JP7225249B2 - Surgical system for detecting irregularities in end effector tissue distribution - Google Patents

Description

(Cross reference to related applications)
This application was filed June 28, 2018 under 35 U.S.C. claims priority benefit to U.S. Provisional Patent Application No. 62/691,227.

This application, filed March 30, 2018, under 35 U.S.C. U.S. Provisional Patent Application No. 62/650,887, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS," entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL"; and U.S. Provisional Patent Application No. 62/650,882, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS." No./650,898 claims priority benefit.

This application is further filed under 35 U.S.C. to U.S. Provisional Patent Application No. 62/640,417, filed on May 1, 2018, and U.S. Provisional Patent Application No. 62/640,415, filed March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR"; Claim priority benefits.

This application is further subject to U.S. provisional patent application entitled "INTERACTIVE SURGICAL PLATFORM," filed Dec. 28, 2017, under 35 U.S.C. Application No. 62/611,341, U.S. Provisional Patent Application No. 62/611,340, filed December 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS," and U.S. Provisional Patent Application No. 62/611,340, entitled "ROBOT ASSISTED SURGICAL PLATFORM," December 2017. It claims the benefit of priority from US Provisional Patent Application No. 62/611,339, filed May 28.

The present disclosure relates to various surgical systems.

SUMMARY In various aspects, a surgical stapling instrument including an end effector is disclosed. The end effector has a first jaw and a second jaw, the first jaw moving between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. a second jaw movable relative to the jaws. The end effector further comprises an anvil and staple cartridge. The staple cartridge includes staples deployable within tissue and deformable by the anvil. The surgical stapling system further comprises control circuitry. A control circuit determines tissue impedance in a predetermined zone, detects irregularities in tissue distribution within the end effector based on the tissue impedance, and adjusts a closure parameter of the end effector according to the irregularities. is configured to do and

SUMMARY In various aspects, a surgical stapling instrument for stapling previously stapled tissue is disclosed. A surgical stapling instrument includes a shaft defining a longitudinal axis extending therethrough and an end effector extending from the shaft. The end effector has a first jaw and a second jaw, the first jaw moving between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. a second jaw movable relative to the jaws. The end effector further comprises an anvil and staple cartridge. The staple cartridge includes staples deployable within previously stapled tissue and deformable by the anvil. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. The surgical stapling instrument further comprises circuitry. The circuitry measures tissue impedance in the predetermined zone, compares the measured tissue impedance to a predetermined tissue impedance signature in the predetermined zone, and determines from the comparison previously stapled tissue in the end effector. and detecting irregularities in at least one of the position and orientation of the .

SUMMARY In various aspects, a surgical stapling instrument including an end effector is disclosed. The end effector has a first jaw and a second jaw, the first jaw moving between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. a second jaw movable relative to the jaws. The end effector further comprises an anvil and staple cartridge. The staple cartridge includes staples deployable within tissue and deformable by the anvil. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. The surgical stapling instrument further comprises control circuitry. The control circuitry determines an electrical parameter of tissue in each of the predetermined zones, detects irregularities in tissue distribution within the end effector based on the determined electrical parameters, and detects the irregularities. and adjusting the closure parameters of the end effector according to the nature of the end effector.

Features of various aspects are set forth with particularity in the accompanying claims. The various aspects, both as to organization and method of operation, however, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings, which follow.
1 is a block diagram of a computer-implemented interactive surgical system, according to at least one aspect of the present disclosure; FIG. A surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. 1 is 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. 122 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure; 3 is a perspective view of a combination generator module comprising bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure; FIG. 4 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, in accordance with at least one aspect of the present disclosure; 1 illustrates a vertical modular housing configured to receive multiple modules, according to at least one aspect of the present disclosure; Cloud modular devices located in one or more operating rooms of a healthcare facility, or any room within a healthcare facility with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure. 1 illustrates a surgical data network with modular communication hubs configured to connect; 1 illustrates a computer-implemented interactive surgical system, according to at least one aspect of the present disclosure; 4 illustrates a surgical hub comprising multiple modules coupled to a modular control tower, according to at least one aspect of the present disclosure; 1 illustrates one aspect of a universal serial bus (USB) network hub device, in accordance with at least one aspect of the present disclosure; 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 11 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 4 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; 1 illustrates a surgical instrument or tool comprising multiple motors that can be activated to perform various functions, in accordance with at least one aspect of the present disclosure; 1 is a schematic diagram of a robotic surgical instrument configured to operate a surgical tool described herein, according to at least one aspect of the present disclosure; FIG. FIG. 10 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member, according to at least one aspect of the present disclosure; 1 is a circuit diagram of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure; FIG. FIG. 5 is a stroke length graph illustrating an example of a control system that varies the stroke length of a clamp assembly based on articulation angle; FIG. FIG. 10 is a closure tube assembly positioning graph illustrating an example control system that changes the longitudinal position of the closure tube assembly based on the articulation angle; 3 is a comparison of a stapling method utilizing controlled tissue compression and a stapling method without controlled tissue compression. 3 is a force graph shown in Section A and an associated displacement graph shown in Section B, the force and displacement graphs having an x-axis representing time and the y-axis of the displacement graph representing the travel displacement of the firing rod; , the y-axis of the force graph indicates the sensed torsional force applied to the motor configured to advance the firing rod. FIG. 10 is a schematic diagram of a tissue contact circuit showing a pair of spaced apart contact plates contacting tissue to complete the circuit. 1 is a perspective view of a surgical instrument having an operably coupled interchangeable shaft assembly in accordance with at least one aspect of the present disclosure; FIG. 26 is an exploded view of a portion of the surgical instrument of FIG. 25 in accordance with 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. 26 is an exploded view of an end effector of the surgical instrument of FIG. 25 in accordance with at least one aspect of the present disclosure; FIG. 26 is a block diagram of the control circuitry of the surgical instrument of FIG. 25, spanning two drawings, in accordance with at least one aspect of the present disclosure; FIG. 26 is a block diagram of the control circuitry of the surgical instrument of FIG. 25, spanning two drawings, in accordance with at least one aspect of the present disclosure; FIG. 26 is a block diagram of the control circuitry of the surgical instrument of FIG. 25 showing the interface between the handle assembly and the power supply assembly and the interface between the handle assembly and the replaceable shaft assembly in accordance with at least one aspect of the present disclosure; FIG. . 1 illustrates an exemplary medical device that may include one or more aspects of the present disclosure; 1 illustrates an exemplary end effector of a medical device encircling tissue in accordance with one or more aspects of the present disclosure; 1 illustrates an exemplary end effector of a medical device for compressing tissue, in accordance with one or more aspects of the present disclosure; FIG. 11 illustrates an exemplary force exerted by an end effector of a medical device compressing tissue in accordance with one or more aspects of the present disclosure; FIG. 4 further illustrates exemplary forces exerted by an end effector of a medical device compressing tissue in accordance with one or more aspects of the present disclosure; 1 illustrates an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure; 4 further illustrates an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure; 4 further illustrates an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure; Similarly, FIG. 4 is an exemplary circuit diagram in accordance with one or more aspects of the disclosure. Similarly, FIG. 4 is an exemplary circuit diagram in accordance with one or more aspects of the disclosure. 4 is a graph illustrating exemplary frequency modulation in accordance with one or more aspects of the disclosure; 4 is a graph illustrating a combined RF signal, according to one or more aspects of the present disclosure; 4 is a graph showing filtered RF signals according to one or more aspects of the present disclosure; 1 is a perspective view of a surgical instrument with an articulatable exchangeable shaft; FIG. Fig. 2 is a side view of the tip of the 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. 50) is plotted. 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. 50) is plotted. 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. 50) is plotted. 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. 50) is plotted. 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. 50) is plotted. 2 is a graph plotting tissue displacement as a function of tissue compression for normal tissue. FIG. 4 is a graph plotting tissue displacement as a function of tissue compression to distinguish between normal and diseased tissue. 1 illustrates an embodiment of an end effector with a first sensor and a second sensor; FIG. 54 is a logic diagram illustrating one embodiment of a process for adjusting the reading of a first sensor based on input from a second sensor of the end effector shown in FIG. 53; FIG. 10 is a logic diagram illustrating one embodiment of a process for determining a lookup table for a first sensor based on input from a second sensor; FIG. 4 is a logic diagram illustrating one embodiment of a process for calibrating a first sensor in response to input from a second sensor; FIG. 100 is a logic diagram illustrating one embodiment of a process for determining and displaying thickness of a tissue section clamped between an end effector anvil and a staple cartridge; FIG. 100 is a logic diagram illustrating one embodiment of a process for determining and displaying thickness of a tissue section clamped between an end effector anvil and a staple cartridge; FIG. 10 is a graph showing a comparison of adjusted Hall effect thickness measurements and uncorrected Hall effect thickness measurements; FIG. 1 illustrates an embodiment of an end effector with a first sensor and a second sensor; 1 illustrates one embodiment of an end effector comprising a first sensor and a plurality of second sensors; FIG. 4 is a logic diagram illustrating one embodiment of a process for adjusting a first sensor reading in response to multiple secondary sensors. 1 illustrates one embodiment of circuitry configured to convert signals from a first sensor and a plurality of secondary sensors into digital signals receivable by a processor. 10 illustrates one embodiment of an end effector with multiple sensors; FIG. 10 is a logic diagram illustrating one embodiment of a process for determining one or more tissue properties based on multiple sensors; 10 illustrates an embodiment of an end effector with multiple sensors coupled to the second jaw member; 10 illustrates one embodiment of a staple cartridge with multiple sensors integrally formed therein; FIG. 10 is a logic diagram illustrating one embodiment of a process for determining one or more parameters of a tissue section clamped within an end effector; 10 illustrates one embodiment of an end effector with multiple redundant sensors; FIG. 4 is a logic diagram illustrating one embodiment of a process for selecting the most reliable output from multiple redundant sensors; FIG. 11 illustrates one embodiment of an end effector with a sensor having a unique sampling rate to limit or eliminate spurious signals; FIG. FIG. 100 is a logic diagram illustrating one embodiment of a process for generating thickness measurements of tissue sections located between an anvil of an end effector and a staple cartridge; FIG. 11 illustrates an embodiment of an end effector with sensors that identify different types of staple cartridges; FIG. FIG. 11 illustrates an embodiment of an end effector with sensors that identify different types of staple cartridges; FIG. 4 illustrates one aspect of a segmented flexible circuit configured to be fixedly attached to a jaw member of an end effector, in accordance with at least one aspect of the present disclosure; 4 illustrates one aspect of a segmented flexible circuit configured to be attached to a jaw member of an end effector, in accordance with at least one aspect of the present disclosure; FIG. 11 illustrates one aspect of an end effector configured to measure tissue gap GT, according to at least one aspect of the present disclosure; FIG. 10 illustrates one aspect of an end effector comprising a segmented flexible circuit, in accordance with at least one aspect of the present disclosure; 79 shows the end effector shown in FIG. 78 with the jaw members clamping tissue between the jaw members and the staple cartridge in accordance with at least one aspect of the present disclosure; 1 is a diagram of an absolute positioning system for a surgical instrument, wherein the absolute positioning system comprises controlled motor drive circuitry comprising a sensor mechanism, in accordance with at least one aspect of the present disclosure; FIG. 1 is a position sensor with a magnetic rotary absolute positioning system, in accordance with at least one aspect of the present disclosure; FIG. FIG. 122 is a cross-sectional view of an end effector of a surgical instrument illustrating a firing member stroke against tissue grasped within the end effector in accordance with at least one aspect of the present disclosure; A 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 and thick and thin tissue during the firing phase. FIG. 5 is a second graph of two firing force (FTF) plots showing the force applied to the firing member to fire through tissue; FIG. According to at least one aspect of the present disclosure, providing gradual closure of the closure member during the firing stroke as the firing member is advanced distally and coupled into the clamp arm to provide a desired closure force load on the closure member. is a graph of a control system configured to decrease the velocity of the firing member to reduce the firing force load on the firing member. 1 illustrates a proportional-integral-derivative (PID) controller feedback control system, according to at least one aspect of the present disclosure; FIG. 10 is a logic flow diagram illustrating a control program or logic configuration process for determining velocity of a closure member, in accordance with at least one aspect of the present disclosure; 4 is a timeline illustrating surgical hub situational awareness, in accordance with at least one aspect of the present disclosure; FIG. 232 is a perspective view of an end effector of a curved surgical stapling and severing instrument including predetermined zones in accordance with at least one aspect of the present disclosure; 89 is a straight partial cross-section of the end effector of the curved surgical stapling and severing instrument of FIG. 88 with tissue grasped by the end effector in accordance with at least one aspect of the present disclosure; FIG. 132 is a perspective view of an end effector of a surgical stapling and severing instrument including predetermined zones, according to at least one aspect of the present disclosure; 89 is a straight, partial cut-away view of the end effector of the curved surgical stapling and severing instrument of FIG. 88 with tissue positioned between jaws of the end effector in accordance with at least one aspect of the present disclosure; FIG. 89 is a straight, partial cut-away view of the end effector of the curved surgical stapling and severing instrument of FIG. 88 with tissue positioned between jaws of the end effector in accordance with at least one aspect of the present disclosure; FIG. 89 is a straight, partial cut-away view of the end effector of the curved surgical stapling and severing instrument of FIG. 88 with tissue positioned between jaws of the end effector in accordance with at least one aspect of the present disclosure; FIG. 92 illustrates the tissue of FIG. 91 being grasped by the end effector of FIG. 88, according to at least one aspect of the present disclosure; 93 shows the tissue of FIG. 92 being grasped by the end effector of FIG. 88, according to at least one aspect of the present disclosure; 94 illustrates the tissue of FIG. 93 being grasped by the end effector of FIG. 88, according to at least one aspect of the present disclosure; FIG. 10 is a logic flow diagram of a process illustrating a control program or logic configuration for identifying tissue distribution irregularities within an end effector of a surgical instrument in accordance with at least one aspect of the present disclosure; 89 is a graph showing three predetermined tissue impedance measurements of the end effector of FIG. 88 over time in accordance with at least one aspect of the present disclosure; 92 is a graph representing the closing force of the end effector of FIG. 88 around the tissue of FIG. 91 plotted against time and the motor speed of the motor effecting end effector closure, in accordance with at least one aspect of the present disclosure; FIG. 93 is a graph representing the closing force of the end effector of FIG. 88 around the tissue of FIG. 92 plotted against time, and the motor speed of the motor effecting end effector closure, in accordance with at least one aspect of the present disclosure; FIG. 94 is a graph representing the closing force of the end effector of FIG. 88 around the tissue of FIG. 93 plotted against time and the motor speed of the motor effecting end effector closure, in accordance with at least one aspect of the present disclosure; FIG. 1 illustrates a control system for a surgical instrument, according to at least one aspect of the present disclosure; 107 is an illustration of a surgical instrument centered on a linear staple transversal incision line using the benefits of the centering tools and techniques described in connection with FIGS. 104-106, according to at least one aspect of the present disclosure; FIG. 6 illustrates the process of aligning the anvil trocar of a circular stapler with the staple overlap portion of a straight staple line created by a double stapling technique, according to at least one aspect of the present disclosure; FIG. 11 illustrates an anvil trocar of a circular stapler that is out of alignment with the staple overlap of a straight staple line created by a double stapling technique; FIG. 6 illustrates the process of aligning the anvil trocar of a circular stapler with the staple overlap portion of a straight staple line created by a double stapling technique, according to at least one aspect of the present disclosure; FIG. 12 shows the anvil trocar of a circular stapler aligned with the center of the staple overlap portion of a straight staple line produced by a double stapling technique; FIG. 6 illustrates the process of aligning the anvil trocar of a circular stapler with the staple overlap portion of a straight staple line created by a double stapling technique, according to at least one aspect of the present disclosure; 104 shows the centering tool displayed on the surgical hub display showing the staple overlap portion of the straight staple line created by the double stapling technique cut by the circular stapler, in which the anvil trocar is shown in FIG. so as not to align with the staple overlap portion of the double staple line. FIG. 12 shows before and after images of a centering tool, according to at least one aspect of the present disclosure; FIG. FIG. 10B of the projected cutting path of the anvil trocar and circular knife before being aligned with the target alignment ring surrounding the image of the straight staple line above the image of the staple overlap presented on the surgical hub display; FIG. It is an image. FIG. 12 shows before and after images of a centering tool, according to at least one aspect of the present disclosure; FIG. FIG. 10B of the projected cutting path of the anvil trocar and circular knife after being aligned with the target alignment ring surrounding the image of the straight staple line above the image of the staple overlap presented on the surgical hub display; It is an image. 10 illustrates a process of aligning the anvil trocar of a circular stapler with the center of a straight staple line, according to at least one aspect of the present disclosure; Fig. 2 shows the anvil trocar not aligned with the center of the straight staple line; 10 illustrates a process of aligning the anvil trocar of a circular stapler with the center of a straight staple line, according to at least one aspect of the present disclosure; FIG. 11 shows an anvil trocar aligned with the center of a straight staple line; FIG. 10 illustrates a process of aligning the anvil trocar of a circular stapler with the center of a straight staple line, according to at least one aspect of the present disclosure; 109 shows the centering tool displayed on the surgical hub display for a straight staple line, where the anvil trocar is not aligned with the staple overlapping portion of the double staple line, as shown in FIG. 109; FIG. 12 is an image of a standard reticle field of view of a surgical straight staple line transectomy viewed through a laparoscope displayed on a surgical hub display in accordance with at least one aspect of the present disclosure; FIG. FIG. 112 is a laser-assisted reticle view image of the surgical site shown in FIG. 112 before the anvil trocar and circular knife of the circular stapler are aligned with the center of the straight staple line, in accordance with at least one aspect of the present disclosure; is. 114 is a laser-assisted reticle view image of the surgical site shown in FIG. 113 after the anvil trocar and circular knife of the circular stapler have been aligned with the center of the straight staple line, according to at least one aspect of the present disclosure; FIG. FIG. 19 is a partial perspective view of a circular stapler showing a circular stapler trocar including a staple cartridge having four predetermined zones, in accordance with at least one aspect of the present disclosure; FIG. 18 is a partial perspective view of a circular stapler showing a circular stapler trocar including a staple cartridge having eight predetermined zones in accordance with at least one aspect of the present disclosure; Two tissues including previously deployed staples, with the two tissues including previously deployed staples properly positioned on the staple cartridge of FIG. 115 to the left, according to at least one aspect of the present disclosure is shown properly positioned on the staple cartridge of FIG. 115 on the right. To the left is tissue containing previously deployed staples properly positioned on the staple cartridge of FIG. 115, and tissue containing previously deployed staples is shown in FIG. is shown on the right properly positioned on a staple cartridge. 117 shows two tissues containing previously deployed staples properly positioned on the staple cartridge of FIG. 116, in accordance with at least one aspect of the present disclosure; 117 shows two tissues containing previously deployed staples improperly placed on the staple cartridge of FIG. 116, in accordance with at least one aspect of the present disclosure; 120 is a graph illustrating tissue impedance signatures of the properly placed tissue of FIG. 119, in accordance with at least one aspect of the present disclosure; FIG. 121 is a graph illustrating tissue impedance signatures of the improperly placed tissue of FIG. 120, in accordance with at least one aspect of the present disclosure; 117 illustrates tissue with previously deployed staples properly positioned on the staple cartridge of FIG. 116, in accordance with at least one aspect of the present disclosure; 117 illustrates tissue with previously deployed staples improperly placed on the staple cartridge of FIG. 116, in accordance with at least one aspect of the present disclosure; 124 is a graph illustrating tissue impedance signatures of the properly placed tissue of FIG. 123, in accordance with at least one aspect of the present disclosure; 125 is a graph illustrating tissue impedance signatures of the improperly placed tissue of FIG. 124, in accordance with at least one aspect of the present disclosure; FIG. 25600 is a logic flow diagram of a process 25600 showing a control program or logic configuration for properly positioning previously stapled tissue within an end effector, in accordance with at least one aspect of the present disclosure; 1 illustrates an end effector extending from a shaft of a surgical instrument in an open configuration, according to at least one aspect of the present disclosure; 129 shows the end effector of FIG. 128 having a blood vessel (BV) extending between jaws of the end effector, in accordance with at least one aspect of the present disclosure; FIG. 129 shows the end effector of FIG. 128 in a tissue-free, closed configuration, in accordance with at least one aspect of the present disclosure; FIG. 129 shows the end effector of FIG. 128 with tissue grasped between jaws of the end effector in accordance with at least one aspect of the present disclosure; FIG. 1 illustrates an end effector extending from a shaft of a surgical instrument in an open configuration, according to at least one aspect of the present disclosure; 129 shows the end effector of FIG. 128 in a tissue-free, closed configuration, in accordance with at least one aspect of the present disclosure; FIG. 129 shows the end effector of FIG. 128 with tissue grasped between jaws of the end effector in accordance with at least one aspect of the present disclosure; FIG.

The applicant of this application owns the following US patent applications filed June 29, 2018, the entire disclosures of each of which are incorporated herein by reference:
- U.S. Patent Application No. ____________, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", Attorney Docket No. END8542USNP/170755;
- U.S. Patent Application No. ______________, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS", Attorney Docket No. END8543USNP/170760;
- U.S. Patent Application No. ______________, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOOPERATIVE INFORMATION", Attorney Docket No. END8543USNP1/170760-1;
- U.S. Patent Application No. ____________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", Attorney Docket No. END8543USNP2/170760-2;
- U.S. Patent Application No. ____________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", Attorney Docket No. END8543USNP3/170760-3;
- U.S. Patent Application No. ____________, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES", Attorney Docket No. END8543USNP4/170760-4;
- U.S. Patent Application No. ____________, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE", Attorney Docket No. END8543USNP5/170760-5;
- U.S. Patent Application No. ____________, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES," Attorney Docket No. END8543USNP6/170760-6;
- U.S. Patent Application No. ____________, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", Attorney Docket No. END8543USNP7/170760-7;
- U.S. Patent Application No. ______________, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", Attorney Docket No. END8544USNP/170761;
- U.S. Patent Application No. ____________, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT", Attorney Docket No. END8544USNP1/170761-1;
- U.S. Patent Application No. ____________, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY", Attorney Docket No. END8544USNP2/170761-2;
- U.S. Patent Application No. ____________, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES", Attorney Docket No. END8544USNP3/170761-3;
- U.S. Patent Application No. ____________, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL," Attorney Docket No. END8545USNP/170762;
- U.S. Patent Application No. ____________, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS," Attorney Docket No. END8545USNP1/170762-1;
- U.S. Patent Application No. ______________, entitled "SURGICAL EVACUATION FLOW PATHS", Attorney Docket No. END8545USNP2/170762-2;
- U.S. Patent Application No. ____________, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL", Attorney Docket No. END8545USNP3/170762-3;
- U.S. Patent Application No. ____________, entitled "SURGICAL EVACUATION SENSING AND DISPLAY", Attorney Docket No. END8545USNP4/170762-4;
- U.S. Patent Application No. ____________, titled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL SURGICAL PLATFORM 6NDP817E, Attorney Docket No. 617E;
- U.S. Patent Application No. ____________, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM", Attorney Docket No. END8546USNP1/170763-1;
・米国特許出願第＿＿＿＿＿＿＿＿＿＿号、発明の名称「ＳＵＲＧＩＣＡＬ ＥＶＡＣＵＡＴＩＯＮ ＳＹＳＴＥＭ ＷＩＴＨ Ａ ＣＯＭＭＵＮＩＣＡＴＩＯＮ ＣＩＲＣＵＩＴ ＦＯＲ ＣＯＭＭＵＮＩＣＡＴＩＯＮ ＢＥＴＷＥＥＮ Ａ ＦＩＬＴＥＲ ＡＮＤ Ａ ＳＭＯＫＥ ＥＶＡＣＵＡＴＩＯＮ ＤＥＶＩＣＥ」、代理人整理番号ＥＮＤ８５４７ＵＳＮＰ／１７０７６４；及び ・米国特許出願第＿＿＿＿＿＿＿＿＿＿号、発明のName "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS", agent reference number END8548USNP/170765.

The applicant of this application owns the following US provisional patent applications, filed June 28, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Provisional Patent Application No. 62/691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES";
- U.S. Provisional Patent Application No. 62/691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
- U.S. Provisional Patent Application No. 62/691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. Provisional Patent Application No. 62/691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";
U.S. Provisional Patent Application No. 62/691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE"; The title of the invention is "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS".

The applicant of this application owns the following US patent applications filed March 29, 2018, the entire disclosures of each of which are incorporated herein by reference:
- U.S. patent application Ser. No. 15/940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. patent application Ser. No. 15/940,648, entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDling OF DEVICES AND DATA CAPABILITIES";
U.S. patent application Ser. No. 15/940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATION ROOM DEVICES";
- U.S. Patent Application No. 15/940,666, entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS";
U.S. patent application Ser. No. 15/940,670, entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS";
- U.S. patent application Ser. No. 15/940,677, entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
- U.S. patent application Ser.
- U.S. patent application Ser.
- U.S. patent application Ser. No. 15/940,645, entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
- U.S. patent application Ser. No. 15/940,649, entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
- US patent application Ser. No. 15/940,654, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
- US patent application Ser. No. 15/940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
- U.S. patent application Ser. No. 15/940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
- U.S. Patent Application No. 15/940,671, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
- U.S. patent application Ser. No. 15/940,686, entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE";
- U.S. patent application Ser. No. 15/940,700, entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
- U.S. patent application Ser. No. 15/940,629, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
- US patent application Ser.
U.S. patent application Ser. No. 15/940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY"; ARRAY IMAGING".

The applicant of this application owns the following US patent applications filed March 29, 2018, the entire disclosures of each of which are incorporated herein by reference:
- U.S. patent application Ser. No. 15/940,636, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
- U.S. patent application Ser. No. 15/940,653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;
- US patent application Ser. No. 15/940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
- U.S. patent application Ser.
U.S. patent application Ser.
- US patent application Ser. No. 15/940,634, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. patent application Ser. No. 15/940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; ”.

The applicant of this application owns the following US patent applications filed March 29, 2018, the entire disclosures of each of which are incorporated herein by reference:
- US patent application Ser. No. 15/940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- US patent application Ser.
- US patent application Ser. No. 15/940,642, entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- US patent application Ser.
- US patent application Ser. No. 15/940,680, entitled "CONTROLLERS FOR ROBOT - ASSISTED SURGICAL PLATFORMS";
- US patent application Ser.
U.S. patent application Ser. No. 15/940,690, entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";PLATFORMS".

The applicant of this application owns the following US provisional patent applications filed March 28, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Provisional Patent Application No. 62/649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. Provisional Patent Application No. 62/649,294, entitled "DATA STRIPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
- U.S. Provisional Patent Application No. 62/649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. Provisional Patent Application No. 62/649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
- U.S. Provisional Patent Application No. 62/649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. Provisional Patent Application No. 62/649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
U.S. Provisional Patent Application No. 62/649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. Provisional Patent Application No. 62/649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. Provisional Patent Application No. 62/649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. Provisional Patent Application No. 62/649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";
- U.S. Provisional Patent Application No. 62/649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES";
U.S. Provisional Patent Application No. 62/649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Provisional Patent Application No. 62/649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and U.S. Provisional Patent Application No. 62/649,323, entitled "SENSING ARRANGEMENTS FOR ROBOT - Assisted Surgical Platforms".

The applicant of this application owns the following US provisional patent applications, filed April 19, 2018, the entire disclosures of each of which are incorporated herein by reference:
• US Provisional Patent Application No. 62/659,900, entitled "METHOD OF HUB COMMUNICATION".

The applicant of this application owns the following US provisional patent applications filed March 30, 2018, the entire disclosures of each of which are incorporated herein by reference:
- U.S. Provisional Patent Application No. 62/650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES";
- U.S. Provisional Patent Application No. 62/650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS";
U.S. Provisional Patent Application No. 62/650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; and U.S. Provisional Patent Application No. 62/650,898, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS".

The applicant of this application owns the following US provisional patent applications filed March 8, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR"; END EFFECTOR AND CONTROL SYSTEM THEREFOR".

The applicant of this application owns the following US provisional patent applications filed December 28, 2017, the entire disclosures of each of which are incorporated herein by reference:
- U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM";
US Provisional Patent Application No. 62/611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS"; and US Provisional Patent Application No. 62/611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM."

Before describing various aspects of surgical devices and generators in detail, it is noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts set forth in the accompanying drawings and description. It should be noted. Example embodiments may be practiced with or incorporated in other aspects, variations, and modifications, and may be practiced or carried out in various ways. Further, unless otherwise stated, the terms and expressions used herein have been chosen for the convenience of the reader for the purpose of describing example embodiments and not for purposes of limitation thereof. . Further, one or more of the aspects, implementations of aspects and/or examples described below may be combined with any of the other aspects, implementations of aspects and/or examples described below. It should be understood that one or more can be combined.

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

FIG. 3 shows an example of surgical system 102 used to perform a surgical procedure on a patient lying on operating table 114 in surgical operating room 116 . Robotic system 110 is used as part of surgical system 102 in a surgical procedure. Robotic 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 is capable of manipulating at least one releasably coupled surgical tool 117 while the surgeon views the surgical site via the surgeon's console 118 during minimally invasive incisions in the patient's body. . Images of the surgical site may be obtained by a medical imaging device 124 , which may be manipulated by the patient-side cart 120 to orient the imaging device 124 . The robotic hub 122 can be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118 .

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

Various examples of cloud-based analytics performed by the cloud 104 and suitable for use with the present disclosure are described in "CLOUD-BASED MEDICAL US Provisional Patent Application No. 62/611,340 entitled ANALYTICS.

In various aspects, imaging device 124 includes 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 imaging device 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate a portion of the surgical field. One or more image sensors can receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.

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

The invisible spectrum (ie, non-emissive spectrum) is the portion of the electromagnetic spectrum that lies 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 and these become invisible infrared (IR), microwave and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum and become invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.

In various aspects, imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include arthroscopes, angioscopes, bronchoscopes, cholangoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes) , endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structure. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments that are sensitive to light from specific wavelengths, including frequencies above the visible light range, such as IR and ultraviolet light. Spectral imaging can allow extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is described in US Provisional Patent Application Serial No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed Dec. 28, 2017, the entire disclosure of which is incorporated herein by reference. Acquisition Module” section. Multispectral monitoring can be a useful tool for repositioning the surgical field to perform one or more of the above-described tests on the treated tissue after one surgical task is completed.

It is self-evident that any surgical procedure requires rigorous sterilization of the operating room and surgical instruments. The stringent hygiene and sterilization conditions required in the "surgical theater", ie operating room or procedure room, require maximum sterility of all medical devices and instruments. Part of that sterilization process is the need to sterilize anything that comes in contact with the patient or enters the sterile field, including imaging device 124 and its accessories and components. A sterile field may be considered a specific area considered free of microorganisms, such as in a tray or on a sterile towel, or a sterile field may be considered an area immediately surrounding a patient prepared for a surgical procedure. It will be appreciated what can be done. A sterile field may include clean team members in appropriate clothing and all equipment and fixtures within the area.

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

As shown in FIG. 2, primary display 119 is positioned within the sterile field so as to be visible to an operator positioned at operating table 114 . Additionally, the visualization tower 111 is positioned 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. A visualization system 108 guided by hub 106 is configured to coordinate information flow to operators inside and outside the sterile field using displays 107, 109, and 119. FIG. For example, hub 106 may cause visualization system 108 to display a snapshot of the surgical site recorded by imaging device 124 on non-sterile display 107 or 109 while maintaining a live image of the surgical site on primary display 119. can be done. A snapshot on a non-sterile display 107 or 109 can, for example, allow a non-sterile operator to perform diagnostic steps related to a surgical procedure.

In one aspect, the hub 106 transmits diagnostic input or feedback entered by a non-sterile operator located at the visualization tower 111 within the sterile field to the primary display 119 within the sterile field, which directs it to the sterile operator located at the operating table. It is also configured so that it can be viewed by In one example, the input may be in the form of modifications to the snapshot displayed on non-sterile display 107 or 109 that can be sent by hub 106 to primary display 119 .

Referring to FIG. 2, surgical instrument 112 is used as part of surgical system 102 in a surgical procedure. Hub 106 is also configured to coordinate information flow to the display of 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 entered by a non-sterile operator at visualization tower 111 may be sent by hub 106 to surgical instrument display 115 within the sterile field, where the diagnostic input or feedback is input to surgical instrument 112 . It may be viewed by an operator. Exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in the "Surgical Instrument Hardware" section and the 2017 publication entitled "INTERACTIVE SURGICAL PLATFORM", the entire disclosures of which are incorporated herein by reference. No. 62/611,341, filed Dec. 28.

Referring now to FIG. 3 , hub 106 is shown in communication with visualization system 108 , robotic system 110 and handheld intelligent surgical instrument 112 . Hub 106 includes hub display 135 , imaging module 138 , generator module 140 , communication module 130 , processor module 132 and storage array 134 . In certain aspects, the hub 106 further includes a smoke evacuation module 126 and/or an aspiration/irrigation module 128, as shown in FIG.

During surgical procedures, the application of energy to tissue for sealing and/or cutting is commonly associated with venting smoke, aspirating excess fluid, and/or irrigating tissue. Fluid, power, and/or data lines from different sources often become entangled during surgical procedures. Valuable time may be lost in addressing this issue during a surgical procedure. Untangling the lines may require uncoupling the lines from their corresponding modules, which may require the modules to be reset. The hub's modular housing 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines.

Aspects of the present disclosure present a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably receivable within a docking station of the hub housing. The docking station includes data and power contacts. A 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 within a single unit. In one aspect, the combination generator module further comprises a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, and smoke generated by application of therapeutic energy to tissue. , at least one smoke evacuation component configured to evacuate fluids and/or particulates, and a fluid line extending from the remote surgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluid line extends from a remote surgical site to an aspiration and irrigation module slidably received within the hub housing. In one aspect, the hub housing includes a fluidic interface.

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

Aspects of the present disclosure present a modular surgical housing for use in surgical procedures involving the application of energy to tissue. A modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue and a first docking port including first data and power contacts. a first docking station comprising: a first energy generator module slidably moveable into electrical engagement with the power and data contacts; and the first energy generator module comprising: Slidably moveable out of electrical engagement with the first power and data contact.

Further to the above, the modular surgical enclosure includes a second energy generator module configured to generate a second energy for application to the tissue, different from the first energy; a second docking station comprising a second docking port including data and power contacts of the second energy generator module slidably moved into electrical engagement with the power and data contacts; Yes, and the second energy generator module is slidably moveable out of electrical engagement with the second power and data contacts.

Additionally, the modular surgical enclosure includes a first docking port and a second docking port configured to facilitate communication between the first energy generator module and the second energy generator module. Further includes a communication bus to and from the port.

Referring to FIGS. 3-7, aspects of the present disclosure are presented for a hub modular housing 136 that allows for modular integration of the generator module 140, the smoke evacuation module 126, and the aspiration/irrigation module 128. be done. The modular housing 136 of the hub further facilitates two-way communication between the modules 140,126,128. As shown in FIG. 5, the generator module 140 is an integrated monopolar, bipolar, and ultra polar generator supported within a single housing unit 139 that is slidably insertable into the hub's modular housing 136 . It may be a generator module comprising an acoustic wave component. As shown in FIG. 5, the generator module 140 can be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. FIG. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules interacting through the hub modular housing 136 . The modular housing 136 of the hub provides bi-directional switching between insertion of multiple generators and generators docked to the modular housing 136 of the hub so that the generators function as a single generator. may be configured to facilitate communication.

In one aspect, the hub's modular housing 136 is a modular power and power module with external and wireless communication headers to allow removable attachment of modules 140, 126, 128 and bi-directional communication therebetween. A communications backplane 149 is provided.

In one aspect, the hub modular housing 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140,126,128. FIG. 4 shows a partial perspective view of surgical hub housing 136 and combination generator module 145 slidably receivable in docking station 151 of surgical hub housing 136 . A docking port 152 with power and data contacts on the rear side of the combination generator module 145 is slid into position within the corresponding docking station 151 of the hub modular housing 136. Corresponding docking ports 150 are configured to engage power and data contacts of corresponding docking stations 151 of hub modular housing 136 . In one aspect, the combination generator module 145 includes bipolar, ultrasonic, and monopolar modules and a smoke evacuation module integrated with a single housing unit 139, as shown in FIG.

In various aspects, the smoke evacuation module 126 includes a fluid line 154 that carries captured/collected smoke and/or fluid away from the surgical site, eg, to the smoke evacuation module 126 . The vacuum suction generated by the smoke evacuation module 126 can draw smoke into the utility conduit openings at the surgical site. A utility conduit coupled to the fluid line may be in the form of flexible tubing that terminates in the smoke evacuation module 126 . The utility conduits and fluid lines define fluid pathways that extend toward the smoke extraction module 126 received within the hub housing 136 .

In various aspects, aspiration/irrigation module 128 is coupled to a surgical tool including an aspiration fluid line and a suction fluid line. In one example, the aspiration and aspiration fluid lines are in the form of flexible tubing that extends from the surgical site toward aspiration/irrigation module 128 . One or more drive systems may be configured to cause irrigation and aspiration of fluid to and from the surgical site.

In one aspect, a surgical tool includes a shaft having an end effector at its distal end, at least one energy treatment portion associated with the end effector, a suction tube, and an irrigation tube. A suction tube can have an inlet port at its distal end and the suction tube extends through the shaft. Similarly, an irrigation tube can extend through the shaft and have an inlet port proximate to the energy delivery device. The energy delivery instrument is configured to deliver ultrasonic and/or RF energy to the surgical site and is initially connected to generator module 140 by a cable extending through the shaft.

The irrigation tube can be in fluid communication with a fluid source and the suction tube can be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed within the aspiration/irrigation module 128 . In one example, the fluid and/or vacuum source may be housed within hub housing 136 separately from aspiration/irrigation module 128 . In such examples, the fluid interface may be configured to connect the aspiration/irrigation module 128 to a fluid source and/or a vacuum source.

In one aspect, the modules 140, 126, 128 and/or their corresponding docking stations on the hub modular housing 136 align the docking ports of the modules to the docking stations on the hub modular housing 136. Alignment features configured to engage their counterparts therein may be included. For example, as shown in FIG. 4, combination generator module 145 has side brackets configured to slidably engage corresponding brackets 156 of corresponding docking stations 151 of hub modular housing 136 . 155 included. The brackets cooperate to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub modular housing 136 .

In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151 . For example, side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, drawers 151 vary in size, each designed to accommodate a particular module.

Additionally, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting a module into a drawer with incompatible contacts.

As shown in FIG. 4, the docking port 150 of one drawer 151 is coupled to the docking port 150 of another drawer 151 via a communication link 157 to accommodate modules housed within the modular housing 136 of the hub. can facilitate two-way communication between Alternatively or additionally, docking ports 150 of hub modular housing 136 may facilitate wireless two-way communication between modules housed within hub modular housing 136 . Any suitable wireless communication may be used, such as, for example, Air Titan-Bluetooth.

FIG. 6 illustrates individual power bus attachments of multiple lateral docking ports of lateral modular housing 160 configured to receive multiple modules of surgical hub 206 . Lateral modular housing 160 is configured to laterally receive and interconnect modules 161 . Modules 161 are slidably inserted into docking stations 162 of lateral modular housings 160 that contain backplanes for interconnecting modules 161 . As shown in FIG. 6, the modules 161 are laterally arranged within the lateral modular housing 160 . Alternatively, modules 161 may be arranged vertically within a lateral modular housing.

FIG. 7 shows a vertical modular housing 164 configured to receive multiple modules 165 of surgical hub 106 . Modules 165 are slidably inserted into docking stations or drawers 167 of vertical modular housings 164 that contain backplanes for interconnecting modules 165 . Although the drawers 167 of the vertical modular housing 164 are vertically oriented, in certain cases the vertical modular housing 164 may include laterally oriented drawers. Additionally, modules 165 may interact with each other via docking ports in vertical modular housing 164 . In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of module 165 . Additionally, vertical modular housing 164 includes master module 178 that houses a plurality of sub-modules that are slidably received within master module 178 .

In various aspects, the imaging module 138 includes a built-in video processor and modular light sources and is adapted for use with various imaging devices. In one aspect, the imaging device consists of 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 removably coupled with the reusable controller, light source module, and camera module. The light source module and/or camera module can be selectively selected depending on the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanning beam imaging. Similarly, the light source module may be configured to deliver white light or different light depending on the surgical procedure.

During a surgical procedure, it can be inefficient to remove a surgical device from the surgical field and replace it with another surgical device that includes a different camera or different light source. Temporary loss of vision in the surgical field can have undesirable consequences. The modular imaging device of the present disclosure is configured to allow replacement of a light source module or camera module midstream during a surgical procedure without having to remove the imaging device from the surgical field.

In one aspect, an imaging device comprises a tubular housing containing a plurality of channels. The first channel is configured to slidably receive a camera module that may be configured for snap fit engagement with the first channel. The second channel is configured to slidably receive a light source module that may be configured for snap fit engagement with the second channel. In another example, the camera modules and/or light source modules can be rotated to their final positions within their corresponding channels. A threaded engagement may be employed instead of a snap-fit engagement.

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

Various image processors and imagers suitable for use with the present disclosure are described in U.S. Patent No. 9, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which is incorporated herein by reference in its entirety. 7,995,045. Further, U.S. Patent 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. Various systems for doing so are described. Such systems may be integrated with imaging module 138 .更に、「ＣＯＮＴＲＯＬＬＡＢＬＥ ＭＡＧＮＥＴＩＣ ＳＯＵＲＣＥ ＴＯ ＦＩＸＴＵＲＥ ＩＮＴＲＡＣＯＲＰＯＲＥＡＬ ＡＰＰＡＲＡＴＵＳ」と題する２０１１年１２月１５日公開の米国特許出願公開第２０１１／０３０６８４０号、及び「ＳＹＳＴＥＭ ＦＯＲ ＰＥＲＦＯＲＭＩＮＧ Ａ ＭＩＮＩＭＡＬＬＹ ＩＮＶＡＳＩＶＥ ＳＵＲＧＩＣＡＬ ＰＲＯＣＥＤＵＲＥ」と題する２０１４年８月２８日Published US Patent Application Publication No. 2014/0243597 is incorporated herein by reference in its entirety for each disclosure.

FIG. 8 illustrates a cloud-based system (e.g., storage) of modular equipment located in one or more operating rooms of a medical facility, or any room within a medical facility with specialized equipment for surgical procedures. A surgical data network 201 is shown comprising a modular communication hub 203 configured to connect to a cloud 204 ), which may include a remote server 213 coupled to devices 205 . In one aspect, modular communication hub 203 comprises network hub 207 and/or network switch 209 that communicate with network routers. Modular communication hub 203 can also be coupled to local computer system 210 to provide local computer processing and data manipulation. Surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to go from one device (or segment) to another and to cloud computing resources. The intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port within network hub 207 or network switch 209 . An intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

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

It will be appreciated that surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and/or multiple network switches 209 with multiple network routers 211 . Modular communication hub 203 may be housed in a modular control tower configured to receive multiple devices 1a-1n/2a-2m. A local computer system 210 may also be housed in the modular control tower. Modular communication hub 203 is connected to display 212 to display images acquired by some of devices 1a-1n/2a-2m, eg, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m include, among other modular devices that can be connected to the modular communication hub 203 of the surgical data network 201, an imaging module 138 coupled to, for example, an endoscope. , a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, an aspiration/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and /or various modules such as contactless sensor modules.

In one aspect, surgical data network 201 includes a combination of network hub(s), network switch(es), and network router(s) that connect devices 1a-1n/2a-2m to the cloud. It's okay. Any one or all of the devices 1a-1n/2a-2m coupled to a network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. . It will be appreciated that cloud computing relies on shared computing resources to handle software applications rather than having local servers or personal devices. Although the term "cloud" can be used as a metaphor for "Internet," the term is not so limited. Accordingly, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing" in which various services such as servers, storage devices, and applications are to modular communication hub 203 and/or computer system 210 located at the surgical site (e.g., fixed, mobile, temporary, or on-site operating room or space) and via the Internet. or delivered to a device connected to computer system 210 . A cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may 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 numerous 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 a computer that communicates with cloud computing resources and storage devices.

By applying cloud computer data processing techniques to data collected by devices 1a-1n/2a-2m, surgical data networks provide improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m can be used to monitor the condition of the tissue after the tissue sealing and cutting procedure to assess leakage or perfusion of the sealed tissue. . at least one of the devices 1a-1n/2a-2m for diagnostic examination of data comprising images of body tissue samples to identify medical conditions such as disease effects using cloud-based computing; Several can be used. This includes tissue and phenotype localization and margin confirmation. Devices 1a-1n/2a for identifying body anatomy using various sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. 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 or local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. . The data will inform surgical interventions by determining whether additional therapies such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and precision robotic applications for tissue-specific sites and conditions can be performed. Can be analyzed to improve results. Such data analysis may further employ prognostic analysis processing, using a standardized approach to confirm or suggest modifications to surgical treatment and surgeon behavior. You can provide useful feedback for any of the

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. Network hub 207 may, in one aspect, be implemented as a local network broadcast device that functions above the physical layer of the Open Systems Interconnection (OSI) model. A network hub provides connectivity to devices 1a-1n located within the same operating room network. Network hub 207 collects the data in packet form and sends them to the router in half-duplex mode. Network hub 207 does not store any Media Access Control/Internet Protocol (MAC/IP) for transferring device data. Only one of the devices 1a-1n can transmit data through the network hub 207 at a time. Network hub 207 does not have routing tables or intelligence about where to send information, it broadcasts all network data across each connection and to remote server 213 (FIG. 9) on cloud 204 . While the network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can be a security risk and create bottlenecks.

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

Network hub 207 and/or network switch 209 are coupled to network router 211 to connect to cloud 204 . Network router 211 functions within the network layer of the OSI model. Network router 211 may cloud data packets received from network hub 207 and/or network switch 211 for further processing and manipulation of data collected by any one or all of devices 1a-1n/2a-2m. Create a route to send to the base computer resource. Network router 211 is used to connect two or more different networks located at different locations, such as different operating rooms in the same medical facility, or different networks located in different operating rooms in different medical facilities. good too. Network router 211 transmits data in packet form to cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. Network routers 211 use IP addresses to transfer data.

In one embodiment, network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. A USB hub can expand a single USB port into several layers so that there are many ports available for connecting devices to a host system computer. Network hub 207 may include wired or wireless capabilities for receiving information over wired or wireless channels. In one aspect, a wireless USB short range high band 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 from fixed and mobile devices over short distances (using short wavelength UHF radio waves in the 2.4-2.485 GHz ISM band). ), and can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard to build a personal area network (PAN). In other aspects, the operating room devices 1a-1n/2a-2m support Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), and Ev - DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT and their Ethernet derivatives, as well as any other radio designated 3G, 4G, 5G and beyond, and Communicate with modular communication hub 203 via a number of wireless or wired communication standards or protocols, including but not limited to wired protocols. A computing module may include multiple communication modules. For example, a first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc. may be dedicated to long-range wireless communication.

The modular communication hub 203 can serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handles data types known as frames. The frames carry data generated by the devices 1a-1n/2a-2m. As frames are received by modular communication hub 203, the frames are amplified and transmitted to network router 211, which uses a number of wireless or wired communication standards or protocols described herein to transmit the frames. Transfer this data to cloud computing resources.

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. Modular communication hubs 203 are generally easy to install, configure, and maintain, making them a good choice for networking operating room devices 1a-1n/2a-2m.

FIG. 9 shows a computer-implemented interactive surgical system 200 . Computer-implemented interactive surgical system 200 is similar in many respects to computer-implemented interactive surgical system 100 . For example, computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to surgical system 102 . Each surgical system 202 includes at least one surgical hub 206 that communicates with cloud 204 that may include remote servers 213 . In one aspect, the computer-implemented 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 within the operating room. . As shown in FIG. 10, modular control tower 236 comprises modular communication hub 203 coupled to computer system 210 . As illustrated in the embodiment of FIG. 9, modular control tower 236 includes imaging module 238 coupled to endoscope 239, generator module 240 coupled to energy device 241, smoke evacuator module 226, aspiration/ Coupled to an irrigation module 228 , a communications module 230 , a processor module 232 , a storage array 234 , a smart device/instrument 235 optionally coupled to a display 237 , and a contactless sensor module 242 . Operating room equipment is coupled to cloud computing resources and data storage via modular control towers 236 . Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices/instruments 235, visualization system 208, among others, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols described herein. Modular control tower 236 may be coupled to hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from imaging modules, device/instrument displays, and/or other visualization systems 208. . The hub display may also display data received from devices connected to the modular control tower along with images and overlay images.

FIG. 10 shows surgical hub 206 comprising multiple modules coupled to modular control tower 236 . Modular control tower 236 includes a modular communication hub 203, eg, a network connection device, and a computer system 210, eg, for providing local processing, visualization, and imaging. As shown in FIG. 10, modular communication hubs 203 are connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to modular communication hub 203 to store data associated with the modules. It can be transferred to computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs/switches within modular communication hub 203 includes three downstream ports and one upstream port. An upstream network hub/switch is connected to the processor to provide communication connections to cloud computing resources and local displays 217 . Communication to cloud 204 can be via either wired or wireless communication channels.

Surgical hub 206 uses non-contact sensor module 242 to measure the dimensions of the operating room and to generate a map of the surgical field using either ultrasound or laser-based non-contact measurement devices. "Surgical Hub Spatial Awareness Within an Operating Room," in U.S. Provisional Patent Application No. 62/611,341, filed Dec. 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is hereby incorporated by reference in its entirety. The ultrasonic-based non-contact sensor module scans the operating room by transmitting bursts of ultrasonic waves and receiving echoes when the bursts of ultrasonic waves reflect off the outer wall of the operating room. and where 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 that reflects off the outer wall of an operating room, compares the phase of the transmitted pulse with the received pulse, and compares the phase of the operating room. Scan the operating room by determining the size and adjusting the Bluetooth pairing distance limit.

Computer system 210 includes processor 244 and network interface 245 . Processor 244 is coupled to communication module 247, storage device 248, memory 249, non-volatile memory 250, and input/output interface 251 through a system bus. The system bus includes a 9-bit bus, Industry Standard Architecture (ISA), Micro Channel Architecture (MSA), Enhanced ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Device Interconnect (PCI), Any, including but not limited to USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association Bus (PCMCIA), Small Computer Systems Interface (SCSI), or any other proprietary bus. It may be any of several types of bus structure(s) including a memory bus or memory controller, a peripheral or external bus, and/or a local bus using various available bus architectures. .

Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor has on-chip memory, e.g., 256 KB of single-cycle flash memory or other non-volatile memory at up to 40 MHz, details of which are available in the product datasheet, to improve performance beyond 40 MHz. a prefetch buffer, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and/or One or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, 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, processor 244 may include a safety controller that includes two controller family families, such as TMS570 and RM4x, also known by the trade designation Hercules ARM Cortex R4, also manufactured by Texas Instruments. Safety controllers may be configured specifically for IEC61508 and ISO26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

System memory includes both volatile and nonvolatile memory. The basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in nonvolatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory can include random access memory (RAM), which acts as external cache memory. Further, RAM includes SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync link DRAM (SLDRAM), and direct RAM bus RAM (DRRAM). available in many forms.

Computer system 210 also includes removable/non-removable, volatile/non-volatile computer storage media, such as disk storage devices. 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, a disc storage device may refer to a storage medium independently or as a compact disc ROM device (CD-ROM), a compact disc recordable drive (CD-R drive), a compact disc rewritable drive (CD-RW drive). , or in combination with other storage media including, but not limited to, an optical disk drive such as a digital versatile disk ROM drive (DVD-ROM). A removable or non-removable interface may be used to facilitate connection of the disk storage device to the system bus.

It should be appreciated that computer system 210 includes software that acts as an intermediary between users and basic computer resources as described in the preferred operating environment. Such software includes an operating system. An operating system, which may be stored on the disk storage device, functions to control and allocate the computer system's resources. System applications take advantage of resource management by the operating system through program modules and program data stored either in system memory or on disk storage devices. It should be appreciated that the various components described herein can be implemented on various operating systems or combinations of operating systems.

A user enters commands or information into computer system 210 through input device(s) coupled to I/O interface 251 . Input devices include pointing devices such as mice, trackballs, styluses, and touch pads, keyboards, microphones, joysticks, gamepads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, and webcams. include but are not limited to: These and other input devices connect to the processor through the system bus via the interface port(s). Interface port(s) include, for example, serial port, parallel port, game port, and USB. Output device(s) use some of the same types of ports as input device(s). Thus, for example, a USB port may be used to provide input to the computer system and output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices such as monitors, displays, speakers, and printers, among other output devices that require special adapters. Output adapters include, by way of example and not limitation, video and sound cards that provide a means of connection between output devices and the system bus. Note that other devices and/or systems of devices, such as remote computer(s), provide both input and output functionality.

Computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices, or other general network nodes, etc., and are typically computers Includes many or all of the elements described for the system. For simplicity, only the memory storage device is shown along with the remote computer(s). Remote computer(s) are logically connected to the computer system through a network interface and then physically connected via a communications connection. The network interface encompasses communication networks such as local area networks (LAN) and wide area networks (WAN). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and variations thereof, packet-switched networks, and Digital Subscriber Lines (DSL).

In various aspects, 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 image processors. may include any dedicated digital signal processor (DSP) used to process the Image processors can use parallel computing with single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) techniques to increase speed and efficiency. A digital image processing engine can perform a variety of tasks. The image processor may be a system on chip with a multi-core processor architecture.

Communication connection(s) refers to hardware/software used to connect a network interface to a bus. Although communication connections are shown internal to the computer system for clarity of illustration, the communication connections may be external to computer system 210 . By way of example only, the hardware/software required to connect to the network interface includes internal and external technologies such as modems, including regular telephone grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards. mentioned.

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

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 transceiver is integrated into the circuitry 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 high speed and low 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 power logic 312 for managing power.

The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 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. SIE 310 typically understands signaling down to the transaction level. The functions it handles include packet recognition, transaction reordering, detection/generation of SOP, EOP, RESET and RESUME signals, clock/data separation, non-return to zero inversion (NRZI) data encoding/decoding and bit stuffing, CRC Generation and checking (tokens and data), packet ID (PID) generation and checking/decoding, and/or serial-parallel-parallel-serial conversion may be included. 310 receives a clock input 314 and suspend/resume logic to control communication between the upstream USB transmit/receive port 302 and the downstream USB transmit/receive ports 304 , 306 , 308 via port logic circuits 320 , 322 , 324 . It is coupled to frame timer 316 circuitry and hub repeater circuitry 318 . SIE 310 is coupled to command decoder 326 via interface logic for controlling commands from the serial EEPROM via serial EEPROM interface 330 .

In various aspects, the USB network hub 300 can connect 127 functions organized in up to 6 logical layers (hierarchies) to a single computer. Additionally, the USB network hub 300 can connect to all peripherals using a standardized four wire cable that provides both communication and power distribution. The power configurations are bus power mode and self power mode. USB network hub 300 has four power management capabilities: a bus-powered hub with either individual port power management or ganged port power management, and a self-powered hub with either individual port power management or ganged port power management. It may be configured to support two modes. In one aspect, using a USB cable, USB network hub 300, the upstream USB transmit/receive port 302 plugs into a USB host controller and the downstream USB transmit/receive ports 304, 306, 308 connect USB compatible devices. and so on.

Surgical Instrument Hardware FIG. 12 illustrates a logic diagram of a surgical instrument or tool control system 470, in accordance with one or more aspects of the present disclosure. System 470 includes control circuitry. The control circuitry includes a microcontroller 461 with a processor 462 and memory 468 . For example, one or more of sensors 472 , 474 , 476 provide real-time feedback to processor 462 . A motor 482 driven by a motor driver 492 operatively couples the longitudinally movable displacement member to drive the I-beam knife element. Tracking system 480 is configured to determine the position of the longitudinally moveable displacement member. The positional information is provided to processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the positions of the firing member, firing bar, and I-beam knife elements. Additional motors may be provided in the tool driver interface to control I-beam firing, obturator tube movement, shaft rotation, and articulation. The display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on display 473 may be overlaid with images acquired via the endoscopic imaging module.

In one aspect, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the main microcontroller 461 has on-chip memory of 256 KB single-cycle flash memory or other non-volatile memory at up to 40 MHz, for example, details of which are available in the product datasheet, improving performance beyond 40 MHz. 32 KB of single-cycle SRAM, internal ROM with StellarisWare software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analogs, and/or or an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments that includes 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 family families, such as the TMS570 and RM4x, also known by the trade designation Hercules ARM Cortex R4, also manufactured by Texas Instruments. Safety controllers may be configured specifically for IEC61508 and ISO26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

The microcontroller 461 may be programmed to perform various functions such as precision control over the speed and position of the knife and articulation system. In one aspect, microcontroller 461 includes 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 the articulation or knife system. In one aspect, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be readily substituted for use in tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems can be found in U.S. Patent Application Publication No. 2017, published Oct. 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is hereby incorporated by reference in its entirety. 0296213.

Microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate the response within the microcontroller 461 software. The calculated response is compared with the measured response of the actual system to obtain the "observed" response, which is used to determine the actual feedback. The observed response is a well-tuned value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

In one aspect, the motor 482 may be controlled by a motor driver 492 and used by the firing system of a surgical instrument or tool. In various forms, motor 482 may be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM. In other configurations, motor 482 may include a brushless motor, cordless motor, synchronous motor, stepper motor, or any other suitable electric motor. Motor driver 492 may comprise, for example, an H-bridge driver including field effect transistors (FETs). Motor 482 may be powered by a power assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power assembly may include a battery that may include multiple battery cells connected in series that may be used as a power source to power a surgical instrument or tool. Under certain circumstances, the battery cells of the power assembly may be replaceable and/or rechargeable. In at least one embodiment, the battery cells can be lithium ion batteries that can be connectable to and separable from the power assembly.

Motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Driver 492 includes an inherent charge pump regulator that provides full (>10V) gate drive for battery voltages up to 7V and allows the A3941 to operate with reduced gate drive down to 5.5V. . Bootstrap capacitors may be used to provide the necessary battery supply voltages for the N-channel MOSFETs. An internal charge pump for the high side drive allows 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 through either the high-side FETs or the low-side FETs. The power FETs are protected from shoot-through by a resistor adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect power MOSFETs under most short circuit conditions. Other motor drivers may be readily substituted for use in tracking system 480 with an absolute positioning system.

Tracking system 480 comprises controlled motor drive circuitry comprising position sensor 472 in accordance with at least one aspect of the present disclosure. A 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 engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing bar or an 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, firing member, firing bar, I-beam, or any element that can be displaced. Used to refer generically. In one aspect, a longitudinally movable drive member is coupled to the firing member, firing bar, and I-beam. Thus, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Accordingly, a longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable linear displacement sensor. Linear displacement sensors may include contact or non-contact displacement sensors. Linear displacement sensors include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), sliding potentiometers, movable magnets and a series of linear A magnetic sensing system comprising an arranged Hall effect sensor, a magnetic sensing system comprising a fixed magnet and a series of movable Hall effect sensors arranged in a straight line, a movable light source and a series of linearly arranged magnetic sensing systems It may comprise an optical detection system comprising a photodiode or photodetector, an optical detection system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof. .

The electric motor 482 may include a rotatable shaft that operably interfaces with a gear assembly that is mounted in meshing 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. The gearing and sensor mechanism can be connected to the linear actuator by a rack and pinion mechanism, or to the rotary actuator by spur gears or other connections. A power supply can power the absolute positioning system and an output indicator can display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member having a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents a longitudinally movable firing member, firing bar, I-beam, or a combination thereof.

One rotation of the sensor element associated with the position sensor 472 corresponds to a longitudinal linear displacement d1 of the displacement member, which is after one rotation of the sensor element coupled to the displacement member after the displacement member reaches the point " is the linear longitudinal distance traveled from point "a" to point "b". The sensor mechanism may be connected via a gear reduction that results in the position sensor 472 completing one or more revolutions for a full stroke of the displacement member. The position sensor 472 can complete multiple revolutions for a full stroke of the displacement member.

A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for more than one revolution of the position sensor 472. may be used in The state of the switch is fed back to the microcontroller 461, which applies logic to determine the longitudinal linear displacement of the displacement member d1+d2+ . . . Determine the unique position signal corresponding to dn. The output of position sensor 472 is provided to microcontroller 461 . The position sensor 472 of the sensor mechanism may comprise a magnetic sensor, an analog rotary sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

Position sensor 472 may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or vector components of the magnetic field. The techniques used to manufacture both types of magnetic sensors involve many aspects of physics and electronics. Techniques used to sense magnetic fields include, inter alia, search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance. , magnetostrictive/piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magneto-optics, and micro-electromechanical systems-based magnetic sensors.

In one aspect, position sensor 472 of tracking system 480 comprising an absolute positioning system comprises a gyromagnetic absolute positioning system. Position sensor 472 may be implemented as an AS5055EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. Position sensor 472 interfaces with 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 area of the position sensor 472 located above the magnets. Additionally, a high resolution ADC and a smart power management controller are provided on-chip. To implement simple and efficient algorithms for computing hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shift, and table lookup operations, digit-by-digit method and boulder A coordinate rotation digital computer (CORDIC) processor, also known as Volder's algorithm, is provided. Angular position, alarm bits, and magnetic field information are transmitted to microcontroller 461 via a standard serial communication interface, such as a serial peripheral interface (SPI) interface. Position sensor 472 provides 12-bit or 14-bit resolution. Position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85 mm package.

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

The absolute positioning system resets the displacement members, such as might be required with a conventional rotary encoder where the motor 482 simply counts the number of steps taken forward or backward to infer the position of machine actuators, drive bars, knives, etc. It provides the absolute position of the displacement member at power up of the instrument without retraction or advancement to the zero (or home) position.

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

In one form, a strain gauge sensor 474 can be used to measure the force exerted on tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force exerted by the end effector on the tissue being treated. A system for measuring the force applied to tissue grasped by an end effector includes strain gauge sensors, e.g., micro strain gauges, configured to measure one or more parameters of the end effector. 474. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the jaw members of the end effector during a clamping operation, which can be indicative of tissue compression. The measured strain is converted to a digital signal and provided to processor 462 of microcontroller 461 . Load sensor 476 can measure the force used to operate the knife element, for example, to cut tissue captured between the anvil and the staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. Magnetic field sensor measurements may also be converted to digital signals and provided to processor 462 .

Measurements of tissue compression, tissue thickness, and/or force required to close the end effector on tissue, as measured by sensors 474, 476, respectively, are determined by the selected position of the firing member, and/or Or it can be used by the microcontroller 461 to characterize the corresponding value of the velocity of the firing member. In one example, memory 468 can store techniques, equations and/or lookup tables that can be used by microcontroller 461 in evaluation.

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

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

FIG. 14 illustrates combinatorial logic 510 configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure. Combinatorial logic 510 may be configured to implement various processes described herein. Combinatorial logic 510 is a finite state machine including combinatorial logic 512 configured to receive data associated with a surgical instrument or tool at input 514 , process the data through combinatorial logic 512 , and provide output 516 . can include

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

FIG. 16 shows a surgical instrument or tool with multiple motors that can be activated to perform various functions. In certain examples, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, and a third motor can be activated. A third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain examples, multiple motors of robotic surgical instrument 600 can be individually activated to produce firing motion, closing motion, and/or articulation motion at the end effector. Firing motion, closing motion, and/or articulation motion can be transmitted to the end effector via, for example, a shaft assembly.

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

In certain examples, a surgical instrument or tool may include a closure motor 603. Closure motor 603 is configured to transmit the closing motion generated by motor 603 to the end effector, specifically to displace the closure tube to close the anvil and compress tissue between the anvil and staple cartridge. It may be operably connected to a closure motor drive assembly 605, which may be configured. The closing motion may cause the end effector to transition from an open configuration to an approximated configuration to capture tissue, for example. The end effector can be transitioned to the open position by reversing the direction of motor 603 .

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

As noted above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool are activated independently or separately to perform one or more functions while other motors remain deactivated. can be implemented. For example, articulation motors 606a, 606b can be activated to articulate the end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and/or advance the cutting edge while articulation motor 606 is deactivated. Additionally, closure motor 603 may be activated simultaneously with firing motor 602 to distally advance the closure tube and I-beam elements as detailed herein below.

In certain examples, a 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 certain examples, a common control module 610 can serve one of multiple motors at a time. For example, a common control module 610 may be individually connectable and disconnectable to multiple motors of the robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as 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 certain examples, the common control module 610 is configured to selectively communicate with one of the motors of the surgical instrument or tool to the other of the motors of the surgical instrument or tool. You can switch.

In at least one embodiment, common control module 610 controls between operable engagement with articulation motors 606a, 606b and operable engagement with either firing motor 602 or closing 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, in a first position 616 the switch 614 may electrically couple the common control module 610 with the firing motor 602, and in a second position 617 the switch 614 may close the common control module 610. In a third position 618a the switch 614 may electrically couple the common control module 610 with the first articulation motor 606a and in a fourth position the switch 614 may be in electrical communication with the motor 603. At 618b, a switch 614 may electrically couple the common control module 610 with the second articulation motor 606b. In certain examples, a separate common control module 610 may be electrically coupled to firing motor 602, closing motor 603, and articulation motors 606a, 606b at the same time. In particular examples, 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 include a torque sensor for measuring the output torque on the shaft of the motor. Forces on the end effector may be sensed in any conventional manner, such as by force sensors outside the jaws or by torque sensors on the motor that actuates the jaws.

In various examples, as shown in FIG. 16, common control module 610 may include motor driver 626, which may include one or more H-bridge FETs. Motor drivers 626 may modulate power transferred from power supply 628 to motors coupled to common control module 610 based on, for example, input from microcontroller 620 (“controller”). In a particular example, as described above, the current drawn by the motors can be determined using, for example, the microcontroller 620 while the motors are coupled to the common control module 610 .

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

In particular examples, power supply 628 may be used to power microcontroller 620, for example. In certain examples, power source 628 may include a battery (or “battery pack” or “power pack”), such as a lithium-ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power surgical instrument 600 . Multiple battery cells connected in series may be used as power source 628 . In certain examples, power source 628 may be replaceable and/or rechargeable, for example.

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

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

In particular examples, memory 624 may contain program instructions for controlling each of the motors of surgical instrument 600 coupleable to a common control module 610 . For example, memory 624 may contain program instructions for controlling firing motor 602, closing motor 603, and articulation motors 606a, 606b. Such program instructions may cause processor 622 to control the firing, closing, and articulating functions according to inputs from an algorithm or control program of the surgical instrument or tool.

In particular examples, one or more mechanisms and/or sensors, such as sensor 630, may be used to alert processor 622 of program instructions to use in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with end effector firing, closing, and articulation. In particular examples, sensor 630 may comprise a position sensor that may be used to sense the position of switch 614, for example. Thus, when processor 622 detects, for example, via sensor 630 that switch 614 is in first position 616, processor 622 can employ program instructions associated with firing the end effector I-beam, causing processor 622 to can use program instructions associated with closing the anvil upon detecting, for example, via sensor 630 that switch 614 is in second position 617, processor 622, for example, via sensor 630, Upon detecting that the switch 614 is in the third position 618a or the fourth position 618b, program instructions associated with end effector articulation can be used.

FIG. 17 is a schematic 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. Robotic surgical instrument 700 uses either single or multiple articulation drive connections to perform distal/proximal translation of the displacement member, distal/proximal displacement of the obturator tube, rotation of the shaft, and articulation. It may be programmed or configured to control movement. In one aspect, surgical instrument 700 may be programmed or configured to individually control the firing member, closure member, shaft member, or one or more articulation members. Surgical instrument 700 includes a control circuit 710 configured to control a motorized firing member, closure member, shaft member, and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700, via a plurality of motors 704a-704e, controls the anvil 716 and I-beam 714 (including sharp cutting edges) portions of the end effector 702, removable staple cartridge 718, shaft 740, and a control circuit 710 configured to control one or more articulation members 742a, 742b. Position sensor 734 may be configured to provide position feedback of I-beam 714 to control circuit 710 . Other sensors 738 may be configured to provide feedback to control circuit 710 . Timer/counter 731 provides timing and counting information to control circuit 710 . An energy source 712 may be provided to operate the motors 704 a - 704 e , and a current sensor 736 provides motor current feedback to the control circuit 710 . Motors 704a-704e can be individually operated by control circuit 710 in open-loop or closed-loop feedback control.

In one aspect, the control circuit 710 comprises one or more microcontrollers, microprocessors, or processors or other suitable devices for executing instructions that cause one or more processors to perform one or more tasks. A processor may be provided. In one aspect, timer/counter circuit 731 provides an output signal, such as elapsed time or a digital count, to control circuit 710 to correlate the position of I-beam 714 determined by position sensor 734 with the output of timer/counter circuit 731 . so that control circuit 710 determines the position of I-beam 714 at a particular time (t) relative to the starting position or time (t) when I-beam 714 is at a particular position relative to the starting position. be able to. Timer/counter 731 may be configured to measure elapsed time, count external events, or time external events.

In one aspect, control circuitry 710 may be programmed to control the function of end effector 702 based on one or more tissue conditions. Control circuitry 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. Control circuit 710 may be programmed to select a firing control program or a closing control program based on tissue condition. A firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better treat different tissue conditions. For example, if thicker tissue is present, control circuitry 710 may be programmed to translate the displacement member at a slower speed and/or with less power. If thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher speed and/or with a higher power. A closure control program may control the closure force applied to tissue by anvil 716 . Other control programs control the rotation of shaft 740 and articulation members 742a, 742b.

In one aspect, control circuit 710 may generate a motor setpoint signal. Motor setpoint signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e implement one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e as described herein. You may prepare. In some embodiments, motors 704a-704e may be brushed DC electric motors. For example, the speed of motors 704a-704e may be proportional to their respective motor drive signals. In some embodiments, the motors 704a-704e may be brushless DC electric motors, with respective motor drive signals provided to one or more stator windings of the motors 704a-704e using PWM signal may be included. Also, in some embodiments, the motor controllers 708a-708e may be omitted and the control circuit 710 may directly generate the motor drive signals.

In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open loop configuration for a first open loop portion of the stroke of the displacement member. Based on the response of robotic surgical instrument 700 during the open-loop portion of the stroke, control circuit 710 may select a closed-loop configuration firing control program. The response of the instrument includes the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to one of the motors 704a-704e during the open loop portion, the motor For example, the total pulse width of the drive signal may be mentioned. After the open loop portion, control circuit 710 may implement the selected firing control program for the second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, control circuit 710 modulates one of motors 704a-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 velocity. You may let

In one aspect, the motors 704a-704e may receive power from the energy source 712. Energy source 712 may be a DC power source powered by mains AC power, batteries, supercapacitors, or any other suitable energy source. Motors 704a-704e are mechanically coupled to respective movable mechanical elements such as I-beam 714, anvil 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706e. may be The transmissions 706a-706e may include one or more gears or other coupling components for coupling the motors 704a-704e to the movable mechanical elements. A position sensor 734 may sense the position of the I-beam 714 . Position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 714 . In some embodiments, position sensor 734 may include an encoder configured to provide a series of pulses to control circuit 710 as I-beam 714 translates distally and proximally. Control circuit 710 may track the pulses to determine the position of I-beam 714 . Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of I-beam 714 movement. Also, in some embodiments, position sensor 734 may be omitted. If any of motors 704a-704e are stepper motors, control circuit 710 may track the position of I-beam 714 by summing the number and direction of steps that motor 704 is instructed to perform. can. The position sensor 734 can be located within the end effector 702 or any other portion of the instrument. Each output of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.

In one aspect, control circuitry 710 is configured to drive a firing member, such as the I-beam 714 portion of end effector 702 . Control circuit 710 provides motor settings to motor control 708a, and motor control 708a provides drive signals to motor 704a. The output shaft of motor 704a is coupled to torque sensor 744a. Torque sensor 744 a is coupled to transmission 706 a which is coupled to I-beam 714 . Transmission device 706 a includes moveable mechanical elements, such as rotating elements and firing members, for controlling distal and proximal movement of I-beam 714 along the longitudinal axis of end effector 702 . In one aspect, 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. Torque sensor 744 a provides a firing force feedback signal to control circuit 710 . The firing force signal represents the force required to fire or displace I-beam 714 . Position sensor 734 may be configured to provide the position of I-beam 714 along the firing stroke, or the position of the firing member, as a feedback signal to control circuit 710 . End effector 702 may include additional sensors 738 configured to provide feedback signals to control circuitry 710 . When ready for use, control circuit 710 can provide a fire signal to motor control 708a. In response to the firing signal, motor 704a drives the firing member distally along the longitudinal axis of end effector 702 from a proximal stroke start position to a stroke end position distal to the stroke start position. be able to. As the firing member translates distally, I-beam 714 , which has a cutting element positioned at its distal end, advances distally to cut tissue located between staple cartridge 718 and anvil 716 .

In one aspect, control circuit 710 is configured to drive a closure member, such as anvil 716 portion of end effector 702 . Control circuit 710 provides motor settings to motor control 708b, which provides drive signals to motor 704b. The output shaft of motor 704b is coupled to torque sensor 744b. Torque sensor 744b is coupled to transmission device 706b which is coupled to anvil 716 . Transmission device 706b includes moveable mechanical elements, such as rotating elements and closing members, for controlling movement of anvil 716 from open and closed positions. In one aspect, motor 704b is coupled to a closed gear assembly that includes a closed reduction gear set supported in meshing engagement with a closed spur gear. Torque sensor 744 b provides a closing force feedback signal to control circuit 710 . The closing force feedback signal represents the closing force applied to anvil 716 . Position sensor 734 may be configured to provide the position of the closure member as a feedback signal to control circuit 710 . An additional sensor 738 in end effector 702 can provide a closure force feedback signal to control circuit 710 . A pivotable anvil 716 is positioned opposite staple cartridge 718 . When ready for use, control circuit 710 can provide a close signal to motor control 708b. In response to the closure signal, motor 704 b advances closure member to grasp tissue between anvil 716 and staple cartridge 718 .

In one aspect, control circuit 710 is configured to rotate a shaft member, such as shaft 740 , to rotate end effector 702 . Control circuit 710 provides motor settings to motor control 708c, which provides drive signals to motor 704c. The output shaft of motor 704c is coupled to torque sensor 744c. Torque sensor 744 c is coupled to transmission 706 c which is coupled to shaft 740 . Transmission 706c includes moveable mechanical elements, such as rotary elements, to control clockwise or counterclockwise rotation of shaft 740 through 360 degrees and beyond. In one aspect, the motor 704c was formed on (or attached to) the proximal end of the proximal closure tube to be operably engaged by a rotating gear assembly operably supported on the tool mounting plate. attached) to a rotary transmission assembly including a tubular gear segment. Torque sensor 744 c provides a rotational force feedback signal to control circuit 710 . The rotational force feedback signal is representative of the rotational force applied to shaft 740 . Position sensor 734 may be configured to provide the position of the closure member as a feedback signal to control circuit 710 . Additional sensors 738 , such as shaft encoders, may provide the rotational position of shaft 740 to control circuit 710 .

In one aspect, control circuit 710 is configured to articulate end effector 702 . Control circuit 710 provides motor settings to motor control 708d, which provides drive signals to motor 704d. The output shaft of motor 704d is coupled to torque sensor 744d. Torque sensor 744d is coupled to transmission 706d that is coupled to articulation member 742a. Transmission device 706d includes moveable mechanical elements such as articulation elements for controlling ±65° articulation of end effector 702 . In one aspect, the motor 704d is coupled to an articulation nut that is rotatably journalled on the proximal end portion of the distal spine portion and articulated on the proximal end portion of the distal spine portion. It is rotatably driven by a motion gear assembly. Torque sensor 744 d provides an articulation force feedback signal to control circuit 710 . The articulation force feedback signal represents the articulation force applied to the end effector 702 . A sensor 738 , such as an articulation encoder, may provide the articulation position of end effector 702 to control circuit 710 .

In another aspect, the articulation features of the robotic surgical system 700 may include two articulation members, or connections 742a, 742b. These articulation members 742a, 742b are driven by separate discs on a robot interface (rack) driven by two motors 708d, 708e. When separate firing motors 704a are provided, to provide resistive holding motion and load to the head when the head is not moving, and to provide articulation when the head is articulating: Each of the articulation links 742a, 742b can be driven antagonistically with respect to the other link. Articulation members 742a, 742b are attached to the head at a fixed radius as the head rotates. Therefore, as the head rotates, the mechanical efficiency of the push-pull connection changes. This change in mechanical efficiency may be more pronounced in other articulating joint drive systems.

In one aspect, one or more of the motors 704a-704e may comprise a brushed DC motor with a gearbox and mechanical connections to the firing, closing, or articulating members. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation connections, closed tubes, and shafts. External influences are unmeasured and unpredictable influences such as friction on tissues, surroundings, and physical systems. Such an external influence is sometimes referred to as a drag acting against one of the electric motors 704a-704e. External influences, such as disturbances, can cause the behavior of a physical system to deviate from the desired behavior of the physical system.

In one aspect, position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may comprise a gyromagnetic absolute positioning system implemented as an AS5055EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. Position sensor 734 can work in conjunction with control circuit 710 to provide an absolute positioning system. The position is located above the magnet and provided to implement simple and efficient algorithms for computing hyperbolic and trigonometric functions, requiring only addition, subtraction, bit-shifting, and table lookup operations. It may include multiple Hall effect elements coupled to the CORDIC processor, also known as the digit-by-digit method and the Boulder algorithm.

In one aspect, control circuitry 710 may communicate with one or more sensors 738 . Sensors 738 are positioned on end effector 702 and adapted to operate with robotic surgical instrument 700 to measure various derived parameters such as gap distance vs. time, tissue compression vs. time, and anvil strain vs. time. may Sensors 738 may be magnetic sensors, magnetic field sensors, strain gauges, load cells, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or one of end effector 702. or any other suitable sensor for measuring two or more parameters. Sensor 738 may include one or more sensors. A sensor 738 may be positioned on the deck of the staple cartridge 718 to determine tissue location using segmented electrodes. Torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and/or articulation forces, among others. Thus, the control circuit 710 determines (1) the closure load faced by the distal obturator tube and its position, (2) the firing member in the rack and its position, and (3) which portion of the staple cartridge 718 has tissue thereon. and (4) load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise strain gauges, such as micro strain gauges, configured to measure the amount of strain in the anvil 716 during clamping conditions. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 738 may include a pressure sensor configured to detect pressure created by the presence of compressed tissue between anvil 716 and staple cartridge 718 . Sensor 738 may be configured to detect the impedance of a section of tissue located between anvil 716 and staple cartridge 718, which may indicate the thickness and/or fullness of tissue located therebetween. indicates

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

In one aspect, sensor 738 may be configured to measure the force exerted on anvil 716 by the closing 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 closure force exerted by the closure tube on the anvil 716 . The force exerted against anvil 716 may represent the tissue compression experienced by the tissue section captured between anvil 716 and staple cartridge 718 . One or more sensors 738 can be positioned at various interaction points along the closure drive system to detect the closing force that the closure drive system applies to anvil 716 . One or more sensors 738 may be sampled in real-time during clamping operations by the processor of control circuit 710 . The control circuit 710 receives real-time sample measurements to provide and analyze time-based information to assess the closing force applied to the clamp arm 716 in real-time.

In one aspect, a 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 I-beam 714, corresponds to the current drawn by one of motors 704a-704e. The force is converted to a digital signal and provided to control circuit 710 . The control circuit 710 may be configured to simulate the actual system response of the instrument in the controller software. The displacement member can be actuated to move the I-beam 714 within the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, for example, any feedback controller including, but not limited to, PID, state feedback, linear-quadratic (LQR), and/or adaptive controllers. may be any one of Robotic surgical instrument 700 can include a power supply for converting signals from the feedback controller into physical inputs such as, for example, case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force. . Further details are disclosed in U.S. patent application Ser. No. 15/636,829, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT," filed Jun. 29, 2017, which is incorporated herein by reference in its entirety. It is

FIG. 18 shows a block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member, according to at least one aspect of the present disclosure. In one aspect, surgical instrument 750 is programmed to control distal translation of a displacement member such as I-beam 764 . Surgical instrument 750 includes an anvil 766 , an I-beam 764 (including sharp cutting edges), 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 I-beam 764 can be measured by absolute positioning system, sensor mechanism and position sensor 784 . Since I-beam 764 is coupled to a longitudinally movable drive member, the position of I-beam 764 can be determined by measuring the position of the longitudinally movable drive member employing position sensor 784. can be done. Accordingly, in the discussion below, position, displacement, and/or translation of I-beam 764 may be accomplished by position sensor 784 as described herein. Control circuitry 760 may be programmed to control translation of a displacement member such as I-beam 764 . In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or processors to control the displacement member, e.g., I-beam 764, in the manner described. Other suitable processors may be provided for execution. In one aspect, timer/counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate the position of I-beam 764 determined by position sensor 784 with the output of timer/counter 781. , so that control circuit 760 can determine the position of I-beam 764 at a particular time (t) relative to the starting position. Timer/counter 781 may be configured to measure elapsed time, count external events, or time external events.

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

Motor 754 may receive power from energy source 762 . Energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. Motor 754 may be mechanically coupled to I-beam 764 via transmission 756 . Transmission 756 may include one or more gears or other coupling components for coupling motor 754 to I-beam 764 . A position sensor 784 may sense the position of the I-beam 764 . Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 764 . In some embodiments, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as I-beam 764 translates distally and proximally. Control circuitry 760 may track the pulses to determine the position of I-beam 764 . Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of I-beam 764 movement. Also, in some embodiments, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 can track the position of I-beam 764 by summing the number and direction of steps motor 754 is instructed to perform. The position sensor 784 can be located within the end effector 752 or any other portion of the instrument.

Control circuitry 760 may communicate with one or more sensors 788 . A sensor 788 may be positioned on the end effector 752 and adapted to work with the surgical instrument 750 to measure various derived parameters such as gap distance vs. time, tissue compression vs. time, and anvil strain vs. time. . Sensors 788 may include one or more of magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or end effector 752 . Any other suitable sensor for measuring the parameter may be included. Sensor 788 may include one or more sensors.

The one or more sensors 788 may comprise strain gauges, such as micro strain gauges, configured to measure the amount of strain in the anvil 766 during clamping conditions. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 788 may include a pressure sensor configured to detect pressure created by the presence of compressed tissue between anvil 766 and staple cartridge 768 . Sensor 788 may be configured to detect the impedance of a section of tissue located between anvil 766 and staple cartridge 768, which may indicate the thickness and/or fullness of tissue located therebetween. indicate.

Sensor 788 may be configured to measure the force exerted by the closing drive system on anvil 766 . For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the anvil 766 to detect the closure force exerted by the closure tube on the anvil 766 . The force exerted against anvil 766 may represent the tissue compression experienced by the tissue section captured between anvil 766 and staple cartridge 768 . One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. One or more sensors 788 may be sampled in real-time during clamping operations by the processor of control circuit 760 . The control circuit 760 receives real-time sample measurements to provide and analyze time-based information to evaluate 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 I-beam 764 corresponds to the current drawn by motor 754 . The force is converted to a digital signal and provided to control circuit 760 .

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

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

Various exemplary aspects are directed to a surgical instrument 750 that includes an end effector 752 having a motorized surgical stapling and cutting device. For example, motor 754 may drive displacement members distally and proximally along the longitudinal axis of end effector 752 . The end effector 752 may comprise a pivotable anvil 766 and a staple cartridge 768 positioned opposite the anvil 766 when configured for use. A clinician may grasp tissue between anvil 766 and staple cartridge 768 as described herein. When instrument 750 is ready for use, the clinician may provide a firing signal, for example, by pressing the trigger of instrument 750 . In response to the firing signal, motor 754 drives the displacement member distally along the longitudinal axis of end effector 752 from a proximal stroke start position to a stroke end position distal to the stroke start position. be able to. As the displacement member is translated distally, an I-beam 764 having a cutting element positioned at its distal end can cut tissue between staple cartridge 768 and anvil 766 .

In various embodiments, surgical instrument 750 includes control circuitry 760 programmed to control distal translation of a displacement member, such as I-beam 764, based on, for example, one or more tissue conditions. You may prepare. Control circuitry 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly as described herein. Control circuit 760 may be programmed to select a firing control program based on tissue condition. A firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better treat different tissue conditions. For example, if thicker tissue is present, control circuitry 760 may be programmed to translate the displacement member at a slower speed and/or with less power. If thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and/or with a higher power.

In some embodiments, control circuit 760 may initially operate motor 754 in an open loop configuration for a first open loop portion of the stroke of the displacement member. Based on the response of instrument 750 during the open-loop portion of the stroke, control circuit 760 may select a firing control program. The response of the instrument includes the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, and the total pulse width of the motor drive signal. etc. can be mentioned. After the open loop portion, control circuit 760 may implement the selected firing control program for the second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, control circuit 760 may closed-loop modulate motor 754 based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Further details can be found in U.S. patent application Ser. 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, surgical instrument 790 is programmed to control distal translation of a displacement member such as I-beam 764 . Surgical instrument 790 includes an end effector 792 that can include an anvil 766, an I-beam 764, and a removable staple cartridge 768 that can be replaced with an RF cartridge 796 (shown in dashed lines).

In one aspect, sensor 788 may be implemented as a limit switch, electromechanical device, solid state switch, Hall effect device, MR device, GMR device, magnetometer, among others. In other implementations, sensor 638 may be a solid state switch that operates under the influence of light, such as a light sensor, IR sensor, UV sensor, among others. Additionally, the switch may be a solid state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, sensors 788 may include conductorless switches, ultrasonic switches, accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolute positioning system comprising a gyromagnetic absolute positioning system implemented as an AS5055EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. Position sensor 784 can work in conjunction with control circuitry 760 to provide an absolute positioning system. The position is located above the magnet and provided to implement simple and efficient algorithms for computing hyperbolic and trigonometric functions, requiring only addition, subtraction, bit-shifting, and table lookup operations. It may include multiple Hall effect elements coupled to the CORDIC processor, also known as the digit-by-digit method and the Boulder algorithm.

In one aspect, the I-beam 764 may be implemented as a knife member comprising a knife body operably supporting a tissue cutting blade thereon, with an anvil engaging tab or feature and a channel engaging feature or foot. may further include: In one aspect, staple cartridge 768 may be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, RF cartridge 796 may be implemented as an RF cartridge. These and other sensor configurations are described in commonly assigned U.S. patent application Ser. AND CUTTING INSTRUMENT” (filed June 20, 2017).

The position, movement, displacement, and/or translation of a linear displacement member such as I-beam 764 can be measured by an absolute positioning system, sensor mechanism, and position sensor represented as position sensor 784 . Since I-beam 764 is coupled to a longitudinally movable drive member, the position of I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using position sensor 784. can be done. Accordingly, in the discussion below, position, displacement, and/or translation of I-beam 764 may be accomplished by position sensor 784 as described herein. Control circuitry 760 may be programmed to control translation of a displacement member, such as I-beam 764, as described herein. In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or processors to control the displacement member, e.g., I-beam 764, in the manner described. Other suitable processors may be provided for execution. In one aspect, timer/counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate the position of I-beam 764 determined by position sensor 784 with the output of timer/counter 781. , so that control circuit 760 can determine the position of I-beam 764 at a particular time (t) relative to the starting position. Timer/counter 781 may be configured to measure elapsed time, count external events, or time external events.

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

Motor 754 may receive power from energy source 762 . Energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. Motor 754 may be mechanically coupled to I-beam 764 via transmission 756 . Transmission 756 may include one or more gears or other coupling components for coupling motor 754 to I-beam 764 . A position sensor 784 may sense the position of the I-beam 764 . Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 764 . In some embodiments, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as I-beam 764 translates distally and proximally. Control circuitry 760 may track the pulses to determine the position of I-beam 764 . Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of I-beam 764 movement. Also, in some embodiments, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 can track the position of I-beam 764 by summing the number and direction of steps the motor is instructed to take. The position sensor 784 can be located within the end effector 792 or any other part of the instrument.

Control circuitry 760 may communicate with one or more sensors 788 . A sensor 788 may be positioned on the end effector 792 and adapted to work with the surgical instrument 790 to measure various derived parameters such as gap distance vs. time, tissue compression vs. time, and anvil strain vs. time. . Sensors 788 may include one or more of magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or end effectors 792 . Any other suitable sensor for measuring the parameter may be provided. Sensor 788 may include one or more sensors.

The one or more sensors 788 may comprise strain gauges, such as micro strain gauges, configured to measure the amount of strain in the anvil 766 during clamping conditions. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 788 may include a pressure sensor configured to detect pressure created by the presence of compressed tissue between anvil 766 and staple cartridge 768 . Sensor 788 may be configured to detect the impedance of a section of tissue located between anvil 766 and staple cartridge 768, which may indicate the thickness and/or fullness of tissue located therebetween. indicate.

Sensor 788 may be configured to measure the force exerted by the closing drive system on anvil 766 . For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the anvil 766 to detect the closure force exerted by the closure tube on the anvil 766 . The force exerted against anvil 766 may represent the tissue compression experienced by the tissue section captured between anvil 766 and staple cartridge 768 . One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. One or more sensors 788 may be sampled in real-time during clamping operations by the processor portion of control circuit 760 . The control circuit 760 receives real-time sample measurements to provide and analyze time-based information to evaluate 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 I-beam 764 corresponds to the current drawn by motor 754 . The force is converted to a digital signal and provided to control circuit 760 .

RF energy source 794 is coupled to end effector 792 and applied to RF cartridge 796 when RF cartridge 796 is loaded into end effector 792 in place of staple cartridge 768 . Control circuitry 760 controls the delivery of RF energy to RF cartridge 796 .

Further details can be found in U.S. Patent Application No. 15, entitled "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME," filed June 28, 2017, which is incorporated herein by reference in its entirety. /636,096.

FIG. 20 shows a stroke length graph 20740 showing how the control system can change the stroke length of the obturator tube assembly based on the articulation angle θ. Such stroke length changes shorten the stroke length (e.g., shown along the x-axis) to a compensating stroke length (e.g., shown along the y-axis) as the articulation angle θ increases. including doing The compensating stroke length defines the length by which the obturator assembly travels distally to close the jaws of the end effector, which is dependent on the articulation angle θ, and when the obturator assembly overtravels. to prevent damage to surgical equipment.

For example, as shown in stroke length graph 20740, when the end effector is not articulated, the stroke length of the closure tube assembly to close the jaws is approximately 0.250 inches and the articulation angle θ is approximately At 60 degrees, the compensating stroke length is approximately 0.242 inches. Such measurements are provided by way of example only and may include any of various angles and corresponding stroke lengths and compensation stroke lengths without departing from the scope of the present disclosure. Furthermore, the relationship between the articulation angle θ and the compensating stroke length is non-linear, and the rate at which the compensating stroke length shortens increases as the articulation angle increases. For example, the decrease in compensating stroke length between 45 degrees of articulation and 60 degrees of articulation is greater than the decrease in compensating stroke length between 0 degrees of articulation and 15 degrees of articulation. In this approach, the control system adjusts the stroke length based on the articulation angle θ to prevent damage to the surgical device (e.g., jamming the distal end of the obturator tube assembly in a distal position). However, the distal obturator tube may still advance during articulation, thereby at least partially closing the jaws.

FIG. 21 shows a closure tube assembly positioning graph 20750 showing one manner in which the control system changes the longitudinal position of the closure tube assembly based on the articulation angle θ. Such a change in the longitudinal position of the obturator assembly causes the obturator assembly to compensate a distance ( e.g., retracting proximally by ) shown along the y-axis. The compensating distance that the closure tube assembly retracts proximally prevents distal advancement of the distal closure tube, thereby maintaining the jaws in an open position during articulation. By retracting the closure tube assembly proximally a compensating distance during articulation, the closure tube assembly can travel a stroke length starting from the proximally retracted position to close the jaws upon actuation of the closure assembly. can.

For example, as shown in closure tube assembly positioning graph 20750, the compensation distance is zero when the end effector is not articulated, and the compensation distance is about 0.008 when the articulation angle θ is about 60 degrees. in inches. In this example, the closure tube assembly is retracted a compensation distance of 0.008 inches during articulation. Thus, the closure tube assembly can be advanced a stalk length starting from this retracted position to close the jaws. Such measurements are provided for illustrative purposes only and may include any of a variety of angles and corresponding compensation distances without departing from the scope of this disclosure. As shown in FIG. 21, the relationship between the articulation angle θ and the compensation distance is nonlinear, and the rate at which the compensation distance increases increases as the articulation 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 force applied through the tissue can reach unacceptably high levels. For example, if a constant closure speed is employed, this force may be high enough to cause excessive trauma to the clamped tissue and may cause deformation of the clamping device, resulting in an unacceptable A possible tissue gap may not be maintained across the stapling path. FIG. 22 shows power applied to tissue during compression (i.e., without controlled tissue compression (CTC)) at a constant anvil closing rate and compression (i.e., with CTC) at a variable anvil closing rate. ) is a graph showing a comparison of the power applied to the tissue during The closure rate may be adjusted to control tissue compression such that the power applied within the tissue remains constant over a portion of the compression. According to FIG. 22, the peak power delivered to the tissue is much lower when variable anvil closure speed is utilized. Based on the applied power, the force exerted by the surgical device (or a parameter related to or proportional to force) can be calculated. In this regard, power is such that the force exerted through the surgical device (e.g., through the jaws of a linear stapler) is such that the tissue gap is tolerable along the entire stapling length when in the fully closed position. It may be limited to not exceed a yield force or pressure that causes the jaws to spread out of bounds. For example, the jaws should be parallel or sufficiently close to parallel so that the tissue gap remains within an acceptable or target range at all staple locations along the length of the jaws. Additionally, limiting the applied power avoids or at least minimizes trauma or damage to 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 curves of FIG. 22 are the same or substantially the same. However, since the peak power is much lower in the example with CTC compared to the example without CTC, the difference in the power profile utilized is quite large.

Power limiting is achieved in embodiments with CTC by slowing the closing speed as indicated by line 20760 . Note that the compression time B' is longer than the closing time B. As shown in FIG. 22, devices and methods that provide constant closure speed (i.e., without CTC) exert the same 50 lb compression force as devices and methods that provide variable closure speed (i.e., with CTC). , achieved with the same 1 mm tissue gap. Devices and methods that provide a constant closure speed can achieve the desired compressive force in the tissue gap in a shorter period of time compared to devices and methods that utilize variable closure speeds, thereby A sudden rise in the power applied to the tissue occurs, as shown in . 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 compared to systems and methods that do not use CTCs.

FIG. 22 and additional examples are provided in U.S. Pat. No. 8,499,992, issued Aug. 6, 2013, entitled "DEVICE AND METHOD FOR CONTROL COMPRESSION OF TISSUE," the entire disclosure of which is incorporated herein by reference. , No. (filed June 1, 2012).

In some aspects, the control system assists the control system in determining the position of the E-beam and/or the angle of articulation of the firing shaft and appropriately controlling the at least one motor based on such determination. , can include multiple predefined force thresholds. For example, the force threshold may vary depending on the length of travel of a firing bar configured to translate the firing shaft, such force threshold being determined by one or more motors in communication with the control system. can be compared with the measured torsional force of Comparing the measured torsional force to a force threshold can provide a reliable method for the control system to determine the position of the end effector's E-beam and/or articulation. This allows the control system to appropriately control one or more motors (e.g., reduce or stop torsional loads) to properly fire and Proper articulation of the end effector can be ensured as well as damage to the system can be prevented.

FIG. 23 shows a force and displacement graph 20800 including the measured force of section A related to the measured displacement of section B. FIG. Sections A and B both have x-axes that indicate time (eg, seconds). The y-axis of section B indicates the firing rod's translational displacement (eg, in millimeters), and the y-axis of section A indicates the force applied to the firing bar thereby advancing the firing shaft. As shown in Section A, moving the firing bar within a first range of articulation 20902 (eg, a first approximately 12 mm of movement) articulates the end effector. For example, at a displacement position of 12 mm, the end effector is fully articulated to the right and no further articulation is mechanically possible. Full articulation results in increased torsional force on the motor, and the control system can detect an articulation force peak 20802 that exceeds the predefined articulation threshold 20804 as shown in section A. The control system can include more than one predefined articulation threshold 20804 to detect more than one maximum articulation direction (eg, left and right articulations). After the control system detects an articulation force peak 20802 that exceeds a predetermined articulation threshold 20804, the control system may reduce or stop motor activation, thereby at least protecting the motor from damage.

After the firing bar is advanced beyond the range of articulation 20902, a shift mechanism within the surgical stapler can cause further distal movement of the firing bar, causing distal movement of the firing shaft. For example, as shown in Section B, a travel displacement of about 12 mm to 70 mm can advance the E-beam along firing stroke 20904 and cut tissue trapped between the jaws, although other The travel length is within the scope of this disclosure. In this example, the E-beam maximum firing stroke position 20906 occurs at 70 mm of travel. At this point, the E-beam or knife abuts the distal end of the cartridge or jaw, thereby increasing the torsional force on the motor and causing a knife travel force peak 20806 as shown in Section A to be sensed by the control system. As shown in Section A, the control system provides a motor threshold 20808 and a knife movement threshold 20810 that diverge from the motor threshold 20808 and decrease (e.g., non-linearly) as the E-beam approaches the maximum firing stroke position 20906. and ends.

The control system monitors the motor torsional force sensed during at least the last portion 20907 of the E-beam's distal travel (e.g., the last ten percent of the firing stroke 904) before reaching the maximum firing stroke position 20906. can be configured as While monitoring along such a final portion 20907 of distal travel, the control system can reduce torsional forces on the motors, thereby reducing the load on the E-beam. This can protect a surgical stapler that includes an E-beam from damage by reducing the load on the E-beam as it approaches the maximum firing stroke position 20906, thereby allowing the E-beam to move from the cartridge or jaws. reduce the impact on the distal end of the As described above, such an impact can cause a knife travel force peak 20806 that can exceed the knife travel threshold 20810 but not the motor threshold 20808, thereby causing the motor to Does no damage. Thus, the control system will stop the motor operation after the knife travel force peak 20806 exceeds the knife travel threshold 20810 and before the knife travel force peak 20806 exceeds the motor threshold 20808, thereby damaging the motor. can be protected from Additionally, increasing the decrease in knife travel threshold 20810 prevents the control system from anticipating that the E-beam has reached the maximum firing stroke position 20906.

After the control system detects a knife travel force peak 20806 that exceeds the knife travel threshold 20810, the control system can ascertain the position of the E-beam (eg, 70 mm displacement and/or the end of firing stroke 20904), such that The firing bar can be retracted based on a known displacement position to return the E-beam to the most proximal position 20908 (eg, 0 mm displacement). At the proximal-most position 20908, as shown in Section A, a knife retraction force peak 20812 exceeding the predetermined knife retraction threshold 20814 can be sensed by the control system. At this point, the control system can recalibrate if necessary and associate the E-beam position as being at the home position. This home position is where the shifter will disengage the E-Beam from the firing bar the next time the firing rod is advanced distally (eg, approximately 12 mm in length). After disengagement, movement of the firing bar through the range of articulation 20902 again causes articulation of the end effector.

Accordingly, the control system senses torsional forces on the motor controlling movement of the firing bar and compares such sensed torsional forces to a plurality of threshold values to determine the position of the E-beam or the articulation angle of the end effector; This allows proper control of the motor to prevent damage to the motor while verifying firing bar and/or E-beam positioning.

As noted above, a tissue contact or pressure sensor determines when the jaw members first contact tissue "T". This allows the surgeon to determine the initial thickness of the tissue "T" and/or the thickness of the tissue "T" prior to clamping. In any of the aspects of the surgical instrument described above, as shown in FIG. 24, contact between the jaw members and tissue "T" is achieved by a pair of opposing plates "P1, P2" provided on the jaw members. to close the sensing circuit "SC" which would otherwise be open. The contact sensor may also include a sensing force transducer that determines the amount of force applied to the sensor. The amount of force applied to the sensor can be assumed to be the same as the amount of force applied to tissue "T". Such forces applied to tissue can then be translated into the amount of tissue compression. The force sensor measures the amount of compression the tissue is undergoing and provides information to the surgeon regarding the force being applied to the tissue "T". Excessive tissue compression can adversely affect the tissue "T" being manipulated. For example, excessive compression of the tissue "T" can lead to tissue necrosis and, in certain procedures, to staple line breakage. Information regarding the pressure being applied to tissue "T" allows the surgeon to better determine that excessive pressure is not being applied to tissue "T".

Any contact sensor disclosed herein includes, but is not limited to, an electrical sensor mounted on the inner surface of the jaws that closes a normally open sensing circuit when in contact with tissue. points of contact can be mentioned. Contact sensors can also include sensing force transducers that detect when the tissue being clamped initially resists compression. Force transducers include, but are not limited to, piezoelectric elements, piezoresistive elements, metal film or semiconductor strain gauges, inductive pressure sensors, capacitive pressure sensors, and driving wiper arms on resistive elements. Potentiometric transducers using Bourdon tubes, capsules or bellows may be mentioned for this purpose.

In one aspect, any one of the aforementioned surgical instruments may include one or more piezoelectric elements for detecting pressure changes occurring in the jaw members. Piezoelectric devices are bi-directional transducers that convert stress into electrical potential. The elements may be made of metallized quartz or ceramic. During operation, when stress is applied to the crystal, the charge distribution in the material changes, resulting in the development of a voltage across the material. A piezoelectric element may be used to indicate when either one or both of the jaw members are in contact with tissue "T" and the amount of pressure applied to tissue "T" after contact is established.

In one aspect, any one of the foregoing surgical instruments may include or be equipped with one or more metal strain gauges disposed within or on a portion of its body. You may have Metal strain gauges work 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. Thus, a resistor made of this material incorporated in a circuit converts strain into a change in electrical signal. Desirably, the strain gauge may be mounted on the surgical instrument such that pressure applied to tissue affects the strain gauge.

Alternatively, in another aspect, one or more semiconductor strain gauges may be used in a manner similar to the metal strain gauges described above, but with a different mode 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 applied stress. This phenomenon is called the piezoresistive effect.

In yet another aspect, any one of the aforementioned surgical instruments may include one or more inductive pressure sensors for converting pressure or force into motion of inductive elements relative to each other. , or may be equipped with it. Movement of the inductive elements relative to each other changes the overall inductance or inductive coupling. A capacitive pressure transducer likewise converts pressure or force into movement of capacitive elements relative to each other, changing the overall capacitance.

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

In one aspect, any one of the aforementioned surgical instruments may include or be equipped with one or more mechanical pressure transducers for converting pressure or force into motion. may be In use, movement of the mechanical element is used to shift the pointer or dial of the gauge. Movement of this pointer or dial can represent the pressure or force applied to the tissue "T". Examples of mechanical elements include, but are not limited to, Bourdon tubes, capsules or bellows. By way of example, mechanical elements may be coupled with other measuring and/or sensing elements, such as potentiometer pressure transducers. In this embodiment the mechanical element is coupled with the wiper on the variable resistor. In use, pressure or force may be converted to mechanical motion by deflecting the wiper of the potentiometer to change the resistance reflecting the applied pressure or force.

The combination of the above aspects, particularly the gap and tissue contact sensors, provides feedback and/or real-time information to the surgeon regarding the condition of the surgical site and/or target tissue "T". For example, information regarding the initial thickness of the tissue "T" can guide the surgeon in selecting the appropriate staple size. Information regarding the clamped thickness of the tissue "T" can inform the surgeon whether the selected staples are properly formed. Information regarding the initial thickness of the tissue "T" and the clamp thickness can be used to determine the amount of compression or strain of the tissue "T". Information regarding the strain of the tissue "T" can also be used to avoid compressing the tissue to excessive strain values and/or stapling overly strained tissue.

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

FIG. 24 and additional examples are provided in U.S. Pat. No. 8,181,839, issued May 5, 2012, entitled "SURGICAL INSTRUMENT EMPLOYING SENSORS," the entire disclosure of which is incorporated herein by reference. filed June 27).

Specific aspects are shown and described to provide an understanding of the structure, function, manufacture, and use of the disclosed apparatus and methods. Features shown or described in one embodiment may be combined with features of other embodiments, and modifications and variations are within the scope of this disclosure.

The terms "proximal" and "distal" refer to the clinician manipulating the handle of the surgical instrument, "proximal" referring to the portion closer to the clinician and "distal" referring to the portion closer to the clinician. Point to the far part. Because surgical instruments can be used in a variety of orientations and positions, for convenience the spatial terms "vertical," "horizontal," "top," and "bottom" used with respect to the drawings are defined and/or absolute. not intended to be

Exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, such devices and methods can be used in other surgical procedures and applications, including, for example, open surgery. Surgical instruments may be inserted through natural orifices or through incisions or punctures made in tissue. The working or end effector portion of the instrument can be inserted directly into the body or through an access device having a working channel through which the end effector and elongated shaft of the surgical instrument can be advanced. can.

25-28 show a motorized cutting and fastening surgical instrument 150010 that may or may not be reused. In the illustrated example, the surgical instrument 150010 includes a housing 150012 with a handle assembly 150014 configured to be grasped, manipulated and actuated by a clinician. Housing 150012 is configured for operable attachment to interchangeable shaft assembly 150200 to which end effector 150300 configured to perform one or more surgical tasks or procedures is operably coupled. It is According to the present disclosure, various forms of interchangeable shaft assemblies may be effectively used in conjunction with robotic surgical systems. The term "housing" refers to a robotic system that houses or operatively supports at least one drive system configured to generate and apply at least one control motion that can be used to actuate an interchangeable shaft assembly. housing or similar portion of the The term "frame" may refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robotic surgical instrument and/or a robotic system that may be used to operatively control a surgical instrument. Interchangeable shaft assemblies may be used in various robotic systems, such as those disclosed in U.S. Patent No. 9,072,535, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," which is incorporated herein by reference in its entirety. Devices, components, and methods may be used together.

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

The handle assembly 150014 may comprise a pair of interconnectable handle housing segments 150016, 150018 interconnected by screws, snap mechanisms, adhesives, or the like. Handle housing segments 150016, 150018 cooperate to form a pistol grip portion 150019 that can be grasped and manipulated by a clinician. The handle assembly 150014 operatively supports a plurality of drive systems for producing controlled motion and applying this controlled motion to corresponding portions of interchangeable shaft assemblies operably attached to the handle assembly. is configured to A 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 multiple drive systems. The frame 150020 can operatively support a “first” or closing drive system 150030 , which can apply closing and opening motions to the interchangeable shaft assembly 150200 . The closure drive system 150030 may include an actuator such as a closure trigger 150032 pivotally supported by the frame 150020. Closure trigger 150032 is pivotally coupled to handle assembly 150014 by pivot pin 150033 to allow closure trigger 150032 to be manipulated by a clinician. When the clinician grasps the pistol grip portion 150019 of the handle assembly 150014, the closure trigger 150032 pivots from a starting or "unactuated" position to an "actuated" position, more specifically to a fully compressed or fully actuated position. can move

The handle assembly 150014 and frame 150020 may operably support a firing drive system 150080, which is configured to apply firing motion to corresponding portions of the interchangeable shaft assemblies to which it is attached. It is Firing drive system 150080 may employ electric motor 150082 located in pistol grip portion 150019 of handle assembly 150014 . Electric motor 150082 may be, for example, a brushed DC motor having a maximum rotational speed of approximately 25,000 RPM. In other configurations, the motor may include a brushless motor, cordless motor, synchronous motor, stepper motor, or any other suitable electric motor. Electric motor 150082 may be powered by power supply 150090 which may comprise a removable power pack 150092 . A removable power pack 150092 may comprise a proximal housing portion 150094 configured to attach to a distal housing portion 150096 . Proximal housing portion 150094 and distal housing portion 150096 are configured to operatively support a plurality of batteries 150098 therein. Batteries 150098 may each include, for example, lithium ion (LI) or other suitable batteries. Distal housing portion 150096 is configured to be removably and operably attached to control circuit board 150100 , which is operably coupled to electric motor 150082 . Several batteries 150098 connected in series can power the surgical instrument 150010 . Power source 150090 may be replaceable and/or rechargeable. A display 150043 located below cover 150045 is electrically coupled to control circuit board 150100 . Cover 150045 may be removed to expose display 150043 .

The electric motor 150082 is a rotatable shaft (Fig. not shown). A longitudinally movable drive member 150120 has a rack of drive teeth 150122 formed thereon for meshing engagement with a corresponding drive gear 150086 of the gear reducer assembly 150084 .

In use, the voltage polarity provided by the power supply 150090 allows the electric motor 150082 to operate in a clockwise direction, whereas the voltage polarity applied by the battery to the electric motor 150082 operates the electric motor 150082 in a counterclockwise direction. can be inverted to When the electric motor 150082 is rotated in one direction, the longitudinally movable drive member 150120 will be axially driven in the distal direction "DD". When the electric motor 150082 is driven in the opposite rotational direction, the longitudinally movable drive member 150120 will be axially driven in the proximal direction "PD". Handle assembly 150014 may include a switch that may be configured to reverse the polarity applied to electric motor 150082 by power supply 150090 . The handle assembly 150014 may include sensors 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.

Actuation of electric motor 150082 may be controlled by firing trigger 150130 pivotally supported on handle assembly 150014 . Firing trigger 150130 may be pivoted between an unactuated position and an actuated position.

Returning to FIG. 25, replaceable shaft assembly 150200 includes an end effector 150300 having an elongated channel 150302 configured to operatively support surgical staple cartridge 150304 therein. End effector 150300 may include an anvil 150306 pivotally supported relative to elongated channel 150302 . Interchangeable shaft assembly 150200 may include articulation joint 150270 . The configuration and operation of the end effector 150300 and articulation joint 150270 are described in U.S. Patent Application Publication No. 2014/0263541, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," which is incorporated herein by reference in its entirety. . Interchangeable shaft assembly 150200 may include a proximal housing or nozzle 150201 comprised of nozzle portions 150202,150203. Interchangeable shaft assembly 150200 may include a closure tube 150260 extending along shaft axis SA, which may be utilized to close and/or open anvil 150306 of 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 actuation of closure trigger 150032 in a manner described in the aforementioned reference, U.S. Patent Application Publication No. 2014/0263541. be. Anvil 150306 is opened by translating closure tube 150260 proximally. In the anvil open position, the closure tube 150260 is moved to its proximal position.

FIG. 27 is another exploded view of a portion of interchangeable shaft assembly 150200, according to at least one aspect of the present disclosure. Interchangeable shaft assembly 150200 may include a firing member 150220 supported for axial movement within spine 150210 . Firing member 150220 includes an intermediate firing shaft 150222 configured to attach to a distal cutting portion or knife bar 150280 . Firing member 150220 is sometimes referred to as a "second shaft" or "second shaft assembly." Intermediate firing shaft 150222 may include a longitudinal slot 150223 at its distal end configured to receive tab 150284 at proximal end 150282 of knife bar 150280 . Longitudinal slot 150223 and proximal end 150282 may be configured to allow relative movement therebetween and may comprise slip joint 150286 . The slip joint 150286 may allow the intermediate firing shaft 150222 of the firing member 150220 to articulate the end effector 150300 about the articulation joint 150270 without moving, or at least substantially not moving, the knife bar 150280 . Once end effector 150300 is properly oriented, intermediate firing shaft 150222 is advanced distally until proximal sidewall of longitudinal slot 150223 contacts tab 150284 to advance and position knife bar 150280 within channel 150302. can fire staple cartridges. Spine 150210 has an elongated opening or window 150213 therein to facilitate assembly and insertion of intermediate firing shaft 150222 into spine 150210 . Once intermediate firing shaft 150222 is inserted therein, top frame segment 150215 may be engaged with shaft frame 150212 to enclose intermediate firing shaft 150222 and knife bar 150280 therein. The operation of firing member 150220 can be found in US Patent Application Publication No. 2014/0263541. Spine 150210 may be configured to slidably support firing member 150220 and a closure tube 150260 extending around spine 150210 . Spine 150210 may slidably support articulation driver 150230 .

Interchangeable shaft assembly 150200 can include a clutch assembly 150400 configured to selectively and releasably couple articulation driver 150230 to firing member 150220 . Clutch assembly 150400 includes a locking collar or locking sleeve 150402 positioned about firing member 150220 in an engaged position in which locking sleeve 150402 couples articulation driver 150230 to firing member 150220 and articulation driver 150230 in an engaged position. 150230 can be rotated between a disengaged position in which 150230 is not operably coupled to firing member 150220 . When locking sleeve 150402 is in its engaged position, distal movement of firing member 150220 can move articulation driver 150230 distally, and proximal movement of firing member 150220 correspondingly causes articulation. Driver 150230 can be moved proximally. When locking sleeve 150402 is in its disengaged position, movement of firing member 150220 is not transmitted to articulation driver 150230 such that firing member 150220 can move independently of articulation driver 150230 . The nozzle 150201 can be used to operatively engage and disengage the articulation drive system and the firing drive system in various manners described in US Patent Application Publication No. 2014/0263541.

The replaceable shaft assembly 150200 can include a slip ring assembly 150600 that, 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 comprise a proximal connector flange 150604 and a distal connector flange 150601 positioned within slots defined in the nozzle portions 150202,150203. The proximal connector flange 150604 can comprise a first surface and the distal connector flange 150601 can have a second surface positioned adjacent to the first surface and movable relative to the first surface. be prepared. Distal connector flange 150601 can rotate relative to proximal connector flange 150604 about shaft axis SA-SA (FIG. 25). The proximal connector flange 150604 can comprise a plurality of concentric, or at least substantially concentric conductors 150602 defined on a first surface thereof. Connector 150607 may be attached to the proximal side of distal connector flange 150601 and may have a plurality of contacts, each contact corresponding to one of conductors 150602 and electrically connected thereto. in contact. Such a configuration allows proximal connector flange 150604 and distal connector flange 150601 to rotate relative to each other while maintaining electrical contact therebetween. The proximal connector flange 150604 can include, for example, an electrical connector 150606 that can place the conductors 150602 in signal communication with the shaft circuit board. In at least one case, a wire harness including multiple 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 hereby incorporated 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.

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

28 is an exploded view of one aspect of the end effector 150300 of the surgical instrument 150010 of FIG. 25, in accordance with at least one aspect of the present disclosure. End effector 150300 may include anvil 150306 and surgical staple cartridge 150304 . Anvil 150306 may be coupled to elongated channel 150302 . An opening 150199 may be defined in the elongated channel 150302 that receives a pin 150152 extending from the anvil 150306 to allow the anvil 150306 to move relative to the elongated channel 150302 and the surgical staple cartridge 150304 from an open position. Allow it to pivot to the closed position. Firing bar 150172 is configured to longitudinally translate into end effector 150300 . Firing bar 150172 may be constructed from one solid piece or may comprise a laminated material comprising a stack of steel plates. Firing bar 150172 includes an I-beam 150178 and a cutting edge 150182 at its distal end. The distally projecting end of firing bar 150172 is attached to I-beam 150178 and spaced from surgical staple cartridge 150304 positioned within elongated channel 150302 when anvil 150306 is in the closed position. 150306 can be assisted. I-beam 150178 may include a sharp cutting edge 150182 for severing tissue while advancing I-beam 150178 distally by firing bar 150172 . In operation, I-beam 150178 can fire surgical staple cartridge 150304 . The surgical staple cartridge 150304 can include a molded cartridge body 150194 that retains a plurality of staples 150191 mounted on staple drivers 150192 within corresponding upwardly opening staple cavities 150195 . Wedge sled 150190 is driven distally by I-beam 150178 to slide over cartridge tray 150196 of surgical staple cartridge 150304 . Wedge sled 150190 cams staple driver 150192 upward to force staple 150191 into deforming contact with anvil 150306 while cutting edge 150182 of I-beam 150178 cuts apart the clamped tissue.

I-beam 150178 can include an upper pin 150180 that engages anvil 150306 during firing. I-beam 150178 may include center pin 150184 and bottom foot 150186 for engaging cartridge body 150194 , cartridge tray 150196 and a portion of elongated channel 150302 . When surgical staple cartridge 150304 is positioned within elongated channel 150302, slots 150193 defined within cartridge body 150194, longitudinal slots 150197 defined within cartridge tray 150196, and slots defined within elongated channel 150302 are aligned. 150189 can be aligned. In use, I-beam 150178 can slide through aligned longitudinal slots 150193, 150197, and 150189, and as shown in FIG. 150189 can engage a groove extending along the bottom surface of elongated channel 150302 along the length of longitudinal slot 150197 and center pin 150184 can engage the top surface of cartridge tray 150196 along the length of longitudinal slot 150197. and the upper pin 150180 can engage the anvil 150306 . As firing bar 150172 is advanced distally to fire staples from surgical staple cartridge 150304 and/or dissect tissue captured between anvil 150306 and surgical staple cartridge 150304, I-beam 150178 , the anvil 150306 and the surgical staple cartridge 150304 can be spaced or limited relative movement therebetween. Firing bar 150172 and I-beam 150178 may be retracted proximally, thereby opening anvil 150306 and releasing the two stapled and severed tissue portions.

29A and 29B are block diagrams of control circuitry 150700 of surgical instrument 150010 of FIG. 25 spanning two figures, according to at least one aspect of the present disclosure. Referring primarily to FIGS. 29A and 29B, handle assembly 150702 may include motor 150714, which may be controlled by motor driver 150715 and may be used by the firing system of surgical instrument 150010. In various forms, motor 150714 may be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM. In other configurations, motor 150714 may include a brushless motor, cordless motor, synchronous motor, stepper motor, or any other suitable electric motor. Motor driver 150715 may include, for example, an H-bridge driver including field effect transistor (FET) 150719 . Motor 150714 may be powered by a power supply assembly 150706 releasably attached to handle assembly 150200 to provide control power to surgical instrument 150010 . The power assembly 150706 may comprise a plurality of serially connected battery cells that may be used as a power source to power the surgical instrument 150010 . Under certain circumstances, the battery cells of power assembly 150706 may be replaceable and/or rechargeable. In at least one embodiment, the battery cells may be lithium ion batteries that may be separately connectable to power supply 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 power assembly 150706 are coupled to the handle assembly 150702. . For example, the interface may include a corresponding shaft assembly electrical connector to enable electrical communication between shaft assembly controller 150722 and power management controller 150716 while shaft assembly 150704 and power assembly 150706 are coupled to handle assembly 150702 . A first interface portion 150725 that may include one or more electrical connectors for interlocking engagement with a connector and one or more electrical connectors for interlocking engagement with a corresponding power assembly electrical connector. and a second interface portion 150727 that may include an electrical connector. One or more communication signals can be sent over the interface to convey one or more of the power requirements of the attached replaceable shaft assembly 150704 to the power management controller 150716. Accordingly, the power management controller can modulate the power output of the battery of power supply assembly 150706 according to the power requirements of the attached shaft assembly 150704, as described in further detail below. The connector is activated after mechanical interlocking engagement between handle assembly 150702 and shaft assembly 150704 and/or power supply assembly 150706 to enable electrical communication between shaft assembly controller 150722 and power management controller 150716. A switch can be provided to allow

The interface may, for example, route such communication signals through the main controller 150717 contained within the handle assembly 150702, thereby providing one or two power management controllers 150716 and 150722 between the power management controller 150716 and the shaft assembly controller 150722. It can facilitate transmission of one or more communication signals. Under other circumstances, the interface provides direct line communication between power management controller 150716 and shaft assembly controller 150722 through handle assembly 150702 while shaft assembly 150704 and power supply assembly 150706 are coupled to handle assembly 150702. can be facilitated.

Main controller 150717 may be any single-core or multi-core processor, such as that known by Texas Instruments under the trade name ARM Cortex. In one aspect, the main controller 150717 has on-chip memory of 256 KB single-cycle flash memory or other non-volatile memory up to 40 MHz, for example, details of which are available in the product datasheet, improving performance beyond 40 MHz. 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2 KB electrically erasable programmable read-only memory (EEPROM), 1 or two or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters with 12 analog input channels (ADC), LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.

The safety controller may be a safety controller platform comprising two controller-based families, such as the TMS570 and RM4x, also known as the Texas Instruments brand name Hercules ARM Cortex R4. Safety controllers may be configured specifically for IEC61508 and ISO26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

The power supply assembly 150706 may include power management circuitry, which may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. The power management circuitry may be configured to modulate the power output of the battery based on the power requirements of shaft assembly 150704 while shaft assembly 150704 and power supply assembly 150706 are coupled to handle assembly 150702 . The power management controller 150716 can be programmed to control the power modulator 150738 of the power output of the power supply assembly 150706, and the current sensing circuit 150736 monitors the power output of the power supply assembly 150706 to provide feedback on the power output of the battery. It can be used to provide power management controller 150716 so that power management controller 150716 can adjust the power output of power supply assembly 150706 to maintain the desired output. Power management controller 150716 and/or shaft assembly controller 150722 may each comprise one or more processors and/or memory units capable of storing a number of software modules.

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

Control circuitry 150700 comprises circuit segments configured to control operation of powered surgical instrument 150010 . The safety controller segment (segment 1) comprises a safety controller and a main controller 150717 segment (segment 2). The safety controller and/or main controller 150717 are configured to interact with one or more additional circuit segments such as an acceleration segment, display segment, shaft segment, encoder segment, motor segment, and power segment. there is Each of the circuit segments may be coupled to a safety controller and/or main controller 150717. Main controller 150717 is also coupled to the flash memory. The main controller 150717 also has a serial communication interface. The main controller 150717 comprises multiple inputs coupled to, for example, one or more circuit segments, a battery, and/or multiple switches. The segmentation circuitry may be implemented by any suitable circuitry, such as, for example, a printed circuit board assembly (PCBA) within powered surgical instrument 150010 . The term processor, as used herein, means any microprocessor, processor, controller or controllers, or central processing unit (CPU) of a computer that combines the functions of a single integrated circuit or It should be understood to include other basic computing devices incorporated on several integrated circuits in . Main controller 150717 is a multi-purpose programmable device that accepts digital data as input, processes that data according to instructions stored in memory, and provides results as output. This is an example of sequential digital logic since it has internal memory. Control circuitry 150700 may be configured to implement one or more processes described herein.

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

The display segment (segment 4) comprises a display connector coupled to the main controller 150717. A display connector couples the main controller 150717 to the display via one or more of the display's integrated circuit drivers. The display's integrated circuit driver 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 the safety controller.

Shaft segment (Segment 5) is a control for and/or a replaceable shaft assembly 150200 (FIGS. 25 and 27) coupled to surgical instrument 150010 (FIGS. 25-28). Includes one or more controls for the coupled end effector 150300. The shaft segment includes a shaft connector configured to couple the main controller 150717 to the shaft PCBA. The shaft PCBA includes a low power microcontroller with ferroelectric random access memory (FRAM), articulation switches, shaft release Hall effect switches, and shaft PCBA EEPROM. The Shaft PCBA EEPROM contains one or more parameters, routines, and/or programs specific to the replaceable shaft assembly 150200 and/or Shaft PCBA. Shaft PCBA may be coupled to interchangeable shaft assembly 150200 and/or may be integral with surgical instrument 150010 . In some examples, the shaft segment comprises a second shaft EEPROM. A second shaft EEPROM stores a plurality of 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 powered surgical instrument 150010. include.

The position encoder segment (segment 6) comprises one or more magnetic angular rotary position encoders. One or more magnetic angular rotary position encoders may be included in motor 150714 of surgical instrument 150010 (FIGS. 25-28), replaceable shaft assembly 150200 (FIGS. 25 and 27), and/or end effector 150300. It is configured to identify the rotational position. In some embodiments, the magnetic angular rotary position encoder may be coupled to the safety controller and/or main controller 150717.

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

Motor controller controls a first motor flag and a second motor flag to indicate the status and position of motor 150714 to main controller 150717 . The main controller 150717 provides pulse width modulated (PWM) high, PWM low, direction, sync, and motor reset signals to the motor controllers through buffers. The power segments are configured to provide segment voltages to each of the circuit segments.

The power segment (segment 8) comprises a battery coupled to the safety controller, main controller 150717, and additional circuit segments. The batteries are connected to the segmentation circuit by battery connectors and current sensors. A current sensor is configured to measure the total current drawn by the segmentation circuit. In some embodiments, one or more voltage converters are configured to provide predetermined voltage values to one or more circuit segments. For example, in some embodiments the segmentation circuit may comprise a 3.3V voltage converter and/or a 5V voltage converter. The boost converter is configured to provide a boost voltage up to a predetermined amount, eg, up to 13V. A boost converter is configured to provide additional voltage and/or current during power intensive operations to prevent brownouts or low power conditions.

A plurality of switches are coupled to the safety controller and/or main controller 150717 . The switch may be configured to control operation of surgical instrument 150010 (FIGS. 25-28), control operation of segmentation circuitry, and/or indicate status of surgical instrument 150010. FIG. The emergency exit door switch and hall effect switch for emergency exit are configured to indicate the status of the emergency exit door. A plurality of articulation switches, for example, a left articulation left switch, a left articulation right switch, a left articulation center switch, a right articulation left switch, a right articulation right switch, and a right articulation center switch, are interchangeable shafts. It is configured to control articulation of assembly 150200 (FIGS. 25 and 27) and/or 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 comprising a left articulation left switch, a left articulation right switch, a left articulation center switch, and a left flip switch is connected to the main controller 150717 by a left flexible connector. A right switch comprising a right articulation left switch, a right articulation right switch, a right articulation center switch, and a right flip switch is connected to the main controller 150717 by a right flexible connector. The firing switch, clamp release switch, and shaft engagement switch are linked to main controller 150717 .

Multiple switches may be implemented in any combination using any suitable mechanical, electromechanical, or solid state switches. For example, the switch may be a limit switch operated by movement of a component associated with surgical instrument 150010 (FIGS. 25-28) or by the presence of an object. Such switches can be used to control various functions associated with surgical instrument 150010 . A limit switch is an electromechanical device consisting of an actuator in mechanical communication with a set of contacts. When an object contacts the actuator, the device manipulates the contact to make or break an electrical connection. Limit switches are used in a variety of applications and environments due to their ruggedness, ease of installation, and reliable operation. A limit switch can determine the presence, absence, passage, placement, and end of movement of an object. In other implementations, 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, among others. good too. In other implementations, the switch may be a solid-state switch that operates under the influence of light, such as an optical sensor, an infrared sensor, an ultraviolet sensor, among others. Further, the switch may be a solid state device such as a transistor (eg, FET, junction FET, metal oxide semiconductor FET (MOSFET), bipolar, etc.). Other switches may include wireless switches, ultrasonic switches, accelerometers, inertial sensors, among others.

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, the surgical instrument of FIG. is another block diagram of the control circuit 150700 of the . The handle assembly 150702 can comprise 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 power management circuitry 150734 that can include a power management controller 150716 , a power modulator 150738 , and a current sensing circuit 150736 . Shaft assembly connectors 150730 , 150732 form interface 150727 . While the replaceable shaft assembly 150704 and power supply assembly 150706 are coupled to the handle assembly 150702, the power management circuitry 150734 may be configured to modulate the power output of the battery 150707 based on the power requirements of the replaceable shaft assembly 150704. . The power management controller 150716 may be programmed to control the power modulator 150738 of the power output of the power supply assembly 150706 and the current sense circuit 150736 monitors the power output of the power supply assembly 150706 to adjust the power output of the battery 150707. may be used to provide feedback to the power management controller 150716 regarding the power output so that the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. Shaft assembly 150704 includes shaft processor 150720 , which is coupled to non-volatile memory 150721 and shaft assembly connector 150728 to electrically couple shaft assembly 150704 to handle assembly 150702 . Shaft assembly connectors 150726 , 150728 form interface 150725 . Main controller 150717, shaft processor 150720, and/or power management controller 150716 may be configured to implement one or more of the processes described herein.

Surgical instrument 150010 (FIGS. 25-28) can include an output device 150742 that provides 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 actuators). Under certain circumstances, the output device 150742 may comprise a display 150743 that may be included in the handle assembly 150702. Shaft assembly controller 150722 and/or power management controller 150716 can provide feedback to a user of surgical instrument 150010 via output device 150742 . Interface 150727 may be configured to connect shaft assembly controller 150722 and/or power management controller 150716 to output device 150742 . Output device 150742 may be integrated with power assembly 150706 . While interchangeable shaft assembly 150704 is coupled to handle assembly 150702, communication between output device 150742 and shaft assembly controller 150722 may be accomplished via interface 150725. Having described control circuitry 150700 (FIGS. 29A-29B and FIG. 6) for controlling the operation of surgical instrument 150010 (FIGS. 25 and 28), the present disclosure is now directed to surgical instrument 150010 (FIGS. 25 and 28). 25-28) and various configurations of control circuit 150700 are described.

Referring to FIG. 31, a surgical stapler 151000 may include a handle component 151002, a shaft component 151004, and an end effector component 151006. Surgical stapler 151000 is constructed and equipped similarly to motorized surgical cutting and fastening instrument 150010 described in connection with FIG. Therefore, for the sake of brevity and clarity, operational and structural details are not repeated here. End effector 151006 may be used to compress, cut, or staple tissue. Referring now to FIG. 32, the end effector 151030 may be positioned by the physician to encircle tissue 151032 prior to compression, cutting, or stapling. As shown in FIG. 32, no compression may be applied to the tissue while preparing the end effector for use. Referring now to FIG. 33, by engaging a handle (eg, handle 151002) of a surgical stapler, a physician can use end effector 151030 to compress tissue 151032. As shown in FIG. In one aspect, the tissue 151032 may be compressed to its maximum threshold, as shown in FIG.

34, various forces may be applied to tissue 151032 by end effector 151030. Referring to FIG. For example, when tissue 151032 is compressed between anvil 151034 and channel frame 151036 of end effector 151030, normal forces F1 and F2 may be applied by that anvil 151034 and channel frame 151036. Referring now to FIG. 35, various oblique and/or lateral forces may also be applied to tissue 151032 when compressed by end effector 151030 . For example, force F3 may be applied. In order to operate a medical device such as the surgical stapler 151000, it may be desirable to sense or calculate various forms of compression being applied to tissue by an end effector. For example, an understanding of vertical or lateral compression may allow an end effector to apply staple motions more precisely or accurately, or surgical staplers may be used more appropriately or safely. Surgical stapler information can be provided to the operator.

Compression through the tissue 151032 can be determined from the impedance of the tissue 151032 . At various compression levels, the impedance Z of tissue 151032 may 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.

Referring now to FIG. 36, in one aspect, RF electrodes 151038 can be positioned on the end effector 151030 (eg, on the staple cartridge, knife, or channel frame of the end effector 151030). Additionally, electrical contacts 151040 may be positioned on anvil 151034 of end effector 151030 . In one aspect, the electrical contacts can be positioned on the channel frame of the end effector. As tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, impedance Z of tissue 151032 changes. Vertical tissue compression 151042 caused by end effector 151030 may be measured as a function of impedance Z of tissue 151032 .

Referring now to FIG. 37, in one aspect, once the RF electrode 151038 is positioned, the electrical contact 151044 can be positioned at the opposite end of the anvil 151034 of the end effector 151030 . As tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, impedance Z of tissue 151032 changes. Lateral tissue compression 151046 caused by end effector 151030 may be measured as a function of impedance Z of tissue 151032 .

38, in one aspect, an electrical contact 151050 can be positioned on the anvil 151034 and an electrical contact 151052 can be positioned on the opposite end of the end effector 151030 in the channel frame 151036. RF electrodes 151048 may be positioned laterally in the middle of the end effector 151030 . As tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, impedance Z of tissue 151032 changes. Lateral or angular compression 151054 and 151056 on either side of the RF electrode 151048 can be caused by the end effector 151030 to cause various changes in the tissue 151032 based on the relative positioning of the RF electrode 151048 and the electrical contacts 151050 and 151052. can be measured as a function of impedance Z.

Referring now to FIG. 39, frequency generator 151222 can receive power or current from power source 151221 and provide one or more RF signals to one or more RF electrodes 151224. can be done. As noted above, one or more RF electrodes may be positioned at various locations or components on an end effector or surgical stapler, such as a staple cartridge or channel frame. One or more electrical contacts, such as electrical contacts 151226 or 151228, may be positioned on the channel frame or anvil of the end effector. Additionally, one or more filters, such as filters 151230 or 151232 may be communicatively coupled with electrical contacts 151226 or 151228 . Filters 151230 and 151232 may filter one or more RF signals provided by frequency generator 151222 before combining them into a single return path 151234 . Voltage V and current I associated with one or more RF signals may be compressed and/or communicatively coupled between one or more RF electrodes 151224 and electrical contacts 151226 or 151228. can be used to calculate the impedance Z associated with the tissue that can be

Still referring to FIG. 39, various components of the tissue compression sensor systems described herein can be placed within the handle 151236 of the surgical stapler. For example, as shown in circuit diagram 151220a, frequency generator 151222 may be located within handle 151236 and receives power from power source 151221 . Also, current I1 and current I2 can be measured on the return paths corresponding to electrical contacts 151228 and 151226. FIG. Using the voltage V applied between the supply and return paths, impedances Z1 and Z2 can be calculated. Z 1 may correspond to the impedance of tissue compressed and/or communicatively coupled between one or more of RF electrodes 151224 and electrical contacts 151228 . Additionally, Z2 may correspond to the impedance of tissue compressed and/or communicatively coupled between one or more of RF electrodes 151224 and electrical contacts 151226 . Applying the equations Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2 corresponding to different compression levels of tissue compressed by the end effector can be calculated.

Referring now to FIG. 40 , one or more aspects of the present disclosure are illustrated in circuit diagram 151250 . In some implementations, a power supply at handle 151252 of the surgical stapler may power frequency generator 151254 . Frequency generator 151254 may generate one or more RF signals. One or more RF signals may be multiplexed or superimposed in a multiplexer 151256, which may be within the shaft 151258 of the surgical stapler. In this manner, two or more RF signals can be superimposed (or nested or modulated together, for example) and transmitted to the end effector. The one or more RF signals may energize one or more RF electrodes 151260 on the end effector 151262 of the surgical stapler (eg, positioned within the staple cartridge). Tissue (not shown) may be compressively and/or communicatively coupled between one or more of the RF electrodes 151260 and one or more electrical contacts. For example, tissue may be compressed between one or more RF electrodes 151260 and electrical contacts 151264 positioned within the channel frame of the end effector 151262 or electrical contacts 151266 positioned within the anvil of the end effector 151262. and/or can be communicatively coupled. Filter 151268 can be communicatively coupled to electrical contacts 151264 and filter 151270 can be communicatively coupled to electrical contacts 151266 .

Voltage V and current I associated with one or more RF signals are applied to the staple cartridge (communicatively coupled to one or more RF electrodes 151260) and the channel frame or anvil (electrical contacts 151264 or 151266, which is communicatively coupled to one or more of 151264 or 151266).

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

Two or more RF signals can be returned on a common path via electrical contacts. Additionally, in order to differentiate the separate tissue impedances represented by the two or more RF signals, the two or more RF signals are filtered before they join on a common path. obtain. Current I1 and current I2 can be measured on the return paths corresponding to electrical contacts 151264 and 151266. FIG. Using the voltage V applied between the supply and return paths, impedances Z1 and Z2 can be calculated. Z1 may correspond to the impedance of tissue compressively and/or communicatively coupled between one or more of RF electrodes 151260 and electrical contacts 151264 . Additionally, Z2 may correspond to the impedance of tissue compressively and/or communicatively coupled between one or more of the RF electrodes 151260 and the electrical contacts 151266 . Applying the equations Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2 corresponding to different compressions of tissue compressed by end effector 151262 can be calculated. In an embodiment, impedances Z1 and Z2 may be calculated by impedance calculator 151272. Impedances Z1 and Z2 can be used to calculate various levels of tissue compression.

Referring now to Figure 41, a frequency graph 151290 is shown. Frequency graph 151290 shows frequency modulation nesting two RF signals. The two RF signals may be nested before reaching the RF electrodes on the end effector, as described above. For example, an RF signal with frequency 1 and an RF signal with frequency 2 can be nested together. Referring now to FIG. 42, the resulting nested RF signal is shown in frequency graph 151300. FIG. The combined signal shown in frequency graph 151300 includes the two RF signals of frequency graph 151290 combined. Referring now to Figure 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, filters 151268 and 151270 may be high Q filters such that the filter range may be narrow (eg, Q=10). Q may be defined by center frequency (Wo)/bandwidth (BW), where Q=Wo/BW. In one example, frequency 1 may be 150 kHz and frequency 2 may be 300 kHz. A viable impedance measurement range can be from 100 kHz to 20 MHz. Other sophisticated techniques such as correlation, quadrature detection, etc. may be used in various embodiments to separate the RF signals.

Using one or more of the techniques and features described herein, a single energized electrode on the staple cartridge or isolated knife of the end effector can simultaneously perform multiple tissue compression measurements. can be used to do When two or more RF signals are superimposed or multiplexed (or nested or modulated), they can be transmitted to the single power side of the end effector and the end effector channel frames or anvils. If a filter is incorporated at the junction of the anvil and channel before they join the common return path, the tissue impedances presented by both paths can be differentiated. This can provide a measure of vertical versus 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 path. The frequency generator and signal processor may be located on one or more chips on a circuit board or sub-board (which may already be present in the surgical stapler).

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

The rate of change of the detected parameter, or how long it takes for the tissue parameter to reach its asymptotic steady-state value, as defined in another way, is itself a separate measurement, and the detection from which it is derived can be more valuable than the parameters specified. To improve tissue parameter measurements, such as waiting a predetermined amount of time before making a measurement, the present disclosure provides novel techniques for using the derivative of the measurement, such as the rate of change of the tissue parameter.

Differential techniques or rate of change measurements are most useful with the understanding that no single measurement can be used alone to dramatically improve staple formation. It is the combination of measurements that make the measurement valid. In the case of tissue gaps, it is useful to know how much the jaws are covered by tissue in order to make relevant gap measurements. Impedance rate-of-change measurements may be combined with strain measurements at the anvil to relate force and compression applied to tissue grasped between jaw members of an end effector, such as an anvil and a staple cartridge. Rate of change measurements can be used by endosurgical devices to determine tissue type as well as tissue compression. Although stomach tissue and lung tissue sometimes have similar thicknesses, and even similar compression properties when lung tissue is calcified, the instrument can be used to measure gap, compression, applied force, and tissue contact area. , and compression rate of change or gap rate of change, it may be possible to distinguish between these tissue types. If either of these measurements were used alone, it could be difficult for an endosurgical device to distinguish between tissue types. The rate of change of compression can also help enable the device to determine whether the tissue is "normal" or whether an abnormality is present. Measuring the variability of the sensor signal as well as the elapsed time and determining the derivative of the signal would provide another measurement that would allow the endosurgical device to measure that signal. Rate of change information can also be used to determine when steady state has been reached and signal the next step in the process. For example, after clamping tissue between jaw members of an end effector, such as an anvil and a staple cartridge, once tissue compression reaches a steady state (e.g., about 15 seconds), an indicator or trigger is enabled to initiate firing of the device. can be

Also provided herein are methods, apparatus, and systems for time-dependent evaluation of sensor data that determine stability, creep, and viscoelastic properties of tissue during surgical instrument operation. Surgical instruments, such as the stapler shown in FIG. 25, have jaw gap size or distance, firing current, tissue compression, amount of jaws covered by tissue, anvil strain, and trigger force, to name a few. A variety of sensors can be included to measure operating parameters such as. These sensed measurements are important for automated 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. Motor current may be monitored using a current sensor in series with battery 2308 .

Referring now to FIG. 44, there is shown a motorized surgical cutting and fastening instrument 151310 that may or may not be reused. Motorized surgical cutting and fastening instrument 151310 is constructed and equipped similarly to motorized surgical cutting and fastening instrument 150010 described in connection with FIGS. In the example shown in FIG. 44, the instrument 151310 includes a housing 151312 with a handle assembly 151314 configured to be grasped, manipulated and actuated by a clinician. Housing 151312 is configured for operable attachment to interchangeable shaft assembly 151500 to which surgical end effector 151600 configured to perform one or more surgical tasks or procedures is operably coupled. It is Motorized surgical cutting and fastening instrument 151310 is constructed and equipped similarly to motorized surgical cutting and fastening instrument 150010 described in connection with FIGS. For the sake of brevity, details of operation and structure are not repeated here.

The housing 151312 shown in FIG. 44 is connected with a replaceable shaft assembly 151500 including an end effector 151600 comprising a surgical cutting and fastening device configured to operably support a surgical staple cartridge 151304 therein. are shown. The housing 151312 includes end effectors adapted to support various sizes and types of staple cartridges and is adapted for use in connection with interchangeable shaft assemblies having various shaft lengths, sizes, types, etc. may be configured to Additionally, the housing 151312 may also be effectively used with a variety of other interchangeable shaft assemblies, including other motions and forms of energy such as radio frequency (RF) Included are 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. Additionally, the end effector, shaft assembly, handle, surgical instrument, and/or surgical instrument system may utilize any suitable fastener to fasten tissue. For example, a fastener cartridge with a plurality of fasteners removably stored therein may be removably inserted and/or attached to the end effector of the shaft assembly.

FIG. 44 shows surgical instrument 151310 with interchangeable shaft assembly 151500 operably coupled thereto. In the illustrated configuration, the handle housing forms a pistol grip portion 151319 that can be grasped and manipulated by the clinician. The handle assembly 151314 operably supports therein a plurality of drive systems that produce various controlled motions and apply this control to their counterparts on interchangeable shaft assemblies operably attached to the handle assembly. configured to apply motion; A trigger 151332 is operatively associated with the pistol grip to control various of these control movements.

With continued reference to FIG. 44, replaceable shaft assembly 151500 includes surgical end effector 151600 with elongated channel 151302 configured to operatively support staple cartridge 151304 therein. End effector 151600 may further include an anvil 151306 pivotally supported relative to elongated channel 151302 .

The inventors believe that the derived parameters may be even more useful than the detected parameters underlying the derived parameters for controlling surgical instruments such as the instrument illustrated in FIG. I found Non-limiting examples of derived parameters include the rate of change of the detected parameter (e.g., jaw gap distance) and the elapsed time for the tissue parameter to reach an asymptotic steady-state value (e.g., 15 seconds). are mentioned. Derived parameters such as rates of change are particularly useful because they dramatically improve measurement accuracy and also provide information that is otherwise not directly apparent from the detected parameters. For example, impedance (i.e., tissue compression) rate of change can be combined with strain on the anvil to relate compression and force, thereby allowing the microcontroller to determine tissue type as well as amount of tissue compression. it becomes possible to This example is only an example, and any derived parameter may be combined with one or more detected parameters to determine tissue type (e.g., stomach and lung), tissue health (calcification, and normal), and more accurate information regarding the operational status of the surgical device (eg, clamping complete). Different tissues have unique viscoelastic properties and unique rates of change, so these and other parameters described herein are useful indicators for monitoring and automatically adjusting surgical procedures. becomes.

FIG. 46 is an exemplary graph showing gap distance over time, where the gap is the space between the jaws occupied by clamped tissue. The vertical (y) axis is distance and the horizontal (x) axis is time. Specifically, referring to FIGS. 44 and 45, gap distance 151340 is the distance between end effector anvil 151306 and elongated channel 151302 . In the open jaw position, at time 0, the gap 151340 between the anvil 151306 and the elongate member is at its maximum distance. The width of gap 151340 decreases as anvil 151306 closes, such as during tissue clamping. Since tissue has non-uniform elasticity, the gap distance rate of change may vary. For example, certain tissue types may initially exhibit rapid compression, resulting in a faster rate of change. However, as the tissue is continuously compressed, the viscoelastic properties of the tissue may reduce the rate of change until the tissue is no longer compressible, at which time the gap distance remains substantially constant. become. The gap decreases over time as tissue is squeezed between the anvil 151306 of the end effector 151340 and the staple cartridge 151304 . For example, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors, such as those shown in FIGS. One or more sensors described in association measure the gap distance "d" between anvil 151306 and staple cartridge 151304 over time "t", as graphically represented in FIG. may be adapted and configured to: The rate of change of gap distance "d" over time "t" is the slope of the curve shown in FIG. 46, slope=Δd/Δt.

FIG. 47 is an exemplary graph showing end effector jaw firing current. The vertical (y) axis is current and the horizontal (x) axis is time. As discussed herein, the surgical instrument and/or its microcontroller shown and described with respect to FIG. 25 may be utilized during various operations such as clamping, cutting, and/or stapling tissue. A current sensor may be included to detect the current drawn. For example, as tissue resistance increases, the instrument's electric motor may require more current to clamp, cut, and/or staple tissue. Similarly, as the resistance decreases, the electric motor may require less current to clamp, cut, and/or staple tissue. As a result, the firing current can be used as an approximation of tissue resistance. Detected currents can be used alone or more preferably in combination with other measurements to provide feedback regarding the target tissue. Still referring to FIG. 47, during some operations such as stapling, the firing current is initially high at time 0, but decreases over time. Current may increase over time as the motor draws more current to overcome the increasing mechanical load during operation of other devices. Additionally, the rate of change of firing current can be used as an indicator that tissue is transitioning from one state to another. Therefore, the firing current and, in particular, the rate of change of the firing current can be used to monitor device operation. The firing current decreases over time as the knife cuts through the tissue. If the tissue being cut presents more or less resistance due to tissue properties or the sharpness of the knife 151305 (FIG. 45), the rate of change of firing current may vary. As the cutting conditions vary, the work done by the motor will vary, resulting in varying firing current over time. A current sensor can be used to measure the firing current over time while the knife 151305 is firing, as graphically represented in FIG. For example, a current sensor can be used to monitor motor current. The current sensor may be adapted and configured to measure the motor firing current "i" over time "t", as graphically represented in FIG. The rate of change of firing current “i” over time “t” is the slope of the curve shown in FIG. 47, slope=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. The impedance is low at time 0, but rises with 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 severed with a knife or sealed using RF energy between 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 tissue is cut, the electrical impedance rises and reaches infinity when the tissue is completely severed by the knife. Also, if the end effector 151340 includes electrodes coupled to a source of RF energy, the electrical impedance of the tissue will increase as energy is delivered through the tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. . The electrical impedance increases as the energy passing through the tissue desiccates 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 very high values, or to infinity if the tissue is disrupted. Additionally, as shown in FIG. 48, different tissues may have unique compression properties that distinguish them, such as compressibility. Tissue impedance can be measured by driving a sub-therapeutic RF current through tissue grasped between first jaw member 9014 and second jaw member 9016 . One or more electrodes may be positioned on either or both anvil 151306 and staple cartridge 151304 . The tissue compression/impedance of the tissue between the anvil 151306 and staple cartridge 151304 can be measured over time as graphically represented in FIG. For example, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors, such as those shown in FIGS. 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 strain on 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 initially large, but decreases as the tissue reaches steady state and exerts less pressure on the anvil 151306 . The rate of change of strain in the anvil 151306 is measured by either the anvil 151306 and the staple cartridge 151304 (FIGS. 44, 45) to measure the pressure or strain applied to the tissue grasped between the anvil 151306 and the staple cartridge 151304. or by pressure sensors or strain gauges positioned on both. Anvil 151306 strain may be measured over time as graphically represented in FIG. The rate of change of strain “S” over time “t” is the slope of the curve shown in FIG. 49, slope=ΔS/Δt.

FIG. 50 is an exemplary graph of trigger force over time. The vertical (y) axis is trigger force and the horizontal (x) axis is time. In certain examples, the trigger force is gradual and provides tactile feedback to the clinician. Thus, at time 0, the trigger 151320 (FIG. 44) pressure may be at its lowest value, and the trigger pressure may increase until the operation (eg, clamping, cutting, or stapling) is completed. The rate of change in trigger force is measured by the handle of instrument 151310 (FIG. 44) to measure the force required to drive knife 151305 (FIG. 45) through tissue grasped between anvil 151306 and staple cartridge 151304. It can be measured by a pressure sensor or strain gauge positioned on the trigger 151302 of 151319 . The trigger force 51332 force can be measured over time as graphically represented in FIG. The rate of change of strain trigger force "F" over time "t" is the slope of the curve shown in FIG. 50, slope=ΔF/Δt.

For example, stomach tissue and lung tissue can be distinguished even though these tissues may have similar thicknesses and similar compression properties when lung tissue is calcified. Stomach tissue and lung tissue can be distinguished 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" versus tissue displacement for various tissues. The vertical (y) axis is tissue pressure and the horizontal (x) axis is tissue displacement. When the tissue pressure reaches a predetermined threshold, such as 50-100 pounds per square inch (psi), the amount of tissue displacement as well as the rate of tissue displacement before reaching the threshold can be used to differentiate tissue. For example, vascular tissue reaches a given pressure threshold with less tissue displacement and a faster rate of change than colon, lung, or stomach tissue. In addition, the rate of change of vascular tissue (tissue pressure versus displacement) is nearly asymptotic at thresholds of 50-100 psi, whereas the rates of change of colon, lung, and stomach are not asymptotic at thresholds of 50-100 psi. As will be appreciated, any pressure threshold may be used such as, for example, 1-1000 psi, more preferably 10-500 psi, even more preferably 50-100 psi. Additionally, multiple or progressive thresholds can be used to provide further resolution of tissue types with similar viscoelastic properties.

The compression rate of change may also allow the microcontroller to determine whether the tissue is "normal" or whether an abnormality, such as calcification, is present. 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 the rate of change of tissue displacement can be used to diagnose calcified lung tissue and/or distinguish it from normal lung tissue.

Additionally, certain detected measurements may benefit from additional sensory input. For example, in the case of jaw gap, knowing how much of the jaw is covered by tissue can make the gap measurement more useful and accurate. If a small portion of the jaw is covered with tissue, the tissue compression may appear to be less than if the entire jaw is covered with tissue. Therefore, jaw coverage can be considered by the microcontroller when analyzing tissue compression and other sensed parameters.

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

Rate of change information is also useful for determining when steady state has been reached and for signaling the next step in the process. For example, during clamping, when tissue compression reaches a steady state, e.g., no significant rate of change occurs after a set period of time, the microcontroller alerts the clinician to initiate the next step of operation, such as firing staples. A signal can be sent to the display. Alternatively, the microcontroller can be programmed to automatically initiate the next step of operation (eg, staple firing) once a steady state is reached.

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

A combination of one or more sensed parameters and derived parameters provides a more reliable and accurate assessment of tissue type and tissue health, leading to more effective device monitoring, control, and clinician intervention. allow feedback to

FIG. 53 shows one embodiment of an end effector 152000 comprising a first sensor 152008a and a second sensor 152008b. End effector 152000 is similar to end effector 150300 described above. End effector 152000 includes a first jaw member or anvil 152002 pivotally coupled to a second jaw member 152004 . Second jaw member 152004 is configured to receive staple cartridge 152006 therein. Staple cartridge 152006 includes a plurality of staples (not shown). A plurality of staples are deployable from staple cartridge 152006 during a surgical operation. End effector 152000 includes a first sensor 152008a. First sensor 152008a is configured to measure one or more parameters of end effector 152000 . For example, in one embodiment, first sensor 152008a is configured to measure gap 152010 between anvil 152002 and second jaw member 152004 . First sensor 152008a may comprise, for example, a Hall effect sensor configured to detect magnetic fields generated by magnets 152012 embedded in second jaw member 152004 and/or staple cartridge 152006 . As another example, in one embodiment, the first sensor 152008a is coupled to the anvil 152002 by the second jaw member 152004 and/or by tissue clamped between the anvil 152002 and the second jaw member 152004. configured to measure one or more forces exerted on the

End effector 152000 includes a second sensor 152008b. Second sensor 152008b is configured to measure one or more parameters of end effector 152000 . For example, in various embodiments, the second sensor 152008b may comprise a strain gauge configured to measure the amount of strain in the anvil 152002 during clamping conditions. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. In various embodiments, the first sensor 152008a and/or the second sensor 152008b are magnetic sensors, e.g., Hall effect sensors, strain gauges, pressure sensors, force sensors, inductive sensors, e.g., eddy current sensors; A resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 152000 may be included. 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 influence 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 related to the one or more parameters measured by the second sensor 152008b. For example, in one embodiment, first sensor 152008a is configured to measure gap 152010 between anvil 152002 and second jaw member 152004 . Gap 152010 represents the thickness and/or compressibility of the tissue section clamped between anvil 152002 and staple cartridge 152006 . First sensor 152008a may include, for example, a Hall effect sensor configured to detect a magnetic field generated by magnet 152012 coupled to second jaw member 152004 and/or staple cartridge 152006 . Although the single point measurement accurately describes the compressed tissue thickness for the calibrated full bit of tissue, partial tissue pinching occurs between the anvil 152002 and the second jaw member 152004. Doing so may produce inaccurate results. Partial tissue pinching, either proximal portion pinching or distal portion pinching, changes the geometry of the anvil 152002 clamp.

In some embodiments, the second sensor 152008b is one or two indicating the type of tissue pinch, e.g., complete pinch, partial proximal pinch, and/or partial distal pinch. configured to detect one or more parameters. To adjust the measurements of the first sensor 152008a so that the measurements of the second sensor 152008b accurately represent the true compressed tissue thickness in the proximally or distally positioned partial pinch may be used for For example, in one embodiment, the second sensor 152008b comprises a strain gauge, eg, a micro strain gauge, configured to monitor the magnitude of strain in the anvil during post-clamping conditions. The magnitude of the strain in the anvil 152002 is used to match the output of the first sensor 152008, e.g., a Hall effect sensor, to accurately represent the true compressed tissue thickness at the proximally or distally positioned partial pinch. 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 the time-based information to be analyzed, for example, by a primary processor (eg, processor 462 (FIG. 12), for example) and recognize tissue thickness and clamp positioning. It can be used to select one or more algorithms and/or lookup tables for dynamically adjusting the measurements.

In some embodiments, the thickness measurement of first sensor 152008a may be provided to an output device of surgical instrument 150010 coupled to end effector 152000 . For example, in one embodiment, end effector 152000 is coupled to surgical instrument 150010 that includes a display (eg, display 473 (FIG. 12), for example). The measurements of the first sensor 152008a are provided to a processor, eg, a primary processor. The primary processor adjusts the measurements of the first sensor 152008a based on the measurements 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 The primary processor outputs the adjusted tissue thickness measurement and an indication of full or partial pinching to the display. The operator may decide whether to deploy staples within staple cartridge 152006 based on the displayed value.

In some embodiments, the first sensor 152008a and the second sensor 152008b are arranged such that, for example, the first sensor 152008a is located inside the patient at the treatment site and the second sensor 152008b is located outside the patient. may be located in different environments, such as The second sensor 152008b may be configured to calibrate and/or modify the output of the first sensor 152008a. First sensor 152008a and/or second sensor 152008b may include, for example, environmental sensors. Environmental sensors may include, for example, temperature sensors, humidity sensors, pressure sensors, and/or any other suitable environmental sensors.

Figure 54 is a logic diagram illustrating one embodiment of a process 152020 for adjusting the reading of a first sensor 152008a based on input from a second sensor 152008b. A first signal 152022a is captured by a first sensor 152008a. The first signal 152022a may be adjusted based on one or more predetermined parameters such as, for example, smoothing functions, lookup tables, and/or any other suitable adjustment parameters. A second signal 152022b is captured by a second sensor 152008b. Second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. A first signal 152022a and a second signal 152022b are provided to a processor, eg, a primary processor. The processor adjusts the measurements of the first sensor 152008a, as represented by the first signal 152022a, based on the second signal 152022b from the second sensor. For example, in one embodiment, the first sensor 152008a comprises a Hall effect sensor and the second sensor 152008b comprises a strain gauge. The distance measurement of the first sensor 152008a is adjusted by the amount of strain measured by the second sensor 152008b to determine the fullness of the pinch of tissue at the end effector 152000. FIG. The adjusted measurements are displayed to the operator (152026), for example, via a display embedded in the surgical instrument 150010.

Figure 55 is a logic diagram illustrating one embodiment of a process 152030 for determining a lookup table for a first sensor 152008a based on input from a second sensor 152008b. A first sensor 152008a captures a signal 152022a indicative of one or more parameters of the end effector 152000 . The first signal 152022a may be adjusted based on one or more predetermined parameters such as, for example, smoothing functions, lookup tables, and/or any other suitable adjustment parameters. A second signal 152022b is captured by a second sensor 152008b. Second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. A first signal 152022a and a second signal 152022b are provided to a processor, eg, a primary processor. Processor 2006 selects a lookup table from one or more available lookup tables 152034a, 152034b based on the value of the second signal. A selected lookup table is used to convert the first signal into a thickness measurement of tissue located between anvil 152002 and staple cartridge 152006 . The adjusted measurements are displayed to the operator (152026), for example, via a display embedded in the surgical instrument 150010.

Figure 56 is a logic diagram illustrating one embodiment of a process 152040 for calibrating a first sensor 152008a in response to input from a second sensor 152008b. First sensor 152008a is configured to capture signal 152022a indicative of one or more parameters of end effector 152000 . The first signal 152022a may be adjusted based on one or more predetermined parameters such as, for example, smoothing functions, lookup tables, and/or any other suitable adjustment parameters. A second signal 152022b is captured by a second sensor 152008b. Second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. A first signal 152022a and a second signal 152022b are provided to a processor, eg, a primary processor. The primary processor calibrates (152042) the first signal 152022a in response to the second signal 152022b. A first signal 152022a is calibrated 152042 to reflect the fullness of the tissue pinch at the end effector 152000 . The calibrated signal is displayed 152026 to the operator, eg, by display 2026 embedded in surgical instrument 150010 .

FIG. 57 is a logic diagram illustrating one embodiment of a process 152050 for determining and displaying the thickness of tissue sections clamped between anvil 152002 and staple cartridge 152006 of end effector 152000. FIG. Process 152050 includes acquiring a Hall effect voltage 152052 through a Hall effect sensor located at the distal tip of anvil 152002, for example. Hall effect voltage 152052 is provided to analog-to-digital converter 152054 and converted to a digital signal. A digital signal is provided to a processor, such as, for example, a primary processor. The primary processor calibrates the curve input of the Hall effect voltage 152052 signal (152056). A strain gauge 152058, eg, a micro strain gauge, is configured to measure one or more parameters of the end effector 152000, eg, the amount of strain exerted on the anvil 152002 during a clamping operation. there is The measured strain is converted (152060) into a digital signal and provided to a processor, eg, a primary processor. Primary processor adjusts Hall effect voltage 152052 using one or more algorithms and/or lookup tables in response to the strain measured by strain gauge 152058 to adjust anvil 152002 and staple cartridge 152006. reflects the true thickness of the clamped tissue and the fullness of its pinch. The adjusted thickness is displayed to the operator (152026), for example, by a display embedded in surgical instrument 150010.

In some embodiments, the surgical instrument can further comprise a load cell or sensor 152082. The load sensor 152082 can be located, for example, within the shaft assembly 150200 described above or within the housing 150012 also described above. FIG. 58 is a logic diagram illustrating one embodiment of a process 152070 for determining and displaying the thickness of tissue sections clamped between anvil 152002 and staple cartridge 152006 of end effector 152000. FIG. The process includes acquiring a Hall effect voltage 152072, for example, through a Hall effect sensor located at the distal tip of the anvil 152002. Hall effect voltage 152072 is provided to analog to digital converter 152074 and converted to a digital signal. A digital signal is provided to a processor, such as, for example, a primary processor. The primary processor calibrates the curve input of the Hall effect voltage 152072 signal (152076). A strain gauge 152078, eg, a micro strain gauge, is configured to measure one or more parameters of the end effector 152000, eg, the amount of strain exerted on the anvil 152002 during a clamping operation. there is The measured strain is converted (152080) into a digital signal and provided to a processor, eg, a primary processor. Load sensor 152082 measures the clamping force of anvil 152002 against staple cartridge 152006 . The measured clamp force is converted (152084) into a digital signal and provided to a processor, eg, a primary processor. The primary processor, in response to strain measured by strain gauge 152078 and clamping force measured by load sensor 152082, generates Hall effect voltage 152072 using one or more algorithms and/or lookup tables. Adjust to reflect the true thickness of the tissue clamped by the anvil 152002 and staple cartridge 152006 and the fullness of its pinch. The adjusted thickness is displayed to the operator (152026), for example, by a display embedded in surgical instrument 150010.

FIG. 59 is a graph 152090 showing a comparison of adjusted Hall effect thickness measurements 152092 and uncorrected Hall effect thickness measurements 152094. FIG. Since a single sensor cannot compensate for distal/proximal partial pinching, resulting in inaccurate thickness measurements, an uncorrected Hall sensor, as shown in FIG. Effective thickness measurements 152094 represent measurements of thicker tissue. Adjusted thickness measurements 152092 are generated, for example, by process 152050 shown in FIG. The adjusted Hall effect thickness measurements 152092 are calibrated based on input from one or more additional sensors such as, for example, strain gauges. The adjusted Hall effect thickness 152092 reflects the true thickness of the tissue located between the anvil 152002 and staple cartridge 152006.

FIG. 60 shows one embodiment of an end effector 152100 comprising a first sensor 152108a and a second sensor 152108b. End effector 152100 is similar to end effector 152000 shown in FIG. End effector 152100 includes a first jaw member or anvil 152102 pivotally coupled to a second jaw member 152104 . Second jaw member 152104 is configured to receive staple cartridge 152106 therein. End effector 152100 includes a first sensor 152108a coupled to 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, for example. Gap 152110 may correspond to the thickness of tissue clamped between anvil 152102 and staple cartridge 152106, for example. 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 may be a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any may include other suitable sensors.

In some embodiments, the end effector 152100 comprises a second sensor 152108b. Second sensor 152108b is coupled to second jaw member 152104 and/or staple cartridge 152106 . Second sensor 152108b is configured to sense one or more parameters of 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 clamping state of the end effector 152100, the end effector Configured to detect one or more instrument states, such as number of uses/number of uses remaining for 152100 and/or staple cartridge 152106, and/or any other suitable instrument state. The second sensor 152108b may be, for example, a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor. Any suitable sensor that detects one or more instrument conditions may be included, such as.

End effector 152100 may be used in conjunction with any of the processes shown in Figures 54-57. For example, in one embodiment, the input from the second sensor 152108b may be used to calibrate the input of the first sensor 152108a. A 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 may, for example, be the height of the cartridge deck, the tissue thickness available/optimal for the staple cartridge, and/or the pattern of staples within the staple cartridge 152106. etc., may correspond to one or more characteristics of the cartridge. Known parameters of staple cartridge 152106 may be used to adjust the thickness measurement provided by first sensor 152108a. For example, if the staple cartridge 152106 has a higher deck height, the thickness measurement 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 via display 2026 coupled to surgical instrument 150010, for example.

FIG. 61 shows an embodiment of an end effector 152150 comprising a first sensor 152158 and a plurality of second sensors 152160a, 152160b. End effector 152150 includes a first jaw member or anvil 152152 and a second jaw member 152154 . Second jaw member 152154 is configured to receive staple cartridge 152156 . Anvil 152152 is pivotally moveable relative to second jaw member 152154 to clamp tissue between anvil 152152 and staple cartridge 152156 . The anvil has a first sensor 152158 . First sensor 152158 is configured to detect one or more parameters of end effector 152150, such as, for example, gap 152110 between anvil 152152 and staple cartridge 152156. Gap 152110 may correspond to the thickness of tissue clamped between anvil 152152 and staple cartridge 152156, for example. 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 may be a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any may include other suitable sensors.

In some embodiments, the end effector 152150 comprises multiple secondary sensors 152160a, 152160b. Secondary sensors 152160 a , 152160 b are configured to detect one or more parameters of end effector 152150 . For example, in some embodiments, secondary sensors 152160a, 152160b are configured to measure the amount of strain exerted on anvil 152152 during a clamping procedure. In various embodiments, the secondary sensors 152160a, 152160b are magnetic sensors such as Hall effect sensors, strain gauges, pressure sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any Other suitable sensors may be provided. Secondary sensors 152160a, 152160b measure one or more of the same parameter at different locations on the anvil 152152, different parameters at the same location on the anvil 152152, and/or different parameters at different locations on the anvil 152152. may be configured to

FIG. 62 is a logic diagram illustrating one embodiment of a process 152170 for adjusting measurements of a first sensor 152158 in response to multiple secondary sensors 152160a, 152160b. In one embodiment, the Hall effect voltage is obtained by, for example, a Hall effect sensor (152172). The Hall effect voltage is converted by an analog-to-digital converter (152174). The transformed Hall effect voltage signal is calibrated (152176). The calibrated curve represents the thickness of the tissue section located between anvil 152152 and staple cartridge 152156 . A plurality of secondary measurements are obtained by a plurality of secondary sensors, eg, strain gauges (152178a, 152178b). The strain gauge input is converted into one or more digital signals (152180a, 152180b), for example, by a plurality of electronic μ-strain conversion circuits. The calibrated Hall effect voltage and the plurality of secondary measurements are provided to a processor, eg, a primary processor. The primary processor utilizes the secondary measurements to adjust the Hall effect voltage (152182), for example by applying an algorithm and/or utilizing one or more lookup tables. The adjusted Hall effect voltage represents the true thickness of the tissue clamped by the anvil 152152 and staple cartridge 152156 and the fullness of its pinch. The adjusted thickness is displayed to the operator (152026), for example, by a display embedded in surgical instrument 150010.

FIG. 63 illustrates one implementation of a circuit 152190 configured to convert signals from a first sensor 152158 and a plurality of secondary sensors 152160a, 152160b into digital signals receivable by a processor, such as a primary processor. showing morphology. Circuitry 152190 comprises an analog to digital converter 152194 . In some embodiments, analog-to-digital converter 152194 includes a 4-channel 18-bit analog-to-digital converter. Those skilled in the art will appreciate that analog-to-digital converter 152194 may comprise any suitable number of channels and/or bits for converting one or more inputs from analog signals to digital signals. will be done. Circuitry 152190 comprises one or more level shifting resistors 152196 configured to accept input from a first sensor 152158, eg, a Hall effect sensor. A level shift resistor 152196 adjusts the input from the first sensor to shift the value to a higher or lower voltage depending on the input. A level shifting resistor 152196 provides a level shifted input from the first sensor 152158 to the analog to digital converter.

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

FIG. 64 shows one embodiment of an end effector 152200 comprising multiple sensors 152208a-152208d. End effector 152200 includes an anvil 152202 pivotally coupled to second jaw member 152204 . Second jaw member 152204 is configured to receive staple cartridge 152206 therein. Anvil 152202 includes a plurality of sensors 152208a-152208d thereon. A plurality of sensors 152208a-152208d are configured to sense one or more parameters of an 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 be, for example, magnetic sensors such as Hall effect sensors, strain gauges, pressure sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors. It may also include sensors, or combinations thereof. For example, in one embodiment, multiple sensors 152208a-152208d may include multiple strain gauges.

In one embodiment, multiple sensors 152208a-152208d enable a robust tissue thickness sensing process. By sensing various parameters along the length of anvil 152202, multiple sensors 152208a-152208d determine whether a surgical instrument, such as surgical instrument 150010, is pinched, e.g., regardless of partial or complete pinching. , allowing the tissue thickness in the jaw to be calculated. In some embodiments, the multiple sensors 152208a-152208d comprise multiple strain gauges. A plurality of strain gauges are configured to measure strain at various points on the anvil 152202 . The strain magnitude and/or slope 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. A plurality of strain gauges are configured to optimize the maximum difference in magnitude and/or gradient based on clamping mechanics to determine tissue thickness, tissue placement, and/or material properties. good too. Time-based monitoring of multiple sensors 152208a-152208d during clamping allows a processor, such as a primary processor, to utilize algorithms and lookup tables to recognize tissue properties and clamp positions, end effector 152200, and/or Alternatively, the tissue clamped between anvil 152202 and staple cartridge 152206 can be dynamically adjusted.

FIG. 65 is a logic diagram illustrating one embodiment of a process 152220 for determining one or more tissue characteristics based on multiple sensors 152208a-152208d. In one embodiment, multiple sensors 152208a-152208d generate multiple signals indicative of one or more parameters of end effector 152200 (152222a-152222d). A plurality of generated signals are converted to digital signals (152224a-152224d) and provided to a processor. For example, in one embodiment that includes multiple strain gauges, multiple electronic μ-strain (microstrain) conversion circuits convert strain gauge signals to digital signals (152224a-152224d). A digital signal is provided to a processor, such as, for example, a primary processor. The primary processor determines (152226) one or more tissue properties based on the plurality of signals. The processor may determine one or more tissue characteristics by applying algorithms and/or lookup tables. One or more tissue properties are displayed to the operator (152026), for example, via a display embedded in surgical instrument 150010. FIG.

FIG. 66 shows an embodiment of an end effector 152250 comprising multiple sensors 152260a-152260d coupled to a second jaw member 3254. FIG. End effector 152250 includes an anvil 152252 pivotally coupled to second jaw member 152254 . Anvil 152252 is moveable relative to second jaw member 152254 to clamp one or more materials, such as tissue section 152264, therebetween. Second jaw member 152254 is configured to receive staple cartridge 152256 . A first sensor 152258 is coupled to the anvil 152252 . The first sensor is configured to detect one or more parameters of the end effector 152150 such as, for example, the gap 152110 between the anvil 152252 and the staple cartridge 152256. Gap 152110 may correspond to the thickness of tissue clamped between anvil 152252 and staple cartridge 152256, for example. 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 inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any may include other suitable sensors.

A plurality of secondary sensors 152260 a - 152260 d are coupled to second jaw member 152254 . A plurality of secondary sensors 152260 a - 152260 d may be integrally formed with the second jaw member 152254 and/or staple cartridge 152256 . For example, in one embodiment, a plurality of secondary sensors 152260a-152260d are disposed on the outer rows of staple cartridge 152256 (see FIG. 67). A plurality of secondary sensors 152260a-152260d are configured to detect one or more parameters of end effector 152250 and/or tissue section 152264 clamped between anvil 152252 and staple cartridge 152256. there is The plurality of secondary sensors 152260a-152260d may be, for example, magnetic sensors such as Hall effect sensors, strain gauges, pressure sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other sensors. Any suitable sensor that senses one or more parameters of end effector 152250 and/or tissue section 152264 may be included, such as suitable sensors, or combinations thereof. Multiple secondary sensors 152260a-152260d may include the same sensors and/or different sensors.

In some embodiments, the plurality of secondary sensors 152260a-152260d includes dual purpose sensors and tissue stabilizing elements. the plurality of secondary sensors 152260a-152260d are configured to create a stabilized tissue condition when the plurality of secondary sensors 152260a-152260d are engaged with the tissue section 152264, such as during a clamping operation; It comprises electrodes and/or sensing features. In some embodiments, one or more of the plurality of secondary sensors 152260a-152260d may be replaced with non-sensing tissue stabilizing elements. Secondary sensors 152260a-152260d create stabilized tissue conditions by controlling tissue flow, staple formation, and/or other tissue conditions during clamping, stapling, and/or other treatment processes. .

FIG. 67 illustrates one embodiment of a staple cartridge 152270 with multiple sensors 152272a-152272h integrally formed therein. Staple cartridge 152270 comprises multiple rows containing multiple holes for storing staples therein. One or more of the holes in the outer row 152278 are replaced with one of the plurality of sensors 152272a-152272h. A cutaway portion is shown to show sensor 152272f coupled to sensor wire 152276b. Sensor wires 152276a, 152276b may include multiple wires coupling multiple sensors 152272a-152272h to one or more circuits of a surgical instrument, such as surgical instrument 150010, for example. In some embodiments, one or more of the plurality of sensors 152272a-152272h are dual purpose sensors and tissue stabilization having electrodes and/or sensing geometries configured to provide tissue stabilization. contains elements. In some embodiments, multiple sensors 152272a-152272h may be replaced and/or co-located with multiple tissue stabilizing elements. Tissue stabilization may be provided, for example, by controlling tissue flow and/or staple formation during the clamping and/or stapling process. A plurality of sensors 152272a-152272h provide signals to one or more circuits of surgical instrument 150010 to improve stapling performance and/or tissue thickness sensing feedback.

FIG. 68 is a logic diagram illustrating one embodiment of a process 152280 for determining one or more parameters of a tissue section 152264 clamped within an end effector, such as end effector 152250 shown in FIG. . In one embodiment, first sensor 152258 is configured to detect one or more parameters of end effector 152250 and/or tissue section 152264 located between anvil 152252 and staple cartridge 152256. ing. A first signal is generated 152282 by a first sensor 152258 . The first signal is indicative of one or more parameters detected by first sensor 152258 . One or more secondary sensors 152260 are configured to detect one or more parameters of 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 . Secondary signal 152284 is generated by secondary sensor 152260 . Secondary signal 152284 is indicative of one or more parameters detected by secondary sensor 152260 . The first signal and the secondary signal are provided to a processor, eg, a primary processor. The processor adjusts 152286 the first signal generated by the first sensor 152258 based on the input generated by the secondary sensor 152260 . The adjusted signal may indicate, for example, the true thickness of the tissue section 152264 and the fullness of the pinch. The conditioned signal is displayed 152026 to the operator, for example, by a display embedded in surgical instrument 150010 .

FIG. 69 shows an embodiment of an end effector 152300 with multiple redundant sensors 152308a, 152308b. End effector 152300 includes a first jaw member or anvil 152302 pivotally coupled to a second jaw member 152304 . Second jaw member 152304 is configured to receive staple cartridge 152306 therein. Anvil 152302 is moveable relative to staple cartridge 152306 to grasp material, eg, tissue sections, between anvil 152302 and staple cartridge 152306 . A plurality of sensors 152308a, 152308b are coupled 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 a gap 152310 between the anvil 152302 and the staple cartridge 152306. Gap 152310 may correspond, for example, to the thickness of tissue located between anvil 152302 and staple cartridge 152306 . A plurality of sensors 152308a, 152308b may detect the gap 152310, for example, by detecting a magnetic field generated by a magnet 152312 coupled to the second jaw member 152304.

In some embodiments, the plurality of sensors 152308a, 152308b includes redundant sensors. Redundant sensors are configured to detect the same characteristics of end effector 152300 and/or tissue sections located between anvil 152302 and staple cartridge 152306 . Redundant sensors may include, for example, Hall effect sensors configured to detect gap 152310 between anvil 152302 and staple cartridge 152306 . Redundant sensors provide signals representing one or more parameters that allow a processor, such as primary processor 2006, to evaluate multiple inputs and determine the most reliable input. In some embodiments, redundant sensors are used to reduce noise, spurious signals, and/or drift. Each redundant sensor is measured in real-time during clamping to analyze time-based information, even allowing algorithms and/or lookup tables to dynamically recognize tissue properties and clamp positioning. good. Inputs of one or more of the redundant sensors may be adjusted and/or selected to identify the true tissue thickness and pinching of the tissue section located between the anvil 152302 and the staple cartridge 152306.

FIG. 70 is a logic diagram illustrating one embodiment of a process 152320 that selects the most reliable output from multiple redundant sensors, eg, multiple sensors 152308a, 152308b shown in FIG. In one embodiment, the first signal is generated by a first sensor 152308a. The first signal is converted (152322a) by an analog-to-digital converter. One or more additional signals are generated by one or more redundant sensors 152308b. One or more additional signals are converted by an analog to digital converter (152322b). The transformed signal is provided to a processor such as, for example, a primary processor. The primary processor evaluates 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, lookup tables, inputs from additional sensors, and/or instrument status. After selecting the most reliable output, the processor may, for example, generate one or more output to reflect the true thickness and pinching of the tissue section located between anvil 152302 and staple cartridge 152306. Output may be adjusted based on additional sensors. The conditioned most reliable output is displayed to the operator (152026), for example, via a display embedded in surgical instrument 150010. FIG.

FIG. 71 shows one embodiment of an end effector 152350 with a sensor 152358 having an inherent sampling rate to limit or eliminate spurious signals. End effector 152350 includes a first jaw member or anvil 152352 pivotally coupled to a second jaw member 152354 . Second jaw member 152354 is configured to receive staple cartridge 152356 therein. Staple cartridge 152356 houses a plurality of staples that may be delivered to a tissue section located between anvil 152352 and staple cartridge 152356 . Sensor 152358 is coupled to anvil 152352 . Sensor 152358 is configured to detect one or more parameters of end effector 152350 such as, for example, gap 152364 between anvil 152352 and staple cartridge 152356 . Gap 152364 may correspond, for example, to the thickness of material, such as a tissue section, and/or the fullness of a sandwich of material located between anvil 152352 and staple cartridge 152356 . Sensor 152358 may be, for example, a magnetic sensor such as a Hall effect sensor, an inductive sensor such as a strain gauge, a pressure sensor, an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor. Any suitable sensor for sensing one or more parameters of the end effector 152350 may be included.

In one embodiment, sensor 152358 includes a magnetic sensor configured to detect magnetic fields generated by electromagnetic wave source 152360 coupled to second jaw member 152354 and/or staple cartridge 152356 . Electromagnetic wave source 152360 produces a magnetic field that is detected by sensor 152358 . The strength of the detected magnetic field may correspond, for example, to the thickness of tissue and/or the fullness of the pinch located between the anvil 152352 and the staple cartridge 152356 . In some embodiments, electromagnetic wave source 152360 generates a signal at a known frequency (eg, 1 MHz, etc.). In other embodiments, the signal generated by the electromagnetic wave source 152360 is responsive to, for example, the type of staple cartridge 152356 installed within the 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, etc.). Signal processor 152362 is configured to process the signal generated by sensor 152358 to eliminate spurious signals and boost the input from sensor 152358 . In some embodiments, the signal processor 152362 may be located separately from the end effector 152350, such as within the handle 150014 of the surgical instrument 150010, for example. In some embodiments, the signal processor 152362 includes algorithms integrally formed with and/or executed by a general processor, eg, a primary processor. Signal processor 152362 is configured to process the signal from sensor 152358 at a frequency substantially equal to the frequency of the signal generated by electromagnetic wave source 152360 . For example, in one embodiment, electromagnetic wave source 152360 produces a signal at a frequency of 1 MHz. The signal is detected by sensor 152358 . Sensor 152358 produces a signal indicative of the detected magnetic field, which signal is provided to signal processor 152362 . The signal is processed by a signal processor 152362 at a frequency of 1 MHz to eliminate spurious signals. The processed signal is provided to a processor, eg a primary processor. The primary processor correlates the received signal to one or more parameters of the end effector 152350, such as the gap 152364 between the anvil 152352 and the staple cartridge 152356, for example.

72 is a logic diagram illustrating one embodiment of a process 152370 for generating thickness measurements of tissue sections located between an anvil of an end effector, such as the end effector 152350 shown in FIG. 71, and a staple cartridge. be. In one embodiment of process 152370, the signal is generated 152372 by modulated electromagnetic wave source 152360. The generated signal may include, for example, a 1 MHz signal. Magnetic sensor 152358 is configured to detect 152374 signals generated by electromagnetic wave source 152360 . Magnetic sensor 152358 generates a signal indicative of the detected magnetic field and provides the signal to signal processor 152362 . Signal processor 152362 processes 152376 the signal to remove noise, remove spurious signals, and/or boost the signal. The processed signal is provided to an analog-to-digital converter for conversion (152378) to a digital signal. Digital signals may be calibrated (152380), for example, by applying a calibration curve entry algorithm and/or a lookup table. Signal processing 152376, conversion 152378, and calibration 152380 may be performed by one or more circuits. The calibrated signal is displayed to the user (152026), for example, by a display integrally formed with the surgical instrument 150010.

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

Sensor 152408 may be operable to detect characteristics of staple cartridge 152406 and thereby identify the type of staple cartridge 152406 . FIG. 74 shows an embodiment in which the sensor 152408 is a light emitter and detector 152410. FIG. The body of staple cartridge 152406 may be of different colors such that the color identifies the type of staple cartridge 152406 . The light emitter and detector 152410 may be operable to obtain color data of the staple cartridge 152406 body. In the illustrated embodiment, light emitter/detector 152410 can detect white light 152412 by receiving reflected light in the red, green, and blue spectra of equal intensity. Light emitter and detector 152410 can detect red 152414 by receiving very little reflected light in the green and blue spectrums and the higher intensity light in the red spectrum.

Alternatively or additionally, the light emitter and detector 152410, or another suitable sensor 152408, can obtain and identify data from some other symbol or mark on the staple cartridge 152406. The symbols or indicia can be any one of barcodes, shapes or letters, color-coded patterns, or any other suitable indicia. Information read by sensor 152408 may be communicated to a microcontroller of surgical device 150010, such as a microcontroller (eg, microcontroller 461 (FIG. 12), for example). The microcontroller may be configured to communicate information regarding the staple cartridge 152406 to the instrument operator. For example, an identified staple cartridge 152406 may not be suitable for a given application, in which case the instrument operator may be notified and/or the instrument functioning improperly. In such instances, the microcontroller may be configured to disable features of the surgical instrument if desired. Alternatively or additionally, the microcontroller may, for example, store parameters of the type of staple cartridge 152406 identified, such as the length of the staple cartridge 152406, or information about the staples, such as height and length, into the surgical instrument 150010. can be configured to notify the operator of the

FIG. 75 illustrates one aspect of a segmented flexible circuit 153430 configured to be fixedly attached to jaw members 153434 of an end effector. Segmented flexible circuit 153430 comprises distal segment 153432a and side segments 153432b, 153432c containing individually addressable sensors to provide localized tissue presence detection. Segments 153432a, 153432b, 153432c are individually addressable for detecting tissue and for measuring tissue parameters based on individual sensors located within each of segments 153432a, 153432b, 153432c. Segments 153432a, 153432b, 153432c of segmented flexible circuit 153430 are attached to jaw members 153434 and are electrically coupled via conductive elements 153436 to an energy source, such as an electrical circuit. A Hall effect sensor 153438 or any suitable magnetic sensor is located at the distal end of jaw member 153434 . A Hall effect sensor 153438 works in conjunction with a magnet to provide a measurement of the opening defined by jaw members 153434, which may also be referred to as the tissue gap as shown in detail in FIG. A 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 illustrates one aspect of a segmented flexible circuit 153440 configured to be attached to jaw members 153444 of an 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 are individually addressable for treating tissue and for reading individual sensors located within each of segments 153442a, 153442b, 153442. Segments 153442a, 153442b, 153442c of segmented flexible circuit 153440 are attached to jaw members 153444 and electrically coupled to an energy source via conductive elements 153446. FIG. A Hall effect sensor 153448 , or other suitable magnetic sensor, is provided at the distal end of jaw member 153444 . A Hall effect sensor 153448 works in conjunction with a magnet to provide a measurement of the opening or tissue gap defined by the jaw members 153444 of the end effector as shown in detail in FIG. In addition, a plurality of lateral asymmetric temperature sensors 153450a, 153450b are mounted on or formally integral with the segmented flexible circuit 153440 to provide tissue temperature feedback to the control circuit. Segmented flexible circuit 153440 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector.

FIG. 77 illustrates one variation of an end effector 153460 configured to measure tissue gap _GT . End effector 153460 includes jaw member 153462 and jaw member 153444 . A flexible circuit 153440 shown in FIG. 76 is attached to jaw member 153444 . Flexible circuit 153440 includes Hall effect sensor 153448 that operates in conjunction with magnet 153464 attached to jaw member 153462 to measure tissue gap G _T . This technique may be used to measure the opening defined between jaw members 153444 and 153462 . Jaw member 153462 may be a staple cartridge.

FIG. 78 shows one aspect of an end effector 153470 comprising a segmented flexible circuit 153468. FIG. End effector 153470 includes jaw member 153472 and staple cartridge 153474 . Segmented flexible circuit 153468 is attached to jaw member 153472 . Each of the sensors disposed within segments 1-5 are configured to detect the presence of tissue positioned between jaw member 153472 and staple cartridge 153474 and represent tissue zones 1-5. . 78, end effector 153470 is shown in an open position ready to receive or grasp tissue between jaw member 153472 and staple cartridge 153474. In the configuration shown in FIG. Segmented flexible circuit 153468 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within end effector 153470 .

FIG. 79 shows the end effector 153470 shown in FIG. 78 with jaw members 153472 clamping tissue 153476 between jaw members 153472, eg, an anvil, and a 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 in segments 1-3 and the absence of tissue (empty) is detected by segments 4-5 in portion 153469. FIG. Information regarding the presence and absence of tissue 153476 located within particular segments 1-3 and 4-5, respectively, is communicated to the control circuitry described herein, eg, via interface circuitry. The control circuit is configured to detect tissue located within segments 1-3. Segments 1-5 may include any suitable temperature, force/pressure, and/or Hall effect magnetic sensors for measuring tissue parameters of tissue located within a particular segment 1-5 and a particular segment 1 It will be appreciated that electrodes for delivering energy to tissue located within .about.5 may be housed. Segmented flexible circuit 153468 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within end effector 153470 .

FIG. 80 is a diagram of an absolute positioning system 153100 that can be used with surgical instruments or systems according to the present disclosure. Absolute positioning system 153100 comprises controlled motor drive circuitry comprising sensor mechanism 153102 in accordance with at least one aspect of the present disclosure. Sensor mechanism 153102 for absolute positioning system 153100 provides a unique position signal corresponding to the position of displacement member 153111 . In one aspect, displacement member 153111 represents a longitudinally movable drive member coupled to a cutting instrument or knife (eg, cutting instrument, I-beam, and/or I-beam 153514 (FIG. 82)). In other aspects, displacement member 153111 represents a firing member coupled to a cutting instrument or knife that may be adapted and configured to include a rack of drive teeth. In yet another aspect, 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, e.g., drive member, firing member, firing bar, cutting member, of the surgical instruments or systems described herein. Used to refer to instruments, knives, and/or I-beams, or any element that can be displaced. Thus, 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 longitudinally movable drive member. In various other aspects, displacement member 153111 may be coupled to any sensor suitable for measuring displacement. Accordingly, the longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable displacement sensor. Displacement sensors may include contact or non-contact displacement sensors. The displacement sensors are linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), sliding potentiometers, movable magnets and a series of linear arrays. A magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, a movable light source and a series of linearly arranged lights It may comprise an optical detection system with diodes or photodetectors, or an optical detection system with a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof. .

The electric motor 153120 may include a rotatable shaft shaft 153116 that operatively interfaces with a gear assembly 153114 mounted in meshing engagement with a set of drive teeth or racks on the displacement member 153111 . Sensor element 153126 may be operatively coupled to gear assembly 153114 such that one rotation of sensor element 153126 corresponds to some linear longitudinal translation of displacement member 153111 . The gearing and sensor 153118 arrangement may be connected to the linear actuator by a rack and pinion arrangement or to the rotary actuator by spur gears or other connections. A power supply 153129 can power the absolute positioning system 153100 and an 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 _d1 of the displacement member 153111, and _d1 corresponds to the displacement member 153111 after one rotation of the sensor element 153126 coupled to the displacement member 153111. is the longitudinal distance traveled from point "a" to point "b". The sensor mechanism 153102 may be connected via a gear reducer that results in the position sensor 153112 completing one or more revolutions for a full stroke of the displacement member 153111 . Position sensor 153112 can complete multiple rotations for a full stroke of displacement member 153111 .

To provide a unique position signal for more than one revolution of position sensor 153112, a series of switches 153122a-153122n, where n is an integer greater than 1, may be used alone or in gear reduction. may be used with the machine. The states of switches 153122a-153122n are fed back to controller 153110, which applies logic to determine the longitudinal displacement of displacement member 153111 d ₁ +d ₂ + . . . Determine the unique position signal corresponding to _dn . Output 153124 of position sensor 153112 is provided to controller 153110 . The position sensor 153112 of the sensor mechanism 153102 may comprise a magnetic sensor, an analog rotary sensor such as a potentiometer, an array of analog Hall effect elements that output a unique combination of position signals or values. Controller 153110 may be housed within a master controller or within a tool mounting portion housing of a surgical instrument or system according to the present disclosure.

The absolute positioning system 153100 can be reset (zero or Provides an absolute position of the displacement member 153111 at power up of the surgical instrument or system without retraction or advancement of the displacement member 153111 to the Home position.

The controller 153110 may be programmed to perform various functions such as precision control over the speed and position of the knife and articulation system. In one aspect, controller 153110 includes processor 153108 and memory 153106 . The electric motor 153120 may be a brushed DC motor with a mechanical connection to the gearbox and articulation or knife system. In one aspect, motor driver 153110 is manufactured by Allegro Microsystems, Inc.; A3941 available from Other motor drivers may be readily substituted for use with the absolute positioning system 153100 .

Controller 153110 may be programmed to provide precise control over the velocity and position of displacement member 153111 and the articulation system. The controller 153110 may be configured to calculate the response within the controller's 153110 software. The calculated response is compared with the measured response of the actual system to obtain the "observed" response, which is used to determine the actual feedback. The observed response is a well-tuned value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

Absolute positioning system 153100 may comprise and/or 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 voltage. Other examples include pulse width modulation (PWM) of voltage, current and force. In addition to the position measured by position sensor 153112, other sensor(s) 153118 may be provided to measure physical parameters of the physical system. In a digital signal processing system, absolute positioning system 153100 is coupled to a digital data acquisition system, where the output of absolute positioning system 153100 has finite resolution and sampling frequency. The Absolute Positioning System 153100 compares and combines the calculated responses with the measured responses using algorithms such as weighted averages and theoretical control loops to drive the calculated responses towards the measured responses. circuit. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, and induced drag in order to predict what the state and output of the physical system will be given the inputs.

Motor driver 153110 is manufactured by Allegro Microsystems, Inc. A3941 available from The A3941 Driver 153110 is a full-bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Driver 153110 includes an inherent charge pump regulator that provides full (>10V) gate drive for battery voltages up to 7V and allows the A3941 to operate with reduced gate drive down to 5.5V. . Bootstrap capacitors may be used to provide the necessary battery supply voltages for the N-channel MOSFETs. An internal charge pump for the high side drive allows 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 through either the high-side FETs or the low-side FETs. The power FETs are protected from shoot-through by a resistor adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect power MOSFETs under most short circuit conditions. Other motor drivers may be readily substituted for use with the absolute positioning system 153100 .

FIG. 81 is a position sensor 153200 view for an absolute positioning system 153100' comprising a magnetic rotary absolute positioning system, in accordance with at least one aspect of the present disclosure. Absolute positioning system 153100' is similar in many respects to absolute positioning system 153100. Position sensor 153200 may be implemented as an AS5055EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. Position sensor 153200 interfaces with controller 153110 to provide absolute positioning system 153100'. Position sensor 153200 is a low voltage and low power component, e.g., a position sensor located above a magnet positioned on a rotating element associated with a displacement member such as a knife drive gear and/or a closing drive gear. Including four Hall effect elements 153228A, 153228B, 153228C, 153228D within region 153230 of 153200 so that displacement of the firing member and/or closure member can be precisely tracked. A high resolution ADC 153232 and a smart power management controller 153238 are also provided on the chip. In order to implement simple and efficient algorithms for computing hyperbolic and trigonometric functions, requiring only addition, subtraction, bit-shifting, and table lookup operations, the digit-by-digit method and Volder's algorithm are also used. A known CORDIC (short for Coordinate Rotation Digital Computer) processor 153236 is provided. Angular position, alarm bits, and magnetic field information are transmitted to controller 153110 via a standard serial communication interface such as SPI interface 153234 . The position sensor 153200 provides 12-bit or 14-bit resolution. The position sensor 153200 may be an AS5055 chip provided in a small QFN16 pin 4x4x0.85mm package.

Hall effect elements 153228A, 153228B, 153228C, 153228D are positioned directly above the rotating magnet. The Hall effect is a well-known effect and will not be described in detail here for the sake of convenience, but in general, the Hall effect is characterized by a magnetic field in an electrical conductor, perpendicular to the current in the electrical conductor and to the magnetic field perpendicular to that current. This voltage difference (Hall voltage) is generated. The Hall coefficient is defined as the ratio of the induced electric field and the current density times the applied magnetic field. Since its value depends on the type, number and properties of the charge carriers that make up the current, the Hall coefficient characterizes the materials that make up the conductor. In the AS5055 position sensor 153200, Hall effect elements 153228A, 153228B, 153228C, 153228D can produce voltage signals indicative of the absolute position of the magnet in degrees over one revolution of the magnet. This angle value is a unique position signal, calculated by the CORDIC Processor 153236 and stored onboard the AS5055 Position Sensor 153200 in a register or memory. Angular values indicative of the position of the magnet over one revolution are provided to controller 153110 in various techniques, such as at power up or when requested by controller 153110 .

The AS5055 Position Sensor 153200 requires only a few external components to operate when connected to the Controller 153110. 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 notify it that a new valid angle can be read. On power-up, the AS5055 Position Sensor 153200 performs a complete power-up 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. Controller 153110 can respond to INT requests on INT output 153242 by reading the angle value from AS5055 position sensor 153200 via SPI interface 153234 . When the angle value is read by controller 153110, INT output 153242 is cleared again. Also, sending a "read angle" command to position sensor 153200 via SPI interface 153234 by controller 153110 automatically powers up the chip and initiates another angle measurement. As soon as Controller 153110 has finished reading the angle value, INT Output 153242 is cleared and the new result is stored in the Angle Register. Completion of the angle measurement is again indicated by setting the INT output 153242 and the corresponding flag 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 (approximately 600 μs) after each power up sequence. As soon as one angle measurement is completed, the AS5055 Position Sensor 153200 pauses and transitions to the power off state. On-chip filtering of angle values by digital averaging is not implemented because it requires multiple angle measurements, resulting in longer power-up times, which is undesirable for low power applications. Angular jitter may be reduced by averaging several angular samples in controller 153110 . For example, averaging 4 samples reduces the jitter by 6 dB (50%).

82 is a cross-sectional view of an end effector 153502 showing the firing stroke of an I-beam 153514 against tissue 153526 grasped within the end effector 153502, in accordance with at least one aspect of the present disclosure. End effector 153502 is configured to work with any surgical instrument or system according to the present disclosure. End effector 153502 comprises anvil 153516 and elongated channel 153503 with staple cartridge 153518 positioned within elongated channel 153503 . Firing bar 153520 is translatable distally and proximally along longitudinal axis 153515 of end effector 153502 . When the end effector 153502 is not articulated, the end effector 153502 is aligned with the shaft of the instrument. I-beam 153514 including cutting edge 153509 is shown at the distal portion of firing bar 153520 . Wedge sled 153513 is positioned within staple cartridge 153518 . As I-beam 153514 translates distally, cutting blade 153509 can contact and cut tissue 153526 positioned between anvil 153516 and staple cartridge 153518 . I-beam 153514 also contacts wedge sled 153513 and pushes it distally, bringing wedge sled 153513 into contact with staple driver 153511 . The staple driver 153511 is pushed up into the staple 153505 so that the staple 153505 can be advanced through the tissue and into the pocket 153507 defined in the anvil 153516 forming the staple 153505 .

An exemplary I-beam 153514 firing stroke is illustrated by chart 153529 aligned with end effector 153502 . Exemplary tissue 153526 is also shown juxtaposed with end effector 153502 . A firing member stroke may include a stroke start position 153527 and a stroke end position 153528 . During the firing stroke of I-beam 153514 , I-beam 153514 may be advanced distally from stroke start position 153527 to stroke end position 153528 . I-beam 153514 is shown at one exemplary location at stroke start position 153527 . Firing member stroke chart 153529 for I-beam 153514 illustrates five firing member stroke regions 153517, 153519, 153521, 153523, 153525. At first firing stroke region 153517, I-beam 153514 may begin to advance distally. In the first firing stroke region 153517, I-beam 153514 may contact wedge sled 153513 and begin to move it distally. However, while in the first region, cutting edge 153509 may not contact tissue and wedge thread 153513 may not contact staple driver 153511 . After static friction is overcome, the force driving I-beam 153514 within first region 153517 may be substantially constant.

At the second firing member stroke region 153519 , the cutting edge 153509 may contact and begin cutting tissue 153526 . Also, wedge sled 153513 may begin to contact staple driver 153511 to drive staple 153505 . The force driving I-beam 153514 may begin to rise. As shown, the initially encountered tissue may be compressed and/or thinner due to the manner in which anvil 153516 pivots relative to staple cartridge 153518 . In the third firing member stroke region 153521 , cutting edge 153509 can continuously contact and cut tissue 153526 and wedge sled 153513 can repeatedly contact staple driver 153511 . The force driving I-beam 153514 may plateau in third region 153521 . By the fourth firing stroke region 153523, the force driving I-beam 153514 may begin to drop. For example, tissue within the portion of the end effector 153502 corresponding to the fourth firing region 153523 may be less compressed than tissue closer to the pivot point of the anvil 153516, requiring less force to cut. Also, cutting edge 153509 and wedge thread 153513 may reach the edge of tissue 153526 while in fourth region 153523 . When the I-beam 153514 reaches the fifth region 153525, the tissue 153526 can be completely cut away. Wedge sled 153513 may contact one or more staple drivers 153511 at or near the edge of the tissue. The force driving I-beam 153514 through fifth region 153525 may be reduced and, in some embodiments, may be similar to the force driving I-beam 153514 within first region 153517 . At the end of the firing member's stroke, the I-beam 153514 may reach the end-of-stroke position 153528 . The locations of firing member stroke regions 153517, 153519, 153521, 153523, 153525 in FIG. 82 are merely exemplary. In some examples, different regions may start at different locations along the longitudinal axis 153515 of the end effector based on, for example, the position of the tissue between the anvil 153516 and the staple cartridge 153518.

As described above, and referring now to FIGS. 80-82, an electric motor positioned within the master controller of the surgical instrument for stapling and/or dissecting tissue captured within the end effector 153502. Utilizing 153120, the shaft assembly's firing system, including the I-beam 153514, can be advanced and/or retracted relative to the shaft assembly's end effector 153502. I-beam 153514 may be advanced or retracted at a desired speed or within a desired speed range. Controller 153110 may be configured to control the velocity of I-beam 153514 . The controller 153110 controls the I-beam 153514 based on various parameters of the power supplied to the electric motor 153120, such as, for example, voltage and/or current, and/or other operating parameters of the electric motor 153120 or external influences. can be configured to predict the velocity of Controller 153110 determines the current state of I-beam 153514 based on previous values of current and/or voltage supplied to electric motor 153120 and/or previous states of the system such as velocity, acceleration, and/or position. can be configured to predict the velocity of Controller 153110 may be configured to sense the velocity of I-beam 153514 utilizing the absolute positioning sensor system described herein. The controller compares the predicted velocity of I-beam 153514 with the sensed velocity of I-beam 153514 to determine whether power to electric motor 153120 should be increased to increase the velocity of I-beam 153514 and/or Or it may be configured to determine whether the velocity of the I-beam 153514 should be reduced to slow it down.

The force acting on I-beam 153514 can be determined using various techniques. The force of I-beam 153514 can be determined by measuring the current of motor 153120, which is based on the load experienced by I-beam 153514 as it advances distally. The force of the I-beam 153514 may be determined by placing strain gauges on the drive member, firing member, I-beam 153514, firing bar, and/or on the proximal end of the cutting blade 153509. The force of I-beam 153514 monitors the actual position of I-beam 153514, which moves at a predicted speed based on the current set speed of motor 153120 after a predetermined elapsed time period _T1 , and monitors the actual position of I-beam 153514 over time period T1. It may be determined by comparing to the predicted position of I-beam 153514 based on the current set speed of motor 153120 at the end of ₁ . Therefore, if the actual position of I-beam 153514 is less than the expected position of I-beam 153514, the force on I-beam 153514 will be greater than the nominal force. Conversely, if the actual position of I-beam 153514 is greater than the expected position of I-beam 153514, the force on I-beam 153514 will be less than the nominal force. The difference between the actual position of I-beam 153514 and the predicted position is proportional to the deviation of the force exerted on I-beam 153514 from the nominal force.

Before beginning a description of closed-loop control techniques for the closure tube and firing member, a brief discussion of FIG. 83 is provided. FIG. 83 shows two closure force (FTC) plots 153606, 153608 graphs 153600 showing the force applied to the closure member to close against thick and thin tissue during the closure phase, and a graph 153600 of thick tissue during the firing phase. and a graph 153601 of two firing force (FTF) plots 153622, 153624 showing the force applied to the firing member to fire through thin tissue. Referring to FIG. 83, graph 153600 illustrates forces applied to thick and thin tissue during the closing stroke to close end effector 153502 against tissue grasped between anvil 153516 and staple cartridge 153518. shows an example of , and the closing force is plotted as a function of time. Closure force plots 153606, 153608 are plotted on two axes. The vertical axis 153602 represents the closing force (FTC) of the end effector 153502 in Newtons (N). The horizontal axis 153604 shows time in seconds and is labeled t ₀ -t ₁₃ for clarity of illustration. A first closure force plot 153606 is an example of the force applied to thick tissue during the closure stroke to close the end effector 153502 against tissue grasped between the anvil 153516 and staple cartridge 153518; A second plot 153608 is an example of the force applied to thin tissue during the closing stroke to close the end effector 153502 against the tissue grasped between the anvil 153516 and staple cartridge 153518. The first closing force plot 153606 and the second closing force plot 153608 are divided into three phases: closing stroke (closed), waiting period (waiting), and firing stroke (firing). During the closure stroke, the closure tube is translated distally (direction “DD”) to move the anvil 153516, eg, relative to the staple cartridge 153518, in response to actuation of the closure stroke by the closure motor. In other examples, the closure stroke involves moving the staple cartridge 153518 relative to the anvil 153516 in response to actuation of the closure motor, and in other examples the closure stroke is responsive to actuation of the closure motor. , with moving staple cartridge 153518 and anvil 153516 . Referring to the first closing force plot 153606, the closing force 153610 during the closing stroke increases from 0 to a maximum force F ₁ from time t ₀ to t ₁ . Referring to the second closing force graph 153608, the closing force 153616 during the closing stroke increases from 0 to a maximum force F ₃ from time t ₀ -t ₁ . The relative difference between the maximum forces F ₁ and F ₃ is due to the difference in closing force required for thick versus thin tissue, with more force required to close the anvil over thick tissue versus thin tissue. A large force is required.

A first closure force plot 153606 and a second closure force plot 153608 show that the closure force within the end effector 153502 increases during the initial clamping period ending at time (t ₁ ). The closing force reaches a maximum force (F ₁ , F ₃ ) at time (t ₁ ). The initial gripping period can be, for example, about 1 second. A waiting period may be applied before beginning the firing stroke. The waiting period allows fluid to drain from the tissue compressed by the end effector 153502, which reduces the thickness of the compressed tissue and results in a smaller gap between the anvil 153516 and staple cartridge 153518. , lowering the closing force at the end of the waiting period. Referring to the first closure force plot 153606, there is a slight drop in closure force 153612 from _F1 to _F2 during the waiting period of _t1 - _t4 . Similarly, referring to the second closing force plot 153608, the closing force 153618 drops slightly from _F3 to _F4 during the waiting period _t1 - _t4 . A waiting period (t ₁ -t ₄ ) selected from a range of about 10 seconds to about 20 seconds is typically used in some embodiments. In the example of first closure force plot 153606 and second closure force plot 153608, a time period of approximately 15 seconds is used. After the waiting period is the firing stroke, which typically lasts for a period selected from, for example, about 3 seconds to, for example, about 5 seconds. The closing force decreases as the I-beam 153514 is advanced against the end effector through the firing stroke. As shown by the closure forces 153614, 153620 of the first and second closure force plots 153606, 153608, respectively, the closure forces 153614, 153620 exerted on the closure tube sharply increase from about time _t4 to about time _t5 . to Time _t4 represents the moment when I-beam 153514 couples into anvil 153516 and begins to experience a closing load. Therefore, the closure 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 also graphically depicts a first firing force plot 153622 and a second firing force plot 153624 plotting the force applied to advance the I-beam 153514 during the firing stroke of a surgical instrument or system according to the present disclosure. 153601. The firing force plots 153622, 153624 are plotted on two axes. The vertical axis 153626 indicates the firing force in Newtons (N) applied to advance the I-beam 153514 during the firing stroke. I-beam 153514 is configured to advance the knife or cutting element and cause the driver to deploy staples during the firing stroke. Horizontal axis 153605 shows time in seconds on the same time scale as horizontal axis 153604 of graph 153600 above.

As noted above, the closing tube force drops precipitously from time _t4 to approximately time _t5 , as I-beam 153514 joins into anvil 153516 and begins to load, and the first firing Represents the instants at which closing force decreases as firing force increases as shown by force plot 153622 and a second firing force plot 153624 . I-beam 153514 is advanced from the stroke start position at time t ₄ to the stroke end position at t ₈ -t ₉ of force plot 153624 for thin tissue and t ₁₃ of force plot 153622 for thick tissue. As the I-beam 153514 is advanced distally during the firing stroke, the closure assembly relinquishes control of the staple cartridge 153518 and anvil 153516 to the firing assembly. This increases firing force and decreases closing force.

In the thick tissue firing force plot 153622, the plot 153622 during the firing period (firing) is divided into three separate segments. _The first segment 153628 shows the firing force as it increases from 0 at _t4 to a peak force F1' just before _t5 . A first segment 153628 is the firing force during the initial phase of the firing stroke when the I-beam 153514 advances distally from the top of the closing ramp until the I-beam 153514 contacts tissue. A second segment 153630 shows the firing force during the second phase of the firing stroke when the I-beam 153514 advances distally to deploy staples and cut tissue. During the second phase of the firing stroke, the firing force decreases from F ₁ ' to F ₂ ' at approximately t ₁₂ . The third segment 153632 shows the firing force during the third and final phase of the firing stroke as the I-beam 153514 leaves tissue and advances to the end of the stroke in a tissue free zone. During the third phase of the firing stroke, the firing force drops from F ₂ ′ to zero (0) at approximately t ₁₃ when I-beam 153514 reaches the end of stroke. In summary, during the firing stroke, the firing force rises dramatically as the I-beam 153514 enters the tissue zone, gradually decreases within the tissue zone during stapling and cutting operations, and the I-beam 153514 passes through the tissue zone. It drops dramatically when exiting and entering the end-of-stroke tissue-free zone.

The thin tissue force plot 153624 follows a similar pattern as the thick tissue force plot 153622 . Thus, during the first phase of the firing stroke, firing force 153634 increases dramatically from 0 to F ₃ ′ at approximately t ₅ . During the second phase of the firing stroke, firing force 153636 tapers off from F ₃ ' to F ₄ ' at approximately t ₈ . During the final phase of the firing stroke, firing force 153638 drops dramatically from F ₄ ′ to 0 from t ₈ -t ₉ .

The I-beam 153514 couples into the anvil 153516 and begins to load, 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. To overcome the steep drop in closure force from time _t4 to approximately time _t5 , which represents the instant, the closure tube is distally advanced while a firing member, such as I-beam 153514, is advanced distally. may be advanced to the next position. A closure tube is represented as a transmission element that applies a closure force to anvil 153516 . As described herein, the control circuit applies the motor set point to the motor control, which applies the motor control signal to the motor to drive the transmission element and move the obturator distally. to apply a closing force on the anvil 153516. A torque sensor coupled to the output shaft of the motor can be used to measure the force applied to the closure tube. Alternatively, the closing force may be measured with strain gauges, load cells, or other suitable force sensors.

FIG. 84 illustrates a closing member (e.g., closure arm 153516) as the firing member (e.g., I-beam 153514) is distally advanced and coupled within the clamping arm (e.g., anvil 153516), according to at least one aspect of the present disclosure. 153950 is a view of control system 153950 configured to provide gradual closure of the tube) to decrease the closure force load on the closure member at a desired rate and reduce the firing force load on the firing member. In one aspect, control system 153950 may be implemented as a nested PID feedback controller. A PID controller is a control-loop feedback mechanism (controller) for continuously calculating an error value as the difference between a desired setpoint and a measured process variable, with proportional, integral, and derivative terms (P , I, and D). Nested PID controller feedback control system 153950 includes primary controller 153952 in primary (outer) feedback loop 153954 and secondary controller 153955 in secondary (inner) feedback loop 153956 . Primary controller 153952 may be PID controller 153972 as shown in FIG. 84 and secondary controller 153955 may also be PID controller 153972 as shown in FIG. Primary controller 153952 controls primary process 153958 and secondary controller 153955 controls secondary process 153960 . The output 153966 (output) of the primary process 153958 is subtracted from the primary set point SP ₁ by a first analog adder 153962 . First analog adder 153962 produces a single sum output signal that is applied to primary controller 153952 . The output of primary controller 153952 is secondary set point _SP2 . The output 153968 of the secondary process 153960 is subtracted from the secondary set point _SP2 by a second analog adder 153964 .

In the situation of controlling the displacement of the closure tube, the control system 153950 determines that the primary setpoint SP ₁ is the desired closing force value and the primary controller 153952 receives the closing force from a torque sensor coupled to the output of the closing motor. to determine the motor speed of the closing motor set point _SP2 . Alternatively, the closing force may be measured with strain gauges, load cells, or other suitable force sensors. Closure Motor Speed Setpoint SP ₂ is compared to the actual speed of the closure tube as determined by secondary controller 153955 . The actual velocity of the closed tube can be measured by comparing the displacement of the closed tube using a position sensor and measuring the elapsed time using a timer/counter. Other techniques such as linear or rotary encoders can be used to measure the displacement of the closed tube. The output 153968 of secondary process 153960 is the actual velocity of the closed tube. This closure tube velocity output 153968 is provided to a primary process 153958 that determines the force acting on the closure tube and is fed back to a summer 153962 that subtracts the measured closure force from the primary set point _SP1 . The primary set point SP ₁ may be an upper threshold or a lower threshold. Based on the output of summer 153962, primary controller 153952 controls the speed and direction of the closed tube motor as described herein. The secondary controller 153955, based on the actual velocity of the closed tube as measured by the secondary process 153960 and a secondary set point _SP2 based on a comparison of the actual firing power to upper and lower firing power thresholds, Controls the speed of the closing motor.

FIG. 85 illustrates a PID feedback control system 153970, according to at least one aspect of the present disclosure. Primary controller 153952 or secondary controller 153955 or both may be implemented as PID controller 153972 . In one aspect, the PID controller 153972 may include a proportional element 153974 (P), an integral element 153976 (I), and a derivative element 153978 (D). The outputs of P-element 153974, I-element 153976 and D-element 153978 are summed by analog adder 153986 which provides control variable u(t) to process 153980. The output of process 153980 is the process variable y(t). Analog Summer 153984 calculates the difference between the desired setpoint r(t) and the measured process variable y(t). The PID controller 153972 provides an error value e( t) (e.g., the difference between the closure force threshold and the measured closure force), calculated by the proportional component 153974 (P), the integral component 153976 (I), and the derivative component 153978 (D), respectively. Apply corrections based on proportional, integral, and derivative terms. PID controller 153972 attempts to minimize error e(t) over time by adjusting control variables u(t) (eg, 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, if the error is large and positive, the control output will also be large and positive. According to the present disclosure, the error term e(t) is different between the desired closure force and the measured closure force of the closure tube. The 'I' element 153976 describes the past value of the error. For example, if the current output is not strong enough, the error integral accumulates over time and the controller responds by applying stronger action. The 'D' element 153978 describes the possible future trend of error based on its current rate of change. For example, returning to the P example above, if a large positive control output succeeds in driving the error closer 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 the motion to prevent this overshoot.

It will be appreciated that other variables and setpoints may be monitored and controlled according to feedback control systems 153950, 153970. For example, the adaptive closure member velocity control algorithm described herein provides, among other things, the parameters of firing member stroke position, firing 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 logic flow diagram illustrating a control program or logic configuration process 153990 for determining closure member velocity, in accordance with at least one aspect of the present disclosure. A control circuit of a surgical instrument or system according to the present disclosure is configured to determine (153992) the actual closure force of the closure member. The control circuit compares the actual closing force to the threshold closing force (153994) and determines a setpoint velocity for displacing the closing member based on this comparison (153996). The control circuit controls the actual speed of the closure member based on the setpoint speed (153998).

84 and 85, in one aspect, the control circuit comprises a proportional, integral and derivative (PID) feedback control system 153950, 153970. The PID feedback control system 153950, 153970 comprises a primary PID feedback loop 153954 and a secondary PID feedback loop 153956. A primary feedback loop 153954 determines a first error between the actual closure force of the closure member and the threshold closure force SP ₁ and sets the closure member speed set point SP ₂ based on the first error. A secondary feedback loop 153956 determines a second error between the actual velocity of the closure member and the setpoint velocity of the closure member and sets the closure member velocity based on the second error.

In one aspect, the threshold closure force _SP1 includes an upper threshold and a lower threshold. A setpoint speed SP ₂ is configured to advance the closure member distally when the actual closure force is less than the lower threshold, and the setpoint speed is configured to advance the closure member distally when the actual closure force is greater than the lower threshold. Sometimes configured to retract the closure member proximally. In one aspect, the setpoint speed is configured to hold the closure member in place when the actual closure force is between the upper and lower threshold values.

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

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

The functions or processes 153990 described herein may be performed by any of the processing circuits described herein. Aspects of the powered surgical instrument may be practiced without the specific details disclosed herein. Some aspects are shown in block diagram form, rather than in detail.

Portions of the disclosure may be represented as instructions that operate on data stored in computer memory. An algorithm refers to a self-consistent sequence of steps leading to a desired result, where "steps" take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared and otherwise manipulated. A physical quantity that can be manipulated. These signals may also be referred to as bits, values, elements, symbols, characters, terms or numbers. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities.

In general, various aspects described herein may be implemented by various types of "electrical circuit". Consequently, an "electrical circuit" is defined as an electrical circuit comprising at least one individual electrical circuit, an electrical circuit comprising at least one integrated circuit, an electrical circuit comprising at least one application-specific integrated circuit, a computer program forming electrical circuits, memory devices forming general-purpose computing devices (e.g., general-purpose computers or processors configured with a computer program that executes, at least in part, the processes and/or devices described herein); for example, in the form of random access memory) and/or electrical circuits forming a communication device (eg, a modem, a communication switch, or an optoelectronic device). These aspects can be implemented in analog or digital form, or a combination thereof.

The foregoing description sets forth aspects of apparatus and/or processes through the use of block diagrams, flowcharts, and/or examples, which may include one or more features and/or acts. Each function and/or act in such block diagrams, flowcharts, or examples may be individually and/or collectively implemented by a wide variety of hardware, software, firmware, or substantially any combination thereof. be able to. In one aspect, some portions of the subject matter described herein include 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, programs, subroutines, logic and/or combinations of hardware and software components), logic gates, or other integrated format. Some aspects of the forms disclosed herein, whether in whole or in part, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., one or as one or more programs running on two or more microprocessors), as firmware, or substantially any combination thereof, equivalently implemented in an integrated circuit, and 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 view of the present disclosure.

The mechanisms of the disclosed subject matter are capable of being distributed as program products in a variety of forms, and exemplary aspects of the subject matter described herein are specific to the particular software used to accomplish the distribution. is used regardless of the type of signal-bearing medium. Examples of signal-bearing media include: recordable-type media such as floppy disks, hard disk drives, compact discs (CDs), digital video discs (DVDs), digital tapes, computer memory, etc., and transmission-type media such as , 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 foregoing description of these aspects has been presented for purposes of description and illustration. It is not intended to be exhaustive or to be limited to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. These aspects were chosen and described in order to illustrate principles and practical applications, thereby enabling a person skilled in the art to utilize the various aspects, together with various modifications, as suitable for the particular applications envisioned. It is what is done. It is intended that the claims presented herewith 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 may include the type of procedure being performed, the type of tissue being manipulated, or the body cavity being treated. Using contextual information related to a surgical procedure, a surgical system can, for example, improve how it controls modular devices (e.g., robotic arms and/or robotic surgical tools) connected to the system; And it can provide contextualized information or suggestions to the surgeon during the course of the surgical procedure.

Referring now to FIG. 87, a timeline 5200 illustrating situational awareness of a hub, such as surgical hub 106 or 206, for example, is shown. Timeline 5200 is an exemplary surgical procedure and contextual information that surgical hubs 106, 206 can derive from data received from data sources at each step of the surgical procedure. Timeline 5200 is taken by nurses, surgeons, and other medical personnel during the course of a segmentectomy surgery, beginning with setting up the operating room and ending with transferring the patient to the post-operative recovery room. A typical process that might be followed is shown.

The situational awareness surgical hub 106, 206 sources data throughout the course of a surgical procedure, including data generated each time a modular device paired with the surgical hub 106, 206 is used. receive from The surgical hubs 106, 206 receive this data from paired modular devices and other data sources to receive new data such as what steps of the procedure are being performed at any given time. Once done, inferences (ie, contextual information) about the ongoing procedure can be continuously derived. The situational awareness system of the surgical hub 106, 206 may, for example, record data regarding procedures to generate reports, verify steps being taken by medical personnel, collect data that may be relevant to specific procedure steps, or Provide prompts (e.g., via a display screen), adjust modular devices based on context (e.g., activate a monitor, adjust the field of view (FOV) of a medical imaging device, or perform ultrasound surgical changing the energy level of the instrument or RF electrosurgical instrument), and any other such actions described above.

As a first step 5202 in this exemplary procedure, hospital personnel retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.

In a second step 5204, personnel scan incoming medical supplies for treatment. The surgical hub 106, 206 cross-references the scanned supplies with lists of supplies utilized in various types of procedures to confirm that the mix of supplies corresponds to the thoracic procedure. Additionally, the surgical hub 106, 206 can also determine that the procedure is not a wedge procedure (either the incoming product does not include the specific product required for a thoracic wedge procedure or the otherwise thoracic wedge procedure). either because it does not correspond to the wedge treatment).

In a third step 5206, medical personnel scan the patient's band via a scanner communicatively connected to the surgical hub 106,206. The surgical hub 106, 206 can then verify the patient's identity based on the scanned data.

In a fourth step 5208, the medical staff turns on the assistive device. The auxiliary devices utilized may vary according to the type of surgical procedure and the technique used by the surgeon, but in this exemplary case they include smoke evacuators, inhalers, and medical imaging equipment. When activated, an auxiliary device that is a modular device can automatically pair with surgical hubs 106, 206 located within a particular proximity of the modular device as part of its initialization process. . The surgical hub 106, 206 can then derive contextual information about the surgical procedure by detecting the type of modular device paired with it during this preoperative or initialization phase. In this particular example, surgical hubs 106, 206 determine that the surgical procedure is a VATS procedure 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 that connects to the hub, the surgical hub 106, 206 can approximate the specific procedure to be performed by the surgical team. can be inferred. Once the surgical hub 106, 206 knows what particular procedure is being performed, then the surgical hub 106, 206 retrieves the procedures for that procedure from memory or from the cloud and then connects. Data subsequently received from other data sources (eg, modular devices and patient monitors) can be cross-referenced to infer which steps of the surgical procedure the surgical team is performing.

In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the surgical hub 106,206. Once the surgical hub 106, 206 begins receiving data from the patient monitor, the surgical hub 106, 206 confirms that the patient is in the operating room.

In a sixth step 5212, medical personnel induce anesthesia in the patient. The surgical hub 106, 206 determines that the patient is under anesthesia based on data from the modular device and/or patient monitor including, for example, EKG data, blood pressure data, ventilator data, or combinations thereof. can be inferred. Completion of the sixth step 5212 completes the preoperative portion of the segmentectomy surgery and begins the surgical portion.

In a seventh step 5214, the lung of the patient being manipulated is collapsed (while ventilation is switched to the contralateral lung). The surgical hub 106, 206, for example, can infer from the ventilator data that the patient's lung has collapsed. The surgical hub 106, 206 can compare the detection of the patient's lung collapse to the expected steps of the procedure (which can be accessed or read out in advance) so that the surgical portion of the procedure is It can be inferred that it has started, thereby determining that collapsing the lung is the first surgical step in this particular procedure.

In an eighth step 5216, a medical imaging device (eg, scope) is inserted and video footage from the medical imaging device is initiated. Surgical hubs 106, 206 receive medical imaging device data (ie, video or image data) through connections to medical imaging devices. Upon receiving the medical imaging device data, the surgical hub 106, 206 can determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 can determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (based on the data received in the second step 5204 of the procedure). Note that the wedge procedure is already discounted by the surgical hubs 106, 206). Data from the medical imaging device 124 (FIG. 2) is used (i.e., activated) by determining the angle of the medical imaging device oriented with respect to visualization of the patient's anatomy. , by monitoring the number or medical imaging devices paired with the surgical hub 106, 206), and by monitoring the type of visualization device being used, among many different methods. can be used to determine contextual information about the type of treatment being performed from. For example, one technique for performing a VATS lobectomy places the camera above the diaphragm in the anterior inferior corner of the patient's thoracic cavity, while one technique for performing a VATS segmentectomy is to place the camera above the diaphragm. is placed in the anterior intercostal position relative to the segmental cleft. For example, using pattern recognition or machine learning techniques, a situational awareness system can be trained to recognize the location of medical imaging devices based on visualizations of patient anatomy. As another example, one technique for performing VATS lobectomy utilizes a single medical imaging device, while another technique for performing VATS segmentectomy utilizes multiple cameras. As yet another example, one technique for performing a VATS segmentectomy uses an infrared light source (which may be communicatively coupled to the surgical hub as part of the visualization system) to visualize the segmental cleft. , which is not used in VATS lobectomy. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can be used for the particular type of surgical procedure being performed and/or the type of surgical procedure being performed. technology can be determined.

At a ninth step 5218, the surgical team begins the incision step of the procedure. The surgical hub 106, 206 receives data from the RF or ultrasound generator indicating that the energy instrument is being fired, so inferring that the surgeon is in the process of cutting and separating the patient's lungs. can be done. The surgical hub 106, 206 cross-references the received data with the readout steps of the surgical procedure to determine the energy being delivered at this point in the process (i.e., after the steps of the procedure described above have been completed). It can be determined that the instrument is compatible with the lancing process. In certain examples, the energy instrument can be an energy tool attached to a robotic arm of a robotic surgical system.

At a tenth step 5220, the surgical team proceeds to the ligation step of the procedure. Because the surgical hub 106, 206 receives data from the surgical stapling and severing instrument indicating that the instrument is being fired, it can be inferred that the surgeon is ligating the artery and vein. Similar to the previous step, the surgical hub 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the read out steps in the process. . In certain examples, the surgical instrument may be a surgical tool mounted on a robotic arm of a robotic surgical system.

In an eleventh step 5222, the segmental excision portion of the treatment is performed. The surgical hub 106, 206 can infer that the surgeon is resecting parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond, for example, to the size or type of staples fired by the instrument. Since different types of staples are utilized with different types of tissue, the cartridge data can indicate the type of tissue being stapled and/or resected. In this case, the types of staples fired are applied to parenchymal tissue (or other similar tissue types), which causes the surgical hub 106, 206 to infer that the segmentectomy portion of the procedure is being performed. can be done.

Subsequently, in a twelfth step 5224, a knot dissection step is performed. The surgical hub 106, 206 infers that the surgical team is cutting the nodule and performing a leak test based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. can be done. For this particular procedure, the RF or ultrasonic instruments used after the parenchyma has been excised correspond to the knototomy process, which allows the surgical hub 106, 206 to make this inference. becomes. Surgeons routinely combine surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) depending on the particular step in the procedure, as different instruments are better suited to specific tasks. ) instruments. Therefore, the particular sequence in which the stapling/cutting instrument and surgical energy instrument are used can indicate which step of the procedure the surgeon is performing. Additionally, in certain instances, robotic tools may be used for one or more steps during a surgical procedure and/or hand-held surgical instruments may be used for one or more steps during a surgical procedure. can be used. The surgeon(s) can, for example, alternate between robotic tools and handheld surgical instruments and/or use the devices simultaneously. Upon completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.

In a thirteenth step 5226, the patient's anesthesia is reversed. The surgical hub 106, 206 can infer, for example, based on the ventilator data (ie, the patient's breathing rate begins to increase) that the patient is emerging from anesthesia.

Finally, a fourteenth step 5228 is for medical personnel to remove various patient monitors from the patient. Therefore, the surgical hub 106, 206 can infer that the patient is being transported to the recovery room when the hub loses EKG, BP, and other data from the patient monitor. As can be seen from this exemplary procedure description, surgical hubs 106, 206 can perform a given surgical procedure based on data received from various data sources communicatively coupled with surgical hubs 106, 206. can be determined or inferred 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, operation of a robotic surgical system, including, for example, 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 the hub 106, 206 based on the information in the

Irregularities in Tissue Distribution Typically, in a surgical stapling procedure, the user positions the jaws of the end effector around tissue to clamp and staple the tissue. In some cases, a majority of the tissue clamped between the jaws of the surgical stapling instrument may be concentrated in a portion of the gap between the jaws while remaining portions of the gap remain unoccupied. or slightly occupied. Irregularities in the distribution of tissue positioned between the jaws of a surgical stapling instrument can reduce the consistency of stapling results. For example, irregular tissue distribution causes excessive tissue compression in one portion of the clamped tissue and insufficient tissue compression in another portion of the clamped tissue, which adversely affects the manipulated tissue. can affect For example, excessive compression of tissue can lead to tissue necrosis and, in certain procedures, to staple line breakage. Inadequate tissue compression can also adversely affect staple deployment and formation, causing the stapled tissue to leak or heal improperly.

Aspects of the present disclosure present a surgical stapling instrument that includes an end effector configured to staple tissue clamped between first and second jaws of the end effector. A surgical stapling instrument is configured to detect and indicate tissue distribution irregularities within an end effector for a number of predetermined zones between a first jaw and a second jaw. The surgical stapling instrument is further configured to detect and indicate irregularities in tissue volume and location between predetermined zones.

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

Absolute measurements of tissue impedance in a given zone can be significantly influenced by the environment in which the end effector is immersed. For example, an end effector immersed in a fluid such as blood will yield different tissue impedance measurements than an end effector not immersed in blood, for example. Also, an end effector clamped around previously stapled tissue will yield different tissue impedance measurements than an end effector clamped around non-stapled tissue. The present disclosure addresses such discrepancies by evaluating tissue impedance measurements in different predetermined zones relative to each other when evaluating tissue distribution in different predetermined zones.

In one aspect, irregularities in tissue clamped between jaws of a surgical stapling instrument result in differential tissue compression in predetermined zones. Aspects of the present disclosure include tissue distribution assessment circuitry configured to detect and indicate irregularities in tissue compression between predetermined zones by measuring impedance between jaws of the end effector in each of the predetermined zones. A surgical stapling instrument is presented.

In one aspect, a tissue distribution assessment circuit of a surgical stapling instrument includes one or more tissue contact circuits configured to measure tissue impedance to assess the location and amount of clamped tissue. , for each of the predetermined zones.

For brevity, one or more of the embodiments of the present disclosure will be described with reference to specific types of surgical instruments. However, this should not be construed as limiting. Embodiments of the present disclosure are applicable to various types of surgical stapling instruments such as, for example, linear surgical stapling instruments, curved surgical stapling instruments, and/or circular stapling instruments. Embodiments of the present disclosure are also equally applicable to surgical instruments that apply therapeutic energy, such as, for example, ultrasound or radio frequency (RF) energy, to tissue.

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

Tissue is clamped between anvil 25007 and staple cartridge 25009 by moving staple cartridge 25009 distally toward anvil 25007 . In certain aspects, anvil 25007 moves proximally toward staple cartridge 25009 to clamp tissue therebetween. In another aspect, the anvil and staple cartridge move relative to each other to clamp tissue therebetween. As shown in FIG. 88, anvil 25007 and staple cartridge 25009 define a stapling plane perpendicular to longitudinal axis L. As shown in FIG. Staples are deployed in curved rows from staple cartridge 25009 into tissue clamped between staple cartridge 25009 and anvil 25007 .

Referring again to FIG. 88, three tissue distribution assessment zones (Zone 1, Zone 2, Zone 3) are defined along the curved length of the anvil 25007. Anvil 25007 is shown in FIG. 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 tissue distribution irregularities between anvil 25007 and staple cartridge 25009 . Zone 1, also referred to herein as the crotch zone, is the inner zone closest to arm 25010. FIG. Zone 3, on the other hand, is the outer zone and is further from arm 25010 than zone 1. Zone 2 is an intermediate zone extending between Zones 1 and 3 . Zones 1 and 3 each extend along approximately one quarter of the curved length of anvil 25007 . In contrast, Zone 2 extends between Zones 1 and 3 along approximately 2/1 of the curved length of the anvil.

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

In the embodiment of FIG. 88, the anvil 25007 has a tissue contacting surface 25012 that is divided into three zones (Zone 1, Zone 2, Zone 3). In various aspects, the number of zones may be greater than or less than 3. In one example, a surgical stapling instrument is shown in FIG. Thus, the surgical stapling instrument may include four zones, as shown in Figure 104. In another embodiment, the surgical stapling instrument may include eight zones, as shown in Fig. 104. The zones may be the same size, or at least substantially may be essentially the same, or the sizes of the zones may vary, as shown in FIG.

A suitable number, size, and location of zones may be selected depending on the type of surgical instrument. For example, a linear surgical stapling instrument may include an inner or proximal zone closest to the shaft, an outer or distal zone furthest from the shaft, and one or more intermediate zones between the inner and outer zones. and may include

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

Each of the three zones of the embodiment of Figure 88 comprises one or more tissue contact circuits configured to measure the impedance of tissue portions present in the given zone. An exemplary tissue contact circuit is shown in FIG. Tissue "T" in contact with the anvil 25007 and staple cartridge 25009 at a given zone will simultaneously establish contact with a pair of opposing plates "P1, P2" provided at the given zone on the anvil 25007 and staple cartridge 25009. closes the normally open sensing circuit "SC" in the given zone.

Any of the contact circuits disclosed herein include, but are not limited to, a sensor mounted on the inner surface of the jaws that closes a normally open sensing circuit when in contact with tissue. It may contain 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 the sensor being the same as the amount of force applied to tissue "T". can be assumed. Such force applied to tissue "T" can then be translated into a compression of the tissue. The force sensor measures the amount of compression experienced by tissue "T" and provides the surgeon with information regarding the force exerted on tissue "T".

As noted above, excessive tissue compression can adversely affect the tissue "T" being manipulated. For example, excessive compression of the tissue "T" can lead to tissue necrosis and, in certain procedures, to staple line failure. Information regarding the pressure applied to tissue "T" allows the surgeon to better determine that excessive pressure is not being applied to tissue "T".

Contact circuit force transducers include, but are not limited to, piezoelectric elements, piezoresistive elements, metal film or semiconductor strain gauges, inductive pressure sensors, capacitive pressure sensors, and wiper arms on resistive elements. Potentiometric transducers using Bourdon tubes, capsules or bellows to drive the .

In various aspects, predetermined zones 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 this disclosure. To measure tissue impedance, the segmented flexible circuit passes subtherapeutic electrical signals through the tissue in each of the predetermined zones.

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

As described above, establishing contact between the tissue "T", the tissue contacting surface of the anvil 25007 and the staple cartridge 25009 in a given zone closes the sensing circuit for that given zone. When the sensing circuit closes, current passes through the tissue "T" in the predetermined zone and the sensing circuit, as shown in FIG. The impedance of tissue "T" in a given 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。

where Z _tissue is the tissue impedance, V is the voltage, I is the current, and Z _{sensing circuit} is the impedance of the sensing circuit.

As shown in FIG. 89, isolation elements 25014 can be placed between adjacent plates (p) to isolate adjacent sensing circuits. Although three sensing circuits are shown in FIG. 89, the number of sensing circuits may differ from three. In various embodiments, the end effector may include 'n' sensing circuits corresponding to 'n' predetermined zones, where 'n' is a numeric integer greater than or equal to three.

FIG. 97 illustrates a logic flow diagram of a process 25030 showing a control program or logic configuration for identifying tissue distribution irregularities within an end effector 25002 of a surgical instrument, in accordance with 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 combinatorial logic 510 (FIG. 14). In yet another aspect, process 25030 may be performed by sequential logic 520 (FIG. 15).

Process 25030 receives (25032) sensor signals from sensor circuits of sensing circuit assembly 25471 corresponding to predetermined zones (eg, zone 1, zone 2, and zone 3) within end effector 25002, and based on the received sensor signals, , including determining 25034 the tissue impedance Z _tissue of tissue portions in such zones. FIG. 98 shows tissue impedance Z _tissue curves 25001, 25003, 25005 corresponding to tissue examples T1, T2, T3, respectively.

Process 25030 further includes conditional steps 25036,25038. If the average tissue impedance of the inner zone (eg, zone 1) and the outer zone (eg, zone 3) is determined to be greater than the tissue impedance of the intermediate zone (eg, zone 2), then the tissue distribution is deemed inappropriate and instructions are given to release the grasped tissue and reposition the end effector 25002 as shown by the examples of FIGS. 25040). In certain examples, during the release cycle, the grasped tissue is only released up to a 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 less than or equal to that of the outer zone. If less than or equal to the tissue impedance, then the tissue distribution is considered adequate and a predetermined Force-To-Close force is applied, as illustrated by the examples of FIGS. , FTC) continue end effector closure while maintaining 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 less than or equal to that of the outer zone. If greater than the tissue impedance, then the tissue distribution is considered adequate, but the FTC threshold velocity is reduced to slower velocities, as shown by the examples of FIGS. (25044).

FIG. 102 shows a logic diagram of a control system 25470 that can be used to implement the process of FIG. Control system 25470 is similar in many respects to control system 470 (FIG. 12). In addition, control system 25470 includes a sensing circuit assembly 25471 that includes 'n' sensing circuits S ₁ -S _n , where 'n' is an integer greater than two. The sensing circuits S ₁ -S _n define predetermined zones within the end effector, as described above.

In various embodiments, sensing circuit assembly 25471 includes 'n' continuous sensors, where 'n' is an integer greater than two. A continuous sensor defines a predetermined zone within the end effector, as described above.

In various embodiments, sensing circuits S ₁ -S _n can be configured to provide sensor signals indicative of tissue compression using impedance measurements. Continuous sensors S ₁ -S _n may be used to signal whether sufficient tissue has been extended into the end effector 25002 . Additionally, the FTC sensor can be used in assessing tissue creep rate to determine tissue distribution within the end effector 25002 .

In various aspects, sensing circuits S ₁ -S _n can be configured to measure tissue impedance by driving sub-therapeutic RF current through tissue grasped by end effector 25002 . One or more electrodes may be positioned on one or both jaws of the end effector 25002 . Tissue compression/impedance of the grasped tissue may be measured over time.

In various aspects, various sensors such as magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors. may be adapted and configured to measure tissue compression/impedance of a predetermined zone within the end effector.

In various aspects, the closure system advancement speed is altered by the microcontroller 461 when more tissue is sensed in the inner zone of the end effector 25002 than in the outer zone. Closure velocity is reduced to improve tissue distribution by allowing tissue in the inner zone to creep outward within the end effector 25002 .

In various aspects, monitoring changes in impedance as the closed gap changes may be used to inform tissue properties and placement as well.

FIG. 99 illustrates a graph 25400 showing end effector FTC 25402 and closing velocity 25404 versus time 25406 for an exemplary firing of an end effector 25002 of a surgical instrument, according to at least one aspect of the present disclosure. See also FIGS. 91, 94 and 97 in the following discussion of graph 25400. FIG. The exemplary launches described herein are intended to demonstrate the concepts discussed above in connection with FIGS. 91, 94, and 97 and should not be construed as limiting in any way. do not have.

Firing of the end effector 25002 can be represented by an FTC curve 25408 and a corresponding velocity curve 25408', as shown in FIGS. Each shows a significant change. Firing can represent, for example, firing of an end effector 25002 of a surgical instrument with control circuitry that performs process 25030 shown in FIG. Once firing of the end effector 25002 is initiated, the processor 462 controls the motor 482 to begin driving the anvil 25007 from its open position and bring the closing speed of the anvil 25007 to a plateau at a specified closing speed (25418 ) (25416). As the anvil 25007 closes, the FTC increases (25410) until it peaks (25412) at a particular time. From the peak (25412), FTC decreases (25414) until tissue "T1" is fully clamped, at which point processor 462 controls motor 482 to stop closing anvil 25007 and the closing speed is Descend to zero (25420).

The firing of FIGS. 91, 94 thus represents the firing of the end effector 25002 and the tissue distribution between jaws 25006 and 25008 is within acceptable limits. In other words, the firing of Figures 91, 94 remains within all control parameters during the process of jaw closure. Accordingly, processor 462 does not suspend anvil 25007 and adjusts the closing speed of anvil 25007 or takes any other corrective action during the process of jaw closure.

FIG. 14 illustrates a graph 25422 showing end effector FTC 25402 and closing velocity 25404 versus time 25406 for an exemplary firing of an end effector 25007 of a surgical instrument, according to at least one aspect of the present disclosure. See also FIGS. 92, 95 and 97 in the following discussion of graph 25422. FIG. The exemplary launches described herein are intended to demonstrate the concepts discussed above in connection with FIGS. 92, 95 and 97 and should not be construed as limiting in any way. do not have.

Firing of the end effector 25002 can be represented by an FTC curve 25424 and a corresponding velocity curve 25424', as shown in FIGS. The change in velocity over time is shown, respectively. 92, 95 can represent, for example, the firing of an end effector 25007 of a surgical instrument with control circuitry that performs process 25030 shown in FIG. When firing of the end effector 25007 begins, the processor 462 controls the motor 482 to begin driving the anvil 25007 from its open position and rapidly increase the closing speed of the anvil 25007 until a specified closing speed is reached ( 25432). As the anvil 25012 closes, the FTC increases (25426) until it peaks (25428) at a particular time. In this case, processor 462 outputs from sensing circuit assembly 25471 indicating that the tissue distribution between jaws 25006 and 2008 is skewed toward the third zone, as shown in FIGS. receives input from

In response, processor 462 instructs the operator of surgical instrument end effector 25007, via display 473, to realign tissue "T2" therein, as outlined in process 25030. 25006 and 25008 are instructed to open. Accordingly, the closing velocity is reduced (25434) until a negative closing velocity is reached, e.g. Indicates that The closing speed then returns to zero (25436) and the jaws 25006, 25008 stop. Correspondingly, when jaws 25006, 25008 are released from tissue "T2", FTC decreases to zero (25430).

FIG. 101 illustrates a graph 25438 showing end effector FTC 25402 and closing velocity 25404 versus time 25406 for an exemplary firing of an end effector 25002 of a surgical instrument, according to at least one aspect of the present disclosure. See also FIGS. 93, 96 and 97 in the following description of seventh graph 25438. FIG. The exemplary launches described herein are intended to demonstrate the concepts discussed above in connection with FIGS. 93, 96, and 97 and should not be construed as limiting in any way. do not have.

Firing of the end effector 25002 can be represented by an FTC curve 21440 and a corresponding velocity curve 25440', as shown in FIGS. The change in velocity over time is shown, respectively. 93, 96 can represent, for example, a surgical instrument end effector 25002 with control circuitry that performs the process 25030 shown in FIG. When firing of end effector 25002 begins, processor 462 controls motor 482 to begin driving anvil 25007 from its open position, rapidly increasing the closing speed of anvil 25007 to a first closing speed v1 (25450 ). As anvil 25007 closes, FTC increases (21442) until time t1. At time t1, control circuit 21002 determines that the tissue distribution is skewed toward zone 1, as shown in FIGS. In response, processor 462 adjusts the speed of motor 482 sufficient to cause tissue “T3” to creep outward toward zone 2 and/or zone 3, as indicated by process 25030 . I can give you time.

FIG. 103 is a view 6000 of a surgical instrument 6002 centered on a staple line 6003 using the benefits of the centering tools and techniques described in connection with FIGS. 104-114, according to at least one aspect of the present disclosure. indicates As used in the following description of FIGS. 104-114, a staple line may include multiple rows of alternating staples, typically, without limitation, two or three rows of alternating staples. include. The staple line may be a double staple line 6004 formed using the double-stapling technique described in connection with FIGS. It may be a straight staple line 6052 formed using the linear transection technique described in connection with FIG. Using the centering tools and techniques described herein, the instrument 6002 located in one portion of the anatomy can be aligned with either the staple line 6003 or another instrument located in another portion of the anatomy. In other words, it is possible to align the positions without receiving the benefit of the line of sight. Centering tools and techniques include displaying the current alignment of the instrument 6002 adjacent to the previous movement. The centering tool is useful, for example, during laparoscopic rectal surgery using the double stapling technique, also called the overlapping stapling technique. In the illustrated 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 positioned within the abdominal cavity.

During laparoscopic rectal surgery, the colon is resected and sealed with a staple line 6003 having length "1". The double stapling technique uses a circular stapler 6002 to form the end anastomosis and is currently widely used in laparoscopic rectal surgery. In order to successfully form an anastomosis using the circular stapler 6002, the anvil trocar 6010 of the circular stapler 6002 must be completely pierced through the tissue and/or prior to puncturing through the center "l/2" of the staple line 6003. Firing the circular stapler 6002 after clamping cuts the staple overlap portion 6012 and should be aligned with the center "l/2" of the transversal incision before forming the anastomosis. Misalignment between the anvil trocar 6010 and the center of the staple line 6003 transversal incision can increase the likelihood of anastomotic failure. This technique may be applied to ultrasonic instruments, electrosurgical instruments, combined ultrasonic/electrosurgical instruments, and/or combined surgical stapler/electrosurgical instruments. Several techniques for aligning the anvil trocar 6010 of the circular stapler 6002 with the center "l/2" of the staple line 6003 will now be described.

In one aspect, as described in FIGS. 104-106 and also referring to FIGS. 1-11, the present disclosure is used to illustrate interaction with an interactive surgical system 100 environment including surgical hubs 106, 206. provides an instrument and method for detecting the overlap of the double staple line 6004 using the double stapling technique in the transcolonectomy of laparoscopic rectal surgery. The overlapping portion of double staple line 6004 is detected and the current position of anvil trocar 6010 of circular stapler 6002 is displayed on surgical hub display 215 coupled to surgical hub 206 . The surgical hub display 215 displays the alignment of the circular stapler 6002 cartridge to the overlapping portion of the double staple line 6004 centered on the double staple line 6004 . Surgical hub display 215 displays a circular image centered around the overlapping double staple line 6004 area such that the overlapping portion of double staple line 6004 is included inside the knife of circular stapler 6002. , thus ensuring that it is removed after circular firing. 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 fully clamps the tissue, and then uses the circular stapler. Firing 6002 cuts staple overlap portion 6012 to form an anastomosis.

104-108 illustrate a process of aligning anvil trocar 6010 of circular stapler 6022 with staple overlap portion 6012 of double staple line 6004 created by a double stapling technique, according to at least one aspect of the present disclosure. show. Staple overlap portion 6012 is at the center of double staple line 6004 formed by a double stapling 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 . Laparoscope 6014 and non-contact sensor 6022 are used to determine the position of anvil trocar 6010 relative to staple overlap portion 6012 of double staple line 6004 . Laparoscope 6014 includes an image sensor for generating images of double staple line 6004 . The image sensor image is transmitted to surgical hub 206 via imaging module 238 . Sensor 6022 generates a signal 6024 that detects metal staples using inductive or capacitive metal sensing techniques. Signal 6024 varies based on the position of anvil trocar 6010 relative to staple overlap portion 6004 . The centering tool 6030 moves a target alignment ring 6032 around 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 portion 6012 on the surgical hub display 215 . and present. Centering tool 6030 also presents projected cutting path 6034 of anvil knife of circular stapler 6002 . The registration process is a target location surrounding the image 6038 of the double staple line 6004 and the image 6038 of the staple overlap portion 6012 cut by the circular knife of the circular stapler 6002 around the image 6038 of the double staple line 6004. including displaying mating ring 6032 . Also displayed is an image of crosshairs 6036 (X) for image 6040 of staple overlap portion 6012 .

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 created by the double stapling technique. The double staple line 6004 has a length “l” and the staple overlapping portion 6012 is located in the middle of the double staple line 6004 at the “l/2” position. As shown in FIG. 104, a circular stapler 6002 is inserted into the colon 6020 section and positioned just below the double staple line 6004 transverse incision. A laparoscope 6014 is positioned over the double staple line 6004 transverse incision to transmit 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 anvil trocar 6010 relative to staple overlap 6012 is detected by sensor 6022 located on circular stapler 6002 . Sensor 6022 also provides surgical hub display 215 with the position of anvil trocar 6010 relative to staple overlapping portion 6012 .

As shown in FIG. 104, the projected path 6018 of the anvil trocar 6010 is shown at the location marked by X along the dashed line. As shown in FIG. 104, projected path 6018 of anvil trocar 6010 is not aligned with staple overlap portion 6012 . Puncture of the anvil trocar 6010 through the double staple line 6044 at a point out of the staple overlapping portion 6012 can lead to anastomotic failure. 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 sensor 6022 is an inductive sensor. Because the staple overlap portion 6012 contains more metal than the rest of the lateral portion of the double staple line 6004, the signal 6024 indicates that the sensor 6022 is aligned with the staple overlap portion 6012 and is proximate to that portion. maximum when Sensor 6022 provides a signal to surgical hub 206 indicative of the position of anvil trocar 6010 relative to staple overlapping portion 6012 . The output signal is translated into a visualization of the position of anvil trocar 6010 relative to staple overlap 6012 displayed on 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 stapling technique. The surgeon can now pierce the anvil trocar 6010 through the staple overlap portion 6012 of the double staple line 6004 and/or fully clamp the tissue, after which the circular stapler 6002 is fired to to form an anastomosis.

FIG. 106 shows the centering tool 6030 displayed on the surgical hub display 215 showing 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 overlap portion 6012 of the double staple line 6004 as shown in FIG. Centering tool 6030 presents to surgical hub display 215 an image 6038 of double staple line 6004 and an image 6040 of staple overlap portion 6012 received from laparoscope 6014 . A target registration ring 6032 centered on the image 6040 of the staple overlap portion 6012 ensures that the staple overlap portion 6012 is aligned with the circular stapler 6002 knife when the projected cutting path 6034 is aligned with the target registration ring 6032 . Wrap around the image 6038 of the double staple line 6004 so that it lies inside the circumference of the projected cutting path 6034 . Crosshairs 6036 (X) represent the position of anvil trocar 6010 relative to staple overlap portion 6012 . Crosshairs 6036(X) indicate points through double staple line 6004 that would puncture if anvil trocar 6010 were advanced from its current position.

As shown in FIG. 106, anvil trocar 6010 is not aligned with the desired penetration location designated by image 6040 of staple overlap portion 6012 . To align the anvil trocar 6010 with the staple overlap 6012, the surgeon aligns the projected cutting path 6034 with the target alignment ring 6032 and the crosshairs 6036 (X) at the center of the image 6040 of the staple overlap 6012. The circular stapler 6002 is operated until the Once aligned, the surgeon may puncture the anvil trocar 6010 through the staple overlap portion 6012 of the double staple line 6004 and/or fully clamp the tissue before firing the circular stapler 6002 to force the staple overlap portion 6012 through. Cut away and form an anastomosis.

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

107 and 108 show before 6042 and after 6043 images of centering tool 6030, in accordance with at least one aspect of the present disclosure. FIG. 107 shows the anvil over the image 6040 of the staple overlap portion 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 trocar 6010 and projected cutting path 6034 of the circular knife is shown. FIG. 108 shows the anvil over the image 6040 of the staple overlap 6040 presented on the surgical hub display 215 after being aligned with the target alignment ring 6032 surrounding the image 6038 of the double staple line 6004 . An image of the trocar 6010 and projected cutting path 6034 of the circular knife is shown. The current position of the anvil trocar 6010 is marked by a crosshair 6036 (X) positioned to the lower left of the center of the image 6040 of the staple overlap 6040 as shown in FIG. As the surgeon moves anvil trocar 6010 along projected path 6046, projected cutting path 6034 aligns with target alignment ring 6032, as shown in FIG. Target alignment ring 6032 may be displayed, for example, as a grayed out alignment circle superimposed over the current position of anvil trocar 6010 relative to the center of double staple line 6004 . The image may include indication marks as to which direction to move. The target alignment ring 6032 may be shown in bold, alternate color, 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 the colorectomy and provide the location of the current position 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 create a uniform suture edge skin deformation) and provides the current position of the anvil trocar 6010. , provides a surgical hub display 215 . This allows the surgeon to center or align the anvil trocar 6010 as desired and then puncture and/or fully clamp the tissue prior to firing the circular stapler 6002 .

In another aspect, as described in FIGS. 109-111 and referring also to FIGS. 1-11, in laparoscopic rectal surgery using a linear stapling technique colonorectomy, the starting point of the straight staple line 6052 and endpoints are detected and the current position of anvil trocar 6010 of circular stapler 6002 is displayed on surgical hub display 215 coupled to surgical hub 206 . Surgical hub display 215 displays a circular image centered on double staple line 6004 (which may create a uniform suture edge skin deformation) and the current position of anvil trocar 6002 is displayed, which After centering or aligning the anvil trocar 6010 and then puncturing through the straight staple line 6052 and/or fully clamping the tissue, the surgeon fires the circular stapler 6002 to center the straight staple line 6052. 6050 can be cut and an anastomosis formed.

109-112 illustrate a process of aligning the anvil trocar 6010 of a circular stapler 6022 with the center 6050 of a straight staple line 6052 created by a linear stapling technique, according to at least one aspect of the present disclosure. 109 and 110 show the laparoscope 6014 and sensor 6022 positioned over the circular stapler 6022 for determining the position of the anvil trocar 6010 relative to the center 6050 of the straight staple line 6052. FIG. Anvil trocar 6010 and sensor 6022 are inserted into colon 6020 below straight staple line 6052 and laparoscope 6014 is inserted through the abdomen above straight staple line 6052 .

109 shows the anvil trocar 6010 not aligned with the center 6050 of the straight staple line 6052 and FIG. 110 shows the anvil trocar 6010 aligned with the center 6050 of the straight staple line 6052. FIG. A 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. An end may be detected when the staple is no longer in the path of sensor 6022 . Upon reaching one of the ends, circular stapler 6002 is moved along linear staple line 6053 until the opposite end is detected. Length “l” of straight staple line 6052 is determined by measurement or by counting individual staples with 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 two ("1/2").

FIG. 111 shows a centering tool 6054 displayed on surgical hub display 215, which provides a representation of straight staple line 6052. FIG. In the figure, the anvil trocar 6010 is not aligned with the staple overlap portion 6012 of the double staple line 6004 as shown in FIG. Surgical hub display 215 presents standard reticle view 6056 of laparoscopic view 6016 of straight staple line 6052 and a portion of colon 6020 . Surgical hub display 215 also presents a target ring 6062 surrounding the image center of the straight staple line and projected cutting path 6064 of the anvil trocar and circular knife. Crosshairs 6066 represent the position of anvil trocar 6010 relative to center 6050 of straight staple line 6052 . Crosshairs 6036(X) indicate points through straight staple line 6052 that would puncture if anvil trocar 6010 were advanced from its current position.

As shown in FIG. 111, anvil trocar 6010 is not aligned with the desired penetration location specified by the offset between target ring 6062 and projected cutting path 6064 . To align the anvil trocar 6010 with the center 6050 of the straight staple line 6052, the surgeon aligns the projected cutting path 6064 with the target alignment ring 6062 and the crosshairs 6066 with the center of the image 6040 of the staple overlap 6012. The circular stapler 6002 is operated until the Once aligned, the surgeon passes the anvil trocar 6010 through the center 6050 of the straight staple line 6052 and/or fully clamps the tissue before firing the circular stapler 6002 to cut off the staple overlap 6012 and anastomosis. to form

In one aspect, the present disclosure uses a linear transverse incision technique and an alignment ring or bullet positioned such that the anvil trocar 6010 of the circular stapler 6022 is properly centered along the straight staple line 6052. , provides an apparatus and method for displaying an image of a straight staple line 6052. The instrument displays a greyed out alignment ring superimposed over the current position of the anvil trocar 6010 with respect to the center 6050 of the straight staple line 6052 . The image may include indication marks to assist the alignment process by indicating in which direction the anvil trocar 6010 should move. The target alignment ring 6032 may be shown in bold, different color, or highlighted when located within a predetermined center distance within acceptable limits.

109-112, FIG. 112 shows a standard of straight staple line 6052 transection of surgery viewed through a laparoscope 6014 displayed on a surgical hub display 215, according to at least one aspect of the present disclosure. 6080 is an image 6080 of a typical reticle field of view 6080. FIG. With a standard reticle view 6080 it is difficult to see straight staple lines 6052 within a standard reticle field of view 6056 . Additionally, there is no alignment aid to assist in aligning and introducing 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 to indicate whether the circular stapler was properly centered, nor does it show the projected trocar path. It is also difficult to see the staples in this figure because there is no contrast with the background image.

109-113, FIG. 113 shows anvil trocar 6010 and circular knife of circular stapler 6002 aligned with center 6050 of straight staple line 6052, according to at least one aspect of the present disclosure. 113 is an image 6082 of the laser assisted reticle field of view 6072 of the surgical site shown in FIG. 112; A laser-based reticle field of view 6072 shows the projected path of the anvil trocar 6010 to aid in placement of the anvil trocar 6010. Alignment marks or Crosshairs 6066 (X) are provided. In addition to the projected path marked by crosshairs 6066 of anvil trocar 6010, image 6082 displays the staples of straight staple line 6052 in a contrasting color to make them more visible against the background. . A straight staple line 6052 is highlighted and a bull's eye target 6070 is displayed above the center 6050 of the straight staple line 6052 . Image 6082 shows anvil trocar 6010 relative to center 6050 of straight staple line 6052 marked by condition warning box 6068, suggestion box 6074, target ring 6062, and crosshairs 6066 outside laser-based reticle field of view 6072. Show the current alignment position. As shown in FIG. 113, status warning box 6068 indicates that the trocar is "out of alignment" and suggestion box 6074 suggests "adjust trocar toward center of staple line."

109-114, FIG. 114 illustrates the anvil trocar 6010 and the circular knife of the circular stapler 6002 after being aligned with the center 6050 of the straight staple line 6052, according to at least one aspect of the present disclosure. 114 is an image 6084 of the laser assisted reticle field of view 6072 of the surgical site shown in FIG. A laser-based reticle field of view 6072 shows the projected path of the anvil trocar 6010 to aid in placement of the anvil trocar 6010. Alignment marks or Crosshairs 6066 (X) are provided. In addition to the projected path marked by crosshairs 6066 of anvil trocar 6010, image 6082 displays the staples of straight staple line 6052 in a contrasting color to make them more visible against the background. . A straight staple line 6052 is highlighted and a bull's eye target 6070 is displayed above the center 6050 of the straight staple line 6052 . Image 6082 shows anvil trocar 6010 relative to center 6050 of straight staple line 6052 marked by condition warning box 6068, suggestion box 6074, target ring 6062, and crosshairs 6066 outside laser-based reticle field of view 6072. Show the current alignment position. As shown in FIG. 113, status warning box 6068 indicates that the trocar is "out of alignment" and suggestion box 6074 suggests "adjust trocar toward center of staple line."

114 is a laser-assisted view of the surgical site shown in FIG. 113 after the anvil trocar 6010 and circular knife have been aligned with the center of the staple line 6052. FIG. In this view, inside the laser-based reticle field of view 6072, the alignment mark crosshairs 6066 (X) are positioned over the center of the staple line 6052 and the highlighted bull's eye target, and the trocar is positioned. It shows alignment with the center of the staple line. Outside the laser-assisted reticle field of view 6072, a status warning box indicates that the trocar is "aligned" and the suggestion is "proceed with trocar introduction."

Referring now to FIGS. 115-119, it is not only the amount and location of tissue that can affect stapling results, but the nature, type, or condition of the tissue can also affect stapling results. obtain. For example, irregular tissue distribution is also present in situations involving stapling previously stapled tissue such as, for example, the J-pouch technique, also known as ileal pouch anal anastomosis, and end-to-end anastomosis. manifest. Poor placement and distribution of previously stapled tissue within the end effector of the staple cartridge causes previously fired staple lines to concentrate within one zone within the end effector rather than another zone. In some cases, this adversely affects the outcome of such treatments.

Aspects of the present disclosure present a surgical stapling instrument that includes an end effector configured to staple tissue clamped between 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 at several predetermined zones within the end effector. In various aspects, tissue impedance measurements can also be utilized to identify overlapping layers of tissue and their locations within the end effector.

115, 117, and 118 show a circular stapler end effector 25500 including a staple cartridge 25502 and an anvil 25504 configured to grasp tissue therebetween. Anvil 25504 and staple cavities 25505 of staple cartridge 25502 have been removed from FIG. 115 to highlight other features of end effector 25500. FIG. Staple cartridge 25502 includes four predetermined zones (Zone ₁ , Zone 2, Zone 3, _{Zone 4} ) defined by sensing circuits (S 1 , S ₂ , S ₃ , S 4 ), according to the present disclosure.

FIG. 116 shows another end effector 25510 of a circular stapler that includes a staple cartridge 25512 and an anvil configured to grasp tissue therebetween. The anvil and staple cavities of staple cartridge 25512 have been removed to highlight other features of end effector 25510 . Staple cartridge 25512 includes eight predetermined zones (Zone ₁ -Zone 8) defined by sensing circuits (S 1 -S ₈ ), according to the present disclosure. The zones defined in each of the circular staplers of FIGS. 115 and 116 are equal or at least substantially equal in size and circumferentially about a longitudinal axis extending longitudinally through the shaft of the circular stapler. placed in

As noted above, previously stapled tissue is tissue that includes staples previously deployed within the tissue. Circular staplers are often used in stapling previously stapled tissue to unstapled tissue (e.g., the J-pouch method), as shown in FIG. 118, and as shown in FIG. As such, it is utilized in stapling previously stapled tissue to other previously stapled tissue (eg, end-to-end anastomosis).

The presence of staples in tissue affects tissue impedance because staples typically have a different conductivity than tissue. The present disclosure monitors and compares tissue impedance in predetermined zones of a circular stapler end effector (e.g., end effectors 25500, 25510) to determine optimal placement and orientation of previously stapled tissue relative to the end effector. We present various tools and techniques for

The left hand examples of FIGS. 117 and 118 show previously stapled tissue properly positioned and oriented with respect to predetermined zones of the circular stapler. Previously stapled tissue extends appropriately through the center of staple cartridge 25502 and intersects the predetermined zone only once. 117, 118 show staples 25508 of staple cartridge 25502 being deployed into properly positioned and oriented previously stapled tissue.

The right hand examples of FIGS. 117, 118 show previously stapled tissue that is poorly placed and oriented. Previously stapled tissue is off-center (Fig. 118) or overlapping (Fig. 31) in one or more predetermined zones. The lower right side of FIGS. 117, 118 show staples 25508 of staple cartridge 25502 being deployed into poorly positioned and oriented previously stapled tissue.

As used in connection with FIGS. 115-119, staple lines may include multiple rows of staggered staples, typically, without limitation, include two or three rows of staggered staples. . In the example of FIG. 117, the circular stapler of FIG. 115 is utilized to staple two pieces of tissue containing previously deployed staple lines SL1, SL2. In the left hand example of FIG. 117, which represents staple lines SL1, SL2 properly positioned and oriented, each of Zones 1-4 receives a separate portion of one of the staple lines SL1, SL2. . A first staple line SL1 extends across zones 2 and 4, while a second staple line SL2, which intersects the first staple line SL1 at a central point, extends across zones 1 and 3. Accordingly, the measured impedances within the four zones are equal, or at least substantially equal, to each other and less than the impedance of unstapled tissue.

In contrast, in the right-hand example of FIG. 117, which represents the improperly placed and oriented staple lines SL1, SL2, the staple lines SL1, SL2 overlap across zones 1 and 3, or The impedance measurements are lower in Zones 1 and 3 compared to Zones 2 and 4 due to the substantially one-on-one extension.

119 and 120 are implemented with the circular stapler end effector 25510 of FIG. 116 including eight predetermined zones (Zone 1-Zone 8) defined by eight sensing circuits S ₁ -S ₈ as described above. 2 shows staple lines SL1, SL2 in an end-to-end anastomosis. The anvil of end effector 25510 and the staple cavities of staple cartridge 25512 have been removed from FIGS. 119 and 120 to highlight other features of end effector 25510. FIG.

Figures 121 and 122 show measured tissue impedance based on sensor signals from sensing circuits S ₁ -S ₈ . Individual measurements define a tissue impedance signature. The vertical axes 25520, 25520' represent the angle of orientation (θ) and the vertical axes 25522, 25522' list the corresponding predetermined zones (Zone 1-Zone 8). Tissue impedance (Z) is plotted on horizontal axes 25524, 25524'.

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

Conversely, in the examples of FIGS. 120, 122, the impedance measurements represent improperly placed and oriented staple lines SL1, SL2. As shown in FIG. 120, staple lines SL1, SL2 extend through Zones 1 and 5 only and overlap each other. Thus, the magnitude of tissue impedance measurements in Zones 1 and 5 are significantly lower than the remaining zones that did not receive previously stapled tissue.

123 and 124 are implemented by the circular stapler end effector 25510 of FIG. 116 which includes eight predetermined zones (Zone 1-Zone 8) defined by eight sensing circuits S ₁ -S ₈ as described above. 1 shows a staple line SL3 in the J-pouch method. The anvil of end effector 25510 and the staple cavities of staple cartridge 25512 have been removed from FIGS. 123 and 124 to highlight other features of end effector 25510. FIG.

Figures 125 and 126 show measured tissue impedance based on sensor signals from sensing circuits S ₁ -S ₈ . Individual measurements define a tissue impedance signature. The vertical axes 25526, 25526' represent the orientation angle (θ) and the vertical axes 25528, 25528' list the corresponding predetermined zones (Zone 1-Zone 8). Tissue impedance (Z) is plotted on horizontal axes 25530, 25530'.

In the examples of FIGS. 123 and 125, the impedance measurements represent a properly placed and oriented staple line SL3. As shown in FIG. 123, staple line SL3 extends through Zones 1 and 5 only. Because the previously stapled tissue is evenly distributed between Zones 1 and 5, the magnitudes of tissue impedance measurements in such zones are the same, or at least substantially the same. , significantly less than the tissue impedance measurements in the remaining zones that did not receive previously stapled tissue.

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

In various aspects, the circular stapler (e.g., the circular stapler of FIG. 115 and the circular stapler of FIG. 116) further comprises a control system 25470 (FIG. 102), the control system 25470 controlling the received sensor signal of the sensing circuit of the circular stapler. may be configured to further analyze the impedance measurements determined from In certain aspects, the control system 25470 shown in FIG. 102 determines geometric parameters of one or more previously deployed staple lines, as shown in connection with FIGS. It includes a microcontroller 461 that can be configured to: In certain examples, microcontroller 461 may also be configured to determine alignment aspects of a circular stapler, as shown in connection with FIGS. 103-114. In certain examples, the microcontroller 461 also determines the position of the circular trocar for circular staples, the length and centerline of the existing staple line, and/or the length of the two series, as shown in connection with FIGS. It can be configured to determine the center intersection of the lines.

Microcontroller 461 may, for example, provide a warning to the surgeon via display 473 regarding 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 action to prevent tissue stapling. For example, microcontroller 461 may signal motor driver 492 to stop motor 482 . In certain examples, microcontroller 461 may recommend new positions and/or orientations to the operating surgeon.

In various aspects, the circular staplers of the present disclosure are communicatively coupled to surgical hubs 106 (FIGS. 3, 4), 206 (FIG. 206) via wired and/or wireless communication channels. Data collected by such circular staplers can be transmitted to surgical hubs 106, 206, which transmit this data to cloud-based systems 104, 104, 104, 104, 104 for further analysis. 204.

FIG. 127 depicts a logic flow diagram of a process 25600 showing a control program or logic configuration for properly positioning previously stapled tissue within an end effector (e.g., end effectors 25500, 25510) of a surgical stapler. In one aspect, process 25600 is performed by control circuit 500 (FIG. 13). In another aspect, process 25600 may be performed by combinatorial logic 510 (FIG. 14). In yet another aspect, process 25600 may be performed by sequential logic 520 (FIG. 15).

For purposes of illustration, the following description shows process 25600 that can be performed by control circuitry including controller 461 including processor 461 . Memory 468 stores program instructions executable by processor 461 to perform process 25600 .

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

Process 25600 then determines (25606) whether the measured tissue impedance within the predetermined zone corresponds to the selected tissue impedance signature. If not, processor 461 may warn the user (25608) and/or override tissue treatment (25610). In one aspect, processor 461 can alert the user via display 473 (25608). Additionally, processor 461 may override tissue treatment by preventing the end effector from completing its firing (25610). Firing completion prevention may be accomplished, for example, by causing motor driver 492 to stop motor 482 (FIG. 102).

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

Referring generally to FIGS. 128-134, tissue overhang is where tissue, such as a vessel (BV) grasped between the jaws of a surgical end effector, extends beyond the optimal treatment area of the end effector. This is a phenomenon that sometimes occurs. Therefore, the overhanging tissue may not receive treatment applied by the end effector. If the tissue contains blood vessels and the procedure involves sealing and severing the blood vessels (BV), the unsealed overhanging portions of the blood vessels may leak with undesirable consequences.

Aspects of the present disclosure present a surgical instrument comprising circuitry configured to detect overhanging tissue within an end effector of the surgical instrument. Aspects of the present disclosure also present a surgical instrument comprising circuitry configured to detect tissue extending beyond a predetermined treatment area within an 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 similar in many respects to other surgical instrument disclosures elsewhere herein, eg, surgical instrument 150010 . At least one of the first jaw 25702 and the second jaw 25704 positions the end effector 25700 in an open configuration (FIGS. 128, 129, 132) and a closed configuration (FIGS. 130, 131, 133, 134). is movable to transition between 128-134, end effector 25700 includes a staple cartridge 25708 containing staples deployable within tissue grasped between jaws 25702 and 25704 and deformable by anvil 25710. In the embodiment of FIGS. In other examples, end effectors according to the present disclosure can treat tissue by applying ultrasound and/or radio 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 pathway that causes current flow through the flex circuit 25706 when in contact with the continuous sensor as shown in FIGS. Current flow indicates the presence of overhanging tissue.

Jaws 25702, 25704 define a treatment region 25714 therebetween when tissue treatment is applied in the closed configuration, as shown in FIGS.

Bent tips or noses 25716, 25718 are defined distal to the treatment region 25714 within the jaws 25702, 25704. FIG. The stepped feature 25720 maintains a minimum distance or gap between the jaws 25702 and 25704 at the bent noses 25716, 25718 in the closed configuration.

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

128-134, end effector 25700 includes treatment region 25714 that resides between anvil 25710 and staple cartridge 25708. In the example of FIGS. Staples are deployed into tissue from staple cartridge 25708 and deformed by anvil 25710 to staple tissue grasped by end effector 25700 within treatment region 25714 . In other examples, the treatment region of the end effector 25700 can seal tissue by applying radiofrequency and/or ultrasonic energy to tissue at the treatment region.

128-134, the continuous sensor is disposed on the distal portion of the staple cartridge 25708 and is defined by an insulated flex circuit 25706, which receives the staple cartridge. are wired through contacts coupled to corresponding contacts in the channel 25726 of the first jaw 25702 configured as follows. A sensor signal indicative of the presence of overhanding tissue is passed through these contacts to a control system, such as control system 470 (FIG. 12), for example.

Flex circuit 25706 extends distally from flat or substantially flat portion 25728 of staple cartridge 25708 between stepped feature 25720 and bent nose 25716 . Flex circuit 25706 further underlies ramp surface 25730 defined by bend nose 25716 and extending from the distal edge of plateau 25728 . Tissue extending beyond stepped feature 25720 onto flat portion 25728 and/or angled surface 25730 triggers a continuous sensor and a sensor signal is sent to control system 470 (FIG. 12).

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

Although a continuous sensor is disposed on staple cartridge 25708, this should not be construed as limiting. For example, in certain examples, a continuous sensor may be disposed on the distal nose 25718 of the anvil 25710.

In various aspects, a surgical instrument comprising an end effector 25700 as shown in FIGS. 128-134 can be a handheld surgical instrument. Alternatively, the end effector 25700 may be incorporated into the robotic system as a component of the robotic arm. Further details of the robotic system are disclosed in US Provisional Patent 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 comprising an end effector 25700 as shown in FIGS. 128-134 can be wired and/or wirelessly communicated as described in more detail with respect to FIGS. 1-11. It can be communicatively coupled to a surgical hub (eg, surgical hub 106 (FIGS. 3, 4), 206 (FIG. 206)) via a channel.

In various aspects, when tissue overhang is detected, display 473 may show at least a partial view of end effector 25700, such as, for example, a cartridge deck of staple cartridges 25708 with tissue overhanging therefrom. Additionally, impedance or other tissue compression estimation sensing means, or 3D stacking or other visualization means may be employed to further indicate the amount of overhanging tissue sensed between curved noses 25716 and 25718. good.

Various aspects of the subject matter described herein are illustrated in the following examples:
Example 1 - Surgical stapling instrument with an end effector. The end effector has a first jaw and a second jaw, the first jaw moving between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. a second jaw movable relative to the jaws. The end effector further comprises an anvil and staple cartridge. The staple cartridge includes staples deployable within tissue and deformable by the anvil. The surgical stapling system further comprises control circuitry. A control circuit determines tissue impedance in a predetermined zone, detects irregularities in tissue distribution within the end effector based on the tissue impedance, and adjusts a closure parameter of the end effector according to the irregularities. is configured to do and

Example 2 - The surgical stapling instrument of Example 1, wherein the end effector comprises sensing circuitry in the predetermined zone.

Example 3 - The surgical stapling instrument of Example 1 or 2, wherein the predetermined zones are separated by insulating elements.

Example 4 - The surgical application of Example 1, 2, or 3, wherein the predetermined zones include an inner predetermined zone, an outer predetermined zone, and an intermediate predetermined zone between the inner predetermined zone and the outer predetermined zone. stapling device.

Example 5 - Detecting tissue distribution irregularities within the end effector includes determining that the average of tissue impedance in the inner predetermined zone and the outer predetermined zone is greater than the tissue impedance in the intermediate predetermined zone; The surgical stapling instrument of Example 4.

Example 6 - Detecting tissue distribution irregularities within the end effector causes the control circuit to alert the user to release and reposition the tissue grasped by the end effector, Examples 1, 2, 6. The surgical stapling instrument of 3, 4 or 5.

Example 7 - Detecting tissue distribution irregularities within the end effector includes determining that the average tissue impedance in the inner predetermined zone and the outer predetermined zone is less than or equal to the tissue impedance in the intermediate predetermined zone; The surgical stapling instrument of Example 4. Detecting tissue distribution irregularities 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—Further comprising a motor configured to induce the end effector to transition into a closed configuration, and detecting irregularities in tissue distribution within the end effector to cause the control circuit to slow down the motor. , Example 1, 2, 3, 4, 5, 6, or 7.

Example 9 - The surgical stapling instrument of Example 1, 2, 3, 4, 5, 6, 7, or 8, wherein the closure parameter is closure speed.

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

Example 11 - A surgical stapling instrument for stapling previously stapled tissue includes a shaft defining a longitudinal axis extending therethrough and an end effector extending from the shaft. Prepare. The end effector has a first jaw and a second jaw, the first jaw moving between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. a second jaw movable relative to the jaws. The end effector further comprises an anvil and staple cartridge. The staple cartridge includes staples deployable within previously stapled tissue and deformable by the anvil. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. The surgical stapling system further comprises circuitry. The circuit measures tissue impedance in the predetermined zone, compares the measured tissue impedance to a predetermined tissue impedance signature in the predetermined zone, and determines from the comparison the previously stapled tissue in the end effector. and detecting irregularities in at least one of the position and orientation of the .

Example 12—The surgical stapling instrument of Example 11, wherein the end effector includes sensing circuitry in the predetermined zone.

Example 13 - The surgical stapling instrument of Example 11 or 12, wherein the predetermined zones are separated by insulating elements.

[00130] Example 14 - The surgical stapling instrument of Example 11, 12, or 13, wherein the predetermined zones are circumferentially arranged about the longitudinal axis.

Example 15 - The surgical stapling instrument of example 11, 12, 13, or 14, wherein detecting the irregularity causes the control circuit to alert the user.

Example 16 - Examples 11, 12, 13, 14, or 15, wherein the control circuit is configured to pass at least one treatment signal through tissue in each of the predetermined zones to determine tissue impedance A surgical stapling instrument as described in .

Example 17 - A surgical stapling instrument comprises an end effector. The end effector has a first jaw and a second jaw, the first jaw moving between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. a second jaw movable relative to the jaws. The end effector further comprises an anvil and staple cartridge. The staple cartridge includes staples deployable within tissue and deformable by the anvil. The end effector further comprises a predetermined zone between the anvil and the staple cartridge. The surgical stapling instrument further comprises control circuitry. The control circuit determines an electrical parameter of tissue in each of the predetermined zones, detects irregularities in tissue distribution within the end effector based on the determined electrical parameters, and and adjusting the closure parameter of the end effector according to.

Example 18 - The surgical stapling instrument of example 17, wherein the end effector comprises sensing circuitry in the predetermined zone.

Example 19 - The surgical stapling instrument of Example 17 or 18, wherein the predetermined zones are separated by insulating elements.

Example 20 - The surgical stapling instrument of Example 17, 18, or 19, wherein the closure parameter is closure speed.

The foregoing detailed description has described various aspects of apparatus and/or processes using block diagrams, flowcharts, and/or examples. To the extent such block diagrams, flowcharts, and/or embodiments include one or more functions and/or operations, it should be understood by those skilled in the art that such block diagrams, flowcharts, and/or examples Each function and/or operation included in the embodiments may be implemented individually and/or collectively by various hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will appreciate that all or part of some aspects of the forms disclosed herein can be understood as one or more computer programs (e.g., one or more computer programs) running on one or more computers. as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., one or more as one or more programs running on a microprocessor), as firmware, or substantially any combination thereof, equivalently embodied on an integrated circuit; , and/or writing software and/or firmware code is within the skill of one of ordinary skill in the art in view of the present disclosure. Moreover, those skilled in the art will appreciate that the subject matter described herein may be distributed in a variety of forms as one or more program products, and is incorporated herein by reference. The specific forms of subject matter described are used regardless of the particular type of signal-bearing medium used to implement the distribution.

Instructions used to program logic to perform various disclosed aspects may be stored in system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage devices. . Additionally, the instructions may be distributed over a network or by other computer-readable media. Thus, a machine-readable medium can include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including floppy diskettes, optical discs, compact discs, read-only memories (CDs), -ROM), as well as magneto-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, Flash memory or tangible machine storage used to transmit information over the Internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.) Not limited to devices. Accordingly, 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 herein, the term "control circuitry" includes, for example, hardwired circuits, programmable circuits (e.g., computer processors including one or more individual instruction processing cores, processing units , processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic unit (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuit, programmable circuit It can refer to firmware that stores instructions to be executed, and any combination thereof. Control circuits, collectively or individually, can be, for example, integrated circuits (ICs), application-specific integrated circuits (ASICs), systems-on-chips (SoCs), desktop computers, laptop computers, tablet computers, servers, smart phones, etc. , may be embodied as circuits forming part of a larger system. Thus, as used herein, "control circuit" includes an electrical circuit comprising at least one discrete electrical circuit, an electrical circuit comprising at least one integrated circuit, an electrical circuit comprising at least one application specific integrated circuit An electrical circuit, a general-purpose computing device configured with a computer program (e.g., a general-purpose computer configured with a computer program that executes, at least in part, the processes and/or apparatus described herein, or electrical circuits forming memory devices (e.g., in the form of random access memories), and/or communication devices ( Examples include, but are not limited to, electrical circuits forming modems, communications switches, or opto-electrical devices). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.

As used in any aspect herein, the term "logic" may refer to applications, software, firmware, and/or circuitry configured to perform any of the operations described above. Software may be embodied as software packages, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions, or sets of instructions in a memory device and/or hard-coded (eg, non-volatile) data.

As used in any aspect of this specification, the terms “component,” “system,” “module,” etc. refer to either hardware, a combination of hardware and software, software, or software in execution. can refer to a computer-related entity that is

As used in any aspect herein, "algorithm" refers to a self-consistent sequence of steps leading to a desired result; , comparison, and manipulation of physical quantities and/or logical states, which may take the form of electrical or magnetic signals capable of being otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.

The network may include packet switched networks. The communication devices can communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include Ethernet communication protocol, which may enable communication using Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" published December 2008 by the Institute of Electrical and Electronics Engineers (IEEE) and/or later versions of this standard. can be. Alternatively or additionally, the communication device may V.25 communication protocol can be used to communicate with each other. X. The V.25 communication protocol may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices can communicate with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or be 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 transceivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published in August 2001 by the ATM Forum under the title "ATM-MPLS Network Interworking 2.0" and/or later versions of this standard. . Of course, different and/or later developed connection-oriented network communication protocols are equally contemplated herein.

Unless expressly specified otherwise, terms such as "process", "calculate", "calculate", "determine", "display", etc. are used throughout the foregoing disclosure as is apparent from the foregoing disclosure. Discussions using the term refer to data represented as physical (electronic) quantities in computer system registers and memory as physical quantities in computer system memory or registers or in any such information storage, transmission, or display device. It will be understood to refer to the actions and processes of a computer system or similar electronic computing device that manipulates and transforms other data that may be similarly represented.

As used herein, one or more components are “configured to,” “configurable to,” “operable/to operable/operative to, adapted/adaptable, capable to, conformable/conformed to)”, etc. Those skilled in the art will understand that "configured to" generally refers to active components and/or inactive components and/or standby configurations, unless the context requires otherwise. It will be understood that it may contain elements.

The terms "proximal" and "distal" are used herein with reference to the clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located farther from the clinician. It will be further appreciated that for convenience and clarity, spatial terms such as "vertical," "horizontal," "above," and "below" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Those skilled in the art will appreciate that the terms used herein generally, and particularly in the appended claims (e.g., the appended claim text), are generally intended as "open" terms. (e.g., the term "including" is to be interpreted as "including but not limited to"; the term "having" is to be interpreted as "including but not limited to"); should be interpreted as "having at least" and the term "includes" should be interpreted as "includes but is not limited to" should be done, etc.). Moreover, where a particular number is intended in an introduced claim recitation, such intent is expressly recited in the claim; and in the absence of such a statement, such intent does not exist. will be understood by those skilled in the art. For example, as an aid to understanding, the following appended claims use the introductory phrases "at least one" and "one or more" to introduce claim recitations. may be included to However, the use of such phrases may be used even if the introductory phrases such as "one or more" or "at least one" are used within the same claim when the claim recitations are introduced by the indefinite article "a" or "an." and any particular claim containing such an introduced claim recitation is limited to the claim containing only one such recitation, even if the indefinite articles "a" or "an" are included. (e.g., "a" and/or "an" should generally be construed to mean "at least one" or "one or more ). the same holds true where the definite article is used to introduce claim recitations.

Moreover, even if a specific number is specified in the introduced claim statement, such statement should typically be construed to mean at least the stated number. , as will be recognized by those skilled in the art (e.g., where there is simply a statement "two statements" without other modifiers, generally there are at least two statements, or two or more statements matter). Further, where notations like "at least one of A, B, and C, etc." are used, such syntax is generally intended in the sense that one skilled in the art would understand the notation (e.g. , "a system having at least one of A, B, and C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C, and/or all of A and B and C, etc.). Where notations like "at least one of A, B, or C, etc." are used, such syntax is generally intended in the sense that one skilled in the art would understand the notation (e.g., " A system having at least one of A, B, or C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C (including systems having both, and/or all of A and B and C, etc.). Further, typically any disjunctive word and/or phrase representing two or more alternative terms is used in the specification unless the context requires otherwise. It is understood to be intended to include one of the terms, either of the terms, or both terms, whether in the claims, or in the drawings. Those skilled in the art will understand that it should. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B."

With regard to the appended claims, those skilled in the art will understand that the operations recited herein can generally be performed in any order. Additionally, while the flow diagrams of various acts are depicted in sequence(s), it is understood that the various acts may occur in orders other than those illustrated, or may occur simultaneously. It should be. Examples of such alternative orderings include overlapping, interleaving, interrupting, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context requires otherwise. may include Further, terms such as "response to", "related to", or other past tense adjectives generally exclude such variations unless the context dictates otherwise. not intended.

Any reference to "an aspect", "an aspect", "exemplary", "an example", etc., includes in at least one aspect the particular feature, structure, or property described in connection with that aspect. It is worth noting that it means Thus, the appearances of the phrases "in one aspect," "in an aspect," "in an example," and "in an example" in various places throughout this specification do not necessarily all refer to the same aspect. Moreover, the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects.

Any patent applications, patents, non-patent publications, or other disclosure material referenced herein and/or listed in any application data sheet is, to the extent the material incorporated herein, is not inconsistent with this specification. , incorporated herein by reference. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting statements incorporated herein by reference. Any content, or portion thereof, that is inconsistent with the current definitions, opinions, or other disclosures set forth herein, is hereby incorporated by reference, but the reference content and the current disclosure are hereby incorporated by reference. References shall be made only to the extent that there is no inconsistency between

In summary, a number of benefits have been described that result from using the concepts described herein. The foregoing description of one or more aspects has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to be limited to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. One or more of the embodiments illustrate principles and practical applications, thereby making the various forms, with various modifications, available to those skilled in the art as suitable for the particular use envisioned. It is selected and described for the purpose. It is intended that the claims presented herewith define the overall scope.

[Mode of implementation]
(1) A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw , a second jaw, and
anvil and
a staple cartridge deployable within the tissue and containing staples deformable by the anvil;
A control circuit,
determining tissue impedance in a given zone;
detecting tissue distribution irregularities within the end effector based on the tissue impedance;
a control circuit configured to: adjust closure parameters of the end effector according to the irregularity.
(2) The surgical stapling instrument of paragraph 1, wherein the end effector includes sensing circuitry in the predetermined zone.
(3) A surgical stapling instrument according to Clause 2, wherein said predetermined zones are separated by insulating elements.
(4) the predetermined zone is
an inner predetermined zone;
an outer predetermined zone;
and an intermediate predetermined zone between the inner predetermined zone and the outer predetermined zone.
(5) detecting the irregularities in tissue distribution within the end effector, wherein an average of the tissue impedance in the inner predetermined zone and the outer predetermined zone is greater than the tissue impedance in the intermediate predetermined zone; 5. The surgical stapling instrument of embodiment 4, comprising determining.

6. An embodiment wherein detecting said irregularities in tissue distribution within said end effector causes said control circuit to alert a user to release and reposition said tissue grasped by said end effector. 6. The surgical stapling instrument according to 5.
(7) detecting said irregularities in tissue distribution within said end effector;
determining that the average of the tissue impedances in the inner predetermined zone and the outer predetermined zone is less than or equal to the tissue impedance in the intermediate predetermined zone;
and determining that the tissue impedance of the inner predetermined zone is greater than the tissue impedance of the outer predetermined zone.
(8) further comprising a motor configured to induce the end effector to transition to the closed configuration, wherein detecting the irregularities in tissue distribution within the end effector causes the control circuit to 8. A surgical stapling instrument according to embodiment 7, which reduces the speed of .
Clause 9. The surgical stapling instrument of clause 1, wherein the closure parameter is closure speed.
Clause 10. The surgical stapling of clause 1, wherein the control circuit is configured to pass at least one treatment signal through tissue in each of the predetermined zones to determine the tissue impedance. instrument.

(11) A surgical stapling instrument for stapling previously stapled tissue, comprising:
a shaft defining a longitudinal axis extending through the interior;
an end effector extending from the shaft, comprising:
a first jaw;
a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw , a second jaw, and
anvil and
a staple cartridge containing staples deployable within the previously stapled tissue and deformable by the anvil;
a predetermined zone between the anvil and the staple cartridge; and
a circuit,
measuring tissue impedance in the predetermined zone;
comparing the measured tissue impedance to a predetermined tissue impedance signature of the predetermined zone;
and detecting irregularities in at least one of position and orientation of the previously stapled tissue within the end effector from the comparison. , surgical stapling instrument.
Clause 12. The surgical stapling instrument of clause 11, wherein the end effector includes sensing circuitry in the predetermined zone.
(13) A surgical stapling instrument according to Clause 12, wherein said predetermined zones are separated by insulating elements.
Clause 14. The surgical stapling instrument of clause 13, wherein the predetermined zones are circumferentially arranged about the longitudinal axis.
Clause 15. The surgical stapling instrument of clause 11, wherein detecting the irregularity causes the control circuit to alert a user.

Clause 16. The surgical stapling of clause 11, wherein the control circuit is configured to pass at least one treatment signal through tissue in each of the predetermined zones to determine the tissue impedance. instrument.
(17) A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw , a second jaw, and
anvil and
a staple cartridge containing staples deployable within the tissue and deformable by the anvil;
a predetermined zone between the anvil and the staple cartridge; and
A control circuit,
determining electrical parameters of the tissue in each of the predetermined zones;
detecting tissue distribution irregularities within the end effector based on the determined electrical parameter;
a control circuit configured to: adjust closure parameters of the end effector according to the irregularity.
Clause 18. The surgical stapling instrument of clause 17, wherein the end effector includes sensing circuitry in the predetermined zone.
(19) A surgical stapling instrument according to Clause 18, wherein said predetermined zones are separated by insulating elements.
(20) The surgical stapling instrument of Clause 17, wherein the closure parameter is closure speed.

Claims (20)

A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw , a second jaw, and
anvil and
a staple cartridge deployable within the tissue and containing staples deformable by the anvil;
A control circuit,
determining tissue impedance in each of the predetermined zones between the anvil and the staple cartridge ;
detecting tissue distribution irregularities within the end effector based on the tissue impedance;
a control circuit configured to: adjust closure parameters of the end effector according to the irregularity. The surgical stapling instrument of any one of the preceding claims, wherein the end effector includes sensing circuitry in the predetermined zone. The surgical stapling instrument of Claim 2, wherein the predetermined zones are separated by insulating elements. The predetermined zone is
an inner predetermined zone;
an outer predetermined zone;
and an intermediate predetermined zone between the inner predetermined zone and the outer predetermined zone. Detecting the irregularities in tissue distribution within the end effector includes determining that the average tissue impedance in the inner predetermined zone and the outer predetermined zone is greater than the tissue impedance in the intermediate predetermined zone. The surgical stapling instrument of claim 4, comprising: 6. The method of claim 5, wherein detecting the irregularities in tissue distribution within the end effector causes the control circuit to alert a user to release and reposition the tissue grasped by the end effector. surgical stapling instrument. Detecting the irregularities in tissue distribution within the end effector comprises:
determining that the average of the tissue impedances in the inner predetermined zone and the outer predetermined zone is less than or equal to the tissue impedance in the intermediate predetermined zone;
and determining that the tissue impedance of the inner predetermined zone is greater than the tissue impedance of the outer predetermined zone. further comprising a motor configured to guide the end effector into transition to the closed configuration, and detecting the irregularities in tissue distribution within the end effector to instruct the control circuit to adjust the speed of the motor; The surgical stapling instrument of Claim 7, wherein the surgical stapling instrument is lowered. The surgical stapling instrument according to claim 1, wherein the closure parameter is closure speed. The surgical stapling instrument of claim 1, wherein the control circuit is configured to pass at least one treatment signal through tissue in each of the predetermined zones to determine the tissue impedance. The surgical stapling instrument is for stapling previously stapled tissue, the surgical stapling instrument further comprising :
a shaft defining a longitudinal axis extending through the interior ;
the end effector extends from the shaft;
The control circuit is
measuring tissue impedance in the predetermined zone;
comparing the measured tissue impedance to a predetermined tissue impedance signature of the predetermined zone;
and detecting irregularities in at least one of position and orientation of the previously stapled tissue within the end effector from the comparison. surgical stapling instrument. The surgical stapling instrument according to claim 11, wherein the end effector includes sensing circuitry in the predetermined zone. The surgical stapling instrument of Claim 12, wherein the predetermined zones are separated by insulating elements. The surgical stapling instrument according to claim 13, wherein the predetermined zones are circumferentially arranged about the longitudinal axis. The surgical stapling instrument of claim 11, wherein detecting the irregularity causes the control circuit to alert a user. The surgical stapling instrument according to claim 11, wherein the control circuit is configured to pass at least one treatment signal through tissue in each of the predetermined zones to determine the tissue impedance. A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw , a second jaw, and
anvil and
a staple cartridge deployable within the tissue and containing staples deformable by the anvil;
A control circuit,
determining an electrical parameter of the tissue in each of predetermined zones between the anvil and the staple cartridge ;
detecting tissue distribution irregularities within the end effector based on the determined electrical parameter;
a control circuit configured to: adjust closure parameters of the end effector according to the irregularity. The surgical stapling instrument according to claim 17, wherein the end effector includes sensing circuitry in the predetermined zone. The surgical stapling instrument according to claim 18, wherein the predetermined zones are separated by insulating elements. The surgical stapling instrument according to claim 17, wherein the closure parameter is closure speed.

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