and rearrange the tissue gripped by the end effector by detecting the irregularity of the tissue distribution in the end effector. Surgical staple fastening device. Detecting the irregularity of the tissue distribution in the end effector
It is determined that the average of the tissue impedances in the inner predetermined zone and the outer predetermined zone is equal to or less than the tissue impedance in the intermediate predetermined zone.
The surgical staple fastening device according to claim 4, wherein the tissue impedance of the inner predetermined zone is determined to be larger than the tissue impedance of the outer predetermined zone. A motor configured to guide the end effector to shift to the closed configuration is further provided, and by detecting the irregularity of the tissue distribution in the end effector, the speed of the motor is transmitted to the control circuit. The surgical staple fastening device according to claim 7, which is lowered. The surgical staple fastening device according to claim 1, wherein the closing parameter is the closing speed. The surgical staple fastening device according to claim 1, wherein the control circuit is configured to pass at least one therapeutic signal through the tissue in each of the predetermined zones to determine the tissue impedance. A surgical stapler for stapling previously stapled tissue,
A shaft that defines a longitudinal axis that extends through the interior,
An end effector extending from the shaft.
With the first Joe
A second jaw that is movable relative to the first jaw between the open and closed configurations to grip the tissue between the first jaw and the second jaw. , With the second Joe,
Anvil and
A staple cartridge containing staples that can be deployed within the previously stapled tissue and that can be deformed by the anvil.
An end effector comprising a predetermined zone between the anvil and the staple cartridge.
It ’s a circuit,
Measuring the tissue impedance in the predetermined zone and
Comparing the measured tissue impedance with a predetermined tissue impedance signature in the predetermined zone,
The comparison comprises a circuit configured to detect and perform irregularities in at least one of the positions and orientations of the previously stapled tissue within the end effector. , Surgical staple fasteners. The surgical staple fastening device according to claim 11, wherein the end effector includes a detection circuit in the predetermined zone. The surgical staple fastening device according to claim 12, wherein the predetermined zone is separated by an insulating element. The surgical staple fastening device according to claim 13, wherein the predetermined zone is arranged in a circumferential direction around the longitudinal axis. The surgical staple fastening device according to claim 11, wherein the control circuit is alerted to the user by detecting the irregularity. The surgical staple fastening device according to claim 11, wherein the control circuit is configured to pass at least one therapeutic signal through the tissue in each of the predetermined zones to determine the tissue impedance. Surgical staple fastening device
It ’s an end effector,
With the first Joe
A second jaw that is movable relative to the first jaw between the open and closed configurations to grip the tissue between the first jaw and the second jaw. , With the second Joe,
Anvil and
A staple cartridge containing staples that can be deployed within the tissue and that can be deformed by the anvil.
An end effector comprising a predetermined zone between the anvil and the staple cartridge.
It ’s a control circuit,
Determining the electrical parameters of the tissue in each of the predetermined zones
Detecting irregularities in the tissue distribution within the end effector based on the determined electrical parameters
A surgical staple fastening device comprising a control circuit, which is configured to adjust the closure parameters of the end effector according to the irregularity. The surgical staple fastening device according to claim 17, wherein the end effector includes a detection circuit in the predetermined zone. The surgical staple fastening device according to claim 18, wherein the predetermined zone is separated by an insulating element. The surgical staple fastening device according to claim 17, wherein the closing parameter is the closing speed.

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