CN111566743B

CN111566743B - Surgical system for detecting end effector tissue distribution irregularities

Info

Publication number: CN111566743B
Application number: CN201880084568.2A
Authority: CN
Inventors: F·E·谢尔顿四世; J·L·哈里斯; T·S·威登豪斯; D·C·耶茨; C·E·埃克特; C·O·巴克斯特三世
Original assignee: Ethicon LLC
Current assignee: Ethicon LLC
Priority date: 2017-12-28
Filing date: 2018-09-21
Publication date: 2024-01-16
Anticipated expiration: 2038-09-21
Also published as: CN111566743A; BR112020013066A2; WO2019130087A1; JP7225249B2; JP2021509043A

Abstract

A surgical stapling instrument includes an end effector having: a first jaw; a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween; an anvil block; and a staple cartridge having staples deployable into the tissue and deformable by the anvil. The surgical stapling instrument further comprises control circuitry configured to: determining tissue impedance at a predetermined region; detecting irregularities in tissue distribution within the end effector based on the tissue impedance; and adjusting a closure parameter of the end effector based on the irregularity.

Description

Surgical system for detecting end effector tissue distribution irregularities

Cross Reference to Related Applications

This patent application claims priority from U.S. provisional patent application serial No. 62/691,227 entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS," filed on 6/28, at clause 119 (e) of the united states code, volume 35, the disclosure of which is incorporated herein by reference in its entirety.

The present application claims priority from U.S. provisional patent application Ser. No. 62/650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," U.S. provisional patent application Ser. No. 62/650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROL," filed on even date 30, U.S. provisional patent application Ser. No. 62/650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," filed on even date 30, and U.S. provisional patent application Ser. No. 62/650,898, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," filed on even date 30, and filed on even date 30, 2018, 35, the disclosure of each of which is incorporated herein by reference in its entirety.

This patent application also claims the priority benefits of U.S. provisional patent application serial No. 62/640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR" filed 3/8/2018 and provisional patent application serial No. 62/640,415 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR" filed 3/8/2018, as prescribed in clause 119 (e) of the united states code, the disclosure of each of which is incorporated herein by reference in its entirety.

The present patent application also claims the benefit of priority from U.S. provisional patent application Ser. No. 62/611,341, filed on U.S. code 35, clause 119 (e), and entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM) at 12, 28, and U.S. provisional patent application Ser. No. 62/611,340, filed on 12, 28, and entitled robotic assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM) at 35, filed on 28, and entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS), the disclosure of each of which is incorporated herein by reference in its entirety.

Background

The present disclosure relates to various surgical systems.

Disclosure of Invention

In various aspects, a surgical stapling instrument that includes an end effector is disclosed. The end effector includes: a first jaw; and a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween. The end effector further comprises an anvil and a staple cartridge. The staple cartridge includes staples that are deployable into the tissue and are deformable by the anvil. The surgical stapling system further comprises a control circuit. The control circuit is configured to determine tissue impedance at a predetermined region, detect an irregularity in tissue distribution within the end effector based on the tissue impedance, and adjust a closure parameter of the end effector according to the irregularity.

In various aspects, a surgical stapling instrument for stapling previously stapled tissue is disclosed. The surgical stapling instrument includes: a shaft defining a longitudinal axis extending therethrough; and an end effector extending from the shaft. The end effector includes: a first jaw; and a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween. The end effector further comprises an anvil and a staple cartridge. The staple cartridge includes staples that are deployable into the previously stapled tissue and are deformable by the anvil. The end effector further includes a predetermined region between the anvil and the staple cartridge. The surgical stapling instrument further includes an electrical circuit. The circuitry is configured to measure tissue impedance at the predetermined region, compare the measured tissue impedance to a predetermined tissue impedance characteristic of the predetermined region, and detect irregularities in at least one of a position and an orientation of the previously stapled tissue within the end effector based on the comparison.

In various aspects, a surgical stapling instrument that includes an end effector is disclosed. The end effector includes: a first jaw; and a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween. The end effector further comprises an anvil and a staple cartridge. The staple cartridge includes staples that are deployable into the tissue and are deformable by the anvil. The end effector further includes a predetermined region between the anvil and the staple cartridge. The surgical stapling instrument further includes a control circuit. The control circuit is configured to determine electrical parameters of the tissue at each of the predetermined regions, detect irregularities in tissue distribution within the end effector based on the determined electrical parameters, and adjust closure parameters of the end effector in accordance with the irregularities.

Drawings

The features of the various aspects are particularly described in the appended claims. The various aspects (related to surgical organization and methods) and further objects and advantages thereof, however, may best be understood by reference to the following description taken in conjunction with the accompanying drawings.

Fig. 1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

Fig. 2 is a surgical system for performing a surgical procedure in an operating room in accordance with at least one aspect of the present disclosure.

Fig. 3 is a surgical hub paired with a visualization system, robotic system, and intelligent instrument, in accordance with at least one aspect of the present disclosure.

Fig. 4 is a partial perspective view of a surgical hub housing and a combined generator module slidably received in a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure.

Fig. 5 is a perspective view of a combined generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation component in accordance with at least one aspect of the present disclosure.

Fig. 6 illustrates a single power bus attachment for a plurality of lateral docking ports of a lateral modular housing configured to slidably receive a plurality of modules in accordance with at least one aspect of the present disclosure.

Fig. 7 illustrates a vertical modular housing configured to slidably receive a plurality of modules in accordance with at least one aspect of the present disclosure.

Fig. 8 illustrates a surgical data network including a modular communication hub configured to enable connection of modular devices located in one or more operating rooms of a medical facility or any room in a medical facility dedicated to surgical operations to a cloud in accordance with at least one aspect of the present disclosure.

Fig. 9 is a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

Fig. 10 illustrates a surgical hub including a plurality of modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure.

Fig. 11 illustrates one aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.

Fig. 12 illustrates a logic diagram of a control system for a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 13 illustrates a control circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 14 illustrates a combinational logic circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 15 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 16 illustrates a surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure.

Fig. 17 is a schematic view of a robotic surgical instrument configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure.

Fig. 18 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure.

Fig. 19 is a schematic view of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure.

Fig. 20 is a stroke length graph illustrating an example of a control system modifying the stroke length of a clamp assembly based on articulation angle.

FIG. 21 is a closure tube assembly positioning graph illustrating an example of a control system modifying a longitudinal position of a closure tube assembly based on an articulation angle;

FIG. 22 is a comparison of a suturing method with controlled tissue compression and a suturing method without controlled tissue compression.

FIG. 23 is a force profile shown in section A and an associated displacement profile shown in section B, wherein the force profile and displacement profile have an x-axis defining time, the y-axis of the displacement profile defines travel displacement of the firing link, and the y-axis of the force profile defines torque force sensed on a motor configured to advance the firing link.

Fig. 24 is a schematic diagram showing a completed tissue contacting circuit of the electrical circuit when a pair of spaced apart contact plates are in contact with tissue.

Fig. 25 is a perspective view of a surgical instrument having an interchangeable shaft assembly operably coupled thereto in accordance with at least one aspect of the present disclosure.

Fig. 26 is an exploded assembly view of a portion of the surgical instrument of fig. 25 in accordance with at least one aspect of the present disclosure.

FIG. 27 is an exploded assembly view of a portion of an interchangeable shaft assembly according to at least one aspect of the present disclosure.

Fig. 28 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. 29A is a block diagram of a control circuit of the surgical instrument of fig. 25 spanning two pages in accordance with at least one aspect of the present disclosure.

Fig. 29B is a block diagram of a control circuit of the surgical instrument of fig. 25 spanning two pages in accordance with at least one aspect of the present disclosure.

Fig. 30 is a block diagram of the control circuit of the surgical instrument of fig. 25 showing interfaces between the handle assembly and the power assembly, and between the handle assembly and the interchangeable shaft assembly, in accordance with at least one aspect of the present disclosure.

Fig. 31 depicts an example medical device that may include one or more aspects of the present disclosure.

Fig. 32 depicts an exemplary end effector of a tissue-surrounding medical device in accordance with one or more aspects of the present disclosure.

Fig. 33 depicts an exemplary end effector of a medical device compressing tissue in accordance with one or more aspects of the present disclosure.

Fig. 34 depicts an exemplary force applied by an end effector of a medical device compressing tissue in accordance with one or more aspects of the present disclosure.

FIG. 35 also depicts exemplary forces applied by an end effector of a medical device compressing tissue in accordance with one or more aspects of the present disclosure.

FIG. 36 depicts an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure.

FIG. 37 also depicts an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure.

FIG. 38 also depicts an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure.

Fig. 39 is also an exemplary circuit diagram in accordance with one or more aspects of the present disclosure.

Fig. 40 is also an exemplary circuit diagram in accordance with one or more aspects of the present disclosure.

Fig. 41 is a graph depicting an exemplary frequency modulation in accordance with one or more aspects of the present disclosure.

Fig. 42 is a graph depicting a composite RF signal in accordance with one or more aspects of the present disclosure.

Fig. 43 is a graph depicting a filtered RF signal in accordance with one or more aspects of the present disclosure.

FIG. 44 is a perspective view of a surgical instrument having interchangeable shafts capable of articulation.

Fig. 45 is a side view of the distal end of a surgical instrument.

Fig. 46-50 are graphs plotting 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).

Fig. 51 is a graph plotting tissue compression as a function of tissue displacement for normal tissue.

Fig. 52 is a graph plotting tissue compression as a function of tissue displacement to distinguish normal tissue from diseased tissue.

FIG. 53 illustrates one embodiment of an end effector that includes a first sensor and a second sensor.

FIG. 54 is a logic diagram illustrating one embodiment of a process for adjusting the measurement of the first sensor based on input from the second sensor of the end effector shown in FIG. 53.

FIG. 55 is a logic diagram illustrating one embodiment of a process for determining a look-up table for a first sensor based on input from a second sensor.

FIG. 56 is a logic diagram illustrating one embodiment of a process for correcting a first sensor in response to an input from a second sensor.

FIG. 57 is a logic diagram illustrating one embodiment of a process for determining and displaying the thickness of a section of tissue clamped between an anvil and a staple cartridge of an end effector.

FIG. 58 is a logic diagram illustrating one embodiment of a process for determining and displaying the thickness of a section of tissue clamped between an anvil and a staple cartridge of an end effector.

FIG. 59 is a graph showing an adjusted Hall effect thickness measurement compared to an unmodified Hall effect thickness measurement.

FIG. 60 illustrates one embodiment of an end effector that includes a first sensor and a second sensor.

FIG. 61 illustrates one embodiment of an end effector comprising a first sensor and a plurality of second sensors.

FIG. 62 is a logic diagram illustrating one embodiment of a process for adjusting measurement results of a first sensor in response to a plurality of second sensors.

Fig. 63 illustrates one embodiment of a circuit configured to convert signals from a first sensor and a plurality of second sensors into digital signals that can be received by a processor.

FIG. 64 illustrates one embodiment of an end effector that includes a plurality of sensors.

FIG. 65 is a logic diagram illustrating one embodiment of a process for determining one or more tissue characteristics based on a plurality of sensors.

Fig. 66 illustrates one embodiment of an end effector including a plurality of sensors coupled to a second jaw member.

FIG. 67 illustrates one embodiment of a staple cartridge including a plurality of sensors integrally formed therein.

FIG. 68 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.

FIG. 69 illustrates one embodiment of an end effector that includes a plurality of redundant sensors.

FIG. 70 is a logic diagram illustrating one embodiment of a process for selecting the most reliable output from a plurality of redundant sensors.

FIG. 71 illustrates one embodiment of an end effector that includes a sensor that includes a particular sampling rate to limit or eliminate glitches.

FIG. 72 is a logic diagram illustrating one embodiment of a process for producing a thickness measurement of a tissue section positioned between an anvil and a staple cartridge of an end effector.

Fig. 73 and 74 illustrate one embodiment of an end effector that includes a sensor for identifying different types of staple cartridges.

Fig. 75 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.

Fig. 76 illustrates one aspect of a segmented flexible circuit configured to be mounted to a jaw member of an end effector in accordance with at least one aspect of the present disclosure.

Fig. 77 illustrates one aspect of an end effector configured to measure tissue gap GT in accordance with at least one aspect of the present disclosure.

Fig. 78 illustrates one aspect of an end effector including a segmented flexible circuit in accordance with at least one aspect of the present disclosure.

FIG. 79 illustrates the end effector illustrated in FIG. 78 with a jaw member clamping tissue therebetween, in accordance with at least one aspect of the present disclosure.

FIG. 80 is a diagram of an absolute positioning system of a surgical instrument, wherein the absolute positioning system includes a controlled motor drive circuit arrangement including a sensor arrangement, in accordance with at least one aspect of the present disclosure.

FIG. 81 is a diagram of a position sensor including a magnetic rotational absolute positioning system in accordance with at least one aspect of the present disclosure.

FIG. 82 is a cross-sectional view of an end effector of a surgical instrument showing a firing member stroke relative to tissue grasped within the end effector in accordance with at least one aspect of the present disclosure.

Fig. 83 is a first plot of two closing Force (FTC) curves depicting forces applied to the closing member to close over thick and thin tissue during the closing phase and a second plot of two firing force (FTF) curves depicting forces applied to the firing member to fire through thick and thin tissue during the firing phase.

FIG. 84 is a diagram of a control system configured to provide progressive closure of a closure member during a firing stroke as the firing member is advanced distally and coupled to a clamp arm to reduce the closure force load on the closure member and reduce the firing force load on the firing member at a desired rate in accordance with at least one aspect of the present disclosure.

FIG. 85 illustrates a proportional-integral-derivative (PID) controller feedback control system in accordance with at least one aspect of the disclosure.

FIG. 86 is a logic flow diagram depicting a process of a control program or logic configuration for determining a speed of a closure member in accordance with at least one aspect of the present disclosure.

Fig. 87 is a timeline depicting situational awareness of a surgical hub in accordance with at least one aspect of the present disclosure.

Fig. 88 illustrates a perspective view of an end effector of a curved surgical stapling and severing instrument including a predetermined region in accordance with at least one aspect of the present disclosure.

FIG. 89 illustrates a straightened partial cross-section of the end effector of the curved surgical stapling and severing instrument of FIG. 88 in accordance with at least one aspect of the present disclosure in which tissue is grasped by the end effector.

FIG. 90 illustrates a perspective view of an end effector of a surgical stapling and severing instrument including a predetermined area in accordance with at least one aspect of the present disclosure.

FIG. 91 illustrates a straightened partial cross-section of the end effector of the curved surgical stapling and severing instrument of FIG. 88 with tissue disposed between jaws of the end effector in accordance with at least one aspect of the present disclosure.

FIG. 92 illustrates a straightened partial cross-section of the end effector of the curved surgical stapling and severing instrument of FIG. 88 with tissue disposed between jaws of the end effector in accordance with at least one aspect of the present disclosure.

Fig. 93 illustrates a straightened partial cross-section of the end effector of the curved surgical stapling and severing instrument of fig. 88 with tissue disposed between jaws of the end effector in accordance with at least one aspect of the present disclosure.

Fig. 94 illustrates the tissue of fig. 91 grasped by the end effector of fig. 88 in accordance with at least one aspect of the present disclosure.

Fig. 95 illustrates the tissue of fig. 92 grasped by the end effector of fig. 88 in accordance with at least one aspect of the present disclosure.

Fig. 96 illustrates the tissue of fig. 93 grasped by the end effector of fig. 88 in accordance with at least one aspect of the present disclosure.

Fig. 97 illustrates a logic flow diagram depicting a process for identifying a control program or logic configuration for tissue distribution irregularities within an end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 98 is a graph representing tissue impedance measurements at three predetermined locations of the end effector of fig. 88 over time in accordance with at least one aspect of the present disclosure.

FIG. 99 is a graph plotting closure force of the end effector of FIG. 88 and motor rate of a motor to effect end effector closure around the tissue of FIG. 91 over time in accordance with at least one aspect of the present disclosure.

FIG. 100 is a graph plotting closure force of the end effector of FIG. 88 and motor rate of a motor to effect end effector closure over time representing tissue surrounding FIG. 92 in accordance with at least one aspect of the present disclosure.

FIG. 101 is a graph plotting closure force of the end effector of FIG. 88 and motor rate of a motor to achieve end effector closure over time representing tissue surrounding FIG. 93 in accordance with at least one aspect of the present disclosure.

FIG. 102 illustrates a control system for a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 103 illustrates a diagram of a surgical instrument centered on a linear staple transection line using the centering tool and techniques described in connection with fig. 104-106, in accordance with at least one aspect of the present disclosure.

Fig. 104-106 illustrate a process of aligning an anvil trocar of a circular stapler with a staple overlap portion of a linear staple line formed by a double stapling technique, in accordance with at least one aspect of the present disclosure, wherein:

FIG. 104 illustrates that the anvil trocar of the circular stapler is not aligned with the staple overlap portion of the linear staple line formed by the double stapling technique;

FIG. 105 illustrates the center alignment of the anvil trocar of the circular stapler with the staple overlap portion of the linear staple line formed by the double stapling technique; and

FIG. 106 illustrates a centering tool displayed on the surgical hub display showing the staple overlap of the linear staple lines formed by the double stapling technique to be cut by a circular stapler wherein the anvil trocar is not aligned with the staple overlap of the double staple lines as shown in FIG. 104.

Fig. 107 and 108 illustrate front and rear images of a centering tool in accordance with at least one aspect of the present disclosure, wherein:

FIG. 107 shows an image of the projected cutting path of the anvil trocar and circular knife prior to alignment with a target alignment ring defining an image of linear staple lines on an image of the staple overlap presented on the surgical hub display;

FIG. 108 shows an image of the projected cutting path of the anvil trocar and circular knife after alignment with a target alignment ring that defines an image of linear staple lines on an image of the staple overlap presented on the surgical hub display.

Fig. 109-111 illustrate a process of aligning an anvil trocar of a circular stapler with a center of a linear staple line, in accordance with at least one aspect of the present disclosure, wherein:

FIG. 109 illustrates an anvil trocar misaligned with the center of a linear staple line;

FIG. 110 illustrates an anvil trocar aligned with the center of a linear staple line;

FIG. 111 illustrates the centering tool shown on the surgical hub display of a linear staple line with the anvil trocar misaligned with the staple overlap portion of the dual staple line as shown in FIG. 109.

FIG. 112 is an image of a standard reticle field of view transected by a laparoscopic surgical linear staple line displayed on a surgical hub display in accordance with at least one aspect of the present disclosure.

FIG. 113 is an image of the laser assisted graticule field of view of the surgical site shown in FIG. 112 prior to the anvil trocar and circular knife of the circular stapler being aligned with the center of the linear staple line in accordance with at least one aspect of the present disclosure.

FIG. 114 is an image of a laser assisted graticule field of view of the surgical site shown in FIG. 113 after an anvil trocar and circular knife of a circular stapler are aligned with the center of a linear staple line in accordance with at least one aspect of the present disclosure.

FIG. 115 illustrates a partial perspective view of a circular stapler including a staple cartridge having four predetermined regions, in accordance with at least one aspect of the present disclosure.

FIG. 116 illustrates a partial perspective view of a circular stapler including a staple cartridge having eight predetermined regions, in accordance with at least one aspect of the present disclosure.

FIG. 117 illustrates two tissues on the left side including a previously deployed staple properly disposed onto the staple cartridge of FIG. 115 and two tissues on the right side including a previously deployed staple properly disposed onto the staple cartridge of FIG. 115 in accordance with at least one aspect of the present disclosure.

FIG. 118 illustrates tissue on the left side including previously deployed staples properly disposed onto the staple cartridge of FIG. 115 and tissue on the right side including previously deployed staples properly disposed onto the staple cartridge of FIG. 115 in accordance with at least one aspect of the present disclosure.

FIG. 119 illustrates two tissues including a previously deployed staple properly disposed onto the staple cartridge of FIG. 116 in accordance with at least one aspect of the present disclosure.

FIG. 120 illustrates two tissues including a previously deployed staple incorrectly disposed onto the staple cartridge of FIG. 116 in accordance with at least one aspect of the present disclosure.

Fig. 121 is a graph depicting tissue impedance characteristics of the properly positioned tissue of fig. 119, in accordance with at least one aspect of the present disclosure.

Fig. 122 is a graph depicting tissue impedance characteristics of incorrectly placed tissue of fig. 120, in accordance with at least one aspect of the present disclosure.

FIG. 123 illustrates tissue including previously deployed staples properly disposed onto the staple cartridge of FIG. 116 in accordance with at least one aspect of the present disclosure.

FIG. 124 illustrates tissue including previously deployed staples incorrectly disposed onto the staple cartridge of FIG. 116 in accordance with at least one aspect of the present disclosure.

Fig. 125 is a graph depicting tissue impedance characteristics of the properly positioned tissue of fig. 123, in accordance with at least one aspect of the present disclosure.

Fig. 126 is a graph depicting tissue impedance characteristics of incorrectly placed tissue of fig. 124, in accordance with at least one aspect of the present disclosure.

Fig. 127 illustrates a logic flow diagram of process 25600 depicting 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.

Fig. 128 illustrates an end effector extending from a shaft of a surgical instrument in an open configuration in accordance with at least one aspect of the present disclosure.

Fig. 129 illustrates the end effector of fig. 128 with a Blood Vessel (BV) extending between jaws of the end effector, in accordance with at least one aspect of the present disclosure.

Fig. 130 illustrates the end effector of fig. 128 in a closed configuration without tissue in accordance with at least one aspect of the present disclosure.

Fig. 131 illustrates the end effector of fig. 128 with tissue grasped between the jaws of the end effector in accordance with at least one aspect of the present disclosure.

Fig. 132 illustrates an end effector extending from a shaft of a surgical instrument in an open configuration in accordance with at least one aspect of the present disclosure.

FIG. 133 illustrates the end effector of FIG. 128 in a closed configuration without tissue in accordance with at least one aspect of the present disclosure.

FIG. 134 illustrates the end effector of FIG. 128 with tissue grasped between the jaws of the end effector in accordance with at least one aspect of the present disclosure.

Detailed Description

The applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 2018, 6, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. patent application Ser. No. __________ entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS" attorney docket number END8542USNP/170755;

U.S. patent application Ser. No. __________, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS", attorney docket number END8543USNP/170760;

U.S. patent application Ser. No. __________, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION", attorney docket number END8543USNP1/170760-1;

U.S. patent application Ser. No. __________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", attorney docket number END8543USNP2/170760-2;

U.S. patent application Ser. No. __________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", attorney docket number END8543USNP3/170760-3;

U.S. patent application Ser. No. __________, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES", attorney docket number END8543USNP4/170760-4;

U.S. patent application Ser. No. __________, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE", attorney docket number END8543USNP5/170760-5;

U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES", attorney docket number END8543USNP6/170760-6;

U.S. patent application Ser. No. __________, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", attorney docket number END8543USNP7/170760-7;

U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", attorney docket number END8544USNP/170761;

U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT", attorney docket number END8544USNP1/170761-1;

U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY", attorney docket number END8544USNP2/170761-2;

U.S. patent application Ser. No. __________, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES", attorney docket number END8544USNP3/170761-3;

U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL," attorney docket number END8545USNP/170762;

U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS", attorney docket number END8545USNP1/170762-1;

U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION FLOW PATHS", attorney docket number END8545USNP2/170762-2;

U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL", attorney docket number END8545USNP3/170762-3;

U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND DISPLAY", attorney docket number END8545USNP4/170762-4;

U.S. patent application Ser. No. __________, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM", attorney docket number END8546USNP/170763;

U.S. patent application Ser. No. __________, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM", attorney docket number END8546USNP1/170763-1;

U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE", attorney docket number END8547USNP/170764; and

U.S. patent application Ser. No. __________ entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS", attorney docket number ND8548USNP/170765.

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 28 th 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application Ser. No. 62/691,228 entitled method (A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES) of using an enhanced flex circuit with multiple sensors with electrosurgical devices;

U.S. provisional patent application Ser. No. 62/691,230 entitled surgical instrument (SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE) with flexible electrode;

U.S. provisional patent application Ser. No. 62/691,219 entitled surgical drainage sensing and MOTOR CONTROL (SURGICAL EVACUATION SENSING AND MOTOR CONTROL);

U.S. provisional patent application serial No. 62/691,257 entitled delivery of smoke evacuation system parameters to a hub or cloud (COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) in a smoke evacuation module for an interactive surgical platform;

U.S. provisional patent application serial No. 62/691,262 entitled surgical evacuation system (SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE) having communication circuitry for communication between the filter and the fume extractor; and

U.S. provisional patent application Ser. No. 62/691,251 entitled DUAL inline large DROPLET filter and small DROPLET filter (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS);

the applicant of the present patent application owns the following U.S. patent applications filed on day 29, 3, 2018, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. patent application Ser. No. 15/940,641 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES) with encrypted communication capability;

U.S. patent application Ser. No. 15/940,648 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA Capobilities) with conditional processing apparatus and data CAPABILITIES;

U.S. patent application Ser. No. 15/940,656 entitled surgical hub coordination of operating room device control and communication (SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES);

U.S. patent application Ser. No. 15/940,666 entitled spatial perception of surgical hubs in operating theatres (SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS);

U.S. patent application Ser. No. 15/940,670, entitled cooperative utilization of data exported from a secondary source by a smart surgical hub (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 arrangement;

U.S. patent application Ser. No. 15/940,632, entitled data stripping method (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD) for querying patient records for data and creating anonymous records;

U.S. patent application Ser. No. 15/940,640 entitled communication hub and storage device (COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS) for storing parameters and conditions of surgical devices to be shared with CLOUD-BASED analysis systems;

U.S. patent application Ser. No. 15/940,645 entitled SELF-DESCRIBING data packet (SELF describe DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT) generated at an issuing instrument;

U.S. patent application Ser. No. 15/940,649, entitled data pairing (DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME) for interconnecting device measurement parameters with results;

U.S. patent application Ser. No. 15/940,654 entitled surgical hub situational awareness (SURGICAL HUB SITUATIONAL AWARENESS);

U.S. patent application Ser. No. 15/940,663, entitled surgical System distributed processing (SURGICAL SYSTEM DISTRIBUTED PROCESSING);

U.S. patent application Ser. No. 15/940,668 entitled aggregation and reporting of surgical hub data (AGGREGATION AND REPORTING OF SURGICAL HUB DATA);

U.S. patent application Ser. No. 15/940,671, entitled SURGICAL HUB space perception (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER) for determining devices in an operating room;

U.S. patent application Ser. No. 15/940,686, entitled TO display alignment of staple cartridge with previous linear staple lines (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 display (STERILE FIELD INTERACTIVE CONTROL display);

U.S. patent application Ser. No. 15/940,629, entitled COMPUTER-implemented Interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);

U.S. patent application Ser. No. 15/940,704, entitled determination OF the characteristics OF backscattered light using laser and red-GREEN-blue color development (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT);

U.S. patent application Ser. No. 15/940,722, entitled tissue irregularities characterized by using monochromatic light refractive index (CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY); and

U.S. patent application Ser. No. 15/940,742 entitled Dual Complementary Metal Oxide Semiconductor (CMOS) array imaging (DUAL CMOS ARRAY IMAGING);

U.S. patent application Ser. No. 15/940,636 entitled adaptive control program update for surgical devices (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);

U.S. patent application Ser. No. 15/940,653, entitled adaptive control program update for surgical hubs (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS);

U.S. patent application Ser. No. 15/940,660, entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER) for customization and recommendation to users;

U.S. patent application Ser. No. 15/940,679 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET) for linking local usage trends with resource acquisition behavior of larger datasets;

U.S. patent application Ser. No. 15/940,694 entitled CLOUD-BASED medical analysis of medical facilities FOR personalizing instrument function segments (CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION);

U.S. patent application Ser. No. 15/940,634 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES) for security and authentication trend and reactivity measurements;

U.S. patent application Ser. No. 15/940,706, entitled data processing and priority (DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK) in a cloud analysis network; and

U.S. patent application Ser. No. 15/940,675, entitled cloud interface (CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES) for a coupled surgical device;

U.S. patent application Ser. No. 15/940,627, entitled drive arrangement FOR robotic-assisted surgical platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,637 entitled communication arrangement for robotic-assisted surgical platforms (COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,642, entitled control for robotic-assisted surgical platforms (CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,676, entitled automatic tool adjustment for robotic-assisted surgical platforms (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,680, entitled controller for robotic-assisted surgical platform (CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,683, entitled cooperative surgical action for robotic-assisted surgical platform (COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,690 entitled display arrangement FOR robotic-assisted surgical platform (DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS); and

U.S. patent application Ser. No. 15/940,711, entitled sensing arrangement FOR robotic-assisted surgical platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on day 28, 3, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application Ser. No. 62/649,302 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES) with encrypted communication capability;

U.S. provisional patent application Ser. No. 62/649,294 entitled data stripping method (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD) for querying patient records and creating anonymous records;

U.S. provisional patent application Ser. No. 62/649,300, entitled surgical hub situational awareness (SURGICAL HUB SITUATIONAL AWARENESS);

U.S. provisional patent application Ser. No. 62/649,309, entitled SURGICAL HUB space perception (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER) for determining devices in an operating room;

U.S. provisional patent application Ser. No. 62/649,310 entitled COMPUTER-implemented interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);

U.S. provisional patent application Ser. No. 62/649291, entitled determination OF the characteristics OF backscattered light using laser and red-GREEN-blue color development (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT);

U.S. provisional patent application Ser. No. 62/649,296, entitled adaptive control program update for surgical devices (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);

U.S. provisional patent application Ser. No. 62/649,333 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER) for customization and recommendation to a user;

U.S. provisional patent application Ser. No. 62/649,327 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES) for security and authentication trend and reactivity measurements;

U.S. provisional patent application Ser. No. 62/649,315, entitled data processing and priority in a cloud analysis network (DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK);

U.S. provisional patent application serial No. 62/649,313 entitled cloud interface (CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES) for a coupled surgical device;

U.S. provisional patent application Ser. No. 62/649,320 entitled drive arrangement FOR robotic-assisted surgical platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. provisional patent application Ser. No. 62/649,307 entitled automatic tool adjustment for robotic-assisted surgical platforms (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS); and

U.S. provisional patent application Ser. No. 62/649,323, entitled sensing arrangement FOR robotic-assisted surgical platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on date 19 of 2018, 4, the disclosures of which are incorporated herein by reference in their entirety:

U.S. provisional patent application Ser. No. 62/659,900, entitled hub communication method (METHOD OF HUB COMMUNICATION);

the applicant of the present patent application owns the following U.S. provisional patent applications filed on 3.30.2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application Ser. No. 62/650,887 entitled SURGICAL System with optimized sensing capability (SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES);

U.S. provisional patent application Ser. No. 62/650,877 entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROL";

U.S. provisional patent application Ser. No. 62/650,882 entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; and

U.S. provisional patent application Ser. No. 62/650,898 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS".

The applicant of the present patent application owns the following U.S. provisional patent applications filed on day 3, 8 of 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application serial No. 62/640,417 entitled temperature control in an ultrasound device and control system therefor (TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR); and

U.S. provisional patent application Ser. No. 62/640,415 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR".

The applicant of the present patent application owns the following U.S. provisional patent applications filed on date 28 of 2017, 12, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)";

U.S. provisional patent application Ser. No. 62/611,340, entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS); and

U.S. provisional patent application Ser. No. 62/611,339, entitled robotic-assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM);

before explaining aspects of the surgical device and generator in detail, it should be noted that the exemplary embodiment is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments for the convenience of the reader and are not for the purpose of limitation. Moreover, it is to be understood that the expression of one or more of the aspects, and/or examples described below may be combined with any one or more of the expression of other aspects, and/or examples described below.

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

Fig. 3 illustrates an example of a surgical system 102 for performing a surgical procedure on a patient lying on an operating table 114 in a surgical operating room 116. The robotic system 110 is used as part of the surgical system 102 in a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robotic hub 122. When the surgeon views the surgical site through the surgeon's console 118, the patient-side cart 120 may manipulate at least one removably coupled surgical tool 117 through a minimally invasive incision in the patient. Images of the surgical site may be obtained by a medical imaging device 124 that may be maneuvered by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 may 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 may be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,339 entitled robotic-assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM), filed on date 28 of 2017, the disclosure of which is incorporated herein by reference in its entirety.

Various examples of CLOUD-BASED analysis performed by the CLOUD 104 and suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS)" filed on date 12, 2017, the disclosure of which is incorporated herein by reference in its entirety.

In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge Coupled Device (CCD) sensors and Complementary Metal Oxide Semiconductor (CMOS) sensors.

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

The one or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye, and may be referred to as visible light or simple light. A typical human eye will respond to wavelengths in the air of about 380nm to about 750 nm.

The invisible spectrum (i.e., the non-emission spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380nm and above about 750 nm). The human eye cannot detect the invisible spectrum. Wavelengths greater than about 750nm are longer than the red visible spectrum, and they become invisible Infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380nm are shorter than the violet spectrum and they become invisible ultraviolet, x-ray and gamma-ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophageal-duodenal scopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroscopes.

In one aspect, the imaging device employs multispectral monitoring to distinguish between topography and underlying structures. Multispectral images are images that capture image data in a specific range of wavelengths across the electromagnetic spectrum. Wavelengths may be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and ultraviolet. Spectral imaging may allow extraction of additional information that the human eye fails to capture with its red, green and blue receptors. Use of multispectral imaging is described in more detail under the heading "advanced imaging acquisition module (Advanced Imaging Acquisition Module)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on month 12, 2017, the disclosure of which is incorporated herein by reference in its entirety. After completing a surgical task to perform one or more of the previously described tests on the treated tissue, multispectral monitoring may be a useful tool for repositioning the surgical site.

It is self-evident that the operating room and surgical equipment need to be strictly sterilized during any surgical procedure. The stringent sanitary and sterilization conditions required in the "surgery room" (i.e., operating or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize the patient or any substance penetrating the sterile field, including the imaging device 124 and its attachments and components. It should be understood that a sterile field may be considered a designated area that is considered to be free of microorganisms, such as within a tray or within a sterile towel, or a sterile field may be considered an area surrounding a patient that is ready for a surgical procedure. The sterile field may include scrubbing team members that are properly worn, as well as all furniture and fixtures in the area.

In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays strategically placed with respect to the sterile field, as shown in fig. 2. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "advanced imaging acquisition module (Advanced Imaging Acquisition Module)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on date 28 of 2017, the disclosure of which is incorporated herein by reference in its entirety.

As shown in fig. 2, the main display 119 is positioned in the sterile field to be visible to an operator at the operating table 114. Furthermore, 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. The visualization system 108, guided by the hub 106, is configured to be able to coordinate the information flow to operators inside and outside the sterile field using the displays 107, 109 and 119. For example, hub 106 may cause imaging 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 real-time feed of the surgical site on main display 119. The snapshot on the non-sterile display 107 or 109 may allow a non-sterile operator to, for example, perform diagnostic steps related to a surgical procedure.

In one aspect, the hub 106 is further configured to be able to route diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower 111 to a main display 119 within the sterile field, where it is viewable by a sterile operator on the console. In one example, the input may be a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be routed through the hub 106 to the main display 119.

Referring to fig. 2, a surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. Hub 106 is also configured to coordinate the flow of information to the display of surgical instrument 112. For example, U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on month 12, 2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower 111 may be routed by the hub 106 to a surgical instrument display 115 within the sterile field, where the inputs or feedback may be observed by an operator of the surgical instrument 112. An exemplary surgical instrument suitable for use in surgical system 102 is described under the heading "surgical instrument hardware (Surgical Instrument Hardware)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on date 12/28 in 2017, the disclosure of which is incorporated herein by reference in its entirety.

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

During surgical procedures, energy application to tissue for sealing and/or cutting is often associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of tissue. Fluid lines, power lines, and/or data lines from different sources are often entangled during a surgical procedure. Solving this problem during a surgical procedure can lose valuable time. Disconnecting the pipeline may require disconnecting the pipeline from its respective module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of entanglement between such lines.

Aspects of the present disclosure provide a surgical hub for a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably received in a docking bay of the hub housing. The docking station includes a data contact and a power contact. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component that are housed in a single unit. In one aspect, the combination generator module further comprises a smoke evacuation component for connecting the combination generator module to at least one energy delivery cable of the surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluids and/or particulates generated by application of therapeutic energy to tissue, 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 the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.

Certain surgical procedures may require more than one type of energy to be applied to tissue. One energy type may be more advantageous for cutting tissue, while a different energy type may be more advantageous for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to house different generators and facilitate interactive communication therebetween. One of the advantages of the hub modular housing 136 is the ability to quickly remove and/or replace various modules.

Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking mount including a first docking port including a first data and power contact, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contact.

Further to the above, the modular surgical housing further comprises a second energy generator module configured to generate a second energy different from the first energy for application to the tissue, and a second docking station comprising a second docking port comprising a second data and power contact, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the second energy generator module is slidably movable out of electrical engagement with the second power and data contact.

In addition, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

Referring to fig. 3-7, aspects of the present disclosure are presented as a hub modular housing 136 that allows for modular integration of the generator module 140, smoke evacuation module 126, and suction/irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. As shown in fig. 5, the generator module 140 may be a generator module with integrated monopolar, bipolar and ultrasonic components supported in a single housing unit 139 slidably inserted into the hub modular housing 136. As shown in fig. 5, the generator module 140 may be configured to be connectable to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. Alternatively, the generator module 140 may include a series of monopolar generator modules, bipolar generator modules, and/or an ultrasound generator module that interact through the hub modular housing 136. The hub modular housing 136 may be configured to facilitate interactive communication between the insertion and docking of multiple generators into the hub modular housing 136 such that the generators will act as a single generator.

In one aspect, the hub modular housing 136 includes a modular power and communication backplane 149 having external and wireless communication connectors to enable removable attachment of the modules 140, 126, 128 and interactive communication therebetween.

In one aspect, the hub modular housing 136 includes a docking bay 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 the surgical hub housing 136 and the combined generator module 145 slidably received in the docking cradle 151 of the surgical hub housing 136. Docking ports 152 having power and data contacts on the back of the combination generator module 145 are configured to engage the corresponding docking ports 150 with the power and data contacts of the corresponding docking bays 151 of the hub module housing 136 when the combination generator module 145 is slid into place within the corresponding docking bays 151 of the hub module housing 136. In one aspect, the combined generator module 145 includes a bipolar, ultrasound and monopolar module and a smoke evacuation module integrated together into a single housing unit 139, as shown in fig. 5.

In various aspects, smoke evacuation module 126 includes a fluid line 154, which fluid line 154 conveys trapped/collected smoke and/or fluid from the surgical site to, for example, smoke evacuation module 126. Vacuum suction from smoke evacuation module 126 may draw smoke into the opening of the common conduit at the surgical site. The common conduit coupled to the fluid lines may be in the form of a flexible tube terminating at smoke evacuation module 126. The common conduit and fluid lines define a fluid path extending toward the smoke evacuation module 126 slidably received in the hub housing 136.

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

In one aspect, a surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, a draft tube, and an irrigation tube. The draft tube may have an inlet at its distal end and the draft tube extends through the shaft. Similarly, the draft tube may extend through the shaft and may have an inlet adjacent the energy delivery tool. The energy delivery tool is configured to deliver ultrasonic energy and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the shaft.

The flush tube may be in fluid communication with a fluid source and the draft tube may be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed in the suction/irrigation module 128. In one example, a fluid source and/or a vacuum source may be housed in the hub housing 136 independently of the suction/irrigation module 128. In such examples, the fluid interface can 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 bays on the hub modular housing 136 may include an alignment feature configured to align the docking ports of the modules into engagement with their corresponding ports in the docking bays of the hub modular housing 136. For example, as shown in fig. 4, combined generator module 145 includes side brackets 155, side brackets 155 configured to slidably engage corresponding brackets 156 of corresponding docking bays 151 of hub module housing 136. The brackets cooperate to guide the mating port contacts of the combined generator module 145 into electrical engagement with the mating 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 size of the modules are adjusted to be received in 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, the drawers 151 are sized differently and each is designed to accommodate a particular module.

In addition, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting the module into a drawer having unmatched contacts.

As shown in fig. 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 by a communication link 157 to facilitate interactive communication between modules housed in the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 may facilitate wireless interactive communication between modules housed in the hub modular housing 136. Any suitable wireless communication may be employed, such as, for example, air titanium-Bluetooth.

Fig. 6 illustrates a single power bus attachment for a plurality of lateral docking ports of a lateral modular housing 160, the lateral modular housing 160 configured to slidably receive a plurality of modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally slidably receive and interconnect the modules 161. The modules 161 are slidably inserted into the docking base 162 of the lateral modular housing 160, which lateral modular housing 160 includes a floor for interconnecting the modules 161. As shown in fig. 6, the modules 161 are laterally disposed in a lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically in a lateral modular housing.

Fig. 7 illustrates a vertical modular housing 164 configured to slidably receive a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into a docking bay or drawer 167 of a vertical modular housing 164, the vertical modular housing 164 including a floor for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are vertically arranged, in some cases, the vertical modular housing 164 may include drawers that are laterally arranged. Further, the modules 165 may interact with each other through the docking ports of the vertical modular housing 164. In the example of fig. 7, a display 177 for displaying data related to the operation of module 165 is provided. Further, the vertical modular housing 164 includes a main module 178 that houses a plurality of sub-modules slidably received in the main module 178.

In various aspects, the imaging module 138 includes an integrated video processor and modular light source and is adapted for use with various imaging devices. In one aspect, an imaging device is constructed of a modular housing that may be fitted with a light source module and a camera module. The housing may be a disposable housing. In at least one example, the disposable housing is removably coupled to the reusable controller, the light source module, and the camera module. The light source module and/or the camera module may be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanning beam imaging. Also, the light source module may be configured to deliver white light or different lights, depending on the surgical procedure.

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

In one aspect, an imaging device includes a tubular housing including a plurality of channels. The first channel is configured to slidably receive a camera module, which may be configured for snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module, which may be configured for snap-fit engagement with the second channel. In another example, the camera module and/or the light source module may be rotated within their respective channels to a final position. Instead of snap-fit engagement, threaded engagement may be employed.

In various examples, multiple imaging devices are placed at different locations in a surgical field to provide multiple views. The imaging module 138 may be configured to be capable of switching between imaging devices to provide an optimal view. In various aspects, the imaging module 138 may be configured to be capable of integrating images from different imaging devices.

Various image processors and imaging devices suitable for use in the present disclosure are described in U.S. patent 7,995,045, entitled combined SBI and conventional image processor (COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR), published 8.8.9 2011, which is incorporated by reference herein in its entirety. Furthermore, U.S. patent 7,982,776, entitled SBI motion artifact removal apparatus and method (SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD), published in 2011, 7, 19, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such a system may be integrated with the imaging module 138. In addition, U.S. patent application publication No.2011/0306840 entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS" published 12/15 in 2011 and U.S. patent application publication No.2014/0243597 entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE" published 28 in 2014, the disclosures of each of which are incorporated herein by reference in their entirety.

Fig. 8 illustrates a surgical data network 201 including a modular communication hub 203, the modular communication hub 203 configured to enable connection of modular devices located in one or more operating rooms of a medical facility or any room in a medical facility specifically equipped for surgical procedures to a cloud-based system (e.g., cloud 204, which may include remote server 213 coupled to storage device 205). In one aspect, modular communication hub 203 includes a network hub 207 and/or a network switch 209 in communication with a network router. Modular communication hub 203 may also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. The passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another device (or segment) and cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuring each port in the hub 207 or network switch 209. The 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 1a-1n located in an operating room may be coupled to a modular communication hub 203. The hub 207 and/or the network switch 209 may be coupled to a network router 211 to connect the devices 1a-1n to the cloud 204 or local computer system 210. The data associated with the devices 1a-1n may be transmitted via routers to cloud-based computers for remote data processing and manipulation. Data associated with the devices 1a-1n may also be transmitted to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. The network switch 209 may be coupled to a network hub 207 and/or a network router 211 to connect the devices 2a-2m to the cloud 204. Data associated with the devices 2a-2n may be transmitted to the cloud 204 via the network router 211 for data processing and manipulation. The data associated with the devices 2a-2m may also be transmitted to the local computer system 210 for local data processing and manipulation.

It should be appreciated that the surgical data network 201 may be extended by interconnecting a plurality of network hubs 207 and/or a plurality of network switches 209 with a plurality of network routers 211. Modular communication hub 203 may be included in a modular control tower configured to slidably receive a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be contained in a modular control tower. Modular communication hub 203 is connected to display 212 to display images obtained by some of devices 1a-1n/2a-2m, for example, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m may include, for example, various modules such as a non-contact sensor module in an imaging module 138 coupled to 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 connected to a display, and/or other modular devices that may be connected to a modular communication hub 203 of a surgical data network 201.

In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(s), and network router(s) that connect the devices 1a-1n/2a-2m to the cloud. Any or all of the devices 1a-1n/2a-2m coupled to the hub or switch may collect data in real time and transmit the data into the cloud computer for data processing and manipulation. It should be appreciated that cloud computing relies on shared computing resources, rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "internet," although the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "types of internet-based computing" in which different services (such as servers, memory, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical room (e.g., stationary, mobile, temporary, or in-situ operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 through the internet. The cloud infrastructure may be maintained by a cloud service provider. In this case, the 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. The cloud computing service may perform a large amount of computation based on data collected by intelligent surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and memory.

Applying cloud computer data processing techniques to the data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical results, reduced costs and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m may be employed to observe tissue conditions to assess leakage or perfusion of sealed tissue following tissue sealing and cutting procedures. At least some of the devices 1a-1n/2a-2m may be employed to identify pathologies, such as the effects of a disease, and data including images of body tissue samples for diagnostic purposes may be examined using cloud-based computing. This includes localization and marginal confirmation of tissue and phenotype. At least some of the devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques, such as overlaying images captured by multiple imaging devices. The data (including image data) collected by the devices 1a-1n/2a-2m may be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. Such data analysis may further employ a result analysis process and may provide beneficial feedback using standardized methods to confirm or suggest modification of surgical treatment and surgeon behavior.

In one implementation, operating room devices 1a-1n may be connected to modular communication hub 203 via a wired channel or a wireless channel, depending on the configuration of devices 1a-1n to the hub. In one aspect, hub 207 may be implemented as a local network broadcaster operating on the physical layer of the Open Systems Interconnection (OSI) model. The hub provides a connection to the devices 1a-1n located in the same operating room network. The hub 207 collects the data in the form of packets and sends it to the router in half duplex mode. The hub 207 does not store any media access control/internet protocol (MAC/IP) for transmitting device data. Only one of the devices 1a-1n may transmit data through the hub 207 at a time. The hub 207 has no routing tables or intelligence about where to send information and broadcast all network data on each connection and all network data to the remote server 213 (fig. 9) through the cloud 204. Hub 207 may detect basic network errors such as collisions, but broadcasting all information to multiple ports may pose a security risk and cause bottlenecks.

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

The hub 207 and/or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 operates in the network layer of the OSI model. Network router 211 creates a route for transmitting data packets received from network hub 207 and/or network switch 211 to cloud-based computer resources to further process and manipulate data collected by any or all of devices 1a-1n/2a-2 m. Network router 211 may be employed to connect two or more different networks located at different locations, such as, for example, different operating rooms at the same medical facility or different networks located at different operating rooms at different medical facilities. The network router 211 sends data in packets to the cloud 204 and operates in full duplex mode. Multiple devices may transmit data simultaneously. The network router 211 uses the IP address to transmit data.

In one example, the hub 207 may be implemented as a USB hub that allows multiple USB devices to connect to a host. USB hubs can extend a single USB port to multiple tiers so that more ports are available to connect devices to a host system computer. Hub 207 may include wired or wireless capabilities for receiving information over a wired or wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in an operating room.

In other examples, operating room devices 1a-1n/2a-2m may communicate with modular communication hub 203 via bluetooth wireless technology standards for exchanging data from stationary devices and mobile devices and constructing Personal Area Networks (PANs) over short distances (using short wavelength UHF radio waves of 2.4 to 2.485GHz in the ISM band). In other aspects, the operating room devices 1a-1n/2a-2m may communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 family), wiMAX (IEEE 802.16 family), IEEE 802.20, long Term Evolution (LTE) and Ev-DO, hspa+, hsdpa+, hsupa+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and above. The computing module may include a plurality of communication modules. For example, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and bluetooth, and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, wiMAX, LTE, ev-DO, etc.

The modular communication hub 203 may serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handle a type of data called frames. The frames carry data generated by the devices 1a-1n/2a-2 m. When the modular communication hub 203 receives the frame, it is amplified and transmitted to the network router 211, which network router 211 transmits the data to the cloud computing resources using a plurality of wireless or wired communication standards or protocols as described herein.

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

Fig. 9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236, the modular control tower 236 being connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in an operating room. As shown in fig. 10, modular control tower 236 includes a modular communication hub 203 coupled to computer system 210. As shown in the example of fig. 9, modular control tower 236 is coupled to imaging module 238 coupled to endoscope 239, generator module 240 coupled to energy device 241, smoke extractor module 226, aspiration/irrigation module 228, communication module 230, processor module 232, storage array 234, smart device/instrument 235 optionally coupled to display 237, and non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via modular control tower 236. The robotic hub 222 may also be connected to a modular control tower 236 and cloud computing resources. The devices/instruments 235, visualization system 208, etc. may be coupled to the modular control tower 236 via a wired or wireless communication standard or protocol, as described herein. The modular control tower 236 may be coupled to the hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization system 208. The hub display may also combine the images and the overlay images to display data received from devices connected to the modular control tower.

Fig. 10 illustrates a surgical hub 206 including a plurality of modules coupled to a modular control tower 236. The modular control tower 236 includes a modular communication hub 203 (e.g., a network connectivity device) and a computer system 210 to provide, for example, local processing, visualization, and imaging. As shown in fig. 10, modular communication hub 203 may be hierarchically configured to connect to expand the number of modules (e.g., devices) that may be connected to modular communication hub 203 and transmit data associated with the modules to computer system 210, cloud computing resources, or both. As shown in fig. 10, each of the hubs/switches in modular communications hub 203 includes three downstream ports and one upstream port. The upstream hub/switch is connected to the processor to provide a communication connection with the cloud computing resources and the local display 217. Communication with cloud 204 may be through a wired or wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measure the size of the operating room and uses ultrasonic or laser type non-contact measurement devices to generate a map of the surgical room. The ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound waves and receiving echoes as it bounces off the operating room's perimeter wall, as described under the heading "surgical hub space perception in operating room (Surgical Hub Spatial Awareness Within an Operating Room)" in U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on day 12, 2017, which is incorporated herein by reference in its entirety, wherein the sensor module is configured to be able to determine the size of the operating room and adjust bluetooth pairing distance limits. The laser-based non-contact sensor module scans the operating room by emitting laser pulses, receiving laser pulses that bounce off the enclosure of the operating room, and comparing the phase of the emitted pulses with the received pulses to determine the size of the operating room and adjust the bluetooth pairing distance limit.

Computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled via a system bus to a communication module 247, a storage 248, a memory 249, a non-volatile memory 250, and an input/output interface 251. The system bus may be any of several types of bus structure including a memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any variety of available bus architectures, including, but not limited to, a 9-bit bus, an Industry Standard Architecture (ISA), a micro-chamdel architecture (MSA), an Extended ISA (EISA), an Intelligent Drive Electronics (IDE), a VESA Local Bus (VLB), a Peripheral Component Interconnect (PCI), a USB, an Advanced Graphics Port (AGP), a personal computer memory card international association bus (PCMCIA), a Small Computer System Interface (SCSI), or any other peripheral bus.

Processor 244 may be any single or multi-core processor such as those provided by texas instruments (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be an on-chip memory available from, for example, texas instruments (Texas Instruments) LM4F230H5QR ARM Cortex-M4F processor core including 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz), a prefetch buffer for improving performance above 40MHz, 32KB single-cycle Sequential Random Access Memory (SRAM), loaded with Internal read-only memory (ROM) of software, 2KB electrically erasable programmable read-only memory (EEPROM), and/or one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Inputs (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, the details of which can be seen in the product data sheet.

In one aspect, the processor 244 may include a security controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by texas instruments (Texas Instruments). The security controller may be configured to be capable of being dedicated to IEC 61508 and ISO 26262 security critical applications, etc., to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.

The system memory includes volatile memory and nonvolatile memory. A 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, the non-volatile memory may include ROM, programmable ROM (PROM), electrically Programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes Random Access Memory (RAM), which acts as external cache memory. Further, the RAM may be available in various forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM) Enhanced SDRAM (ESDRAM), synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM).

Computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media such as, for example, magnetic disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, jaz drives, zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disk drive such as a compact disk ROM device (CD-ROM), compact disk recordable drive (CD-R drive), compact disk rewritable drive (CD-RW drive) or a digital versatile disk ROM drive (DVD-ROM). To facilitate connection of the disk storage devices to the system bus, a removable or non-removable interface may be used.

It is to be appreciated that computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environment. Such software includes an operating system. An operating system, which may be stored on disk storage, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored either in system memory or on disk storage. It is to be appreciated that the various components described herein can be implemented with various operating systems or combinations of operating systems.

A user enters commands or information into the computer system 210 through input device(s) coupled to the I/O interface 251. Input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices are connected to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial, parallel, game, and USB. The output device(s) use the same type of port as the input device(s). Thus, for example, a USB port may be used to provide input to a computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (e.g., monitors, displays, speakers, and printers) that require special adapters among other output devices.

Computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as a cloud computer(s), or local computers. The remote cloud computer(s) may be a personal computer, a server, a router, a network PC, a workstation, a microprocessor based appliance, a peer device or other common network node and the like, and typically includes many or all of the elements described relative to computer systems. For simplicity, only memory storage devices having remote computer(s) are shown. The remote computer(s) is logically connected to the computer system through a network interface and then physically connected via communication 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 switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210, imaging module 238 and/or visualization system 208 of fig. 10, and/or the processor module 232 of fig. 9-10 may include an image processor, an image processing engine, a media processor, or any special purpose Digital Signal Processor (DSP) for processing digital images. The image processor may employ parallel computation with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a series of tasks. The image processor may be a system on a chip having a multi-core processor architecture.

Communication connection(s) refers to hardware/software for connecting a network interface to a bus. Although shown as a communication connection for exemplary clarity within a computer system, it can also be external to computer system 210. The hardware/software necessary for connection to the network interface includes, for exemplary purposes only, internal and external technologies such as, modems including regular telephone grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.

Fig. 11 illustrates a functional block diagram of one aspect of a USB hub 300 device in accordance with at least one aspect of the present disclosure. In the illustrated aspect, USB hub device 300 employs a TUSB2036 integrated circuit hub of texas instruments (Texas Instruments). The USB hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP 0) input paired with a differential data positive (DM 0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including differential data positive (DP 1-DP 3) outputs paired with differential data negative (DM 1-DM 3) outputs.

The USB hub 300 device is implemented with a digital state machine rather than a microcontroller and does not require firmware programming. Fully compatible USB transceivers are integrated into the circuitry for the upstream USB transceiver port 302 and all of the downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full speed and low speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB hub 300 device may be configured to be capable of being in a bus power mode or a self-powered mode and include hub power logic 312 for managing power.

The USB hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in chapter 8 of the USB specification. SIE 310 generally includes signaling up to the transaction level. The processing functions thereof can include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, non return to zero inversion (NRZI) data encoding/decoding and digit stuffing, CRC generation and checking (token and data), packet ID (PID) generation and checking/decoding, and/or serial-parallel/parallel-serial conversion. 310 receives a clock input 314 and is coupled to pause/resume logic and frame timer 316 circuitry and hub repeater circuitry 318 to control communications between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 via port logic circuitry 320, 322, 324. SIE 310 is coupled to command decoder 326 via interface logic to control commands from a serial EEPROM via serial EEPROM interface 330.

In various aspects, the USB hub 300 may connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB hub 300 may be connected to all external devices using standardized four-wire cables that provide both communication and power distribution. The power is configured in a bus power mode and a self-powered mode. USB hub 300 may be configured to support four power management modes: bus-powered hubs with individual port power management or ganged port power management, and self-powered hubs with individual port power management or ganged port power management. In one aspect, the USB hub 300, the upstream USB transceiver port 302, are plugged into a USB host controller using USB cables, and the downstream USB transceiver ports 304, 306, 308 are exposed for connection to USB compatible devices, etc.

Surgical instrument hardware

Fig. 12 illustrates a logic diagram of a control system 470 for a surgical instrument or tool in accordance with one or more aspects of the present disclosure. The system 470 includes control circuitry. The control circuit includes a microcontroller 461 that includes a processor 462 and memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor drive 492, is operatively coupled to the longitudinally movable displacement member to drive the I-beam knife element. The tracking system 480 is configured to determine a position of a longitudinally movable displacement member. The position information is provided to a processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member and the position of the firing member, firing bar, and I-beam knife element. Additional motors may be provided at the tool driver interface to control I-beam firing, closure tube travel, shaft rotation, and articulation. The display 473 displays various operating conditions of the instrument and may include touch screen functionality for data input. The information displayed on the display 473 may be superimposed with the image acquired via the endoscopic imaging module.

In one aspect, the microcontroller 461 may be any single or multi-core processor, such as those known under the trade name ARM Cortex, produced by Texas instruments Inc. (Texas Instruments). In one aspect, the master microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core, available from, for example, texas instruments (Texas Instruments), which includes 256KB of single-cycle flash memory or other non-volatile memory (up to40 MHZ), prefetch buffer for improving performance above 40MHZ, 32KB single cycle SRAM, loaded withInternal ROM for software, EEPROM for 2KB, one or more PWM modules, one or more QEI simulations, and/or one or more 12-bit ADCs with 12 analog input channels, the details of which can be seen in the product data sheet.

In one aspect, the microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by texas instruments (Texas Instruments). The security controller may be configured to be capable of being dedicated to IEC 61508 and ISO 26262 security critical applications, etc., to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.

The microcontroller 461 can be programmed to perform various functions such as precise control of the speed and position of the knife and articulation system. In one aspect, the microcontroller 461 includes a processor 462 and memory 468. The electric motor 482 may be a brushed Direct Current (DC) motor having a gear box and a mechanical link to an articulation or knife system. In one aspect, the motor drive 492 may be a3941 available from Allegro microsystems, inc (Allegro Microsystems, inc). Other motor drives may be readily replaced for use in tracking system 480, including an absolute positioning system. A detailed description of absolute positioning systems is described in U.S. patent application publication 2017/0296213, entitled system and method for controlling surgical stapling and severing instrument (SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT), published at 10 and 19 in 2017, which is incorporated herein by reference in its entirety.

The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement member and articulation system. The microcontroller 461 may be configured to be able to calculate responses in the software of the microcontroller 461. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used in the actual feedback decision. The observed response is an advantageous tuning value that equalizes the smooth continuous nature of the simulated response with the measured response, which can detect external effects on the system.

In one aspect, the motor 482 can be controlled by a motor drive 492 and can be employed by a firing system of the surgical instrument or tool. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of about 25,000 rpm. In other arrangements, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including a Field Effect Transistor (FET). The motor 482 may be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly may include a battery that may include a plurality of battery cells connected in series that may be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and/or rechargeable. In at least one example, the battery cell may be a lithium ion battery, which may be coupled to and separable from the power component.

The motor drive 492 may be a3941 available from Allegro microsystems, inc (Allegro Microsystems, inc). A3941 492 is a full bridge controller for use with an external N-channel power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) specifically designed for inductive loads, such as brushed DC motors. The driver 492 includes a unique charge pump regulator that provides full (> 10V) gate drive for battery voltages as low as 7V and allows a3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor may be employed to provide the above-described battery supply voltage required for an N-channel MOSFET. The internal charge pump of the high side drive allows dc (100% duty cycle) operation. Diodes or synchronous rectification may be used to drive the full bridge in either a fast decay mode or a slow decay mode. In slow decay mode, current recirculation may pass through either the high-side or low-side FETs. The dead time, which is adjustable by a resistor, protects the power FET from breakdown. The overall diagnostics provide indications of brown-out, over-temperature, and power bridge faults, and may be configured to protect the power MOSFET under most short circuit conditions. Other motor drives may be readily replaced for use in tracking system 480, including an absolute positioning system.

Tracking system 480 includes a controlled motor drive circuit arrangement including a 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 that includes 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 I-beam, each of which may be adapted and configured as a rack that can include drive teeth. Thus, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, firing bar, I-beam, or any element that can be displaced. In one aspect, a longitudinally movable drive member is coupled to the firing member, the firing bar, and the I-beam. Thus, the absolute positioning system may 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 adapted to measure linear displacement. Thus, a longitudinally movable drive member, firing bar, or I-beam, or combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may comprise a contact type displacement sensor or a non-contact type displacement sensor. The linear displacement sensor may comprise a Linear Variable Differential Transformer (LVDT), a Differential Variable Reluctance Transducer (DVRT), a sliding potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing 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 operably interfacing with a gear assembly mounted on the displacement member in meshing engagement with a set or rack of drive teeth. The sensor element may be operably coupled to the gear assembly such that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor arrangement may be connected to the linear actuator via a rack and pinion arrangement, or to the rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system and the output indicator may display an output of the absolute positioning system. The displacement member represents a longitudinally movable drive member that includes racks of drive teeth formed thereon for meshing engagement with corresponding drive gears of the gear reducer assembly. The displacement member represents a longitudinally movable firing member, firing bar, I-beam, or combination thereof.

The single rotation of the sensor element associated with position sensor 472 is equivalent to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance the displacement member moves from point "a" to point "b" after the single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via gear reduction that causes the position sensor 472 to complete only one or more rotations for the full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.

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

The position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or vector component of the magnetic field. Technologies for producing the two types of magnetic sensors described above cover a number of aspects of physics and electronics. Techniques for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spin, superconducting quantum interferometers (SQUIDs), hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoresistance, magnetostriction/piezoelectric composites, magneto-sensitive diodes, magneto-sensitive transistors, optical fibers, magneto-optical, and microelectromechanical system based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480 including an absolute positioning system includes a magnetic rotational absolute positioning system. The position sensor 472 may be implemented AS an AS5055EQFT monolithic magnetic rotation position sensor, which is commercially available from austria microsystems (Austria Microsystems, AG). The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power component and includes four hall effect elements located in the area of the position sensor 472 on the magnet. A high resolution ADC and intelligent power management controller are also provided on the chip. A coordinate rotation digital computer (CORDIC) processor (also known as a bitwise and Volder algorithm) is provided to perform simple and efficient algorithms to calculate hyperbolic and trigonometric functions, which require only addition, subtraction, digital displacement and table lookup operations. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 through a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. The position sensor 472 provides 12 or 14 bit resolution. The site sensor 472 may be an AS5055 chip provided in a small QFN16 pin 4 x 0.85mm package.

The tracking system 480, including an absolute positioning system, may include and/or may be programmed to implement feedback controllers such as PID, status feedback, and adaptive controllers. The power source converts the signal from the feedback controller into a physical input to the system: in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the locations measured by location sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, the other sensor(s) may include sensor arrangements such as those described in the following patents: U.S. patent 9,345,481, entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE tissen THICKNESS), issued 5/24 a, the entirety of which is incorporated herein by reference; U.S. patent application publication 2014/0263552 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE tissu THICKNESS), published at 9, 18, 2014, which is incorporated herein by reference in its entirety; and U.S. patent application Ser. No. 15/628,175, entitled technique for adaptive control of motor speed for surgical stapling and cutting instruments (TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT), filed on 6/20 of 2017, which is incorporated herein by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, wherein the output of the absolute positioning system will have a limited resolution and sampling frequency. The absolute positioning system may include a comparison and combination circuit to combine the calculated response with the measured response using an algorithm (such as a weighted average and a theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system by knowing the inputs.

Thus, the absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument and does not retract or advance the displacement member to a reset (clear or home) position as may be required by conventional rotary encoders that merely count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, or the like.

The sensor 474 (such as, for example, a strain gauge or a micro-strain gauge) is configured to measure one or more parameters of the end effector, such as, for example, an amplitude of strain exerted on the anvil during a clamping operation, which may be indicative of a closing force applied to the anvil. The measured strain is converted to a digital signal and provided to the processor 462. Alternatively or in addition to the sensor 474, a sensor 476, such as a load sensor, may measure the closing force applied to the anvil by the closure drive system. A sensor 476, such as a load sensor, may 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 sled configured to cam the staple drivers upward to push staples out into deforming contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to sever tissue when the I-beam is advanced distally through the firing bar. Alternatively, a current sensor 478 may be employed to measure the current drawn by the motor 482. The force required to advance the firing member may correspond to, for example, the current consumed by the motor 482. The measured force is converted to a digital signal and provided to the processor 462.

In one form, the strain gauge sensor 474 may be used to measure the force applied to tissue by the end effector. A strain gauge may be coupled to the end effector to measure forces on tissue being treated by the end effector. A system for measuring force applied to tissue grasped by an end effector includes a strain gauge sensor 474, such as, for example, a microstrain gauge, configured to measure one or more parameters of the end effector, for example. In one aspect, the strain gauge sensor 474 can measure an amplitude or magnitude of strain applied to the jaw member 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 a processor 462 of the microcontroller 461. Load sensor 476 may measure a force used to operate a knife element, for example, to cut tissue trapped between an anvil and a staple cartridge. A magnetic field sensor may be employed to measure the thickness of the trapped tissue. The measurements of the magnetic field sensors may also be converted to digital signals and provided to the processor 462.

The microcontroller 461 can use measurements of tissue compression, tissue thickness, and/or force required to close the end effector, as measured by the sensors 474, 476, respectively, to characterize corresponding values of the selected position of the firing member and/or the speed of the firing member. In one example, the memory 468 may store techniques, formulas, and/or look-up tables that may be employed by the microcontroller 461 in the evaluation.

The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with a modular communication hub, as shown in fig. 8-11.

Fig. 13 illustrates a control circuit 500 configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. The control circuit 500 may be configured to enable the various processes described herein. The circuit 500 may include a microcontroller including one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement the various processes described herein. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. Memory circuit 504 may include volatile storage media and nonvolatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

Fig. 14 illustrates a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. Combinational logic circuit 510 may be configured to enable the various processes described herein. The combinational logic circuit 510 may comprise a finite state machine comprising combinational logic 512, the combinational logic 512 being configured to receive data associated with a surgical instrument or tool at input 514, process the data through the combinational logic 512 and provide output 516.

Fig. 15 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. Sequential logic 520 or combinational logic 522 may be configured to enable the various processes described herein. Sequential logic circuit 520 may include a finite state machine. Sequential logic circuit 520 may include, for example, combinational logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with a surgical instrument or tool from the input 526, process the data through the combinational logic 522 and provide the output 528. In other aspects, the circuitry may include a combination of a processor (e.g., processor 502, fig. 13) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may comprise a combination of combinational logic circuitry (e.g., combinational logic circuitry 510, fig. 14) and sequential logic circuitry 520.

Fig. 16 illustrates a surgical instrument or tool including multiple motors that may be activated to perform various functions. In some cases, a first motor may be activated to perform a first function, a second motor may be activated to perform a second function, and a third motor may be activated to perform a third function. In some instances, multiple motors of the robotic surgical instrument 600 may be individually activated to cause firing motions, closing motions, and/or articulation in the end effector. Firing motions, closing motions, and/or articulation motions may be transmitted to the end effector, for example, through a shaft assembly.

In some instances, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 is operably coupled to a firing motor drive assembly 604 that may be configured to transmit firing motions generated by the motor 602 to the end effector, particularly for displacing the I-beam elements. In some cases, the firing motion generated by motor 602 may cause, for example, staples to be deployed from a staple cartridge into tissue captured by an end effector and/or cause a cutting edge of an I-beam element to be advanced to cut the captured tissue. The I-beam element may be retracted by reversing the direction of motor 602.

In some cases, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605, the closure motor drive assembly 605 being configured to transmit a closure motion generated by the motor 603 to the end effector, in particular for displacing a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closing motion may transition, for example, the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.

In some instances, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operably coupled to respective articulation motor drive assemblies 608a, 608b that may be configured to transmit articulation generated by the motors 606a, 606b to the end effector. In some cases, articulation may cause the end effector to articulate relative to a shaft, for example.

As described above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be activated individually or independently to perform one or more functions while other motors remain inactive. For example, the articulation motors 606a, 606b may be activated to articulate the end effector while the firing motor 602 remains inactive. Alternatively, the firing motor 602 may be activated to fire a plurality of staples and/or advance the cutting edge while the articulation motor 606 remains inactive. Further, the closure motor 603 may be activated simultaneously with the firing motor 602 to distally advance the closure tube and I-beam elements, as described in more detail below.

In some instances, a surgical instrument or tool may include a common control module 610, which common control module 610 may be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 may adjust one of the plurality of motors at a time. For example, the common control module 610 may be individually coupled to and separable from multiple motors of the surgical instrument. In some instances, multiple motors of a surgical instrument or tool may share one or more common control modules, such as common control module 610. In some instances, multiple motors of a surgical instrument or tool may independently and selectively engage a common control module 610. In some cases, the common control module 610 may switch from interfacing with one of the plurality of motors of the surgical instrument or tool to interfacing with another of the plurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can be selectively switched between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closure motor 603. In at least one example, as shown in fig. 16, the switch 614 may be movable or transitionable between a plurality of positions and/or states. In the first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in the second position 617, the switch 614 may electrically couple the common control module 610 to the closure motor 603; in the third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a; and in the fourth position 618b, the switch 614 may electrically couple the common control module 610 to, for example, the second articulation motor 606b. In some instances, a separate common control module 610 may be electrically coupled to the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b simultaneously. In some cases, the switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector can be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of a motor for actuating the jaws.

In various cases, as shown in fig. 16, the common control module 610 may include a motor driver 626, which motor driver 626 may include one or more H-bridge field effect FETs. The motor driver 626 may regulate power emitted from a power source 628 to a motor coupled to the common control module 610, e.g., based on input from the microcontroller 620 ("controller"). In some cases, when the motors are coupled to the common control module 610, the microcontroller 620 may be employed, for example, to determine the current consumed by the motors, as described above.

In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform the various functions and/or computations described herein. In some cases, one or more of the memory units 624 may be coupled to the processor 622, for example.

In some cases, power source 628 may be used, for example, to power microcontroller 620. In some cases, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some instances, the battery pack may be configured to be releasably mountable to the handle for powering the surgical instrument 600. A plurality of series-connected battery cells may be used as the power source 628. In some cases, the power source 628 may be, for example, replaceable and/or rechargeable.

In various circumstances, the processor 622 may control the motor driver 626 to control the position, rotational direction, and/or speed of the motor coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and/or deactivate the motor coupled to the common controller 610. It should be appreciated that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that incorporates the functionality of the Central Processing Unit (CPU) of a computer on one integrated circuit or at most a few integrated circuits. A processor is a versatile programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. Because the processor has internal memory, this is an example of sequential digital logic. The objects of operation of the processor are numbers and symbols represented in a binary digital system.

In one example, the processor 622 may be any single or multi-core processor, such as those known under the trade name ARM Cortex, produced by Texas instruments Inc. (Texas Instruments). In some cases, microcontroller 620 may be, for example, LM4F230H5QR, available from Texas Instruments. In at least one example, texas Instruments LM F230H5QR is an ARM Cortex-M4F processor core, comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded withInternal ROM for software, 2KB EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features that are readily available. Other microcontrollers could be easily replaced for use with the module 4410. Accordingly, the present disclosure should not be limited in this context.

In some cases, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that may be coupled to the common controller 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closure motor 603, and the articulation motors 606a, 606 b. Such program instructions may cause the processor 622 to control firing, closing, and articulation functions in accordance with inputs from algorithms or control programs for the surgical instrument or tool.

In some cases, one or more mechanisms and/or sensors (such as sensor 630) may be used to alert the processor 622 of program instructions that should be used in a particular setting. For example, the sensor 630 may alert the processor 622 to use program instructions associated with firing, closing, and articulation end effectors. In some cases, the sensor 630 may include, for example, a position sensor that may be used to sense the position of the switch 614. Thus, the processor 622 may use program instructions associated with firing the I-beam of the end effector when the switch 614 is detected in the first position 616, for example, by the sensor 630; processor 622 may use program instructions associated with closing the anvil upon detecting, for example, by sensor 630 that switch 614 is in second position 617; and the processor 622 may use program instructions associated with articulating the end effector when it is detected, for example by the sensor 630, that the switch 614 is in the third position 618a or the fourth position 618 b.

Fig. 17 is a schematic view of a robotic surgical instrument 700 configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of the displacement member, distal/proximal displacement of the closure tube, shaft rotation, and articulation with a single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to individually control the firing member, the closure member, the shaft member, and/or one or more articulation members. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, and/or one or more articulation members.

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

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

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

In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e, as described herein. In some examples, motors 704a-704e may be brushed DC electric motors. For example, the speed of motors 704a-704e may be proportional to the corresponding motor drive signal. In some examples, the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704 e. Also, in some examples, motor controllers 708a-708e may be omitted and control circuit 710 may directly generate 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 travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open loop portion of the stroke, the control circuit 710 may select a firing control routine in a closed loop configuration. The response of the instrument may include 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 sum of the pulse widths of the motor drive signals, and the like. After the open loop portion, the control circuit 710 may implement a selected firing control routine for a second portion of the displacement member travel. For example, during a closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e to translate the displacement member at a constant speed based on translation data describing the position of the displacement member in a closed-loop manner.

In one aspect, motors 704a-704e may receive power from energy source 712. The energy source 712 may be a DC power source driven by a main alternating current power source, a battery, a super capacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to individual movable mechanical elements, such as I-beam 714, anvil 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706 e. The transmissions 706a-706e may include one or more gears or other linkage members to couple the motors 704a-704e to movable mechanical elements. The position sensor 734 may sense the position of the I-beam 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the I-beam 714 translates distally and proximally. The control circuit 710 may track the pulses to determine the position of the I-beam 714. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the I-beam 714. Also, in some examples, the position sensor 734 may be omitted. In the case where any of motors 704a-704e is a stepper motor, control circuit 710 may track the position of I-beam 714 by aggregating the number and direction of steps that motor 704 has been commanded to perform. The position sensor 734 may be located in the end effector 702 or at any other portion of the instrument. The output of each 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, the control circuit 710 is configured to drive a firing member, such as an I-beam 714 portion of the end effector 702. Control circuit 710 provides a motor setpoint to motor control 708a, which provides a drive signal to motor 704 a. An output shaft of motor 704a is coupled to torque sensor 744a. The torque sensor 744a is coupled to the transmission 706a that is coupled to the I-beam 714. The transmission 706a includes movable mechanical elements such as rotary elements and firing members to control the movement of the I-beam 714 distally and proximally along the longitudinal axis of the 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 744a provides a firing force feedback signal to control circuit 710. The firing force signal is indicative of the force required to fire or displace the I-beam 714. The position sensor 734 may be configured to provide the position of the I-beam 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end effector 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 710. When ready for use, the control circuit 710 may provide a firing signal to the motor control 708 a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to an end-of-stroke position distal to the stroke start position. As the firing member is translated distally, the I-beam 714 with the cutting element positioned at the distal end is advanced distally to cut tissue between the staple cartridge 718 and the anvil 716.

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

In one aspect, the control circuit 710 is configured to enable rotation of a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708c, which motor control 708c provides a drive signal to the motor 704 c. An output shaft of motor 704c is coupled to torque sensor 744c. The torque sensor 744c is coupled to the transmission 706c, and the transmission 706c is coupled to the shaft 740. The transmission 706c includes a movable mechanical element, such as a rotating element, to control the rotation of the shaft 740 more than 360 degrees clockwise or counterclockwise. In one aspect, the motor 704c is coupled to a rotary transmission assembly that includes a tube gear section formed on (or attached to) a proximal end of the proximal closure tube for operative engagement by a rotary gear assembly that is operatively supported on the tool mounting plate. Torque sensor 744c provides a rotational force feedback signal to control circuit 710. The rotational force feedback signal is indicative of the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.

In one aspect, the control circuitry 710 is configured to enable articulation of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708d, which motor control 708d provides a drive signal to the motor 704 d. An output shaft of motor 704d is coupled to torque sensor 744d. The torque sensor 744d is coupled to the transmission 706d, and the transmission 706d is coupled to the articulation member 742a. The transmission 706d includes movable mechanical elements, such as articulation elements, to control articulation of the end effector 702 + -65 deg.. In one aspect, the motor 704d is coupled to an articulation nut rotatably journaled on the proximal end portion of the distal spine and rotatably driven thereon by an articulation gear assembly. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal is representative of the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members or links 742a, 742b. These articulation members 742a, 742b are driven by separate disks on a robot interface (rack) driven by the two motors 708d, 708 e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b may be antagonistic driven relative to the other link to provide resistance preserving motion and load to the head when the head is not moving and articulation when the head is articulating. The articulation members 742a, 742b attach to the head at a fixed radius as the head rotates. Thus, the mechanical advantage of the push-pull link changes as the head rotates. This variation in mechanical advantage may be more pronounced for other articulation link drive systems.

In one aspect, one or more of the motors 704a-704e can include a brushed DC motor with a gear box and a mechanical link with a firing member, a closure member, or an articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on a physical system. Such external effects may be referred to as drag forces, which act against one of the electric motors 704a-704e. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a magnetic rotational absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotational position sensor, which is commercially available from australian microsystems (Austria Microsystems, AG). Position sensor 734 may interface with control circuit 710 to provide an absolute positioning system. The location may include a plurality of hall effect elements located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition operations, subtraction operations, digital displacement operations and table lookup operations.

In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression and time, and anvil strain and time. The sensors 738 may include magnetic sensors, magnetic field sensors, strain gauges, load sensors, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. The sensor 738 can be located on the deck of the staple cartridge 718 to determine tissue location using segmented electrodes. The torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and/or articulation forces, and the like. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the portion of the staple cartridge 718 having tissue thereon, and (4) the load and position on the two articulation bars.

In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the anvil 716 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 738 may comprise a pressure sensor configured to detect pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect an impedance of a tissue section located between the anvil 716 and the staple cartridge 718 that is indicative of the thickness and/or integrity of the tissue located therebetween.

In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid state switches, hall effect devices, magnetoresistive (MR) devices, giant Magnetoresistive (GMR) devices, magnetometers, and the like. In other implementations, the 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, and so forth. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensors 738 may include non-electrical conductor switches, ultrasonic switches, accelerometers, inertial sensors, and the like.

In one aspect, the sensor 738 may be configured to measure the force exerted by the closure drive system on the anvil 716. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the anvil 716 to detect the closing force applied by the closure tube to the anvil 716. The force exerted on the anvil 716 may be indicative of the tissue compression experienced by the section of tissue trapped between the anvil 716 and the staple cartridge 718. One or more sensors 738 may be positioned at various points of interaction along the closure drive system to detect the closing force applied to the anvil 716 by the closure drive system. The one or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. Control circuitry 710 receives real-time sample measurements to provide and analyze time-based information and evaluate in real-time the closing force applied to anvil 716.

In one aspect, a current sensor 736 may be used to measure the current consumed by each of the motors 704a-704 e. The force required to advance any of the movable mechanical elements, such as the I-beams 714, corresponds to the current consumed by one of the motors 704a-704 e. The force is converted to a digital signal and provided to the processing circuit 710. Control circuitry 710 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the I-beam 714 in the end effector 702 at or near a target speed. Robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, PID, state feedback, linear square (LQR), and/or adaptive controllers. The robotic surgical instrument 700 may include a power source to convert signals from a feedback controller into physical inputs, such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example. Additional details are disclosed in U.S. patent application Ser. No. 15/636,829, entitled closed loop speed control technique for robotic surgical instruments (CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT), filed on publication No. 6/29, 2017, which is incorporated herein by reference in its entirety.

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

The position, motion, displacement, and/or translation of a linear displacement member, such as an I-beam 764, may be measured by an absolute positioning system, a sensor arrangement, and a position sensor 784. Since the I-beam 764 is coupled to the longitudinally movable drive member, the position of the I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the I-beam 764 may be achieved by the position sensor 784 as described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as an I-beam 764. In some examples, the control circuitry 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement members (e.g., I-beams 764) in the manner described. In one aspect, timer/counter 781 provides an output signal, such as a time elapsed or a digital count, to control circuit 760 to correlate the position of I-beam 764 as 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 relative to a starting position at a particular time (t). Timer/counter 781 may be configured to be able to measure elapsed time, count external events, or determine the time of an external event.

Control circuit 760 may generate motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the 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 examples, 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 examples, the motor controller 758 may be omitted and the control circuit 760 may directly generate the motor drive signal 774.

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

Control circuitry 760 can be in communication with one or more sensors 788. The sensor 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensor 788 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force 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 for measuring one or more parameters of the end effector 752. The sensor 788 may include one or more sensors.

The one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to measure a magnitude of strain in the anvil 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 766 and cartridge 768. The sensor 788 may be configured to detect an impedance of a tissue segment located between the anvil 766 and the staple cartridge 768 that is indicative of a thickness and/or completeness of tissue located therebetween.

The sensor 788 may be configured to measure the force exerted by the closure drive system on the anvil 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the anvil 766 to detect a closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of the tissue compression experienced by the section of tissue trapped between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various points of interaction along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during a clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.

A current sensor 786 may be employed to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754. The force is converted to a digital signal and provided to control circuitry 760.

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

The actual drive system of the surgical instrument 750 is configured to drive a displacement member, cutting member, or I-beam 764 via a brushed dc motor having a gear box and mechanical connection to an articulation and/or knife system. Another example is an electric motor 754 that operates a displacement member and an articulation driver, such as an interchangeable shaft assembly. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on a physical system. Such external effects may be referred to as drag forces acting against the electric motor 754. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.

Various exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical stapling and severing tool. For example, motor 754 may drive the displacement member distally and proximally along a longitudinal axis of end effector 752. The end effector 752 may include a pivotable anvil 766 and, when configured for use, the staple cartridge 768 is positioned opposite the anvil 766. The clinician may grasp tissue between the anvil 766 and the staple cartridge 768 as described herein. When the instrument 750 is ready to be used, the clinician may provide a firing signal, for example, by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along a longitudinal axis of the end effector 752 from a proximal stroke start position to an end-of-stroke position distal of the stroke start position. As the displacement member translates distally, the I-beam 764 with the cutting element positioned at the distal end may cut tissue between the staple cartridge 768 and the anvil 766.

In various examples, surgical instrument 750 may include control circuitry 760 programmed to control distal translation of a displacement member (such as I-beam 764) based on one or more tissue conditions. The control circuit 760 may be programmed to directly or indirectly sense a tissue condition, such as thickness, as described herein. The control circuit 760 may be programmed to select a firing control routine based on the tissue condition. The firing control procedure may describe distal movement of the displacement member. Different firing control procedures may be selected to better address different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower speed and/or with lower power. When thinner tissue is present, control circuitry 760 may be programmed to translate the displacement member at a higher speed and/or with a higher power.

In some examples, control circuit 760 may operate motor 754 initially in an open loop configuration for a first open loop portion of the travel of the displacement member. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control routine. The response of the instrument may include the sum of 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, the pulse width of the motor drive signal, and the like. After the open loop portion, the control circuit 760 may implement a selected firing control routine for a second portion of the displacement member stroke. For example, during a closed-loop portion of the stroke, the control circuit 760 may adjust the motor 754 in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant speed. Additional details are disclosed in U.S. patent application Ser. No. 15/720,852, entitled System and method for controlling a display of a surgical instrument (SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT), filed on publication No. 9/29 of 2017, which is incorporated herein by reference in its entirety.

Fig. 19 is a schematic view of a surgical instrument 790 configured to control various functions in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control distal translation of a displacement member, such as an I-beam 764. Surgical instrument 790 includes an end effector 792 that may comprise an anvil 766, an I-beam 764, and a removable staple cartridge 768 that is interchangeable with an RF cartridge 796 (shown in phantom).

In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid state switch, a hall effect device, an MR device, a GMR device, a magnetometer, or the like. In other implementations, the sensor 638 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, and so forth. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensor 788 may include a no-electrical-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.

In one aspect, the position sensor 784 may be implemented AS an absolute positioning system including a magnetic rotating absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotating position sensor, which is commercially available from austria microsystems (Austria Microsystems, AG). Position sensor 784 interfaces with control circuit 760 to provide an absolute positioning system. The location may include a plurality of hall effect elements located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition operations, subtraction operations, digital displacement operations and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife member including a knife body that operably supports a tissue cutting blade thereon, and may further include an anvil-engaging tab or feature and a channel-engaging feature or foot. In one aspect, staple cartridge 768 can be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, the RF bin 796 may be implemented as an RF bin. These and other sensor arrangements are described in commonly owned U.S. patent application Ser. No. 15/628,175 entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," filed on even date 20 at 6 of 2017, which is incorporated herein by reference in its entirety.

The position, movement, displacement, and/or translation of a linear displacement member, such as an I-beam 764, may be measured by an absolute positioning system, a sensor arrangement, and a position sensor, represented as position sensor 784. Since the I-beam 764 is coupled to the longitudinally movable drive member, the position of the I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the I-beam 764 may be achieved by the position sensor 784 as described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as an I-beam 764, as described herein. In some examples, the control circuitry 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement members (e.g., I-beams 764) in the manner described. In one aspect, timer/counter 781 provides an output signal, such as a time elapsed or a digital count, to control circuit 760 to correlate the position of I-beam 764 as 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 relative to a starting position at a particular time (t). Timer/counter 781 may be configured to be able to measure elapsed time, count external events, or determine the time of an external event.

Motor 754 may receive power from an energy source 762. The energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to an I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage members for coupling the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the I-beam 764 translates distally and proximally. The control circuit 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the I-beam 764. Also, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuitry 760 may track the position of I-beam 764 by aggregating the number and direction of steps that the motor has been instructed to perform. The position sensor 784 may be located in the end effector 792 or at any other portion of the instrument.

Control circuitry 760 can be in communication with one or more sensors 788. The sensor 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters, such as gap distance and time, tissue compression and time, and anvil strain and time. The sensor 788 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force 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 for measuring one or more parameters of the end effector 792. The sensor 788 may include one or more sensors.

The sensor 788 may be configured to measure the force exerted by the closure drive system on the anvil 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the anvil 766 to detect a closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of the tissue compression experienced by the section of tissue trapped between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various points of interaction along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time by the processor portion of the control circuit 760 during a clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.

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

Additional details are disclosed in U.S. patent application Ser. No. 15/636,096, filed on 6/2017, entitled surgical System coupleable with a staple cartridge and a RADIO FREQUENCY cartridge, and methods of use thereof (SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME), which is incorporated herein by reference in its entirety.

Fig. 20 shows a stroke length graph 20740, which illustrates how the control system may modify the stroke length of the closure tube assembly based on the articulation angle θ. Such modifications of the stroke length include shortening the stroke length to a compensating stroke length (e.g., defined along the y-axis) as the joint angle θ increases (e.g., defined along the x-axis). The compensating stroke length defines a length of travel of the closure tube assembly in a distal direction to close the jaws of the end effector, the compensating stroke length being dependent upon the articulation angle θ and preventing excessive travel of the closure tube assembly from damaging the surgical device.

For example, as shown in the stroke length graph 20740, the stroke length of the closure tube assembly to close the jaws is about 0.250 inches when the end effector is not articulated, and the compensation stroke length is about 0.242 inches when the articulation angle θ is about 60 degrees. Such measurements are provided by way of example only, and may include any of a variety of angles and corresponding stroke lengths, as well as compensating stroke lengths, without departing from the scope of the present disclosure. Further, the relationship between the articulation angle θ and the compensation stroke length is nonlinear, and the shortening rate of the compensation stroke length increases with an increase in the articulation angle. For example, the decrease in the compensation stroke length between 45 degrees and 60 degrees of articulation is greater than the decrease in the compensation stroke length between 0 degrees and 15 degrees of articulation. While with 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 closure tube assembly in the distal position), the distal closure tube is still allowed to advance during articulation, potentially at least partially closing the jaws.

Fig. 21 illustrates a closure tube assembly positioning graph 20750 showing one aspect of the control system modifying the longitudinal position of the closure tube assembly based on the articulation angle θ. Such modification of the longitudinal position of the closure tube assembly includes proximally retracting the closure tube assembly a compensating distance (e.g., defined along the y-axis) as the end effector is articulated and based on the articulation angle θ (e.g., defined along the x-axis). The compensation distance for the proximal retraction of the closure tube assembly prevents distal advancement of the distal closure tube, thereby maintaining the jaws in the open position during articulation. By retracting the closure tube assembly proximally a compensating distance during articulation, the closure tube assembly can begin a travel stroke length from a proximal retracted position to close the jaws upon activation of the closure assembly.

For example, as shown in the closure tube assembly positioning graph 20750, the offset distance is zero when the end effector is not articulated and is about 0.008 inches when the articulation angle θ is about 60 degrees. In this example, the closure tube assembly is retracted during articulation by a compensating distance of 0.008 inches. Thus, to close the jaws, the closure tube assembly can begin a push stroke length from this retracted position. Such measurements are provided for purposes of example only, and may include any of a variety of angles and corresponding compensation distances without departing from the scope of the present 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 is lengthened increases with increasing articulation angle θ. For example, an increase in the compensation distance between 45 degrees and 60 degrees is greater than an increase in the compensation distance between 0 degrees and 15 degrees.

When clamping patient tissue, the force and tissue applied by the clamping device (e.g., linear stapler) may reach unacceptably high levels. For example, when a constant closure rate is employed, the force may become high enough to cause excessive trauma to the clamped tissue and may cause deformation in the clamping device such that an acceptable tissue gap is not maintained throughout the suturing path. Fig. 22 is a graph showing power applied to tissue at a constant anvil closure rate (i.e., without using Controlled Tissue Compression (CTCs)) during compression versus and during compression at a variable anvil closure rate (i.e., using CTCs). The closing rate may be adjusted to control tissue compression such that power applied to the tissue remains constant over a portion of the compression. When using a variable anvil closure rate, the peak power applied to the tissue according to fig. 22 is much lower. Based on the applied power, the force (or a parameter related or proportional to the force) applied by the surgical device may be calculated. In this regard, the power may be limited such that the force applied by the surgical device (e.g., by the jaws of a linear stapler) does not exceed the yield force or pressure that causes the jaws to open such that when in the fully closed position, the tissue gap is not within an acceptable range along the entire stapling length. For example, the jaws should be parallel or sufficiently nearly parallel such that the tissue gap remains within an acceptable or target range for all staple positions along the entire length of the jaws. Furthermore, the limitation of the applied power avoids or at least minimizes trauma or injury to the tissue.

In fig. 22, the total energy applied in the method without using CTCs is the same as the total energy applied in the method using CTCs, i.e., the area under the power curve of fig. 22 is the same or substantially the same. However, the power distribution utilized is very different because the peak power in the example using CTCs is much lower than in the example without CTCs.

In the example using CTCs, the limitation of power is achieved by slowing the closing rate, as shown by line 20760. It should be noted that the compression time B' is longer than the closing time B. As shown in fig. 22, the device and method providing a constant closure rate (i.e., without CTCs) achieved the same 50lb compression force at the same 1mm tissue gap as the device and method providing a variable closure rate (i.e., with CTCs). While devices and methods that provide a constant closure rate may achieve a compressive force at a desired tissue gap in a shorter period of time as compared to devices and methods that use a variable closure rate, this produces a peak in the power applied to the tissue, as shown in fig. 22. In contrast, the exemplary aspect shown using CTCs begins to slow the closure rate to limit 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 relative to systems and methods that do not use CTCs.

Fig. 22 and additional examples are further described in U.S. patent No.8,499,992, entitled "DEVICE AND METHOD FOR CONTROLLING COMPRESSION OF TISSUE," filed on 1, 6, 2012, which is published on 6, 8, 2013, the entire disclosure of which is incorporated herein by reference.

In some aspects, the control system may include a plurality of predefined force thresholds that assist the control system in determining the position of the electron beam and/or the articulation angle of the firing shaft and in appropriately controlling the at least one motor based on such determination. For example, the force threshold may vary according to a length of travel of a firing bar configured to translate a firing shaft, and such force threshold may be compared to measured torque of one or more motors in communication with a control system. Comparison of the measured torsion to the force threshold may provide a reliable way for the control system to determine the position of the electron beam and/or articulation of the end effector. This may allow the control system to properly control one or more motors (e.g., reduce or stop torsional loads) to ensure proper firing of the firing assembly and articulation of the end effector, as well as prevent damage to the system, as will be described in more detail below.

Fig. 23 shows a force and displacement graph 20800 that includes measured forces in part a that are related to measured displacements in part B. Both parts a and B have an x-axis (e.g., seconds) defining time. The y-axis of section B defines the travel displacement (e.g., in millimeters) of the firing link, and the y-axis of section a defines the force applied to the firing bar, thereby advancing the firing shaft. As shown in section A, travel of the firing bar within the first range of articulation 20202 (e.g., a first about 12mm of travel) causes the end effector to articulate. For example, at a 12mm displacement position, the end effector is fully articulated to the right and is mechanically unable to further articulate. With full articulation, the torque on the motor will increase and the control system may sense that the articulation force peak 20802 exceeds a predefined articulation threshold 20804, as shown in section a. The control system may include more than one predefined articulation threshold 20804 for sensing more than one maximum articulation direction (e.g., left articulation and right articulation). After the control system detects an articulation force peak 20802 that exceeds a predetermined articulation threshold 20804, the control system may reduce or stop actuation of the motor, thereby protecting at least the motor from damage.

After the firing bar is advanced beyond the articulation range 20202, a displacement mechanism within the surgical stapler can cause further distal travel of the firing bar to cause distal travel of the firing shaft. For example, as shown in section B, traveling between travel displacements of about 12mm and 70mm may cause the electron beam to advance along the firing stroke 20904 and cut tissue trapped between the jaws, however, other travel lengths are within the scope of the present disclosure. In this example, the maximum firing travel position 2096 of the electron beam occurs at 70mm travel. At this point, the electron beam or knife abuts the distal end of the cartridge or jaw, increasing the torque on the motor and causing the control system to sense the knife travel force peak 20806 as shown in section a. As shown in part a, the control system may include a motor threshold 20808 and an end of knife travel threshold 20810 that branches from the motor threshold 20808 and decreases (e.g., non-linearly) as the electron beam approaches the maximum firing travel position 2096.

The control system may be configured to monitor the sensed motor torque during at least a last portion of the distal stroke 20007 of the electron beam (e.g., the last 10% of the firing stroke 904) before the electron beam reaches the maximum firing stroke position 2096. When monitored along such a final portion of the distal stroke 20007, the control system may cause the motor to decrease the torque force, thereby reducing the load on the electron beam. This can protect the surgical stapler (including the e-beam) from damage by reducing the load on the e-beam as it approaches the maximum firing travel position 2096, thereby reducing the impact of the e-beam on the distal end of the cartridge or jaw. As described above, such an impact may create a blade travel force peak 20806 that may exceed the blade travel threshold 20810 but not the motor threshold 20808, so as not to damage the motor. Thus, the control system may stop actuation of the motor 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 protecting the motor from damage. Further, the gradual decrease in the knife travel threshold 20810 prevents the control system from initially assuming that the electron beam has reached the maximum firing travel position 2096.

After the control system detects that the knife travel force peak 20806 exceeds the knife travel threshold 20810, the control system may confirm the position of the electron beam (e.g., at 70mm displacement and/or at the end of the firing stroke 20404), and may retract the firing bar based on such known displacement positions to reset the electron beam at the proximal-most position 20108 (e.g., 0mm displacement). At the proximal-most position 20508, the control system may sense a knife retraction force peak 20812 that exceeds a predefined knife retraction threshold 20814, as shown in section a. At this point, if desired, the control system can recalibrate and correlate the position of the electron beam to be in a home position where subsequent advancement of the firing link in the distal direction (e.g., about 12mm long) will cause the shifter to disengage the electron beam from the firing bar. Once disengaged, travel of the firing bar through the range of articulation 20202 again causes articulation of the end effector.

Thus, the control system can sense torque on the motor that controls travel of the firing bar and compare such sensed torque to a plurality of thresholds to determine the position of the electron beam or the articulation angle of the end effector, to properly control the motor to prevent damage to the motor, and to confirm positioning of the firing bar and/or the electron beam.

As described above, the tissue contact or pressure sensor determines when the jaw member is initially in contact with tissue "T". This enables 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 above surgical instrument aspects, as shown in fig. 24, contact of the jaw member with tissue "T" closes an otherwise open sensing circuit "SC" by establishing contact with a pair of opposing plates "P1, P2" disposed on the jaw member. The touch sensor may also include a force sensitive transducer that determines the amount of force applied to the sensor, which may be assumed to be the same as the amount of force applied to the tissue "T". Such forces applied to the tissue may then be translated into an amount of tissue compression. The force sensor measures the amount of compression experienced by the tissue and provides the surgeon with information about the force applied to the tissue "T". Excessive tissue compression can negatively impact the tissue "T" being operated on. For example, excessive compression of tissue "T" can lead to tissue necrosis and, in certain procedures, staple line failure. Information about the pressure applied to the tissue "T" enables the surgeon to better determine that excessive pressure is not being applied to the tissue "T".

Any of the contact sensors disclosed herein can include, but are not limited to, electrical contacts disposed on an inner surface of a jaw that closes an otherwise open sensing circuit upon contact with tissue. The contact sensor may also include a force sensitive transducer that detects when the clamped tissue first resists compression. The force transducers may include, but are not limited to, piezoelectric elements, piezoresistive elements, metal or semiconductor strain gauges, inductive pressure sensors, capacitive pressure sensors, and potentiometric pressure transducers that use a spring tube, capsule, or bellows to drive a wiper arm on a resistive element.

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

In one aspect, any of the foregoing surgical instruments may include or be provided with one or more metallic strain gauges disposed within or on a portion of the body of the surgical instrument. The working principle of a metal strain gauge is that the electrical resistance of the material depends on length, width and thickness. Thus, when the material of the metallic strain gauge experiences strain, the electrical resistance of the material changes. Thus, a resistor made of such a material incorporated into the circuit will convert the strain into a change in the electrical signal. Advantageously, a strain gauge may be placed on the surgical instrument such that pressure applied to the tissue affects the strain gauge.

Alternatively, in another aspect, one or more semiconductor strain gauges may be used in a similar manner to the metal strain gauges described above, but with a different transduction mode. In operation, when the lattice structure of a semiconductor strain gauge is deformed due to an applied stress, the electrical resistance of the material changes. This phenomenon is known as the piezoresistive effect.

In another aspect, any of the foregoing surgical instruments may include or be provided with one or more inductive pressure sensors to convert pressure or force into motion of the inductive elements relative to each other. This movement of the inductive elements relative to each other changes the overall inductance or inductive coupling. Capacitive pressure transducers similarly convert pressure or force into movement of capacitive elements relative to each other, thereby changing the overall capacitance.

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

In one aspect, any of the foregoing surgical instruments may include or be provided with one or more mechanical pressure transducers to convert pressure or force into motion. In use, movement of the mechanical element is used to deflect a pointer or dial on a gauge. Such movement of the pointer or dial may be indicative of pressure or force applied to the tissue "T". Examples of mechanical elements include, but are not limited to, spring tubes, capsules, or bellows. By way of example, the mechanical element may be coupled with other measurement and/or sensing elements such as potentiometer pressure transducers. In this example, the mechanical element is coupled with a wiper on the variable resistor. In use, pressure or force may be converted into mechanical motion that deflects a wiper on the potentiometer, thereby changing the resistance to reflect the applied pressure or force.

The combination of the above aspects, particularly the combination of gap and tissue contact sensors, provides feedback information 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 tissue "T" may guide the surgeon in selecting an appropriate staple size, information regarding the clamping thickness of tissue "T" may let the surgeon know whether the selected staple will be properly formed, information regarding the initial thickness and clamping thickness of tissue "T" may be used to determine the amount of compression or strain on tissue "T", and information regarding strain on tissue "T" may use the strain to avoid compressing tissue to an overstrain value and/or to avoid suturing tissue that has undergone overstrain.

Additionally, force sensors may be used to provide the surgeon with an amount of pressure applied to the tissue. The surgeon may use this information to avoid applying excessive pressure to tissue "T" or to avoid suturing tissue "T" that has undergone excessive strain.

Fig. 24 and additional examples are further described in U.S. patent No.8,181,839, entitled "SURGICAL INSTRUMENT EMPLOYING SENSORS," filed on even 27 at 2011, published 5 at 2012, the entire disclosure of which is incorporated herein by reference.

Certain aspects are shown and described to provide an understanding of the structure, function, manufacture, and use of the disclosed devices and methods. The features shown or described in one example may be combined with features of other examples, and modifications and variations are within the scope of the disclosure.

The terms "proximal" and "distal" are relative to a clinician manipulating a handle of a surgical instrument, where "proximal" refers to a portion closer to the clinician and "distal" refers to a portion farther from the clinician. For convenience, the spatial terms "vertical," "horizontal," "upward" and "downward" are used with respect to the figures are not intended to be limiting and/or absolute, as the surgical instrument can be used in a number of orientations and positions.

Exemplary devices and methods for performing laparoscopic and minimally invasive surgical procedures are provided. However, such devices and methods can be used in other surgical procedures and applications, including, for example, open surgical procedures. Surgical instruments may be inserted through natural orifices or through incisions or puncture holes formed in tissue. The working portion 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 elongate shaft of the surgical instrument can be advanced.

Fig. 25-28 depict a motor-driven surgical instrument 150010 for cutting and fastening that may or may not be reusable. In the illustrated example, the surgical instrument 150010 includes a housing 150012 that includes a handle assembly 150014 configured to be grasped, manipulated, and actuated by a clinician. The housing 150012 is configured for operable attachment to an interchangeable shaft assembly 150200 having an end effector 150300 operably coupled thereto that is configured to perform one or more surgical tasks or surgical procedures. In accordance with the present disclosure, various forms of interchangeable shaft assemblies may be effectively employed in connection with robotically controlled surgical systems. The term "housing" may encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system configured to generate and apply at least one control motion that may be used to actuate an interchangeable shaft assembly. The term "frame" may refer to a portion of a hand-held surgical instrument. The term "frame" may also refer to a portion of a robotically controlled surgical instrument and/or a portion of a robotic system that may be used to operably control a surgical instrument. The interchangeable shaft assembly may be used with the various robotic systems, instruments, components, and methods 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.

Fig. 25 is a perspective view of a surgical instrument 150010 having an interchangeable shaft assembly 150200 operably coupled thereto in accordance with at least one aspect of the present disclosure. Housing 150012 includes an end effector 150300 comprising a surgical cutting and fastening device configured to operably support a surgical staple cartridge 150304 therein. The housing 150012 can be configured for use in conjunction with an interchangeable shaft assembly that includes an end effector that is adapted to support staple cartridges of different sizes and types, with different shaft lengths, sizes, and types. The housing 150012 can be used with a variety of interchangeable shaft assemblies, including assemblies configured to apply other motions and forms of energy, such as Radio Frequency (RF) energy, ultrasonic energy, and/or motion, to an end effector arrangement suitable for use in connection with a variety of surgical applications and procedures. The end effector, shaft assembly, handle, surgical instrument, and/or surgical instrument system may utilize any suitable fastener or fasteners to fasten tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and/or attached to an end effector of a shaft assembly.

The handle assembly 150014 can include a pair of interconnectable handle housing sections 150016, 150018, interconnected by screws, snap features, adhesives, or the like. The handle housing segments 150016, 150018 cooperate to form a pistol grip portion 150019 that may be grasped and manipulated by the clinician. The handle assembly 150014 operably supports a plurality of drive systems configured to generate and apply control motions to corresponding portions of an interchangeable shaft assembly operably attached thereto. The display may be disposed below the cover 150045.

Fig. 26 is an exploded assembly view of a portion of the surgical instrument 150010 of fig. 25 in accordance with at least one aspect of the present disclosure. The handle assembly 150014 can include a frame 150020 that operably supports a plurality of drive systems. The frame 150020 operably supports a "first" or closure drive system 150030 that can impart closure and opening motions to the interchangeable shaft assembly 150200. The closure drive system 150030 can include an actuator, such as a closure trigger 150032 pivotally supported by the frame 150020. The closure trigger 150032 is pivotally coupled to the handle assembly 150014 by a pivot pin 150033 to enable the 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 can pivot from a start or "unactuated" position to an "actuated" position and more particularly to a fully compressed or fully actuated position.

The handle assembly 150014 and frame 150020 operably support a firing drive system 150080 configured to apply firing motions to corresponding portions of an interchangeable shaft assembly attached thereto. The firing drive system 150080 can employ an electric motor 150082 located in the pistol grip portion 150019 of the handle assembly 150014. The electric motor 150082 can be a direct current brush motor having a maximum rotational speed of, for example, about 25,000 rpm. In other constructions, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The electric motor 150082 can be powered by a power source 150090, which can include a removable power pack 150092. The removable power pack 150092 can include a proximal housing portion 150094 configured to be attached to a distal housing portion 150096. The proximal housing portion 150094 and the distal housing portion 150096 are configured to operably support a plurality of batteries 150098 therein. The batteries 150098 can each comprise, for example, lithium Ion (LI) or other suitable batteries. The distal housing portion 150096 is configured for removable operative attachment to a control circuit board 150100 operatively coupled to the electric motor 150082. A number of batteries 150098 connected in series may power the surgical instrument 150010. The power source 150090 can be replaceable and/or rechargeable. A display 150043 located below the cover 150045 is electrically coupled to the control circuit board 150100. The cover 150045 can be removed to expose the display 150043.

The electric motor 150082 can include a rotatable shaft (not shown) operably interfacing with a gear reducer assembly 150084 that is mounted in meshing engagement with a set or rack of drive teeth 150122 on the longitudinally movable drive member 150120. The longitudinally movable drive member 150120 has racks of drive teeth 150122 formed thereon for meshing engagement with corresponding drive gears 150086 of the gear reducer assembly 150084.

In use, the polarity of the voltage provided by the power source 150090 can operate the electric motor 150082 in a clockwise direction, wherein the polarity of the voltage applied to the electric motor by the battery can be reversed to operate the electric motor 150082 in a counter-clockwise direction. When the electric motor 150082 is rotated in one direction, the longitudinally movable drive member 150120 will be driven axially 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 driven axially in the proximal direction "PD". The handle assembly 150014 can include a switch that can be configured to reverse the polarity applied to the electric motor 150082 by the power source 150090. The handle assembly 150014 can include a sensor configured to detect the position of the longitudinally movable drive member 150120 and/or the direction in which the longitudinally movable drive member 150120 is moving.

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

Turning back to fig. 25, the interchangeable shaft assembly 150200 includes an end effector 150300 comprising an elongate channel 150302 configured to operably support a surgical staple cartridge 150304 therein. The end effector 150300 may include an anvil 150306 that is pivotally supported relative to the elongate channel 150302. The interchangeable shaft assembly 150200 may include an articulation joint 150270. The construction and operation of the end effector 150300 and articulation joint 150270 is 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. The interchangeable shaft assembly 150200 may include a proximal housing or nozzle 150201 that is comprised of nozzle portions 150202, 150203. The interchangeable shaft assembly 150200 may include a closure tube 150260 extending along a shaft axis SA that may be utilized to close and/or open the anvil 150306 of the end effector 150300.

Turning back to fig. 25, the closure tube 150260 is translated distally (direction "DD") to close the anvil 150306, for example, in response to actuation of a closure trigger 150032, in a manner described in the aforementioned reference U.S. patent application publication No. 2014/0263541. The anvil 150306 is opened by translating the closure tube 150260 proximally. In the anvil open position, the closure tube 150260 is moved to the proximal position.

Fig. 27 is another exploded assembly view of a portion of an interchangeable shaft assembly 150200 in accordance with at least one aspect of the present disclosure. The interchangeable shaft assembly 150200 may include a firing member 150220 supported for axial travel within the spine 150210. The firing member 150220 includes an intermediate firing shaft 150222 that is configured to be attached to a distal cutting portion or knife bar 150280. The firing member 150220 may be referred to as a "second shaft" and/or a "second shaft assembly. The intermediate firing shaft 150222 can include a longitudinal slot 150223 in the distal end configured to receive a tab 150284 on the proximal end 150282 of the knife bar 150280. The longitudinal slot 150223 and the proximal end 150282 may be configured to permit relative movement therebetween and may include a 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 moving, the knife bar 150280. Once the end effector 150300 has been properly oriented, the intermediate firing shaft 150222 can be advanced distally until the proximal sidewall of the longitudinal slot 150223 contacts the tab 150284 to advance the knife bar 150280 and fire the staple cartridge positioned within the channel 150302. The spine 150210 has an elongated opening or window 150213 therein to facilitate assembly and insertion of the intermediate firing shaft 150222 into the spine 150210. Once the intermediate firing shaft 150222 has been inserted into the spine, the top frame segment 150215 can be engaged with the shaft frame 150212 to enclose the intermediate firing shaft 150222 and knife bar 150280 therein. The operation of the firing member 150220 can be found in U.S. patent application publication No. 2014/0263541. The spine 150210 can be configured to slidably support the firing member 150220 and a closure tube 150260 extending around the spine 150210. The ridge 150210 can slidably support the articulation driver 150230.

The interchangeable shaft assembly 150200 may include a clutch assembly 150400 configured to selectively and releasably couple the articulation driver 150230 to the firing member 150220. The clutch assembly 150400 includes a lock collar or lock sleeve 150402 positioned about the firing member 150220, wherein the lock sleeve 150402 is rotatable between an engaged position in which the lock sleeve 150402 couples the articulation driver 150230 to the firing member 150220 and a disengaged position in which the articulation driver 150230 is not operably coupled to the firing member 150220. When the locking sleeve 150402 is in the engaged position, distal movement of the firing member 150220 can move the articulation driver 150230 distally; and, correspondingly, proximal movement of the firing member 150220 can move the articulation driver 150230 proximally. When the locking sleeve 150402 is in the disengaged position, movement of the firing member 150220 is not transmitted to the articulation driver 150230; and, as such, the firing member 150220 can be moved independently of the articulation driver 150230. The nozzle 150201 may be used to operably engage and disengage an articulation drive system with a firing drive system in a variety of ways as described in U.S. patent application publication No. 2014/0263541.

The interchangeable shaft assembly 150200 may include a slip ring assembly 150600 that may be configured to, for example, conduct electrical power to and/or from the end effector 150300 and/or to communicate signals to and/or from the end effector 150300. The slip ring assembly 150600 may include a proximal connector flange 150604 and a distal connector flange 150601 that are positioned within slots defined in the nozzle portions 150202, 150203. The proximal connector flange 150604 can comprise a first face and the distal connector flange 150601 can comprise a second face positioned adjacent to and movable relative to the first face. The distal connector flange 150601 is rotatable about the shaft axis SA-SA (fig. 25) relative to the proximal connector flange 150604. The proximal connector flange 150604 can include a plurality of concentric or at least substantially concentric conductors 150602 defined in a first face thereof. The connector 150607 can be mounted on the proximal side of the distal connector flange 150601 and can have a plurality of contacts, wherein each contact corresponds to and is in electrical contact with one of the conductors 150602. This arrangement allows for relative rotation between the proximal connector flange 150604 and the distal connector flange 150601 while maintaining electrical contact between the two flanges. The proximal connector flange 150604 can include an electrical connector 150606 that can, for example, place the conductors 150602 in signal communication with the shaft circuit board. In at least one example, a wire harness including a plurality of conductors may extend between the electrical connector 150606 and the shaft circuit board. The electrical connector 150606 may extend proximally through a connector opening defined in the chassis mounting flange. U.S. patent application publication No.2014/0263551 entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" is incorporated herein by reference in its entirety. U.S. patent application publication No.2014/0263552 entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" is incorporated herein by reference in its entirety. Further details of Guan Huahuan assembly 150600 can be found in U.S. patent application publication No.2014/0263541.

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

Fig. 28 is an exploded view of an 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 an anvil 150306 and a surgical staple cartridge 150304. Anvil 150306 can be coupled to elongate channel 150302. A hole 150199 may be defined in the elongate channel 150302 to receive a pin 150152 extending from the anvil 150306 to allow the anvil 150306 to pivot relative to the elongate channel 150302 and the surgical staple cartridge 150304 from an open position to a closed position. The firing bar 150172 is configured to longitudinally translate into the end effector 150300. The firing bar 150172 can be constructed from one solid piece or can comprise a laminate comprising a stack of steel plates. The firing bar 150172 includes an I-beam 150178 and a cutting edge 150182 at a distal end thereof. The distal protruding end of the firing bar 150172 can be attached to the I-beam 150178 to help space the anvil 150306 from the surgical staple cartridge 150304 positioned in the elongate channel 150302 when the anvil 150306 is in the closed position. The I-beam 150178 can include a sharp cutting edge 150182 that severs tissue when the I-beam 150178 is advanced distally by the firing bar 150172. In operation, the I-beam 150178 can fire the surgical staple cartridge 150304. The surgical staple cartridge 150304 can comprise a molded cartridge body 150194 that retains a plurality of staples 150191 that are disposed on staple drivers 150192 that are positioned in corresponding upwardly open 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 squeeze staples 150191 out of deforming contact with anvil 150306 while cutting edge 150182 of I-beam 150178 severs clamped tissue.

The I-beam 150178 can include upper pins 150180 that engage the anvil 150306 during firing. The I-beam 150178 can include intermediate pins 150184 and bottom pedestals 150186 that engage portions of the cartridge body 150194, the cartridge tray 150196, and the elongated channels 150302. When the surgical staple cartridge 150304 is positioned within the elongate channel 150302, the slots 150193 defined in the cartridge body 150194 can be aligned with the longitudinal slots 150197 defined in the cartridge tray 150196 and the slots 150189 defined in the elongate channel 150302. In use, the I-beam 150178 can be slid through the aligned longitudinal slots 150193, 150197, and 150189, wherein, as shown in fig. 28, the bottom base 150186 of the I-beam 150178 can be engaged with a groove extending along the bottom surface of the elongate channel 150302 along the length of the slot 150189, the middle pin 150184 can be engaged with the top surface of the cartridge tray 150196 along the length of the longitudinal slot 150197, and the upper pin 150180 can be engaged with the anvil 150306. The I-beam 150178 can separate or limit relative movement between the anvil 150306 and the surgical staple cartridge 150304 as the firing bar 150172 is advanced distally to fire staples from the surgical staple cartridge 150304 and/or to incise tissue trapped between the anvil 150306 and the surgical staple cartridge 150304. The firing bar 150172 and the I-beam 150178 can be retracted proximally, allowing the anvil 150306 to be opened to release the two stapled and severed tissue portions.

Fig. 29A and 29B are block diagrams of the control circuit 150700 of the surgical instrument 150010 of fig. 25 spanning two pages, in accordance with at least one aspect of the present disclosure. Referring primarily to fig. 29A and 29B, the handle assembly 150702 may include a motor 150714 that may be controlled by a motor driver 150715 and may be used by the firing system of the surgical instrument 150010. In various forms, the motor 150714 can be a direct current brush drive motor having a maximum rotational speed of about 25,000 rpm. In other arrangements, the motor 150714 can comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 150715 can comprise, for example, an H-bridge driver including a Field Effect Transistor (FET) 150719. The motor 150714 can be powered by a power assembly 150706 that is releasably mounted to the handle assembly 150200 for supplying control power to the surgical instrument 150010. The power assembly 150706 may include a battery that may include a plurality of battery cells connected in series that may be used as a power source to power the surgical instrument 150010. In some cases, the battery cells of the power assembly 150706 may be replaceable and/or rechargeable. In at least one example, the battery cell can be a lithium ion battery detachably coupled to the power assembly 150706.

The shaft assembly 150704 may include a shaft assembly controller 150722 that may communicate with the safety controller and the power management controller 150716 via interfaces when the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702. For example, the interface may include a first interface portion 150725 that may include one or more electrical connectors for coupling engagement with corresponding shaft assembly electrical connectors and a second interface portion 150727 that may include one or more electrical connectors for coupling engagement with corresponding power assembly electrical connectors, thereby allowing electrical communication between the shaft assembly controller 150722 and the power management controller 150716 when the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702. One or more communication signals may be transmitted through the interface to communicate one or more power requirements of the attached interchangeable shaft assembly 150704 to the power management controller 150716. In response, the power management controller may adjust the power output of the battery of the power assembly 150706 according to the power requirements of the attached shaft assembly 150704, as described in more detail below. The connector may include switches that may be activated after the handle assembly 150702 is mechanically coupled to the shaft assembly 150704 and/or the power assembly 150706 to allow electrical communication between the shaft assembly controller 150722 and the power management controller 150716.

For example, the interface routes one or more communication signals through a master controller 150717 located in the handle assembly 150702, thereby facilitating the transfer of such communication signals between the power management controller 150716 and the shaft assembly controller 150722. In other cases, when the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702, the interface may facilitate a direct communication line between the power management controller 150716 and the shaft assembly controller 150722 through the handle assembly 150702.

The host controller 150717 may be any single or multi-core processor, such as those provided by texas instruments (Texas Instruments) under the trade name ARM Cortex. In one aspect, master controller 150717 can be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from texas instruments (Texas Instruments), comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle Serial Random Access Memory (SRAM), load withInternal read-only memory (ROM) of software, electrically erasable programmable read-only memory (EEPROM) of 2KB, one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, the details of which can be seen in the product data sheet.

The security controller may be a security controller platform comprising two controller-based families such as TMS570 and RM4x, also known as Texas Instruments and sold under the trade name Hercules ARM Cortex R4. The security controller may be configured to be capable of being dedicated to IEC 61508 and ISO 26262 security critical applications, etc., to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.

The power component 150706 may include power management circuitry that may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. When the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702, the power management circuitry may be configured to adjust the power output of the battery based on the power requirements of the shaft assembly 150704. The power management controller 150716 can be programmed to control the power modulator 150738 to regulate the power output of the power component 150706 and the current sense circuit 150736 can be used to monitor the power output of the power component 150706 to provide feedback to the power management controller 150716 regarding the power output of the battery such that the power management controller 150716 can regulate the power output of the power component 150706 to maintain a desired output. The power management controller 150716 and/or the shaft assembly controller 150722 may each include one or more processors and/or memory units that may store a plurality of software modules.

The surgical instrument 150010 (fig. 25-28) can include an output 150742, which can include means for providing sensory feedback to a user. Such devices may include, for example, visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or haptic feedback devices (e.g., haptic actuators). In certain instances, the output device 150742 can comprise a display 150743, which can be included in the handle assembly 150702. The shaft assembly controller 150722 and/or the power management controller 150716 may provide feedback to a user of the surgical instrument 150010 via the output device 150742. The interface may be configured to connect the shaft assembly controller 150722 and/or the power management controller 150716 to the output device 150742. Alternatively, the output device 150742 can be integrated with the power component 150706. In such cases, when the shaft assembly 150704 is coupled to the handle assembly 150702, communication between the output device 150742 and the shaft assembly controller 150722 may be achieved through an interface.

The control circuit 150700 includes circuit segments configured to control the operation of the powered surgical instrument 150010. The safety controller section (section 1) includes a safety controller and a main controller 150717 section (section 2). The safety controller and/or the main controller 150717 are configured to be capable of interacting with one or more additional circuit segments, such as an acceleration segment, a display segment, a shaft segment, an encoder segment, a motor segment, and a power segment. Each of the circuit segments may be coupled to a safety controller and/or a master controller 150717. The main controller 150717 is also coupled to a flash memory. The main controller 150717 also includes a serial communication interface. The main controller 150717 includes a plurality of inputs coupled to, for example, one or more circuit segments, a battery, and/or a plurality of switches. The segmented circuit may be implemented by any suitable circuit, such as a Printed Circuit Board Assembly (PCBA) within the powered surgical instrument 150010. It should be appreciated that the term "processor" as used herein includes any microprocessor, processor, microcontroller, controller, or other basic computing device that incorporates the functionality of a Central Processing Unit (CPU) of a computer onto one or at most a few integrated circuits. The main controller 150717 is a versatile programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and provides the result as output. Because the processor has internal memory, this is an example of sequential digital logic. The control circuitry 150700 can be configured to enable one or more of the processes described herein.

The acceleration section (section 3) includes an accelerometer. The accelerometer is configured to detect movement or acceleration of the powered surgical instrument 150010. Inputs from the accelerometer may be used, for example, to transition to and from sleep mode to other modes, to identify the orientation of the powered surgical instrument, and/or to identify when the surgical instrument has been lowered. In some examples, the acceleration segment is coupled to a safety controller and/or a master controller 150717.

The display segment (segment 4) includes a display connector coupled to the main controller 150717. The display connector couples the main controller 150717 to the display through one or more integrated circuit drivers of the display. The integrated circuit driver of the display may be integrated with the display and/or may be located separately from the display. The display may include any suitable display, such as an Organic Light Emitting Diode (OLED) display, a Liquid Crystal Display (LCD), and/or any other suitable display. In some examples, the display segment is coupled to a safety controller.

The shaft segment (segment 5) includes controls for coupling to the interchangeable shaft assembly 150200 (fig. 25 and 27) of the surgical instrument 150010 (fig. 25-28) and/or one or more controls for coupling to the end effector 150300 of the interchangeable shaft assembly 150200. The shaft section includes a shaft connector configured to couple the main controller 150717 to the shaft PCBA. The shaft PCBA includes a low power microcontroller having a Ferroelectric Random Access Memory (FRAM), an articulation switch, a shaft release hall effect switch, and a shaft PCBA EEPROM. The shaft PCBA EEPROM includes one or more parameters, routines, and/or programs specific to the interchangeable shaft assembly 150200 and/or the shaft PCBA. The shaft PCBA may be coupled to the interchangeable shaft assembly 150200 and/or integrated with the surgical instrument 150010. In some examples, the shaft segment includes a second shaft EEPROM. The second shaft EEPROM includes a number of algorithms, routines, parameters, and/or other data corresponding to one or more shaft assemblies 150200 and/or end effectors 150300 that may interface with the powered surgical instrument 150010.

The position encoder section (section 6) includes one or more magnetic angular rotation position encoders. The one or more magnetic angular rotational position encoders are configured to identify rotational positions of the motor 150714, the interchangeable shaft assembly 150200 (fig. 25 and 27), and/or the end effector 150300 of the surgical instrument 150010 (fig. 25-28). In some examples, the magnetic angular rotation position encoder may be coupled to the safety controller and/or the main controller 150717.

The motor circuit segment (segment 7) includes a motor 150714 configured to control movement of the powered surgical instrument 150010 (fig. 25-28). The motor 150714 is coupled to the main microcontroller processor 150717 by an H-bridge driver including 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 coupled in series with the motor for measuring current consumption of the motor. The motor current sensor is in signal communication with the main controller 150717 and/or the safety controller. In some examples, the motor 150714 is coupled to a motor electromagnetic interference (EMI) filter.

The motor controller controls the first motor flag and the second motor flag to indicate the status and position of the motor 150714 to the main controller 150717. The main controller 150717 supplies a Pulse Width Modulation (PWM) high signal, a PWM low signal, a direction signal, a synchronization signal, and a motor reset signal to the motor controller through the buffer. The power segments are configured to provide a segment voltage to each of the circuit segments.

The power section (section 8) includes a battery coupled to the safety controller, the main controller 150717, and the additional circuit section. The battery is coupled to the segmented circuit through a battery connector and a current sensor. The current sensor is configured to measure a total current consumption of the segmented circuit. In some examples, the one or more voltage converters are configured to provide a predetermined voltage value to the one or more circuit segments. For example, in some examples, the segmented circuit may include a 3.3V voltage converter and/or a 5V voltage converter. The boost converter is configured to provide a boost voltage of up to a predetermined amount (such as up to 13V). The boost converter is configured to provide additional voltage and/or current during power-intensive operation and is capable of preventing a voltage-reduced condition or a low-power condition.

A plurality of switches are associated to the security controller and/or the main controller 150717. The switches may be configured to control operation of the surgical instrument 150010 (fig. 25-28), operation of the segmented circuit, and/or indicate a status of the surgical instrument 150010. Emergency door switches and hall effect switches for emergency use are configured to indicate the status of the emergency door. A plurality of articulation switches, such as a left lateral left articulation switch, a left lateral right articulation switch, a left lateral center articulation switch, a right lateral left articulation switch, a right lateral right articulation switch, and a right lateral center articulation switch, are configured to control articulation of the interchangeable shaft assembly 150200 (fig. 25 and 27) and/or the end effector 150300 (fig. 25 and 28). The left and right side reversing switches are associated with a main controller 150717. The left side switches (including left side to left articulation switch, left side to right articulation switch, left side to center articulation switch, and left side reversing switch) are coupled to the main controller 150717 via a left flex connector. The right side switches (including the right side to left articulation switch, the right side to right articulation switch, the right side to center articulation switch, and the right side diverter switch) are coupled to the main controller 150717 by a right flex connector. The firing switch, the clamp release switch, and the shaft engagement switch are coupled to the main controller 150717.

Any suitable mechanical, electromechanical or solid state switch may be used in any combination to implement the plurality of switches. For example, the switch may be a limit switch that is operated with movement of a component associated with the surgical instrument 150010 (fig. 25-28) or the presence of some object. Such switches may be used to control various functions associated with the surgical instrument 150010. Limit switches are electromechanical devices that are made up of an actuator mechanically connected to a set of contacts. The device operates the contacts to make or break electrical connection when an object is in contact with the actuator. The limit switch is durable, simple and convenient to install and reliable in operation, so that the limit switch is suitable for various applications and environments. Limit switches can determine the presence or absence of an object, the passage, location, and the end of the object's travel. In other implementations, the switch may be a solid state switch that operates under the influence of a magnetic field, such as a hall effect device, a magneto-resistive (MR) device, a giant magneto-resistive (GMR) device, a magnetometer, or the like. 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, and others. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, metal Oxide Semiconductor FET (MOSFET), bipolar transistor, etc.). Other switches may include wireless switches, ultrasonic switches, accelerometers, inertial sensors, and others.

Fig. 30 is another block diagram of the control circuit 150700 of the surgical instrument of fig. 25 showing the interface between the handle assembly 150702 and the power assembly 150706, and between the handle assembly 150702 and the interchangeable shaft assembly 150704, in accordance with at least one aspect of the present disclosure. The handle assembly 150702 may include a main controller 150717, a shaft assembly connector 150726, and a power assembly connector 150730. The power component 150706 may include a power component connector 150732, a power management circuit 150734, which may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. The shaft assembly connectors 150730, 150732 form an interface 150727. The power management circuit 150734 may be configured to regulate the power output of the battery 150707 based on the power requirements of the interchangeable shaft assembly 150704 when the interchangeable shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702. The power management controller 150716 can be programmed to control the power modulator 150738 to regulate the power output of the power component 150706 and the current sense circuit 150736 can be used to monitor the power output of the power component 150706 to provide feedback to the power management controller 150716 regarding the power output of the battery 150707 such that the power management controller 150716 can regulate the power output of the power component 150706 to maintain a desired output. The shaft assembly 150704 includes a shaft processor 150720 that is coupled to a non-volatile memory 150721 and a shaft assembly connector 150728 to electrically couple the shaft assembly 150704 to the handle assembly 150702. The shaft assembly connectors 150726, 150728 form an interface 150725. The main controller 150717, the shaft processor 150720, and/or the power management controller 150716 can be configured to enable one or more of the processes described herein.

The surgical instrument 150010 (fig. 25-28) can include an output 150742 for providing sensory feedback to a user. Such devices may include visual feedback devices (e.g., LCD display, LED indicators), auditory feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators). In certain instances, the output device 150742 can comprise a display 150743, which can be included in the handle assembly 150702. The shaft assembly controller 150722 and/or the power management controller 150716 may provide feedback to a user of the surgical instrument 150010 via the output device 150742. The interface 150727 can be configured to connect the shaft assembly controller 150722 and/or the power management controller 150716 to the output device 150742. The output device 150742 can be integrated with the power component 150706. When the interchangeable shaft assembly 150704 is coupled to the handle assembly 150702, communication between the output device 150742 and the shaft assembly controller 150722 may be achieved through the interface 150725. Having described control circuitry 150700 (fig. 29A, 29B, and 6) for controlling the operation of surgical instrument 150010 (fig. 25-28), the present disclosure now turns to various configurations of surgical instrument 150010 (fig. 25-28) and control circuitry 150700.

Referring to fig. 31, surgical stapler 151000 can include a handle component 151002, a shaft component 151004, and an end effector component 151006. The surgical stapler 151000 is similarly constructed and equipped as the motor-driven surgical cutting and fastening instrument 150010 described in connection with fig. 25. Accordingly, details of operation and construction will not be repeated herein for convenience and clarity. The end effector 151006 can be used to compress, cut, or staple tissue. Referring now to fig. 32, prior to compression, cutting or stapling, a physician can position end effector 151030 around tissue 151032. As shown in fig. 32, no compression can be applied to the tissue in preparation for use of the end effector. Referring now to fig. 33, by engaging with the handle (e.g., handle 151002) of the surgical stapler, the physician can compress tissue 151032 using end effector 151030. In one aspect, the tissue 151032 may be compressed to its maximum threshold, as shown in fig. 33.

Referring to fig. 34, various forces can be applied to tissue 151032 by end effector 151030. For example, when tissue 151032 is compressed between anvil 151034 and channel frame 151036 of end effector 151030, vertical forces F1 and F2 may be applied through the anvil and channel frame. Referring now to fig. 35, as tissue 151032 is compressed by end effector 151030, various diagonal and/or lateral forces may also be applied to the tissue. For example, force F3 may be applied. To operate a medical device such as a surgical stapler 151000, it may be desirable to sense or calculate various forms of compression applied to tissue by an end effector. For example, vertical or lateral compression is known to allow the end effector to perform a stapling operation more accurately or precisely or to notify an operator of the surgical stapler so that the surgical stapler can be used more properly or safely.

The compression through tissue 151032 may be determined from the impedance of 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, impedance Z of tissue 151032 can be determined at various compression levels. For example, the impedance Z may be calculated by dividing the applied voltage V by the current I.

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

Referring now to fig. 37, in one aspect, electrical contacts 151044 can be positioned on opposite ends of anvil 151034 of end effector 151030 when RF electrode 151038 is positioned. As tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, the impedance Z of tissue 151032 changes. The lateral tissue compression 151046 caused by the end effector 151030 can be measured as a function of the impedance Z of the tissue 151032.

Referring now to fig. 38, in one aspect, electrical contacts 151050 can be positioned on anvil 151034 and electrical contacts 151052 can be positioned on opposite ends of end effector 151030 at channel frame 151036. The RF electrode 151048 can be positioned transverse to the center of the end effector 151030. As tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, the impedance Z of tissue 151032 changes. Lateral compression 151054 or angular compression 151056 on either side of RF electrode 151048 may be caused by end effector 151030 and may be measured as a function of different impedances Z of tissue 151032 based on the relative positioning of RF electrode 151048 and electrical contacts 151050 and 151052.

Referring now to fig. 39, a frequency generator 151222 can receive power or current from a power source 151221 and can supply one or more RF signals to one or more RF electrodes 151224. As described 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. Further, one or more filters (such as filters 151230 or 151232) may be communicatively coupled to electrical contacts 151226 or 151228. Filters 151230 and 151232 may filter one or more RF signals provided by frequency generator 151222 prior to joining single return path 151234. The voltage V and current I associated with the one or more RF signals may be used to calculate an impedance Z associated with tissue that may be compressed and/or communicatively coupled between the one or more RF electrodes 151224 and the electrical contacts 151226 or 151228.

Still referring to fig. 39, the various components of the tissue compression sensor system described herein may be located in the handle 151236 of the surgical stapler. For example, as shown in circuit diagram 151220a, frequency generator 151222 can be located in handle 151236 and receive power from power source 151221. In addition, current I1 and current I2 may be measured on return paths corresponding to electrical contacts 151228 and 151226. The impedances Z1 and Z2 can be calculated using the voltage V applied between the supply path and the return path. Z1 may correspond to an impedance of tissue compressed and/or communicatively coupled between RF electrode 151224 and one or more of electrical contacts 151228. Further, Z2 may correspond to an impedance of tissue compressed and/or communicatively coupled between RF electrode 151224 and one or more of electrical contacts 151226. Applying 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 described in circuit diagram 151250. In one implementation, a power source at the handle 151252 of the surgical stapler can provide power to the frequency generator 151254. The frequency generator 151254 may generate one or more RF signals. One or more RF signals may be multiplexed or superimposed at a multiplexer 151256, which may be in the shaft 151258 of the surgical stapler. In this way, two or more RF signals may be superimposed (or, for example, nested or modulated together) and transmitted to the end effector. The one or more RF signals may power one or more RF electrodes 151260 at an end effector 151262 of the surgical stapler (e.g., positioned in a staple cartridge). Tissue (not shown) may be compressed 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 and/or communicatively coupled between one or more RF electrodes 151260 and electrical contacts 151264 positioned in a channel frame of end effector 151262 or electrical contacts 151266 positioned in an anvil of end effector 151262. The filter 151268 can be communicatively coupled to the electrical contact 151264 and the filter 151270 can be communicatively coupled to the electrical contact 151266.

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

In one aspect, the various components of the tissue compression sensor systems described herein may be located in 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, nonvolatile memory 151276, and communication channel 151278 can be located in shaft 151258. In one example, the frequency generator 151254, the impedance calculator 151272, the controller 151274, the nonvolatile memory 151276, and the communication channel 151278 can be located on a circuit board in the shaft 151258.

Two or more RF signals may be returned on a common path via the electrical contacts. Further, two or more RF signals may be filtered prior to joining the RF signals on a common path to distinguish individual tissue impedances represented by the two or more RF signals. The current I1 and the current I2 may be measured on return paths corresponding to the electrical contacts 151264 and 151266. The impedances Z1 and Z2 can be calculated using the voltage V applied between the supply path and the return path. Z1 may correspond to an impedance of tissue compressed and/or communicatively coupled between RF electrode 151260 and one or more of electrical contacts 151264. Further, Z2 may correspond to an impedance of tissue compressed and/or communicatively coupled between RF electrode 151260 and one or more of electrical contacts 151266. Applying equations z1=v/I1 and z2=v/I2, the impedance Z1 and Z2 corresponding to different compressions of tissue compressed by the end effector 151262 can be calculated. In an example, the impedances Z1 and Z2 may be calculated by an impedance calculator 151272. The impedances Z1 and Z2 can be used to calculate various compression levels of the tissue.

Referring now to fig. 41, a frequency plot 151290 is shown. The frequency plot 151290 shows the frequency modulation of nested two RF signals. As described above, the two RF signals may nest before reaching the RF electrode at the end effector. For example, an RF signal having a frequency of 1 and an RF signal having a frequency of 2 may be nested together. Referring now to fig. 42, the resulting nested RF signal is shown in a frequency plot 151300. The composite signal shown in frequency plot 151300 includes two RF signals of composite frequency plot 151290. Referring now to fig. 43, a frequency plot 151400 is shown. Frequency plot 151400 shows an RF signal having frequencies 1 and 2 after being filtered (by, for example, filters 151268 and 151270). The resulting RF signal may 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 (e.g., q=10). Q may be defined by a center frequency (Wo)/Bandwidth (BW), where q=wo/BW. In one example, frequency 1 may be 150kHz and frequency 2 may be 300kHz. A possible impedance measurement range may be 100kHz-20MHz. In various examples, other complex techniques such as correlation, quadrature detection, etc. may be used to separate the RF signals.

Using one or more of the techniques and features described herein, a single powered electrode on the staple cartridge or an isolation knife of the end effector can be used to make multiple tissue compression measurements simultaneously. If two or more RF signals are superimposed or multiplexed (or nested or modulated), they can be transmitted down a single power side of the end effector and can be returned on the channel frame or anvil of the end effector. If a filter is built into the anvil and channel contacts before they are joined to a common return path, the tissue impedance represented by the two paths can be distinguished. This may provide a measure of vertical tissue and lateral tissue compression. This approach may also provide proximal and distal tissue compression depending on the placement of the filter and the location of the metallic circuit. The frequency generator and signal processor may be located on one or more chips on a circuit board or daughter board (which may already be present in the surgical stapler).

In one aspect, the present disclosure provides an instrument 150010 (described in connection with fig. 25-30) configured with various sensing systems. Accordingly, details of operation and construction will not be repeated herein for convenience and clarity. In one aspect, the sensing system includes a viscoelastic/rate of change sensing system to monitor knife acceleration, rate of change of impedance, and rate of change of tissue contact. In one example, the rate of change of the knife acceleration may be used as a measure of the tissue type. In another example, the rate of change of impedance may be measured with a pulse sensor and may be used as a measure of compressibility. Finally, a sensor based on the knife firing rate may be utilized to measure the rate of change of tissue contact to measure tissue flow.

The rate of change of the sensed parameter, or otherwise stated, is how long it takes for the tissue parameter to reach an asymptotically steady state value, which itself is a separate measurement, and may be more valuable than the sensed parameter from which it is derived. To enhance the measurement of tissue parameters, such as waiting a predetermined amount of time before taking the measurement, the present disclosure provides a novel technique for deriving using the measurement, such as the rate of change of the tissue parameters.

Derivatization techniques or rate of change measurements become most useful, it being understood that there are no separate measurements that can be employed alone to significantly improve staple formation. The combination of the plurality of measurements makes the measurements effective. In the case of tissue gaps, it is helpful to know how many jaws are covered by tissue to correlate the gap measurements. The rate of change measurement of the impedance can be combined with a strain measurement in the anvil to correlate the force and pressure applied to tissue grasped between jaw members of the end effector, such as the anvil and staple cartridge. Endoscopic surgical devices may employ rate of change measurements to determine tissue type rather than just tissue compression. Although stomach and lung tissue sometimes have similar thickness and similar compression characteristics even when the lung tissue is calcified, the instrument can distinguish between these tissue types by employing a combination of measurements such as gap, compression, applied force, tissue contact area, rate of change of compression, or rate of change of gap. If any of these measurements are used alone, it may be difficult for an endoscopic surgical device to distinguish one tissue type from another. The rate of change of compression may also help the device determine whether the tissue is "normal" or if there are some anomalies. Not only is it measured how much time has elapsed, but also measuring the change in the sensor signal and determining the derivative of the signal will provide another measurement to enable the endoscopic surgical device to measure the signal. The rate of change information may also be employed to determine when steady state is reached to signal the next step in the process. For example, after grasping tissue between jaw members of an end effector (such as an anvil and a staple cartridge), an indicator or trigger to begin firing the device may be activated when tissue compression reaches a steady state (e.g., about 15 seconds).

Methods, devices, and systems for time-dependent evaluation of sensor data to determine stability, creep, and viscoelastic characteristics of tissue during operation of a surgical instrument are also provided herein. Surgical instruments, such as the stapler shown in fig. 25, may include various sensors for measuring operating parameters such as jaw gap size or distance, firing current, tissue compression, amount of jaws covered by tissue, anvil strain and trigger force, and the like. These sensed measurements are important for automatic control of the surgical instrument and for providing feedback to the clinician.

The examples shown in connection with fig. 30-49 may be employed to measure various derived parameters such as gap distance and time, tissue compression and time, and anvil strain and time. A current sensor in series with the battery 2308 may be used to monitor motor current.

Turning now to fig. 44, a reusable or non-reusable motor-driven surgical cutting and fastening instrument 151310 is depicted. The motor-driven surgical cutting and fastening instrument 151310 is similarly constructed and equipped as the motor-driven surgical cutting and fastening instrument 150010 described in connection with fig. 25-30. In the example shown in fig. 44, the instrument 151310 includes a housing 151312 that includes a handle assembly 151314 configured to be grasped, manipulated, and actuated by a clinician. The housing 151312 is configured for operative attachment to an interchangeable shaft assembly 151500 having a surgical end effector 151600 operatively coupled thereto configured to perform one or more surgical tasks or surgical procedures. Since the motor-driven surgical cutting and fastening instrument 151310 is similarly configured and equipped as the motor-driven surgical cutting and fastening instrument 150010 described in connection with fig. 25-30, details of operation and configuration will not be repeated here for convenience and clarity.

The housing 151312 depicted in fig. 44 is illustrated in conjunction with an interchangeable shaft assembly 151500 that includes an end effector 151600 comprising a surgical cutting and fastening device configured to operably support a surgical staple cartridge 151304 therein. The housing 151312 can be configured for use with interchangeable shaft assemblies that include end effectors adapted to support different sizes and types of staple cartridges, having different shaft lengths, sizes and types, and the like. Additionally, the housing 151312 can also be usefully employed with a variety of other interchangeable shaft assemblies, including those configured to apply other motions and forms of energy, such as Radio Frequency (RF) energy, ultrasonic energy, and/or motion, to end effector arrangements suitable for use in connection with various surgical applications and procedures. In addition, 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 including a plurality of fasteners removably stored therein can be removably inserted into and/or attached to an end effector of a shaft assembly.

Fig. 44 illustrates a surgical instrument 151310 to which the interchangeable shaft assembly 151500 is operably coupled. In the arrangement shown, the handle housing forms a pistol grip portion 151319 that can be grasped and manipulated by the clinician. The handle assembly 151314 operably supports a plurality of drive systems therein that are configured to generate and apply various control motions to corresponding portions of the interchangeable shaft assembly operably attached thereto. A trigger 151332 is operatively associated with the pistol grip portion for controlling various of these control motions.

With continued reference to fig. 44, the interchangeable shaft assembly 151500 includes a surgical end effector 151600 that includes an elongate channel 151302 configured to operably support a staple cartridge 151304 therein. The end effector 151600 can further comprise an anvil 151306 that is pivotally supported relative to the elongate channel 151302.

The inventors have found that for controlling a surgical instrument (such as the instrument shown in fig. 44), derivative parameters may even be more useful than one or more sensed parameters on which the derivative parameters are based. Non-limiting examples of derivative parameters include the rate of change of the sensed parameter (e.g., jaw gap distance) and the length of time that elapses before the tissue parameter reaches an asymptotically steady-state value (e.g., 15 seconds). Derived parameters (such as rate of change) are particularly useful because they significantly improve measurement accuracy and also provide information directly from sensed parameters. For example, the rate of change of impedance (i.e., tissue compression) may be combined with strain in the anvil to correlate compression and force, which enables the microcontroller to determine the tissue type and not just the amount of tissue compression. This example is merely exemplary, and any derived parameter may be combined with one or more sensed parameters to provide more accurate information about tissue type (e.g., stomach and lung), tissue health (calcification and normal), and surgical device operational status (e.g., clamping complete). Different tissues have unique viscoelasticity and unique rates of change, making these and other parameters discussed herein useful markers for monitoring and automatically adjusting surgical procedures.

FIG. 46 is an exemplary graph showing gap distance as a function of time, where gap is the spacing between jaws occupied by clamped tissue. The vertical (y) axis is distance and the horizontal (x) axis is time. In particular, referring to fig. 44 and 45, the gap distance 151340 is the distance between the anvil 151306 of the end effector and the elongate channel 151302. In the open jaw position, at time zero, the gap 151340 between the anvil 151306 and the elongate member is at its maximum distance. The width of the gap 151340 decreases as the anvil 151306 closes, such as during tissue clamping. The rate of change of gap distance may vary because the tissue has non-uniform elasticity. 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 viscoelasticity of the tissue may cause a decrease in the rate of change until the tissue cannot be further compressed, at which point the gap distance will remain substantially constant. As tissue is compressed between the anvil 151306 and the staple cartridge 151304 of the end effector 151340, the gap decreases over time. One or more sensors described in connection with fig. 31-43, 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 sensor, may be adapted and configured to measure a gap distance "d" between anvil 151306 and staple cartridge 151304 as graphically represented in fig. 46 as a function of time "t". The rate of change of the gap distance "d" over time "t" is the slope of the curve shown in fig. 46, where slope = Δd/Δt.

FIG. 47 is an exemplary graph illustrating firing current of an end effector jaw. The vertical (y) axis is current and the horizontal (x) axis is time. As described herein, as shown and described in connection with fig. 25, the surgical instrument and/or microcontroller thereof may include a current sensor that detects current utilized during various operations, such as clamping, cutting, and/or stapling tissue. For example, as the tissue resistance increases, the electric motor of the instrument may require more current to clamp, cut, and/or staple tissue. Similarly, if the electrical resistance is lower, the electric motor may require less current to clamp, cut, and/or staple tissue. Thus, the firing current may be used as an approximation of the tissue resistance. The sensed current may be used alone or more preferably in combination with other measurements to provide feedback about the target tissue. Still referring to fig. 47, during some operations (such as stapling), the firing current is initially higher at time zero, but decreases over time. During operation of other devices, if the motor consumes more current to overcome the increasing mechanical load, the current may increase over time. In addition, the rate of change of the firing current may be used as an indicator of the transition of tissue from one state to another. Thus, the firing current, and in particular the rate of change of the firing current, can be used to monitor device operation. As the knife cuts through tissue, the firing current decreases over time. The rate of change of firing current may vary if the tissue being cut provides more or less resistance due to tissue characteristics or the sharpness of the knife 151305 (fig. 45). As the cutting conditions change, the work done by the motor changes, and thus the firing current will change over time. When the knife 151305 is firing, a current sensor can be employed to measure the firing current over time, as graphically represented in fig. 47. For example, a current sensor may be employed to monitor motor current. The current sensor may be adapted and configured to measure motor firing current "i" as a function of time "t", as graphically represented in fig. 47. The rate of change of firing current "i" over time "t" is the slope of the curve shown in fig. 47, where 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 lower at time zero, but increases over time as tissue pressure increases under manipulation (e.g., clamping and stapling). The rate of change varies over time as the tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304 is severed by a knife or sealed using RF energy between electrodes located between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. For example, as tissue is cut, the electrical impedance increases, and when the tissue is completely severed by the knife, the electrical impedance reaches infinity. In addition, if the end effector 151340 includes electrodes coupled to a source of RF energy, the electrical impedance of the tissue increases as energy is delivered through the tissue between the anvil 151306 and the staple cartridge 151304 of the end effector 151340. As energy passing through the tissue dries the tissue by evaporating the water in the tissue, the electrical impedance increases. Eventually, when the proper amount of energy is delivered to the tissue, the impedance increases to a very high value or infinity as the tissue is severed. Further, as shown in fig. 48, different tissues may have unique compression characteristics, such as compression rate, that distinguish the tissues. Tissue impedance may be measured by driving a sub-therapeutic radio frequency current through tissue grasped between the first jaw member 9014 and the second jaw member 9016. One or more electrodes may be positioned on either or both of anvil 151306 and staple cartridge 151304. Time-varying tissue compression/impedance of tissue between anvil 151306 and staple cartridge 151304 may be measured, as graphically represented in fig. 48. The sensors described in connection with fig. 31-43, 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 be capable of measuring tissue compression/impedance. The sensor may be adapted and configured to be able to measure tissue impedance "Z" over time "t", as graphically represented in fig. 48.

Fig. 49 is an exemplary plot of strain versus time for anvil 151306 (fig. 44, 45). The vertical (y) axis is strain and the horizontal (x) axis is time. During stapling, for example, anvil 151306 strain is initially high, but decreases as the tissue reaches steady state, and less pressure is applied to anvil 151306. The rate of change of the anvil 151306 strain can be measured by a pressure sensor or strain gauge positioned on either or both of the anvil 151306 and the staple cartridge 151304 (fig. 44, 45) to measure the pressure or strain applied to the tissue grasped between the anvil 151306 and the staple cartridge 151304. The anvil 151306 strain over time may be measured as graphically represented in fig. 49. The rate of change of the strain "S" over time "t" is the slope of the curve shown in fig. 49, where slope = Δs/Δt.

FIG. 50 is an exemplary graph of trigger force versus time. The vertical (y) axis is the trigger force and the horizontal (x) axis is time. In some examples, the trigger force is progressive to provide tactile feedback to the clinician. Thus, at time zero, the trigger 151320 (fig. 44) pressure may be at its lowest and the trigger pressure may be increased until the operation (e.g., clamping, cutting, or stapling) is completed. The rate of change of trigger force can be measured by a pressure sensor or strain gauge positioned on trigger 151302 of handle 151319 of instrument 151310 (fig. 44) to measure the force required to drive knife 151305 (fig. 45) through tissue grasped between anvil 151306 and cartridge 151304. The time-varying force of the trigger 151332 can be measured as graphically represented in fig. 50. The rate of change of the strain-triggering force "F" over time "t" is the slope of the curve shown in fig. 50, where slope = Δf/Δt.

For example, even though stomach and lung tissue may have similar thicknesses, these tissues may be differentiated and may have similar compression characteristics if the lung tissue is calcified. Stomach and lung tissue can be distinguished by analyzing jaw gap distance, tissue compression, applied force, tissue contact area, rate of change of compression, and rate of change of jaw gap. For example, FIG. 51 shows a graph of tissue pressure "P" as a function of tissue displacement of various tissues. The vertical (y) axis is tissue pressure and the horizontal (x) axis is tissue displacement. When tissue pressure reaches a predetermined threshold, such as 50 pounds per square inch to 100 pounds per square inch (psi), tissue displacement and the rate at which tissue displacement is before the threshold is reached may be used to differentiate tissue. For example, vascular tissue reaches a predetermined pressure threshold with a smaller tissue displacement and a faster rate of change than colon, lung or stomach tissue. Furthermore, the rate of change of vascular tissue (tissue pressure divided by displacement) is almost asymptotic at a threshold of 50psi to 100psi, whereas the rate of change of colon, lung and stomach is not asymptotic at a threshold of 50psi to 100 psi. It should be appreciated that any pressure threshold may be used, such as between 1psi and 1000psi, more preferably between 10psi and 500psi, and still more preferably between 50psi and 100 psi. Furthermore, multiple thresholds or progressive thresholds may be used to provide further resolution of tissue types having similar viscoelasticity.

The rate of change of compression may also enable the microcontroller to determine whether the tissue is "normal" or whether there are some abnormalities, such as calcification. For example, referring to fig. 52, the compression of calcified lung tissue follows a different curve than the compression of normal lung tissue. Thus, tissue displacement and the rate of change of tissue displacement may be used to diagnose and/or distinguish calcified lung tissue from normal lung tissue.

In addition, certain sensed measurements may benefit from additional sensory input. For example, knowing how much of the jaw is covered by tissue may make the gap measurement more useful and accurate in terms of jaw gap. If a small portion of the jaws are covered in tissue, the tissue compression may appear to be less than if the entire jaw were covered in tissue. Thus, the amount of jaw coverage can be considered by the microcontroller when analyzing tissue compression and other sensed parameters.

In some cases, elapsed time may also be an important parameter. Measuring how much time has elapsed, along with sensed parameters and derivative parameters (e.g., rate of change), provides more useful information. For example, if the jaw gap rate of change remains constant after a set period of time (e.g., 5 seconds), the parameter may have reached its asymptotic value.

The rate of change information is also useful for determining when steady state is reached to signal 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 may send a signal to the display alerting the clinician to begin the next step in the procedure, such as staple firing. Alternatively, the microcontroller may be programmed to automatically begin the next surgical stage (e.g., staple firing) once steady state is reached.

Similarly, the rate of change of resistance may be combined with strain in the anvil to correlate force and compression. The rate of change will allow the device to determine the tissue type rather than just measure the compression value. For example, if the lung is calcified, the stomach and lung sometimes have similar thickness, and even similar compression characteristics.

The combination of one or more sensed parameters with the derived parameters provides a more reliable and accurate assessment of tissue type and tissue health, and allows for better device monitoring, control, and clinician feedback.

Fig. 53 illustrates one embodiment of an end effector 152000 that includes a first sensor 152008a and a second sensor 152008 b. The end effector 152000 is similar to the end effector 150300 described above. The 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. The staple cartridge 152006 includes a plurality of staples (not shown). The plurality of staples may be deployed from staple cartridge 152006 during a surgical procedure. The end effector 152000 includes a first sensor 152008a. The first sensor 152008a is configured to measure one or more parameters of the end effector 152000. For example, in one embodiment, first sensor 152008a is configured to measure gap 152010 between anvil 152002 and second jaw member 152004. First sensor 152008a can comprise, for example, a hall effect sensor configured to detect a magnetic field generated by magnet 152012 embedded in second jaw member 152004 and/or staple cartridge 152006. As another example, in one embodiment, first sensor 152008a is configured to measure one or more forces exerted on anvil 152002 by second jaw member 152004 and/or tissue clamped between anvil 152002 and second jaw member 152004.

The end effector 152000 includes a second sensor 152008b. The second sensor 152008b is configured to measure one or more parameters of the end effector 152000. For example, in various embodiments, the second sensor 152008b can comprise a strain gauge configured to measure a magnitude of strain in the anvil 152002 during the clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. In various embodiments, the first sensor 152008a and/or the second sensor 152008b can include, for example, a magnetic sensor (such as a hall effect sensor), a strain gauge, a pressure sensor, a force 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 for measuring one or more parameters of the end effector 152000. The first sensor 152008a and the second sensor 152008b can be arranged in a serial and/or parallel configuration. In a series configuration, the second sensor 152008b can be configured to directly affect the output of the first sensor 152008 a. In a parallel configuration, second sensor 152008b can be configured to indirectly affect the output of first sensor 152008 a.

In one embodiment, the one or more parameters measured by the first sensor 152008a are correlated 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 a tissue section clamped between anvil 152002 and staple cartridge 152006. First sensor 152008a can comprise, 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. The measurement at a single location accurately describes the compressed tissue thickness of a full bite of corrected tissue, but may provide inaccurate results when a partial bite of tissue is provided between the anvil 152002 and the second jaw member 152004. Partial bite of tissue (proximal partial bite or distal partial bite) changes the clamping geometry of anvil 152002.

In some embodiments, the second sensor 152008b is configured to detect one or more parameters indicative of a tissue bite type (e.g., full bite, partial proximal bite, and/or partial distal bite). The measurements of the second sensor 152008b can be used to adjust the measurements of the first sensor 152008a to accurately represent the true compressed tissue thickness of the proximally or distally located partial bite. For example, in one embodiment, the second sensor 152008b comprises a strain gauge, such as a micro-strain gauge, configured to monitor the amplitude of strain in the anvil during the clamped state. The strain amplitude of anvil 152002 is used to modify the output of first sensor 152008a (e.g., a hall effect sensor) to accurately represent the true compressed tissue thickness of a proximally or distally located partial bite. The first sensor 152008a and the second sensor 152008b may be measured in real time during a clamping operation. The real-time measurements allow time-based information to be analyzed, such as by a main processor (e.g., processor 462 (fig. 12)), and used to select one or more algorithms and/or look-up tables, thereby identifying tissue characteristics and clamp positioning to dynamically adjust tissue thickness measurements.

In some embodiments, the tissue measurements of the first sensor 152008a can be provided to an output device of a surgical instrument 150010 coupled to the end effector 152000. For example, in one embodiment, the end effector 152000 is coupled to a surgical instrument 150010 that includes, for example, a display (e.g., display 473 (fig. 12)). The measurement result of the first sensor 152008a is provided to a processor, for example, a main processor. The main processor adjusts the measurement of the first sensor 152008a based on the measurement of the second sensor 152008b to reflect the actual tissue thickness of the tissue section clamped between the anvil 152002 and the staple cartridge 152006. The main processor outputs the adjusted tissue thickness measurement and an indication of full or partial bite to a display. An operator may determine whether to deploy staples in staple cartridge 152006 based on the displayed values.

In some embodiments, the first sensor 152008a and the second sensor 152008b can be positioned in different environments, such as the first sensor 152008a being positioned at a treatment site within a patient and the second sensor 152008b being positioned external to the patient. The second sensor 152008b can be configured to be able to correct and/or modify the output of the first sensor 152008 a. The first sensor 152008a and/or the second sensor 152008b can comprise, for example, an environmental sensor. The environmental sensor may include, for example, a temperature sensor, a humidity sensor, a pressure sensor, and/or any other suitable environmental sensor.

Fig. 54 is a logic diagram illustrating one embodiment of a process 152020 for adjusting the measurement of the first sensor 152008a based on input from the second sensor 152008 b. The first signal 152022a is captured by the first sensor 152008 a. The first signal 152022a may be adjusted based on one or more predetermined parameters, such as a smoothing function, a look-up table, and/or any other suitable adjustment parameters. Second signal 152022b is captured by second sensor 152008 b. The second signal 152022b can be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as a main processor. The processor adjusts the measurement of the first sensor 152008a 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 strain amplitude measured by the second sensor 152008b to determine the completeness of tissue occlusion in the end effector 152000. The adjusted measurement is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 55 is a logic diagram illustrating one embodiment of a process 152030 for determining a look-up table of a first sensor 152008a based on input from a second sensor 152008 b. The 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 a smoothing function, a look-up table, and/or any other suitable adjustment parameters. Second signal 152022b is captured by second sensor 152008 b. The second signal 152022b can be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as a main processor. The processor selects a lookup table from the one or more available lookup tables 152034a, 152034b based on the value of the second signal. The selected look-up table is used to convert the first signal into a thickness measurement of tissue positioned between the anvil 152002 and the staple cartridge 152006. The adjusted measurement is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 56 is a logic diagram illustrating one embodiment of a process 152040 for correcting the first sensor 152008a in response to an input from the second sensor 152008 b. The first sensor 152008a is configured to capture 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 a smoothing function, a look-up table, and/or any other suitable adjustment parameters. Second signal 152022b is captured by second sensor 152008 b. The second signal 152022b can be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as a main processor. The main processor corrects 152042 the first signal 152022a in response to the second signal 152022b. The 152042 first signal 152022a is corrected to reflect the completeness of tissue occlusion in the end effector 152000. The corrected signal is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 57 is a logic diagram illustrating one embodiment of a process 152050 for determining and displaying the thickness of a tissue section clamped between an anvil 152002 and a staple cartridge 152006 of an end effector 152000. The process 152050 includes obtaining the hall effect voltage 152052 by, for example, a hall effect sensor positioned at the distal end of the anvil 152002. The hall effect voltage 152052 is provided to an analog-to-digital converter 152054 and converted to a digital signal. The digital signal is provided to a processor, such as a host processor. The main processor corrects 152056 the curve input of the hall effect voltage 152052 signal. The strain gauge 152058 (such as a micro-strain gauge) is configured to measure one or more parameters of the end effector 152000, such as the amplitude of strain applied to the anvil 152002 during a clamping operation. The measured strain is converted 152060 into a digital signal and provided to a processor, such as a host processor. The main processor adjusts the hall effect voltage 152052 in response to the strain measured by the strain gauge 152058 using one or more algorithms and/or look-up tables to reflect the true thickness and bite integrity of the tissue clamped by the anvil 152002 and staple cartridge 152006. The adjusted thickness is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

In some embodiments, the surgical instrument may further include a load cell or load sensor 152082. The load cell 152082 may be located, for example, in the shaft assembly 150200 (as described above) or in 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 a tissue section clamped between an anvil 152002 and a staple cartridge 152006 of an end effector 152000. The process includes obtaining a hall effect voltage 152072 by, for example, a hall effect sensor positioned at the distal end of anvil 152002. The hall effect voltage 152072 is provided to an analog-to-digital converter 152074 and converted to a digital signal. The digital signal is provided to a processor, such as a host processor. The main processor corrects 152076 the curve input of the hall effect voltage 152072 signal. The strain gauge 152078 (such as a micro-strain gauge) is configured to measure one or more parameters of the end effector 152000, such as the amplitude of strain applied to the anvil 152002 during a clamping operation. The measured strain is converted 152080 into a digital signal and provided to a processor, such as a host processor. The load cell 152082 measures the clamping force of the anvil 152002 relative to the staple cartridge 152006. The measured clamping force is converted 152084 to a digital signal and provided to a processor, such as a main processor. The main processor adjusts the hall effect voltage 152072 using one or more algorithms and/or look-up tables in response to the strain measured by the strain gauge 152078 and the clamping force measured by the load sensor 152082 to reflect the true thickness and bite integrity of the tissue clamped by the anvil 152002 and the staple cartridge 152006. The adjusted thickness is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 59 is a graph 152090 showing an adjusted hall effect thickness measurement 152092 compared to an unmodified hall effect thickness measurement 152094. As shown in fig. 59, the unmodified hall effect thickness measurement 152094 indicates a thicker tissue measurement because a single sensor cannot compensate for a portion of the distal/proximal bite that resulted in an incorrect thickness measurement. The adjusted thickness measurement 152092 is generated by a process 152050, such as that shown in fig. 57. The adjusted hall effect thickness measurement 152092 is corrected based on input from one or more additional sensors, such as strain gauges. The adjusted hall effect thickness 152092 reflects the true thickness of the tissue positioned between the anvil 152002 and the staple cartridge 152006.

Fig. 60 illustrates one embodiment of an end effector 152100 that includes a first sensor 152108a and a second sensor 152108 b. The end effector 152100 is similar to the end effector 152000 shown in fig. 53. The 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. The end effector 152100 includes a first sensor 152108a coupled to the anvil 152102. The first sensor 152108a is configured to measure one or more parameters of the end effector 152100, such as the gap 152110 between the anvil 152102 and the staple cartridge 152106. The gap 152110 can correspond to, for example, the thickness of tissue clamped between the anvil 152102 and the staple cartridge 152106. The first sensor 152108a can comprise any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152108a can comprise 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.

In some embodiments, the end effector 152100 includes a second sensor 152108b. Second sensor 152108b is coupled to second jaw member 152104 and/or staple cartridge 152106. The second sensor 152108b is configured to detect one or more parameters of the end effector 152100. For example, in some embodiments, second sensor 152108b is configured to detect one or more instrument conditions, such as a color of staple cartridge 152106 coupled to second jaw member 152104, a length of staple cartridge 152106, a clamping condition of end effector 152100, a number of uses/remaining uses of end effector 152100 and/or staple cartridge 152106, and/or any other suitable instrument condition. The second sensor 152108b can comprise any suitable sensor for detecting a state of one or more instruments, such as 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.

The end effector 152100 can be used with any of the processes shown in fig. 54-57. For example, in one embodiment, the input from the second sensor 152108b can be used to correct the input of the first sensor 152108 a. Second sensor 152108b can be configured to detect one or more parameters of staple cartridge 152106, such as a color and/or length of staple cartridge 152106. The detected parameters (such as the color and/or length of staple cartridge 152106) can correspond to one or more characteristics of the cartridge, such as the height of the cartridge deck, the available/optimal tissue thickness for the staple cartridge, and/or the staple pattern in staple cartridge 152106. The known parameters of staple cartridge 152106 can be used to adjust the thickness measurements provided by first sensor 152108 a. For example, if staple cartridge 152106 has a higher deck height, the thickness measurements provided by first sensor 152108a can be reduced to compensate for the increased deck height. The adjusted thickness may be displayed to the operator by, for example, a display coupled to the surgical instrument 150010.

Fig. 61 illustrates one embodiment of an end effector 152150 including a first sensor 152158 and a plurality of second sensors 152160a, 152160 b. The 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 can be pivotally moved relative to second jaw member 152154 to clamp tissue between anvil 152152 and staple cartridge 152156. The anvil includes a first sensor 152158. The first sensor 152158 is configured to detect one or more parameters of the end effector 152150, such as the gap 152110 between the anvil 152152 and the staple cartridge 152156. The gap 152110 can correspond to, for example, the thickness of tissue clamped between the anvil 152152 and the staple cartridge 152156. The first sensor 152158 can comprise any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152158 can comprise 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.

In some embodiments, the end effector 152150 includes a plurality of second sensors 152160a, 152160b. The second sensors 152160a, 152160b are configured to detect one or more parameters of the end effector 152150. For example, in some embodiments, the second sensors 152160a, 152160b are configured to measure the amplitude of strain applied to the anvil 152152 during a clamping procedure. In various embodiments, the second sensor 152160a, 152160b can include 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. The second sensors 152160a, 152160b can be configured to measure one or more of the same parameters at different locations on the anvil 152152, different parameters at the same location on the anvil 152152, and/or different parameters at different locations on the anvil 152152.

Fig. 62 is a logic diagram illustrating one embodiment of a process 152170 for adjusting the measurement of the first sensor 152158 in response to the plurality of second sensors 152160a, 152160b. In one embodiment, the 152172 hall effect voltage is obtained, for example, by a hall effect sensor. The 152174 hall effect voltage is converted by an analog to digital converter. The hall effect voltage signal converted by 152176 is corrected. The calibration curve represents the thickness of a section of tissue positioned between anvil 152152 and staple cartridge 152156. A plurality of second measurements of 152178a, 152178b are obtained by a plurality of second sensors (such as a plurality of strain gauges). The Strain gauge inputs are converted 152180a, 152180b into one or more digital signals, for example, by a plurality of electronic μstrain conversion circuits. The corrected hall effect voltage and a plurality of second measurements are provided to a processor, such as a main processor. The main processor adjusts 152182 the hall effect voltage using the second measurement and, for example, by applying an algorithm and/or using one or more look-up tables. The adjusted hall effect voltage is indicative of the true thickness of the tissue clamped by anvil 152152 and staple cartridge 152156 and the integrity of the bite. The adjusted thickness is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 63 illustrates one embodiment of a circuit 152190 configured to convert signals from a first sensor 152158 and a plurality of second sensors 152160a, 152160b into digital signals that can be received by a processor, such as a main processor. The circuit 152190 includes an analog-to-digital converter 152194. In some implementations, the analog-to-digital converter 152194 includes a 4-channel, 18-bit analog-to-digital converter. Those skilled in the art will recognize that the analog-to-digital converter 152194 can comprise any suitable number of channels and/or bits to convert one or more inputs from an analog signal to a digital signal. The circuit 152190 includes one or more level shifting resistors 152196 configured to receive an input from a first sensor 152158 (such as a hall effect sensor). The level shift resistor 152196 regulates the input from the first sensor, thereby converting the value to a higher or lower voltage depending on the input. The level shift resistor 152196 provides the level shift input from the first sensor 152158 to the analog-to-digital converter.

In some embodiments, the plurality of second sensors 152160a, 152160b are coupled to a plurality of bridges 152192a, 152192b within the circuit 152190. The plurality of bridges 152192a, 152192b can provide filtering of the input from the plurality of second sensors 152160a, 152160 b. After filtering the input signal, the plurality of bridges 152192a, 152192b provide inputs from the plurality of second sensors 152160a, 152160b to the analog-to-digital converter 152194. In some implementations, a switch 152198 coupled to one or more level shifting resistors can be coupled to the analog-to-digital converter 152194. The switch 152198 is configured to be able to correct one or more of the input signals, such as input from a hall effect sensor. The switch 152198 can be used to provide one or more level shifting signals to adjust the input to one or more of the sensors, such as to thereby correct the input to the hall effect sensor. In some embodiments, regulation is not necessary and the switch 152198 is held in an open position to disengage the level shifting resistor. The switch 152198 is coupled to the analog-to-digital converter 152194. The analog-to-digital converter 152194 provides the output to one or more processors, such as a main processor. The main processor calculates one or more parameters of the end effector 152150 based on the input from the analog-to-digital converter 152194. For example, in one embodiment, the main processor calculates the thickness of tissue positioned between the anvil 152152 and the staple cartridge 152156 based on inputs from one or more sensors 152158, 152160a, 152160 b.

Fig. 64 illustrates one embodiment of an end effector 152200 that includes a plurality of sensors 152208a-152208d. The end effector 152200 includes an anvil 152202 pivotally coupled to the 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. The plurality of sensors 152208a-152208d are configured to detect one or more parameters of the end effector 152200, such as the anvil 152202. The plurality of sensors 152208a-152208d can include one or more identical sensors and/or different sensors. The plurality of sensors 152208a-152208d can include, 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 or combinations thereof. For example, in one embodiment, the plurality of sensors 152208a-152208d can include a plurality of strain gauges.

In one embodiment, the plurality of sensors 152208a-152208d allows for a robust tissue thickness sensing process to be implemented. By detecting various parameters along the length of the anvil 152202, the plurality of sensors 152208a-152208d allow a surgical instrument (such as surgical instrument 150010) to calculate the thickness of tissue in the jaws regardless of bite, e.g., partial bite or full bite. In some embodiments, the plurality of sensors 152208a-152208d includes a plurality of strain gauges. The plurality of strain gauges are configured to measure strain at various points on the anvil 152202. The amplitude and/or slope of the strain at each of the various points on the anvil 152202 can be used to determine the thickness of the tissue between the anvil 152202 and the staple cartridge 152206. The plurality of strain gauges may be configured to be capable of optimizing a maximum amplitude and/or slope difference based on clamping dynamics to determine thickness, tissue placement, and/or material properties of the tissue. Time-based monitoring of the plurality of sensors 152208a-152208d during clamping allows a processor (such as a main processor) to utilize algorithms and look-up tables to identify tissue characteristics and clamping locations and dynamically adjust the end effector 152200 and/or tissue clamped between the anvil 152202 and the staple cartridge 152206.

Fig. 65 is a logic diagram illustrating one embodiment of a process 152220 for determining one or more tissue characteristics based on a plurality of sensors 152208a-152208 d. In one embodiment, the plurality of sensors 152208a-152208d generate a plurality of signals 152222a-152222d indicative of one or more parameters of the end effector 152200. The plurality of generated signals are converted 152224a-152224d to digital signals and provided to a processor. For example, in one embodiment including multiple Strain gauges, multiple electronic μstrain conversion circuits convert the Strain gauge signals 152224a-152224d to digital signals. The digital signal is provided to a processor, such as a host processor. The main processor determines 152226 one or more tissue characteristics based on the plurality of signals. The processor may determine one or more tissue characteristics by applying an algorithm and/or a look-up table. The one or more tissue characteristics are displayed 152026 to an operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 66 illustrates one embodiment of an end effector 152250 that includes a plurality of sensors 152260a-152260d coupled to a second jaw member 3254. The end effector 152250 includes an anvil 152252 pivotally coupled to the second jaw member 152254. Anvil 152252 can be moved relative to second jaw member 152254 to clamp one or more materials therebetween, such as tissue section 152264. Second jaw member 152254 is configured to receive staple cartridge 152256. The first sensor 152258 is coupled to the anvil 152252. The first sensor is configured to detect one or more parameters of the end effector 152150, such as the gap 152110 between the anvil 152252 and the staple cartridge 152256. The gap 152110 can correspond to, for example, the thickness of tissue clamped between the anvil 152252 and the staple cartridge 152256. The first sensor 152258 can comprise any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152258 can comprise 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.

A plurality of second sensors 152260a-152260d are coupled to second jaw member 152254. A plurality of second sensors 152260a-152260d can be integrally formed with second jaw member 152254 and/or staple cartridge 152256. For example, in one embodiment, a plurality of second sensors 152260a-152260d are disposed on an outer row of staple cartridges 152256 (see fig. 67). The plurality of second sensors 152260a-152260d are configured to detect one or more parameters of the end effector 152250 and/or a tissue section 152264 clamped between the anvil 152252 and the staple cartridge 152256. The plurality of second sensors 152260a-152260d can include any suitable sensor for detecting one or more parameters of the end effector 152250 and/or tissue segment 152264, 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 sensor or combination thereof. The plurality of second sensors 152260a-152260d can include the same sensor and/or different sensors.

In some embodiments, the plurality of second sensors 152260a-152260d includes a dual purpose sensor and a tissue stabilizing element. The plurality of second sensors 152260a-152260d includes electrodes and/or sensing geometry configured to generate a steady tissue state when the plurality of second sensors 152260a-152260d are engaged with the tissue segment 152264, for example, during a clamping operation. In some embodiments, one or more of the plurality of second sensors 152260a-152260d can be replaced by a non-sensing tissue stabilizing element. The second sensors 152260a-152260d create a steady tissue state by controlling tissue flow, staple deformation, and/or other tissue states during clamping, stapling, and/or other procedures.

Fig. 67 illustrates one embodiment of a staple cartridge 152270 that includes a plurality of sensors 152272a-152272h integrally formed therein. The staple cartridge 152270 includes a plurality of rows containing a plurality of apertures for storing staples therein. One or more apertures in the outboard row 152278 are replaced by one of the plurality of sensors 152272a-152272 h. A cutaway portion is shown to illustrate a sensor 152272f coupled to a sensor line 152276 b. The sensor wires 152276a, 152276b can include a plurality of wires for coupling the plurality of sensors 152272a-152272h to one or more circuits of a surgical instrument (such as surgical instrument 150010). In some embodiments, one or more of the plurality of sensors 152272a-152272h includes a dual purpose sensor and a tissue stabilizing element having electrodes and/or sensing geometry configured to provide tissue stabilization. In some embodiments, the plurality of sensors 152272a-152272h can be replaced and/or occupied by a plurality of tissue stabilizing elements. Tissue stabilization may be provided by, for example, controlling tissue flow and/or staple formation during the clamping and/or stapling process. The plurality of sensors 152272a-152272h provide signals to one or more circuits of the surgical instrument 150010 to enhance suture performance and/or feedback of tissue thickness sensing.

Fig. 68 is a logic diagram illustrating one embodiment of a process 152280 for determining one or more parameters of a tissue segment 152264 clamped within an end effector (such as the end effector 152250 shown in fig. 66). In one embodiment, the first sensor 152258 is configured to detect one or more parameters of the end effector 152250 and/or a tissue segment 152264 positioned between the anvil 152252 and the staple cartridge 152256. A first signal is generated 152282 by the first sensor 152258. The first signal is indicative of one or more parameters detected by the first sensor 152258. The one or more second sensors 152260 are configured to detect one or more parameters of the end effector 152250 and/or the tissue section 152264. As with the first sensor 152258, the second sensor 152260 can be configured to be able to detect the same parameter, additional parameters, or different parameters. A second signal 152284 is generated by a second sensor 152260. The second signal 152284 is indicative of one or more parameters detected by the second sensor 152260. The first signal and the second signal are provided to a processor, such as a main processor. The processor adjusts 152286 the first signal generated by the first sensor 152258 based on the input generated by the second sensor 152260. The modulated signal may be indicative of, for example, the true thickness and bite integrity of the tissue segment 152264. The adjusted signal is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 69 illustrates one embodiment of an end effector 152300 that includes a plurality of redundant sensors 152308a, 152308 b. The 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 can be moved relative to staple cartridge 152306 to grasp material (such as a tissue section) 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 end effector 152300 and/or a tissue section positioned between 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. The gap 152310 can correspond to, for example, a thickness of tissue positioned between the anvil 152302 and the staple cartridge 152306. Multiple sensors 152308a, 152308b can detect gap 152310 by, for example, detecting a magnetic field generated by magnet 152312 coupled to 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 the end effector 152300 and/or a section of tissue positioned between the anvil 152302 and the staple cartridge 152306. The redundant sensor may include, for example, a hall effect sensor configured to detect the gap 152310 between the anvil 152302 and the staple cartridge 152306. The redundant sensor provides a signal representative of one or more parameters, allowing a processor (e.g., a host processor) to evaluate multiple inputs and determine the most reliable input. In some embodiments, redundant sensors are used to reduce noise, glitches, and/or drift. Each of the redundant sensors may be measured in real-time during clamping, thereby allowing analysis of time-based information and utilizing algorithms and/or look-up tables to dynamically identify tissue characteristics and clamping locations. Inputs to one or more of the redundant sensors may be adjusted and/or selected to identify the true tissue thickness and bite of the tissue section positioned between the anvil 152302 and the staple cartridge 152306.

Fig. 70 is a logic diagram illustrating one embodiment of a process 152320 for selecting the most reliable output from multiple redundant sensors (such as the multiple sensors 152308a, 152308b shown in fig. 69). In one embodiment, the first signal is generated by a first sensor 152308 a. 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 152308 b. The one or more additional signals are converted 152322b by an analog-to-digital converter. The converted signal is provided to a processor, such as a main processor. The main processor evaluates 152324 the redundant inputs to determine the most reliable output. The most reliable output may be selected based on one or more parameters, such as an algorithm, a look-up table, inputs from additional sensors, and/or instrument status. After selecting the most reliable output, the processor may adjust the output based on one or more additional sensors to reflect, for example, the actual thickness and bite of the tissue section positioned between the anvil 152302 and the staple cartridge 152306. The most reliable output of the adjustment is displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 71 illustrates one embodiment of an end effector 152350 that includes a sensor 152358 that includes a particular sampling rate to limit or eliminate glitches. The end effector 152350 includes a first jaw member or anvil 152352 that is pivotably coupled to a second jaw member 152354. Second jaw member 152354 is configured to receive staple cartridge 152356 therein. The staple cartridge 152356 includes a plurality of staples that can be delivered to a tissue section positioned between the anvil 152352 and the staple cartridge 152356. The sensor 152358 is coupled to the anvil 152352. The sensor 152358 is configured to detect one or more parameters of the end effector 152350, such as the gap 152364 between the anvil 152352 and the staple cartridge 152356. The gap 152364 can correspond to a thickness of material (such as a tissue section) and/or a snap-in integrity of the material positioned between the anvil 152352 and the staple cartridge 152356. The sensor 152358 can comprise any suitable sensor for detecting one or more parameters of the end effector 152350, 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.

In one embodiment, the sensor 152358 comprises a magnetic sensor configured to detect a magnetic field generated by an electromagnetic source 152360 coupled to the second jaw member 152354 and/or the staple cartridge 152356. Electromagnetic source 152360 generates a magnetic field that is detected by sensor 152358. The strength of the detected magnetic field may correspond to, for example, the thickness and/or the integrity of the bite of the tissue positioned between the anvil 152352 and the staple cartridge 152356. In some embodiments, electromagnetic source 152360 generates a signal of a known frequency (such as 1 MHz). In other embodiments, the signal generated by electromagnetic source 152360 can be adjusted based on, for example, the type of staple cartridge 152356 installed in second jaw member 152354, one or more additional sensors, algorithms, and/or one or more parameters.

In one embodiment, the signal processor 152362 is coupled to an end effector 152350, such as an anvil 152352. The signal processor 152362 is configured to process the signals generated by the sensor 152358 to eliminate glitches and enhance the input from the sensor 152358. In some embodiments, the signal processor 152362 can be positioned independent of the end effector 152350, such as in the handle 150014 of the surgical instrument 150010. In some embodiments, the signal processor 152362 is integrally formed with and/or includes algorithms executed by a general-purpose processor (such as a main processor). The signal processor 152362 is configured to process signals from the sensor 152358 at a frequency substantially equivalent to the frequency of the signals generated by the electromagnetic source 152360. For example, in one embodiment, electromagnetic source 152360 generates a signal at a frequency of 1 MHz. The signal is detected by the sensor 152358. The sensor 152358 generates a signal indicative of the detected magnetic field provided to the signal processor 152362. The signal is processed by the signal processor 152362 at a frequency of 1MHz to eliminate glitches. The processed signal is provided to a processor, such as a main processor. The main processor correlates the received signals with one or more parameters of the end effector 152350, such as the gap 152364 between the anvil 152352 and the staple cartridge 152356.

Fig. 72 is a logic diagram illustrating one embodiment of a process 152370 for producing a thickness measurement of a tissue section positioned between an anvil and a staple cartridge of an end effector (such as end effector 152350 shown in fig. 71). In one embodiment of process 152370, the 152372 signal is generated by a modulated electromagnetic source 152360. The generated signal may comprise, for example, a 1MHz signal. The magnetic sensor 152358 is configured to detect 152374 a signal generated by the electromagnetic source 152360. The magnetic sensor 152358 generates a signal indicative of the detected magnetic field and provides the signal to the signal processor 152362. The signal processor 152362 processes 152376 the signal to remove noise, glitches, and/or enhance the signal. The processed signal is provided to an analog-to-digital converter for conversion 152378 to a digital signal. The digital signal may be corrected 152380, for example, by applying a correction curve input algorithm and/or a look-up table. The signal processing 152376, conversion 152378, and correction 152380 can be performed by one or more circuits. The corrected signal is displayed 152026 to the user, for example, via a display integrally formed with the surgical instrument 150010.

Fig. 73 and 74 illustrate one embodiment of an end effector 152400 that includes a sensor 152408 for identifying different types of staple cartridges 152406. The end effector 152400 includes a first jaw member or anvil 152402 pivotally coupled to a second jaw member or elongate channel 152404. The elongate channel 152404 is configured to operably support a staple cartridge 152406 therein. The end effector 152400 also includes a sensor 152408 positioned in the proximal region. The sensor 152408 can be any of an optical sensor, a magnetic sensor, an electrical sensor, or any other suitable sensor.

The sensor 152408 is operable to detect a characteristic of the staple cartridge 152406 and thereby identify the staple cartridge 152406 type. Fig. 74 shows an example of the sensor 152408 as an optical emitter and detector 152410. The bodies of the staple cartridges 152406 can have different colors such that the colors identify the type of staple cartridge 152406. The optical emitter and detector 152410 are operable to interrogate the color of the body of the cartridge 152406. In the illustrated example, the optical emitter and detector 152410 can detect white 152412 by receiving reflected light of equal intensities in the red, green, and blue spectra. The optical emitter and detector 152410 can detect red 152414 by receiving very little reflected light in the green and blue spectra while receiving light of a higher intensity in the red spectrum.

Alternatively or in addition, the optical emitter and detector 152410 or another suitable sensor 152408 can interrogate and identify some other symbol or marking on the staple cartridge 152406. The symbol or indicia may be any of a bar code, a shape or character, a color coded logo, or any other suitable indicia. The information read by the sensor 152408 may be transmitted to a microcontroller, such as a microcontroller (e.g., microcontroller 461 (fig. 12)) in the surgical device 150010. The microcontroller may be configured to communicate information about the staple cartridge 152406 to an operator of the instrument. For example, the identified staple cartridge 152406 may not be suitable for a given application; in this case, the operator of the instrument may be notified and/or the instrument may not function properly. In this case, the microcontroller may optionally be configured to disable functions of the surgical instrument that may be disabled. Alternatively or in addition, the microcontroller may be configured to notify an operator of the surgical instrument 150010 of parameters of the identified cartridge 152406 type, such as the length of the cartridge 152406, or information about the staples (such as height and length).

Fig. 75 illustrates one aspect of a segmented flex circuit 153430 configured to be fixedly attached to a jaw member 153434 of an end effector. The segmented flexible circuit 153430 includes a distal segment 153432a and lateral segments 153432b, 153432c, which include individually addressable sensors for providing localized tissue presence detection. Segments 153432a, 153432b, 153432c are individually addressable to detect tissue and measure tissue parameters based on a single sensor located within each of segments 153432a, 153432b, 153432 c. Segments 153432a, 153432b, 153432c of segmented flexible circuit 153430 are mounted to jaw member 153434 and electrically coupled to an energy source, such as an electrical circuit, via conductive element 153436. A hall effect sensor 153438 or any suitable magnetic sensor is located on the distal end of jaw member 153434. The hall effect sensor 153438 operates in conjunction with a magnet to provide a measurement of an aperture defined by the jaw member 153434, which aperture may also be referred to as a tissue gap, as particularly shown in fig. 77. The segmented flex 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 flex circuit 153440 configured to be mounted to a jaw member 153444 of an end effector. The segmented flex circuit 153440 includes a distal segment 153442a and lateral segments 153442b, 153442c having individually addressable sensors for tissue control. Segments 153442a, 153442b, 153442c are individually addressable to treat tissue and read a single sensor located within each of segments 153442a, 153442b, 153442c. Segments 153442a, 153442b, 153442c of segmented flexible circuit 153440 are mounted to jaw member 153444 and electrically coupled to an energy source by conductive element 153446. A hall effect sensor 153448 or other suitable magnetic sensor is provided on the distal end of the jaw member 153444. The hall effect sensor 153448 operates in conjunction with a magnet to provide a measurement of the aperture or tissue gap defined by the jaw member 153444 of the end effector, as particularly shown in fig. 77. In addition, a plurality of laterally asymmetric temperature sensors 153450a, 153450b are mounted on or integrally formed with the segmented flexible circuit 153440 to provide tissue temperature feedback to the control circuit. The segmented flex circuit 153440 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector.

FIG. 77 shows a tissue gap G configured to be measured _T An aspect of the end effector 153460. End effector 153460 includes jaw member 153462 and jaw member 153444. The flex circuit 153440 depicted in fig. 76 is mounted to jaw member 153444. Flex circuit 153440 includes a hall effect sensor 153448 that operates in conjunction with magnet 153464 mounted to jaw member 153462 to measureMeasuring tissue gap G _T . This technique can be used to measure an aperture defined between jaw member 153444 and jaw member 153462. Jaw member 153462 can be a staple cartridge.

Fig. 78 illustrates one aspect of an end effector 153470 that includes a segmented flex circuit 153468. End effector 153470 includes jaw member 153472 and staple cartridge 153474. Segmented flex circuit 153468 is mounted to jaw member 153472. Each sensor disposed within segments 1-5 is configured to detect the presence of tissue positioned between jaw member 153472 and staple cartridge 153474 and to represent a tissue area 1-5. In the configuration shown in fig. 78, end effector 153470 is shown in an open position ready to receive or grasp tissue between jaw member 153472 and staple cartridge 153474. The segmented flex circuit 153468 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector 153470.

Fig. 79 illustrates the end effector 153470 shown in fig. 78, wherein the jaw member 153472 clamps tissue 153476 between the jaw member 153472 (e.g., anvil) and a staple cartridge. As shown in FIG. 79, tissue 153476 is positioned between segments 1-3 and represents tissue regions 1-3. Thus, tissue 153476 is detected by the sensors in segments 1-3 and the absence (empty) of tissue is detected in segment 153469 by segments 4-5. Information regarding the presence and absence of the tissue 153476 located within certain segments 1-3 and 4-5, respectively, is communicated to a control circuit as described herein via, for example, an interface circuit. The control circuitry is configured to detect tissue located in segments 1-3. It should be appreciated that segments 1-5 may include any suitable temperature, force/pressure and/or hall effect magnetic sensors that measure tissue parameters of tissue located within certain segments 1-5 and electrodes that deliver energy to tissue located in certain segments 1-5. The segmented flex circuit 153468 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector 153470.

Fig. 80 is a schematic view of an absolute positioning system 153100 that may be used with a surgical instrument or system according to the present disclosure. The absolute positioning system 153100 includes a controlled motor drive circuit arrangement including a sensor arrangement 153102 in accordance with at least one aspect of the present disclosure. The sensor arrangement 153102 for the absolute positioning system 153100 provides a unique position signal corresponding to the position of the displacement member 153111. In one aspect, displacement member 153111 represents a longitudinally movable drive member coupled to a cutting instrument or blade (e.g., cutting instrument, I-beam, and/or I-beam 153514 (fig. 82)). In other aspects, the displacement member 153111 represents a firing member coupled to a cutting instrument or knife that can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member 153111 represents a firing bar or I-beam, each of which may be adapted and configured to include a rack of drive teeth.

Thus, as used herein, the term displacement member is used generically to refer to any movable member of a surgical instrument or system as described herein, such as a drive member, a firing bar, a cutting instrument, a knife, and/or an I-beam, or any element that may 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. Thus, a longitudinally movable drive member, firing bar, or I-beam, or combination thereof, may be coupled to any suitable displacement sensor. The displacement sensor may comprise a contact type displacement sensor or a non-contact type displacement sensor. The displacement sensor may comprise a Linear Variable Differential Transformer (LVDT), a Differential Variable Reluctance Transducer (DVRT), a sliding potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, or an optical sensing system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

The electric motor 153120 can include a rotatable shaft 153116 operably interfacing with a gear assembly 153114 that is mounted in meshing engagement with a set or rack of drive teeth on a displacement member 153111. The sensor element 153126 is operably coupled to the gear assembly 153114 such that a single rotation of the sensor element 153126 corresponds to some linear longitudinal translation of the displacement member 153111. The arrangement of the gear and sensor 153118 can be connected to the linear actuator via a rack and pinion arrangement, or to the rotary actuator via spur gears or other connection. The power source 153129 supplies electrical power to the absolute positioning system 153100 and the output indicator 153128 can display the output of the absolute positioning system 153100.

A single rotation of the sensor element 153126 associated with the position sensor 153112 is equivalent to the longitudinal displacement d of the displacement member 153111 ₁ Wherein d is ₁ Is the longitudinal distance that displacement member 153111 moves from point "a" to point "b" after a single rotation of sensor element 153126 coupled to displacement member 153111. The sensor arrangement 153102 may be connected via gear reduction that causes the position sensor 153112 to complete one or more rotations for a full stroke of the displacement member 153111. The position sensor 153112 can complete multiple rotations for the full stroke of the displacement member 153111.

A series of switches 153122a-153122n (where n is an integer greater than one) can be used alone or in combination with gear reduction to provide unique position signals for more than one rotation of the position sensor 153112. The state of the switches 153122a-153122n is fed back to the controller 153110, which applies logic to determine the longitudinal displacement d corresponding to displacement member 153111 ₁ +d ₂ +…d _n Is provided. The output 153124 of the position sensor 153112 is provided to the controller 153110. The position sensor 153112 of the sensor arrangement 153102 can include a magnetic sensor, an analog rotation sensor (such as a potentiometer), an array of analog hall effect elements that output unique combinations of position signals or values. The controller 153110 may be contained within a master controller or may be contained within a tool mounting portion housing of a surgical instrument or system according to the present disclosure.

The absolute positioning system 153100 provides the absolute position of the displacement member 153111 upon power up of the surgical instrument or system without retracting or advancing the displacement member 153111 to a reset (clear or home) position as may be required by conventional rotary encoders that merely count the number of forward or backward steps taken by the motor 153120 to infer the position of the device actuator, drive rod, knife, etc.

The controller 153110 can be programmed to perform various functions such as precise control of the speed and position of the knife and articulation system. In one aspect, the controller 153110 includes a processor 153108 and a memory 153106. The electric motor 153120 can be a brushed dc motor with a gear box and mechanical link to an articulation or knife system. In one aspect, the motor drive 153110 can be a3941 available from Allegro microsystems (Allegro Microsystems, inc). Other motor drives may be easily replaced for use in the absolute positioning system 153100.

The controller 153110 can be programmed to provide precise control over the speed and position of the displacement member 153111 and the articulation system. The controller 153110 can be configured to calculate a response in the software of the controller 153110. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used in the actual feedback decision. The observed response is an advantageous tuning value that equalizes the smooth continuous nature of the simulated response with the measured response, which can detect external effects on the system.

The absolute positioning system 153100 may include and/or may be programmed to implement feedback controllers such as PID, status feedback, and adaptive controllers. The power source 153129 converts the signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include Pulse Width Modulation (PWM) of voltage, current, and force. In addition to the locations measured by the location sensors 153112, one or more other sensors 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, wherein the output of absolute positioning system 153100 will have a limited resolution and sampling frequency. The absolute positioning system 153100 may include a comparison and combination circuit to combine the calculated response with the measured response using an algorithm (such as a weighted average and a theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductance resistance, etc. to predict the state and output of the physical system by knowing the inputs.

The motor drive 153110 can be a3941 available from Allegro microsystems (Allegro Microsystems, inc). 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 a unique charge pump voltage regulator that provides complete (> 10V) gate drive for battery voltages as low as 7V and allows a3941 to operate with a reduced gate drive as low as 5.5V. The bootstrap capacitor may be employed to provide the above-described battery supply voltage required for an N-channel MOSFET. The internal charge pump of the high side drive allows dc (100% duty cycle) operation. Diodes or synchronous rectification may be used to drive the full bridge in either a fast decay mode or a slow decay mode. In slow decay mode, current recirculation may pass through either the high-side or low-side FETs. The dead time, which is adjustable by a resistor, protects the power FET from breakdown. The overall diagnostics indicate undervoltage, overheating, and power bridge faults, and may be configured to be able to protect the power MOSFET during most short circuit conditions. Other motor drives may be easily replaced for use in the absolute positioning system 153100.

Fig. 81 is a schematic diagram of a position sensor 153200 of an absolute positioning system 153100' including a magnetic rotational absolute positioning system in accordance with at least one aspect of the present disclosure. The absolute positioning system 153100' is similar in many respects to the absolute positioning system 153100. The position sensor 153200 may be implemented AS an AS5055EQFT monolithic magnetic rotation position sensor, which is commercially available from austria microsystems (Austria Microsystems, AG). The position sensor 153200 interfaces with the controller 153110 to provide an absolute positioning system 153100'. The position sensor 153200 is a low voltage and low power component and includes four hall effect elements 153228a, 153228B, 153228C, 153228D in a region 153230 of the position sensor 153200 that is located above a magnet positioned on a rotating element associated with a displacement member (such as a knife drive gear and/or a closure drive gear) such that displacement of the firing member and/or closure member can be accurately tracked. A high resolution ADC 153232 and an intelligent power management controller 153238 are also provided on the chip. CORDIC processor 153236 (for a coordinate rotation digital computer (Coordinate Rotation DIgital Computer)), also known as bitwise and Volder algorithms, is set up to implement simple and efficient algorithms to calculate hyperbolic functions and trigonometric functions, which only require addition operations, subtraction operations, bit shift operations and table lookup operations. The angular position, alarm bits, and magnetic field information are communicated to controller 153110 via a standard serial communication interface such as SPI interface 153234. The position sensor 153200 provides 12 or 14 bit resolution. The site sensor 153200 may be an AS5055 chip provided in a small QFN 16 pin 4 x 0.85mm package.

The hall effect elements 153228A, 153228B, 153228C, 153228D are located directly above the rotating magnets. The hall effect is a well known effect and will not be described in detail herein for convenience, but in general, the hall effect produces a voltage difference across the electrical conductor (hall voltage) that is transverse to the current in the conductor, and a magnetic field that is perpendicular to the current. Hall coefficient is defined as the ratio of the induced electric field to the product of the current density and the applied magnetic field. It is a property of the material from which the conductor is made, since its value depends on the type, number and properties of the charge carriers constituting the current. In the AS5055 position sensor 153200, the hall effect elements 153228A, 153228B, 153228C, 153228D are capable of generating a voltage signal that indicates the absolute position of the magnet according to the angle through which the magnet passes a single rotation. This value of angle (which is a unique position signal) is calculated by the CORDIC processor 153236 and stored on-board on AS5055 position sensor 153200 in a register or memory. In various techniques, such as upon power-up or upon request from the controller 153110, the value of the angle is provided to the controller 153110, which indicates the position of the magnet after one revolution.

AS5055 position sensor 153200 requires only a few external components to operate when connected to controller 153110. Simple applications using a single power source require six wires: two wires for power and four wires 153240 for SPI interface 153234 interfacing with controller 153110. A seventh connection may be added to send an interrupt to the controller 153110 to inform that a new valid angle can be read. At power up, AS5055 position sensor 153200 performs a full power up sequence, including an angle measurement. The completion of this cycle is indicated as INT output 153242 and the angle value is stored in an internal register. Once this output is set, AS5055 position sensor 153200 pauses to sleep mode. The controller 153110 can read the angle value from the AS5055 position sensor 153200 through the SPI interface 153234 in response to the INT request at the INT output 153242. Once the controller 153110 reads the angle value, INT output 153242 is cleared again. Sending a "read angle" command by controller 153110 through SPI interface 153234 to position sensor 153200 also automatically powers up the chip and initiates another angle measurement. Upon completion of the reading of the angle value by the controller 153110, the INT output 153242 is cleared and the new result is stored in the angle register. Again, completion of the angle measurement is indicated by setting the INT output 153242 and corresponding flags in the status register.

Due to the measurement principle of the AS5055 position sensor 153200, only a single angle measurement is performed in a very short time (-600 mus) after each power-up sequence. AS soon AS the measurement of an angle is completed, AS5055 position sensor 153200 is suspended to a power down state. On-chip filtering of angle values according to digital averaging is not achieved, as this would require more than one angle measurement and thus longer power-up time, which is undesirable in low power applications. Angular jitter may be reduced by averaging several angular samples in the controller 153110. For example, averaging four samples may reduce jitter by 6dB (50%).

Fig. 82 is a cross-sectional view of an end effector 153502 showing a firing stroke of an I-beam 153514 relative to tissue 153526 grasped within the end effector 153502 in accordance with at least one aspect of the present disclosure. The end effector 153502 is configured to operate with any surgical instrument or system according to the present disclosure. The end effector 153502 includes an anvil 153516 and an elongate channel 153503 with a staple cartridge 153518 positioned in the elongate channel 153503. The firing bar 153520 is configured to translate distally and proximally along the longitudinal axis 153515 of the end effector 153502. When the end effector 153502 is not articulated, the end effector 153502 is in line with the axis of the instrument. An I-beam 153514 including a cutting edge 153509 is shown at a distal portion of the firing member 153520. Wedge sled 153513 is positioned in staple cartridge 153518. As the I-beam 153514 translates distally, the cutting edge 153509 contacts and can cut tissue 153526 positioned between the anvil 153516 and the staple cartridge 153518. Moreover, the I-beam 153514 contacts and pushes the wedge sled 153513 distally, causing the wedge sled 153513 to contact the staple drivers 153511. The staple drivers 153511 can be driven upwardly into the staples 153505, causing the staples 153505 to advance through tissue and into pockets 153507 defined in the anvil 153516 which form the staples 153505.

The exemplary I-beam 153514 firing stroke is illustrated by chart 153529 aligned with the end effector 153502. An exemplary tissue 153526 is also shown aligned with the end effector 153502. The firing member stroke may include a stroke start position 153527 and an end of stroke position 153528. During the I-beam 153514 firing stroke, the I-beam 153514 can be advanced distally from a start of stroke position 153527 to an end of stroke position 153528. The I-beam 153514 is shown at one exemplary location at a start of travel location 153527. The I-beam 153514 firing member travel chart 153529 illustrates five firing member travel regions 153517, 153519, 153521, 153523, 153525. In the first stroke zone 153517, the I-beam 153514 may begin to advance distally. In the first stroke issue area 153517, the I-beam 153514 can contact the wedge sled 153513 and begin moving it distally. However, in the first region, the cutting edge 153509 can be free of contact with tissue and the wedge sled 153513 can be free of contact with the staple driver 153511. After overcoming the static friction force, the force driving the I-beam 153514 in the first region 153517 may be substantially constant.

In the second firing member travel region 153519, the cutting edge 153509 can begin to contact and cut the tissue 153526. Moreover, the wedge sled 153513 can come into contact with the staple drivers 153511 to drive the staples 153505. The force driving the I-beam 153514 can begin to ramp up. As shown, due to the manner in which the anvil 153516 pivots relative to the staple cartridge 153518, the initially encountered tissue may be compressed and/or thinned. In the third firing member travel region 153521, the cutting edge 153509 can continuously contact and cut the tissue 153526 and the wedge sled 153513 can repeatedly contact the staple drivers 153511. The force driving the I-beam 153514 can be smoothed in the third region 153521. Through the fourth firing travel region 153523, the force driving the I-beam 153514 may begin to drop. For example, tissue in the portion of the end effector 153502 corresponding to the fourth firing region 153523 can be compressed less than tissue closer to the pivot point of the anvil 153516, thereby requiring less cutting force. Moreover, the cutting edge 153509 and wedge sled 153513 can reach the end of tissue 153526 while in the fourth region 153523. When the I-beam 153514 reaches the fifth region 153525, the tissue 153526 can be completely severed. The wedge sled 153513 can contact one or more staple drivers 153511 at or near the end of tissue. The force urging the I-beam 153514 through the fifth region 153525 can be reduced and, in some examples, can be similar to the force driving the I-beam 153514 in the first region 153517. At the end of the firing member stroke, the I-beam 153514 can reach an end-of-stroke position 153528. The positioning of the firing member travel areas 153517, 153519, 153521, 153523, 153525 in fig. 82 is merely one example. In some examples, different regions may begin at different locations along the end effector longitudinal axis 153515, for example, based on the positioning of tissue between the anvil 153516 and the staple cartridge 153518.

As described above and referring now to fig. 80-82, an electric motor 153120 positioned within a main controller of the surgical instrument can be utilized to advance and/or retract a firing system of the shaft assembly (including the I-beam 153514) relative to the end effector 153502 of the shaft assembly in order to staple and/or incise tissue trapped within the end effector 153502. The I-beam 153514 can be advanced or retracted at a desired speed or within a desired speed range. The controller 153110 can be configured to control the speed of the I-beam 153514. The controller 153110 can be configured to predict the speed of the I-beam 153514 based on, for example, various parameters of the power provided to the electric motor 153120 (such as voltage and/or current) and/or other operating parameters or external influences of the electric motor 153120. The controller 153110 can be configured to predict the current speed of the I-beam 153514 based on previous values of current and/or voltage provided to the electric motor 153120 and/or previous states of the system (e.g., speed, acceleration, and/or position). The controller 153110 can be configured to sense the speed of the I-beam 153514 using the absolute position sensor system described herein. The controller may be configured to compare the predicted speed of the I-beam 153514 with the sensed speed of the I-beam 153514 to determine whether the power of the electric motor 153120 should be increased in order to increase the speed of the I-beam 153514 and/or decreased in order to decrease the speed of the I-beam 153514.

Various techniques may be used to determine the force acting on the I-beam 153514. The I-beam 153514 force can be determined by measuring the motor 153120 current, wherein the motor 153120 current is based on the load experienced by the I-beam 153514 when it is desired to advance distally. The I-beam 153514 force can be determined by positioning strain gauges on the proximal ends of the drive member, firing member, I-beam 153514, firing bar, and/or cutting edge 153509. Can be monitored to be based on the time period T which is determined in advance ₁ The actual position of the I-beam 153514 and the actual position of the I-beam 153514 are then compared to the actual position of the I-beam 153514 and based on the time period T for the current set speed of the motor 153120 ₁ The expected position of the I-beam 153514 at the current set speed of the motor 153120 is compared to determine the I-beam 153514 force. Thus, if the actual position of the I-beam 153514 is less than the expected position of the I-beam 153514, the force on the I-beam 153514 is greater than the nominal force. Conversely, if the actual position of the I-beam 153514 is greater than the expected position of the I-beam 153514, the force on the I-beam 153514 is less than the nominal force. The difference between the actual and expected positions of the I-beam 153514 is greater than the I-shapeThe force on the beam 153514 is proportional to the deviation from the nominal force.

Before turning to a description of the closed loop control technique of the closure tube and firing member, the description briefly turns to FIG. 83. Fig. 83 is a graph 153600 depicting two closing Force (FTC) curves 153606, 153608 depicting forces applied to a closing member to close over thick and thin tissue during a closing phase and a graph 153601 depicting two firing force (FTF) curves 153622, 153624 depicting forces applied to a firing member to fire through thick and thin tissue during a firing phase. Referring to fig. 83, a graph 153600 depicts an example of forces applied to thick and thin tissue during a closing stroke to close an end effector 153502 against tissue grasped between an anvil 153516 and a staple cartridge 153518, wherein the closing force is plotted as a function of time. Closing force curves 153606, 153608 are plotted on two axes. Vertical axis 153602 indicates the closing Force (FTC) of end effector 153502 in newtons (N). The horizontal axis 153604 indicates time in seconds and is labeled t for clarity of description ₀ To t ₁₃ . The first closing force curve 153606 is an example of the force applied to thick tissue during a closing stroke to close the end effector 153502 relative to tissue grasped between the anvil 153516 and the staple cartridge 153518, and the second curve 153608 is an example of the force applied to thin tissue during a closing stroke to close the end effector 153502 relative to tissue grasped between the anvil 153516 and the staple cartridge 153518. The first closing force curve 153606 and the second closing force curve 153608 are divided into three phases: a closing stroke (CLOSE), a WAIT period (WAIT), and a firing stroke (FIRE). During the closing stroke, the closure tube translates distally (direction "DD") to move the anvil 153516, for example, relative to the staple cartridge 153518 in response to actuation of the closing motor to the closing stroke. In other cases, the closing stroke involves moving the staple cartridge 153518 relative to the anvil 153516 in response to actuation of the closing motor, and in other cases, the closing stroke involves moving the staple cartridge 153518 and the anvil 153516 in response to actuation of the closing motor. Referring to the first closing force curve 153606, during a closing stroke, the closing force 153610 is calculated from time t ₀ To t ₁ Increasing from 0 to maximum forceF ₁ . Referring to the second closing force curve 153608, during a closing stroke, the closing force 153616 is calculated from time t ₀ To t ₁ Increasing from 0 to maximum force F ₃ . Maximum force F ₁ And F ₃ The relative difference between these is due to the difference in closing force required for thick tissue relative to thin tissue, where more force is required to close the anvil onto the thick tissue than for thin tissue.

The first and second closing force curves 153606 and 153608 indicate the closing force in the end effector 153502 at time (t ₁ ) The initial clamping period at the end increases. Closing force at time (t ₁ ) At a maximum force (F) ₁ ,F ₃ ). The initial clamping period may be, for example, about one second. A wait period may be applied before initiating the firing stroke. The waiting period allows fluid to flow out of the tissue compressed by the end effector 153502, which reduces the thickness of the compressed tissue, creating a smaller gap between the anvil 153516 and the staple cartridge 153518, and reduces the closing force at the end of the waiting period. Referring to the first closing force curve 153606, at t ₁ To t ₄ During the waiting period between, the closing force 153612 is from F ₁ To F ₂ A nominal drop occurs. Similarly, referring to the second closing force curve 153608, at t ₁ To t ₄ During the waiting period between, the closing force 153618 is from F ₃ To F ₄ The nominal dip. In some examples, a waiting period (t) selected from the range of about 10 seconds to about 20 seconds is typically employed ₁ To t ₄ ). In the exemplary first closing force curve 153606 and second closing force curve 153608, a time period of about 15 seconds is employed. The wait period is after a firing stroke, which typically lasts for a period of time selected from the range of about 3 seconds, for example, to about 5 seconds, for example. As the I-beam 153514 advances through the firing stroke relative to the end effector, the closing force decreases. The closing forces 153614, 153620 applied to the closure tube are from about time t as indicated by the closing forces 153614, 153620 of the first and second closing force curves 153606, 153608, respectively ₄ To about time t ₅ And drops sharply. Time t ₄ Representing the coupling of the I-beam 153514 to the anvil 153516 and begin to bear the closing load. Thus, as shown by the first firing force curve 153622 and the second firing force curve 153624, the closing force decreases as the firing force increases.

Fig. 83 also depicts a graph 153601 of a first firing force curve 153622 and a second firing force curve 153624 that plots the force applied to advance an I-beam 153514 during a firing stroke of a surgical instrument or system in accordance with the present disclosure. Firing force curves 153622, 153624 are plotted on two axes. Vertical axis 153626 indicates the firing force in newtons (N) applied to advance I-beam 153514 during the firing stroke. The I-beam 153514 is configured to advance a knife or cutting element and to energize a driver to deploy staples during a firing stroke. The horizontal axis 153605 indicates time in seconds on the same time scale as the horizontal axis 153604 of the upper graph 153600.

As previously described, the closing tube force is from time t ₄ To about time t ₅ This represents the moment when the I-beam 153514 is coupled into the anvil 153516 and begins to bear the load and the closing force decreases as the firing force increases, as shown by the first firing force curve 153622 and the second firing force curve 153624. When the I-beam 153514 is from time t ₄ At the beginning of the stroke, for thin tissue, the firing force profile 153624 to t ₈ And t ₉ End of travel position in between, and firing force curves 153622 to t for thick tissue ₁₃ End of travel position at that time. As the I-beam 153514 is advanced distally during the firing stroke, the closure assembly passes control of the staple cartridge 153518 and anvil 153516 to the firing assembly, which results in an increase in firing force and a decrease in closure force.

In the thick tissue firing force curve 153622, the curve 153622 is divided into three distinct segments during the firing cycle (FIRE). First segment 153628 indicates that the force is being fired from t ₄ The 0 at the point increases to just at t ₅ Peak force F before ₁ ' force of impact at time. The first segment 153628 is the firing force during the initial phase of the firing stroke, with the I-beam 153514 distally advanced from the top of the closure ramp until the I-beam 153514 contacts tissue. The second segment 153630 indicates the second order in the firing stroke The firing force during the segment, wherein the I-beam 153514 is being advanced distally, deploying the staples and cutting the tissue. During the second phase of the firing stroke, the firing force is at about t ₁₂ From F ₁ ' drop to F ₂ '. The third segment 153632 indicates the firing force during the third and last phases of the firing stroke, with the I-beam 153514 exiting the tissue and advancing to the end of the stroke in the tissue free region. During the third phase of the firing stroke, the firing force is at about t ₁₃ From F ₂ ' drop to zero (0), wherein the I-beam 153514 reaches the end of travel. In summary, during the firing stroke, the firing force rises sharply as the I-beam 153514 enters the tissue region, and during the stapling and severing operation, the firing force steadily decreases in the tissue region, while the firing force drops sharply as the I-beam 153514 leaves the tissue region and enters the tissue free region at the end of the stroke.

The thin tissue firing force profile 153624 follows the same pattern as the thick tissue firing force profile 153622. Thus, during the first phase of the firing stroke, the firing force 153634 is at about t ₅ Where from 0 to F increases sharply ₃ '. During the second phase of the firing stroke, the firing force 153636 is at about t ₈ From F ₃ ' steadily drop to F ₄ '. During the final phase of the firing stroke, the firing force 153638 is at t ₈ And t ₉ From F' ₄ And drops sharply to 0.

To overcome the closing force from time t ₄ To about time t ₅ This represents the moment that the I-beam 153514 is coupled into the anvil 153516 and begins to bear the load and the closing force decreases as the firing force increases, as shown by the first firing force curve 153622 and the second firing force curve 153624, the closure tube may advance distally while the firing member (such as the I-beam 153514) advances distally. The closure tube is represented as a transmission element that applies a closing force to the anvil 153516. As described herein, the control circuit applies a motor set point to a motor control that applies a motor control signal to the motor to drive the transmission element and advance the closure tube distally to apply a closure force to the anvil 153516. Coupled to the output shaft of the motorCan be used to measure the force applied to the closure tube. In other aspects, the closing force may be measured with a strain gauge, load cell, or other suitable force sensor.

Fig. 84 is a schematic view of a control system 153950 configured to provide progressive closure of a closure member (e.g., a closure tube) as a firing member (e.g., an I-beam 153514) is advanced distally and coupled to a clamp arm (e.g., an anvil 153516) to reduce closure force load on the closure member and reduce firing force load on the firing member at a desired rate, in accordance with at least one aspect of the present disclosure. In one aspect, the control system 153950 can be implemented as a nested PID feedback controller. The PID controller is a control loop feedback mechanism (controller) that is used to continuously calculate an error value as the difference between a desired set point and a measured process variable and to apply corrections based on proportional, integral and derivative terms (sometimes denoted as P, I and D, respectively). The nested PID controller feedback control system 153950 includes a primary controller 153952 in a primary (outer) feedback loop 153954 and a secondary controller 153955 in a secondary (inner) feedback loop 153956. The primary controller 153952 can be a PID controller 153972 as shown in fig. 84, and the secondary controller 153955 can also be a PID controller 153972 as shown in fig. 85. The primary controller 153952 controls the primary process 153958 and the secondary controller 153955 controls the secondary process 153960. OUTPUT 153966 (OUTPUT) of the master process 153958 is the slave master setpoint SP ₁ The first summer 153962 is subtracted. The first summer 153962 produces a single sum output signal that is applied to the main controller 153952. The output of the main controller 153952 is the secondary set point SP ₂ . The output 153968 of the secondary process 153960 is from the secondary set point SP ₂ The second summer 153964 is subtracted.

In the case of controlling the displacement of the closure tube, the control system 153950 can be configured such that the main set point SP ₁ Is a desired closing force value, and the main controller 153952 is configured to receive the closing force from a torque sensor coupled to the output of the closing motor and determine a set point SP of the closing motor ₂ Motor speed. In other aspects, the closing force may be measured using strain gauges, load cells, or otherA suitable force sensor. Will close the motor speed setpoint SP ₂ The actual speed of the closure tube is compared to the actual speed determined by the secondary controller 153955. The actual speed of the closure tube can be measured by comparing the displacement of the closure tube with the position sensor and measuring the elapsed time with a timer/counter. Other techniques such as linear encoders or rotary encoders may be employed to measure the displacement of the closure tube. The output 153968 of the secondary process 153960 is the actual speed of the closure tube. The closure tube speed output 153968 is provided to a main process 153958 which determines the force acting on the closure tube and feeds back to the summer 153962, which is from the main setpoint SP ₁ The measured closing force is subtracted. Main setpoint SP ₁ May be an upper threshold or a lower threshold. Based on the output of adder 153962, master controller 153952 controls the speed and direction of the closure tube motor as described herein. The secondary controller 153955 is based on the actual speed of the closure tube and the secondary setpoint SP measured by the secondary process 153960 ₂ To control the speed of the closing motor based on a comparison of the actual firing force with the upper and lower firing force thresholds.

Fig. 85 illustrates a PID feedback control system 153970 in accordance with at least one aspect of the present disclosure. The primary controller 153952 or the secondary controller 153955 or both may be implemented as PID controllers 153972. In one aspect, the PID controller 153972 can include a proportional element 153974 (P), an integral element 153976 (I), and a derivative element 153978 (D). The outputs of the P-element 153974, I-element 153976, D-element 153978 are summed by a summer 153986, which provides a control variable u (t) to the process 153980. The output of process 153980 is the process variable y (t). Summer 153984 calculates the difference between the desired set point r (t) and the measured process variable y (t). The PID controller 153972 continuously calculates an error value e (t) (e.g., the difference between the closing force threshold and the measured closing force) as the difference between the desired set point r (t) (e.g., the closing force threshold) and the measured process variable y (t) (e.g., the speed and direction of the closing tube) and applies a correction based on the proportional, integral, and derivative terms calculated by the proportional, integral, and derivative elements 153974 (P), 153976 (I), 153978 (D), respectively. The PID controller 153972 attempts to minimize the time-varying error e (t) by adjusting the control variable u (t) (e.g., the speed and direction of the closed pipe).

The "P" element 153974 calculates the current value of the error according to the PID algorithm. For example, if the error is large and positive, then the control output will also be large and positive. According to the present disclosure, the error term e (t) is different between the desired closing force of the closed tube and the measured closing force. The "I" element 153976 calculates the past value of the error. For example, if the current output is not strong enough, then the integral of the error will accumulate over time and the controller will respond by applying a stronger action. The "D" element 153978 calculates the future possible trend of the error from its current rate of change. For example, continuing with the above example of P, when the large positive control output successfully brings the error closer to zero, it also places the process in the path of the nearest future large negative error. In this case, the derivative becomes negative and the D-module reduces the intensity of the action to prevent this overshoot.

It should be appreciated that other variables and setpoints may be monitored and controlled in accordance with the feedback control systems 153950, 153970. For example, the adaptive closure member speed control algorithm described herein may measure at least two of the following parameters: firing member travel position, firing member load, displacement of the cutting element, speed of the cutting element, closure tube travel position, closure tube load, and the like.

Fig. 86 is a logic flow diagram depicting a process 153990 for determining a control program or logic configuration for a speed of a closure member in accordance with at least one aspect of the present disclosure. The control circuitry of the surgical instrument or system according to the present disclosure is configured to determine the actual closing force of the 153992 closure member. The control circuit compares 153994 the actual closing force to a threshold closing force and determines 153996 a setpoint speed to displace the closing member based on the comparison. The control circuit controls 153998 the actual speed of the closure member based on the setpoint speed.

Referring now also to fig. 84 and 85, in one aspect, the control circuitry includes a proportional, integral and derivative (PID) feedback control system 153950, 153970.The PID feedback control systems 153950, 153970 include a primary PID feedback loop 153954 and a secondary PID feedback loop 153956. The primary feedback loop 153954 determines the actual closing force of the closing member and the threshold closing force SP ₁ A first error therebetween and based thereon, set a closure member speed setpoint SP ₂ . The secondary feedback loop 153956 determines a second error between the actual speed of the closure member and the set point speed of the closure member and sets the closure member speed based on the second error.

In one aspect, a threshold closing force SP ₁ Including an upper threshold and a lower threshold. Set point speed SP ₂ Is configured to advance the closure member distally when the actual closing force is less than the lower threshold, and the setpoint speed is configured to retract the closure member proximally when the actual closing force is greater than the lower threshold. 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 thresholds.

In one aspect, the control system further includes a force sensor (e.g., any of sensors 472, 474, 476 (fig. 12)) coupled to the control circuit. The force sensor is configured to be able 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 sensor coupled to the closure member. In one aspect, the control system includes a position sensor coupled to the closure member, wherein the position sensor is configured to measure a position of the closure member.

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

The functions or methods 153990 described herein may be performed by any of the processing circuits described herein. Aspects of the motorized surgical instrument may be practiced without the specific details disclosed herein. Some aspects have been shown as block diagrams rather than details.

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

In general, aspects described herein, which may be implemented in various hardware, software, firmware, or any combination thereof, alone and/or in combination, may be considered to be comprised of various types of "electronic circuits". Thus, "electronic circuitry" includes electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer or processor configured by a computer program that at least partially implements the processes and/or devices described herein), electronic circuitry forming a memory device (e.g., in the form of a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, communication switch, or optoelectronic device). These aspects may be implemented in analog or digital form or a combination thereof.

The foregoing description has set forth aspects of the apparatus and/or processes via the use of block diagrams, flowcharts, and/or examples, which may include one or more functions and/or operations. Each function and/or operation within such block diagrams, flowcharts, or examples may be implemented, individually and/or collectively, by various hardware, software, firmware, or virtually any combination thereof. In one aspect, portions of the subject matter described herein may be implemented via Application Specific Integrated Circuits (ASICs), field Programmable Gate Arrays (FPGAs), digital Signal Processors (DSPs), programmable logic Devices (DSPs), circuits, registers and/or software elements (e.g., programs, subroutines, logic and/or combinations of hardware and software elements), logic gates, or other integrated formats. Some aspects disclosed herein may be equivalently implemented in integrated circuits, 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., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and it will be within the skill of one of skill in the art in light of this disclosure to design the circuit and/or write the code for the software and/or hardware.

The mechanisms of the subject matter disclosed herein are capable of being distributed as a program product in a variety of forms, and that an illustrative aspect of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution. Examples of signal bearing media include the following: recordable media such as a floppy disk, a hard disk drive, compact Discs (CDs), digital Video Discs (DVDs), digital magnetic tapes, computer memory, etc.; and transmission media such as digital and/or analog communications media (e.g., fiber optic cables, waveguides, wired communications links, wireless communications links (e.g., transmitters, receivers, transmission logic, reception logic), etc.).

The foregoing description of these aspects has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations of the present invention are possible in light of the above teachings. These aspects were chosen and described in order to illustrate the principles and practical application to thereby enable one of ordinary skill in the art to utilize the aspects and make modifications as are suited to the particular use contemplated. The claims filed herewith are intended to define the full scope.

Situational awareness

Situational awareness refers to 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 subjected to the procedure, or the body cavity being the subject of the procedure. Using background information related to the surgical procedure, the surgical system can, for example, improve the manner in which the surgical system controls a modular device (e.g., robotic arm and/or robotic surgical tool) connected thereto, and provide the surgeon with background information or advice during the course of the surgical procedure.

Referring now to fig. 87, a time axis 5200 depicting situational awareness of a hub (e.g., surgical hub 106 or 206) is shown. The timeline 5200 is illustrative of a surgical procedure and background information that the surgical hub 106, 206 may derive from data received from a data source for each step in the surgical procedure. The time axis 5200 depicts typical steps that nurses, surgeons and other medical personnel will take during a lung segment removal procedure, starting from the establishment of an operating room and until the patient is transferred to a post-operative recovery room.

The situation awareness surgical hubs 106, 206 receive data from the data sources throughout the surgical procedure, including data generated each time a medical professional utilizes a modular device paired with the surgical hubs 106, 206. The surgical hubs 106, 206 can receive this data from paired modular devices and other data sources and continually derive inferences about the ongoing procedure (i.e., background information) as new data is received, such as which step of the procedure to perform at any given time. The situational awareness system of the surgical hubs 106, 206 can, for example, record data related to the procedure used to generate the report, verify steps that medical personnel are taking, provide data or cues that may be related to particular procedure steps (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 change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such action described above.

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

In a second step 5204, the staff member scans the incoming medical supplies for the protocol. The surgical hubs 106, 206 cross-reference the scanned supplies with the list of supplies used in the various types of protocols and confirm that the supplied mixture corresponds to the chest protocol. In addition, the surgical hubs 106, 206 can also determine that the procedure is not a wedge procedure (because the incoming supplies lack certain supplies required for, or otherwise do not correspond to, a chest wedge procedure).

Third step 5206, the medical personnel scans the patient frequency band via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 may then confirm the identity of the patient based on the scanned data.

Fourth step 5208, the medical staff opens the auxiliary equipment. The ancillary equipment utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case they include smoke evacuators, insufflators and medical imaging devices. When activated, the auxiliary equipment as a modular device may automatically pair with a surgical hub 106, 206 located in a specific vicinity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive background information about the surgical procedure by detecting the type of modular device paired therewith during the pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines 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 procedure and the type of modular device connected to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will perform. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 can retrieve the steps of the procedure from memory or the cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular device and patient monitoring device) to infer what steps of the surgical procedure the surgical team is performing.

Fifth step 5210, the staff member attaches the EKG electrode and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the surgical hubs 106, 206. When the surgical hub 106, 206 begins to receive data from the patient monitoring device, the surgical hub 106, 206 thus confirms that the patient is in the operating room.

Sixth step 5212, the medical personnel induce anesthesia in the patient. The surgical hubs 106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or the patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. At the completion of the sixth step 5212, the preoperative portion of the lung segmental resection procedure is complete and the operative portion begins.

Seventh step 5214, the patient's lungs being operated on are folded (while ventilation is switched to the contralateral lung). For example, the surgical hub 106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The surgical hub 106, 206 may infer that the surgical portion of the procedure has begun because it may compare the detection of the patient's lung collapse to the expected steps of the procedure (which may be previously accessed or retrieved), thereby determining that collapsing the lung is the first surgical step in that particular procedure.

Eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is activated. The surgical hubs 106, 206 receive medical imaging device data (i.e., video or image data) through their connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmental resection, rather than a leaf resection (note that the wedge procedure has been excluded based on the surgical hub 106, 206 based on the data received at the second step 5204 of the procedure). The data from the medical imaging device 124 (fig. 2) can be used to determine background information related to the type of procedure being performed in a number of different ways, including by determining the angle of the visual orientation of the medical imaging device relative to the patient's anatomy, monitoring the number of medical imaging devices utilized (i.e., activated and paired with the surgical hub 106, 206), and monitoring the type of visualization device utilized. For example, one technique for performing a vat lobectomy places the camera in the lower anterior corner of the patient's chest over the septum, while one technique for performing a vat segmented resection places the camera in an anterior intercostal position relative to the segmented slit. For example, using pattern recognition or machine learning techniques, the situational awareness system may be trained to recognize the positioning of the medical imaging device from the visualization of the patient anatomy. As another example, one technique for performing a vat lobectomy utilizes a single medical imaging apparatus, while another technique for performing a vat segmented excision utilizes multiple cameras. As another example, a technique for performing vat segmental resections utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental slots that are not used in vat pulmonary resections. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can thus determine the particular type of surgical procedure being performed and/or the technique used for the particular type of surgical procedure.

Ninth step 5218, the surgical team begins the anatomical steps of the procedure. The surgical hub 106, 206 may infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or the ultrasound generator indicating that the energy instrument is being fired. The surgical hub 106, 206 may cross the received data with the retrieval step of the surgical procedure to determine that the energy instrument fired at that point in the procedure (i.e., after the previously discussed procedure steps are completed) corresponds to an anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of the robotic surgical system.

Tenth step 5220, the surgical team proceeds with the ligation step of the procedure. The surgical hubs 106, 206 can infer that the surgeon is ligating arteries and veins because they receive data from the surgical stapling and severing instrument indicating that the instrument is being fired. Similar to the previous steps, the surgical hubs 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the retrieval steps in the process. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, a segmental resection portion of the procedure is performed. The surgical hubs 106, 206 can infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data may correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissue, the cartridge data can be indicative of the type of tissue being stapled and/or transected. In this case, the type of staples being fired is for parenchyma (or other similar tissue type), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is ongoing.

In a twelfth step 5224, a node dissection step is performed. The surgical hub 106, 206 may infer that the surgical team is dissecting a node and performing a leak test based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasonic instrument used after transection of the parenchyma corresponds to a node dissection step that allows the surgical hub 106, 206 to make such inferences. It should be noted that the surgeon switches back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments periodically, depending on the particular steps in the procedure, as the different instruments are better suited for the particular task. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used may dictate the steps of the procedure that the surgeon is performing. Further, in some cases, robotic tools may be used for one or more steps in a surgical procedure, and/or hand-held surgical instruments may be used for one or more steps in a surgical procedure. The surgeon(s) may alternate between, for example, robotic tools and hand-held surgical instruments and/or may use the devices simultaneously. At the completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.

Thirteenth step 5226, the patient is reversed from anesthesia. For example, the surgical hub 106, 206 may infer that the patient is waking from anesthesia based on, for example, ventilator data (i.e., the patient's respiration rate begins to increase).

Finally, a fourteenth step 5228 is for the medical personnel to remove the various patient monitoring devices from the patient. Thus, when the hub loses EKG, BP, and other data from the patient monitoring device, the surgical hub 106, 206 may infer that the patient is being transferred to the recovery room. As can be seen from the description of this exemplary procedure, the surgical hub 106, 206 can determine or infer when each step of a given surgical procedure occurs from data received from various data sources communicatively coupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. provisional patent application Ser. No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on 12/28 at 2017, which is incorporated herein by reference in its entirety. In some cases, operation of robotic surgical systems (including the various robotic surgical systems disclosed herein) may be controlled, for example, by hubs 106, 206 based on their situational awareness and/or feedback from their components and/or based on information from cloud 104.

Irregularities in tissue distribution

Typically, in surgical stapling procedures, a user places jaws of an end effector around tissue to grasp 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 the remainder of the gap remains unoccupied or slightly occupied. Irregularities in tissue distribution positioned between the jaws of a surgical stapling instrument can reduce stapling result uniformity. For example, irregular tissue distribution may result in excessive tissue compression in the portion of tissue being clamped, and insufficient tissue compression in other portions of tissue being clamped, which may have a negative impact on the tissue being manipulated. For example, excessive compression of tissue can lead to tissue necrosis and, in some procedures, staple line failure. Insufficient tissue compression also adversely affects staple deployment and formation, and can lead to leakage or improper healing of the stapled tissue.

Aspects of the present disclosure present a surgical stapling instrument that comprises an end effector configured to staple tissue clamped between a first jaw and a second jaw of the end effector. The surgical stapling instrument is configured to sense and indicate irregularities in tissue distribution within the end effector relative to a plurality of predetermined regions between the first jaw and the second jaw. The surgical stapling instrument is further configured to sense and indicate irregularities in the amount and location of tissue in a predetermined region.

In one aspect, the surgical stapling instrument is configured to provide feedback regarding the most appropriate location and positioning of tissue in the event that tissue irregularities are detected.

Absolute measurements of tissue impedance at predetermined regions can be significantly affected by the environment in which the end effector is immersed. For example, an end effector immersed in a fluid (such as blood) will, for example, produce a different tissue impedance measurement than an end effector not immersed in blood. Moreover, an end effector clamped around previously stapled tissue will produce a different tissue impedance measurement than an end effector clamped around unstitched tissue. The present disclosure addresses such differences when evaluating tissue distribution in different predetermined regions by comparing tissue impedance measurements at different predetermined regions to each other.

In one aspect, the irregularities of tissue clamped between the jaws of the surgical stapling instrument create differential tissue compression at predetermined areas. Aspects of the present disclosure present a surgical stapling instrument that includes a tissue distribution evaluation circuit configured to be able to sense and indicate irregularities in tissue compression in predetermined regions by measuring an impedance between jaws of an end effector at each of the predetermined regions.

In one aspect, the tissue distribution evaluation circuit of the surgical stapling instrument includes one or more tissue contact circuits at each of predetermined regions configured to measure tissue impedance to evaluate the location and amount of clamped tissue.

For simplicity, one or more of the embodiments of the present disclosure are described in connection with a particular type of surgical instrument. 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 equally applicable to surgical instruments that apply therapeutic energy to tissue, such as, for example, ultrasonic or Radio Frequency (RF) energy.

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

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

Referring again to fig. 88, three tissue distribution evaluation zones (zone 1, zone 2, zone 3) are defined along the curved length of the anvil 25007. Each of the three regions extends along a portion of the curved length of the anvil 25007. Tissue impedance is measured at each of the three regions to assess irregularities in tissue distribution between the anvil 25007 and the staple cartridge 25009. Region 1 (also referred to herein as the crotch region) is the inner region that is located closest to arm 25010, while region 3 is the outer region and is farther from arm 25010 than region 1. Region 2 is an intermediate region extending between region 1 and region 3. Each of regions 1 and 3 extends along about one-fourth of the curved length of anvil 25007. Zone 2, on the other hand, extends along about one half of the bending length of the anvil between zone 1 and zone 3.

FIG. 89 is a partial cross-sectional view of the end effector of FIG. 88, showing grasping tissue between its jaws at three tissue distribution evaluation zones (zone 1, zone 2, zone 3). Fig. 90 illustrates a perspective view of an end effector 25020 of a surgical stapling and severing instrument that includes tissue distribution assessment regions (region 1, region 2, region 3) that are similar in many respects to the tissue distribution assessment regions (region 1, region 2, region 3) of end effector 25002.

In the embodiment of fig. 88, anvil 25007 has a tissue contacting surface 25012 that is divided into three regions (region 1, region 2, region 3). Tissue impedance measurements at the three regions represent tissue distribution within the end effector 25002. In various aspects, the number of regions may be greater than or less than three. In one example, the surgical stapling instrument can comprise four regions, as shown in fig. 103. In another example, the surgical stapling instrument can comprise eight regions, as shown in fig. 104. The size of the regions may be the same, or at least substantially the same. Alternatively, the size of the region may vary, as shown in fig. 88.

The appropriate number, size and location of the regions may be selected according to the type of surgical instrument. For example, a linear surgical stapling instrument can comprise an inner or proximal region closest to the shaft, an outer or distal region furthest from the shaft, and one or more intermediate regions between the inner and outer regions.

Three regions of the embodiment of fig. 88 are defined relative to the tissue contacting surface 25012 of the anvil 25007. However, in other embodiments, the tissue distribution assessment area can be defined relative to the tissue contacting surface of the staple cartridge. In other words, to assess tissue distribution within the end effector, the tissue contacting surface of the staple cartridge may be divided into predetermined regions.

Each of the three regions of the embodiment of fig. 88 includes one or more tissue contact circuits configured to measure impedance of a tissue portion located at a predetermined region. An example tissue contacting circuit is shown in fig. 24. The tissue "T" in contact with the anvil 25007 and the staple cartridge 25009 at a predetermined region closes an otherwise open sensing circuit "SC" at the predetermined region by simultaneously establishing contact with a pair of opposing plates "P1, P2" disposed on the anvil 25007 and the staple cartridge 25009 at the predetermined region.

Any of the contact circuits disclosed herein can include, but are not limited to, electrical contacts disposed on an inner surface of a jaw that closes an otherwise open sensing circuit upon contact with tissue.

The contact circuit may also include a force sensitive transducer that determines the amount of force applied to the sensor, which may be assumed to be the same as the amount of force applied to the tissue "T". Such forces applied to tissue "T" may then be translated into an amount of tissue compression. The force sensor measures the amount of compression experienced by the tissue "T" and provides information to the surgeon regarding the force applied to the tissue "T".

As described above, excessive tissue compression can negatively impact the tissue "T" being operated on. For example, excessive compression of tissue "T" can lead to tissue necrosis and, in certain procedures, staple line failure. Information about the pressure applied to the tissue "T" enables the surgeon to better determine that excessive pressure is not being applied to the tissue "T".

The force transducers of the contact circuit may include, but are not limited to, piezoelectric elements, piezoresistive elements, metal film or semiconductor strain gauges, inductive pressure sensors, capacitive pressure sensors, and potentiometric pressure transducers that use a spring tube, capsule or bellows to drive a wiper arm on a resistive element.

In various aspects, the predetermined region within the end effector 25002 can 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 flex circuits are described in connection with fig. 75 of the present disclosure. To measure tissue impedance, the segmented flexible circuit passes the sub-therapeutic electrical signal through the tissue at each of the predetermined regions.

Fig. 91-96 illustrate three examples of tissue distribution (T1, T2, T3) within end effector 25002. The straightened cross-sectional view of the end effector 25002 in fig. 91-93 illustrates the initial distribution of tissue in three regions (region 1, region 2, region 3) within the end effector 25002 according to each of the three examples. The straightened cross-sectional view of the end effector of fig. 94-96 shows tissue subjected to an initial compression to close three examples of sensing contact circuitry between the tissue contacting surfaces of the anvil 25007 and staple cartridge 25009.

As described above, establishing contact between the tissue "T" and the tissue contacting surfaces of the anvil 25007 and staple cartridge 25009 at a predetermined region closes the sensing circuit at the predetermined region. Closure of the sensing circuit causes current to pass through tissue "T" at a predetermined region, as shown in fig. 89, and through the sensing circuit. The impedance of tissue "T" at a predetermined region can be calculated by:

wherein Z is _{Tissue of} Is tissue impedance, V is voltage, I is current, and Z _{Sensing circuit} Is the impedance of the sensing circuit.

As shown in fig. 89, insulating elements 25014 may be positioned between adjacent plates (P) to separate adjacent sensing circuits. Although three sensing circuits are shown in fig. 89, the number of sensing circuits may be different from three. In various examples, the end effector can include "n" number of sensing circuits corresponding to "n" number of predetermined regions, where "n" is an integer greater than or equal to the number 3.

Fig. 97 illustrates a logic flow diagram depicting a process 25030 for identifying control procedures or logic configurations of 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 combinational logic circuit 510 (fig. 14). In yet another aspect, process 25030 may be performed by sequential logic circuit 520 (fig. 15).

The process 25030 includes receiving 25032 sensor signals from sensor circuits of the sensing circuit assembly 25471 corresponding to predetermined regions (e.g., region 1, region 2, and region 3) within the end effector 25002, thereby determining 25034 a tissue impedance Z of a tissue portion at such regions based on the received sensor signals _{Tissue of} . FIG. 98 shows tissue impedance Z _{Tissue of} Curves 25001, 25003, 25005, which correspond to organization examples T1, T2, T3, respectively.

Process 25030 also includes conditional steps 25036, 25038. If it is determined that the average of the tissue impedance of the inner region (e.g., region 1) and the outer region (e.g., region 3) is greater than the tissue impedance of the intermediate region (e.g., region 2), then the tissue distribution is deemed insufficient and instructions are provided for releasing 25040 the grasped tissue and repositioning the end effector 25002, as shown by way of example in fig. 92, 95, 98, 100. In some cases, the grasped tissue is released only to a minimum threshold during the release period, and then re-clamped so that the tissue does not slip out of the end effector 25002.

However, if the average of the tissue impedance of the outer region (e.g., region 1) and the inner region (e.g., region 3) is less than or equal to the tissue impedance of the intermediate region (e.g., region 2) and the tissue impedance of the inner region is less than or equal to the tissue impedance of the outer region, then the tissue distribution is deemed to be sufficient and the end effector closure continues 25042 while maintaining a predetermined closure Force (FTC) threshold rate, as shown by way of example in fig. 91, 94, 98, 99.

However, if the average of the tissue impedance of the outer region (e.g., region 1) and the inner region (e.g., region 3) is less than or equal to the tissue impedance of the middle region (e.g., region 2), and the tissue impedance of the inner region is greater than the tissue impedance of the outer region, then the tissue distribution is considered sufficient, but the FTC threshold rate is reduced 25044 to a slower rate, as shown by example in fig. 93, 96, 98, 101.

Fig. 102 illustrates a logic diagram of a control system 25470 that may be used to perform the process of fig. 97. The control system 25470 is similar in many respects to the control system 470 (fig. 12). In addition, the control system 25470 includes a sense circuit assembly 25471 that includes "n" number of sense circuits S ₁ To S _n Wherein "n" is an integer greater than two. Sensing circuit S ₁ To S _n A predetermined region within the end effector is defined, as described above.

In various examples, the sensing circuit assembly 25471 includes "n" number of continuity sensors, where "n" is an integer greater than two. As described above, the continuity sensor defines a predetermined area within the end effector.

In various examples, the sensing circuit S ₁ To S _n Can be configured to provide a sensor signal indicative of tissue compression using the impedance measurements. Continuity sensor S ₁ To S _n May be used to inform whether sufficient tissue extends within end effector 25002. Additionally, FTC sensors can be used to evaluate tissue creep rates in order to determine tissue distribution within the end effector 25002.

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

In various aspects, various sensors such as magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as, for example, eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors may be adapted and configured to be capable of measuring tissue compression/impedance at predetermined regions within the end effector.

In various aspects, if more tissue is sensed in the inner region of the end effector 25002 than in the outer region, the rate of closure system advancement is changed by the microcontroller 461. The closing rate is slowed to improve tissue distribution by allowing tissue in the interior region time to creep outward within end effector 25002.

In various aspects, monitoring changes in impedance as the closing gap changes may also be used to inform tissue properties and localization.

Fig. 99 illustrates a graph 25400 depicting exemplary firing of an end effector 25002 of a surgical instrument, an end effector FTC 25402 and a closing velocity 25404 over time 25406, in accordance with at least one aspect of the present disclosure. In the following description of graph 25400, reference should also be made to fig. 91, 94, 97. The exemplary firing described herein is for the purpose of demonstrating the concepts discussed above with reference to fig. 91, 94, 97 and should not be construed as limiting in any way.

As shown in fig. 91, 94, firing of the end effector 25002 may be represented by FTC curve 25408 and corresponding speed curve 25408', which illustrate FTC and closing speed changes over time during firing, respectively. Firing may represent, for example, firing of the end effector 25002 of the surgical instrument, including the control circuitry performing the procedure 25030 shown in fig. 97. When firing of the end effector 25002 begins, the processor 462 controls the motor 482 to begin driving the anvil 25007 from its open position, causing the closing speed of the anvil 25007 to increase sharply 25416 until it stabilizes 25418 at a particular closing speed. When anvil 25007 is closed, FTC increases 25410 until it reaches peak 25412 at a particular time. FTC decreases 25414 from peak 25412 until tissue "T1" is fully clamped, at which point processor 462 controls motor 482 to stop closing of anvil 25007 and the closing speed drops 25420 to zero.

Thus, the firing of fig. 91, 94 represents the firing of the end effector 25002, wherein the tissue between the jaws 25006, 25008 is distributed within acceptable limits. In other words, the firing of fig. 91, 94 remains within all control parameters during the jaw closure process. Thus, the processor 462 does not pause the anvil 25007, adjust the closing speed of the anvil 25007, or take any other corrective action during the process.

Fig. 14 illustrates a graph 25422 depicting an exemplary firing of an end effector 25007 of a surgical instrument, an end effector FTC 25402 and a closing speed 25404 over time 25406, in accordance with at least one aspect of the present disclosure. In the following description of graph 25422, reference should also be made to fig. 92, 95, 97. The exemplary firing described herein is for the purpose of demonstrating the concepts discussed above with reference to fig. 92, 95, 97 and should not be construed as limiting in any way.

As shown in fig. 92, 95, 97, firing of the end effector 25002 may be represented by FTC curve 25424 and corresponding speed curve 25424', which illustrate FTC and closing speed changes over time during firing, respectively. The firing of fig. 92, 95 may represent, for example, the firing of an end effector 25007 of a surgical instrument, including the control circuitry performing the procedure 25030 illustrated in fig. 97. 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, causing the closing speed of the anvil 25007 to increase sharply 25432 until it reaches a particular closing speed. When the anvil 25012 is closed, the FTC increases 25426 until it reaches a peak 25428 at a particular time. In this case, the processor 462 receives input from the sensing circuitry assembly 25471 indicating that the tissue distribution between the jaws 25006, 2008 is skewed toward the third region, as shown in fig. 92, 95

In response, the processor 462 instructs the operator of the end effector 25007 of the surgical instrument to open the jaws 25006, 25008 via the display 473 to readjust tissue "T2" therein, as outlined in process 25030. Thus, the closing speed decreases 25434 until it reaches a negative closing speed, which indicates that the jaws 25006, 25008 are being opened, for example, to easily allow tissue "T2" to be readjusted within the jaws 25006, 25008. The closing speed is then returned 25436 to zero and the jaws 25006, 25008 are stopped. Accordingly, FTC decreases 25430 to zero as jaws 25006, 25008 are released from tissue "T2".

Fig. 101 illustrates a graph 25438 depicting an exemplary firing of a surgical instrument as a function of time 25406 of an end effector FTC 25402 and a closing speed 25404 in accordance with at least one aspect of the present disclosure. In the following description of the seventh graph 25438, reference should also be made to fig. 93, 96, 97. The exemplary firing described herein is for the purpose of demonstrating the concepts discussed above with reference to fig. 93, 96, 97 and should not be construed as limiting in any way.

As shown in fig. 93, 96, 97, firing of the end effector 25002 may be represented by FTC profile 21440 and corresponding speed profile 25440', which show FTC and closing speed changes over time during firing, respectively. The firing of fig. 93, 96 may represent, for example, an end effector 25002 of a surgical instrument, including control circuitry to perform the procedure 25030 illustrated in fig. 11. When firing of the end effector 25002 begins, the processor 462 controls the motor 482 to begin driving the anvil 25007 from its open position, causing the closing speed of the anvil 25007 to increase sharply 25450 to the first closing speed v1. When anvil 25007 is closed, FTC increases 21442 until time t1. At time t1, the control circuit 21002 determines that the tissue distribution is skewed toward region 1, as shown in fig. 93, 96. In response, as indicated by process 25030, processor 462 may adjust the rate of motor 482 to allow tissue "T3" sufficient time to creep outwardly toward region 2 and/or region 3.

Fig. 103 illustrates fig. 6000 of a surgical instrument 6002 centered on a staple line 6003 using the centering tools and techniques described in connection with fig. 104-114, in accordance with at least one aspect of the present disclosure. As used in the description of fig. 104-114 below, staple lines may include multiple rows of staggered staples, and typically include two or three rows of staggered staples, but are not limited thereto. The staple line may be a double staple line 6004 formed using a double stitching technique as described in connection with figures 104-108, or may be a linear staple line 6052 formed using a linear transection technique as described in connection with figures 109-114. The centering tools and techniques described herein can be used to align an instrument 6002 located in one portion of an anatomy with a staple line 6003 or with another instrument located in another portion of the anatomy without the benefit of a sight line. Centering tools and techniques include current alignment of the display instrument 6002 adjacent to previous operations. For example, the centering tool is useful during laparoscopic assisted rectal surgery employing a double suture technique (also known as an overlap suture technique). In the illustrated example, during a laparoscopic assisted rectal surgical procedure, the circular stapler 6002 is positioned in the patient's rectum 6006 within the pelvic cavity 6008, and the laparoscope is positioned in the peritoneal cavity.

During laparoscopic assisted rectal surgery, the colon is transected and sealed by a staple line 6003 having a length "l". The double suturing technique uses a circular stapler 6002 to form an end-to-end anastomosis and is currently widely used in laparoscopic assisted rectal surgery. To successfully form an anastomosis using circular stapler 6002, anvil trocar 6010 of circular stapler 6002 should be aligned with center "l/2" of staple line 6003 transverse to staple line 6003 prior to piercing center "l/2" of staple line 6003 and/or fully clamping it to tissue prior to firing circular stapler 6002 to sever staple overlap 6012 and form an anastomosis. Misalignment of the anvil trocar 6010 from the center transverse to the staple line 6003 may result in high rate anastomosis failure. The techniques may be applied to ultrasonic instruments, electrosurgical instruments, combination ultrasonic/electrosurgical instruments, and/or combination surgical staplers/electrosurgical instruments. Several techniques for aligning anvil trocar 6010 of circular stapler 6002 with center "l/2" of staple line 6003 are now described.

In one aspect, as described in fig. 104-106, and with further reference to fig. 1-11, to illustrate interaction with an environment of an interactive surgical system 100 including surgical hubs 106, 206, the present disclosure provides an apparatus and method for detecting overlapping portions of a double staple line 6004 in a laparoscopic assisted rectal surgical colorectal transection using double stitching techniques. 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. Surgical hub display 215 shows the alignment of the circular stapler 6002 cartridge relative to the overlapping portion of the double staple line 6004 at the center of the double staple line 6004. The surgical hub display 215 displays a circular image centered around the area of the overlapping double staple lines 6004 to ensure that the overlapping portions of the double staple lines 6004 are contained within the knife of the circular stapler 6002 and are therefore removed after circular firing. Using the display, the surgeon aligns anvil trocar 6010 with the center of double staple line 6004 before piercing the center of double staple line 6004 and/or fully clamping it onto tissue before firing circular stapler 6002 to sever staple overlap 6012 and form an anastomosis.

Fig. 104-108 illustrate a process of aligning an anvil trocar 6010 of a circular stapler 6022 with a staple overlap portion 6012 of a double staple line 6004 formed by a double stapling technique in accordance with at least one aspect of the present disclosure. The staple overlap portion 6012 is centered over a double staple line 6004 that is formed by a double stitching technique. A circular stapler 6002 is inserted into the colon 6020 below the double spike 6004, and a laparoscope 6014 is inserted through the abdomen above the double spike 6004. The laparoscope 6014 and the non-contact sensor 6022 are used to determine the position of the anvil trocar 6010 relative to the staple overlap portion 6012 of the dual staple line 6004. The laparoscope 6014 includes an image sensor to generate images of the double staple lines 6004. The image sensor image is transmitted to the surgical hub 206 via the imaging module 238. The sensor 6022 generates a signal 6024 that detects the metal spike using inductive or capacitive metal sensing techniques. The signal 6024 varies based on the position of the anvil trocar 6010 relative to the staple overlap 6004. The centering tool 6030 presents an image 6038 of the double staple line 6004 and a target alignment ring 6032 defining the image 6038 of the double staple line 6004 centered about the image 6040 of the staple overlap portion 6012 on the surgical hub display 215. Centering tool 6030 also presents a projected cutting path 6034 of the anvil knife of circular stapler 6002. The alignment process includes displaying an image 6038 of the double staple line 6004 and a target alignment ring 6032 defining the image 6038 of the double staple line 6004 centered on the image 6040 of the staple overlap portion 6012 to be cut by a circular knife of the circular stapler 6002. An image of crosshair 6036 (X) is also shown relative to image 6040 of staple overlap 6012.

Fig. 104 shows that the anvil trocar 6010 of the circular stapler 6002 is not aligned with the staple overlap portion 6012 of the double staple line 6004 formed by a double stapling technique. Double staple line 6004 has a length "l" and staple overlap portion 6012 is located at "l/2" along double staple line 6004. As shown in fig. 104, a circular stapler 6002 is inserted into a segment of the colon 6020 and positioned directly below the transection of the double staple line 6004. The laparoscope 6014 is positioned over the transection of the double staple line 6004 and feeds images of the double staple line 6004 and 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 that is located on circular stapler 6002. Sensor 6022 also provides the position of anvil trocar 6010 relative to staple overlap portion 6012 to surgical hub display 215.

As shown in fig. 104, the projected path 6018 of the anvil trocar 6010 is shown along a dashed line to a position marked by X. As shown in fig. 104, the projected path 6018 of the anvil trocar 6010 is not aligned with the staple overlap portion 6012. Piercing anvil trocar 6010 through double staple line 6044 at a point away from staple overlap 6012 may result in a failed anastomosis. Using the centering tool 6030 of the anvil trocar 6010 depicted in fig. 106, a surgeon may align the anvil trocar 6010 with the staple overlap 6012 using the images displayed by the centering tool 6030. For example, in one implementation, sensor 6022 is an inductive sensor. Since staple overlap 6012 contains more metal than the remainder of the lateral portion of double staple line 6004, signal 6024 is greatest when sensor 6022 is aligned with and proximate to staple overlap 6012. Sensor 6022 provides a signal to surgical hub 206 indicative of the position of anvil trocar 6010 relative to staple overlap 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 a staple overlap portion 6012 at the center of a double staple line 6004 formed by a double stapling technique. Before firing circular stapler 6002 to sever staple overlap portion 6012 and form an anastomosis, the surgeon may now pierce anvil trocar 6010 through staple overlap portion 6012 of double staple line 6004 and/or clamp it completely against tissue.

Fig. 106 shows a centering tool 6030 displayed on the surgical hub display 215 that provides a display of a staple overlap portion 6012 of a double staple line 6004 formed by a double stapling technique wherein an anvil trocar 6010 is not aligned with the staple overlap portion 6012 of the double staple line 6004, as shown in fig. 104. The centering tool 6030 presents an image 6038 of the double staple line 6004 and an image 6040 of the staple overlap portion 6012 received from the laparoscope 6014 on the surgical hub display 215. A target alignment ring 6032 centered around the image 6040 of the staple overlap portion 6012 defines an image 6038 of the double staple line 6004 to ensure that the staple overlap portion 6012 is located within the circumference of the projected cutting path 6034 of the circular stapler 6002 knife when the projected cutting path 6034 is aligned with the target alignment ring 6032. Crosshair 6036 (X) represents the position of anvil trocar 6010 relative to staple overlap portion 6012. Crosshair 6036 (X) indicates the point through double staple line 6004 where anvil trocar 6010 would puncture if it were advanced from its current position.

As shown in fig. 106, anvil trocar 6010 is not aligned with the desired penetration location specified by image 6040 of staple overlap 6012. To align anvil trocar 6010 with staple overlap portion 6012, the surgeon manipulates circular stapler 6002 until projected cutting path 6034 overlaps target alignment ring 6032 and crosshair 6036 (X) is centered over image 6040 of staple overlap portion 6012. Once aligned, the surgeon may pierce anvil trocar 6010 through staple overlap portion 6012 of double staple line 6004 and/or fully clamp it against tissue before firing circular stapler 6002 to sever staple overlap portion 6012 and form an anastomosis.

As discussed above, the sensor 6022 is configured to detect the position of the anvil trocar 6010 relative to the staple overlap 6012. Thus, the position of the crosshair 6036 (X) presented on the surgical hub display 215 is determined by the surgical stapler sensor 6022. In another aspect, the sensor 6022 can be located on a laparoscope 6014, wherein the sensor 6022 is configured to detect the tip of the anvil trocar 6010. In other aspects, a sensor 6022 may be located on the circular stapler 6022 or the laparoscope 6014, or both, to determine the position of the anvil trocar 6010 relative to the staple overlap 6012 and provide information to the surgical hub display 215 via the surgical hub 206.

Fig. 107 and 108 illustrate a front image 6042 and a rear image 6043 of a centering tool 6030 in accordance with at least one aspect of the present disclosure. Fig. 107 shows an image of the projected cutting path 6034 of the anvil trocar 6010 and circular knife prior to alignment with the target alignment ring 6032 that defines an image 6038 of the double staple line 6004 on an image 6040 of the staple overlap portion 6040 presented on the surgical hub display 215. Fig. 108 shows an image of the projected cutting path 6034 of the anvil trocar 6010 and circular knife after alignment with a target alignment ring 6032 that defines an image 6038 of a double staple line 6004 on an image 6040 of a staple overlap portion 6040 presented on the surgical hub display 215. The current position of anvil trocar 6010 is marked by crosshairs 6036 (X) that are positioned below and to the left of the center of image 6040 of staple overlap 6040 as shown in fig. 107. As shown in fig. 108, as the surgeon moves anvil trocar 6010 along projection path 6046, projection cutting path 6034 is aligned with target alignment ring 6032. For example, the target alignment ring 6032 may be displayed as a grayed alignment ring overlaying the current position of the anvil trocar 6010 relative to the center of the double staple line 6004. The image may include an indicator as to which direction of movement. The target alignment ring 6032 may be shown in bold, change color, or be highlighted when it is within a predetermined center distance within acceptable limits.

In another aspect, the sensor 6022 can be configured to detect the beginning and end of a linear staple line in a colorectal cross-cut and provide the location of the current location of the anvil trocar 6010 of the circular stapler 6002. In another aspect, the present disclosure provides a surgical hub display 215 to present a circular stapler 6002 centered on a linear staple line (which will form a uniform crimp) and to provide the current position of the anvil trocar 6010 to allow a surgeon to center or align the anvil trocar 6010 as desired prior to firing the circular stapler 6002 prior to puncturing and/or fully clamping onto tissue.

In another aspect, as described in fig. 109-111, and with further reference to fig. 1-11, in a laparoscopic assisted rectal surgical colorectal transection using a linear stapling technique, the beginning and ending of the linear staple line 6052 is detected and the current position of the anvil trocar 6010 of the circular stapler 6002 is shown on a surgical hub display 215 coupled to the surgical hub 206. The surgical hub display 215 displays a circular image centered on the double staple line 6004 (which will form a uniform crimp) and the current position of the anvil trocar 6002 to allow the surgeon to center or align the anvil trocar 6010 before firing the circular stapler 6002 to cut the center 6050 of the linear staple line 6052 to form an anastomosis before piercing the linear staple line 6052 and/or fully clamping it onto tissue.

Fig. 109-112 illustrate a process of aligning an anvil trocar 6010 of a circular stapler 6022 with a center 6050 of a linear staple line 6052 formed by a linear stapling technique in accordance with at least one aspect of the present disclosure. Fig. 109 and 110 illustrate a laparoscope 6014 and a sensor 6022 positioned on a circular stapler 6022 that determine the position of an anvil trocar 6010 relative to the center 6050 of a linear staple line 6052. Anvil trocar 6010 and sensor 6022 are inserted into colon 6020 below linear staple line 6052 and laparoscope 6014 is inserted through the abdomen above linear staple line 6052.

Fig. 109 shows anvil trocar 6010 not aligned with center 6050 of linear staple line 6052 and fig. 110 shows anvil trocar 6010 aligned with center 6050 of linear staple line 6052. The sensor 6022 is used to detect the center 6050 of the linear staple line 6052 to align the anvil trocar 6010 with the center of the staple line 6052. In one aspect, the center 6050 of the linear staple line 6052 may be positioned by moving the circular stapler 6002 until one end of the linear staple line 6052 is detected. The end may be detected when there are no more staples in the path of sensor 6022. Once one of the ends is reached, the circular stapler 6002 moves along the linear staple line 6053 until the opposite end is detected and the length "l" of the linear staple line 6052 is determined by measurement or counting individual staples by the sensor 6022. Once the length of the linear staple line 6052 is determined, the center 6050 of the linear staple line 6052 may be determined by dividing the length by two "l/2".

Fig. 111 shows a centering tool 6054 displayed on the surgical hub display 215 that provides a display of linear staple lines 6052 wherein the anvil trocar 6010 is not aligned with the staple overlap portion 6012 of the dual staple line 6004 as shown in fig. 109. The surgical hub display 215 presents a linear staple line 6052 and a standard reticle field 6056 of a laparoscopic field 6016 of a portion of the colon 6020. The surgical hub display 215 also presents a target ring 6062 defining the image center of the linear staple line and a projected cutting path 6064 of the anvil trocar and circular knife. Crosshair 6066 represents the position of anvil trocar 6010 relative to center 6050 of linear staple line 6052. Crosshair 6036 (X) indicates the point through the linear staple line 6052 where it will puncture if the anvil trocar 6010 is advanced from its current position.

As shown in fig. 111, anvil trocar 6010 is not aligned with the desired penetration position 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 linear staple line 6052, the surgeon manipulates the circular stapler 6002 until the projected cutting path 6064 overlaps the target alignment ring 6062 and the crosshair 6066 is centered over the image 6040 of the staple overlap portion 6012. Once aligned, the surgeon may pierce the anvil trocar 6010 through the center 6050 of the linear staple line 6052 and/or fully clamp it onto the tissue before firing the circular stapler 6002 to sever the staple overlap portion 6012 and form an anastomosis.

In one aspect, the present disclosure provides an apparatus and method for displaying an image of a linear staple line 6052 using a linear transection technique and an alignment ring or bullnose positioned as if the anvil trocar 6010 of a circular stapler 6022 were properly centered along the linear staple line 6052. The apparatus shows a graying alignment ring overlaying the current position of the anvil trocar 6010 relative to the center 6050 of the linear staple line 6052. The image may include an indicator mark to aid in the alignment process by indicating the direction of moving the anvil trocar 6010. The target alignment ring 6032 may be shown in bold, change color, or be highlighted when it is within a predetermined center distance within acceptable limits.

Referring now to fig. 109-112, fig. 112 is an image 6080 of a standard reticle field of view 6080 transected by a surgical linear staple line 6052 as viewed through a laparoscope 6014 displayed on a surgical hub display 215 in accordance with at least one aspect of the present disclosure. In the standard reticle view 6080, it is difficult to see the linear staple line 6052 in the standard reticle field of view 6056. Furthermore, there is no alignment aid that helps align the anvil trocar 6010 with the center 6050 of the linear staple line and introduce to the center 6050 of the linear staple line. This view does not show alignment circles or alignment marks to indicate whether the circular stapler is properly centered, and does not show the projected trocar path. In this view, it is also difficult to see the nail because there is no contrast with the background image.

Referring now to fig. 109-113, fig. 113 is an image 6082 of a laser assisted graticule field of view 6072 of the surgical site shown in fig. 112 prior to alignment of an anvil trocar 6010 and circular knife of a circular stapler 6002 with a center 6050 of a linear staple line 6052 in accordance with at least one aspect of the present disclosure. The laser assisted reticle field of view 6072 provides an alignment mark or crosshair 6066 (X), which is currently positioned below and to the left of the center of the linear staple line 6052, showing the projected path of the anvil trocar 6010 to help position the anvil trocar 6010. In addition to the projected path marked by crosshairs 6066 of anvil trocar 6010, image 6082 also displays the staples of linear staple line 6052 in a contrasting color to make them more visible against the background. The linear staple line 6052 is highlighted and the bulls-eye 6070 is shown over the center 6050 of the linear staple line 6052. Outside of the laser assisted reticle field of view 6072, the image 6082 displays the current alignment position of the status warning frame 6068, the advice frame 6074, the target ring 6062, and the anvil trocar 6010 marked by the crosshair 6066 relative to the center 6050 of the linear staple 6052. As shown in fig. 113, status warning box 6068 indicates that the trocar is "misaligned" and suggestion box 6074 declares "adjust trocar to center staple line".

Referring now to fig. 109-114, fig. 114 is an image 6084 of a laser assisted reticle field 6072 of the surgical site shown in fig. 113 after alignment of an anvil trocar 6010 and circular knife of a circular stapler 6002 with a center 6050 of a linear staple line 6052 in accordance with at least one aspect of the present disclosure. The laser assisted reticle field of view 6072 provides an alignment mark or crosshair 6066 (X), which is currently positioned below and to the left of the center of the linear staple line 6052, showing the projected path of the anvil trocar 6010 to help position the anvil trocar 6010. In addition to the projected path marked by crosshairs 6066 of anvil trocar 6010, image 6082 also displays the staples of linear staple line 6052 in a contrasting color to make them more visible against the background. The linear staple line 6052 is highlighted and the bulls-eye 6070 is shown over the center 6050 of the linear staple line 6052. Outside of the laser assisted reticle field of view 6072, the image 6082 displays the current alignment position of the status warning frame 6068, the advice frame 6074, the target ring 6062, and the anvil trocar 6010 marked by the crosshair 6066 relative to the center 6050 of the linear staple 6052. As shown in fig. 113, status warning box 6068 indicates that the trocar is "misaligned" and suggestion box 6074 declares "adjust trocar to center staple line".

FIG. 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 staple line 6052. In this view, within the field of view 6072 of the laser-assisted reticle, an alignment mark crosshair 6066 (X) is positioned over the center of the staple line 6052 and the highlighted bullseye target to indicate the alignment of the trocar with the center of the staple line. Outside of the field of view 6072 of the laser assisted reticle, the status warning box indicates that the trocar is "aligned" and is suggested as "continue introduction of the trocar".

Referring now to fig. 115-119, the amount and location of tissue may affect not only the suturing result, but also the nature, type, or state of the tissue. For example, irregular tissue distribution is also manifested in cases involving suturing previously sutured tissue, such as, for example, in the J-Pouch procedure (also known as ileal Pouch anal anastomosis) and end-to-end anastomosis procedures. Poor positioning and distribution of previously stapled tissue within the end effector of a staple cartridge can cause previously fired staple lines to be concentrated in one region within the end effector rather than another, which negatively affects the outcome of such procedures.

Aspects of the present disclosure present a surgical stapling instrument that comprises an end effector configured to staple tissue clamped between a first jaw and a second jaw of the end effector. In one aspect, the location and orientation of previously stapled tissue within an end effector is determined by measuring and comparing tissue impedance at a plurality of predetermined regions within the end effector. In various aspects, tissue impedance measurements may also be used to identify overlapping layers of tissue and their location within the end effector.

Fig. 115, 117, 118 illustrate an end effector 25500 of a circular stapler including a staple cartridge 25502 and an anvil 25504 configured to grasp tissue therebetween. Anvil 25504 and staple cavity 25505 of staple cartridge 25502 are removed from fig. 115 to highlight other features of end effector 25500. According to the present disclosure, staple cartridge 25502 includes a circuit (S ₁ 、S ₂ 、S ₃ 、S ₄ ) Four predetermined regions (region 1, region 2, region 3, region 4) are defined.

FIG. 116 illustrates another end effector 25510 of a circular stapler including a staple cartridge 25512 configured to grasp tissue therebetween and an anvil. The anvil and staple cavities of staple cartridge 25512 are removed to highlight other features of end effector 25510. In accordance with the present disclosure, staple cartridge 25512 includes a sensing circuit (S ₁ To S ₈ ) Eight predetermined regions (region 1 to region 8) are defined. The regions defined in each of the circular staplers of figures 115 and 116 are equal in size or at least substantially equal and are circumferentially arranged about a longitudinal axis extending longitudinally through the shaft of the circular stapler.

As described above, the previously stapled tissue is tissue that includes staples previously deployed into the tissue. Circular staplers are often used to stitch previously stapled tissue to unstitched tissue (e.g., a J-touch procedure), as shown in fig. 118, and to stitch previously stapled tissue to other previously stapled tissue (e.g., an end-to-end anastomosis procedure), as shown in fig. 117.

The presence of staples in tissue affects tissue impedance because staples generally have a different electrical conductivity than tissue. The present disclosure presents various tools and techniques for monitoring and comparing tissue impedance at predetermined regions of an end effector (e.g., end effectors 25500, 25510) of a circular stapler to determine an optimal positioning and orientation of previously stapled tissue relative to the end effector.

The examples on the left side of fig. 117, 118 show previously stapled tissue correctly positioned and oriented with respect to a predetermined region of a circular stapler. The previously stapled tissue properly extends through the center of staple cartridge 25502 and intersects the predetermined area only once. The bottom left side of fig. 117, 118 shows staples 25508 of staple cartridge 25502 deployed into previously stapled tissue properly positioned and oriented.

The examples on the right side of fig. 117, 118 show poorly positioned and oriented previously stapled tissue. Previously stapled tissue is eccentric (fig. 118) or overlapping (fig. 31) in one or more predetermined areas. The bottom right side of fig. 117, 118 shows staples 25508 of staple cartridge 25502 deployed into poorly positioned and oriented previously stapled tissue.

As used in connection with fig. 115-119, staple lines may include multiple rows of staggered staples, and typically include two or three rows of staggered staples, but are not limited thereto. In the example of fig. 117, the circular stapler of fig. 115 is utilized to staple two tissues including previously deployed staple lines SL1, SL 2. In the example of the left side of fig. 117, which represents properly positioned and oriented staple lines SL1, SL2, each of regions 1 through 4 receives a discrete portion of one of the staple lines SL1, SL 2. The first staple line SL1 extends across the regions 2 and 4, while the second staple line SL2, which intersects the first staple line SL1 at a center point, extends across the regions 1 and 3. Thus, the measured impedances in the four regions will be equal to each other or at least substantially equal and will be less than the impedance of the unstitched tissue.

In contrast, in the example of the right side of fig. 117, which represents incorrectly positioned and oriented staple lines SL1, SL2, staple lines SL1, SL2 overlap or extend substantially above each other across region 1 and region 3, producing lower impedance measurements in region 1 and region 3 than region 2 and region 4.

FIGS. 119 and 120 illustrate staple lines SL1, SL2 in an end-to-end anastomosis procedure performed by end effector 25510 of the circular stapler of FIG. 116, including a staple line formed by eight sensing circuits S ₁ To S ₈ Eight predetermined regions (region 1 to region 8) are defined, as described above. The anvil of end effector 25510 and the staple cavities of staple cartridge 25512 are removed from fig. 119 and 120 to highlight other features of end effector 25510.

Fig. 121 and 122 show that the sensing circuit S is based on ₁ To S ₈ Is measured by the sensor signal of (a). Each measurement defines a tissue impedance characteristic. The vertical axes 25520, 25520 'represent the angle of orientation (θ), while the vertical axes 25522, 25522' list the corresponding predetermined zones (zone 1 to zone 8). Tissue impedance (Z) is shown on horizontal axes 25524, 25524'.

In the examples of fig. 119 and 121, the impedance measurements represent properly positioned 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. Since the previously stapled tissue is evenly distributed in regions 1, 3, 5 and 7, the tissue impedance measurements at such regions are the same, or at least substantially the same, and are significantly smaller than the tissue impedance measurements at regions 2, 4, 6 and 8, which do not receive the previously stapled tissue.

Conversely, in the examples of fig. 120, 122, the impedance measurements represent incorrectly positioned and oriented staple lines SL1, SL2. As shown in fig. 120, staple lines SL1, SL2 overlap one another, extending only through regions 1 and 5. Thus, the tissue impedance measurements at regions 1 and 5 are significantly lower in magnitude than the remaining regions that did not receive previously stapled tissue.

FIGS. 123 and 124 illustrate staple line SL3 in the J-Pouch procedure performed by end effector 25510 of the circular stapler of FIG. 116, including a staple line formed by eight sense circuits S ₁ To S ₈ Eight predetermined regions (region 1 to region 8) are defined, as described above. The anvil of end effector 25510 and the staple cavities of staple cartridge 25512 are removed from fig. 123 and 124 to highlight other features of end effector 25510.

Fig. 125 and 126 show that the sensing circuit S is based on ₁ To S ₈ Is measured by the sensor signal of (a). Each measurement defines a tissue impedance characteristic. The vertical axes 25526, 25526 'represent the angle of orientation (θ), while the vertical axes 25528, 25528' list the corresponding predetermined zones (zone 1 to zone 8). Tissue impedance (Z) is shown on horizontal axes 25530, 25530'.

In the examples of fig. 123 and 125, the impedance measurement indicates the properly positioned and oriented staple line SL3. As shown in fig. 123, staple line SL3 extends only through region 1 and region 5. Since previously stapled tissue is evenly distributed in regions 1 and 5, the tissue impedance measurements at such regions are the same, or at least substantially the same, in magnitude and significantly less than at the remaining regions where previously stapled tissue was not received.

Conversely, in the examples of fig. 124, 126, the impedance measurement indicates an incorrectly positioned and oriented staple line SL3. As shown in fig. 124, staple line SL3 extends through zone 4, zone 5, and zone 6, all on one side of staple cartridge 25510. Thus, the tissue impedance measurements at regions 4, 5 and 6 are significantly lower in magnitude than the remaining regions that do 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 includes a control system 25470 (fig. 102) that can be configured to further analyze the impedance measurements determined from the received sensor signals of the sensing circuitry of the circular stapler. In certain aspects, as shown in fig. 102, the control system 25470 includes a microcontroller 461 that can be configured to be able to determine the geometric parameters of one or more previously deployed staple lines, as shown in connection with fig. 115-126. In some cases, the microcontroller 461 can also be configured to be able to determine an alignment aspect of a circular stapler, as shown in connection with fig. 103-114. In some cases, the microcontroller 461 may also be configured to be able to determine the location of the circular trocar of the circular staple, the length and centerline of the pre-existing staple line, and/or the center intersection of two sequential lines, as shown in connection with fig. 103-114.

The microcontroller 461 may alert the surgical operator, for example, via the display 473, of the detected incorrect positioning and/or orientation of the previously stapled tissue. Other audio, tactile, and/or visual means may also be employed. The microcontroller 461 may also take steps to prevent tissue suturing. For example, the microcontroller 461 may signal the motor driver 492 to deactivate the motor 482. In some cases, the microcontroller 461 may recommend a new position and/or orientation to the surgical operator.

In various aspects, the circular stapler of the present disclosure is communicatively coupled to the surgical hub 106 (fig. 3, 4), the surgical hub 206 (fig. 206) via a wired and/or wireless communication channel. The data collected by such circular staplers can be transmitted to a surgical hub 106, 206, which can further transmit the data to the cloud-based system 104, 204 for additional analysis.

Fig. 127 shows a logic flow diagram of process 25600 illustrating 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 circuitry 500 (fig. 13). In another aspect, process 25600 is performed by combinational logic circuit 510 (fig. 14). In yet another aspect, process 25600 is performed by sequential logic circuit 520 (fig. 15).

For illustrative purposes, the following description depicts the process 25600 as being executable by control circuitry that includes a controller 461, which includes a processor 461. The memory 468 stores program instructions that are executable by the processor 461 to perform the process 25600.

The process 25600 determines 25602 the type of surgical procedure being performed by the surgical stapler. Various techniques described under the heading "situational awareness" may be used to determine the type of surgical procedure. The processor 25600 then selects 25604 a tissue impedance characteristic for the previously stapled tissue that is properly positioned based on the determined type of surgical procedure. As described above, previously stapled tissue that was properly positioned in a J-touch procedure, for example, includes different tissue impedance characteristics than in an end-to-end anastomosis procedure, for example.

The process 25600 then determines 25606 whether the measured tissue impedance in the predetermined region corresponds to the selected tissue impedance characteristic. If not, the processor 461 may alert 25608 the user and/or override 25610 the organization process. In one aspect, the processor 461 may alert 25608 the user through the display 473. In addition, the processor 461 may override 25610 tissue processing by preventing the end effector from completing its firing, which may be accomplished by, for example, causing the motor drive 492 to stop the motor 482 (fig. 102).

However, if the measured tissue impedance in the predetermined region corresponds to the selected tissue impedance characteristic, the processor 461 allows the end effector to proceed 25612 with tissue treatment.

Referring generally to fig. 128-134, tissue overhang is a phenomenon that occurs when tissue grasped between the jaws of a surgical end effector, such as, for example, a Blood Vessel (BV), extends beyond the optimal treatment area of the end effector. Thus, the overhanging tissue may not accept the treatment applied by the end effector. Where the tissue comprises a blood vessel and the treatment involves sealing and cutting the Blood Vessel (BV), the unsealed overhanging portion of the blood vessel may leak, leading to undesirable consequences.

Aspects of the present disclosure present a surgical instrument that comprises circuitry configured to detect overhanging tissue in an end effector of the surgical instrument. Aspects of the present disclosure also present a surgical instrument that comprises circuitry configured to detect tissue extending beyond a predetermined treatment region in an end effector of the surgical instrument.

In various examples, the end effector 25700 of the surgical instrument 25701 includes a first jaw 25702 and a second jaw 25704. The surgical instrument 25701 is similar in many respects to other surgical instruments disclosed elsewhere herein, such as, for example, surgical instrument 150010. At least one of the first jaw 25702 and the second jaw 25704 is movable to transition the end effector 25700 between an open configuration (fig. 128, 129, 132) and a closed configuration (fig. 130, 131, 133, 134). In the example of fig. 128-134, the end effector 25700 includes a staple cartridge 25708 that includes staples that are deployable into tissue grasped between the jaws 25702 and 25704 and are deformable by the anvil 25710. In other examples, an end effector according to the present disclosure may treat tissue by applying ultrasonic and/or radiofrequency energy.

The end effector 25700 further includes a flexible circuit 25706 that includes a continuity sensor for detecting overhanging tissue. When overhanging tissue comes into contact with the continuity sensor, as shown in fig. 131, 134, an electrical path is established that causes current to flow through the flexible circuit 25706. The current indicates the presence of overhanging tissue.

The jaws 25702, 25704 define a treatment area 25714 therebetween, wherein tissue treatment is applied in a closed configuration, as shown in fig. 131, 134.

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

The flexible circuit 25706 is nested in the nose 25716 of the first jaw 25702 such that when tissue is not present, the gap 25724 is maintained over the flexible circuit 25706 by the stepped feature 25720.

In the example of fig. 128-134, the end effector 25700 includes a treatment region 25714 between the anvil 25710 and the staple cartridge 25708. To staple tissue grasped by the end effector 25700 in the treatment region 25714, staples are deployed from the staple cartridge 25708 into the tissue and deformed by the anvil 25710. In other examples, the treatment region of end effector 25700 can seal tissue by applying radio frequency and/or ultrasonic energy to tissue at the treatment region.

In the example of fig. 128-134, a continuity sensor is provided on the distal portion of the staple cartridge 25708 and is defined by an insulated flexible circuit 25706 that is wired through contacts coupled to corresponding contacts in the channel 25726 of the first jaw 25702 that is configured to receive the staple cartridge. A sensor signal indicating the presence of overhanging tissue passes through the contact to a control system, such as, for example, control system 470 (fig. 12).

The flexible circuit 25706 extends distally from the flat or substantially flat portion 25728 of the staple cartridge 25708 between the stepped feature 25720 and the curved nose 25716. The flexible circuit 25706 also extends down a ramp 25730 defined by the curved nose 25716 and extends from the distal edge of the flat portion 25728. Tissue extending beyond the stepped feature 25720 onto the flat portion 25728 and/or the ramp 25730 triggers the continuity sensor, causing the sensor signal to be transmitted to the control system 470 (fig. 12).

The distal end of the curved nose includes corresponding alignment features 25722, 25732 positioned distally of the continuity sensor. In the example of fig. 128-134, the alignment feature 25722 includes a raised surface and the alignment feature 25732 includes a corresponding recessed surface configured to receive the raised surface of the alignment feature 25722.

Although a continuity sensor is provided to staple cartridge 25708, this should not be construed as limiting. For example, in some instances, a continuity sensor may be provided to the distal nose 25718 of the anvil 25710.

In various aspects, as shown in fig. 128-134, the surgical instrument including the end effector 25700 can be a hand-held surgical instrument. Alternatively, the end effector 25700 may be incorporated into a robotic system as part of a robotic arm. Additional details regarding robotic systems are disclosed in U.S. provisional patent application 62/611,339 filed on 12/28 in 2017, which is incorporated herein by reference in its entirety.

In some instances, as shown in fig. 128-134, a surgical instrument 25701 including an end effector 25700 may be communicatively coupled to a surgical hub (e.g., surgical hub 106 (fig. 3, 4), surgical hub 206 (fig. 206)) via a wired and/or wireless communication channel, as described in more detail in connection with fig. 1-11.

In various aspects, when tissue overhang is detected, the display 473 can illustrate at least a partial view of the end effector 25700, such as, for example, a cartridge deck of the staple cartridge 25708 from which tissue is overhanging. Furthermore, impedance or another tissue compression estimation sensing device or a 3D stack or another visualization device may be employed to further indicate the amount of overhanging tissue sensed between the curved noses 25716, 25718.

Examples

Various aspects of the subject matter described herein are set forth in the following examples:

example 1-a surgical stapling instrument that includes an end effector. The end effector includes: a first jaw; and a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween. The end effector further comprises an anvil and a staple cartridge. The staple cartridge includes staples that are deployable into the tissue and are deformable by the anvil. The surgical stapling system further comprises a control circuit. The control circuit is configured to determine tissue impedance at a predetermined region, detect an irregularity in tissue distribution within the end effector based on the tissue impedance, and adjust a closure parameter of the end effector according to the irregularity.

Embodiment 2-the surgical stapling instrument of embodiment 1, wherein said end effector comprises sensing circuitry at said predetermined region.

Embodiment 3-the surgical stapling instrument of embodiment 1 or 2, wherein the predetermined regions are separated by insulating elements.

Embodiment 4-the surgical stapling instrument of embodiments 1, 2, or 3, wherein the predetermined region comprises a predetermined interior region, a predetermined exterior region, and a predetermined intermediate region between the predetermined interior region and the predetermined exterior region.

Embodiment 5-the surgical stapling instrument of embodiment 4, wherein detecting the irregularity in tissue distribution within the end effector comprises determining that an average value of the tissue impedance at the predetermined inner region and at the predetermined outer region is greater than the tissue impedance at the predetermined intermediate region.

Embodiment 6-the surgical stapling instrument of embodiments 1, 2, 3, 4, or 5, wherein detecting the irregularity 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.

Embodiment 7-the surgical stapling instrument of embodiment 4, wherein detecting the irregularity in tissue distribution within the end effector comprises determining that an average value of the tissue impedance at the predetermined inner region and at the predetermined outer region is less than or equal to the tissue impedance at the predetermined intermediate region. Detecting the irregularity in tissue distribution within the end effector further includes determining that the tissue impedance of the predetermined inner region is greater than the tissue impedance of the predetermined outer region.

Embodiment 8-the surgical stapling instrument of embodiments 1, 2, 3, 4, 5, 6, or 7, further comprising a motor configured to actuate the end effector to transition to the closed configuration, wherein detecting the irregularity in tissue distribution within the end effector causes the control circuit to reduce a rate of the motor.

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

Embodiment 10-the surgical stapling instrument of embodiments 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the control circuitry is configured to pass at least one treatment signal through tissue at each of the predetermined regions to determine the tissue impedance.

Example 11-a surgical stapling instrument for stapling previously stapled tissue, the surgical stapling instrument comprising: a shaft defining a longitudinal axis extending therethrough; and an end effector extending from the shaft. The end effector includes: a first jaw; and a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween. The end effector further comprises an anvil and a staple cartridge. The staple cartridge includes staples that are deployable into the previously stapled tissue and are deformable by the anvil. The end effector further includes a predetermined region between the anvil and the staple cartridge. The surgical stapling instrument further includes an electrical circuit. The circuitry is configured to measure tissue impedance at the predetermined region, compare the measured tissue impedance to a predetermined tissue impedance characteristic of the predetermined region, and detect irregularities in at least one of a position and an orientation of the previously stapled tissue within the end effector based on the comparison.

Embodiment 12-the surgical stapling instrument of embodiment 11, wherein said end effector comprises sensing circuitry at said predetermined region.

Embodiment 13-the surgical stapling instrument of embodiments 11 or 12, wherein the predetermined regions are separated by insulating elements.

Embodiment 14-the surgical stapling instrument of embodiments 11, 12, or 13, wherein the predetermined region is disposed circumferentially about the longitudinal axis.

Embodiment 15-the surgical stapling instrument of embodiments 11, 12, 13, or 14, wherein detecting the irregularity causes the control circuit to alert a user.

Embodiment 16-the surgical stapling instrument of embodiments 11, 12, 13, 14, or 15, wherein the control circuitry is configured to pass at least one treatment signal through tissue at each of the predetermined regions to determine the tissue impedance.

Example 17-a surgical stapling instrument that comprises an end effector. The end effector includes: a first jaw; and a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween. The end effector further comprises an anvil and a staple cartridge. The staple cartridge includes staples that are deployable into the tissue and are deformable by the anvil. The end effector further includes a predetermined region between the anvil and the staple cartridge. The surgical stapling instrument further includes a control circuit. The control circuit is configured to determine electrical parameters of the tissue at each of the predetermined regions, detect irregularities in tissue distribution within the end effector based on the determined electrical parameters, and adjust closure parameters of the end effector in accordance with the irregularities.

Embodiment 18-the surgical stapling instrument of embodiment 17, wherein said end effector comprises sensing circuitry at said predetermined region.

Embodiment 19-the surgical stapling instrument of embodiments 17 or 18, wherein the predetermined regions are separated by insulating elements.

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

The foregoing detailed description has set forth various forms of the apparatus and/or methods via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein may be equivalently implemented in integrated circuits, 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., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the electronic circuitry and/or writing the code for the software and/or hardware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as a program product or products in a variety of forms, and that an illustrative form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.

Instructions for programming logic to perform the various disclosed aspects can be stored within a memory within a system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Furthermore, the instructions may be distributed via a network or by other computer readable media. Thus, a machine-readable medium may include, but is not limited to, a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), a floppy disk, an optical disk, a compact disk, a read-only memory (CD-ROM), a magneto-optical disk, a read-only memory (ROM), a Random Access Memory (RAM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic or optical card, a flash memory, or a tangible, machine-readable storage device for use in transmitting information over the internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

As used in any aspect herein, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, digital Signal Processors (DSPs), programmable Logic Devices (PLDs), programmable Logic Arrays (PLAs), field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware storing instructions executed by the programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry forming part of a larger system, such as an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a system-on-a-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smart phone, or the like. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially implements the methods and/or apparatus described herein, or a microprocessor configured by a computer program that at least partially implements the methods and/or apparatus described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, communication switch, or optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital fashion, or some combination thereof.

As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to be capable of performing any of the foregoing operations. The software may be embodied as software packages, code, instructions, instruction sets, and/or data recorded on a non-transitory computer readable storage medium. The firmware may be embodied as code, instructions or a set of instructions and/or data that are hard-coded (e.g., non-volatile) in a memory device.

As used in any aspect herein, the terms "component," "system," "module," and the like can refer to a computer-related entity, hardware, a combination of hardware and software, or software in execution.

As used in any aspect herein, an "algorithm" refers to an organized sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states that may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. Are often used to refer to signals such 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 conditions.

The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may allow for communication using transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with an ethernet standard known as the "IEEE 802.3 standard" published by the Institute of Electrical and Electronics Engineers (IEEE) at month 12 of 2008 and/or a higher version of the standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or conform to standards promulgated by the international telecommunications union telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or conform to standards promulgated by the international committee for telephone and telephone negotiations (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard promulgated by the ATM forum at month 8 of 2001 under the name "ATM-MPLS network interworking 2.0" and/or a higher version of the standard. Of course, different and/or later developed connection oriented network communication protocols are likewise contemplated herein.

Unless specifically stated otherwise as apparent from the above disclosure, it is appreciated that throughout the above disclosure, discussions utilizing terms such as "processing," "computing," "calculating," "determining," "displaying," or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

One or more components may be referred to herein as "configured to be capable of", "configurable to be capable of", "operable/operable", "adapted/adaptable", "capable of", "conformable/conformable", and the like. Those skilled in the art will recognize that "configured to be capable of" may generally encompass active and/or inactive and/or standby components unless the context indicates otherwise.

The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located away from the clinician. It will also be appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" 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 recognize that, in general, terms used herein, and particularly in the appended claims (e.g., bodies of the appended claims) are generally intended to be "open" terms (e.g., the term "including" should be construed as "including but not limited to," the term "having" should be construed as "having at least," the term "comprising" should be construed as "including but not limited to," etc.). It will be further understood by those with skill in the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim(s). However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Moreover, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include but not be limited to systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" shall include but not be limited to systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). It will be further understood by those within the art that, in general, unless the context indicates otherwise, disjunctive words and/or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to encompass the possibility of including one of the terms, either of the terms, or both. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".

For the purposes of the appended claims, those skilled in the art will understand that the operations recited therein can generally be performed in any order. In addition, while a plurality of operational flow diagrams are listed in order(s), it should be understood that the plurality of operations may be performed in other orders than shown, or may be performed concurrently. Examples of such alternative ordering may include superposition, interleaving, interruption, reordering, incrementing, preparing, supplementing, simultaneous, reverse, or other altered ordering unless the context dictates otherwise. Moreover, unless the context dictates otherwise, terms such as "responsive to," "related to," or other past-type adjectives are generally not intended to exclude such variants.

It should be appreciated that any reference to "one aspect," "an example," or "an example" means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example," and "in an example" in various places throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or other disclosure material referred to in this specification and/or listed in any application data sheet is incorporated herein by reference, as if the incorporated material was not inconsistent herewith. Accordingly, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

In summary, many of the benefits resulting from employing the concepts described herein have been described. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations of the present invention are possible in light of the above teachings. One or more of the forms selected and described are chosen to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize the various forms and various modifications as are suited to the particular use contemplated. The claims filed herewith are intended to define the full scope.

Claims

1. A circular surgical stapling instrument for stapling previously stapled tissue, the circular surgical stapling instrument comprising:

a shaft defining a longitudinal axis extending therethrough;

an end effector extending from the shaft, the end effector comprising:

a first jaw;

a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue therebetween;

an anvil block;

a circular staple cartridge comprising staples configured to be deployed into the previously stapled tissue and deformable by the anvil; and

a predetermined region between the anvil and the circular staple cartridge, wherein the predetermined region is circumferentially arranged, and wherein the predetermined region is configured to define a plane transverse to the longitudinal axis; and

a circuit configured to enable:

measuring tissue impedance at the predetermined region;

comparing the measured tissue impedance to a predetermined tissue impedance characteristic of the predetermined region; and

An irregularity in at least one of a position and an orientation of the previously stapled tissue within the end effector is detected from the comparison.

2. The circular surgical stapling instrument of claim 1, wherein said end effector comprises sensing circuitry at said predetermined region.

3. The circular surgical stapling instrument of claim 2, wherein the predetermined regions are separated by insulating elements.

4. The circular surgical stapling instrument of claim 1, wherein detecting said irregularity causes said circuit to alert a user.

5. The circular surgical stapling instrument of claim 1, wherein said circuitry is configured to pass at least one treatment signal through tissue at each of said predetermined regions to determine said tissue impedance.

6. A circular surgical stapling instrument for stapling previously stapled tissue, the circular surgical stapling instrument comprising:

a shaft defining a longitudinal axis extending therethrough;

an end effector extending from the shaft, the end effector comprising:

a first jaw;

an anvil block;

a predetermined region between the anvil and the circular staple cartridge, wherein the predetermined region is disposed circumferentially about the longitudinal axis; and circuitry configured to enable:

measuring tissue impedance at the predetermined region; and

an irregularity in at least one of a position and an orientation of the previously stapled tissue within the end effector is detected based on the measured tissue impedance and a predetermined tissue impedance characteristic at the predetermined region.