CN111542886A

CN111542886A - System for adjusting end effector parameters based on perioperative information

Info

Publication number: CN111542886A
Application number: CN201880084587.5A
Authority: CN
Inventors: F·E·谢尔顿四世; J·L·哈里斯; D·C·耶茨
Original assignee: Ethicon LLC
Current assignee: Ethicon LLC
Priority date: 2017-12-28
Filing date: 2018-09-21
Publication date: 2020-08-14
Also published as: JP2021509313A; JP2023106542A; BR112020012917A2

Abstract

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

Description

System for adjusting end effector parameters based on perioperative information

Cross Reference to Related Applications

This patent application claims the benefit of priority from U.S. provisional patent application serial No. 62/691,227 entitled "control a basic insertion and correction TO SENSED closed loop patent applications," filed on 28.6.2018, as specified in title 119 (e) of volume 35 of the united states code, the disclosure of which is incorporated herein by reference in its entirety.

The present application claims U.S. provisional patent application serial No. 62/650,887 entitled "minor SYSTEMS WITH optional sensitive requirements" filed in 2018, 3, 30, and U.S. provisional patent application serial No. 62/650,877 entitled "minor smake achievement increment sensitive CONTROLS" filed in 2018, 3, 30, 2018, us provisional patent application serial No. 62/650,882 entitled "minor alteration FOR INTERACTIVE minor alteration apply" filed in 2018, 3, 30, and U.S. provisional patent application serial No. 62/650,898 entitled "CAPACITIVE COUPLED RETURN PATHPAD WITH minor ARRAY ELEMENTS" filed in 2018, 3, 30, the disclosure of each of these provisional patent applications being incorporated herein by reference in their entirety.

This patent application also claims the benefit OF priority from U.S. provisional patent application serial No. 62/640,417 entitled "temparature CONTROL IN ultra sound DEVICE AND CONTROL SYSTEM for" filed on 3, 8.2018 AND provisional patent application serial No. 62/640,415 entitled "ESTIMATING STATE OF ultra sound END effect AND CONTROL SYSTEM for" filed on 3, 8.2018, the disclosure OF each OF which is incorporated herein by reference IN its entirety, as specified IN clause 119 (e) OF the U.S. code, volume 35.

The present patent application further claims the benefit of priority from U.S. provisional patent application serial No. 62/611,341 entitled interactive SURGICAL PLATFORM (INTERACTIVE SURGICAL PLATFORM) filed on 2017, 12, 28, date 35, the U.S. provisional patent application serial No. 62/611,340 entitled CLOUD-BASED medical analysis (CLOUD-BASED medical analysis) filed on 2017, 12, 28, date 12, 28, and U.S. provisional patent application serial No. 62/611,339 entitled robotically ASSISTED SURGICAL PLATFORM (ROBOT ASSISTED SURGICAL PLATFORM) filed on 2017, 12, 28, date, the disclosure of each of these provisional patent applications being incorporated herein by reference in its entirety.

Background

The present disclosure relates to various surgical systems.

Disclosure of Invention

A surgical system includes a surgical instrument. The surgical instrument includes an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument further includes a motor configured to move the first jaw relative to the second jaw as a function of the closure rate of change parameter and the closure threshold parameter. The surgical instrument further includes a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector. The surgical system also includes a control circuit communicatively coupled to the sensor. The control circuitry is configured to receive perioperative information, wherein the perioperative information includes one or more of perioperative disease, perioperative treatment, and type of surgical procedure. The control circuit is further configured to receive a sensor signal from the sensor and determine adjustments to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal.

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

Drawings

The features of the various aspects are set out with particularity in the appended claims. The various aspects (relating to the surgical tissues 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 according to at least one aspect of the present disclosure.

Fig. 3 is a surgical hub paired with a visualization system, a robotic system, and a smart instrument according to at least one aspect of the present disclosure.

Fig. 4 is a partial perspective view of a surgical hub housing and a composite generator module slidably received in a drawer of the surgical hub housing according to 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 according to 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 connect 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 according to 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 according to 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 of 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 sequential logic circuitry 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, according to 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 a stroke length of a clamp assembly based on an articulation angle.

FIG. 21 is a closure tube assembly positioning graph illustrating an example of a control system modifying the longitudinal position of the 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 a time, a y-axis of the displacement profile defines a travel displacement of the firing link, and the y-axis of the force profile defines a torque force sensed on a motor configured to advance the firing link.

Fig. 24 is a schematic diagram illustrating a completed tissue contacting circuit of the circuit when a pair of spaced apart contact plates are in contact with the 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 portions of an interchangeable shaft assembly in accordance with 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 the control circuitry 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 the control circuitry 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 a control circuit of the surgical instrument of fig. 25 illustrating the interface 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 example end effector of a medical device surrounding tissue according to one or more aspects of the present disclosure.

Fig. 33 depicts an example end effector of a medical device compressing tissue according to 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 according to one or more aspects of the present disclosure.

Fig. 35 also depicts an exemplary force applied by an end effector of a medical device compressing tissue according to one or more aspects of the present disclosure.

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

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

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

Fig. 39 is also an exemplary circuit diagram according to 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 example 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 an interchangeable shaft capable of articulation.

FIG. 45 is a side view of a tip 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 between normal and diseased tissue.

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

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

Figure 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.

Figure 56 is a logic diagram illustrating one embodiment of a process for calibrating a first sensor in response to 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 illustrating adjusted Hall effect thickness measurements compared to unmodified Hall effect thickness measurements.

FIG. 60 illustrates one embodiment of an end effector including 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 measurements 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 comprising a plurality of sensors.

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

Fig. 66 illustrates an embodiment of an end effector comprising 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 comprising 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 including 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 generating a thickness measurement of a section of tissue positioned between an anvil and a staple cartridge of an end effector.

Fig. 73 and 74 illustrate one embodiment of an end effector including sensors 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 an aspect of an end effector configured to measure a 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 flex circuit according to at least one aspect of the present disclosure.

FIG. 79 illustrates the end effector illustrated in FIG. 78 with the jaw members clamping tissue between the jaw members and the staple cartridge in accordance with at least one aspect of the present disclosure.

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

Fig. 81 is a diagram of a position sensor including a magnetic rotary 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 illustrating firing member travel relative to tissue grasped within the end effector in accordance with at least one aspect of the present disclosure.

FIG. 83 is a first graph of two closing Force (FTC) curves depicting the force applied to the closure member to close on thick and thin tissue during the closure phase and a second graph of two firing force (FTF) curves depicting the force 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 gradual closure of the closure member during a firing stroke as the firing member advances distally and is coupled to the clamp arm to reduce a closure force load on the closure member and reduce a firing force load on the firing member at a desired rate according to 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 present disclosure.

Fig. 86 is a logic flow diagram depicting a process of a control routine 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 for a surgical hub, in accordance with at least one aspect of the present disclosure.

Fig. 88 illustrates a block diagram of a surgical system configured to control surgical functions in accordance with at least one aspect of the present disclosure.

Fig. 89 illustrates a block diagram of a situational aware surgical system configured to control surgical functions in accordance with at least one aspect of the present disclosure.

Fig. 90 is a logic flow diagram depicting a situational awareness-based algorithm for controlling surgical functions in accordance with at least one aspect of the present disclosure.

Fig. 91 is a logic flow diagram depicting an algorithm for controlling surgical functions in accordance with at least one aspect of the present disclosure.

Fig. 92 illustrates a portion of patient tissue including a tumor and a surgical margin defined relative to the tumor in accordance with at least one aspect of the present disclosure.

Fig. 93 is a logic flow diagram depicting a process of control procedure or logic configuration for addressing device selection issues in accordance with at least one aspect of the present disclosure.

Fig. 94 illustrates a block diagram of a surgical system configured to determine the appropriateness of a surgical instrument based on device parameters and sensed parameters in accordance with at least one aspect of the present disclosure.

Fig. 95 illustrates a block diagram of a surgical instrument in accordance with at least one aspect of the present disclosure.

FIG. 96 illustrates a logic flow diagram for a process for controlling a surgical instrument as a function of the integrity of clamped tissue in accordance with at least one aspect of the present disclosure.

Fig. 97 illustrates a first graph depicting force versus time for closure for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 98 illustrates a second graph depicting force versus time for closure of an end effector for an exemplary firing of a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 99 illustrates a logic flow diagram of a process for controlling a surgical instrument as a function of a physiological type of clamped tissue in accordance with at least one aspect of the present disclosure.

Fig. 100A illustrates a side elevation view of an end effector gripping substance with the end effector in an initial contact position with the substance in accordance with at least one aspect of the present disclosure.

Fig. 100B illustrates a side elevation view of an end effector gripping substance, wherein the end effector is in a closed state, according to at least one aspect of the present disclosure.

Fig. 101A illustrates a side elevation view of an end effector grasping a vessel, with the end effector in an initial contact position with the vessel, according to at least one aspect of the present disclosure.

Fig. 101B illustrates a side elevation view of an end effector grasping a vessel, with the end effector in a closed state, according to at least one aspect of the present disclosure.

Fig. 102 illustrates first and second graphs depicting force and closure velocity, respectively, for closure over time for an exemplary fired end effector of a surgical instrument grasping parenchyma, in accordance with at least one aspect of the present disclosure.

Fig. 103 illustrates third and fourth graphs depicting, respectively, force and closure velocity for closure over time for an exemplary fired end effector of a surgical instrument grasping a vessel, in accordance with at least one aspect of the present disclosure.

Fig. 104 illustrates a fifth graph depicting force and closure speed for closure over time for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 105 illustrates a fifth graph depicting force and closure velocity for closure over time for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 106 illustrates a fifth graph depicting force and closure speed for closure over time for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 107 illustrates a graph depicting impedance as a function of time to determine when jaws of a surgical instrument contact tissue and/or staples in accordance with at least one aspect of the present disclosure.

Fig. 108 illustrates a first graph depicting various tissue closure thresholds for controlling end effector closure in accordance with at least one aspect of the present disclosure.

Fig. 109 illustrates a second graph depicting various tissue closure thresholds for controlling end effector closure in accordance with at least one aspect of the present disclosure.

Fig. 110 is a logic flow diagram depicting a process for adjusting a control program or logic configuration of a closure rate algorithm 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 29.6.2018, 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 ARRAYELEMENTS," attorney docket No. END8542 USNP/170755;

U.S. patent application Ser. No. __________ entitled "control A SURGICAL INSTRUMENT ACCORDING TO SENSE DCLOSURE PARAMETERS," attorney docket No. END8543 USNP/170760;

U.S. patent application Ser. No. __________ entitled "SYSTEM FOR ADJUSTING END EFFECTOR PARAMETERS BASED ONPERIORATIVE INFORMATION", attorney docket number END8543USNP 1/170760-1;

U.S. patent application Ser. No. __________ entitled "SAFETY SYSTEMS FOR SMART POWER SURGICAL STAPLING," attorney docket No. END8543USNP 2/170760-2;

U.S. patent application Ser. No. __________ entitled "SAFETY SYSTEMS FOR SMART POWER SURGICAL STAPLING," attorney docket No. END8543USNP 3/170760-3;

U.S. patent application Ser. No. __________ entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUEDISTRIBUTION IRREGULARITIES", attorney docket No. END8543USNP 4/170760-4;

U.S. patent application Ser. No. __________ entitled "SYSTEM FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE", attorney docket number END8543USNP 5/170760-5;

U.S. patent application Ser. No. __________ entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES," attorney docket No. END8543USNP 6/170760-6;

U.S. patent application Ser. No. __________ entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", attorney docket No. END8543USNP 7/170760-7;

U.S. patent application Ser. No. __________ entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE," attorney docket No. END8544 USNP/170761;

U.S. patent application Ser. No. __________ entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT", attorney docket number END8544USNP 1/170761-1;

U.S. patent application Ser. No. __________ entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY", attorney docket No. END8544USNP 2/170761-2;

U.S. patent application Ser. No. __________ entitled "SURGICAL SYSTEMS WITH PRIORIZED DATA TRANSMISSIONCAPABILITIES," attorney docket number END8544USNP 3/170761-3;

U.S. patent application Ser. No. __________ entitled "SURGICAL EVACUTION SENSING AND MOTOR CONTROL," attorney docket No. END8545 USNP/170762;

U.S. patent application Ser. No. __________ entitled "SURGICAL EVACUTION SENSOR ARRANGEMENTS," attorney docket number END8545USNP 1/170762-1;

U.S. patent application Ser. No. __________ entitled "SURGICAL EVACUTION FLOW PATHS," attorney docket number END8545USNP 2/170762-2;

U.S. patent application Ser. No. __________ entitled "SURGICAL EVACUTION SENSING AND GENERATOR CONTROL," attorney docket No. END8545USNP 3/170762-3;

U.S. patent application Ser. No. __________ entitled "SURGICAL EVACUTION SENSING AND DISPLAY," attorney docket No. END8545USNP 4/170762-4;

U.S. patent application Ser. No. __________ entitled "COMMUNICATION OF SMOKE EVACUTION SYSTEM PARAMETERS TO HUBOR CLOUD IN SMOKE EVACUTION MODULE FOR INTERACTIVE SURGICAL PLATFORM", attorney docket number END8546 USNP/170763;

U.S. patent application Ser. No. __________ entitled "SMOKE EVACUTION SYSTEM INCLUDING A SEGMENTED CONTROL IRCUIT FOR INTERACTIVE SURGICAL PLATFORM," attorney docket number END8546USNP 1/170763-1;

U.S. patent application Ser. No. __________ entitled "SURGICAL EVACATION SYSTEM WITH A COMMUNICATION CIRCUIT FORCOMMUNICATION BETWEEN A FILTER AND A SMOKE EVACATION DEVICE," attorney docket number END8547 USNP/170764; and

U.S. patent application Ser. No. __________ entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS," attorney docket No. ND8548 USNP/170765.

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2018, 6/28, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application serial No. 62/691,228, entitled a Method of using an enhanced flex circuit having multiple sensors with electrosurgical devices (a Method of using a re-formed flex circuit with multiple sensors with electronic devices);

U.S. provisional patent application serial No. 62/691,230, entitled SURGICAL INSTRUMENT with FLEXIBLE ELECTRODEs (SURGICAL INSTRUMENT);

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

U.S. provisional patent application serial No. 62/691,257, entitled system FOR delivering SMOKE EVACUATION system parameters TO a HUB OR CLOUD IN a SMOKE EVACUATION MODULE FOR an interactive surgical PLATFORM (composite OF SMOKE EVACUATION system TO HUB OR CLOUD IN SMOKE EVACUATION MODULE);

U.S. provisional patent application serial No. 62/691,262, entitled SURGICAL extraction system WITH COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN filter and smoke exhaust (SURGICAL extraction system WITH extraction CIRCUIT FOR COMMUNICATION BETWEEN filter and smoke exhaust A FILTER AND A topical extraction DEVICE); and

U.S. provisional patent application serial No. 62/691,251, entitled DUAL tandem macroand minidroplet FILTERS (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS);

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

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

U.S. patent application serial No. 15/940,648, entitled interactive surgical system with conditional processing device and data CAPABILITIES (INTERACTIVE SURGICAL SYSTEMS WITH conditioning hand ling OF DEVICESAND DATA CAPABILITIES);

U.S. patent application Ser. No. 15/940,656, entitled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION for operating room DEVICES (SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING DEVICES);

U.S. patent application serial No. 15/940,666, entitled spatial perception OF a SURGICAL hub IN an OPERATING room (SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS);

U.S. patent application Ser. No. 15/940,670, entitled COOPERATIVE UTILIZATION OF data derived FROM secondary sources BY an Intelligent SURGICAL hub (COOPERATIVE diagnosis OF DATA DERIVED FROM SECONDARY OURCES BY INTELLIGENT SURGICAL HUBS);

U.S. patent application serial No. 15/940,677, entitled surgical hub control arrangement;

U.S. patent application Ser. No. 15/940,632, entitled data stripping METHOD for data interrogation of PATIENT RECORDS and creation of anonymous RECORDS (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORD and ANDCREATE ANONYMIZED RECORD);

U.S. patent application Ser. No. 15/940,640, entitled COMMUNICATION HUB AND storage DEVICE FOR STORING parameters AND conditions OF a SURGICAL DEVICE TO BE shared with a CLOUD-BASED analysis system (COMMUNICATION HUB AND STORAGE EVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS);

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

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

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

U.S. patent application Ser. No. 15/940,663, entitled surgical System DISTRIBUTED PROCESSING (SURGICAL SYSTEMS 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 serial No. 15/940,671, entitled SURGICAL HUB spatial perception for determining devices in an operating room (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN operatingtheother);

U.S. patent application Ser. No. 15/940,686, entitled DISPLAY for aligning a staple cartridge with a previously linear staple line (DISPLAY OF Aligninment OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE);

U.S. patent application Ser. No. 15/940,700, entitled sterile field Interactive CONTROLs display (STERILEFIELD 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 "determining characteristics OF backscattered light Using laser light and Red-Green-BLUE COLORATION" (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINONEPIERTIES OF BACK SCATTERED LIGHT);

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

U.S. patent application serial 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 hub (ADAPTIVE CONTROL PROGRAM update FOR SURGICAL hub);

U.S. patent application Ser. No. 15/940,660, entitled CLOUD-BASED medical analysis FOR CUSTOMIZATION AND recommendation to USERs (CLOOUD-BASED MEDICAL ANALYTICS FOR CURSTOMIZATION AND RECOMMENDITIONSTO A USER);

U.S. patent application Ser. No. 15/940,679, entitled CLOUD-BASED medical analysis for linking LOCAL USAGE trends with RESOURCE ACQUISITION behavior OF larger DATA SETs (CLOOUD-BASED MEDICAL ANALYTICS FORLINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEIORS OFLARGER DATA SET);

U.S. patent application serial No. 15/940,694, entitled CLOUD-BASED medical analysis OF medical facilities FOR personalizing INSTRUMENT FUNCTION segments (CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITYSEGMENTED differentiation OF inertial FUNCTIONs);

U.S. patent application Ser. No. 15/940,634, entitled CLOUD-BASED medical analysis FOR Security and certification trends and reactivity measurements (CLOOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTATION TRENDS AND REACTIVE MEASURES);

U.S. patent application serial No. 15/940,706 entitled data processing and priority IN CLOUD analysis NETWORKs (DATA HANDLING AND priority IN a CLOUD analysis NETWORK); and

U.S. patent application serial No. 15/940,675, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES (CLOUD INTERFACE FOR coated led DEVICES);

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

U.S. patent application Ser. No. 15/940,637, entitled COMMUNICATION arrangement FOR a robotic ASSISTED surgery platform (COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,642, entitled control FOR a robotically-ASSISTED SURGICAL platform (controlfor ROBOT-ASSISTED surgery PLATS);

U.S. patent application Ser. No. 15/940,676, entitled AUTOMATIC TOOL adjustment FOR robotically-ASSISTED SURGICAL PLATFORMS (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,680, entitled controller FOR a robotic-ASSISTED SURGICAL platform (controlers FOR ROBOT-ASSISTED SURGICAL platform);

U.S. patent application Ser. No. 15/940,683, entitled collaborative SURGICAL action FOR a robotically ASSISTED SURGICAL platform (collaborative SURGICAL action FOR Robot-ASSISTED SURGICAL PLATFORMS);

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

U.S. patent application serial No. 15/940,711, entitled sensing arrangement FOR a robotic-ASSISTED SURGICAL platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED surgery platformes).

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

U.S. provisional patent application serial No. 62/649,302, entitled interactive surgical system with encrypted communication capability (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED communicative capabilities);

U.S. provisional patent application serial No. 62/649,294, entitled data stripping METHOD for interrogating PATIENT RECORDS and creating anonymous RECORDS (DATA STRIPPING METHOD TO interface PATIENT RECORDS and anonymous RECORDS);

U.S. provisional patent application serial No. 62/649,300, entitled SURGICAL HUB SITUATIONAL AWARENESS (SURGICAL HUB SITUATIONAL aware);

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

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

U.S. provisional patent application serial No. 62/649291, entitled "USE OF laser and red, GREEN, BLUE COLORATION TO determine the characteristics OF backscattered light" (USE OF LASER LIGHT AND RED-GREEN-BLUE color TO detection OF particles OF BACK SCATTERED LIGHT);

U.S. provisional patent application serial No. 62/649,296, entitled ADAPTIVE CONTROL PROGRAM update FOR SURGICAL DEVICES (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);

U.S. provisional patent application serial No. 62/649,333, entitled CLOUD-BASED medical analysis FOR CUSTOMIZATION and recommendation TO USERs (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION and computing services TO a USER);

U.S. provisional patent application serial No. 62/649,327, entitled CLOUD-BASED medical analysis FOR SECURITY and certification trends and reactivity measurements (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY and identification TRENDS AND REACTIVE MEASURES);

U.S. provisional patent application serial No. 62/649,315 entitled data processing and priority IN CLOUD analysis NETWORKs (DATA HANDLING AND priority IN a CLOUD analysis NETWORK);

U.S. provisional patent application serial No. 62/649,313, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES (CLOUD INTERFACE FOR coated led DEVICES);

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

U.S. provisional patent application serial No. 62/649,307, entitled AUTOMATIC TOOL adjustment FOR robotic ASSISTED SURGICAL platform (AUTOMATIC TOOL adjustment FOR ROBOT ASSISTED SURGICAL platform); and

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

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

U.S. provisional patent application serial No. 62/659,900, entitled hub COMMUNICATION METHOD (METHOD office COMMUNICATION);

the applicant of the present patent application owns the following U.S. provisional patent applications filed on 30.3.2018, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application serial No. 62/650,887, entitled SURGICAL system with OPTIMIZED SENSING CAPABILITIES (SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES);

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

U.S. provisional patent application serial No. 62/650,882 entitled "SMOKE opportunity MODULE FOR INTERACTIVE television program"; and

U.S. provisional patent application serial No. 62/650,898 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH seperable armeyelments".

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 8.3.2018, the disclosure of each of which is incorporated herein by reference in its entirety:

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

U.S. provisional patent application serial No. 62/640,415 entitled "ESTIMATING STATE OF ultrasilicon END effect AND control system tool.

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

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

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

U.S. provisional patent application serial No. 62/611,339, entitled robot assisted SURGICAL PLATFORM (robot assisted surgery PLATFORM);

before explaining various aspects of the surgical device and generator in detail, it should be noted that the example illustrated application or use is not limited 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 limiting the invention. Moreover, it is to be understood that expressions of one or more of the following described aspects, and/or examples may be combined with any one or more of the other below described aspects, and/or examples.

Certain exemplary aspects will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the disclosed devices and methods. One or more examples of these aspects are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects and that the scope of the various aspects is defined solely by the claims. Features illustrated or described in connection with one exemplary aspect may be combined with features of other aspects. Such modifications and variations are intended to be included within the scope of the claims.

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., cloud 104, which may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with 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 handheld smart surgical instrument 112 configured to communicate with each other and/or with the hub 106. In some aspects, 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 handheld intelligent surgical instruments 112, where M, N, O and P are integers greater than or equal to one.

Fig. 3 shows an example of a surgical system 102 for performing a surgical procedure on a patient lying on an operating table 114 in a surgical room 116. The robotic system 110 is used as part of the surgical system 102 during surgery. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. As the surgeon views the surgical site through the surgeon's console 118, the patient side cart 120 can manipulate at least one removably coupled surgical tool 117 through a minimally invasive incision in the patient. An image of the surgical site may be obtained by the medical imaging device 124, which may be manipulated by the patient side cart 120 to orient the imaging device 124. The robot 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 ROBOT ASSISTED SURGICAL PLATFORM (ROBOT ASSISTED SURGICAL PLATFORM), filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.

Various examples of CLOUD-BASED analyses performed by the CLOUD 104 and suitable for use with 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 28.12.2017, 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 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 air from about 380nm to about 750 nm.

The invisible spectrum (i.e., the non-luminescent 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, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-nephroscopes, sigmoidoscopes, thoracoscopes, and intrauterine scopes.

In one aspect, the imaging device employs multispectral monitoring to distinguish topography from underlying structures. A multispectral image is an image that captures image data across a particular range of wavelengths of the electromagnetic spectrum. The 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" of U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICALPLATFORM)", filed 2017, 12, 28, the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring may be a useful tool for repositioning the surgical site after completion of a surgical task to perform one or more of the previously described tests on the treated tissue.

It is self-evident that strict disinfection of the operating room and surgical equipment is required during any surgery. The stringent hygiene and disinfection conditions required in a "surgical room" (i.e., an operating room or a treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is any substance that needs to be sterilized, including the imaging device 124 and its attachments and components, in contact with the patient or penetrating the sterile field. It should be understood that a sterile field may be considered a designated area that is considered free of microorganisms, such as within a tray or within a sterile towel, or a sterile field may be considered an area around a patient that has been prepared for surgery. The sterile field may include a properly worn swabbed team member, 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 that are strategically arranged relative 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" of U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICALPLATFORM)", filed 2017, 12, 28, the disclosure of which is incorporated herein by reference in its entirety.

As shown in fig. 2, a main display 119 is positioned in the sterile field to be visible to the operator at the surgical table 114. Further, the visualization tower 111 is positioned outside the sterile field. Visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. Visualization system 108, guided by hub 106, is configured to be able to coordinate information flow to operators inside and outside the sterile

field using displays

107, 109, and 119. For example, the hub 106 may cause the imaging system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the

non-sterile display

107 or 109 while maintaining a real-time feed of the surgical site on the main display 119. A snapshot on

non-sterile display

107 or 109 may allow a non-sterile operator to, for example, perform diagnostic steps associated with a surgical procedure.

In one aspect, hub 106 is also configured to be able to route diagnostic inputs or feedback entered by non-sterile operators at visualization tower 111 to main display 119 within the sterile field, where it can be viewed by sterile operators on the operating floor. In one example, the input may be a modified form of a snapshot displayed on

non-sterile display

107 or 109, which may be routed through hub 106 to main display 119.

Referring to fig. 2, a surgical instrument 112 is used in surgery 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 serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by non-sterile operators at visualization tower 111 may be routed by hub 106 to surgical instrument display 115 within the sterile field, where the inputs or feedback may be viewed by the operator of surgical instrument 112. Exemplary Surgical instruments suitable for use in Surgical system 102 are 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 28.12.2017, 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 handheld 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 storage array 134. In certain aspects, as shown in fig. 3, hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.

During surgery, the application of energy to tissue for sealing and/or cutting is typically associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of the tissue. Fluid lines, power lines and/or data lines from different sources are often tangled during surgery. Valuable time may be lost in addressing the problem during surgery. Disconnecting the lines may require disconnecting the lines from their respective modules, which may require resetting the modules. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of tangling between such lines.

Aspects of the present disclosure provide a surgical hub for use in a surgical procedure involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a composite generator module slidably received in a docking station of the hub housing. The docking station includes data contacts and power contacts. 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 seated in a single cell. In one aspect, the combined generator module further comprises a smoke evacuation component for connecting the combined 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 particles generated by application of the therapeutic energy to the 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 a suction 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 energy type 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 accommodate 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 station 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.

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

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 ultrasound components supported in a single housing unit 139 that is 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 modules 140 may include a series of monopole generator modules, bipolar generator modules, and/or ultrasonic generator modules that interact through the hub modular housing 136. The hub modular housing 136 can be configured to facilitate the insertion of multiple generators and the interactive communication between generators docked 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 communications backplane 149 having external and wireless communications connections to enable removable attachment of the

modules

140, 126, 128 and interactive communications therebetween.

In one aspect, the hub modular housing 136 includes a docking cradle or drawer 151 (also referred to herein as a drawer) configured to slidably receive the

modules

140, 126, 128. Fig. 4 illustrates a partial perspective view of the surgical hub housing 136 and the composite generator module 145 slidably received in the docking station 151 of the surgical hub housing 136. The docking ports 152 having power and data contacts on the back of the combined generator module 145 are configured to engage the corresponding docking ports 150 with the power and data contacts of the corresponding docking station 151 of the hub module housing 136 when the combined generator module 145 is slid into place within the corresponding docking station 151 of the hub module housing 136. In one aspect, the combined generator module 145 includes bipolar, ultrasonic, and monopolar modules integrated together into a single housing unit 139, as shown in fig. 5.

In various aspects, the smoke evacuation module 126 includes a fluid line 154 that communicates captured/collected smoke and/or fluid from the surgical site to, for example, the 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 utility conduit coupled to the fluid line may be in the form of a flexible tube terminating at the 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 suction/irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one example, the aspiration fluid line and the suction fluid line are in the form of flexible tubes extending from the surgical site toward the suction/irrigation module 128. The one or more drive systems may be configured to irrigate 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 suction tube, and an irrigation tube. The draft tube may have an inlet at a distal end thereof, and the draft tube extends through the shaft. Similarly, a 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 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 irrigation tube may be in fluid communication with a fluid source, and the aspiration tube may be in fluid communication with a vacuum source. The fluid source and/or vacuum source may be seated in the suction/irrigation module 128. In one example, the fluid source and/or vacuum source may be seated in the hub housing 136 independently of the suction/irrigation module 128. In such examples, the fluid interface can connect the suction/irrigation module 128 to a fluid source and/or a vacuum source.

In one aspect, the

modules

140, 126, 128 on the hub modular housing 136 and/or their corresponding docking stations may include alignment features configured to enable alignment of the docking ports of the modules into engagement with their corresponding ports in the docking stations of the hub modular housing 136. For example, as shown in fig. 4, the combined generator module 145 includes side brackets 155, the side brackets 155 configured to be slidably engageable with corresponding brackets 156 of corresponding docking stations 151 of the hub modular housing 136. The brackets cooperate to guide the docking port contacts of the combined generator module 145 into electrical engagement with the docking port contacts of the hub modular housing 136.

In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the modules are sized to be received in the drawers 151. For example, the 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 are each 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 seated in the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 can facilitate wireless interactive communication between modules seated in the hub modular housing 136. Any suitable wireless communication may be employed, such as, for example, Air Titan-Bluetooth.

Fig. 6 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular housing 160, the lateral modular housing 160 configured to slidably receive multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to be able to slidably receive and interconnect the modules 161 laterally. The modules 161 are slidably inserted into docking feet 162 of a 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 arranged laterally 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 surgical hub 106. The modules 165 are slidably inserted into docking feet or drawers 167 of a vertical modular housing 164, which vertical modular housing 164 includes a floor for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in some cases, the vertical modular housing 164 may include laterally arranged drawers. Further, the modules 165 may interact with each other through docking ports of the vertical modular housing 164. In the example of FIG. 7, a display 177 is provided for displaying data related to the operation of module 165. In addition, the vertical modular housing 164 includes a main module 178 that seats 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 a variety of imaging devices. In one aspect, the imaging device is constructed of a modular housing that can 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 the surgical operation. 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 be able to deliver white light or different light, depending on the surgical procedure.

During a surgical procedure, it may be inefficient to remove a surgical device from a surgical site and replace the surgical device with another surgical device that includes a different camera or a different light source. Temporary loss of vision at the surgical site can lead to undesirable consequences. The modular imaging apparatus of the present disclosure is configured to enable the replacement of a light source module or a 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 that may be configured for snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module that may be configured for snap-fit engagement with the second channel. In another example, the camera module and/or the light source module may be rotated within their respective channels to a final position. Threaded engagement may be used instead of snap-fit engagement.

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 able to switch between imaging devices to provide an optimal view. In various aspects, the imaging module 138 may be configured to be able to integrate images from different imaging devices.

Various IMAGE PROCESSORs AND imaging devices suitable for use in the present disclosure are described in united states patent 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR (COMBINED SBI AND associated IMAGE PROCESSOR) published on 9/8/2011, which is incorporated by reference herein in its entirety. Further, U.S. patent 7,982,776 entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD (SBI MOTION ARTIFACT REMOVAL MOTION ARTIFACT AND METHOD), published 7/19/2011, 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. Further, U.S. patent application publication No.2011/0306840 entitled "control MAGNETIC SOURCE TO fine text inner porous APPARATUS" published on 15.2011 and U.S. patent application publication No.2014/0243597 entitled "SYSTEM FOR PERFORMING AMINIMALLY INVASIVE SURGICAL PROCEDURE" published on 28.8.2014, 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 the medical facility specially equipped for surgical operations to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, modular communication hub 203 includes a network hub 207 and/or a network switch 209 that communicate with network routers. Modular communication hub 203 may also be coupled to local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured to be 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) as well as 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. Network hub 207 and/or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with the devices 1a-1n may be transmitted via the router to the cloud-based computer 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. Network switch 209 may be coupled to network hub 207 and/or network router 211 to connect devices 2a-2m to cloud 204. Data associated with the devices 2a-2n may be transmitted via the network router 211 to the cloud 204 for data processing and manipulation. 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 understood that surgical data network 201 may be expanded by interconnecting multiple hubs 207 and/or multiple network switches 209 with multiple network routers 211. The modular communication hub 203 may be contained in a modular control tower configured to slidably receive a plurality of devices 1a-1n/2a-2 m. Local computer system 210 may also be contained in a modular control tower. The modular communication hub 203 is connected to a display 212 to display images obtained by some of the devices 1a-1n/2a-2m, for example, during surgery. In various aspects, the devices 1a-1n/2a-2m may include, for example, various modules such as non-contact sensor modules 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, a suction/irrigation module 128, a communication module 130, a processor module 132, a memory 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 (es), 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 network 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. Accordingly, the term "cloud computing" may be used herein to refer to a "type 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., a fixed, mobile, temporary, or live operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 over 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 the devices 1a-1n/2a-2m located in one or more operating rooms. Cloud computing services can perform a large amount of computing based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware enables multiple devices or connections to connect to a computer in communication with the 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 a tissue sealing and cutting procedure. At least some of the devices 1a-1n/2a-2m may be employed to identify pathologies, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes localization and edge confirmation of tissues and phenotypes. 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 the 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 outcome analysis processing, and use of standardized methods may provide beneficial feedback to confirm or suggest modification of the behavior of the surgical treatment and surgeon.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 through a wired channel or a wireless channel, depending on the configuration of the devices 1a-1n to the network hub. In one aspect, hub 207 may be implemented as a local network broadcaster operating at the physical layer of the Open Systems Interconnection (OSI) model. The hub provides connectivity to devices 1a-1n located in the same operating room network. The hub 207 collects the data in the form of packets and transmits it to the router in half duplex mode. Hub 207 does not store any media access control/internet protocol (MAC/IP) used to transmit device data. Only one of the devices 1a-1n may transmit data through the hub 207 at a time. The hub 207 does not have routing tables or intelligence as to where to send information and broadcast all network data on each connection and to the remote server 213 (fig. 9) through the cloud 204. Hub 207 may detect basic network errors such as conflicts, but broadcasting all information to multiple ports may present a security risk and lead to 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. Network switch 209 operates in the data link layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a-2m located in the same operating room to the network. Network switch 209 sends data in frames to network router 211 and operates in full duplex mode. Multiple devices 2a-2m may transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to transmit data.

Network hub 207 and/or network switch 209 are coupled to network router 211 to connect to cloud 204. 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 the cloud-based computer resources for further processing and manipulation of 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 of the same medical facility or different networks located in different operating rooms of different medical facilities. Network router 211 sends data in packets to cloud 204 and operates in full duplex mode. Multiple devices may transmit data simultaneously. The network router 211 transmits data using the IP address.

In one example, hub 207 may be implemented as a USB hub, which allows multiple USB devices to be connected to a host. A USB hub may extend a single USB port to multiple tiers so that more ports are available for connecting devices to a host system computer. Hub 207 may include wired or wireless capabilities for receiving information over a wired channel or a 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, the operating room devices 1a-1n/2a-2m may communicate with the modular communication hub 203 via the Bluetooth wireless technology standard for exchanging data from stationary and mobile devices over short distances (using short wavelength UHF radio waves of 2.4 to 2.485GHz in the ISM band) and building Personal Area Networks (PANs). 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 series), WiMAX (IEEE 802.16 series), 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, and the like.

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 data type called a frame. 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 network hub and network switch to form a larger network. The modular communication hub 203 is generally easy to install, configure and maintain, making it a good option to network the 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, the modular control tower 236 includes a modular communication hub 203 coupled to the computer system 210. As shown in the example of fig. 9, a modular control tower 236 is coupled to an imaging module 238 of an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke ejector module 226, a suction/irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via modular control tower 236. Robot hub 222 may also be connected to 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 wired or wireless communication standards or protocols, 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 image and the overlay image to display data received from devices connected to the modular control tower.

Fig. 10 shows the 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, the modular communication hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communication hub 203 and transmit data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in fig. 10, each of the network hubs/switches in modular communication 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 the cloud 204 may be through a wired or wireless communication channel.

The surgical hub 206 employs the non-contact sensor module 242 to measure dimensions of the operating room and uses ultrasound or laser type non-contact measurement devices to generate a map of the operating room. An ultrasound-based non-contact sensor module scans an Operating Room by emitting a burst of ultrasound waves and receiving echoes as they bounce off the enclosure of the Operating Room, as described under U.S. provisional patent application serial No. 62/611,341 entitled "interactive Surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on 28.12.2017, entitled "Surgical Hub space sensing in an Operating Room," 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 the bluetooth pairing distance limit. The laser-based non-contact sensor module scans the operating room by emitting laser pulses, receiving laser pulses bouncing off the enclosure of the operating room, and comparing the phase of the emitted pulses to the received pulses to determine the size of the operating room and adjust the bluetooth paired distance limit.

Computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled via a system bus to the communication module 247, storage 248, memory 249, non-volatile memory 250, and input/output interface 251. The system bus can be any of several types of bus structure(s) including the 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, 9-bit bus, Industrial Standard Architecture (ISA), micro Charmel architecture (MSA), extended ISA (eisa), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), personal computer memory card international association bus (PCMCIA), Small Computer System Interface (SCSI), or any other peripheral bus.

Processor 244 may be any single-core or multi-core processor, such as those provided by texas instruments under the trade name ARM Cortex. In one aspect, the processor may be a processor core available from, for example, Texas Instruments LM4F230H5QR ARM Cortex-M4F, which includes 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHZ), a prefetch buffer for improving performance above 40MHz, 32KB of single cycle Sequential Random Access Memory (SRAM), loaded with a load of memory, etc

Software internal Read Only Memory (ROM), 2KB Electrically Erasable Programmable Read Only Memory (EEPROM), and/or one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, the details of which can be seen in the product data sheet.

In one aspect, the processor 244 may comprise a safety controller comprising two series controller-based controllers (such as TMS570 and RM4x), also known under the trade name Hercules ARM Cortex R4, also manufactured by Texas Instruments. The safety controller can be configured to be dedicated to IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. The basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory can include ROM, Programmable ROM (PROM), Electrically Programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes Random Access Memory (RAM), which acts as external cache memory. Further, RAM may be available in a variety of forms, such as SRAM, Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDRSDRAM), Enhanced SDRAM (ESDRAM), Synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card, or memory stick. In addition, 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 the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environments. 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 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). The interface port(s) include, for example, a serial port, a parallel port, a game port, and a 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 (such as monitors, displays, speakers, and printers) that require special adapters among other output devices.

The 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 a local computer. The remote cloud computer(s) can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other common network nodes and the like, and typically includes many or all of the elements described relative to the computer system. For purposes of brevity, only a memory storage device with remote computer(s) is illustrated. The remote computer(s) is logically connected to the computer system through a network interface and then physically connected via a communications connection. Network interfaces encompass communication networks such as Local Area Networks (LANs) and Wide Area Networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, token Ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks 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 dedicated Digital Signal Processor (DSP) for processing digital images. The image processor may employ parallel computing 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 the hardware/software used to interface the network to the bus. While a communication connection is shown for exemplary clarity within the 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, the USB hub device 300 employs a TUSB2036 integrated circuit hub from 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 (DP0) input paired with a differential data positive (DM0) input. The three downstream

USB transceiver ports

304, 306, 308 are differential data ports, where each port includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.

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 downstream

USB transceiver ports

304, 306, 308. The downstream

USB transceiver ports

304, 306, 308 support both full-speed devices 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-powered mode or a self-powered mode and includes 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 section 8 of the USB specification. The SIE 310 typically includes signaling up to the transaction level. The processing functions thereof may include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, no return to zero inversion (NRZI) data encoding/decoding and digit stuffing, CRC generation and verification (token and data), packet id (pid) generation and verification/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 through

port logic circuits

320, 322, 324. The SIE 310 is coupled to a command decoder 326 via interface logic to control commands from the serial EEPROM via a 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 a standardized four-wire cable that provides both communication and power distribution. The power configuration is a bus powered mode and a self-powered mode. The USB hub 300 may be configured to support four power management modes: bus-powered hubs with individual port power management or package port power management, and self-powered hubs with individual port power management or package port power management. In one aspect, the USB hub 300, upstream USB transceiver port 302, are plugged into the USB host controller using a USB cable, and downstream

USB transceiver ports

304, 306, 308 are exposed for connection of USB compatible devices, or the like.

Surgical instrument hardware

Fig. 12 illustrates a logic diagram for a control system 470 for a surgical instrument or tool according to 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 a 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 operably coupled to the longitudinally movable displacement member to drive the I-beam knife element. The tracking system 480 is configured to be able to determine the position of the longitudinally movable displacement member. The position information is provided to a processor 462 that may be programmed or configured to determine the position of the longitudinally movable drive member as well as the positions of the firing member, firing bar, and I-beam knife element. Additional motors may be provided at the tool driver interface to control the I-beam firing, closure tube travel, shaft rotation, and articulation. The display 473 displays a variety of operating conditions of the instrument and may include touch screen functionality for data entry. The information displayed on the display 473 may be overlaid with the image acquired via the endoscopic imaging module.

In one aspect, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In one aspect, main microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, Inc. (Texas Instruments), for example, that includes 256KB of on-chip memory of single-cycle flash or other non-volatile memory (up to 40MHZ), a prefetch buffer for improving performance above 40MHz, 32KB of single-cycle SRAM, loaded with a load of memory above 40MHz

Internal ROM of software, EEPROM of 2KB, one or more PWM modules, one or more QEI analog, and/or one or more 12-bit ADC with 12 analog input channels, the details of which can be seen in the product data table.

In one aspect, microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, also manufactured by Texas Instruments. The safety controller can be configured to be dedicated to IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

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, microcontroller 461 includes 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 driver 492 may be a3941 available from Allegro Microsystems, Inc. Other motor drives can be readily substituted for use in tracking system 480, including an absolute positioning system. Detailed description of absolute positioning system U.S. patent application publication 2017/0296213 entitled system and method FOR CONTROLLING a SURGICAL stapling and severing instrument (SYSTEMS AND METHODS FOR CONTROLLING a SURGICAL stapling a SURGICAL STAPLING AND cutting system), which is published on 19/10/2017, is incorporated herein by reference in its entirety.

The microcontroller 461 may be programmed to provide precise control of the speed and position of the displacement member and the articulation system. The microcontroller 461 may be configured to be able to calculate a response 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 for the actual feedback decision. The observed response is a favorable tuning value that balances 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 driver 492 and can be employed by a firing system of a 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 comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may comprise, 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, which 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 separated from the power assembly.

The motor driver 492 may be a3941 available from Allegro Microsystems, Inc. A 3941492 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. 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 aforementioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side drive allows for direct current (100% duty cycle) operation. The full bridge may be driven in fast decay mode or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation can pass through either the high-side or low-side FETs. The power FET is protected from breakdown by a resistor adjustable dead time. The integral diagnostics provide an indication of undervoltage, overheating, and power bridge faults, and may be configured to protect the power MOSFETs under most short circuit conditions. Other motor drives can be readily substituted for use in tracking system 480, including an absolute positioning system.

The 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. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Thus, as used herein, the term displacement member is used generally 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 in fact track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may comprise a contact displacement sensor or a non-contact 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 that operably interfaces with a gear assembly mounted on the displacement member in meshing engagement with the 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 arrangement of the transmission and sensor 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 including a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents a longitudinally movable firing member, firing bar, I-beam, or combination thereof.

A 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 that the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via a 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 conjunction with the gear reduction to provide unique position signals for more than one rotation 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.

Position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors that are classified according to whether they measure the total or vector component of the magnetic field. The techniques for producing the two types of magnetic sensors described above encompass a number of aspects of physics and electronics. Technologies for magnetic field sensing include search coils, flux gates, optical pumps, nuclear spins, superconducting quantum interferometers (SQUIDs), hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedances, magnetostrictive/piezoelectric composites, magnetodiodes, magnetotransistors, optical fibers, magneto-optical, and magnetic sensors based on micro-electromechanical systems, among others.

In one aspect, the position sensor 472 for the tracking system 480 including an absolute positioning system comprises a magnetic rotary absolute positioning system. The position sensor 472 may be implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage 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 an intelligent power management controller are also provided on the chip. Coordinate rotation digital computer (CORDIC) processors (also known as bitwise and Volder algorithms) are provided to perform simple and efficient algorithms to compute 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 position sensor 472 may be an AS5055 chip provided in a small QFN 16 pin 4 × 4 × 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, state 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 location measured by the 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 tissue thickness sensor) issued 5/24/2016, which is incorporated herein by reference in its entirety; U.S. patent application publication 2014/0263552 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE TISSUE thicknes) published 9, 18, 2014, which is incorporated herein by reference in its entirety; and us patent application serial No. 15/628,175 entitled technique FOR adaptive control OF MOTOR speed FOR SURGICAL stapling and CUTTING INSTRUMENTs (TECHNIQUES FOR ADAPTIVE OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT) filed 2017, which is hereby incorporated 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 comparison and combination circuitry 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, inductive 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, which simply count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, etc.

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, the amplitude of the strain exerted on the anvil during a clamping operation, which may be indicative of the 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 the 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 by 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 the force on the tissue being treated by the end effector. The system for measuring the force applied to tissue grasped by the end effector includes a strain gauge sensor 474, such as, for example, a micro-strain gauge, configured to be capable of measuring one or more parameters of, for example, the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain applied to the jaw members of the end effector during a clamping operation, which can indicate tissue compression. The measured strain is converted to a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 may measure a force used to operate the knife member, for example, to cut tissue trapped between the anvil and the 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 selected positions of the firing member and/or corresponding values of the velocity 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 the 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 according to at least one aspect of the present disclosure. The control circuit 500 may be configured to implement the various processes described herein. The circuit 500 may include a microcontroller including one or more processors 502 (e.g., microprocessors, microcontrollers) 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 the 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. The memory circuit 504 may include volatile storage media and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to be able 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. The combinational logic circuit 510 may be configured to enable the various processes described herein. Combinatorial logic circuitry 510 may include a finite state machine including combinatorial logic 512, where combinatorial logic 512 is configured to receive data associated with a surgical instrument or tool at input 514, process the data through combinatorial logic 512, and provide output 516.

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 circuit 520 or combinational logic 522 may be configured to enable the various processes described herein. Sequential logic circuit 520 may comprise a finite state machine. Sequential logic circuitry 520 may include, for example, combinatorial 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 inputs 526, process the data through the combinational logic 522, and provide the outputs 528. In other aspects, a circuit may comprise 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 include 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 can be activated to perform various functions. In some cases, the first motor may be activated to perform a first function, the second motor may be activated to perform a second function, and the 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, closing, and/or articulation motions in the end effector. Firing motions, closing motions, and/or articulation motions can be transmitted to the end effector, for example, by a shaft assembly.

In certain 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, which may be configured to transmit a firing motion generated by the motor 602 to the end effector, in particular for displacing the I-beam element. In some instances, the firing motion generated by the motor 602 may cause, for example, staples to be deployed from the staple cartridge into tissue captured by the end effector and/or cause a cutting edge of the I-beam member to be advanced to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the motor 602.

In some cases, the surgical instrument or tool may include a closure motor 603. The closure motor 603 can be operably coupled to a closure motor drive assembly 605, the closure motor drive assembly 605 being configured to transmit the closure motions 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 staple cartridge. The closing motion can 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 cases, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606 b. The motors 606a, 606b can be operably coupled to respective articulation

motor drive assemblies

608a, 608b, which can be configured to transmit articulation motions generated by the motors 606a, 606b to the end effector. In some cases, the articulation can articulate the end effector relative to the 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 advance the closure tube and I-beam member distally, 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 regulate one of the plurality of motors at a time. For example, the common control module 610 may be individually coupled to and decoupled from multiple motors of the surgical instrument. In some cases, 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 moved or transitioned 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 close motor 603; in the third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606 a; and in the fourth position 618b, the switch 614 may electrically couple the common control module 610 to, for example, the second articulation motor 606 b. In certain instances, a single 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 used to actuate the jaws.

In various instances, 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 FETs. The motor driver 626 may regulate power transmitted from a power source 628 to the motors coupled to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In some cases, the microcontroller 620 may be employed, for example, to determine the current drawn by the motors when the motors are coupled to the common control module 610, 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 various functions and/or computations as 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, the power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery, for example. In some cases, 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 replaceable and/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626 to control the position, rotational direction, and/or speed of the motors 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 is to be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functions of a computer's Central Processing Unit (CPU) on one integrated circuit or at most several integrated circuits. A processor is a multipurpose 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, it is an example of sequential digital logic. The operands of the processor are numbers and symbols represented in a binary numerical system.

In one example, processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments (Texas Instruments). In some cases, microcontroller 620 may be, for example, LM4F230H5QR, available from Texas Instruments. In at least one example, the Texas instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB single cycle flash or other non-volatileOn-chip memory for volatile memory (up to 40MHz), prefetch buffer for improved performance above 40MHz, 32KB single cycle SRAM, load with load

Internal ROM of software, EEPROM of 2KB, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Other microcontrollers could be readily substituted for use with module 4410. Accordingly, the present disclosure should not be limited to this context.

In certain instances, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600, which 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, closure, and articulation functions according to input from an algorithm or control program of the surgical instrument or tool.

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

Fig. 17 is a schematic view of a robotic surgical instrument 700 configured to operate a surgical tool described herein, according to 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 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 the motor-driven firing member, closure member, 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 an anvil 716 and I-beam 714 (including sharp cutting edges) portion of the end effector 702, a removable staple cartridge 718, a 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. The timer/counter 731 provides timing and count information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e may be operated individually by the control circuit 710 in open loop or closed loop feedback control.

In one aspect, the control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to perform one or more tasks. In one aspect, the 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 with the output of the timer/counter 731 so that the control circuit 710 can determine the position of the I-beam 714 at a particular time (t) relative to a starting position or the time (t) at which the I-beam 714 is at a particular position relative to a starting position. The 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 circuit 710 can be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuit 710 may be programmed to sense a tissue condition, such as thickness, directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or a closure control program based on the tissue condition. The firing control routine may describe distal movement of the displacement member. Different firing control programs may be selected to better address different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower speed and/or at a lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher speed and/or at a higher power. The closure control program can control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and the 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-708 e. 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, the motors 704a-704e may be brushed DC electric motors. For example, the speeds of the motors 704a-704e may be proportional to the respective motor drive signals. In some examples, the motors 704a-704e can be brushless DC electric motors, and the respective motor drive signals can include PWM signals provided to one or more stator windings of the motors 704a-704 e. Also, in some examples, the motor controllers 708a-708e may be omitted and the control circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open loop configuration for a first open loop portion of the stroke of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program in a closed-loop configuration. The response of the instrument may include the translation 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 so forth. After the open loop portion, the control circuit 710 may implement the selected firing control routine for a second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e based on translation data that describes the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed.

In one aspect, the motors 704a-704e may receive power from an energy source 712. The energy source 712 may be a DC power source driven by a main ac 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 components to couple the motors 704a-704e to the 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 is translated 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, position sensor 734 may be omitted. Where any of the motors 704a-704e are stepper motors, the control circuit 710 may track the position of the I-beam 714 by aggregating the number and direction of steps that the 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. The control circuit 710 provides a motor set point to the motor control 708a, which provides a drive signal to the motor 704 a. The output shaft of motor 704a is coupled to a torque sensor 744 a. Torque sensor 744a is coupled to a transmission 706a that is coupled to I-beam 714. The transmission 706a includes movable mechanical elements, such as rotating elements and firing members, to control the distal and proximal movement of the I-beam 714 along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to 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 an additional sensor 738 configured to provide a feedback signal 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 can 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 of the stroke start position. As the firing member is translated distally, the I-beam 714, having a cutting element positioned at the distal end, is advanced distally to cut tissue located 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. The output shaft of motor 704b is coupled to torque sensor 744 b. The torque sensor 744b is coupled to a transmission 706b that is coupled to the anvil 716. The actuator 706b includes movable mechanical elements, such as rotating elements and closure members, to control the movement of the anvil 716 from the open and closed positions. In one aspect, the 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, the control circuit 710 may provide a close signal to the motor control 708 b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the anvil 716 and the staple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaft member, such as 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. The output shaft of motor 704c is coupled to a torque sensor 744 c. The torque sensor 744c is coupled to the transmission 706c, which transmission 706c is coupled to the shaft 740. Transmission 706c includes a movable mechanical element, such as a rotating element, to control shaft 740 to rotate more than 360 ° 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) the proximal end of the proximal closure tube for operable engagement by a rotary gear assembly operably supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the control circuit 710 with the rotational position of the shaft 740.

In one aspect, the control circuit 710 is configured to articulate 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. The output shaft of motor 704d is coupled to torque sensor 744 d. The torque sensor 744d is coupled to the transmission 706d, which transmission 706d is coupled to the articulation member 742 a. The transmission 706d includes movable mechanical elements, such as articulation elements, to control the articulation of the end effector 702 ± 65 °. In one aspect, the motor 704d is coupled to an articulation nut that is 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 represents the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the control circuit 710 with the articulated position of the end effector 702.

In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members or links 742a, 742 b. These articulation members 742a, 742b are driven by separate disks on the robotic 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 can be driven antagonistic to the other link to provide resistance holding motion and load to the head when the head is not moving and to provide articulation when the head is articulating. When the head is rotated, the articulation members 742a, 742b are attached to the head at a fixed radius. Thus, the mechanical advantage of the push-pull link changes as the head rotates. This variation in mechanical advantage may be more apparent for other articulation link drive systems.

In one aspect, one or more of the motors 704a-704e can include a brushed DC motor having a gearbox and a mechanical link to a firing member, a closure member, or an articulation member. Another example includes electric motors 704a-704e that operate moveable 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 the physical system. Such external influences may be referred to as drag forces, which act against one of the electric motors 704a-704 e. 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, position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a magnetic rotary absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. Position sensor 734 may interface with control circuitry 710 to provide an absolute positioning system. The location may include a plurality of hall effect elements located above the magnets and coupled to a CORDIC processor, also known as a bitwise method and a Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only an addition operation, a subtraction operation, a digit shift operation, and a table lookup operation.

In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 can be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derivative parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus 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 sensors for measuring one or more parameters of the end effector 702. The sensors 738 may include one or more sensors. A sensor 738 may be located on the staple cartridge 718 deck 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, among others. Thus, the control circuit 710 may 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 upper tissue portion of the staple cartridge 718, 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 a magnitude of strain in the anvil 716 during the clamped condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 738 can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensor 738 can be configured to detect an impedance of a section of tissue 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 sensors 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 a non-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.

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 positioned 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 tissue compression experienced by a section of tissue captured between the anvil 716 and the staple cartridge 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closure force applied to the anvil 716 by the closure drive system. The one or more sensors 738 may be sampled in real time by a processor of the control circuit 710 during a clamping operation. The control circuit 710 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to the anvil 716 in real-time.

In one aspect, the current sensor 736 can be used to measure the current consumed by each of the motors 704a-704 e. The force required to propel any of the movable mechanical elements, such as the I-beam 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. The control circuit 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. The 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, for example, convert signals from a feedback controller into physical inputs, such as housing voltages, PWM voltages, frequency modulated voltages, currents, torques, and/or forces. Additional details are disclosed in U.S. patent application serial No. 15/636,829 entitled CLOSED LOOP VELOCITY CONTROL technology FOR ROBOTIC SURGICAL INSTRUMENTs (CLOSED LOOP VELOCITY CONTROL FOR ROBOTIC SURGICAL INSTRUMENTs) filed on 29.6.2017, 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 may be determined by measuring the position of the longitudinally movable drive member with 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 the 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 member (e.g., the I-beam 764) in the manner described. In one aspect, the timer/counter 781 provides an output signal, such as a elapsed time or a digital count, to the control circuit 760 to correlate the position of the I-beam 764, as determined by the position sensor 784, with the output of the timer/counter 781, such that the control circuit 760 can determine the position of the I-beam 764 relative to the starting position at a particular time (t). The timer/counter 781 may be configured to measure elapsed time, count external events or time external events.

The control circuit 760 may generate a 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 be capable of providing a motor drive signal 774 to the motor 754 to drive the motor 754, as described herein. In some examples, the 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, the motor 754 may be a brushless DC electric motor, and the motor drive signals 774 may include PWM signals provided to one or more stator windings of the motor 754. Also, in some examples, the motor controller 758 may be omitted and the control circuitry 760 may generate the motor drive signal 774 directly.

The motor 754 may receive electrical power from an energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage components 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 is translated distally and proximally. The control circuitry 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 motion of the I-beam 764. Also, in some examples, position sensor 784 may be omitted. Where the motor 754 is a stepper motor, the control circuit 760 may track the position of the I-beam 764 by aggregating the number and direction of steps the 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.

The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derivative parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors 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 a clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect an impedance of a section of tissue located between the anvil 766 and the staple cartridge 768, which impedance is indicative of the thickness and/or integrity of the 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 the closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of tissue compression experienced by a section of tissue captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied by the closure drive system to the anvil 766. The one or more sensors 788 may be sampled in real time by the processor of the control circuitry 760 during the clamping operation. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to the 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 propel 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 circuit 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. The surgical instrument 750 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, a PID, status feedback, LQR, and/or adaptive controller. The surgical instrument 750 may include a power source to, for example, convert signals from the feedback controller into physical inputs such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force.

The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or I-beam 764 through a brushed dc motor having a gearbox and mechanical connection to the articulation and/or knife system. Another example is an electric motor 754 that operates a displacement member and articulation driver, for example, of an interchangeable shaft assembly. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on the physical system. This external influence may be referred to as a drag force 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 including an end effector 752 having a motor-driven surgical stapling and cutting tool. For example, the motor 754 can drive the displacement member distally and proximally along a longitudinal axis of the end effector 752. End effector 752 may include a pivotable anvil 766 and, when configured for use, staple cartridge 768 is positioned opposite 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 for use, 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 can drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke start position to an end of stroke position distal to the stroke start position. The I-beam 764 with the cutting element positioned at the distal end can cut tissue between the staple cartridge 768 and the anvil 766 as the displacement member is translated distally.

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

In some examples, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of the stroke of the displacement member. Based on the response of 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 translation 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 sum of the pulse widths of the motor drive signals, and the like. After the open loop portion, the control circuit 760 may implement the selected firing control routine for a second portion of the displacement member travel. For example, during the 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 serial No. 15/720,852 entitled system and method FOR controlling a DISPLAY OF a SURGICAL INSTRUMENT (SYSTEM AND METHODS FOR controlling DISPLAY OF a SURGICAL INSTRUMENT), filed 2017, 9,29, 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. The surgical instrument 790 includes an end effector 792 that may include an anvil 766, an I-beam 764, and a removable staple cartridge 768 that may be interchanged with an RF cartridge 796 (shown in phantom).

In one aspect, the sensor 788 can 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 sensors 788 may include a non-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 rotary absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. The position sensor 784 interfaces with the control circuitry 760 to provide an absolute positioning system. The location may include a plurality of hall effect elements located above the magnets and coupled to a CORDIC processor, also known as a bitwise method and a Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only an addition operation, a subtraction operation, a digit shift operation, and a table lookup operation.

In one aspect, the I-beam 764 may be realized 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 bins 796 may be implemented as RF bins. These and other sensor arrangements are described in commonly owned U.S. patent application serial No. 15/628,175 entitled "techiques for ADAPTIVE CONTROL OF MOTOR vehicle STAPLING AND current sensing system," filed on 20/6/2017, which is incorporated herein by reference in its entirety.

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 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 may be determined by measuring the position of the longitudinally movable drive member with 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 the 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 member (e.g., the I-beam 764) in the manner described. In one aspect, the timer/counter 781 provides an output signal, such as a elapsed time or a digital count, to the control circuit 760 to correlate the position of the I-beam 764, as determined by the position sensor 784, with the output of the timer/counter 781, such that the control circuit 760 can determine the position of the I-beam 764 relative to the starting position at a particular time (t). The timer/counter 781 may be configured to measure elapsed time, count external events or time external events.

The motor 754 may receive electrical power from an energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage components 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 is translated distally and proximally. The control circuitry 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 motion of the I-beam 764. Also, in some examples, position sensor 784 may be omitted. In the case where the motor 754 is a stepper motor, the control circuit 760 may track the position of the 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.

The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derivative parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors 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 the closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of tissue compression experienced by a section of tissue captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied by the closure drive system to the anvil 766. The one or more sensors 788 may be sampled in real time by the processor portion of the control circuitry 760 during the clamping operation. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to the 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. The control circuitry 760 controls the delivery of RF energy to the RF bin 796.

Additional details are disclosed in U.S. patent application serial No. 15/636,096 filed on 28.6.2017, entitled SURGICAL SYSTEM coupleable with a staple cartridge and a RADIO FREQUENCY cartridge and METHOD OF use thereof (SURGICAL SYSTEM on shelf WITHSTAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME), which is incorporated herein by reference in its entirety.

Fig. 20 illustrates a stroke length graph 20740 showing how the control system may modify the stroke length of the closure tube assembly based on the articulation angle θ. Such modification of the stroke length includes shortening the stroke length to a compensation stroke length (e.g., defined along the y-axis) as the joint angle θ increases (e.g., defined along the x-axis). The compensated stroke length defines a length of travel of the closure tube assembly in the distal direction to close the jaws of the end effector, depends on the articulation angle θ, and prevents damage to the surgical device from over-travel of the closure tube assembly.

For example, as shown in the stroke length graph 20740, the closure tube assembly closure jaw has a stroke length of about 0.250 inches when the end effector is not articulated and a compensation stroke length of about 0.242 inches when the articulation angle θ is about 60 degrees. Such measurements are provided as examples only, and any of various angles and corresponding stroke lengths, as well as compensated stroke lengths, may be included without departing from the scope of the present disclosure. Further, the relationship between the articulation angle θ and the compensation stroke length is non-linear, and the rate of shortening of the compensation stroke length increases as the articulation angle increases. For example, the reduction in the compensation stroke length between 45 degrees and 60 degrees of articulation is greater than the reduction 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 a distal position), the distal closure tube is still allowed to advance during articulation, possibly 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 retracting the closure tube assembly proximally a compensating distance (e.g., defined along the y-axis) as the end effector articulates and based on the articulation angle θ (e.g., defined along the x-axis). The compensating distance by which the closure tube assembly is proximally retracted prevents the distal closure tube from being advanced distally, thereby maintaining the jaws in an open position during articulation. By retracting the closure tube assembly proximally a compensating distance during articulation, the closure tube assembly may be advanced a stroke length from a proximally 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 compensation 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 retracts a compensating distance of 0.008 inches during articulation. Thus, to close the jaws, the closure tube assembly can be advanced a stroke length from the retracted position. Such measurements are provided for example purposes 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 non-linear, and the rate at which the compensation distance extends increases as the articulation angle θ increases. For example, the increase in the compensation distance between 45 degrees and 60 degrees is greater than the increase in the compensation distance between 0 degrees and 15 degrees.

When clamping tissue of a patient, the force and tissue applied by the clamping device (e.g., a linear stapler) can 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 suture path. Fig. 22 is a graph showing power applied to tissue at a constant anvil closure rate (i.e., without the use of Controlled Tissue Compression (CTC)) during compression versus and at a variable anvil closure rate (i.e., with CTC) during compression. The closure rate can be adjusted to control tissue compression so that the power applied into 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 a yield force or pressure that causes the jaws to open such that when in a fully closed position, the tissue gap is not within an acceptable range along the entire length of the suture. For example, the jaws should be parallel or sufficiently close to parallel such that the tissue gap remains within an acceptable or targeted 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 damage to the tissue.

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

In the example using CTC, the limitation of power is achieved by slowing the rate of closure, 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 CTC) 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 CTC). 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 than 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, using the exemplary aspect shown by CTC 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 may be minimized relative to systems and methods that do not use CTCs.

FIG. 22 and additional examples are further described in U.S. Pat. No.8,499,992 entitled "DEVICE AND METHOD FOR ROTATING COMPRESSION OF TISSUE", filed on 6.1.2012, which was 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 help the control system determine the position of the electron beam and/or the articulation angle of the firing axis and appropriately control the at least one motor based on such determinations. For example, the force threshold may vary according to a length of travel of a firing bar configured to translate the firing shaft, and such force threshold may be compared to a measured torque force of one or more motors in communication with the control system. The comparison of the measured torque force to the force threshold may provide a reliable way for the control system to determine the position of the electron beam and/or the articulation of the end effector. This may allow the control system to appropriately control the one or more motors (e.g., reduce or stop the torsional load) 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.

Figure 23 shows a force and displacement graph 20800, which includes the measured forces in section a in relation to the measured displacement in section B. Both part a and part B have an x-axis (e.g., seconds) that defines time. The y-axis of part B defines the travel displacement of the firing link (e.g., in millimeters), and the y-axis of part a defines the force applied to the firing bar to advance the firing shaft. As shown in part A, travel of the firing bar within the first articulation range 20902 (e.g., the first approximately 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 cannot be mechanically articulated any further. As a result of being in full articulation, the torque force on the motor will increase, and the control system may sense that the articulation force peak 20802 exceeds the predefined articulation threshold 20804, as shown in section a. The control system may include more than one predefined articulation thresholds 20804 for sensing more than one direction of maximum articulation (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 advances beyond the range of articulation 20902, a shifting mechanism within the surgical stapler may cause further distal travel of the firing bar to cause distal travel of the firing shaft. For example, as shown in part B, travel 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 lengths of travel are within the scope of the present disclosure. In this example, the maximum firing stroke position 20906 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 can include a motor threshold 20808 and an end of knife travel threshold 20810 that branches off from the motor threshold 20808 and decreases (e.g., non-linearly) as the electron beam approaches the maximum firing stroke position 20906.

The control system may be configured to monitor the sensed motor torque force during at least a last portion of the distal stroke 20907 of the electron beam (e.g., the last 10% of the firing stroke 904) before the electron beam reaches the maximum firing stroke position 20906. When monitored along such a final portion of the distal stroke 20907, the control system may cause the motor to reduce the torque, thereby reducing the load on the electron beam. This can protect the surgical stapler (including the electron beam) from damage by reducing the load on the electron beam as it approaches the maximum firing stroke position 20906, thereby reducing the impact of the electron beam on the distal end of the cartridge or jaw. As described above, such an impact may produce a knife travel force peak 20806 that may exceed a knife travel threshold 20810 but not a motor threshold 20808, thereby not damaging the motor. Accordingly, 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 deeming that the electron beam has reached the maximum firing stroke position 20906.

After the control system detects that the knife travel force peak 20806 exceeds the knife travel threshold 20810, the control system can confirm the position of the electron beam (e.g., at 70mm displacement and/or at the end of the firing stroke 20904) and can retract the firing rod based on such known displacement positions to reset the electron beam at a proximal-most position 20908 (e.g., 0mm displacement). At a proximal-most position 20908, 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 may recalibrate and correlate the position of the electron beam to be at 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 rod within the articulation range 20902 will again cause articulation of the end effector.

Thus, the control system may sense torque forces on a motor that controls travel of the firing bar and compare such sensed torque forces to a plurality of thresholds to determine the position of the electron beam or the articulation angle of the end effector, to appropriately 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 members are 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-described surgical instrument aspects, as shown in fig. 24, contact of the jaw member with the tissue "T" closes the otherwise open sensing circuit "SC" by establishing contact with a pair of opposing plates "P1, P2" disposed on the jaw member. The contact 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 the tissue is subjected to 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, over-compression of the tissue "T" can cause tissue necrosis and, in certain procedures, staple line failure. The 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 placed on the inner surface of the jaws that, when in contact with tissue, close an otherwise open sensing circuit. The contact sensor may also include a force sensitive transducer that detects when the clamped tissue first resists compression. 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 over 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. The piezoelectric element is a bidirectional transducer that converts stress into electrical potential. The element may be composed of metalized quartz or ceramic. In operation, when a stress is applied to the crystal, the charge distribution of the material changes, resulting in a voltage being generated across the material. The piezoelectric element can be used to indicate when either or both of the jaw members are in contact with the tissue "T" and the amount of pressure exerted on the tissue "T" after contact is established.

In one aspect, any of the foregoing surgical instruments may include or be provided with one or more metal strain gauges placed within or on a portion of the body of the surgical instrument. The working principle of metal strain gauges is that the resistance of a material depends on length, width and thickness. Thus, when the material of a metal strain gauge experiences strain, the resistance of the material changes. Thus, the incorporation of a resistor made of such a material into an electrical circuit will convert the strain into a change in an electrical signal. Advantageously, the 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 different transduction modes. In operation, when the lattice structure of a semiconductor strain gauge is deformed due to an applied stress, the resistance of the material changes. This phenomenon is called 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 movement 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, thereby changing 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 serves to deflect a pointer or dial on the 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, a spring tube, a capsule, or a bellows. By way of example, the mechanical element may be coupled with other measuring and/or sensing elements such as a potentiometer pressure transducer. 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 member on the potentiometer, thereby changing the resistance to reflect the applied pressure or force.

The combination of the above aspects, particularly the combination of the gap and tissue contact sensors, provides the surgeon with feedback information and/or real-time information about the condition of the surgical site and/or the target tissue "T". For example, information about the initial thickness of the tissue "T" may guide the surgeon in selecting an appropriate staple size, information about the clamped thickness of the tissue "T" may let the surgeon know whether the selected staple will be properly shaped, information about the initial thickness and clamped thickness of the tissue "T" may be used to determine the amount of compression or strain on the tissue "T", and information about the strain on the tissue "T" may use the strain to avoid compressing the tissue to an excessive strain value and/or to avoid stapling tissue that has experienced excessive strain.

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

Fig. 24 and additional examples are further described in united states patent No.8,181,839 entitled "SURGICAL INSTRUMENTING TECHNOLOGY SENSORS" filed on 7.2011.6.27, which was published on 5.2012, 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 apparatus and methods. Features illustrated 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" used with respect to the figures are not intended to be limiting and/or absolute, as the surgical instrument may be used in many orientations and positions.

Exemplary devices and methods for performing laparoscopic and minimally invasive surgical procedures are provided. However, such devices and methods may be used for other surgical procedures and applications, including, for example, open surgical procedures. The surgical instrument may be inserted through a natural orifice or through an incision or puncture 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 that is 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 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 the 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 assemblies can be used WITH various robotic systems, INSTRUMENTS, components, and methods disclosed in U.S. patent No.9,072,535 entitled "SURGICAL INSTRUMENTS WITH rotable stage design", which is hereby incorporated 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. The housing 150012 includes an end effector 150300 that includes 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 different sizes and types of staple cartridges, having 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 motions, to end effector arrangements adapted 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 may include a pair of interconnectable handle

housing segments

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 can be grasped and manipulated by a clinician. The handle assembly 150014 operably supports a plurality of drive systems configured to generate and apply control motions to corresponding portions of the 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, according to at least one aspect of the present disclosure. The handle assembly 150014 can include a frame 150020 that can operably support a plurality of drive systems. The frame 150020 operably supports a "first" or closure drive system 150030 that can impart closing and opening motions to the interchangeable shaft assembly 150200. The closure drive system 150030 may include an actuator, such as a closure trigger 150032 pivotally supported by the frame 150020. The closure trigger 150032 is pivotally coupled to the handle assembly 150014 by a pivot pin 150033 such that the closure trigger 150032 can be manipulated by a clinician. The closure trigger 150032 may pivot from an activated or "unactuated" position to an "actuated" position and more specifically to a fully compressed or fully actuated position when the clinician grasps the pistol grip portion 150019 of the handle assembly 150014.

The handle assembly 150014 and the frame 150020 operably support a firing drive system 150080 that is configured to apply firing motions to corresponding portions of the interchangeable shaft assembly attached thereto. The firing drive system 150080 may employ an electric motor 150082 located in a pistol grip portion 150019 of the handle assembly 150014. The electric motor 150082 may be a direct current brushed 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 may be powered by a power source 150090, which may include a removable power pack 150092. Removable power pack 150092 may include a proximal housing portion 150094 configured to attach 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 may each include, for example, a Lithium Ion (LI) or other suitable battery. The distal housing portion 150096 is configured for removable operable attachment to a control circuit board 150100 that is operably coupled to the electric motor 150082. A number of batteries 150098 connected in series may provide power to the surgical instrument 150010. The power source 150090 may be replaceable and/or rechargeable. A display 150043 located below the cover 150045 is electrically coupled to the control circuit board 150100. Cover 150045 can be removed to expose display 150043.

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

In use, the 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 by the battery to the electric motor can be reversed to operate the electric motor 150082 in a counterclockwise 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 may include a switch that may be configured to enable the polarity applied to the electric motor 150082 by the power source 150090 to be reversed. The handle assembly 150014 may include a sensor configured to detect the position of the longitudinally movable drive member 150120 and/or the direction in which the longitudinally movable drive member 150120 is moving.

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

Turning again to fig. 25, the interchangeable shaft assembly 150200 includes an end effector 150300 that includes an elongate channel 150302 that is 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 can include an articulation joint 150270. The construction and operation of the end effector 150300 and ARTICULATION joint 150270 is set forth in U.S. patent application publication No.2014/0263541, entitled "ARTICULATION SURGICAL INSTRUMENT compensation AN ARTICULATION LOCK," which is hereby incorporated by reference in its entirety. The interchangeable shaft assembly 150200 can include a proximal housing or nozzle 150201 comprised of

nozzle portions

150202, 150203. The interchangeable shaft assembly 150200 can include a closure tube 150260 that extends along a shaft axis SA that can be utilized to close and/or open an anvil 150306 of the end effector 150300.

Turning again to FIG. 25, the closure tube 150260 is translated distally (direction "DD") to close the anvil 150306, for example, in response to actuation of the closure trigger 150032, in the 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 a proximal position.

Fig. 27 is another exploded assembly view of portions of an interchangeable shaft assembly 150200 in accordance with at least one aspect of the present disclosure. The interchangeable shaft assembly 150200 can include a firing member 150220 that is supported for axial travel within the spine 150210. The firing member 150220 includes an intermediate firing shaft 150222 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 may include a longitudinal slot 150223 in a distal end configured to receive the tab 150284 on the proximal end 150282 of the knife bar 150280. The longitudinal slot 150223 and proximal end 150282 may be configured to allow relative movement therebetween and may include a slip joint 150286. The slip joint 150286 can 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 side wall of the longitudinal slot 150223 contacts the tab 150284 to advance the knife bar 150280 and fire a 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 may engage the shaft frame 150212 to enclose the intermediate firing shaft 150222 and knife bar 150280 therein. Operation of the firing member 150220 can be found in U.S. patent application publication No. 2014/0263541. The ridge 150210 can be configured to slidably support a firing member 150220 and a closure tube 150260 that extends around the ridge 150210. The spine 150210 may slidably support the articulation driver 150230.

The interchangeable shaft assembly 150200 can 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 accordingly, proximal movement of the firing member 150220 may move the articulation driver 150230 proximally. When the locking sleeve 150402 is in the disengaged position, motion of the firing member 150220 is not transmitted to the articulation driver 150230; and thus, the firing member 150220 may move independently of the articulation driver 150230. The nozzle 150201 may be used to operably engage and disengage an articulation drive system from a firing drive system in a variety of ways described in U.S. patent application publication No. 2014/0263541.

Interchangeable shaft assembly 150200 can include a slip ring assembly 150600 that can be configured to conduct electrical power to and/or from the end effector 150300, and/or communicate signals to and/or from the end effector 150300, for example. Slip ring assembly 150600 may include a proximal connector flange 150604 and a distal connector flange 150601 positioned within slots defined in

nozzle portions

150202, 150203. The proximal connector flange 150604 may include a first face and the distal connector flange 150601 may include a second face positioned adjacent to and movable relative to the first face. The distal connector flange 150601 is rotatable about an axis SA-SA (fig. 25) relative to the proximal connector flange 150604. The proximal connector flange 150604 may include a plurality of concentric or at least substantially concentric conductors 150602 defined in a first face thereof. The connector 150607 may be mounted on a proximal side of the distal connector flange 150601 and may have a plurality of contacts, where each contact corresponds to and is in electrical contact with one of the conductors 150602. This arrangement allows 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 may include an electrical connector 150606 that may, for example, place a conductor 150602 in signal communication with the axle 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 hereby incorporated by reference in its entirety. U.S. patent application publication No.2014/0263552, entitled STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM, is hereby incorporated by reference in its entirety. More details regarding slip ring assembly 150600 may be found in U.S. patent application publication No. 2014/0263541.

The interchangeable shaft assembly 150200 can include a proximal portion that can be fixedly mounted to the handle assembly 150014, and a distal portion that can rotate about a longitudinal axis. The rotatable distal shaft portion may be rotatable relative to the proximal portion about the slip ring assembly 150600. The distal connector flange 150601 of 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, according to at least one aspect of the present disclosure. The end effector 150300 may include an anvil 150306 and a surgical staple cartridge 150304. An anvil 150306 may be coupled to the elongate channel 150302. Holes 150199 may be defined in the elongate channel 150302 to receive pins 150152 extending from the anvil 150306 to allow the anvil 150306 to pivot relative to the elongate channel 150302 and surgical staple cartridge 150304 from an open position to a closed position. The firing bar 150172 is configured to translate longitudinally into the end effector 150300. The firing bar 150172 may be constructed of one solid section or may comprise a laminate material 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. A distal protruding end of the firing bar 150172 may be attached to the I-beam 150178 to help space the anvil 150306 away 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 as the I-beam 150178 is advanced distally through the firing bar 150172. In operation, the I-beam 150178 may fire the surgical staple cartridge 150304. The surgical staple cartridge 150304 can comprise a molded cartridge body 150194 that holds a plurality of staples 150191 disposed on staple drivers 150192 that are located in respective upwardly open staple cavities 150195. The wedge sled 150190 is driven distally by the I-beam 150178 to slide over the cartridge tray 150196 of the surgical staple cartridge 150304. The wedge sled 150190 cams the staple drivers 150192 upward to extrude the staples 150191 into deforming contact with the anvil 150306 while the cutting edges 150182 of the I-beam 150178 sever the clamped tissue.

The I-beam 150178 can include upper pins 150180 that engage the anvil 150306 during firing. The I-beam 150178 can comprise a middle pin 150184 and a bottom base 150186 that engage portions of the cartridge body 150194, the cartridge tray 150196, and the elongate channel 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 engage a groove extending along the bottom surface of the elongate channel 150302 along the length of the slot 150189, the middle pin 150184 can engage the top surface of the cartridge tray 150196 along the length of the longitudinal slot 150197, and the upper pin 150180 can engage the anvil 150306. The I-beam 150178 may space 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 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, thereby 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 can include a motor 150714 that can be controlled by a motor driver 150715 and can be used by the firing system of the surgical instrument 150010. In various forms, the motor 150714 may be a direct current brushed driving motor having a maximum rotational speed of about 25,000 RPM. In other arrangements, the motor 150714 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 150715 may include, for example, an H-bridge driver including a Field Effect Transistor (FET) 150719. The motor 150714 may 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 power assembly 150706 may be replaceable and/or rechargeable. In at least one example, the battery cell may be a lithium ion battery that is detachably coupled to the power assembly 150706.

The shaft assembly 150704 can include a shaft assembly controller 150722 that can communicate with the safety controller and power management controller 150716 through an interface when the shaft assembly 150704 and 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 shaft assembly controller 150722 and power management controller 150716 when shaft assembly 150704 and power assembly 150706 are coupled to handle assembly 150702. One or more communication signals may be transmitted over 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 power assembly 150706 according to the power requirements of attachment 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 the master controller 150717 located in the handle assembly 150702, whereby such communication signals may be facilitated to be communicated between the power management controller 150716 and the shaft assembly controller 150722. In other instances, 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 master controller 150717 may be any single-core or multi-core processor, such as those available under the trade name ARM Cortex from Texas instruments, Inc. (Texas instruments). In one aspect, master controller 150717 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments (Texas Instruments), which includes: 256KB of on-chip memory of Single cycle flash or other non-volatile memory (up to 40MHz), prefetch buffer to improve performance beyond 40MHz, 32KB of Single cycleSerial Random Access Memory (SRAM) loaded with

Internal Read Only Memory (ROM) for software, Electrically Erasable Programmable Read Only Memory (EEPROM) for 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 (ADCs) 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 by Texas Instruments under the trade name Hercules ARM Cortex R4. The safety controller can be configured to be dedicated to IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety 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 sense circuit 150736. When shaft assembly 150704 and power assembly 150706 are coupled to handle assembly 150702, the power management circuitry may be configured to regulate the power output of the battery based on the power requirements of shaft assembly 150704. The power management controller 150716 may be programmed to control the power modulator 150738 to regulate the power output of the power component 150706, and the current sensing circuit 150736 may 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, so that the power management controller 150716 may regulate the power output of the power component 150706 to maintain a desired output. The power management controller 150716 and/or the axle 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) may include an output device 150742 that may include a 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 tactile feedback devices (e.g., haptic actuators). In some instances, the output device 150742 may include a display 150743, which may be included in the handle assembly 150702. The shaft assembly controller 150722 and/or power management controller 150716 may provide feedback to a user of the surgical instrument 150010 via an output device 150742. The interface may be configured to be able to connect the axle assembly controller 150722 and/or the power management controller 150716 to the output device 150742. Alternatively, the output device 150742 may be integrated with the power assembly 150706. In such instances, 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 enabled through the interface.

The control circuit 150700 includes a circuit segment configured to control the operation of the powered surgical instrument 150010. The safety controller segment (segment 1) includes a safety controller and main controller 150717 segment (segment 2). The safety and/or main controllers 150717 are configured to be able to interact 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 main controller 150717. The main controller 150717 is also coupled to flash memory. The main controller 150717 also includes a serial communication interface. The main controller 150717 includes a number of inputs coupled to, for example, one or more circuit segments, a battery, and/or a number 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 is to be understood that the term "processor" as used herein includes any microprocessor, processor, microcontroller, controller or other basic computing device that combines the functions of a computer's Central Processing Unit (CPU) onto one integrated circuit or at most a few integrated circuits. The master controller 150717 is a multipurpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and provides results as output. Because the processor has internal memory, it is an example of sequential digital logic. The control circuitry 150700 may be configured to enable one or more of the processes described herein.

The acceleration segment (segment 3) includes an accelerometer. The accelerometer is configured to detect movement or acceleration of the powered surgical instrument 150010. Inputs from the accelerometer can be used, for example, to transition to and from sleep modes, identify the orientation of the powered surgical instrument, and/or identify when the surgical instrument has been dropped. In some examples, the acceleration segment is coupled to 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 an interchangeable shaft assembly 150200 (fig. 25 and 27) coupled to the surgical instrument 150010 (fig. 25-28) and/or one or more controls for an end effector 150300 coupled to the interchangeable shaft assembly 150200. The shaft segment includes a shaft connector configured to couple the main controller 150717 to the shaft PCBA. The shaft PCBA includes a low power microcontroller 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 that are 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 plurality 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) comprises one or more magnetic angular rotary position encoders. The one or more magnetic angular rotational position encoders are configured to identify the rotational position 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, a magnetic angular rotational position encoder may be coupled to the safety controller and/or the master 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). Motor 150714 is coupled to main microcontroller processor 150717 by an H-bridge driver and motor controller that includes one or more H-bridge Field Effect Transistors (FETs). The H-bridge driver is also coupled to the safety controller. A motor current sensor is coupled in series with the motor for measuring a current draw of the motor. The motor current sensor is in signal communication with the master 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 state and position of the motor 150714 to the master controller 150717. The main controller 150717 provides a Pulse Width Modulated (PWM) high signal, a PWM low signal, a direction signal, a synchronization signal, and a motor reset signal to the motor controller through a buffer. The power segment is configured to provide a segment voltage to each of the circuit segments.

The power section (section 8) includes a battery coupled to a safety controller, a main controller 150717 and additional circuit sections. The battery is coupled to the segmented circuit by 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 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 operations and is capable of preventing a reduced voltage condition or a low power condition.

A plurality of switches are coupled to the safety controller and/or the main controller 150717. These switches may be configured to control operation of the surgical instrument 150010 (fig. 25-28), to segment operation of the circuit, and/or to indicate a state of the surgical instrument 150010. An emergency door switch and hall effect switch for an emergency are configured to indicate a status of the emergency door. A plurality of articulation switches (such as a left articulation switch, a left right articulation switch, a left center articulation switch, a right left articulation switch, a right articulation switch, and a right 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 hand and right hand side reversing switches are coupled to a main controller 150717. The left switches (including the left articulation switch, the left right articulation switch, the left center articulation switch, and the left direction switch) are coupled to a master controller 150717 through a left flex connector. The right switches (including the right left articulation switch, the right articulation switch, the right center articulation switch, and the right reversing switch) are coupled to a master controller 150717 through a right flex connector. The firing switch, clamp release switch, and shaft engagement switch are associated with a 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 by 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 consisting of an actuator mechanically connected to a set of contacts. When an object comes into contact with the actuator, the device operates the contacts to make or break the electrical connection. The limit switch is durable, simple and convenient to install, reliable in operation and suitable for various applications and environments. The limit switches can determine the presence or absence, the passage, the location, and the end of travel of the object. In other implementations, the switches may be solid state switches that operate under the influence of a magnetic field, such as hall effect devices, Magnetoresistive (MR) devices, Giant Magnetoresistive (GMR) devices, magnetometers, and 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 switches may be solid state devices such as transistors (e.g., FETs, junction FETs, metal oxide semiconductor FETs (mosfets), bipolar transistors, 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 illustrating 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

axle 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 power assembly 150706 are coupled to the handle assembly 150702. The power management controller 150716 may be programmed to control the power modulator 150738 to regulate the power output of the power component 150706, and the current sensing circuit 150736 may 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 may 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 the non-volatile memory 150721 and the shaft assembly connector 150728 to electrically couple the shaft assembly 150704 to the handle assembly 150702. The axle assembly connectors 150726, 150728 form an interface 150725. The master controller 150717, the axis processor 150720, and/or the power management controller 150716 may be configured to enable one or more of the processes described herein.

The surgical instrument 150010 (fig. 25-28) may include an output device 150742 for providing sensory feedback to the user. Such devices may include visual feedback devices (e.g., LCD display screens, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., haptic actuators). In some instances, the output device 150742 may include a display 150743, which may be included in the handle assembly 150702. The shaft assembly controller 150722 and/or power management controller 150716 may provide feedback to a user of the surgical instrument 150010 via an output device 150742. Interface 150727 may be configured to enable connection of axle assembly controller 150722 and/or power management controller 150716 to output device 150742. The output device 150742 may be integrated with the power assembly 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 accomplished through the interface 150725. Having described the control circuit 150700 (fig. 29A, 29B, and 6) for controlling the operation of the surgical instrument 150010 (fig. 25-28), the present disclosure now turns to various configurations of the surgical instrument 150010 (fig. 25-28) and the control circuit 150700.

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

Referring to fig. 34, various forces can be applied to the tissue 151032 by the end effector 151030. For example, as the tissue 151032 is compressed between the anvil 151034 and the channel frame 151036 of the end effector 151030, perpendicular 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 the end effector. For example, it is known that vertical or lateral compression may allow the end effector to more accurately or precisely perform stapling operations or may inform the operator of the surgical stapler so that the surgical stapler can be used more correctly or safely.

The compression across tissue 151032 can be determined from the impedance of the tissue 151032. At various levels of compression, the impedance Z of the tissue 151032 can increase or decrease. By applying a voltage V and a current I to the tissue 151032, the impedance Z of the tissue 151032 can be determined at various levels of compression. 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, the RF electrode 151038 can be positioned on the end effector 151030 (e.g., on a cartridge, knife, or channel frame of the end effector 151030). In addition, electrical contacts 151040 can be positioned on the anvil 151034 of the end effector 151030. In one aspect, the electrical contacts can be positioned on a channel frame of the end effector. As the tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. The vertical tissue compression 151042 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, when positioning the RF electrode 151038, the electrical contacts 151044 can be positioned on opposing ends of the anvil 151034 of the end effector 151030. As the tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the 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 the anvil 151034 and electrical contacts 151052 can be positioned on opposing ends of the end effector 151030 at the channel frame 151036. The RF electrode 151048 can be positioned transverse to the center of the end effector 151030. As the tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. Lateral compression 151054 or angular compression 151056 on either side of RF electrode 151048 may be induced by end effector 151030 and may be measured as a function of the 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, frequency generator 151222 may receive power or current from power source 151221 and may 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 the 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 filter 151230 or 151232) may be communicatively coupled to

electrical contacts

151226 or 151228. The filters 151230 and 151232 may filter one or more RF signals provided by the frequency generator 151222 prior to joining the 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

electrical contacts

151226 or 151228.

Still referring to fig. 39, the various components of the tissue compression sensor systems described herein may be located in a handle 151236 of a surgical stapler. For example, as shown in circuit diagram 151220a, the frequency generator 151222 may be located in the handle 151236 and receive power from the power source 151221. Additionally, current I1 and current I2 may be measured on the return path 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 the formulas Z1-V/I1 and Z2-V/I2 may calculate impedances Z1 and Z2 corresponding to different levels of compression of tissue compressed by the end effector.

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. As such, two or more RF signals may be superimposed (or, e.g., nested or modulated together) and transmitted to the end effector. The one or more RF signals can power one or more RF electrodes 151260 at an end effector 151262 (e.g., positioned in a staple cartridge) of the surgical stapler. Tissue (not shown) may be compressed and/or communicatively coupled between one or more of RF electrodes 151260 and one or more electrical contacts. For example, tissue can be compressed and/or communicatively coupled between one or more RF electrodes 151260 and electrical contacts 151264 positioned in a channel frame of the end effector 151262 or electrical contacts 151266 positioned in an anvil of the end effector 151262. The filter 151268 may be communicatively coupled to the electrical contact 151264, and the filter 151270 may 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 system 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, non-volatile memory 151276, and communication channel 151278 may be located in shaft 151258. In one example, the frequency generator 151254, the impedance calculator 151272, the controller 151274, the non-volatile memory 151276, and the communication channel 151278 may 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, the two or more RF signals may be filtered prior to being joined on the common path to distinguish individual tissue impedances represented by the two or more RF signals. Current I1 and current I2 may be measured on the return path corresponding to

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 the formulas Z1-V/I1 and Z2-V/I2 may calculate impedances Z1 and Z2 corresponding to different compressions of tissue compressed by the end effector 151262. In an example, the impedances Z1 and Z2 may be calculated by the impedance calculator 151272. The impedances Z1 and Z2 can be used to calculate various levels of compression of the tissue.

Referring now to fig. 41, a frequency plot 151290 is shown. The frequency plot 151290 illustrates frequency modulation of nested two RF signals. As described above, the two RF signals can be nested before reaching the RF electrode at the end effector. For example, an RF signal having a frequency 1 and an RF signal having a frequency 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. The frequency plot 151400 shows the RF signal having frequency 1 and frequency 2 after being filtered (through, for example, filters 151268 and 151270). The resulting RF signal may be used for a separate impedance calculation or measurement on the return path, as described above.

In one aspect, the

filters

151268 and 151270 may be high Q filters such that the filter range may be 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 300 kHz. A feasible impedance measurement range may be 100kHz-20 MHz. 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 a staple cartridge or an isolated knife of an end effector may be used to simultaneously make multiple tissue compression measurements. If two or more RF signals are superimposed or multiplexed (or nested or modulated), they may be transmitted down a single power side of the end effector and may 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 versus lateral tissue compression. This method may also provide proximal and distal tissue compression depending on the placement of the filter and the location of the metal loop. 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, the details of operation and construction are not repeated here for the sake of convenience and clarity. In one aspect, the sensing system includes a visco-elastic/rate of change sensing system to monitor blade acceleration, rate of change of impedance, and rate of change of tissue contact. In one example, the rate of change of blade acceleration may be used as a measure of tissue type. In another example, the rate of change of impedance may be measured with an impulse sensor and may be used as a measure of compressibility. Finally, a sensor based on the firing rate of the knife 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 stated otherwise, how long it takes for the tissue parameter to reach the asymptotic steady state value, is itself a separate measurement and may be more valuable than the sensed parameter from which it was derived. To enhance the measurement of tissue parameters, such as waiting a predetermined amount of time before making a measurement, the present disclosure provides a novel technique for deriving from the measurement, such as the rate of change of a tissue parameter.

Derivative techniques or rate of change measurements become most useful, it being understood that no separate measurement exists that can be taken alone to significantly improve staple formation. The combination of multiple measurements makes the measurement efficient. In the case of a tissue gap, it is helpful to know how much of the jaws are covered by tissue to correlate the gap measurement. The rate of change measurement of impedance can be combined with a strain measurement in the anvil to correlate 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 thicknesses and even similar compression characteristics 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 either of these measurements is used alone, the endoscopic surgical device may have difficulty distinguishing one tissue type from another. The rate of change of compression may also help the device determine whether the tissue is "normal" or whether there are some abnormalities. Not only is it measured how much time has elapsed, but also the change in the sensor signal is measured and a derivative of the signal is determined to provide another measurement to enable the endoscopic surgical device to measure the signal. The rate of change information can 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 can 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. A surgical instrument, 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 jaw covered by tissue, anvil strain and trigger force, and the like. These sensed measurements are important for the automatic control of the surgical instrument and to provide 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. The motor current may be monitored using a current sensor in series with the battery 2308.

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 configured and equipped with the motor-driven surgical cutting and fastening instrument 150010 described in connection with fig. 25-30. In the example shown in fig. 44, instrument 151310 includes a housing 151312 that includes a handle assembly 151314 configured to be grasped, manipulated and actuated by a clinician. Housing 151312 is configured for operable attachment to an interchangeable shaft assembly 151500 having a surgical end effector 151600 operably coupled thereto that is configured to perform one or more surgical tasks or procedures. Because the motor-driven surgical cutting and fastening instrument 151310 is similarly configured and equipped with the motor-driven surgical cutting and fastening instrument 150010 described in connection with fig. 25-30, details of operation and construction will not be repeated here for the sake of convenience and clarity.

Fig. 44 depicts housing 151312 shown in conjunction with an interchangeable shaft assembly 151500 that includes an end effector 151600 that includes a surgical cutting and fastening device configured to operably support a surgical staple cartridge 151304 therein. Housing 151312 may be configured for use in conjunction with an interchangeable shaft assembly that includes an end effector that is adapted to support different sizes and types of staple cartridges, have different shaft lengths, sizes, types, etc. Additionally, housing 151312 can also be used effectively 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. Further, 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 illustrated arrangement, the handle housing forms a pistol grip 151319 that can be grasped and manipulated by a 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 that is configured to operably support a staple cartridge 151304 therein. The end effector 151600 may also include an anvil 151306 that is pivotally supported relative to the elongate channel 151302.

The inventors have discovered that derived parameters may be even more useful for controlling a surgical instrument (such as the instrument shown in fig. 44) than the one or more sensed parameters upon which the derived parameters are based. Non-limiting examples of derived 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 asymptotic 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 the 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 (calcified versus normal), and surgical device operating status (e.g., clamping complete). The distinct viscoelastic properties and distinct rates of change of the different tissues make these and other parameters discussed herein useful markers for monitoring and automatically adjusting the surgical procedure.

FIG. 46 is an exemplary graph illustrating the change in gap distance over time, where gap is the spacing between the jaws occupied by clamped tissue. The vertical (y) axis is distance and the horizontal (x) axis is time. Specifically, referring to fig. 44 and 45, the gap distance 151340 is the distance between the anvil 151306 and the elongate channel 151302 of the end effector. 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 with closure of the anvil 151306, such as during tissue clamping. The rate of change of gap distance may vary because the tissue has uneven 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 viscoelastic properties of the tissue may cause the rate of change to decrease until the tissue cannot be compressed further, at which time the gap distance will remain substantially constant. As tissue is squeezed 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 sensors, may be adapted and configured to measure the gap distance "d" between the anvil 151306 and the staple cartridge 151304 as a function of time "t," as represented graphically in fig. 46. The rate of change of the gap distance "d" with time "t" is the slope of the curve shown in fig. 46, where the slope is Δ d/Δ t.

FIG. 47 is an exemplary graph illustrating firing current of end effector jaws. The vertical (y) axis is current, and the horizontal (x) axis is time. As described herein, the surgical instrument and/or microcontroller thereof may include a current sensor that detects the current utilized during various operations (such as clamping, cutting, and/or stapling tissue), as shown and described in connection with fig. 25. For example, as 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 low, 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 high at time zero, but decreases over time. During operation of other devices, the current may increase over time if the motor consumes more current to overcome the increasing mechanical load. In addition, the rate of change of firing current may be used as an indicator of tissue transition from one state to another. Thus, the firing current, and in particular the rate of change of the firing current, may be used to monitor device operation. As the knife cuts through tissue, the impinging power flow decreases over time. The rate of change of the firing current may vary if the tissue being cut provides more or less resistance due to the tissue properties 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. While the knife 151305 is firing, a current sensor may 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 the motor current. The current sensor may be adapted and configured to measure a motor firing current "i" as a function of time "t", as represented graphically in fig. 47. The rate of change of the firing current "i" with time "t" is the slope of the curve shown in fig. 47, where the slope is Δ i/Δ t.

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 and the staple cartridge 151304 of the end effector 151340 is severed by a knife or sealed using RF energy between electrodes located between the anvil 151306 and the staple cartridge 151304 of the end effector 151340. 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. Additionally, 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. The electrical impedance increases as the energy passing through the tissue dries the tissue by evaporating water from the tissue. Eventually, when the appropriate 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 rates, that differentiate 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 the anvil 151306 and the staple cartridge 151304. The time varying tissue compression/impedance of the tissue between the anvil 151306 and the 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 capable of measuring tissue impedance "Z" as a function of time "t", as graphically represented in fig. 48.

Fig. 49 is an exemplary plot of anvil 151306 (fig. 44, 45) strain over time. The vertical (y) axis is strain and the horizontal (x) axis is time. During stapling, for example, the anvil 151306 strain is initially higher but decreases as the tissue reaches steady state and less pressure is applied to the anvil 151306. The rate of change of the anvil 151306 strain may be measured by pressure sensors or strain gauges 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 may be measured over time as graphically represented in fig. 49. The rate of change of strain "S" with time "t" is the slope of the curve shown in fig. 49, where the slope is Δ S/Δ t.

FIG. 50 is an exemplary graph of trigger force over time. The vertical (y) axis is the trigger force and the horizontal (x) axis is time. In some examples, the trigger force is gradual 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 increase 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 the trigger 151302 of the handle 151319 of the instrument 151310 (fig. 44) to measure the force required to drive the knife 151305 (fig. 45) through tissue grasped between the anvil 151306 and the staple cartridge 151304. The time-varying force of trigger 151332 may be measured, as graphically represented in fig. 50. The rate of change of the strain trigger force "F" over time "t" is the slope of the curve shown in fig. 50, where the slope is Δ F/Δ t.

For example, even though the stomach and lung tissues may have similar thicknesses, these tissues may be distinguished, and if the lung tissue is calcified, these tissues may have similar compression characteristics. Gastric and pulmonary tissue can be distinguished by analyzing the 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 for various tissues. The vertical (y) axis is tissue pressure and the horizontal (x) axis is tissue displacement. When the tissue pressure reaches a predetermined threshold, such as 50-100 pounds per square inch (psi), the amount of tissue displacement and the rate at which the tissue displacement precedes the threshold may be used to differentiate tissue. For example, vascular tissue reaches a predetermined pressure threshold with less 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 nearly 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 understood 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. In addition, multiple thresholds or progressive thresholds may be used to provide further resolution of tissue types having similar viscoelastic properties.

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 can be used to diagnose and/or differentiate calcified lung tissue from normal lung tissue.

Furthermore, certain sensed measurements may benefit from additional sensory inputs. For example, in terms of jaw gap, knowing how much jaw is covered by tissue can make gap measurements more useful and accurate. If a small portion of the jaws is covered in tissue, the tissue compression may appear to be less than if the entire jaws were covered in tissue. Thus, the amount of jaw coverage may 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 the sensed parameters and derivative parameters (e.g., rate of change), provides more useful information. For example, if the rate of change of the jaw gap 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 can 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 phase (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 measuring the compression value. For example, if the lung calcifies, the stomach and lung sometimes have similar thicknesses, and even similar compression characteristics.

The combination of one or more sensed parameters with 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 an 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 152008 a. The first sensor 152008a is configured to measure one or more parameters of the end effector 152000. For example, in one embodiment, the first sensor 152008a is configured to measure a gap 152010 between the anvil 152002 and the second jaw member 152004. The first sensor 152008a can comprise, for example, a hall effect sensor configured to detect a magnetic field generated by a magnet 152012 embedded in the second jaw member 152004 and/or staple cartridge 152006. As another example, in one embodiment, the first sensor 152008a is configured to measure one or more forces exerted on the anvil 152002 by the second jaw member 152004 and/or tissue clamped between the anvil 152002 and the second jaw member 152004.

The end effector 152000 includes a second sensor 152008 b. 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 an amount of strain in the anvil 152002 during a clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. In various embodiments, first sensor 152008a and/or 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 end effector 152000. The first sensor 152008a and the second sensor 152008b may be arranged in a series configuration and/or a parallel configuration. In a series configuration, the second sensor 152008b can be configured to directly affect the output of the first sensor 152008 a. In a parallel configuration, the second sensor 152008b can be configured to indirectly affect the output of the 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 152008 b. For example, in one embodiment, the first sensor 152008a is configured to measure a gap 152010 between the anvil 152002 and the second jaw member 152004. The gap 152010 represents the thickness and/or compressibility of the section of tissue clamped between the anvil 152002 and the staple cartridge 152006. The first sensor 152008a can include, for example, a hall effect sensor configured to detect a magnetic field generated by the magnet 152012 coupled to the second jaw member 152004 and/or staple cartridge 152006. The measurement at a single location accurately describes the compressed tissue thickness of the corrected full bite of tissue, but may provide inaccurate results when a partial bite of tissue is disposed between the anvil 152002 and the second jaw member 152004. The partial occlusion of the tissue (proximal partial occlusion or distal partial occlusion) changes the clamping geometry of the anvil 152002.

In some embodiments, the second sensor 152008b is configured to be capable of detecting 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 includes a strain gauge, such as a micro-strain gauge, configured to monitor strain amplitude in the anvil during the clamped state. The strain amplitude of the anvil 152002 is used to modify the output of the first sensor 152008a (e.g., a hall effect sensor) to accurately represent the true compressed tissue thickness of the proximally or distally located partial bite. The first sensor 152008a and the second sensor 152008b may be measured in real time during the gripping operation. The real-time measurements allow time-based information to be analyzed, for example, by a host processor (e.g., processor 462 (fig. 12)) and used to select one or more algorithms and/or look-up tables from which to identify tissue characteristics and clamp positioning to dynamically adjust the tissue thickness measurements.

In some embodiments, the tissue measurements of the first sensor 152008a may be provided to an output device of the 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 of the first sensor 152008a is provided to a processor, e.g., a host processor. The primary processor adjusts the measurement of the first sensor 152008a based on the measurement of the second sensor 152008b to reflect the true tissue thickness of the section of tissue 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 occlusion to a display. The 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's body 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 include, for example, an environmental sensor. The environmental sensor may include, for example, a temperature sensor, a humidity sensor, a pressure sensor, and/or any other suitable environmental sensor.

Fig. 54 is a logic diagram illustrating one embodiment of a process 152020 for adjusting measurements 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 parameter. The second signal 152022b is captured by the second sensor 152008 b. The second signal 152022b may 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 engagement 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 for the first sensor 152008a based on input from the 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 parameter. The second signal 152022b is captured by the second sensor 152008 b. The second signal 152022b may 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 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 calibrating the first sensor 152008a in response to 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 parameter. The second signal 152022b is captured by the second sensor 152008 b. The second signal 152022b may 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 152022 b. The first signal 152022a is corrected 152042 to reflect the completeness of tissue engagement 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 section of tissue clamped between the anvil 152002 and the staple cartridge 152006 of the end effector 152000. The process 152050 includes obtaining a hall effect voltage 152052 by, for example, a hall effect sensor positioned at the distal tip 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 for 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 the strain exerted on the anvil 152002 during a clamping operation. The measured strain is converted 152060 to a digital signal and provided to a processor, such as a host processor. The primary processor adjusts the hall effect voltage 152052 using one or more algorithms and/or look-up tables in response to the strain measured by the strain gauge 152058 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 element 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 as described above). FIG. 58 is a logic diagram illustrating one embodiment of a process 152070 for determining and displaying the thickness of a section of tissue clamped between the anvil 152002 and the staple cartridge 152006 of the end effector 152000. The process includes obtaining a hall effect voltage 152072 by, for example, a hall effect sensor positioned at the distal tip of the 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 for the profile 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 the strain exerted on the anvil 152002 during a clamping operation. The measured strain is converted 152080 to a digital signal and provided to a processor, such as a host processor. The load sensor 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 host processor. The primary 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 cell 152082 to reflect the true thickness and bite completeness 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.

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 partial distal/proximal bite that results in an incorrect thickness measurement. Adjusted thickness measurements 152092 are generated by, for example, process 152050 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 tissue positioned between the anvil 152002 and the staple cartridge 152006.

Fig. 60 illustrates an 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 a gap 152110 between the anvil 152102 and the staple cartridge 152106. The gap 152110 may correspond to, for example, the thickness of tissue clamped between the anvil 152102 and the staple cartridge 152106. The first sensor 152108a may include any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152108a may 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.

In some embodiments, the end effector 152100 includes a second sensor 152108 b. A 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, the second sensor 152108b is configured to detect one or more instrument conditions, such as the color of the staple cartridge 152106 coupled to the second jaw member 152104, the length of the staple cartridge 152106, the clamping status of the end effector 152100, the number of uses/remaining uses of the end effector 152100 and/or staple cartridge 152106, and/or any other suitable instrument conditions. The second sensor 152108b may include any suitable sensor for detecting one or more instrument states, 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 may be used with any of the processes shown in fig. 54-57. For example, in one embodiment, input from the second sensor 152108b can be used to correct input of the first sensor 152108 a. The second sensor 152108b may be configured to detect one or more parameters of the staple cartridge 152106, such as the color and/or length of the staple cartridge 152106. The detected parameters, such as the color and/or length of the staple cartridge 152106, may 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 the staple cartridge 152106. Known parameters of the staple cartridge 152106 can be used to adjust the thickness measurements provided by the first sensor 152108 a. For example, if the staple cartridge 152106 has a higher deck height, the thickness measurement provided by the first sensor 152108a can be decreased to compensate for the increased deck height. The adjusted thickness may be displayed to an operator via, 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. The anvil 152152 can be pivotally moved relative to the second jaw member 152154 to clamp tissue between the anvil 152152 and the 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 a gap 152110 between the anvil 152152 and the staple cartridge 152156. The gap 152110 may correspond to, for example, the thickness of tissue clamped between the anvil 152152 and the staple cartridge 152156. The first sensor 152158 may include any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152158 may 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.

In some embodiments, the end effector 152150 includes a plurality of

second sensors

152160a, 152160 b. 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 be capable of measuring the amplitude of the strain applied to the anvil 152152 during the clamping procedure. In various embodiments, the

second sensors

152160a, 152160b may include 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. The

second sensors

152160a, 152160b may be configured to measure one or more of the same parameters at different locations of the anvil 152152, different parameters at the same locations 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 measurements of a first sensor 152158 in response to a plurality of

second sensors

152160a, 152160 b. In one embodiment, the 152172 hall effect voltage is obtained, for example, by a hall effect sensor. The hall effect voltage is converted 152174 by an analog to digital converter. The converted hall effect voltage signal is corrected 152176. The correction curve represents the thickness of a section of tissue positioned between the anvil 152152 and the staple cartridge 152156. A plurality of

second measurements

152178a, 152178b are obtained by a plurality of second sensors, such as a plurality of strain gauges. The input of the Strain gauge is converted 152180a, 152180b into one or more digital signals, e.g. by a plurality of electronic mu Strain conversion circuits. The corrected hall effect voltage and the plurality of second measurements are provided to a processor, such as a host 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 the anvil 152152 and staple cartridge 152156 and the completeness of the occlusion. 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 be capable of converting 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 host processor. Circuit 152190 includes an analog-to-digital converter 152194. In some embodiments, analog-to-digital converter 152194 includes a 4-channel, 18-bit analog-to-digital converter. Those skilled in the art will recognize that analog-to-digital converter 152194 may include 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 be able to receive input from a first sensor 152158 (such as a hall effect sensor). The level shifting resistor 152196 adjusts the input from the first sensor, thereby shifting the value to a higher or lower voltage depending on the input. The level shift resistor 152196 provides a level shifted input from the first sensor 152158 to the analog to digital converter.

In some embodiments, the plurality of

second sensors

152160a, 152160b are coupled to a plurality of bridges 152192a, 152192b within the circuit 152190. The plurality of bridges 152192a, 152192b may provide filtering for inputs from the plurality of

second sensors

152160a, 152160 b. After filtering the input signals, 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 embodiments, a switch 152198 coupled to one or more level shifting resistors may 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 may be used to provide one or more level shifted signals to adjust the input of one or more of the sensors, such as to correct the input of the hall effect sensor accordingly. In some embodiments, no adjustment is necessary, and switch 152198 remains in the open position to disengage the level shifting resistor. Switch 152198 is coupled to analog-to-digital converter 152194. The analog-to-digital converter 152194 provides an output to one or more processors, such as a host processor. The main processor calculates one or more parameters of the end effector 152150 based on input from the analog-to-digital converter 152194. For example, in one embodiment, the primary processor calculates the thickness of tissue positioned between the anvil 152152 and the staple cartridge 152156 based on input 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-152208 d. 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. The 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 may include one or more of the same sensor and/or different sensors. The plurality of sensors 152208a-152208d may include, for example, magnetic sensors (such as hall effect sensors), strain gauges, pressure sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensor or combination thereof. For example, in one embodiment, the plurality of sensors 152208a-152208d may include a plurality of strain gauges.

In one embodiment, the plurality of sensors 152208a-152208d allow for a robust tissue thickness sensing process. 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 the occlusion, e.g., partial occlusion or full occlusion. 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 strain amplitude and/or slope at each of the various points on the anvil 152202 may 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 optimize maximum amplitude and/or slope difference based on clamping dynamics to determine thickness, tissue placement, and/or material properties of the tissue. The time-based monitoring of the plurality of sensors 152208a-152208d during clamping allows a processor (such as a master processor) to utilize algorithms and look-up tables to identify tissue characteristics and clamping positions and dynamically adjust the end effector 152200 and/or the 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 properties 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 into digital signals and provided to a processor. For example, in one embodiment that includes multiple Strain gauges, multiple electronic μ Strain conversion circuits convert 152224a-152224d the Strain gauge signals into digital signals. The digital signal is provided to a processor, such as a host processor. The host 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 properties are displayed 152026 to the operator via, for example, a display embedded in the surgical instrument 150010.

Fig. 66 illustrates an embodiment of an end effector 152250 including 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. The anvil 152252 can be moved relative to the second jaw member 152254 to clamp one or more materials therebetween, such as tissue segments 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 a gap 152110 between the anvil 152252 and the staple cartridge 152256. The gap 152110 may correspond to, for example, the thickness of tissue clamped between the anvil 152252 and the staple cartridge 152256. The first sensor 152258 may include any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152258 may 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.

A plurality of second sensors 152260a-152260d are coupled to the second jaw member 152254. The plurality of second sensors 152260a-152260d may be integrally formed with the second jaw member 152254 and/or the 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 section of tissue 152264 clamped between the anvil 152252 and the staple cartridge 152256. The plurality of second sensors 152260a-152260d may include any suitable sensor for detecting one or more parameters of the end effector 152250 and/or tissue section 152264, such as, 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 or combination thereof. The plurality of second sensors 152260a-152260d may 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 include electrodes and/or sensing geometries configured to enable a stable tissue state when the plurality of second sensors 152260a-152260d are engaged with the tissue section 152264, for example, during a clamping operation. In some embodiments, one or more of the plurality of second sensors 152260a-152260d may be replaced with a non-sensing tissue stabilizing element. The second sensors 152260a-152260d generate a stable tissue state by controlling tissue flow, staple deformation, and/or other tissue states during clamping, stapling, and/or other treatment processes.

FIG. 67 illustrates one embodiment of a staple cartridge 152270 including a plurality of sensors 152272a-152272h integrally formed therein. Staple cartridge 152270 includes multiple rows containing multiple apertures for storing staples therein. One or more of the apertures in the outboard row 152278 are replaced by one of a plurality of sensors 152272a-152272 h. A cutaway portion is shown to illustrate sensor 152272f coupled to sensor line 152276 b. The

sensor wires

152276a, 152276b may include a plurality of wires for coupling the plurality of sensors 152272a-152272h to one or more circuits of a surgical instrument, such as a surgical instrument 150010. In some embodiments, one or more of the plurality of sensors 152272a-152272h includes a dual purpose sensor and a tissue stabilization element having electrodes and/or sensing geometry configured to provide tissue stabilization. In some embodiments, the plurality of sensors 152272a-152272h may 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 feedback of stapling performance and/or 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 section 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 section of tissue 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 tissue segment 152264. Like the first sensor 152258, the second sensor 152260 may 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 host 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 adjusted signal may indicate, for example, the true thickness and bite completeness of the tissue section 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 including a plurality of

redundant sensors

152308a, 152308 b. The end effector 152300 includes a first jaw member or anvil 152302 that is pivotally coupled to a second jaw member 152304. Second jaw member 152304 is configured to receive staple cartridge 152306 therein. The anvil 152302 may be moved relative to the staple cartridge 152306 to capture material (such as tissue sections) between the anvil 152302 and the 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 section of tissue 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 may correspond to, for example, the thickness of tissue positioned between the anvil 152302 and the staple cartridge 152306. The plurality of

sensors

152308a, 152308b can detect the gap 152310 by, for example, detecting a magnetic field generated by the magnet 152312 coupled to the second jaw member 152304.

In some embodiments, the plurality of

sensors

152308a, 152308b includes redundant sensors. The 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 sensors may comprise, for example, hall effect sensors configured to detect a gap 152310 between the anvil 152302 and the staple cartridge 152306. The redundant sensors provide signals representative of one or more parameters, allowing a processor (e.g., a main 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 can be measured in real time during clamping, thereby allowing time-based information to be analyzed and algorithms and/or look-up tables utilized to dynamically identify tissue characteristics and clamp location. The input of one or more of the redundant sensors may be adjusted and/or selected to identify the true tissue thickness and the bite of a section of tissue 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 outputs from a plurality of redundant sensors, such as the plurality of

sensors

152308a, 152308b shown in fig. 69. In one embodiment, the first signal is generated by the first sensor 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 host 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, an input from another sensor, and/or an instrument state. After selecting the most reliable output, the processor may adjust the output based on one or more additional sensors to reflect, for example, the true thickness and bite of the section of tissue 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 pivotally 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 section of tissue 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 a gap 152364 between the anvil 152352 and the staple cartridge 152356. The gap 152364 may correspond to a thickness of a material (such as a tissue section) and/or a bite integrity of the material positioned between the anvil 152352 and the staple cartridge 152356. Sensor 152358 may include any suitable sensor for detecting one or more parameters of end effector 152350, such as, 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 the electromagnetic source 152360 coupled to the second jaw member 152354 and/or staple cartridge 152356. The electromagnetic source 152360 generates a magnetic field that is detected by the sensor 152358. The strength of the detected magnetic field may correspond to, for example, the thickness and/or the completeness of occlusion of the tissue positioned between the anvil 152352 and the staple cartridge 152356. In some embodiments, the electromagnetic source 152360 generates a signal of a known frequency (such as 1 MHz). In other embodiments, the signal generated by the electromagnetic source 152360 can be adjusted based on, for example, the type of staple cartridge 152356 installed in the 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 be able to process the signal generated by the sensor 152358 to eliminate glitches and enhance the input from the sensor 152358. In some embodiments, the signal processor 152362 may 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 an algorithm executed by a general purpose processor (such as a host processor). The signal processor 152362 is configured to be able to process a signal from the sensor 152358 at a frequency that is substantially equivalent to the frequency of the signal generated by the electromagnetic source 152360. For example, in one embodiment, the electromagnetic source 152360 generates a signal at a frequency of 1 MHz. The signal is detected by 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 a signal processor 152362 at a frequency of 1MHz to remove glitches. The processed signal is provided to a processor, such as a host processor. The primary processor correlates the received signals to 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 generating thickness measurements of a section of tissue positioned between an anvil and a staple cartridge of an end effector (such as the 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 be able 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 into 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 may be performed by one or more circuits. The corrected signal is displayed 152026 to the user via, for example, a display integrally formed with the surgical instrument 150010.

Fig. 73 and 74 illustrate one embodiment of an end effector 152400 including 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 may be any of an optical sensor, a magnetic sensor, an electrical sensor, or any other suitable sensor.

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

Alternatively or in addition, the optical emitter and detector 152410 or another suitable sensor 152408 may 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 communicated 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 function of the instrument is not appropriate. In this case, the microcontroller may optionally be configured to disable the functionality that the surgical instrument 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 staple cartridge 152406 type, such as the length of the staple cartridge 152406, or information about the staples (such as height and length).

Fig. 75 illustrates an aspect of segmented flexible circuit 153430 configured to be fixedly attached to jaw member 153434 of an end effector. Segmented flexible circuit 153430 includes distal segment 153432a and

lateral segments

153432b, 153432c that include individually addressable sensors for providing local tissue presence detection. The

segments

153432a, 153432b, 153432c are individually addressable to detect tissue and measure tissue parameters based on a single sensor located within each of the

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 electrically conductive elements 153436. A hall effect sensor 153438 or any suitable magnetic sensor is located on the distal end of jaw member 153434. Hall effect sensor 153438 operates in conjunction with a magnet to provide a measurement of the aperture defined by jaw member 153434, which may also be referred to as tissue gap, as particularly shown in fig. 77. 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 segmented flexible circuit 153440 configured to be mounted to jaw member 153444 of an end effector. Segmented flex circuit 153440 includes a distal segment 153442a and

lateral segments

153442b, 153442c with individually addressable sensors for tissue control. The

segments

153442a, 153442b, 153442c are individually addressable to treat tissue and read individual sensors located within each of the

segments

153442a, 153442b, 153442 c.

Segments

153442a, 153442b, 153442c of segmented flex circuit 153440 are mounted to jaw member 153444 and electrically coupled to an energy source through electrically conductive elements 153446. A hall effect sensor 153448 or other suitable magnetic sensor is disposed on the distal end of jaw member 153444. Hall effect sensor 153448 operates in conjunction with a magnet to provide a measurement of the aperture or tissue gap defined by jaw member 153444 of the end effector, as particularly shown in fig. 77. Additionally, a plurality of laterally

asymmetric temperature sensors

153450a, 153450b are mounted on or integrally formed with segmented flex circuit 153440 to provide tissue temperature feedback to the control circuit. 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 device configured to measure tissue gap G_T An end effector 153460. End effector 153460 includes jaw member 153462 and jaw member 153444. Flexible circuit 153440, depicted in fig. 76, is mounted to jaw member 153444. The flexible circuit 153440 includes a hall effect sensor 153448 that operates in conjunction with a magnet 153464 mounted to the jaw member 153462 to measure the tissue gap G_T. This technique can be used to measure the hole 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 including a segmented flex circuit 153468. End effector 153470 includes a jaw member 153472 and a staple cartridge 153474. Segmented flexible 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 is indicative of tissue regions 1-5. In the configuration illustrated 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 illustrated in FIG. 78, wherein jaw member 153472 clamps tissue 153476 between jaw member 153472 (e.g., an 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 of tissue (empty) is detected in segment 153469 by segments 4-5. Information regarding the presence and absence of tissue 153476 located within certain segments 1-3 and 4-5, respectively, is communicated to the control circuitry as described herein via, for example, interface circuitry. The control circuitry is configured to detect tissue located in segments 1-3. It should be understood 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 knife (e.g., cutting instrument, I-beam, and/or I-beam 153514 (fig. 82)). In other aspects, the displacement member 153111 represents a firing member that is coupled to a cutting instrument or knife that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member 153111 represents a firing bar or I-beam, each of which may be adapted and configured to include a rack of drive teeth.

Thus, as used herein, the term displacement member is used generally to refer to any movable member of a surgical instrument or system as described herein, such as a drive member, firing bar, cutting instrument, knife, and/or I-beam, or any element that may be displaced. Thus, the absolute positioning system 153100 may 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, the longitudinally movable drive member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable displacement sensor. The displacement sensor may comprise a contact displacement sensor or a non-contact 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 may 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 the 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 gear drive and sensor 153118 arrangement may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. Power source 153129 supplies power to absolute positioning system 153100, and output indicator 153128 may display the output of absolute positioning system 153100.

A single rotation of the sensor element 153126 associated with the position sensor 153112 is equivalent to a longitudinal displacement d of the displacement member 153111₁Wherein d is₁Is 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 a gear reduction that causes the position sensor 153112 to complete one or more rotations for the full stroke of the displacement member 153111. Position sensor 153112 may complete multiple rotations for the full stroke of displacement member 153111.

A series of switches 153122a-153122n (where n is an integer greater than one) may be used alone or in conjunction 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 the displacement member 153111₁+d₂+…d_nA unique position signal of. 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 a unique combination of position signals or values. The controller 153110 may be contained within the master controller or may be contained within the 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 when the surgical instrument or system is powered up, without retracting or advancing the displacement member 153111 to a reset (clear or home) position as may be required by conventional rotary encoders that simply 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 knife and the speed and position of the articulation system. In one aspect, the controller 153110 includes a processor 153108 and a memory 153106. The electric motor 153120 may be a brushed dc motor having a gear box and a mechanical link to an articulation or knife system. In one aspect, the motor driver 153110 may be a3941 available from Allegro Microsystems, Inc. Other motor drives may be readily substituted for use in 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 be able 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 for the actual feedback decision. The observed response is a favorable 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 be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. The power source 153129 converts the signal from the feedback controller into a physical input, in this case a voltage, to the system. Other examples include Pulse Width Modulation (PWM) of voltage, current, and force. In addition to the location measured by the location sensor 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, where the output of absolute positioning system 153100 will have a limited resolution and sampling frequency. The absolute positioning system 153100 may include comparison and combination circuitry 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, inductive resistance, etc. to predict the state and output of the physical system by knowing the inputs.

The motor drive 153110 may be a3941 available from Allegro Microsystems, Inc. The a3941 driver 153110 is a full-bridge controller for use with an external N-channel power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) specifically designed for inductive loads, such as brushed dc motors. Driver 153110 includes a unique charge pump voltage 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 aforementioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side drive allows for direct current (100% duty cycle) operation. The full bridge may be driven in fast decay mode or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation can pass through either the high-side or low-side FETs. The power FET is protected from breakdown by a resistor adjustable dead time. The overall diagnostics indicate undervoltage, overheating, and power bridge faults, and may be configured to protect the power MOSFETs under most short circuit conditions. Other motor drives may be readily substituted for use in absolute positioning system 153100.

Fig. 81 is a schematic diagram of a position sensor 153200 of an absolute positioning system 153100' including a magnetic rotary absolute positioning system in accordance with at least one aspect of the present disclosure. Absolute positioning system 153100' is similar in many respects to absolute positioning system 153100. The position sensor 153200 may be implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. The position sensor 153200 interfaces with the controller 153110 to provide an absolute positioning system 153100'. The position sensor 153200 is a low voltage and low power component 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) so that the 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 Coordinate Rotation DIgital Computer (Coordinate Rotation DIgital Computer)), also known as the bitwise and Volder algorithms, is set to implement simple and efficient algorithms to compute hyperbolic and trigonometric functions that require only addition, subtraction, bit-shifting and table-lookup operations. The angular position, alarm bits, and magnetic field information are communicated to the controller 153110 through a standard serial communication interface, such as SPI interface 153234. The position sensor 153200 provides 12 or 14 bit resolution. The position sensor 153200 may be an AS5055 chip provided in a small QFN 16-pin 4 × 4 × 0.85mm package.

The

hall effect elements

153228A, 153228B, 153228C, 153228D are located directly above the rotating magnet. The hall effect is a well-known effect and will not be described in detail herein for convenience, but in general, it produces a voltage difference (hall voltage) across an electrical conductor that is transverse to the current in the conductor and a magnetic field that is perpendicular to the current. The 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, as its value depends on the type, number and properties of the charge carriers that make up the current. In the AS5055 position sensor 153200, the

hall effect elements

153228A, 153228B, 153228C, 153228D are capable of generating a voltage signal that indicates the absolute position of the magnet according to the angle through which the magnet has undergone a single rotation. This value of the angle, which is a unique position signal, is calculated by the CORDIC processor 153236 and stored on-board the AS5055 position sensor 153200 in a register or memory. In various techniques, such as upon power up or upon request by the controller 153110, a value for the angle is provided to the controller 153110 that indicates the position of the magnet over one rotation.

The AS5055 position sensor 153200 requires only a few external components to be operable when connected to the controller 153110. A simple application using a single power source requires six wires: two wires are used for power and four wires 153240 are used for SPI interface 153234 that interfaces with controller 153110. A seventh connection may be added to send an interrupt to the controller 153110 to inform that a new valid angle may be read. Upon power up, the AS5055 position sensor 153200 performs a full power up sequence, including an angle measurement. Completion of the loop is indicated as INT output 153242 and the angle value is stored in an internal register. Once this output is set, the AS5055 position sensor 153200 pauses into sleep mode. The controller 153110 may respond to an INT request at the INT output 153242 by reading an angle value from the AS5055 position sensor 153200 through the SPI interface 153234. Once the controller 153110 reads the angle value, the INT output 153242 is cleared again. Sending a "read angle" command by the controller 153110 to the position sensor 153200 through the SPI interface 153234 also automatically powers up the chip and initiates another angle measurement. As soon as the controller 153110 completes reading the angle value, the INT output 153242 is cleared and the new result is stored in the angle register. Completion of the angle measurement is again indicated by setting the INT output 153242 and the corresponding flag in the status register.

Due to the measurement principle of the AS5055 position sensor 153200, only a single angular measurement is performed in a very short time (600 μ s) after each power-up sequence. AS soon AS the measurement of an angle is completed, the AS5055 position sensor 153200 pauses to the 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 hence 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 the end effector 153502 showing the firing stroke of the 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 be operable 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 being 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 is translated distally, the cutting edge 153509 contacts and can cut tissue 153526 positioned between the anvil 153516 and the staple cartridge 153518. Also, the I-beam 153514 contacts and pushes the wedge sled 153513 distally, causing wedge sled 153513 to contact staple driver 153511. The staple drivers 153511 can be driven upward into the staples 153505, causing the staples 153505 to advance through the tissue and into the pockets 153507 defined in the anvil 153516, which form the staples 153505.

An exemplary I-beam 153514 firing stroke is illustrated by chart 153529 aligned with the end effector 153502. An exemplary tissue 153526 aligned with the end effector 153502 is also shown. The firing member stroke may include a stroke start position 153527 and a stroke end position 153528. During the I-beam 153514 firing stroke, the I-beam 153514 may 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 position at a stroke start position 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 zone 153517, the I-beam 153514 may contact the wedge sled 153513 and begin moving it distally. However, in the first region, cutting edge 153509 may not contact tissue and wedge sled 153513 may not contact staple drivers 153511. After overcoming the static friction, 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 may begin to contact and cut tissue 153526. Also, wedge sled 153513 may begin to contact staple driver 153511 to drive staples 153505. The force driving the I-beam 153514 may begin to ramp up. As shown, due to the manner in which the anvil 153516 pivots relative to the staple cartridge 153518, tissue initially encountered may be compressed and/or thinned. In the third firing member travel region 153521, the cutting edge 153509 can continuously contact and cut tissue 153526 and the wedge sled 153513 can repeatedly contact the staple drivers 153511. The force driving the I-beam 153514 can be smoothed out in the third zone 153521. With the fourth firing stroke region 153523, the force driving the I-beam 153514 may begin to fall. For example, tissue in the portion of the end effector 153502 corresponding to the fourth firing region 153523 may be compressed less than tissue closer to the pivot point of the anvil 153516, requiring less cutting force. Further, the cutting edge 153509 and the wedge sled 153513 can reach the end of the tissue 153526 while in the fourth region 153523. When the I-beam 153514 reaches the fifth region 153525, the tissue 153526 may be completely severed. Wedge sled 153513 can contact one or more staple drivers 153511 at or near the end of the tissue. The force urging the I-beam 153514 through the fifth region 153525 may be reduced, and in some examples, may 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 may reach an end of stroke position 153528. The positioning of the firing

member travel regions

153517, 153519, 153521, 153523, 153525 in fig. 82 is but one example. In some examples, different regions can begin at different positions along the end effector longitudinal axis 153515, e.g., 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, a firing system of the shaft assembly (including the I-beam 153514) can be advanced and/or retracted relative to the end effector 153502 of the shaft assembly using an electric motor 153120 positioned within a main controller of the surgical instrument in order to staple and/or incise tissue trapped within the end effector 153502. The I-beam 153514 may be advanced or retracted at a desired speed or within a desired speed range. The controller 153110 may be configured to control the speed of the I-beam 153514. The controller 153110 may be configured to be able 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 may be configured to be able 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 may be configured to be able to sense the velocity of the I-beam 153514 using the absolute positioning sensor system described herein. The controller may be configured to compare the predicted speed of the I-beam 153514 to 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 forces acting on the I-beams 153514. The I-beam 153514 force may 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 advanced distally. The I-beam 153514 force may be determined by positioning a strain gauge on the proximal end of the drive member, firing member, I-beam 153514, firing bar, and/or cutting edge 153509. Can be monitored to determine the time period T based on the time period₁The actual position of the I-beam 153514 is then moved at the expected speed of the current set speed of the motor 153120 and the actual position of the I-beam 153514 is compared to the expected position based on the time period T₁The 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 position and the expected position of the I-beam 153514 is proportional to the force on the I-beam 153514 versus 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 the force applied to the closure member to close on thick and thin tissue during the closure phase, and a graph 153601 depicting two firing force (FTF) curves 153622, 153624, depicting the force applied to the firing member to pass through thick and thin groups during the firing phaseForce of the fabric to fire). Referring to fig. 83, the graph 153600 depicts an example of forces applied to thick and thin tissue to close the end effector 153502 relative to tissue grasped between the anvil 153516 and the staple cartridge 153518 during a closure stroke, wherein the closure forces are plotted as a function of time. The closing force curves 153606, 153608 are plotted on two axes. The vertical axis 153602 indicates the closing Force (FTC) of the end effector 153502 in newtons (N). The horizontal axis 153604 indicates time in seconds, and is labeled t for clarity of description₀To t₁₃. The first closing force profile 153606 is an example of the force applied to thick tissue to close the end effector 153502 relative to tissue grasped between the anvil 153516 and the staple cartridge 153518 during a closing stroke, and the second profile 153608 is an example of the force applied to thin tissue to close the end effector 153502 relative to tissue grasped between the anvil 153516 and the staple cartridge 153518 during a closing stroke. The first closing force curve 153606 and the second closing force curve 153608 are divided into three phases: a CLOSE stroke (CLOSE), a WAIT period (WAIT), and a FIRE stroke (FIRE). During a closure stroke, the closure tube translates distally (direction "DD") to move the anvil 153516 relative to the staple cartridge 153518, for example, in response to actuation of the closure stroke by the closure motor. In other instances, the closure stroke involves moving the staple cartridge 153518 relative to the anvil 153516 in response to actuation of the closure motor, and in other instances, the closure stroke involves moving the staple cartridge 153518 and the anvil 153516 in response to actuation of the closure motor. Referring to the first closing force profile 153606, during the closing stroke, the closing force 153610 is from time t₀To t₁Increase from 0 to maximum force F₁. Referring to the second closing force profile 153608, during the closing stroke, the closing force 153616 is from time t₀To t₁Increase from 0 to maximum force F₃. Maximum force F₁And F₃The relative difference therebetween is due to the difference in closing force required for thick tissue versus thin tissue, wherein a greater force is required to close the anvil onto thick tissue as compared to thin tissue.

The first and second closing force curves 153606, 153608 are indicative of the end effector 153502At time (t) of closing force₁) And increased during the initial clamping period to end. Closing force at time (t)₁) To reach a maximum force (F)₁,F₃). The initial clamping time 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, thereby creating a smaller gap between the anvil 153516 and the staple cartridge 153518 and reducing the closing force at the end of the waiting period. Referring to the first closing force curve 153606, at t₁To t₄During the waiting period in between, the closing force 153612 is from F₁To F₂A nominal drop occurs. Similarly, referring to the second closing force curve 153608, at t₁To t₄During the waiting period in between, the closing force 153618 is from F₃To F₄Nominally decreasing. In some examples, a waiting period (t) selected from the range of about 10 seconds to about 20 seconds is typically employed₁To t₄). 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 follows a firing stroke that typically lasts for a period of time selected from a range of, for example, about 3 seconds to, for example, about 5 seconds. As the I-beam 153514 is advanced through the firing stroke relative to the end effector, the closing force decreases. The closing

forces

153614, 153620 exerted on the closure tube are indicated from about time t as indicated by closing

forces

153614, 153620 of first and second closing force curves 153606, 153608, respectively₄To about time t₅And drops sharply. Time t₄Indicating the time at which the I-beam 153514 is coupled into the anvil 153516 and begins to bear the closing load. Thus, as shown by the first firing force profile 153622 and the second firing force profile 153624, the closing force decreases as the firing force increases.

FIG. 83 also depicts a graph 153601 of a first firing force profile 153622 and a second firing force profile 153624 plotting the forces applied to advance the I-beam 153514 during the firing stroke of the surgical instrument or system according to the present disclosure. Firing force curves 153622, 153624 are plotted on two axes. The vertical axis 153626 indicates the firing force in newtons (N) applied to advance the I-beam 153514 during the firing stroke. 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 closure tube force is from time t₄To about time t₅A sharp drop, which represents the moment at which the I-beam 153514 is coupled into the anvil 153516 and begins to bear a load and the closing force decreases with increasing firing force, as shown by the first firing force curve 153622 and the second firing force curve 153624. When the I-beam 153514 comes from time t₄Stroke start position advance of time, firing force curve 153624 to t for thin tissue₈And t₉End of stroke position in between, and firing force profile 153622 through t for thick tissue₁₃The end of travel position of the time. As the I-beam 153514 advances distally during a firing stroke, the closure assembly relinquishes control of the staple cartridge 153518 and anvil 153516 to the firing assembly, which results in an increase in the firing force and a decrease in the closure force.

In the thick tissue firing force curve 153622, the curve 153622 is divided into three distinct segments during the firing cycle (FIRE). The first segment 153628 indicates the force at impact from t ₄0 at is increased to just at t₅Previous peak force F₁Force of percussion at time. The first segment 153628 is the firing force during the initial stage of the firing stroke, wherein the I-beam 153514 advances distally from the top of the closure ramp until the I-beam 153514 contacts the tissue. The second segment 153630 indicates a firing force during a second stage of the firing stroke in which the I-beam 153514 is advancing distally, deploying staples and cutting tissue. During the second phase of the firing stroke, the firing force is at about t₁₂From F₁' Down to F₂'. The third segment 153632 indicates the firing force during the third and final stages of the firing stroke, wherein the I-beam 153514 exits the tissue and advances to the end of the stroke in the non-tissue region. During a third phase of the firing stroke, the firing force is at about t₁₃From F₂' Down to zero (0), wherein the I-beam153514 reach the end of travel. In summary, the firing force rises sharply during the firing stroke as the I-beam 153514 enters the tissue region, falls steadily in the tissue region during the stapling and severing operations, and falls sharply as the I-beam 153514 exits the tissue region and enters the non-tissue region at the end of the stroke.

The thin tissue firing force curve 153624 follows the same pattern as the thick tissue firing force curve 153622. Thus, during the first stage of the firing stroke, the firing force 153634 is at about t₅Is sharply increased from 0 to F₃'. During the second stage of the firing stroke, the firing force 153636 is at about t₈From F₃' Stable drop to F₄'. During the final stage of the firing stroke, the firing force 153638 is at t₈And t₉From F 'to'₄Drops sharply to 0.

To overcome the closing force from time t₄To about time t₅Which represents the moment the I-beam 153514 is coupled into the anvil 153516 and begins to bear a load and the closing force decreases with increasing firing force, the closure tube may be advanced distally while the firing member (such as the I-beam 153514) is advanced distally, as shown by the first firing force curve 153622 and the second firing force curve 153624. 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 the motor control, which applies motor control signals to the motor to drive the transmission elements and advance the closure tube distally to apply a closing force to the anvil 153516. A torque sensor coupled to the output shaft of the motor may 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 gradual closure of a closure member (e.g., closure tube) as a firing member (e.g., I-beam 153514) is advanced distally and coupled to a clamp arm (e.g., anvil 153516) to lower the closure member (e.g., closure tube) at a desired rate in accordance with at least one aspect of the present disclosureClosing force loading on the closure member and reducing firing force loading on the firing member. In one aspect, the control system 153950 can be implemented as a nested PID feedback controller. A 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 apply corrections based on proportional, integral, and derivative terms (sometimes denoted 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 may be a PID controller 153972 as shown in fig. 84, and the secondary controller 153955 may also be a PID controller 153972 as shown in fig. 85. The master controller 153952 controls the primary process 153958 and the secondary controller 153955 controls the secondary process 153960. OUTPUT 153966(OUTPUT) of primary process 153958 is a slave master set point SP₁The first summer 153962 is subtracted. First summer 153962 generates a single sum output signal that is applied to master controller 153952. The output of the main controller 153952 is a secondary set point SP₂. Output 153968 of secondary process 153960 is a slave secondary set point SP₂The second summer 153964 is subtracted.

In the case of controlling the displacement of the closure tube, the control system 153950 may be configured such that the main set point SP is₁Is 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 for the closing motor₂The motor speed. In other aspects, the closing force may be measured with a strain gauge, load cell, or other suitable force sensor. Will close the motor speed set point SP₂Compared to the actual velocity of the closure tube, as determined by the secondary controller 153955. The actual velocity of the closure tube may be measured by comparing the closure tube to the displacement of the position sensor and measuring the elapsed time with a timer/counter. Other techniques such as linear encoders or rotary encoders may be used to measure the displacement of the closure tube. The output 153968 of the secondary process 153960 is the actual velocity of the closed tube. Providing the closed tube velocity output 153968To primary process 153958, which determines the force acting on the closure tube and feeds back to summer 153962, which is driven from the main set point SP₁The measured closing force is subtracted. Main set point SP₁May be an upper threshold or a lower threshold. Based on the output of the summer 153962, the main controller 153952 controls the speed and direction of the close tube motor as described herein. The secondary controller 153955 is based on the actual speed of the closed tube measured by the secondary process 153960 and the secondary set point SP₂To control the speed of the closure motor based on a comparison of the actual firing force to 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 may 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, and D-element 153978 are summed by summer 153986, which provides a control variable u (t) to process 153980. The output of the process 153980 is a 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 closed tube), and applies corrections based on the proportional, integral, and derivative terms calculated by the proportional element 153974(P), the integral element 153976(I), and the derivative element 153978(D), respectively. The PID controller 153972 attempts to minimize the time-varying error e (t) by adjusting the control variables u (t) (e.g., the speed and direction of the closed tube).

The "P" element 153974 calculates the current value of the error according to a 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 and the measured closing force of the closure tube. The "I" element 153976 calculates a past value of the error. For example, if the current output is not strong enough, 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 probable trend of the error based on its current rate of change. For example, continuing the above P example, when a large positive control output successfully brings the error closer to zero, it also places the process in the path of the most recent future large negative error. In this case, the derivative becomes negative and the D module reduces the strength of the action to prevent this overshoot.

It should be understood that other variables and set points may be monitored and controlled according to the

feedback control systems

153950, 153970. For example, the adaptive closing member speed control algorithm described herein may measure at least two of the following parameters: firing member travel position, firing member load, cutting element displacement, cutting element velocity, closure tube travel position, closure tube load, and the like.

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

Referring now also to fig. 84 and 85, in one aspect, the control circuit 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 closure member from a threshold closing force SP₁And set the closing member speed set point SP based on the first error therebetween₂. 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, the threshold closing force SP₁Including an upper threshold and a lower threshold. Set point speed SP₂Is configured to advance the closure member distally when the actual closing force is less than a 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 closing force is between the upper threshold and the lower threshold.

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 circuitry. A 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 processing circuit described herein. Aspects of a motorized surgical instrument may be practiced without the specific details disclosed herein. Some aspects have been illustrated as block diagrams, rather than details.

Portions of the present disclosure may be presented as instructions to operate on data stored in a computer memory. An algorithm is a self-consistent sequence of steps leading to a desired result, where "step" refers to the 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 individually and/or collectively in various hardware, software, firmware, or any combination thereof, may be viewed as being comprised of multiple types of "electronic circuitry". 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 a processor configured by a computer program that implements, at least in part, the processes and/or devices described herein), electronic circuitry forming a memory device (e.g., in the form of random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an 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 devices and/or processes via the use of block diagrams, flowcharts, and/or examples that 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 a wide variety of 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 components (e.g., programs, subroutines, logic, and/or combinations of hardware and software components), logic gates, or other integrated formats. Aspects disclosed herein may be equivalently implemented in integrated circuits, in whole or in part, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and designing the 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.

The mechanisms of the subject matter disclosed herein are capable of being distributed as a program product in a variety of forms, and exemplary aspects of the subject matter described herein apply 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 floppy disks, hard disk drives, Compact Disks (CDs), Digital Video Disks (DVDs), digital tapes, computer memory, etc.; and a transmission-type medium such as a digital and/or analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link (e.g., transmitter, receiver, transmission logic, reception logic), etc.).

The foregoing description of these aspects 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 are possible in light of the above teachings. The aspects were chosen and described in order to illustrate principles and practical applications to enable one of ordinary skill in the art to utilize the aspects and with various modifications as are suited to the particular use contemplated. The claims as filed herewith are intended to define the full scope.

Situation 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 a database and/or instruments. The information may include the type of procedure being performed, the type of tissue undergoing surgery, or the body cavity that is the subject of the procedure. With background information related to a surgical procedure, a surgical system may, for example, improve the manner in which the surgical system controls modular devices (e.g., robotic arms and/or robotic surgical tools) connected thereto, and provide background information or recommendations to a surgeon during the course of the surgical procedure.

Referring now to fig. 87, a timeline 5200 depicting situational awareness of a hub (e.g., surgical hub 106 or 206) is shown. The time axis 5200 is illustrative of the surgical procedure and background information that the

surgical hub

106, 206 may derive from the data received from the data source at 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 resection procedure, starting from the establishment of an operating room and ending with the transfer of the patient to a post-operative recovery room.

The situation aware

surgical hub

106, 206 receives data from data sources throughout the surgical procedure, including data generated each time medical personnel utilize a modular device paired with the

surgical hub

106, 206. The

surgical hub

106, 206 may receive this data from the 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 is performed at any given time. The situational awareness system of the

surgical hub

106, 206 can, for example, record data related to the process used to generate the report, verify that the medical personnel are taking steps, provide data or prompts (e.g., via a display screen) that may be related to particular procedure steps, adjust the modular device based on context (e.g., activate a monitor, adjust a field of view (FOV) of the medical imaging device, or change an energy level of the ultrasonic or RF electrosurgical instrument), and take any other such actions described above.

As a first step 5202 in the exemplary procedure, the 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 scans the incoming medical supply for the procedure. The

surgical hub

106, 206 cross-references the scanned supplies with a list of supplies used in various types of protocols and confirms that the supplied mix corresponds to a chest protocol. In addition, the

surgical hub

106, 206 is also able to determine that the procedure is not a wedge procedure (because the incoming supplies lack some of the supplies required for the chest wedge procedure, or otherwise do not correspond to the chest wedge procedure).

In a third step 5206, medical personnel scan 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, the medical staff opens the ancillary equipment 5208. The ancillary equipment utilized may vary depending on the type of surgery and the technique to be used by the surgeon, but in this exemplary case they include smoke ejectors, insufflators, and medical imaging devices. When activated, the auxiliary device as a modular device may be automatically paired 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 contextual information about the surgical procedure by detecting the type of modular device with which it is paired 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 the 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 may retrieve the steps of the procedure from memory or cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular devices and patient monitoring devices) to infer what steps of the surgical procedure are being performed by the surgical team.

In a fifth step 5210, the staff member attaches EKG electrodes 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 hub

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. Upon completion of the sixth step 5212, the pre-operative portion of the lung segmentation resection procedure is completed and the surgical portion begins.

In a seventh step 5214, the patient's lungs being operated on are collapsed (while ventilation is switched to the contralateral lungs). 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 conclude 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 have been previously visited or retrieved) to determine that collapsing the lungs is the first surgical step in that particular procedure.

In an eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is initiated. The

surgical hub

106, 206 receives medical imaging device data (i.e., video or image data) through its connection to the medical imaging device. After receiving the medical imaging device data, the

surgical hub

106, 206 may determine that a laparoscopic portion of the surgical procedure has begun. In addition, 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 data received by the

surgical hub

106, 206 at the second step 5204 of the procedure). Data from the medical imaging device 124 (fig. 2) may be used to determine contextual information relating to the type of procedure being performed in a number of different ways, including by determining the angle of visualization orientation of the medical imaging device relative to the patient 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 devices utilized. For example, one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest above the septum, while one technique for performing a VATS segmental resection places the camera in an anterior intercostal location relative to the segmental cleft. 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 a visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmental resection utilizes multiple cameras. As another example, one technique for performing a VATS segmental resection utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental fissures that are not used in a VATS pulmonary resection. 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 being used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step 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 ultrasound generator indicating that the energy instrument is being fired. The

surgical hub

106, 206 may intersect the received data with the retrieved steps of the surgical procedure to determine that the energy instrument fired at that point in the procedure (i.e., after completion of the previously discussed procedure steps) corresponds to an anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a robotic surgical system.

In a tenth step 5220, the surgical team continues with the ligation step of the procedure. The

surgical hub

106, 206 may infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and severing instrument indicating that the instrument is being fired. Similar to the previous steps, the

surgical hub

106, 206 may deduce the inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the retrieval steps in the procedure. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

An eleventh step 5222, a segmental resection portion of the procedure is performed. The

surgical hub

106, 206 may infer that the surgeon is transecting 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 indicate the type of tissue being stapled and/or transected. In this case, the type of staple fired is used for parenchyma (or other similar tissue type), which allows the

surgical hub

106, 206 to infer that a segmental resection portion of the procedure is in progress.

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 instruments used after transecting parenchyma correspond to a node dissection step that allows the

surgical hub

106, 206 to make such inferences. It should be noted that the surgeon periodically switches back and forth between the surgical stapling/severing instrument and the surgical energy (i.e., RF or ultrasonic) instrument according to specific steps in the procedure, as different instruments are better suited to the particular task. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used may indicate the steps of the procedure being performed by the surgeon. Further, in some cases, robotic implements 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 and/or may use the device simultaneously, for example, between a robotic tool and a hand-held surgical instrument. Upon completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.

A thirteenth step 5226, reverse the patient's anesthesia. For example, the

surgical hub

106, 206 may infer that the patient is waking up from anesthesia based on, for example, ventilator data (i.e., the patient's breathing rate begins to increase).

Finally, a fourteenth step 5228 is for the medical personnel to remove 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 a recovery room. As can be seen from the description of the exemplary procedure, the

surgical hub

106, 206 may determine or infer from data received from various data sources communicatively coupled to the

surgical hub

106, 206 when each step of a given surgical procedure occurs.

Situational awareness is further described in U.S. provisional patent application serial No. 62/611,341 entitled "INTERACTIVE SURGICAL PLATFORM," filed on 28.12.2017, which is incorporated herein by reference in its entirety. In certain instances, operation of the robotic surgical system (including the various robotic surgical systems disclosed herein) may be controlled, for example, by the

hub

106, 206 based on its situational awareness and/or feedback from its components and/or based on information from the cloud 104.

Safety system for intelligent powered surgical suturing

Various aspects of the present disclosure relate to improved safety systems that are capable of adjusting, controlling, and/or tuning the internal driving operation of a surgical instrument in response to tissue parameters detected via one or more sensors of the surgical instrument. According to at least one aspect, the force detected at the jaws of the end effector via the one or more sensors can be a magnitude that inhibits one or more subsequent/additional functions of the end effector from being performed. According to another aspect, a metal object can be detected via one or more sensors, such as within a jaw of an end effector, that inhibits one or more subsequent/additional functions of the end effector from being performed. Fig. 88 shows a surgical system 23000 including a surgical instrument 23002, a surgical hub 23004, and a user interface 23006. In such aspects, the surgical instrument 23002 may include one or more sensors 23008, and the parameters detected by the one or more sensors 23008 of the surgical instrument 23002 may be transmitted/communicated (e.g., wirelessly) to the control circuit 23010 of the surgical hub 23004. Additionally, in such aspects, the surgical hub 23004 can be configured to determine whether a surgical function (e.g., dissection, clamping, coagulation, stapling, cutting, rotation, articulation, etc.) associated with a component (e.g., end effector, shaft, etc.) of the surgical instrument 23002 can be safely performed based on a parameter detected by the one or more sensors 23008 of the surgical instrument 23002. Notably, in such aspects, the surgical hub 23004 can be configured to transmit/communicate one or more results associated with the determination (i.e., an alert associated with the surgical function, a reason to prevent the surgical function, etc.) to the user interface 23006. Further, according to various aspects, the various user interfaces disclosed herein may include selectable user interface features (e.g., override element 23012) to continue surgical functions despite any warnings and/or reasons to support prevention. Notably, in such aspects, such user interface features (e.g., overwriting element 23012) may not be displayed (e.g., performing a surgical function may compromise the patient).

Referring to fig. 89, according to various aspects of the present disclosure, a surgical system 23100 can include control circuitry (23112, 23122, 23132, and/or 23142, e.g., one or more optional positions shown in phantom), a user interface (23118, 23128, 23138, 23148, and/or 23158, e.g., optional positions shown in phantom), and a surgical instrument 23102 including, e.g., a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. In such aspects, the control circuit may be integrated into one or more components (e.g., handle assembly 23110, shaft assembly 23120, and/or end effector assembly 23130, etc.) of the surgical instrument 23102 (e.g., 23112, 23122, and/or 23132) and/or into a surgical hub 23140 (e.g., 23142) that is paired (e.g., wirelessly) with the surgical instrument 23102. Notably, according to various aspects, the surgical instrument 23102 and/or the surgical hub 23140 may be a situation-aware surgical instrument and/or a situation-aware surgical hub. Situational awareness refers to the ability of a surgical system (e.g., 23100) to determine or infer information related to a surgical procedure from data received from a database (e.g., historical data associated with the surgical procedure (e.g., 23149 and/or 23150)) and/or data received from a surgical instrument (e.g., sensor data during the surgical procedure). For example, the determined or inferred information may include the type of procedure being performed, the type of tissue undergoing surgery, the body cavity that is the subject of the procedure, and the like. Based on such contextual information related to the surgical procedure, the surgical system may, for example, control the pair of surgical instruments 23102 or components thereof (e.g., 23110, 23120, and/or 23130) throughout the surgical procedure and/or provide contextual information or recommendations to the surgeon (e.g., via the

user interfaces

23118, 23128, 23138, 23148, and/or 23158). Additional details regarding situational awareness may be found, for example, under the heading "situational awareness" above.

Also in fig. 89, according to one aspect, the situational aware surgical hub 23140 is paired (e.g., wirelessly) with a surgical instrument 23102 for performing a surgical procedure. In such aspects, the surgical instrument 23102 can include an end effector assembly 23130 comprising a first jaw, a second jaw pivotably coupled to the first jaw, and a sensor 23134 configured to detect a parameter associated with a function of the end effector assembly 23130 (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) and transmit the detected parameter to the control circuit 23142 of the surgical hub 23140.

Additionally, in such aspects, the surgical instrument 23102 can further include a shaft assembly 23120 including a sensor 23124 configured to detect a parameter associated with a function (e.g., rotation, articulation, etc.) of the shaft assembly 23120 and transmit the detected parameter to the control circuit 23142 of the surgical hub 23140. Notably, it should be appreciated that, as referenced herein and in other disclosed aspects, the sensors can include a plurality of sensors configured to be capable of detecting a plurality of parameters associated with a plurality of end effector assembly and/or shaft assembly functions. Thus, additionally, in such aspects, the surgical hub control circuit 23142 can be configured to receive detected parameters (e.g., sensor data) from such sensors 23134 and/or 23124 throughout the course of a surgical procedure.

The detected parameters may be received each time an associated end effector assembly 23130 function (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) and/or an associated shaft assembly 23120 function (e.g., rotation, articulation, etc.) is performed. The surgical hub control circuit 23142 can also be configured to receive data from an internal database (e.g., the surgical hub database 23149) and/or an external database (e.g., from the cloud database 23150) throughout the course of a surgical procedure. According to various aspects, the data received from the internal database and/or the external database may include protocol data (e.g., steps of performing a surgical procedure) and/or historical data (e.g., data indicating expected parameters based on historical data associated with the surgical procedure).

In various aspects, the protocol data may include current/recognized standard of care protocols for the surgical procedure, and the historical data may include preferred/ideal parameters and/or preferred/ideal parameter ranges (e.g., system-defined constraints) based on the historical data associated with the surgical procedure. Based on the received data (e.g., sensor data, internal and/or external data, etc.), the surgical hub control circuit 23142 can be configured to continually derive inferences (e.g., background information) about the surgical procedure being performed. That is, the situational aware surgical hub may be configured to, for example, record data related to the surgical procedure used to generate the report, verify the steps the surgeon is taking to perform the surgical procedure, provide data or prompts that may be related to particular procedure steps (e.g., via a user interface associated with the surgical hub and/or surgical instrument (e.g., 23148, 23158, 23118, 23128, and/or 23138)), control surgical instrument functions, and the like. According to various aspects, the situational aware surgical hub 23140 may infer the next surgical function to be performed (e.g., after performing an initial surgical function of the end effector assembly 23130 or shaft assembly 23120) based on protocol data received from the internal database 23149 and/or the external database 23150.

Additionally, in such aspects, the situational aware surgical hub 23140 may evaluate the detected parameters (e.g., parameters received from sensors 23134 and/or 23124 in response to the initial surgical function) based on historical data (e.g., preferred/ideal parameters) received from the internal database 23149 and/or the external database 23150. Here, the situation-aware surgical hub 23140 may allow for and/or not prevent/control execution of a next surgical function if the detected parameter does not exceed the preferred/ideal parameter and/or is within a corresponding preferred/ideal parameter range. Alternatively, if the detected parameter does exceed the preferred/ideal parameter and/or is not within the corresponding preferred/ideal parameter range, the situational aware surgical hub 23140 may actively prevent the next surgical function from being performed.

In accordance with another aspect of the present disclosure, the situational aware surgical hub 23140 may receive a communication (e.g., from a component of the surgical instrument 23102, e.g., 23130 and/or 23120) that a particular surgical function is being attempted/requested/actuated. In such aspects, the situational aware surgical hub 23140 may compare the particular surgical function to the inferred next surgical function to ensure that current/recognized standard of care protocols are followed. If so, the situation aware surgical hub 23140 may then evaluate the detected parameters (e.g., as described) before allowing the particular surgical function to continue (as described). If not, the situation-aware surgical hub 23140 may prevent the particular surgical function from being performed, or until an override is received (e.g., via the

user interfaces

23, 158, 23148, 23138, 23128, and/or 23118, see, e.g., FIG. 88, selectable user interface element 23012). In such aspects, if an override is received, the situational aware surgical hub 23140 may then evaluate the detected parameters (as described above) before allowing the particular surgical function to continue.

Referring again to fig. 89, according to another aspect, the situational aware surgical instrument 23102 may be used to perform a surgical procedure. In such aspects, the surgical instrument 23102 may include a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. The end effector assembly 23130 may include a first jaw, a second jaw pivotably coupled to the first jaw, and a sensor 23134 configured to detect a parameter associated with a function of the end effector assembly 23130 (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) and transmit the detected parameter to a control circuit (23112, 23122, 23132, and/or 23142, e.g., one or more optional locations shown in phantom).

For example, in such aspects, the detected parameter may be transmitted to the control circuitry 23132 of the end effector assembly 23130. Here, the end effector assembly control circuitry 23132 may be configured to receive detected parameters (e.g., sensor data) from the sensors 23134 throughout the surgical procedure. The detected parameters may be received each time an associated end effector assembly 23130 function (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) is performed.

The end effector assembly 23130 may also be configured to receive data from internal databases (e.g., the end effector memory 23136) and/or external databases (e.g., from the cloud database 23150 via the surgical hub 23140, from the surgical hub database 23149, etc.) throughout the course of a surgical procedure. According to various aspects, the data received from the internal database and/or the external database may include staple cartridge data (e.g., the size and/or type of staples associated with a staple cartridge positioned in the end effector assembly) and/or historical data (e.g., data indicative of expected tissue and/or the type of tissue to be stapled with those sizes and/or types of staples based on the historical data). In various aspects, the received data may include preferred/desired parameters and/or preferred/desired parameter ranges associated with those sizes and/or types of staples or those expected tissues and/or tissue types based on historical data (e.g., system-defined constraints). Based on the received data (e.g., sensor data, internal and/or external data, etc.), the end effector control circuit 23132 may be configured to continually derive inferences (e.g., background information) about the surgical procedure being performed. Notably, according to alternative aspects, the sensor 23134 of the end effector assembly 23130 can transmit the detected parameter to a control circuit (e.g., 23112 and/or 23122) associated with another surgical instrument 23102 component (e.g., handle assembly 23110 and/or shaft assembly 23120). In such aspects, other surgical instrument component control circuits (e.g., 23112 and/or 23122) may be similarly configured to implement various aspects of the end effector control circuit 23132 as described above. Further, according to various aspects, the shaft assembly 23120 of the surgical instrument 23102 may include a sensor 23124 configured to detect a parameter associated with a function (e.g., rotation, articulation, etc.) of the shaft assembly 23120 and transmit the detected parameter to a control circuit (e.g., 23112) similarly configured to implement various aspects of the end effector control circuit 23132 as described above. Finally, the situational aware surgical instrument 23102 may be configured to, for example, alert a user thereof of the discrepancy (e.g., via the user interface 23138 of the end effector assembly 23130, via the user interface (e.g., 23128 and/or 23118) of another surgical instrument 23102 component (e.g., the shaft assembly 23120 and/or the handle assembly 23110), and/or via the user interface 23148 and/or 23158 associated with the surgical hub 23140 coupled to the surgical instrument 23102). For example, the difference may include the detected parameter exceeding a preferred/desired parameter and/or preferred/desired parameter range associated with those sizes and/or types of staples or those expected tissues and/or tissue types. As another example, the situational aware surgical instrument 23102 may be configured to control the function of the surgical instrument 23102 based on the difference. According to at least one aspect, the situational aware surgical instrument 23102 may prevent surgical function based on the difference.

Situational aware functional control

As highlighted herein, various aspects of the present disclosure relate to a surgical instrument that performs a function (e.g., clamping), detects a parameter associated with the function, evaluates via a control circuit using a situational awareness aspect whether the detected parameter is below or above a predefined parameter (e.g., deemed ideal/preferred) or below or above a predefined range of the parameter (e.g., deemed normal), and performs an action (i.e., stop one or more functions, alert a user, notify a user of a possible cause, etc.) in response to the detected parameter being outside the predefined parameter and/or the predefined parameter/range. For example, fig. 90 illustrates an algorithm 23200 for implementing such aspects, wherein the control circuit receives one or more detected parameters associated with a surgical function performed by the surgical instrument 23202 and retrieves situational awareness data from an internal and/or external database 23204. The control circuitry then evaluates the one or more detected parameters in accordance with the situational awareness data 23206 and performs an action based on the evaluation 23208.

In accordance with various aspects of the present disclosure, the force detected at the jaws of the end effector assembly (e.g., via one or more sensors) may be of a magnitude that inhibits one or more subsequent/additional functions of the end effector assembly from being performed. For example, referring back to fig. 12, the force may be detected via

sensors

474, 476, and/or 478. In such aspects, the sensor 474 may be a strain gauge coupled to the end effector, wherein the strain gauge is configured to measure a magnitude/amplitude of strain on one or more jaws of the end effector that is indicative of the closing force applied to the one or more jaws. Further, in such aspects, the sensor 476 can be a load sensor configured to measure the closing force applied to the jaws by the closure drive system. Further, in such aspects, the sensor 478 can be a current sensor configured to measure the current drawn by the motor as a function of the closing force applied to the jaws. In addition or as another example, referring back to fig. 17, the force may be detected via sensors 744a and/or 744 b. In such aspects, the sensors 744a and/or 744b can be torque sensors configured to provide firing force feedback signals indicative of the closing force applied to the jaws by the closure drive system.

In one aspect, referring back to fig. 58, the load sensor 152082 (e.g., positioned in the shaft assembly or handle assembly) can be configured to detect a load after the shaft assembly is attached to the handle assembly. In such aspects, the detected load may exceed a predefined load and/or a predefined load range. In such an aspect, referring to fig. 89, for example, control circuitry associated with the surgical instrument (e.g., integrated into

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can evaluate the detected load and use situational awareness (e.g., based on historical data) to determine that the shaft assembly and/or end effector assembly is/must be damaged. In such aspects, the control circuit can be configured to record a unique identifier associated with the shaft assembly 23120 and/or the end effector assembly 23130 and designate the unique identifier as being prohibited from further use and/or attachment to the handle assembly 23110.

In another aspect, referring to fig. 89, for example, control circuitry associated with the surgical instrument (e.g., integrated into

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can be configured to evaluate forces detected/sensed at the jaws (e.g., via one or more sensors as described) and determine a firing function/cycle that prevents the end effector assembly. In particular, the control circuitry may use situational awareness (e.g., based on historical data) to determine that a force detected/sensed at the jaws (e.g., detected prior to the start of a firing function/cycle) exceeds a predefined force and/or a predefined force range. In such aspects, the control circuit may be configured to prevent the firing function/cycle from starting. Further, in such aspects, referring again to fig. 89, the control circuit can be configured to alert the user (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or 23158 associated with the surgical hub) that the firing function/cycle cannot be performed, and/or to notify the user of a possible reason (e.g., so that the user can attempt to reduce the force detected/sensed at the jaws). According to various aspects, the control circuitry may be configured to allow the firing function/cycle to begin if the force detected/sensed at the jaws decreases to a predefined force and/or is within a predefined force range.

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can evaluate the force detected/sensed at the jaws (e.g., via one or more sensors, e.g., a load sensor, a torque sensor, etc., as described) and initially determine that the firing function/cycle of the end effector assembly is permitted. However, after beginning the firing function/cycle, the control circuitry may use situational awareness (e.g., based on historical data) to determine that a firing force (e.g., a force detected during the firing function/cycle) exceeds a predefined firing force and/or a predefined firing force range. In such aspects, the control circuit may be configured to stop the firing function/cycle (e.g., prevent the firing function/cycle from continuing). Further, in such aspects, referring again to fig. 89, the control circuit can be configured to provide an alert to the surgeon (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or the user interface 23158 associated with the surgical hub) as to the firing force or range of firing forces exceeded. According to various aspects, the control circuitry may also be configured to be capable of receiving an override command (e.g., via one or more user interfaces, see, e.g., fig. 88, selectable user interface element 23012) to allow the firing function/cycle to continue. In such aspects, the control circuitry may use situational awareness (e.g., based on historical data) to determine that a second firing force (e.g., a force detected during the continued firing function/cycle) exceeds a second predefined firing force and/or a second predefined firing force range (e.g., a higher threshold). In such aspects, the control circuitry may be configured to again stop the firing function/cycle, alert the surgeon and/or receive an override command as described.

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can evaluate the force detected/sensed at the jaws (e.g., via one or more sensors as described). Further, the control circuitry may also evaluate the forces detected/sensed within the shaft assembly (i.e., via one or more sensors as described). Here, according to various aspects, the control circuitry may cross-reference the forces detected/sensed at the jaws and/or the forces detected/sensed within the shaft assembly in the context of performing a surgical procedure. According to such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that a force detected/sensed within the shaft assembly exceeds a predefined shaft force and/or a predefined shaft force range. In one example, the shaft assembly may comprise a specialized shaft assembly configured for use with a particular tissue type in a particular surgical procedure. In such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that the force detected/sensed within the specialized shaft assembly is too high (e.g., exceeds a predefined shaft force and/or a predefined shaft force range associated with the specialized shaft assembly) and/or that the force detected/sensed at the jaws is not a predefined force and/or is not within a predefined range (e.g., an expected force historically associated with the surgical procedure being performed). In such aspects, the control circuit may be configured to be capable of ceasing the firing function/cycle (e.g., preventing the firing function/cycle from starting and/or continuing). Further, in such aspects, referring again to fig. 89, the control circuit can be configured to provide an alert to the surgeon (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or the user interface 23158 associated with the surgical hub) as to the exceeding axial force and/or axial force range. In various aspects, the alert may inform the surgeon to consider separating a specialized shaft assembly (e.g., 23120) from the handle assembly 23110 and attaching another shaft assembly (e.g., configured for detected/sensed forces and conventional reloading of encountered tissue) to the handle assembly 23110. In such aspects, the control circuitry may be configured to allow the firing function/cycle to begin and/or continue while the appropriate shaft assembly is attached.

In another aspect, referring to fig. 89, for example, control circuitry associated with the surgical instrument (e.g., integrated in

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated in a coupled surgical hub 23142) can evaluate forces detected/sensed at the jaws during a surgical procedure (e.g., via one or more sensors as described). According to such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that the tissue creep wait time is below a predefined creep wait time and/or a predefined creep wait time range associated with a particular thickness and a particular tissue clamped during a surgical procedure. In other words, according to fig. 83 and 84 herein, the initial closing force may have decayed and reached creep stability at a lower closing force more quickly than expected. In such aspects, the control circuit may be configured to be capable of ceasing the firing function/cycle (e.g., preventing the firing function/cycle from starting and/or continuing). Additionally, in such aspects, referring again to fig. 89, the control circuit can be configured to provide an alert to the surgeon (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or the user interface 23158 associated with the surgical hub) regarding reduced creep latency. In various aspects, the alert may inform the surgeon to consider detaching an end effector assembly (e.g., 23130) from a handle assembly and attaching another end effector assembly (e.g., an end effector assembly configured to treat tissue having a detected creep latency) to the handle assembly 23110. In such aspects, the control circuitry can be configured to allow the firing function/cycle to begin and/or continue while the appropriate end effector assembly is attached.

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can evaluate the force detected/sensed at the jaws (e.g., via one or more sensors as described). In addition, the control circuitry may also evaluate the position detected/sensed for the articulating member (i.e., by one or more sensors). For example, referring back to fig. 12, the position may be detected/sensed by a sensor 472 coupled to the articulation member. In one aspect, the sensor 472 may be a position sensor configured to measure linear displacement, wherein a single rotation of the sensor element corresponds to a particular linear displacement of the articulation member. In another example, referring back to fig. 17, the position can be detected/sensed by a position sensor 734 located in the end effector. Here, the position sensor 734 may be a proximity sensor or a sensor configured to provide a series of pulses that may be tracked by the control circuit to determine the position of the articulation member. Here, according to various aspects, the control circuitry may cross-reference the force detected/sensed at the jaws and/or the position detected/sensed for the articulation member in the context of performing a surgical procedure. According to such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that the detected/sensed position for the articulation member indicates that the articulation member has advanced (e.g., within the shaft assembly) beyond a predetermined advanced position and/or a predetermined range of advanced positions. In various aspects, the predetermined advanced position and/or predetermined range of advanced positions can be associated with a closing force detected/sensed at the jaws. In such aspects, the control circuitry may be configured to stop the firing function/cycle (e.g., prevent the firing function/cycle from starting and/or continuing) in the event that a specified predetermined advancement position is exceeded. Further, in such aspects, referring again to fig. 89, the control circuit can be configured to provide an alert to the surgeon (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or the user interface 23158 associated with the surgical hub) as to the advancement position and/or range of advancement positions exceeded. In various aspects, the alert can inform the surgeon regarding the retraction of the articulation member to a predetermined advanced position and/or within a predetermined range of advanced positions. Here, in one example, the predetermined advancement position and/or predetermined range of advancement positions may historically achieve a desired and/or successful firing function/cycle of the corresponding closing force. In such aspects, the control circuitry may be configured to allow the firing function/cycle to begin and/or continue when the appropriate advancement position is achieved.

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated in a coupled surgical hub 23142) can evaluate forces detected/sensed at the jaws during a surgical procedure (e.g., via one or more sensors as described). According to such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that the closure force is above a predefined closure force and/or a predefined closure force range associated with the particular tissue clamped during the surgical procedure. In other words, per fig. 83 and 84 herein, the detected/sensed closure force is higher than expected to allow the firing function/cycle to continue. In such aspects, the control circuit may be configured to be capable of ceasing the firing function/cycle (e.g., preventing the firing function/cycle from starting and/or continuing). Additionally, in such aspects, referring again to fig. 89, the control circuit can be configured to provide an alert to the surgeon regarding the elevated closing force (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or the user interface 23158 associated with the surgical hub). In various aspects, the alert may inform the surgeon regarding adjusting the firing motor speed. In one example, if the particular tissue is rigid tissue, the alert may advise the surgeon to slow down the firing motor speed to avoid tearing the rigid tissue. In such aspects, the speed may be adjusted down based on historical data associated with the surgical procedure being performed. In another example, if the particular tissue is a weak shear strength viscous tissue, the alert may advise the surgeon to turn the firing motor speed up to ensure that the tissue is properly clamped. In such aspects, the speed may be adjusted up based on historical data associated with the surgical procedure being performed. In such aspects, the control circuitry may be configured to allow the firing function/cycle to begin and/or continue while setting the appropriate firing motor speed.

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated in a coupled surgical hub 23142) can evaluate forces detected/sensed at the jaws during a surgical procedure (e.g., via one or more sensors as described). According to such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that the cyclic force on the firing system is above a predefined cyclic force and/or a predefined cyclic force range during the surgical procedure. In other words, the detected/sensed cycling force is higher than expected and may indicate an impending motor failure based on historical data. In such aspects, the control circuitry may be configured to be capable of ceasing the firing function/cycle (e.g., preventing the firing function/cycle from starting and/or continuing to advance). Additionally, in such aspects, referring again to fig. 89, the control circuit can be configured to provide alerts to the surgeon (e.g., via

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or user interfaces 23148 and/or 23158 associated with the surgical hub) regarding elevated cyclic forces and possible motor failures. According to various aspects, the control circuitry may also be configured to receive an override command (e.g., via a user interface, see, e.g., fig. 88, selectable user interface element 23012) to allow the firing function/cycle to continue. In such aspects, the control circuit may continue to monitor whether the cyclic force on the firing system is above the predefined cyclic force and/or the predefined cyclic force range during the surgical procedure. In such aspects, the control circuitry may be configured to again stop the firing function/cycle, alert the surgeon and/or receive an override command as described.

According to another aspect of the present disclosure, referring to fig. 89, for example, control circuitry associated with the surgical instrument (e.g., integrated into

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can evaluate the force detected/sensed at the jaws (e.g., via one or more sensors as described). In addition, the control circuit may also evaluate the force/torque to articulate the end effector assembly 23130. In such aspects, the articulation force/torque may be detected via one or more sensors (e.g., a force sensor associated with the articulation member, a torque sensor associated with the articulation member, a current sensor associated with a motor configured to drive the articulation member, etc.). For example, referring back to fig. 17, the articulation force/torque may be detected/sensed by torque sensors 744d and/or 744e coupled to the articulation drive system. Additionally and/or alternatively, referring again to fig. 17, the articulation force/torque may be associated with the current consumed by the motors 704d and/or 704e as measured by the sensor 736. Here, according to various aspects, the control circuitry may cross-reference the forces detected/sensed at the jaws and/or the articulation forces/torques detected for the articulation members in the context of performing a surgical procedure. According to such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that the detected articulation force/torque for the articulation member exceeds a predefined articulation force/torque and/or a predefined articulation force/torque range. In various aspects, the predefined articulation force/torque and/or predefined articulation force/torque range may be associated with a force detected/sensed at the jaws. In such aspects, the control circuit can be configured to stop articulation of the end effector assembly (e.g., to prevent continued articulation) if a specified articulation force/torque is exceeded. Further, in such aspects, referring again to fig. 89, the control circuit can be configured to provide an alert to the surgeon (e.g., via

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or user interfaces 23148 and/or 23158 associated with the surgical hub) as to the articulation force/torque and/or articulation force/torque range exceeded. According to various aspects, the control circuitry may be further configured to be capable of receiving an override command (e.g., via a user interface, see, e.g., fig. 88, selectable user interface element 23012) to allow the articulation to continue. In such aspects, the control circuit may continue to monitor whether the articulation force/torque is above the predefined articulation force/torque and/or the predefined articulation force/torque range during the surgical procedure. In such aspects, the control circuitry may be configured to again stop articulation, alert the surgeon and/or receive an override command as described.

According to yet another aspect of the present disclosure, referring to fig. 89, for example, control circuitry associated with the surgical instrument (e.g., integrated into

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can evaluate the force detected/sensed at the jaws (e.g., via one or more sensors as described). In addition, the control circuit may also evaluate the force/torque of the rotating shaft assembly 23120 (e.g., shaft member). In such aspects, the rotational force/torque may be detected via one or more sensors (e.g., a force sensor associated with the rotation/shaft member, a torque sensor associated with the rotation/shaft member, a current sensor associated with a motor configured to be capable of rotating the rotation/shaft member, etc.). For example, referring back to fig. 17, the rotational force/torque may be detected/sensed by a torque sensor 744c coupled to the rotational/shaft member drive system. Additionally and/or alternatively, referring again to fig. 17, the rotational force/torque may be associated with the current drawn by the motor 704c as measured by the sensor 736. Here, according to various aspects, the control circuitry may cross-reference the force detected/sensed at the jaw and/or the rotational force/torque detected for the rotational/shaft member in the context of performing a surgical procedure. According to such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that a rotational force/torque detected for the rotation/shaft member exceeds a predefined rotational force/torque and/or a predefined rotational force/torque range. In various aspects, the predefined rotational force/torque and/or predefined rotational force/torque range may be associated with a force detected/sensed at the jaws. In other aspects, the predefined rotational force/torque and/or predefined range of rotational forces/torques may correspond to the force/torque that the rotational/shaft member itself is capable of withstanding. In such aspects, the control circuit may be configured to stop rotation of the shaft assembly (e.g., prevent the rotation/shaft member from continuing to rotate) if a specified rotational force/torque is exceeded. Further, in such aspects, referring again to fig. 89, the control circuit can be configured to provide an alert to the surgeon (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or the user interface 23158 associated with the surgical hub) as to the rotational force/torque and/or rotational force/torque range exceeded. According to various aspects, the control circuitry may be further configured to be capable of receiving an overwrite command (e.g., via a user interface, see, e.g., fig. 88, selectable user interface element 23012) to allow the rotation to continue. In such aspects, the control circuit may continue to monitor during the surgical procedure whether the rotational force/torque is above the predefined rotational force/torque and/or the predefined rotational force/torque range. In such aspects, the control circuitry may be configured to again stop rotation, alert the surgeon and/or receive an override command as described.

components

23132, 23122, and/or 23112 of the surgical instrument, or integrated into a coupled surgical hub 23142) can be configured to evaluate an opening force detected/sensed at the jaws (e.g., via one or more sensors as described) and determine to prevent the jaws from opening. In particular, the control circuitry may use situational awareness (e.g., based on historical data) to determine that the opening force detected/sensed at the jaws exceeds a predefined opening force and/or a predefined opening force range. In such aspects, the control circuitry can be configured to maintain the jaws in a clamped or partially clamped position. Further, in such aspects, referring again to fig. 89, the control circuit can be configured to alert the user (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or 23158 associated with the surgical hub) that the jaws cannot be opened, and/or to notify the user of a possible reason (e.g., so that the user can attempt to reduce the opening force detected/sensed at the jaws). According to various aspects, the control circuitry may be configured to allow the jaws to open if the detected/sensed opening force at the jaws decreases to a predefined opening force and/or within a predefined opening force range.

Short circuit detection and function control

According to various other aspects of the present disclosure, the function of the surgical instrument may be controlled based on one or more sensors configured to detect a short circuit. That is, if a metal object is detected within the jaws, at least one surgical instrument function/actuation (e.g., cutting, coagulation, etc.) may be prevented/inhibited. For example, fig. 91 illustrates an algorithm 23300 for implementing such aspects, in which a control circuit receives one or more detected parameters indicative of a short 23302. The control circuitry can also retrieve internal and/or external database data 23304. The control circuit then evaluates one or more detected parameters and/or database data 23306 and performs an action based on that evaluation 23308.

Referring again to fig. 89, according to aspects of the present disclosure, the surgical system 23100 can include control circuitry (23112, 23122, 23132, and/or 23142, e.g., one or more optional positions shown in phantom), a user interface (23118, 23128, 23138, 23148, and/or 23158, e.g., optional positions shown in phantom), and a surgical instrument 23100 including, e.g., a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. In such aspects, the control circuit may be integrated into one or more components (e.g., handle assembly 23110, shaft assembly 23120, and/or end effector assembly 23130, etc.) of the surgical instrument 23102 (e.g., 23112, 23122, and/or 23132) and/or into a surgical hub 23140 (e.g., 23142) that is paired (e.g., wirelessly) with the surgical instrument 23102. In such aspects, the end effector assembly 23130 can include a first jaw, a second jaw pivotably coupled to the first jaw, and a sensor 23134 configured to detect a parameter associated with a function (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) of the end effector assembly 23130 and transmit the detected parameter to a control circuit (e.g., 23112, 23122, 23132, and/or 23142). In various aspects, the first jaw can comprise an anvil and the second jaw can comprise an elongate channel configured to receive a staple cartridge. Additionally, in such aspects, the surgical instrument 23102 may further include a shaft assembly 23120 including a sensor 23124 configured to detect a parameter associated with a function (e.g., rotation, articulation, etc.) of the shaft assembly 23120 and transmit the detected parameter to a control circuit (e.g., 23112, 23122, 23132, and/or 23142). In such aspects, the control circuitry can be configured to receive detected parameters (e.g., sensor data) from such sensors (e.g., 23134 and/or 23124) throughout the surgical procedure. The detected parameters may be received each time an associated end effector assembly 23130 function (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) and/or an associated shaft assembly 23120 function (e.g., rotation, articulation, etc.) is performed. The control circuit may also be configured to receive data from internal databases (e.g., in the

memories

23136, 23126 and/or 23116 of the components of the surgical instrument or in the surgical hub database 23149) and/or external databases (e.g., from the surgical hub database 23149, the cloud database 23150, etc.) throughout the course of the surgical procedure. According to various aspects, the data received from the internal database and/or the external database may include protocol data (e.g., steps of performing a surgical procedure) and/or historical data (e.g., data indicating expected parameters based on historical data associated with the surgical procedure). In various aspects, the protocol data may include current/recognized standard of care protocols for the surgical procedure, and the historical data may include preferred/ideal parameters and/or preferred/ideal parameter ranges (e.g., system-defined constraints) based on the historical data associated with the surgical procedure. Based on the received data (e.g., sensor data, internal and/or external data, etc.), the control circuitry (e.g., 23112, 23122, 23132, and/or 23142) may be configured to be able to continually derive inferences (e.g., background information) about the ongoing procedure. That is, the surgical instrument can be configured to, for example, record data related to the surgical procedure used to generate the report, verify that the surgeon is taking steps to perform the surgical procedure, provide data or prompts that may be related to particular procedure steps (e.g., via the user interface 23158 and/or

user interface

23138, 23128, and/or 23118 associated with the surgical instrument and/or

user interface

23148, 23102 functions, and/or the like.

Referring back to fig. 89, in one aspect, during and/or after clamping the target tissue between the jaws of the end effector assembly, the control circuitry (23112, 23122, 23132, and/or 23142) can be configured to check for continuity between the jaws before allowing subsequent functions (e.g., firing, coagulation, etc.). Here, according to various aspects, the surgical instrument can comprise an electrosurgical instrument that includes an electrode in at least one of the jaws (e.g., integrated with the anvil and/or the staple cartridge). In such aspects, if there is a short circuit between the electrodes, it can be difficult to treat tissue grasped between the jaws with electrosurgical energy (e.g., RF energy). In one example, a conductive object (e.g., a clip, nail, metal element, etc.) between the electrodes can cause conduction between the jaws. In another example, if there is not sufficient clearance between the jaws (e.g., after clamping the target tissue), the electrodes may contact, thereby allowing conduction between the jaws. Referring back to fig. 53, for example, in one aspect of the present disclosure, the sensor 152008a is configured to measure the gap between the end effector jaws. In such aspects, the sensor 152008a of the first jaw can comprise a hall effect sensor configured to detect a magnetic field generated by the magnet 152012 of the second jaw to measure a gap between the first jaw and the second jaw. Notably, the gap can represent a thickness of tissue clamped between the first jaw and the second jaw. Here, if there is continuity between the jaws, undesirable surgical results (e.g., incomplete tissue treatment, excessive heating of the electrically conductive object, etc.) may result.

According to one aspect (e.g., a bipolar mode), the first jaw may comprise an anvil and the second jaw may comprise an elongate channel configured to receive a staple cartridge, such as depicted in fig. 25. In one example, the staple cartridge can include an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue, and at least a portion of the anvil can act as a return electrode. In one example, the anvil can include an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue, and at least a portion of the elongate channel can act as a return electrode. According to another aspect (e.g., a monopolar mode), the first jaw can comprise an anvil and the second jaw can comprise an elongate channel configured to receive a staple cartridge. In one example, the staple cartridge can include active electrodes to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue, and return electrodes (e.g., ground pads) can be separately positioned on the patient's body. In another example, the anvil can include an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue, and a return electrode (e.g., ground pad) can be separately positioned on the patient's body. Various configurations for detecting short circuits are described in U.S. patent No.9,554,854, entitled "DETECTING SHORT CIRCUITS INELECTROSURGICAL MEDICAL DEVICES," the entire disclosure of which is incorporated herein by reference.

Referring again to fig. 89, according to various aspects, the control circuit (23112, 23122, 23132 and/or 23142) may be configured to be able to check for conduction in a variety of ways. In one aspect, a generator that generates electrosurgical energy and/or a sensor (e.g., 23134) integrated in a surgical instrument may be configured to detect when an impedance between electrodes falls below a threshold for a threshold period of time (i.e., a drop in impedance indicative of a short circuit). Here, referring back to fig. 48, the sensor (e.g., 23134) may be configured to be able to measure impedance over time. In one example, when the electrode encounters a conductive staple line, the current may spike, and the impedance and voltage drop sharply. In another example, the conduction may be present as a current sink with minimal voltage variation. Various alternative methods for checking for conduction/detecting shorts, such as those described in U.S. patent No.9,554,854, entitled "DETECTING SHORT CIRCUITSIN ELECTROSURGICAL MEDICAL DEVICES," are expressly incorporated herein by reference (e.g., comparing impedance values at different locations within a pulse of a series of pulses).

In such aspects, if conduction is detected, an electrically conductive object (e.g., a clip, staple line, metallic element, etc.) may be present/exposed in the tissue grasped between the jaws. Notably, such conductive objects may be from a current surgical procedure and/or a previous surgical procedure. In such aspects, the control circuit may be configured to provide an alert to the surgeon (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or the user interface 23158 associated with the surgical hub) as to the detection of the conductive object. For example, the alert may indicate to the surgeon to reposition the end effector assembly 23130 so that the electrode does not contact any conductive object and/or remove the conductive object that caused the short circuit. According to various aspects, the control circuitry may also be configured to be capable of receiving an override command (e.g., via a user interface, see, e.g., fig. 88, selectable user interface element 23012) to allow subsequent functionality (e.g., cutting, coagulation, etc.) despite detection of a conductive object (e.g., a clamp, a nail, a staple line, a metal element, etc.).

According to one aspect, the control circuit (23112, 23122, 23132 and/or 23142) may be configured to be able to check for conduction to avoid chopping the clamp. In such aspects, after detecting the short circuit, the control circuit can be configured to provide an alert to the surgeon (e.g., via the

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or the user interface 23148 and/or 23158 associated with the surgical hub) that a conductive object is detected between the jaws. In one aspect, the surgeon may adjust the sensitivity of the control circuit via a user interface (e.g., an interactive user interface element on the surgical instrument, surgical hub, generator, etc.). In such aspects, based on the adjustment, the control circuit can be configured to prevent firing if a conductive object is detected between the jaws.

Referring again to fig. 89, according to another aspect, the control circuit 23142 can be integrated into a surgical hub 23140 that is paired (e.g., wirelessly) with the electrosurgical instrument 23102. In such aspects, the surgical hub 23140 can be preloaded with respect to surgeon/user settings in which a conductive object is detected between the jaws. In one example, the surgeon/user settings include preventing firing if a conductive object is detected between the jaws. In another example, if a conductive object is detected between the jaws, the surgeon/user settings include issuing an alert before firing is allowed. In yet another aspect, the surgeon/user settings include allowing the surgeon/user to override the alert. In yet another aspect, the surgeon/user settings include a temporary reset, allowing the surgeon/user to correct the situation (e.g., move jaws, remove conductive objects) before checking for continuity again.

Referring again to fig. 89, according to yet another aspect, the control circuit (23112, 23122, 23132 and/or 23142) can be configured to be capable of checking for conduction intentionally across the staple line. Here, in some surgical procedures, it may be beneficial to have a cross staple line to ensure a continuous transection (e.g., a lung resection, especially wedges from multiple angles, cannula procedures, etc.). In such aspects, upon detecting the conduction, the control circuitry can be configured to provide an alert (e.g., an audible and/or visual cue) to the surgeon (e.g., via

user interfaces

23138, 23128, and/or 23118 of the components of the surgical instrument, and/or user interfaces 23148 and/or 23158 associated with the surgical hub) that a conductive object (e.g., an existing staple line) is detected between the jaws.

Referring again to fig. 89, according to other aspects, the control circuit (23112, 23122, 23132, and/or 23142) can be configured to receive data from an internal database (e.g., in the

memory

23136, 23126, and/or 23116 of the components of the surgical instrument or in the surgical hub database 23149) and/or an external database (e.g., from the surgical hub database 23149, the cloud database 23150, etc.) throughout the course of the surgical procedure. According to various aspects, the data received from the internal database and/or the external database may include surgical history data (e.g., data regarding previous surgeries performed on the patient, data regarding current surgeries, etc.). In one example, the surgical history data may indicate that the staples were used in a previous surgical procedure and/or where the staples were used, and the current surgical data may indicate whether the clip applier has been used to apply the clip. Based on the received data (e.g., surgical history data, etc.), the control circuitry (23112, 23122, 23132, and/or 23142) may be configured to continually derive inferences (e.g., context information) about the ongoing procedure. That is, the surgical instrument 23120 may be situation-aware and may be configured to be able to infer/determine that the detected conduction may be a staple line from a previous surgical procedure or a clip from a current surgical procedure, for example. As another example, if the patient has never performed a surgical procedure, the clip applier has not been used for the current surgical procedure, and the staple cartridge has been fired in the current surgical procedure, the control circuitry can be configured to infer/determine that the conductive object detected between the jaws is a previous staple line. As another example, if the patient has never performed a surgical procedure, the clip applier has been used for the current procedure, and no staple cartridge has been fired in the current surgical procedure, the control circuitry can be configured to infer/determine that the conductive object detected between the jaws is a clamp.

Examples

Various aspects of the subject matter described herein under the heading "SAFETY SYSTEMS FOR SMART POWER DSURGICAL STAPLING" are set forth in the following examples:

example 1-a surgical system comprising a control circuit and a surgical instrument. The surgical instrument includes a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly coupled to a distal end of the shaft assembly. The end effector assembly includes a first jaw, a second jaw pivotably coupled to the first jaw, and a sensor. The sensor is configured to detect a parameter associated with a function of the end effector and transmit the detected parameter to the control circuit. The control circuit is configured to analyze the detected parameter based on system-defined constraints and prevent at least one function of the surgical instrument based on the analysis. The surgical system also includes a user interface configured to provide a current status regarding at least one prevented function of the surgical instrument.

Embodiment 2-the surgical system of embodiment 1, wherein the system-defined constraints comprise at least one of a predefined parameter or a predefined parameter range based on historical data associated with a surgical procedure performed by the surgical system.

Example 3-the surgical system of examples 1 or 2, wherein the current state includes a first message that at least one function of the surgical instrument is prevented and a second message indicating a reason for the at least one function of the surgical instrument being prevented.

Example 4-the surgical system of examples 1, 2, or 3, wherein the user interface includes a user interface element selectable to override the control circuit to allow at least one function of the surgical instrument.

Example 5-the surgical system of examples 1, 2, 3, or 4, wherein the sensor comprises a force sensor coupled to the end effector, wherein the detected parameter comprises a force applied to at least one of the first jaw or the second jaw of the end effector, and wherein the at least one function prevented via the control circuitry comprises one or more of: preventing use of an attached shaft, preventing the start of a firing cycle, preventing articulation of an end effector, preventing rotation of a shaft, or preventing opening of one or more of a first jaw or a second jaw.

Example 6-the surgical system of examples 1, 2, 3, 4, or 5, wherein the function of the end effector associated with the detected parameter comprises a gripping function, and wherein the at least one function of the surgical instrument prevented via the control circuit comprises one or more of: dissection, coagulation, suture, or cutting functions.

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

Embodiment 8-the surgical system of embodiment 7, wherein one of the handle assembly or the surgical hub comprises a user interface.

Example 9-the surgical system of examples 1, 2, 3, 4, 5, 6, 7, or 8, wherein one of the handle assembly, shaft assembly, or end effector assembly of the surgical instrument comprises a control circuit.

Example 10-the surgical system of examples 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the shaft assembly comprises a sensor configured to detect a shaft parameter associated with a function of the shaft and transmit the detected shaft parameter to the control circuit. The control circuit is also configured to prevent at least one function of the surgical instrument further based on the detected shaft parameter.

Example 11-a surgical system comprising a surgical hub and a surgical instrument communicatively coupled to the surgical hub. The surgical instrument includes a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly coupled to a distal end of the shaft assembly. The end effector assembly includes a first jaw, a second jaw pivotably coupled to the first jaw, and a sensor. The sensor is configured to detect a parameter associated with a function of the end effector and transmit the detected parameter to the surgical hub. The surgical hub includes a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to analyze the detected parameters based on system-defined constraints and prevent at least one function of the surgical instrument based on a result of the analysis. The surgical system also includes a user interface configured to provide a current status regarding at least one prevented function of the surgical instrument.

Example 12-the surgical system of example 11, wherein the system-defined constraints comprise at least one of a predefined parameter or a predefined parameter range based on historical data associated with a surgical procedure performed by the surgical system.

Example 13-the surgical system of examples 11 or 12, wherein the current state includes a first message that at least one function of the surgical instrument is prevented and a second message indicating a reason for the at least one function of the surgical instrument being prevented.

Example 14-the surgical system of examples 11, 12, or 13, wherein the user interface includes a user interface element selectable to override the surgical hub to allow at least one function of the surgical instrument.

Example 15-the surgical system of examples 11, 12, 13, or 14, wherein the sensor comprises a force sensor coupled to the end effector, wherein the detected parameter comprises a force applied to at least one of the first jaw or the second jaw of the end effector, and wherein the at least one function prevented via the surgical hub comprises one or more of: preventing use of an attached shaft, preventing the start of a firing cycle, preventing articulation of an end effector, preventing rotation of a shaft, or preventing opening of one or more of a first jaw or a second jaw.

Example 16-the surgical system of examples 11, 12, 13, 14, or 15, wherein the function of the end effector associated with the detected parameter comprises a clamping function, and wherein the at least one function of the surgical instrument prevented via the surgical hub comprises one or more of: dissection, coagulation, suture, or cutting functions.

Example 17-the surgical system of examples 11, 12, 13, 14, 15, or 16, wherein at least one of the handle assembly or the surgical hub comprises a user interface.

Example 18-the surgical system of examples 11, 12, 13, 14, 15, 16, or 17, wherein the shaft assembly comprises a sensor configured to detect a shaft parameter associated with a function of the shaft and transmit the detected shaft parameter to the surgical hub. The memory also stores instructions executable by the processor to prevent at least one function of the surgical instrument further based on the detected shaft parameter.

Example 19-a non-transitory computer readable medium storing computer readable instructions that, when executed, cause a processor to analyze a detected parameter associated with a function of an end effector of a surgical system based on system-defined constraints, the surgical system comprising a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly coupled to a distal end of the shaft assembly. The end effector assembly includes a first jaw, a second jaw pivotably coupled to the first jaw, and a sensor configured to detect the detected parameter and transmit the detected parameter to the machine. The instructions, when executed, further cause the machine to prevent at least one function of the surgical system based on a result of the analysis, and generate a user interface. The user interface provides a current status regarding at least one prevented function of the surgical system.

Embodiment 20-the non-transitory computer-readable medium of embodiment 19, further comprising instructions that, when executed, further cause the machine to generate an overwrite element on the user interface. The override element is selectable to allow at least one function of the surgical system.

For intelligent electric surgeryStitched security system

Safety system for evaluating operating parameters

Various aspects of the present disclosure relate to improved safety systems that are capable of adjusting, controlling, and/or tuning the internal driving operation of a surgical instrument in response to tissue parameters detected via one or more sensors of the surgical instrument. More particularly, various aspects relate to sensing and indicating the adequacy of current device parameters to sensed tissue parameters.

For example, the sensed tissue parameters may include the type of tissue, the thickness of the tissue, the stiffness of the tissue, the location of the tissue on the patient's anatomy, vascularization of the tissue, etc., and the current device parameters may include cartridge color, cartridge type, attachment, clamp load, gap, firing rate, etc. Thus, according to aspects of the present disclosure, physiological sensing may indicate improper use of the device or components thereof and/or improper positioning of the device.

In one example, improper use of the surgical instrument or components thereof and/or improper positioning of the surgical instrument may be determined via an associated control circuit based on physiological sensing detected via one or more sensors at a jaw of the end effector. In such an example, the associated control circuitry may prevent one or more functions of the end effector (e.g., stapling) from being performed after a determined improper use and/or a determined incorrect positioning. Further, in such examples, the associated control circuitry may allow one or more functions of the end effector if the associated control circuitry determines that the positioning of the surgical instrument or components thereof and/or the surgical instrument has been rectified (e.g., an incorrect staple cartridge replaced, a surgical instrument repositioned, etc.) or an override has been received (e.g., via a user interface on the surgical instrument, a user interface coupled to a surgical hub of the surgical instrument, a user interface in a surgical operating room, etc.).

Referring to fig. 94, according to various aspects of the present disclosure, a surgical system 24200 can include control circuitry (24212, 24222, 24232, and/or 24242, e.g., one or more optional locations shown in phantom), a user interface (24214, 24224, 22234, 24244, and/or 24254, e.g., one or more optional locations shown in phantom), and a surgical instrument 24202. The surgical instrument 24202 includes a number of components, such as component-a 24216 through component-N24218 of the end effector assembly 24210, and similarly, for purposes of illustration, includes in abbreviated form the components-a (C-a) through-N (C-N) of the shaft assembly 24220 and handle assembly 24230, respectively. In various aspects, each component of the surgical instrument 24202 may include at least one device parameter. For example, the component-A24216 of the end effector assembly 24210 may comprise the parameter PAa-PAn 24217, the component-N24218 of the end effector assembly 24210 may comprise the parameter PNa-PNn 24219, and so on. As another example, each of the C-a to C-N of the shaft assembly 24220 and each of the C-a to C-N of the handle assembly 24230 can similarly include at least one device parameter. Each component may be configured to be capable of transmitting its one or more respective device parameters to the control circuitry. The surgical instrument 24202 also includes a sensor (24213, 24223, and/or 24233) configured to detect a tissue parameter associated with a function of the surgical instrument and transmit the detected tissue parameter to the control circuit. The control circuitry may be configured to analyze the detected tissue parameters in cooperation with each respective device parameter based on system-defined constraints.

Referring again to fig. 94, in various aspects, the control circuits 24212, 24222, and/or 24232 (e.g., elements shown as the end effector assembly 24210, the shaft assembly 24220, and the handle assembly 24230, respectively) can be integrated into one or more of the various components of the surgical instrument 24202 (e.g., the handle of the handle assembly 24230, the shaft of the shaft assembly 24220, the end effector of the end effector assembly 24210, the staple cartridge of the end effector assembly, etc.) or into a surgical hub 24240 (e.g., 24242) that is paired (e.g., wirelessly) with the surgical instrument 24202. Similarly, one or

more sensors

24213, 24223, and/or 24233;

user interfaces

24214, 24224, and/or 24234; and in various aspects, the memory 24215, 24225, and/or 24235 (e.g., elements shown as the end effector assembly 24210, the shaft assembly 24220, and the handle assembly 24230, respectively) can be integrated into one or more of a plurality of components. Notably, according to various aspects, the surgical instrument 24202 and/or the surgical hub 24240 can be a situation-aware surgical instrument and/or a situation-aware surgical hub. Situational awareness refers to the ability of a surgical system (e.g., 24200) to determine or infer information related to a surgical procedure from data received from a database (e.g., historical data associated with the surgical procedure) and/or data received from a surgical instrument (e.g., sensor data during the surgical procedure). For example, the determined or inferred information may include the type of procedure being performed, the type of tissue undergoing surgery, the body cavity that is the subject of the procedure, and the like. Based on such contextual information relating to the surgical procedure, the surgical system may, for example, control the pair of surgical instruments or components thereof throughout the surgical procedure and/or provide contextual information or recommendations to the surgeon.

According to one aspect, a situational aware surgical hub (e.g., 24240) is paired with (e.g., wirelessly) a surgical instrument 24202 for performing a surgical procedure. In such aspects, the surgical instrument 24202 may comprise multiple components, including an end effector (e.g., component-a 24216). The end effector 24216 can include a first jaw, a second jaw pivotably coupled to the first jaw, a cutting blade, and an integrated sensor 24213 configured to detect a tissue parameter associated with a function of the end effector 24216 (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) and transmit the detected tissue parameter to the control circuitry 24242 of the surgical hub 24240. Each of the plurality of components (e.g., component-N24218, e.g., staple cartridge, etc.) of the surgical instrument 24202 including the end effector 24216 is also configured to transmit its respective device parameter(s) (e.g., 24219 and 24217, respectively) to the surgical hub 24240. Notably, it should be appreciated that, as referenced herein and in other disclosed aspects, the sensors (e.g., 24213) can include a plurality of sensors configured to be capable of detecting a plurality of tissue parameters associated with a plurality of end effector 24216 functions. Thus, in addition, in such aspects, the surgical hub control circuit 24242 can be configured to receive such parameter data (e.g., one or more detected tissue parameters, device parameters for each component comprising the end effector, etc.) throughout the surgical procedure. The detected tissue parameters may be received each time an associated end effector function (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) is to be performed. The surgical hub control circuit 24242 can also be configured to receive data from an internal database (e.g., surgical hub database 24249) and/or an external database (e.g., from cloud database 24269) throughout the course of a surgical procedure. According to various aspects, the data received from the internal database 24249 and/or the external database 24269 may include protocol data (e.g., steps of performing a surgical procedure, data indicative of respective device parameters associated with the surgical procedure) and/or historical data (e.g., data indicative of expected tissue parameters based on historical data associated with the surgical procedure, surgical history data for the patient, etc.). In various aspects, the protocol data may include current/recognized standard of care protocols for the surgical procedure, and the historical data may include preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges (e.g., system-defined constraints) for each received device parameter based on the historical data associated with the surgical procedure. Based on the received data (e.g., parametric data, internal and/or external data, etc.), the surgical hub control circuit 24242 can be configured to continually derive inferences (e.g., background information) about the surgical procedure being performed. That is, the situational aware surgical hub may be configured to, for example, record data related to the surgical procedure used to generate the report, verify the steps the surgeon is taking to perform the surgical procedure, provide data or prompts that may be related to particular procedure steps (e.g., via user interface 24244 and/or user interface 24254 and/or

user interfaces

24214, 24224, and/or 24234 associated with the surgical hub), control surgical instrument functions, and the like.

According to another aspect, a situational aware surgical instrument (e.g., 24202) may be used to perform a surgical procedure. In such aspects, the surgical instrument 24202 may comprise multiple components, including the end effector 24216, as described herein. The end effector may include a first jaw, a second jaw pivotably coupled to the first jaw, a cutting blade, and an integrated sensor 24213 configured to detect a tissue parameter associated with a function of the end effector 24216 (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) and to transmit the detected tissue parameter to the control circuitry. Notably, in such aspects, the detected tissue parameters can be transmitted to the integrated control circuit 24212 of the end effector 24216. Each of the plurality of components of the surgical instrument (e.g., component-N24218, e.g., a staple cartridge, etc.) including the end effector 24216 is configured to transmit its respective device parameter(s) to the integrated end effector control circuit 24212. In such aspects, the integrated end effector control circuit 24212 may be configured to receive such parameter data (e.g., one or more detected tissue parameters, one or more device parameters including each component of the end effector) throughout the surgical procedure. The detected tissue parameters may be received each time an associated end effector function (e.g., dissection, clamping, coagulation, cutting, stapling, etc.) is to be performed. The integrated end effector control circuit 24212 may also be configured to receive data from internal databases (e.g., the end effector memory 24215) and/or external databases (e.g., from the cloud database 24269 via the surgical hub 24240, from the surgical hub database 24249, etc.) throughout the course of a surgical procedure. According to various aspects, the data received from the internal database and/or the external database may include staple cartridge data (e.g., the size and/or type of staples associated with a staple cartridge (e.g., 24218) for which one or more device parameters have been received by the end effector control circuitry 24212) and/or historical data (e.g., data indicative of expected tissue and/or the type of tissue to be stapled with those sizes and/or types of staples based on the historical data). In various aspects, the internal data and/or the external data may include preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges (e.g., system-defined constraints) for each received device parameter based on historical data associated with the surgical procedure. In one example, based on historical data (e.g., system-defined constraints), the internal data and/or the external data may include preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges for an expected tissue and/or tissue type or for a size and/or type of staples associated with device parameters of a staple cartridge (e.g., 24218). Based on the received data (e.g., parametric data, internal and/or external data, etc.), the end effector control circuitry 24212 can be configured to continually derive inferences (e.g., contextual information) about the procedure being performed. Notably, according to alternative aspects, the integrated sensor 24213 of the end effector 24216 can transmit the one or more detected tissue parameters to control circuitry (e.g., 24222 and/or 24232) associated with another surgical instrument component (e.g., the handle of the handle assembly 24230). In such aspects, other surgical instrument component control circuits (e.g., 24222 and/or 24232) may similarly be configured to perform various aspects of the end effector control circuit 24212 as described above. Finally, the situational aware surgical instrument (e.g., 24202) may be configured to, for example, alert its user of the discrepancy (e.g., via the user interface 24214 of the end effector, via the user interfaces 24224 and/or 24234 of another surgical instrument component (e.g., the handle of the handle assembly 24230), or via the user interface 24244 associated with the surgical hub 24240 coupled to the surgical instrument 24202). For example, the difference may include the detected tissue parameter exceeding a preferred/desired tissue parameter and/or preferred/desired tissue parameter range associated with those sizes and/or types of staples or those expected tissues and/or tissue types. As another example, a situational aware surgical instrument (e.g., 24202) may be configured to control a surgical instrument function based on the difference. According to at least one aspect, a situational aware surgical instrument (e.g., 24202) may prevent surgical function based on the difference.

Improper device placement

According to various aspects of the present disclosure, physiological sensing (e.g., detection via one or more sensors) may indicate a device placement issue. More particularly, according to such aspects, physiological incompatibilities may exist within/between the first and second jaws of the end effector (e.g., after clamping), and other functions of the end effector (e.g., coagulation, cutting, stapling, etc.) may be inhibited/prevented.

According to various aspects, the surgical procedure may include resecting a target tissue (e.g., a tumor). Referring to fig. 92, for example, a portion of patient tissue 24000 can include a tumor 24002. In such aspects, a surgical margin 24004 can be defined around the tumor 24002. Notably, during surgery, it is desirable to avoid and/or minimize resection of healthy tissue surrounding the tumor. However, to ensure complete removal of the tumor, current/accepted standard of care procedures associated with this surgical procedure may support resection of a predetermined surgical margin defined by a distance around the tumor and/or a predetermined surgical margin range defined by a range of distances around the tumor. In one aspect, the surgical margins supported can be tumor-based (e.g., based on the type of tumor, the size of the tumor, etc.). In another aspect, the surgical margin supported may depend on the degree to which the tumor micro-invades the surrounding tissue. In other aspects, the supported surgical margin can be associated with improved long-term survival based on historical data associated with the tumor and/or the surgical procedure. In other aspects, the associated control circuitry (e.g., in accordance with fig. 94, in the surgical instrument, in a component of the

surgical instrument

24212, 24222, 24232, in a surgical hub coupled to the surgical instrument, etc.) can actively adjust the supported surgical margin based on data received from the internal databases 24215, 24225, and/or 24235 and/or the external databases 24249 and/or 24269 (e.g., patient surgical history data, patient medical history data, standard of care protocols for recurring tumors, etc., from the cloud, from the surgical hub, etc.). In such aspects, referring back to fig. 92, the generally supported surgical margin (e.g., 24004) can make changes to the adjusted surgical margin (e.g., 24012) in a determined amount/distance (e.g., 24010) based on such received data (e.g., the patient's surgical history data and/or medical history data can indicate that the tumor may have further micro-invaded surrounding tissue, the patient may have had instances of a recurring tumor, etc.).

Moreover, in various aspects, after establishing a target surgical margin (e.g., 24004 and/or 24012) for a surgical procedure, it can be difficult to effectively and/or accurately identify and resect a tumor and/or its target surgical margin during the surgical procedure. Referring again to fig. 94, according to various aspects of the present disclosure, the end effector (e.g., 24216) of the surgical instrument 24202 may include a first sensor (e.g., 24213) configured to measure and transmit a first signal to an associated control circuit (e.g., in the surgical instrument, in a component of the surgical instrument 24212, 24222, and/or 24232, in a surgical hub coupled to the surgical instrument, 24242, etc.). In such aspects, a second sensor configured to measure and transmit a second signal to associated control circuitry may be positioned on/within the tumor prior to resection of the tumor using the surgical instrument (see fig. 92, e.g., relative to a central location 24006 of the tumor). Here, according to various aspects, the second sensor may be separate from the surgical instrument. Additionally and/or alternatively, in such aspects, the second sensor can comprise a sensor positioned at the periphery of the tumor (see fig. 92, e.g., 24008) prior to resection of the tumor using the surgical instrument. According to another aspect, a plurality of second sensors may be positioned around the periphery of the tumor. Here, in such aspects, the control circuit may be configured to be capable of dynamically calculating the distance between the first sensor and the second sensor based on the first signal and the second signal. According to various aspects, the first sensor may be positioned at/near a cutting blade of the end effector. Additional exemplary METHODs FOR detecting a surgical edge of a target are described in U.S. patent application publication No.2016/0192960, entitled "SYSTEM AND METHOD FOR A time reset marker DEVICE," the entire disclosure of which is incorporated herein by reference.

In one example, if the second sensor is positioned on/within the tumor (e.g., at center location 24006), the control circuitry can also be configured to determine an edge distance between the second sensor and a target surgical edge established for the surgical procedure. In such examples, the control circuitry can compare the dynamically calculated distance (e.g., the distance between the first sensor and the second sensor) to the determined edge distance to effectively and accurately position the end effector (e.g., cutting blade) at the targeted surgical edge (e.g., the end effector is positioned correctly when the dynamically calculated distance is equal or substantially equal to the determined edge distance). The control circuitry may be configured to utilize such techniques to effectively and accurately position an end effector (e.g., cutting blade) around a target surgical edge (e.g., during resection).

In another example, if the second sensor is positioned at the periphery of the tumor or a plurality of second sensors are positioned around the periphery of the tumor (e.g., 24008), the control circuitry may be further configured to determine an edge distance between the one or more second sensors and a target surgical edge established for the surgical procedure. In such examples, the control circuitry can compare the dynamically calculated distance (e.g., the distance between the first sensor and the second sensor) to the determined edge distance to effectively and accurately position the end effector (e.g., cutting blade) at the targeted surgical edge (e.g., the end effector is positioned correctly when the dynamically calculated distance is equal or substantially equal to the determined edge distance). The control circuitry may be configured to utilize such techniques to effectively and accurately position an end effector (e.g., cutting blade) around a target surgical edge (e.g., during resection). Such aspects may be beneficial when the tumor is abnormally shaped.

Referring again to fig. 94, according to various aspects, the control circuit can be configured to notify the surgeon (e.g., via real-time notification of the

user interfaces

24214, 24224, and/or 24234 on the surgical instrument, the user interface 24244 coupled to the surgical hub of the surgical instrument, and/or the user interface 24254 in the surgical operating room, etc.) when the end effector (e.g., or cutting blade thereof) is properly positioned relative to the target surgical edge (e.g., 24004 and/or 24012). For example, the user interface may include at least one of: i) a video image of the surgical site with a digital overlay indicating a target surgical edge of the surgeon to visually confirm positioning and/or navigation of the end effector (e.g., or a cutting blade thereof) at and/or relative to the target surgical edge, ii) tactile feedback in the surgical instrument 24202 itself to indicate positioning of the cutting blade of the end effector at the target surgical edge, and/or iii) audible feedback to indicate positioning of the cutting blade of the end effector at the target surgical edge.

Referring again to fig. 94, according to further aspects, the control circuitry can be configured to prevent firing of the surgical instrument 24202 if the end effector (e.g., cutting blade) is too close to the cancerous edge and/or within the cancerous edge (e.g., within the targeted surgical edge, near surrounding tissue micro-invaded by a tumor, etc.). According to such aspects, the control circuitry may also be configured to receive an override command (e.g., via a

user interface

24214, 24224, and/or 24234 on the surgical instrument, a user interface 24244 coupled to a surgical hub of the surgical instrument, and/or a user interface 24254 in the surgical operating room, etc.) to allow firing to continue. In one example, such a user interface may include a user interface element that is selectable to allow firing to continue, e.g., 24251. In such aspects, the control circuitry may continue to monitor the end effector (e.g., or cutting blade thereof) relative to the cancerous edge. Further, in such aspects, the control circuitry may be configured to again stop firing, alert the surgeon and/or receive an override command as described. According to other aspects, the control circuitry can be configured to prevent firing until a reset event occurs (e.g., opening jaws of the end effector and repositioning the jaws of the end effector relative to the cancerous edge).

Referring again to fig. 94, according to other aspects of the present disclosure, the one or more sensors of the surgical system 24200 can detect blood flow through tissue clamped between/within the first and second jaws of the end effector (e.g., 24216). For example, a doppler imaging detector (e.g., integrated on the end effector 24213, coupled to a surgical hub, such as a parameter sensing component 24253 including a doppler imaging detector, etc.) may be configured to be capable of locating and identifying blood vessels that may not otherwise be visible at the surgical site (e.g., via red, green, and/or blue lasers), and may perform speckle contrast analysis to determine blood flow and/or blood velocity through such blood vessels. Notably, in one example, it may be desirable to seal some blood vessels (e.g., blood vessels associated with a tumor) but not other blood vessels (e.g., blood vessels associated with healthy tissue/organs). Accordingly, associated control circuitry (e.g., in a surgical instrument, 24212, 24222, and/or 24232 in a component of the surgical instrument, 24242 in a surgical hub coupled to the surgical instrument, etc.) may be configured to prevent firing of the surgical instrument 24202 if blood flow exceeds a predetermined blood flow and/or blood flow velocity. According to such aspects, the control circuitry may also be configured to receive an override command (e.g., via a

user interface

24214, 24224, and/or 24234 on the surgical instrument, a user interface 24244 on a surgical hub coupled to the surgical instrument, and/or a user interface 24254 in the surgical operating room, etc.) to allow firing to continue (e.g., if blood flow is associated with the tumor). In one example, such a user interface may include a user interface element that is selectable to allow firing to continue, e.g., 24251. In such aspects, the control circuitry may continue to monitor blood flow of the clamped tissue. Further, in such aspects, the control circuitry may be configured to again stop firing, alert the surgeon and/or receive an override command as described. According to other aspects, the control circuitry can be configured to prevent firing until a reset event occurs (e.g., opening the jaws and repositioning the jaws of the end effector relative to a blood vessel comprising blood flow in excess of a predefined blood flow and/or blood flow velocity).

Referring again to fig. 94, in accordance with other aspects of the present disclosure, the one or more sensors of the surgical system 24200 can detect an increase in blood pressure while and/or immediately after clamping tissue between/within the first and second jaws of the end effector (e.g., 24216). For example, a blood pressure monitor (e.g., coupled to a surgical hub, e.g., including a parameter sensing component 24253 of the blood pressure monitor, etc.) can detect an increase in blood pressure that occurs concurrently with clamping. According to various aspects, the surgical system 24200 is situational aware and can infer that a detected increase in blood pressure is caused by clamping tissue between/within the jaws of the end effector. For example, blood vessels that include critical blood flow may have become trapped between/within the jaws, causing blood flow to constrict. Thus, according to various aspects, the associated control circuitry (e.g., in a surgical instrument, 24212, 24222, and/or 24232 in a component of the surgical instrument, 24242 in a surgical hub coupled to the surgical instrument, etc.) may be configured to prevent firing of the surgical instrument 24202 if blood pressure rises above a predetermined amount and/or a predetermined range. According to such aspects, the control circuitry may also be configured to receive an override command (e.g., via

user interfaces

24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 coupled to a surgical hub of the surgical instrument, and/or user interface 24254 in a surgical operating room, etc.) to allow firing to continue (e.g., the surgeon observes that blood pressure has dropped while tissue is still clamped, that the situational aware surgical system attributes the blood pressure to another cause, etc.). In one example, such a user interface may include a user interface element that is selectable to allow firing to continue, e.g., 24251. In such aspects, the control circuitry may continue to monitor the patient's blood pressure. Further, in such aspects, the control circuitry may be configured to again stop firing, alert the surgeon and/or receive an override command as described. According to other aspects, the control circuitry can be configured to prevent firing until a reset event occurs (e.g., opening the jaws and repositioning the jaws of the end effector relative to the clamped tissue).

Referring again to fig. 94, according to other aspects of the present disclosure, the one or more sensors of the surgical system can detect a number of nerve bundles within tissue clamped between/within the first jaw and the second jaw of the end effector (e.g., 24216). For example, a heart rate monitor (e.g., integrated onto the end effector 24213, coupled to a surgical hub (e.g., a parameter sensing component 24253 including a heart rate monitor), etc.) can detect an increase in heart rate while and/or immediately after clamping tissue between/within the first and second jaws. According to various aspects, the surgical system 24200 is situation-aware and, in the context of data received from the

internal databases

24215, 24225, 24235, 24249 and/or the external databases 24249 and/or 24269 (e.g., anatomical information associated with the surgical site of the surgical procedure being performed), can infer that the detected heart rate increase was caused by clamping tissue between/within the jaws of the end effector. According to such aspects, the associated control circuitry (e.g., in the surgical instrument, in a component of the surgical instrument 24212, 24222, and/or 24232, in a surgical hub coupled to the surgical instrument 24242, etc.) can be configured to prevent firing of the surgical instrument 24202 based on the inference. Further, according to such aspects, the control circuitry may be configured to receive an override command (e.g., via

user interfaces

24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 coupled to a surgical hub of the surgical instrument, and/or user interface 24254 in a surgical operating room, etc.) to allow firing to continue (e.g., the surgeon observes that the patient's heart rate has dropped while the tissue is still clamped, that the situation-aware surgical system attributes the heart rate to another cause, etc.). In one example, such a user interface may include a user interface element that is selectable to allow firing to continue, e.g., 24251. In such aspects, the control circuitry may continue to monitor the heart rate of the patient. Further, in such aspects, the control circuitry may be configured to again stop firing, alert the surgeon and/or receive an override command as described. According to other aspects, the control circuitry can be configured to prevent firing until a reset event occurs (e.g., opening the jaws and repositioning the jaws of the end effector relative to the clamped tissue).

Referring again to fig. 94, according to other aspects of the present disclosure, the one or more sensors of the surgical system 24200 can detect that the surgical instrument 24202 is in contact with an energizing device (e.g., an RF instrument/device). In one example, the surgical instruments and energizing devices are communicatively coupled to a surgical hub 24240 in a surgical system 24200. For example, referring back to fig. 9, the devices/instruments 235 and the energy devices 241 can be coupled to the modular control tower 236 of the surgical hub 206. In such examples, any of the generator 240 that generates electrosurgical energy for the energized device 241 and/or a sensor integrated into the energized device may be configured to detect when the impedance associated with the energized device falls below a threshold for a threshold period of time (i.e., a drop in impedance indicative of a short circuit). Similar to fig. 48, the integrated sensor of the powered device may be configured to be able to measure impedance over time. Various alternative methods for detecting short circuits, such as those described in U.S. patent No.9,554,854, entitled "DETECTING SHORT CIRCUITSIN ELECTROSURGICAL MEDICAL DEVICES," are expressly incorporated herein by reference (e.g., comparing impedance values at different locations within a pulse of a series of pulses, etc.). According to various aspects, the surgical system 24200 is situational aware and, in the case of data received from

internal databases

24215, 24225, 24235, 24249 and/or external databases 24249 and/or 24269 (e.g., protocol data indicating steps of a surgical procedure involving the use of a separate surgical instrument (e.g., electrosurgical instrument/device) and/or current steps), it may be inferred that a detected short circuit was caused by the separate surgical instrument (e.g., a conductive surface of the surgical instrument may be in contact with an energized device, causing a short circuit). According to such aspects, the associated control circuitry (e.g., in the surgical instrument, in a component of the surgical instrument 24212, 24222, and/or 24232, in a surgical hub coupled to the surgical instrument and the energizing device 24242, etc.) can be configured to prevent firing of the surgical instrument 24202 based on the inference. If a short circuit is present, it may be difficult to treat (e.g., coagulate) tissue with electrosurgical energy (e.g., RF energy), and may lead to undesirable surgical results (e.g., incomplete tissue treatment, excessive heating of electrically conductive objects, etc.). In such a case, the control circuit can be configured to notify the surgeon (e.g., via real-time notification of the

user interfaces

24214, 24224, and/or 24234 on the surgical instrument, the user interface 24244 on a surgical hub coupled to the surgical instrument, and/or the user interface 24254 in the surgical operating room, etc.) that a short circuit exists and that firing of the surgical instrument 24202 has been suspended. Further, according to such aspects, the control circuitry may also be configured to receive an override command (e.g., via

user interfaces

24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and/or user interface 24254 in the surgical operating room, etc.) to allow firing to continue (e.g., the surgeon confirms that there is no short circuit, the target tissue comprises a low impedance, etc.). In one example, such a user interface may include a user interface element that is selectable to allow firing to continue, e.g., 24251. In such aspects, the control circuit may continue to monitor for shorts. Further, in such aspects, the control circuitry may be configured to again stop firing, alert the surgeon and/or receive an override command as described. According to other aspects, the control circuit can be configured to prevent firing until a reset event occurs (e.g., the surgical instrument is repositioned relative to the energizing device such that the two are no longer in contact).

Inappropriate device selection/proposed use

According to various aspects of the present disclosure, physiological sensing (e.g., detection via one or more sensors) may indicate a surgical instrument/device selection issue. More particularly, according to such aspects, surgical device-tissue incompatibility may exist and other functions of the end effector (e.g., coagulation, cutting, stapling, etc.) may be inhibited/prevented.

Referring again to fig. 94, according to an aspect of the present disclosure, the control circuitry (e.g., in the components 24212, 24222, and/or 24232 of the surgical instrument, in the surgical hub coupled to the surgical instrument, etc.) can be configured to provide a warning if any combination of tissue-specific staplers (e.g., vascular staplers) and sensed information (e.g., information detected via one or more sensors) indicates that the target tissue may not be suitable (e.g., counter-indicating) for that tissue-specific stapler.

Fig. 93 illustrates an example security process 24100 for solving the device selection problem in accordance with various aspects of the present disclosure. According to at least one aspect, the safety procedure 24100 may be performed/implemented (e.g., during a surgical procedure) by control circuitry (e.g., 24242 of fig. 94) associated with a situational aware surgical hub of a surgical system (e.g., 24200 of fig. 94). According to other aspects, the safety process 24100 may be performed/implemented (e.g., during a surgical procedure) by control circuitry (e.g., 24212, 24222, and/or 24232 of fig. 94) associated with a situational aware surgical instrument of a surgical system (e.g., 24200 of fig. 94).

Referring to fig. 93, the tissue identification process 24108 can receive input including device selection 24102 (e.g., stapler selection, e.g., staplers suitable for substantial firing, staplers suitable for vascular firing, staplers suitable for bronchial firing, etc.), various device measurements 24104 (e.g., end effector closure angle, length of tissue in contact with the end effector, closure force/compression curve, etc.) detected by one or more sensors, and situational awareness information 24106 (e.g., protocol information, surgeon preference, etc.).

According to fig. 93, at a device selection 24102, the control circuitry executing/implementing the safety process 24100 can be configured to receive device parameters from and/or associated with each component (e.g., staple cartridge) of the selected stapler/device to indicate the device selection. For example, device parameters associated with a staple cartridge may include the type of cartridge, the color of the cartridge, the appendages of the cartridge, the clamp load limit of the cartridge, the gap range of the cartridge, the firing rate of the cartridge, and the like. According to one aspect, one or more device parameters may be transmitted by the stapler/device to the control circuit when coupled to the surgical system. According to an alternative aspect, device selections may be entered via a user interface (e.g., associated with a surgical hub and/or in a surgical suite, such as 24244 and/or 24254 of fig. 94) and/or received from an internal database and/or an external database (e.g., data regarding the surgical procedure being performed and/or available surgical instruments, such as 24249 and/or 24269 of fig. 94).

Additionally, according to fig. 93, device measurements 24104 can be detected via one or more sensors (e.g., as described herein in fig. 17, 18, 53, 78, etc.) associated with the end effector (e.g., part-a, 24216 of fig. 94) and/or other parts of the surgical instrument (part-N, 24218 of fig. 94 (e.g., a staple cartridge)). For example, one or more tissue sensors may be positioned and configured to be used to check conduction and/or measure tissue impedance along the length of the end effector to assess the length of tissue in contact with the end effector (e.g., one or more sensors 738 of fig. 17 determine tissue location and/or measure tissue impedance using segmented electrodes, sensor 153468 of fig. 78 determines the presence of tissue along the length of the end effector, etc.). As another example, one or more sensors can be positioned and configured to be capable of detecting/evaluating jaw/end effector closure angles (e.g., a displacement sensor (e.g., position sensor 734 of fig. 17) to detect displacement of the clamp actuator/drive member, a gap sensor (e.g., sensor 152008a of fig. 53) to detect a gap between the first and second jaws of the end effector, etc.). As another example, one or more sensors can be positioned and configured to be capable of detecting a force compressing/closing tissue between the first jaw and the second jaw (e.g., a force sensor on a tissue surface of the first jaw and/or the second jaw (e.g., sensor 738 of fig. 17 including a force sensor) to detect a force while clamping tissue, a sensor (e.g., current sensor 736 of fig. 17) to detect a current draw of the drive member related to a force applied to tissue, a torque sensor (e.g., 744b of fig. 17) to measure a closing force, etc.). Various other aspects for detecting the end effector closure angle, the length of tissue in contact with the end effector, and the closure force/compression curve have been discussed elsewhere herein.

Next, in accordance with fig. 93, the surgical perception information 24106 may be received via the internal database 24249 and/or the external database 24269 associated with the surgical hub 24242 and/or via the

internal databases

24215, 24225, 24235 and/or the

external databases

24249, 24269, etc. associated with the surgical instrument 24202, as per fig. 94.

Returning to fig. 93, the tissue identification process 24108 is configured to be able to determine the type of tissue (e.g., parenchyma, blood vessels, bronchi, etc.) encountered by the surgical instrument. In one example, the tissue identification process 24108 can determine that the tissue type is parenchymal based on various inputs (e.g., tissue contact detected along the length of the jaws when the jaws are fully open, closure versus aperture curve indicating that the tissue is substantially identical, etc.). In another example, the tissue identification process 24108 can determine that the tissue type is a blood vessel (e.g., PA/PV) based on various inputs (e.g., tissue contact detected almost immediately during closure, tissue contact detected as being only on a small area of the stapler and detected as being defined on the distal side, an initial detected closure force indicating that the tissue structure is consistent with the blood vessel, etc.). In another example, the tissue identification process 24108 can determine that the tissue type is bronchial based on various inputs (e.g., tissue contact detected almost immediately during closure, tissue contact detected as being over a small region of the stapler and detected as being defined on both the distal and proximal sides, an initial detected closure force indicating that a rigid tissue structure is in line with the bronchi, etc.). According to various aspects, such tissue type determinations may also be based on tissue parameters including thickness of the tissue, stiffness of the tissue, location of the tissue (e.g., relative to the patient), and vascularization in the tissue detected by and/or derived from measurements made via one or more sensors described herein. Notably, prior to deriving the tissue identification output/result, the tissue identification process 24108 may further evaluate such initial tissue determination in the context of additional inputs (e.g., stapler selection, surgical information, surgeon preference, etc.). This situational awareness ultimately produces tissue recognition output/results. Various aspects for identifying encountered tissue have been further discussed elsewhere herein (e.g., thoracic surgical examples, etc.).

Referring back to fig. 93, the tissue recognition output/results can be used to determine 24110 whether the selected stapler/device and/or each component (e.g., staple cartridge, shaft, etc.) of the selected stapler/device is optimal for the surgical procedure. In such aspects, the control circuit may receive the additional information 24112 from internal and/or external databases (e.g., see fig. 94, internal and/or

external databases

24249, 24269 associated with the surgical hub 24242, internal and/or

external databases

24215, 24225, 24235 and/or

external databases

24249, 24269 associated with the surgical instrument 24202, etc.). More specifically, additional information 24112 may include other available staplers, other available energy devices, other stapler components (e.g., staple cartridge, shaft, etc.) available for use with the selected stapler/device, etc. According to at least one aspect, availability may be limited by current inventory at the surgical site. Notably, the additional information 24112 can also include device parameters associated with each other available stapler, each other available energy device, each other stapler component available for use with the selected stapler/device, and the like.

According to various aspects, when evaluating whether the selected stapler/device is optimal 24110, the control circuitry executing/implementing the safety process 24100 may be configured to be capable of analyzing each detected tissue parameter (e.g., detected via one or more sensors as described herein) in cooperation with each received device parameter associated with the selected stapler/device 24102 based on system-defined constraints. Further, according to such aspects, the control circuitry can be configured to analyze each detected tissue parameter (e.g., detected via one or more sensors described herein) using the received device parameters associated with each other available stapler, each other available energy device, each other stapler component available for use with the selected stapler/device, and so forth, based on system-defined constraints. According to such aspects, the control circuitry may be configured to determine, based on the detected tissue parameters, whether one or more of the other available staplers, other available energy devices, and/or other stapler components available for use with the selected stapler/device are more optimal than the selected stapler/device 24102 and/or selected components of the stapler/device 24102.

In various aspects, the one or more detected tissue parameters may include, for example, a type of tissue, a thickness of the tissue, a stiffness of the tissue, a location of the tissue, vascularization in the tissue, etc., and the received device parameters may include, for example, a type of staple cartridge, a color of the staple cartridge, an adjunct to the staple cartridge, a clamp load limit of the staple cartridge, a gap range of the staple cartridge, a firing rate of the staple cartridge, etc. According to various aspects, system-defined constraints (e.g., based on historical data and/or procedure data accessed in a situational aware surgical system) may include preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges for each received device parameter. For example, a preferred/desired tissue thickness and/or a preferred/desired tissue thickness range may be associated with each staple cartridge color. In such examples, each staple cartridge color may indicate the type and/or size of staples in the staple cartridge. Here, staple cartridges comprising short staples may not be optimal for thick tissue. According to further aspects, system-defined constraints (e.g., based on historical data and/or protocol data accessed in a situational aware surgical system) may include preferred/ideal clamp load limits and/or preferred/ideal clamp load limit ranges for each detected tissue type. For example, each staple cartridge associated with its respective clamp load limit may indicate the type of tissue that it can optimally staple. Here, the present disclosure contemplates various combinations of received device parameters (e.g., type of staple cartridge, color of staple cartridge, adjunct of staple cartridge, clamp load limit of staple cartridge, gap range of staple cartridge, firing rate of staple cartridge, etc.), and detected tissue parameters (e.g., type of tissue, thickness of tissue, stiffness of tissue, location of tissue, vascularization in tissue, etc.), as well as established system-defined constraints (e.g., associated with received device parameters and/or detected tissue parameters based on historical data and/or procedure data accessed in a situational aware surgical system).

Referring again to fig. 93, if the selected device 24102 is determined to be optimal, the control circuitry executing/implementing the security process 24100 may be configured to initially not perform any operations (e.g., later recommendations) and/or record that analysis has been performed 24114. Conversely, if it is determined that the selected device 24102 is not optimal, the control circuitry may be configured to determine if a security issue 24116 exists. According to various aspects, when evaluating whether the selected stapler/device 24102 presents a safety issue, the control circuitry may be configured to analyze each detected tissue parameter in cooperation with each received device parameter associated with the selected stapler/device 24102 based on system-defined constraints.

Similar to the above, the detected tissue parameters may include, for example, the type of tissue, the thickness of the tissue, the stiffness of the tissue, the location of the tissue, vascularization in the tissue, etc., and the received device parameters may include, for example, the type of staple cartridge, the color of the staple cartridge, the adjunct to the staple cartridge, the clamp load limit of the staple cartridge, the gap range of the staple cartridge, and the firing rate of the staple cartridge, etc. According to various aspects, system-defined constraints (e.g., based on historical data and/or procedure data accessed in a situational aware surgical system) may include preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges for each received device parameter. For example, a preferred/desired tissue thickness and/or a preferred/desired tissue thickness range may be associated with each staple cartridge color. In such examples, each staple cartridge color may indicate the type and/or size of staples in the staple cartridge. Here, continuing the example, if the received device parameters of the selected stapler/device 24102 include a staple cartridge color (e.g., indicating a short staple), and the detected tissue parameters indicate a tissue thickness that exceeds a preferred/ideal tissue thickness and/or a preferred/ideal tissue thickness range associated with the staple cartridge color of the selected stapler/device 24102, then the selected stapler/device 24102 presents a safety issue. Utilizing an improper staple cartridge can result in less than satisfactory results and/or undesirable results (e.g., suture failure, bleeding, hemorrhage, etc.). In such a case, the control circuitry can be configured to alert the surgeon 24118 (e.g., see fig. 94, via the

user interfaces

24214, 24224, and/or 24234 on the selected stapler/device, via the user interface 24244 associated with the surgical hub, via the user interface 24254 in the surgical operating room, etc.) that a safety issue exists. In such aspects, the control circuitry may also be configured to be capable of receiving an override command 24120 (e.g., via the

user interfaces

24214, 24224, and/or 24234 on the selected stapler/device, via the user interface 24244 associated with the surgical hub, via a user interface in a surgical operating room, etc. 24254) to allow the surgical procedure to proceed. In one example, referring to fig. 94, such a user interface may include a user interface element that is selectable to allow the procedure to continue, e.g., 24251. In an alternative aspect, in response to the warning, the surgeon may correct the indicated safety issue (e.g., replace an improper staple cartridge with another staple cartridge), at which point the device selection safety procedure 24100 may be performed/implemented again.

Similar to the above, according to further aspects, system-defined constraints (e.g., based on historical data and/or protocol data accessed in a situational aware surgical system) can include preferred/ideal clamp load limits and/or preferred/ideal clamp load limit ranges for each detected tissue type. For example, each staple cartridge associated with its respective clamp load limit may indicate the type of tissue that it can optimally staple. Here, continuing the example, if the received device parameters of the selected stapler/device 24102 include its staple cartridge clamp load limit, and the tissue identified by the tissue identification process 24108 indicates a tissue type requiring a staple cartridge with a higher clamp load limit, then the selected stapler/device 24102 presents a safety issue. Utilizing an improper staple cartridge can result in less than satisfactory results and/or undesirable results (e.g., suture failure, bleeding, hemorrhage, etc.). In such a case, the control circuitry can be configured to alert the surgeon 24118 (e.g., see fig. 94, via the

user interfaces

24214, 24224, and/or 24234 on the selected stapler/device, via the user interface 24244 associated with the surgical hub, via the user interface 24254 in the surgical suite, etc.) to allow the surgical procedure to proceed. In one example, referring to fig. 94, such a user interface may include a user interface element that is selectable to allow the procedure to continue, e.g., 24251. In an alternative aspect, in response to the warning, the surgeon may correct the indicated safety issue (e.g., replace an improper staple cartridge with another staple cartridge), at which point the device selection safety procedure 24100 may be performed/implemented again. Likewise, the present disclosure contemplates various combinations of received device parameters (e.g., type of staple cartridge, color of staple cartridge, adjunct of staple cartridge, clamp load limit of staple cartridge, gap range of staple cartridge, firing rate of staple cartridge, etc.), and detected tissue parameters (e.g., type of tissue, thickness of tissue, stiffness of tissue, location of tissue, vascularization in tissue, etc.), as well as established system-defined constraints (e.g., associated with received device parameters and/or detected tissue parameters based on historical data and/or procedure data accessed in a situational aware surgical system).

Referring back to fig. 93, if it is determined that the selected stapler/device 24116 does not present a safety issue, the control circuitry executing/implementing the safety procedure 24100 may be configured to provide a recommendation 24122 to the surgeon. In accordance with at least one aspect of the present disclosure, if another available stapler, another available energy device, and/or another stapler component (e.g., staple cartridge, shaft, etc. available for use with the selected stapler/device) 24112 is more optimized or more selectable, the control circuitry may be configured to alert the surgeon (e.g., see fig. 94, via

user interfaces

24214, 24224, and/or 24234 on the selected stapler/device, via a user interface 24244 associated with the surgical hub, via a user interface 24254 in the surgical suite, etc.) of its availability and recommend its use in the current surgical procedure. In such aspects, the control circuitry may also be configured to receive acceptance of the recommendation (e.g., via the

user interface

24214, 24224, and/or 24234 on the selected stapler/device, via the user interface 24244 associated with the surgical hub, via the user interface 24254 in the surgical operating room, etc.). Upon acceptance, the control circuitry may be configured to be capable of presenting more optimized information 24124 regarding other available staplers, other available energy devices, and/or other stapler components (e.g., see fig. 94, component a through component N, e.g., staple cartridges, shafts, etc., available for use with the selected stapler/device) 24112. Upon rejection, the control circuitry may be configured to end 24126 the device selection security algorithm and/or perform subsequent processes.

According to various other aspects, although specifically discussed with respect to the staplers/devices herein, the present disclosure should not be limited thereto. More particularly, aspects of the present disclosure are similarly applicable to other surgical instruments, including energy devices (e.g., RF and/or ultrasonic surgical instruments) and/or corresponding components thereof and/or endoscopic devices and/or corresponding components thereof.

Examples

example 1-a surgical system comprising a control circuit and a surgical instrument. The surgical instrument includes a plurality of components and a sensor. Each of the plurality of components of the surgical instrument includes a device parameter. Each component is configured to be capable of transmitting its respective device parameter to the control circuit. The sensor is configured to detect a tissue parameter associated with a proposed function of the surgical instrument and transmit the detected tissue parameter to the control circuit. The control circuitry is configured to analyze the detected tissue parameters in cooperation with each respective device parameter based on system-defined constraints. The surgical system also includes a user interface configured to indicate whether a surgical instrument including a plurality of components is suitable for performing the proposed function.

Embodiment 2-the surgical system of embodiment 1, wherein the detected tissue parameter comprises at least one of a type of tissue, a thickness of tissue, a stiffness of tissue, a location of tissue, or vascularization of tissue.

Example 3-the surgical system of examples 1 or 2, wherein the component of the surgical instrument comprises a staple cartridge, and wherein the device parameter comprises at least one of a type of the staple cartridge, a color of the staple cartridge, an adjunct to the staple cartridge, a clamp load limit of the staple cartridge, a gap range of the staple cartridge, and a firing rate of the staple cartridge.

Example 4-the surgical system of examples 1, 2, or 3, wherein the component of the surgical instrument comprises an end effector, and wherein the detected tissue parameter comprises at least one of: the angle of closure of the end effector on the tissue, the length of tissue in contact with the tissue contacting surface of the end effector, and the force with which the tissue is compressed within the end effector.

Example 5-the surgical system of example 4, wherein the control circuitry is further configured to identify the tissue as parenchymal, vascular, or bronchial based on the at least one detected tissue parameter.

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

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

Example 8-the surgical system of examples 1, 2, 3, 4, 5, 6, or 7, wherein the control circuit is further configured to prevent the proposed function when a constraint defined by the system is exceeded.

Example 9-the surgical system of example 8, wherein the user interface includes a user interface element selectable to override the control circuit to allow the proposed function of the surgical instrument.

Example 10-the surgical system of examples 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the proposed function of the surgical instrument includes one or more of clamping tissue, coagulating tissue, cutting tissue, and stapling tissue.

Example 11-the surgical system of examples 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, further comprising a surgical hub communicatively coupled to the surgical instrument, wherein the surgical hub comprises the control circuit.

Example 12-the surgical system of example 11, wherein one of the surgical instrument or the surgical hub comprises a user interface.

Example 13-a surgical system comprising a surgical hub and a surgical instrument communicatively coupled to the surgical hub. The surgical instrument includes a plurality of components and a sensor. Each of the plurality of components of the surgical instrument includes a device parameter. Each component is configured to transmit its respective device parameter to the surgical hub. The sensor is configured to detect a tissue parameter associated with the proposed function of the surgical instrument and transmit the detected tissue parameter to the surgical hub. The surgical hub includes a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to analyze the detected tissue parameters in cooperation with each respective device parameter based on system-defined constraints. The surgical system also includes a user interface configured to indicate whether a surgical instrument including a plurality of components is suitable for performing the proposed function.

Example 14-the surgical system of example 13, wherein the detected tissue parameter comprises at least one of a type of tissue, a thickness of tissue, a stiffness of tissue, a location of tissue, or vascularization of tissue.

Example 15-the surgical system of examples 13 or 14, wherein the component of the surgical instrument comprises a staple cartridge, and wherein the device parameter comprises at least one of a type of the staple cartridge, a color of the staple cartridge, an adjunct to the staple cartridge, a clamp load limit of the staple cartridge, a gap range of the staple cartridge, and a firing rate of the staple cartridge.

Example 16-the surgical system of examples 13, 14, or 15, wherein the component of the surgical instrument comprises an end effector, and wherein the detected tissue parameter comprises at least one of an angle of closure of the end effector on the tissue, a length of tissue in contact with a tissue contacting surface of the end effector, and a force compressing the tissue within the end effector.

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

Example 18-the surgical system of examples 13, 14, 15, 16, or 17, wherein the instructions are further executable by the processor of the surgical hub to prevent the proposed function when a system-defined constraint is exceeded.

Example 19-a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to analyze a detected tissue parameter in cooperation with a device parameter of each of a plurality of components of a surgical instrument of a surgical system based on system-defined constraints, wherein the detected tissue parameter is associated with a proposed function of the surgical instrument. The surgical system includes a surgical instrument that includes a plurality of components. Each component is configured to be capable of transmitting its respective device parameter to the machine. The surgical system also includes a sensor configured to detect the detected tissue parameter and transmit the detected tissue parameter to the machine. The instructions, when executed, further cause the machine to generate a user interface, wherein the user interface provides an indication of whether a surgical instrument comprising a plurality of components is suitable for performing a proposed function of the surgical system.

Example 20-the non-transitory computer readable medium of example 19, the instructions, when executed, further cause the machine to generate an override element on the user interface, wherein the override element is selectable to allow the proposed function of the surgical instrument.

Controlling a surgical instrument based on sensed closure parameters

Measuring compressibility of tissue integrity

In various aspects, the surgical instrument can detect a variety of different variables or parameters associated with the closure of the jaws of the surgical instrument, which in turn can be used to adjust or affect various operating parameters that indicate how the surgical instrument is functioning. The rate at which the jaws of the surgical instrument transition from an open position to a closed position to clamp tissue therebetween can be defined as a clamping rate or a closing rate. In various aspects, the rate of closure can be variable or constant during an instance of jaw closure. A threshold value that is compared to a particular parameter associated with closure of the jaws may be defined as a closure threshold value.

Grasping tissue at an inappropriate closure rate or at an inappropriate closure threshold can result in damage to the tissue (e.g., the tissue can be torn due to the jaws applying excessive force to the tissue) and/or operational failure of the surgical instrument (e.g., the staples can become misshapen due to the tissue not being fixedly held by the jaws when the staples are fired). Thus, in some aspects, a surgical instrument is configured to detect a characteristic of tissue clamped by the surgical instrument and adjust one or more closure rates, one or more closure thresholds, and other operating parameters accordingly. Further, each surgical procedure may involve a plurality of different tissue types and/or tissues having different characteristics. Thus, in some aspects, the surgical instrument is configured to dynamically detect tissue characteristics each time tissue is clamped and correspondingly adjust one or more closure rates, one or more closure thresholds, and other operating parameters.

The present disclosure provides at least one solution in which a surgical instrument is configured to detect a parameter associated with compression of tissue gripped by an end effector. The surgical instrument may also be configured to differentiate between tissues exhibiting different integrity properties based on the detected tissue compression characteristics. The motor can then be controlled to affect the rate of jaw closure and/or provide feedback to the user based on the integrity of the tissue. For example, the surgical instrument can be configured to reduce a rate of closure of the jaws if the detected tissue compression characteristic indicates that the tissue is rigid and/or provide a recommendation to a user to augment with the adjunct if the tissue compression characteristic indicates that the tissue has a low shear strength.

Fig. 95 illustrates a block diagram of a surgical instrument 21000 in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument 21000 includes a control circuit 21002 coupled to a motor 21006, a user interface 21010, and one or more sensors 21004. The motor 21006 is coupled to the end effector 21008 such that the motor 21006 transitions jaws of the end effector 21008 (e.g., the anvil 150306 and/or the channel 150302 of the surgical instrument 150010 shown in fig. 25) between a first or open configuration and a second or closed configuration, e.g., as discussed with respect to fig. 26. One or more sensors 21004 can be communicatively coupled to the control circuit 21002 such that the control circuit 21002 receives data and/or signals therefrom. The control circuit 21002 can be communicatively coupled to the motor 21006 such that the control circuit 21002 controls operation of the motor 21006 in accordance with, for example, data and/or signals received from one or more sensors 21004. The user interface 21010 includes a device, such as a display or speaker, configured to provide feedback to a user of the surgical instrument.

In various aspects, the one or more sensors 21004 can be configured to detect a compression parameter of tissue clamped at the end effector. In one aspect, the one or more sensors 21004 can be configured to detect a closing Force (FTC) of the jaws of the end effector 21008, i.e., a force applied to transition the jaws from an open configuration to a closed configuration. For example, the one or more sensors 21004 may include a motor current sensor configured to be capable of detecting current consumed by the motor, such as discussed with respect to fig. 12, 18, or 19. For a DC motor, the current drawn by the motor corresponds to the motor torque (e.g., the torque of the output shaft of the motor 21006), which represents the FTC of the end effector 21008. The FTC of the end effector 21008 corresponds to tissue compression of the clamped tissue, as it represents the force transmitted from the end effector 21008 to the clamped tissue when the end effector 21008 is closed on the tissue. The greater the force applied to the tissue, the greater the degree to which the tissue is compressed. In another aspect, the one or more sensors 21004 include a first electrode disposed on the end effector 21008 that is configured to receive RF signals from a corresponding second electrode, such as discussed with respect to fig. 36-38. The electrical impedance of the tissue may correspond to its tissue thickness, which in turn may correspond to tissue compression of the clamped tissue. In yet another aspect, the one or more sensors 21004 include a force sensitive transducer configured to be able to determine the magnitude of force applied to the one or more sensors 21004, such as discussed with reference to fig. 24. Similar to the discussion above with respect to the FTC, the force detected by the transducer represents the force transmitted from the end effector 21008 to the clamped tissue when the end effector 21008 is closed on the tissue. The greater the force applied to the tissue, the greater the degree to which the tissue is compressed. The user interface 21010 includes a device, such as a display or speaker, configured to provide feedback to a user of the surgical instrument. In other aspects, the one or more sensors 21004 can include various combinations of the foregoing sensors and other such sensors capable of detecting compression parameters associated with tissue clamped at the end effector. For example, an end effector (such as the end effector 15200 shown in fig. 53) can include a first sensor 152008a (including a force sensitive transducer) and a second sensor 152008b (including an impedance sensor).

The control circuit 21002 can be configured to adjust the rate of closure of the jaws of the end effector 21008 to accommodate different tissue types. The control circuit 21002 can be configured to monitor the compressive force exerted on the tissue (e.g., FTC) or another parameter associated with the compression of the tissue (e.g., tissue impedance) over an initial compression period and adjust the jaw closure rate or time accordingly based on the rate of change of the tissue compression parameter. For example, for more viscoelastic tissues, it may be beneficial to decrease the closure rate or increase the closure time, rather than apply the total compression force over a short period of time, as discussed above with respect to fig. 22.

Fig. 96 illustrates a logic flow diagram for a process 21050 for controlling a surgical instrument as a function of the integrity of clamped tissue in accordance with at least one aspect of the present disclosure. In the following description of process 21050, reference should also be made to figure 95. The illustrated process may be performed by, for example, the control circuitry 21002 of the surgical instrument 21000. Accordingly, the control circuitry 21002 performing the procedure receives 21052 data and/or signals (e.g., digital or analog) from the one or more sensors 21004 relating to the tissue compression parameters sensed thereby. In various aspects, the tissue compression parameters may include parameters associated with the characteristics, type, attributes, and/or state of the tissue being operated on; parameters associated with internal operations and/or properties of the surgical instrument 21000; or a component thereof. In one aspect, the tissue compression parameters can include, for example, the FTC of the end effector 21008. In another aspect, the tissue compression parameter can include, for example, the thickness of the clamped tissue. The control circuitry 21002 may receive 21052 data relating to tissue compression parameters as one or more discrete values transmitted by one or more sensors 21004, signals transmitted by one or more sensors 21004 that may then be correlated with one or more associated values, and the like.

Accordingly, the control circuitry 21002 determines how the value of the sensed tissue compression parameter compares to one or more thresholds and then generates a response accordingly. In one aspect, the control circuit 21002 determines 21054 a relative relationship of a value of the sensed tissue compression parameter to a first threshold value. For example, the control circuitry 21002 may determine whether the tissue compression parameter sensed by 21054 exceeds or is greater than a first or higher threshold. In one aspect, if the sensed tissue compression parameter exceeds the first threshold, the process 21050 continues along the yes branch and the control circuit 21002 controls 21056 the motor 21006 to increase the length of time it takes to close the jaws of the end effector 21008. The control circuit 21002 may control 21056 the motor 21006 to increase the jaw closing time, for example, by: reducing the rate at which the jaws are closed, increasing the length of time that the movement of the jaws is halted after initial clamping of tissue (i.e., tissue creep latency), or lowering the stability threshold to end the clamping phase. If the sensed tissue compression parameter does not exceed the first threshold, process 21050 continues along the "no" branch and, in various aspects, process 21050 may end or process 21050 may continue and control circuitry 21002 may compare the value of the sensed tissue compression to one or more additional thresholds or continue to receive 21052 tissue parameter data and/or signals.

In another aspect, the control circuit 21002 also determines 21058 a relative relationship of the value of the sensed tissue compression parameter to a second threshold value. For example, the control circuitry 21002 may determine whether the tissue compression parameter sensed by 21058 is below or less than a second or lower threshold. In one aspect, if the sensed tissue parameter is below the second threshold, the process 21050 continues along the yes branch and the control circuitry 21002 provides 21060 corresponding feedback via, for example, the user interface 21010. The provided 21060 feedback may include, for example, visual feedback provided via a display or audio feedback provided by a speaker. In one aspect, the feedback may suggest that the user should take one or more corrective actions to ameliorate the situation that results in the sensed tissue compression parameter being unexpectedly low. Such corrective measures include, FOR example, the use of adjunct enhancements (i.e., TISSUE THICKNESS COMPENSATORs), such as disclosed in U.S. patent application No.8,657,176 entitled "TISSUE THICKNESS COMPENSATOR FOR a TISSUE stage," which is hereby incorporated by reference herein. In various aspects, the adjunct reinforcement can comprise a layer or series of layers of compressible material configured to accommodate and/or apply additional compressive forces to tissue captured between the anvil 150306 (fig. 25) and the staple cartridge 150304 (fig. 25).

The thresholds discussed above may include, for example, values for one or more parameters sensed by one or more sensors 21004 and/or derivatives of one or more parameters sensed by one or more sensors 21004 (e.g., time-rate changes in the sensed parameters). In aspects where the tissue compression parameter comprises the FTC of the end effector 21008, the first threshold may indicate such delineation: above a first threshold, the clamped tissue is considered rigid. Rigid tissue can tear relatively easily during re-expansion due to the mechanical action of the jaws on the tissue, or for lung tissue. Further, the second threshold may indicate such delineation: below a second threshold, the clamped tissue is considered to have a weak shear strength (i.e., viscous). During stapling and/or firing of the cutting member (i.e., the I-beam 150178 having the cutting edge 150182), the end effector 21008 may be relatively difficult to securely grasp tissue having weak shear strength or otherwise hold it in place.

It should be noted that while the steps of the particular example of process 21050 in fig. 96 are depicted as occurring in a particular order or sequence, such depiction is for illustrative purposes only and the particular order of process 21050 is not intended unless a particular sequence of particular steps is explicitly required from the above description. For example, in other aspects of the process 21050, the control circuitry 21002 may determine 21058 whether the sensed tissue compression parameter is below a second or lower threshold before determining 21054 whether the sensed tissue compression parameter exceeds a first or upper threshold.

Fig. 97 illustrates a first graph 21100 depicting end effector FTC 21104 versus time 21102 for an exemplary firing of a surgical instrument 21000, in accordance with at least one aspect of the present disclosure. In the following description of the first graph 21100, reference should also be made to fig. 95 to 96. The first graph 21100 depicts a first firing 21110 and a second firing 21114, which are exemplary firings by the surgical instrument 21000 controlled by the control circuit 21002 that performs the process 21050 described above with respect to fig. 96. In this illustrative example, first threshold 21106 includes a particular time rate change of FTC (i.e., Δ FTC), and second threshold 21108 includes a particular FTC. In various aspects, the

thresholds

21106, 21108 can be fixed or predetermined values, defined with respect to one or more other variables, or programmed or set by a user of the surgical instrument 21000.

For a first shot 21110, control circuitry 21002 performing the process shown in FIG. 96 receives 21052 the tissue compression parameter data and/or signals and determines 21058 at time t₁Where FTC falls below a second threshold 21108. Accordingly, the control circuit 21002 provides 21060 feedback to the user, including advising the user to take certain actions and/or indicating that the end effector 21008 is grasping tissue having a low shear strength. In one aspect, the 21060 feedback provided may include the following recommendations: the user is advised to unclamp the end effector 21008 and to re-fire the surgical instrument 21000 with a tissue compensator (e.g., the tissue compensator described in U.S. patent application No.8,657,176) applied to the end effector 21008 in order to enhance and/or compensate for low shear strength tissue. In one aspect, control circuitry 21002 may also be providedConfigured to cause the motor 21006 to stop closing the jaws of the end effector 21008 if the FTC is below a second threshold. In another aspect, the control circuit 21002 can be configured to provide a recommendation for a user to stop closing the jaws of the end effector 21008 if the FTC is below a second threshold. 21060 feedback provided may take a variety of forms including, for example, prompts displayed on the operating room displays 107, 109, 119 (fig. 2) and/or surgical instrument displays, audible messages emitted via speakers located in the operating room and/or on the surgical instrument, tactile feedback via the surgical instrument, or combinations thereof.

For a second firing 21114 (which may be a firing with a tissue compensator after the first firing 21110), the control circuitry 21002 executing the process 21050 shown in fig. 96 receives 21052 the tissue compression parameter data and/or signal and does not determine that the FTC falls below the second threshold or exceeds the first threshold at any point in the process of closing the end effector 21008. Thus, the control circuitry 21002 does not affect the rate of jaw closure, provides no feedback to the user, and takes no other such action.

Fig. 98 illustrates a second graph 21116 depicting an end effector FTC 21102 versus time 21104 for an exemplary firing of a surgical instrument 21000, in accordance with at least one aspect of the present disclosure. In the following description of the second graph 21116, reference should also be made to fig. 95 to 96. The second graph 21116 depicts a third firing 21118, which is an exemplary firing by the surgical instrument 21000 controlled by the control circuit 21002 that performs the process 21050 described above with respect to fig. 96. In this illustrative example, first threshold 21106 comprises a particular time rate change of FTC (i.e., Δ FTC).

For the third firing 21116, the control circuitry 21002 performing the process illustrated in FIG. 96 receives 21052 the tissue compression parameter data and/or signals and determines 21058 at time t₂At Δ FTC exceeds a first threshold 21106. Accordingly, the control circuitry 21002 controls 21056 the motor 21006 to increase the jaw closure time, such as by decreasing the jaw closure rate, which correspondingly decreases the rate at which the FTC 21102 is increased. Increasing the closing time of the jaws can beIt is beneficial to avoid damage to rigid tissue, for example, by preventing the application of a relatively large amount of force on the tissue over a short period of time. In one aspect, the first threshold 21106 may comprise a default rate of change of FTC (Δ FTC)_D) I.e., a default or baseline FTC rate of the surgical instrument 21000, without any modification to the FTC by a control algorithm according to the tissue type and other such parameters. In this regard, if the surgical instrument 21000 experiences an FTC that exceeds the FTC during surgery_DThen the control circuitry 21002 executing process 21050 may control 21056 the motor 21006 to increase the jaw closure time.

The time at which the control circuit 21002 executing the aforementioned algorithm or process determines to compare the parameter sensed by the one or more sensors 21004 to the one or more thresholds may include a discrete instance during a firing stroke of the surgical instrument 21000, a series of discrete instances during a firing stroke, and/or a continuous time interval during a firing stroke. The tissue compression parameter monitored by the control circuitry 21002 and compared to a threshold value may include, for example, an FTC value (e.g., the second threshold value 21108 shown in fig. 97) or a Δ FTC value (e.g., the first threshold value 21106 shown in fig. 97-98).

In one aspect, the control circuit 21002 can also be configured to store data related to firing of the surgical instrument 21000 and then optionally utilize the data from previous firings to adjust an algorithm for determining tissue integrity of the clamped tissue. For example, data from a previous firing may be used to adjust the first threshold and/or the second threshold of the process 21050 shown in fig. 96. In one aspect, the SURGICAL instrument 21000 can be configured to be capable of being paired with a SURGICAL HUB 106 (fig. 1-3) implementing a SITUATIONAL AWARENESS system, as described above under the heading "SITUATIONAL AWARENESS" and as described in U.S. patent application No.15/940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS," filed on 29.3.2018, which is hereby incorporated by reference in its entirety. In this regard, the situational awareness system can determine the type of tissue being operated on during a surgical procedure and adjust the algorithm for determining the tissue integrity of the clamped tissue accordingly. In another aspect, the surgical instrument 21000 can be configured to receive user input indicating the type of tissue being operated on and adjust the algorithm for determining tissue integrity accordingly. For example, the surgical instrument 21000 can be configured to adjust the first threshold and/or the second threshold of the process 21050 shown in fig. 96 from a default value according to the type of tissue input by the user.

The techniques described above allow the surgical instrument 21000 to avoid damaging clamped tissue and prevent operational failures (e.g., malformations) caused by the rate of jaw closure that are inappropriate or undesirable for the particular characteristics of the tissue being operated on. In addition, the techniques described above improve the ability of the surgical instrument to respond appropriately to the characteristics of the tissue encountered during the course of a surgical procedure.

Initial tissue contact to determine tissue type

The present disclosure provides at least one solution in which a surgical instrument is configured to characterize a tissue type of clamped tissue as a function of a degree of tissue contact against a jaw surface and a relative position of the jaws at an initial point of contact with the tissue. The rate of closure of the jaws and the threshold for adjusting the rate of closure of the jaws can then be set to an appropriate level for the tissue type characterized by the detected degree of tissue contact and the detected position of the jaws. For example, the surgical instrument can be configured to distinguish between parenchyma and blood vessels because parenchyma contacts the jaw surfaces to a greater extent and at a greater angle at the initial contact point than the blood vessels. The surgical instrument can then control the motor to affect the rate of jaw closure and correspondingly affect the adjustment threshold for the detected tissue type.

Referring back to fig. 95, in one aspect, the surgical instrument 21000 includes a control circuit 21002 coupled to a motor 21006, a user interface 21010, and one or more sensors 21004. The motor 21006 is coupled to the end effector 21008 such that the motor 21006 transitions jaws of the end effector 21008 (e.g., the anvil 150306 and/or the channel 150302 of the surgical instrument 150010 shown in fig. 25) between a first or open configuration and a second or closed configuration, as discussed with respect to fig. 26. One or more sensors 21004 can be communicatively coupled to the control circuit 21002 such that the control circuit 21002 receives data and/or signals therefrom. The control circuit 21002 can be communicatively coupled to the motor 21006 such that the control circuit 21002 controls operation of the motor 21006 in accordance with, for example, data and/or signals received from one or more sensors 21004.

In various aspects, the one or more sensors 21004 can be configured to detect physical contact of tissue against a jaw surface of the end effector 21008. In one aspect, the one or more sensors 21004 can comprise one or more tissue contacting sensors disposed along a tissue contacting surface of the end effector 21008 (such as an anvil and cartridge or channel). The tissue contact sensor may include a plurality of sensors or segments of segmented circuitry, e.g., arranged sequentially along a surface of the jaws, each configured to be capable of determining whether tissue is positioned against the jaws, as discussed above with reference to fig. 75-79. In one aspect, the one or more sensors 21004 comprises a plurality of electrodes, each electrode configured to receive RF signals from a corresponding electrode disposed on the opposing jaw, such as discussed with reference to fig. 36-38. Thus, the control circuit 21002 may perform a continuity test along the length of the end effector 21008 to determine that tissue is present at a location corresponding to each electrode that is capable of receiving a signal from its corresponding electrode (because a signal transmission medium (i.e., tissue) must be located between the two electrodes in order for the electrodes to receive a signal from their corresponding electrodes). In another aspect, the one or more sensors 21004 includes a plurality of force sensitive transducers, each configured to be capable of determining an amount of force applied to the one or more sensors 21004, such as discussed with reference to fig. 24. Thus, the control circuitry 21002 may determine that tissue is present at a location corresponding to each force sensitive transducer detecting a non-zero force thereagainst. In other aspects, the one or more sensors 21004 include a plurality of load sensors, pressure sensors, and/or other sensors configured to be capable of detecting physical contact thereagainst. Similar to the discussion above with respect to the force sensitive transducer, the control circuitry 21002 can determine that tissue is present at a location corresponding to each load sensor, pressure sensor, and/or other sensor that detects a non-zero force thereagainst. In yet another aspect, the one or more sensors 21004 includes a current sensor configured to be able to detect an amount of current consumed by the motor 21006, such as discussed with reference to fig. 12, 18, or 19. Accordingly, the control circuit 21002 can determine the point at which the jaws of the end effector 21008 initially contact tissue as a function of when the current drawn by the motor 21006 increases to compensate for the increased clamping load experienced by the motor 21006 when the jaws contact tissue and begin to apply a clamping force thereagainst, such as discussed with respect to fig. 83 (i.e., FTC increases 153610, 153616 as the jaws clamp tissue, and FTC corresponds to the motor current). The various aspects described above may be used alone or in combination with other aspects for determining an initial point of contact between the end effector 21008 and tissue being clamped and/or a degree of contact between the tissue and the end effector 21008.

Fig. 99 illustrates a logic flow diagram for a process 21200 for controlling a surgical instrument according to a physiological type of tissue being clamped in accordance with at least one aspect of the present disclosure. In the following description of process 21200, reference should also be made to fig. 95. The illustrated process may be performed by, for example, the control circuitry 21002 of the surgical instrument 21000. Accordingly, the control circuitry 21002 executing the illustrated process 21200 receives 2120 tissue contact data and/or signals from one or more sensors 21004 (such as the tissue contact sensors discussed above and illustrated in fig. 100A-101B). The received tissue contact data and/or signals of 21202 indicate whether tissue is contacting at least one of the sensors 21004. Accordingly, the control circuit 21002 may determine 21204 the initial point of contact between the end effector 21008 and the tissue being clamped. In one aspect, the control circuit 21002 determines 21204 when initial tissue contact occurs by detecting when at least one of the sensors 21004 disposed on each of the jaws detects tissue contact thereagainst.

Thus, the control circuit 21002 determines 21206 the position of the jaw at the initial tissue contact point. In one aspect, the control circuit 21002 can be communicatively coupled to a hall effect sensor disposed on one of the jaws of the end effector 21008, which can be configured to detect the relative position of a corresponding magnetic element disposed on the opposing jaw, such as discussed with reference to fig. 77. Accordingly, the control circuit 21002 may determine 21206 the position of the jaws based on the sensed distance or gap between the jaws. In another aspect, the control circuit 2100 is communicatively coupled to a position sensor configured to detect an absolute or relative position of a closure tube configured to close the jaws when the closure tube is driven from a first or proximal position to a second or distal position, such as discussed with reference to fig. 20-21 and 25. Accordingly, the control circuit 21002 may determine 21206 the position of the jaws from the sensed position of the closure tube. In yet another aspect, the control circuit 21002 can be communicatively coupled to an angle sensor, such as TLE5012B360 ° angle sensor from Infineon Technologies, configured to be capable of detecting an angle at which at least one of the jaws is oriented. Accordingly, the control circuit 21002 may determine 21206 the jaw position from the sensed angle at which the jaws are oriented.

Accordingly, the control circuitry 21002 determines 21208 the degree of contact between the grasped tissue and one or more tissue contacting surfaces of the jaws. The degree of tissue contact may correspond to the number or ratio of sensors 21004 that have detected the presence (or absence) of tissue, such as discussed with reference to fig. 79. In one aspect, the control circuitry 21002 may determine the degree of tissue contact from a ratio of one or more sensors 21004 that have detected the presence of tissue to one or more sensors 21004 that do not detect the presence of tissue.

Thus, the control circuit 21002 sets 21210 control parameters for the motor 21006 based on the determined 21206 jaw position and the determined 21208 degree of tissue contact. The motor control parameters may include, for example, a time to close the jaws and/or one or more closing thresholds. In one aspect, the control circuitry 21002 may be configured to be capable of performing runtime calculations and/or accessing memory (e.g., a look-up table) to retrieve motor control parameters (e.g., jaw closure rate and closure threshold) associated with a particular position of a jaw and a particular degree of tissue contact sensed via various sensors. In various aspects, the control circuit 21002 may control the motor 21006 to adjust the jaw closing time by, for example, adjusting the rate at which the jaws transition from an open position to a closed position, adjusting the length of time that the jaws pause after initial clamping of tissue (i.e., tissue creep latency), and/or adjusting a stability threshold that ends the clamping phase. In various aspects, the one or more closure thresholds may include, for example, a maximum allowable FTC of the end effector 21008 or a rate of change of the FTC at which the control circuit 21002 stops the motor 21006 driving the jaw closure or takes other action (i.e., Δ FTC), as discussed above under the heading "determine compression rate of tissue integrity". Control circuitry 21002 may then control motor 21206 according to a set of motor control parameters 21210 via process 212000.

The position of the jaws and the degree of contact with the tissue at the point of initial contact with the tissue corresponds to the thickness or geometry of the tissue being grasped, which in turn corresponds to the physiological type of tissue. Thus, the control circuit 21002 may be configured to be able to distinguish between tissue types and then set 21210 the control parameters of the motor 21006 accordingly. For example, the control circuit 21002 may be configured to determine whether parenchymal or vascular tissue has been grasped by the end effector 21008, and then set 21210 motor control parameters appropriate for the detected tissue type.

In some aspects, the jaw closure rate may be selected for each tissue type to maintain the maximum FTC and/or Δ FTC below a particular closure threshold, which may likewise be selected for each tissue type. In one aspect, the control circuitry 21002 can be configured to be capable of setting a minimum clamping rate such that the closing motion of the jaws is never permanently stopped. In one aspect, the control circuitry 21002 can be configured to control the maximum pause time to ensure that jaw closure occurs at least at a default rate. In one aspect, the control circuit 21002 can be configured to stop the motor 21006 and/or provide feedback to a user when a closure threshold is exceeded or otherwise set aside during use of the surgical instrument 21000.

It should be noted that while the steps of the particular example of process 21200 in fig. 99 are depicted as occurring in a particular order or sequence, such depiction is for illustrative purposes only and the particular order of process 212000 is not intended unless a particular sequence of particular steps is explicitly required from the above description. For example, in other aspects of process 21200, control circuitry 21002 may determine 21208 the degree of tissue contact prior to determining 21206 the jaw position at the initial point of contact.

Fig. 100A-101B illustrate various side elevation views of an end effector 21008 grasping parenchyma 21030 and a blood vessel 21032 at both an initial contact position with tissue and a closed position, in accordance with at least one aspect of the present disclosure. In the depicted aspect, the end effector 21008 comprises a plurality of tissue contacting sensors 21016 disposed along tissue contacting surfaces of the jaws, including an anvil 21012 and a channel 21014. In other aspects, the tissue contact sensors 21016 can be disposed along the cartridge 150304 (fig. 25) in addition to or instead of being disposed along the channel 21014 of the surgical instrument 21000. For simplicity, in the following description, tissue contact sensors 21016 will be discussed as being disposed along pathway 21014; however, it should be noted that the concepts discussed herein are equally applicable to aspects in which the tissue contact sensors 21016 are disposed along the cartridge 150304. As described above, the tissue contact sensor 21016 may include, for example, impedance sensors, load sensors, force sensitive transducers, and combinations thereof. During use of the surgical instrument 21000 in a surgical procedure, the tissue contact sensor 21016 can be depicted as an activated sensor 21018 (i.e., a sensor that senses the presence of tissue) and an inactivated sensor 21020 (i.e., a sensor that does not sense the presence of tissue).

Fig. 100A and 101A illustrate initial contact points of the end effector 21008 with parenchyma 21030 and a blood vessel 21032, respectively. In one aspect, the initial point of contact between the end effector 21008 and tissue can be defined as the point where there is at least one activation sensor 21018 on both the anvil 21012 and the channel 21014. As described above, the tissue types can be distinguished based on the position of the jaws (i.e., the anvil 21012 and/or the channel 21014) and the degree of contact between the tissue and the jaws at the point of initial contact with the tissue. For example, fig. 100A and 101A illustrate how parenchyma 21030 and blood vessels 21032 may be distinguished based on the scale of sensors 21018 activated at the initial tissue contact point. That is, clamping the vessel 21032 results in fewer active sensors 21018 relative to clamping the parenchyma 21030. It should also be noted that the number of activated tissue sensors 21018 on the anvil 21012 and the channel 21014 need not be equal at the initial tissue contact point. As another example, fig. 100A and 101A illustrate how parenchyma 21030 and blood vessels 21032 may be distinguished based on the angle at which the anvil 21012 is oriented relative to the channel 21014 at the initial tissue contact point. That is, the anvil 21012 is at an initial contact point with the anvil 21030 at a first angle θ₁Oriented and at a second angle θ at the initial point of contact with the blood vessel 21032₂And (4) orientation. The difference between the proportion of the sensor 21018 activated and the angle at which the anvil 21012 is oriented can be used alone or in combination (e.g., by process 21200 shown in fig. 99) to characterize the physiological type of tissue being clamped, and then to set the appropriate jaw closure rate, closure threshold, and other motor control parameters for that tissue type.

Figures 100B and 101B illustrate the point at which the end effector 21008 has fully clamped the parenchyma 21030 and the blood vessel 21032, respectively. It can be seen that changes in the number or ratio of activated sensors 21018 and unactuated sensors 21020 when the end effector 21008 is grasping tissue can also be used to determine the type of tissue and/or the physical characteristics of the tissue, the degree to which the tissue is compressed, and/or the distance between the anvil 21012 and the channel 21014, as well as various other parameters. For example, the vessel 21032 is much more distorted than the parenchyma 21030 when fully clamped, which results in a relatively large change in the number of sensors 21018 activated when the end effector 21008 clamps the vessel 21032. In some aspects, the control circuitry can perform a process to determine the tissue type (i.e., a type of physiological tissue or tissue having certain physical characteristics) from a change or rate of change in the number of sensors 21018 activated while the end effector 21008 is clamped. In some aspects, the control circuitry can perform a process to determine the degree to which tissue is compressed and/or deformed from the change or rate of change in the number of sensors 21018 activated while the end effector 21008 is clamped.

In some aspects in which the surgical instrument 21000 includes control circuitry 21002 that performs the process 21200 described above in fig. 99, when the control circuitry 21002 determines that jaws 21013 have initially contacted tissue, the control circuitry 21002 can be configured to detect or measure the spacing θ between the jaws and the length or degree L of tissue contact between the tissue and the jaws. The closing threshold (e.g., FTC threshold or Δ FTC threshold), the initial closing velocity, and the one or more adjusted closing velocities (i.e., the one or more closing velocities at which the jaws 21013 close after the closing threshold is exceeded) can each be a function of θ and L. As shown in FIGS. 100A-100B, the jaw spacing may be defined as θ₁And the degree of tissue contact may be defined as L at the initial contact point with the first tissue (e.g., parenchyma 21030)₁. As shown in fig. 101A-101B, the jaw spacing may be defined as θ₂And the degree of tissue contact at the initial point of contact with a second tissue (e.g., blood vessel 21032) may be defined as L₂. Thus, at θ₁>θ₂And L₁>L₂In some aspects of (1), the substantially FTC threshold value FTC_p>Blood vessel FTC threshold value FTC_v(ii) a Substantial Δ FTC threshold Δ FTC_p>Blood vessel slope threshold Δ FTC_v(ii) a And the initial closing velocity v of the blood vessel_V1>Substantially initial closing velocity v_P1. Further details are provided below with reference to fig. 102 to 103Operational differences between these thresholds are discussed in detail.

Fig. 102 illustrates a first graph 21300 and a second graph 21302 depicting, respectively, end effector FTC21304 and closure velocity 21306 over time 21308 for an illustrative firing of a surgical instrument 21000 grasping a parenchyma 21030, in accordance with at least one aspect of the present disclosure. In the following description of the first graph 21300 and the second graph 21302, reference should also be made to fig. 95 and 99 to 100B. The exemplary firing described herein is intended to illustrate the concepts discussed above with reference to fig. 95 and 99-100B, and should not be construed as limiting in any way.

The first firing of the surgical instrument 21000 can be represented by a first FTC curve 21310 and a corresponding first speed curve 21310', which respectively illustrate the FTC and closing speed as a function of time during the first firing. The first firing may represent, for example, a default firing of the surgical instrument 21000 or a firing of the surgical instrument 21000 that does not include the control circuit 21002 to perform the process 21200 shown in fig. 99. When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, thereby sharply increasing 21318 the closure velocity of the anvil 21012 to an initial or default closure velocity v_d1. When the anvil 21012 is driven from the open position, it is in contact with the clamped tissue, which for this particular firing is parenchyma 21030. When the anvil 21012 is at time t₀Upon contact with clamped tissue, the FTC is at time t₁Increase 21312 from the initial FTC (e.g., zero) to a peak 21314. At time t₁The control circuit 21002 of the surgical instrument 21000 determines that the FTC has reached or exceeded an FTC threshold (which may be, for example, a default threshold independent of the tissue type), and controls the motor 21006 to stop the movement of the anvil 21012, thereby causing the closing speed to drop 21320 to zero. The motion of the anvil 21012 may be paused for a duration p₁During which the closing speed remains 21322 at zero. During the pause, the FTC gradually decreases 21316 as the clamped tissue relaxes.

A second firing of the surgical instrument 21000 can be represented by a second FTC profile 21324 and a corresponding first speed profile 21324' which respectively show the variation of the FTC and the closing speed over time during the course of the second firing. The second firing, as compared to the first firing, may represent, for example, firing of the surgical instrument 21000, including the control circuit 21002 performing the process illustrated in fig. 99. When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, thereby causing the closing speed of the anvil 21014 to sharply increase 21336. Due to the relative thickness and/or geometry of the parenchyma 21030, the initial point of contact between the tissue (i.e., parenchyma 21030) and the jaw 21013 occurs shortly after the anvil 21012 begins to be driven by the motor 21006; thus, the control circuitry 21002 performing the process 21200 shown in fig. 99 is able to determine almost immediately when the parenchyma 21030 is being gripped and set the time to close the jaws, one or more closing thresholds, and other closing parameters at a relatively early point in the closing process accordingly. Thus, the control circuit 21002 controls the motor 21006 to sharply increase 21336 the closing speed of the anvil 21014 to an initial closing speed v specific to parenchymal 21320 tissue_p1。

When the anvil 21012 is driven from the open position, it is in contact with the clamped tissue, which for this particular firing is parenchyma 21030. When the anvil 21012 is at time t₀Upon contact with clamped tissue, the FTC is at time t₂Increase 21326 from the initial FTC (e.g., zero) to a first peak 21328. It should be noted that the FTC is increased 21326 more slowly during the second firing than the first firing because the control circuitry 21002 executing the process 21200 selects the first or initial closing speed v suitable for the type of tissue clamped in the second firing_p1Thereby reducing the amount of force exerted on the tissue as compared to unmodified firing of the surgical instrument 21000. At time t₂The control circuit 21002 of the surgical instrument 21000 determines that the FTC has reached or exceeded the FTC threshold FTC_p(when the control circuit 21002 determines that parenchyma 21030 tissue is clamped, the threshold has been at t₀Time or later set by the control circuit 21002). Virtual FTC threshold FTC_pMay represent, for example, the maximum force that may be safely or advantageously applied to parenchyma 21030 tissue. Thus, the control circuit21002 controls the motor 21006 to stop the movement of the anvil 21012, causing the closing speed to drop 21338 to zero. The motion of the anvil 21012 may be paused for a duration p₂During which the closing speed remains 21340 at zero. During the pause, the FTC gradually decreases 21330 as the clamped tissue relaxes. Duration of pause p₂May be equal to a default pause duration (e.g., p)₁) Or closure parameters selected by the control circuit 21002 for parenchyma 21030 tissue.

At time t₃For a pause duration p₂After having elapsed, the control circuit 21002 reengages the motor 21006 and resumes closing the anvil 21012. Thus, the closing velocity is increased 21342 to a second closing velocity v_p2. In some aspects, FTC is first exceeded by a substantial FTC threshold_pThereafter, the control circuit 21002 reduces the closing speed at which the anvil 21012 is closed to a second closing speed v specific to parenchyma 21030 tissue_p2Wherein v is_p2<v_p1. The control circuitry 21002 may be configured to be capable of exceeding a substantial FTC threshold FTC_pThe anvil 21012 is then closed at a slower speed as this may indicate that the tissue is thicker, more rigid, or otherwise more resistant to the closing force from the anvil 21012 than expected for the detected tissue type. Accordingly, it may be desirable to reduce the closing speed in an attempt to reduce the amount of closing force subsequently applied to the clamped tissue.

When the anvil 21012 is at time t₃Upon closure resumption, the FTC begins to increase again until it is at time t₄Peak 21332 is reached and substantial force threshold FTC is again reached or exceeded_p. At the time of_tAt 4, the control circuit 21002 of the surgical instrument 21000 determines that the FTC has reached or exceeded the FTC threshold FTC_p. Thus, the control circuit 21002 controls the motor 21006 to stop the movement of the anvil 21012, causing the closing speed to drop 21346 to zero. The motion of the anvil 21012 may be paused for a duration p₃During which the closing speed remains 21348 at zero. During the pause, the FTC gradually decreases 21334 as the clamped tissue relaxes.

Fig. 103 illustrates a third graph 21350 and a fourth graph 21352, respectively depicting the variation of the end effector FTC21354 and the closure velocity 21356 over time 21358 for an illustrative firing of a surgical instrument 21000 grasping a blood vessel 21032, in accordance with at least one aspect of the present disclosure. In the following description of the third graph 21350 and the second graph 21352, reference should also be made to fig. 95, fig. 99, and fig. 101A to fig. 101B. The exemplary firing described herein is for the purpose of illustrating the concepts discussed above with reference to fig. 95, 99, 101A-101B, and should not be construed as limiting in any way.

A third firing of the surgical instrument 21000 can be represented by a third FTC curve 21360 and a corresponding first speed curve 21360', which respectively show the FTC and closing speed over time during the course of the third firing. The third firing may represent, for example, a default firing of the surgical instrument 21000 or a firing of the surgical instrument 21000 that does not include the control circuit 21002 to perform the process shown in fig. 99. When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, thereby abruptly increasing 21370 the closure velocity of the anvil 21012 to an initial or default closure velocity v_d2. Initial closing velocity v_d2May or may not be equal to the initial closing velocity v in graph 102_d1. As the anvil 21012 is driven from the open position, it travels for a period of time before contacting the clamped tissue, which for this particular firing is a blood vessel 21032. It should be noted that this is in contrast to firing of the surgical instrument 21000 clamp substance 21030, as shown in figure 102. When the vessel 21032 is relatively thin, the anvil 21012 must typically travel a distance before initial contact with the vessel 21032, while the parenchyma 21032 is typically thicker than the vessel 21032, so the anvil 21012 typically makes almost immediate initial contact with the vessel 21032. Thus, the FTC is initially flat 21362 because the anvil 21012 travels for a period of time without contacting tissue. Once the anvil 21012 is at time t₀Contacting tissue, FTC is at time t₂From an initial or flat 21376FTC (e.g., zero) increases 21364 to a peak 21366. At time t₂The control circuitry 21002 of the surgical instrument 21000 determines that the FTC has reached or exceeded an FTC threshold (which may be, for example, a default threshold independent of tissue type), and controlsThe motor 21006 stops the movement of the anvil 21012, thereby decreasing the closing speed 21372 to zero. The motion of the anvil 21012 may be paused for a duration p₄During which the closing speed remains 21374 at zero. During the pause, the FTC gradually decreases 21368 as the clamped tissue relaxes.

A fourth firing of the surgical instrument 21000 can be represented by a second FTC curve 21375 and a corresponding first speed curve 21375', which respectively show the FTC and closing speed over time during the course of the second firing. A fourth firing, as compared to the first firing, may represent, for example, firing of the surgical instrument 21000, including the control circuit 21002 performing the process 21200 shown in fig. 99. When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, thereby causing the closing speed of the anvil 21014 to sharply increase 21386. Due to the relative thinness and/or geometry of the vessel 21032 (as compared to, for example, parenchyma 21030), the initial point of contact between the tissue (i.e., vessel 21032) and the jaw 21013 does not occur until after the anvil 21012 has been driven by the motor 21006 for a period of time; accordingly, the control circuitry 21002 performing the process 21200 shown in fig. 99 is unable to determine when the blood vessel 21032 is being grasped and to set the time to close the jaws, one or more closure thresholds, and other suitable closure parameters accordingly until a closure process has been performed for a period of time. Because the anvil 21012 does not contact the thinner tissue of the vessel 21032 for a period of time, and thus the control circuit 21002 is accordingly unable to detect the type of tissue being clamped, the control circuit 21002 controls the motor 21006 to sharply increase 21386 the closing speed of the anvil 21014 to the default speed v_d。

When the anvil 21012 is driven from the open position, the FTC is initially flat 21376 because the anvil 21012 travels for a period of time without contacting the tissue. Once the anvil 21012 is at time t₀Upon contacting the tissue, the FTC increases 21378 from the initial FTC (e.g., zero). After contacting the blood vessel 21032, the control circuitry 21002 performing the process 21200 shown in fig. 99 can determine when the blood vessel 21032 is being grasped and set the time to close the jaws accordingly, one or more closure thresholds, and other closure parameters at that point in the closure process. At the time ofTime t₁Control circuitry 21002 determines that Δ FTC has reached or exceeded a Δ FTC threshold Δ FTC_v(when the control circuit 21002 determines that the blood vessel 21032 is clamped, the threshold has been at t₀Time or later set by the control circuit 21002). Blood vessel Δ FTC threshold Δ FTC_vMay represent, for example, the maximum rate of change of force that may be safely or advantageously exerted on the tissue of the vessel 21032. Thus, the control circuit 21002 controls the motor 21006 to decrease 21388 the closure velocity to a vessel closure velocity v specific to the tissue of the vessel 2032_v1Wherein v is_v1<v_d。

When the anvil 21012 is at a lower vessel closing velocity v_v1As it advances, FTC increases 21380 more slowly than before until it is at time t₃Reaching a peak 21382. At time t₃The control circuitry 21002 determines that the FTC has reached or exceeded the FTC threshold FTC_v(when the control circuit 21002 determines that the blood vessel 21032 is clamped, the threshold has been at t₀Time or later set by the control circuit 21002). Blood vessel FTC threshold value FTC_vMay represent, for example, the maximum force that may be safely or advantageously exerted on the tissue of the vessel 21032. Thus, the control circuit 21002 controls the motor 21006 to stop the movement of the anvil 21012, causing the closing speed to drop 21932 to zero. The motion of the anvil 21012 may be paused for a duration p₅During which the closing speed remains 21394 at zero. During the pause, the FTC gradually decreases 21384 as the clamped tissue relaxes. Duration of pause p₅May be equal to a default pause duration (e.g., p)₁) Or a closure parameter selected by the control circuit 21002 for the tissue of the blood vessel 21032.

In summary, fig. 102-103 highlight different ways in which the surgical instrument 21000 functions with and without the control circuit 21002 performing the process 21200 shown in fig. 99.

Fig. 104 illustrates a fifth graph 21400 depicting end effector FTC 21402 and closure speed 21404 versus time 21406 for an illustrative firing of a surgical instrument, in accordance with at least one aspect of the present disclosure. In the following description of the fifth graph 21400, reference should also be made to fig. 95 and 99 to 101B. The exemplary firing described herein is intended to illustrate the concepts discussed above with reference to fig. 95 and 99-101B, and should not be construed as limiting in any way.

A fifth firing of the surgical instrument 21000 can be represented by a fifth FTC curve 21408 and a corresponding fifth speed curve 21408', which respectively show the FTC and closing speed over time during the course of the fifth firing. The fifth firing may represent, for example, firing of the surgical instrument 21000, including the control circuit 21002 performing the process illustrated in fig. 99. When the firing of the surgical instrument 21000 is initiated, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, thereby sharply increasing 21416 the closure velocity of the anvil 21014 until it stabilizes 21418 at a particular closure velocity. As the anvil 21012 is closed, the FTC increases 21410 until a peak 21412 is reached at a particular time. The FTC decreases 21414 from peak 21412 until the tissue is fully clamped, at which point the control circuit 21002 controls the motor 21006 to stop the closure of the anvil 21012 and the closure speed drops 21420 to zero.

Thus, the fifth firing represents firing of the surgical instrument 21000 in which the FTC threshold, Δ FTC threshold, or any other closure threshold is not reached or exceeded during closure of the jaws 21013. In other words, during the process of closing the jaws 21013, the fifth firing remains within all control parameters. Thus, the control circuit 21002 does not pause the anvil 21012, adjust the closing speed of the anvil 21012, or take any other corrective action during the process of closing the jaws 21013.

Fig. 105 illustrates a sixth curve 21422 that depicts the end effector FTC 21402 and closure velocity 21404 as a function of time 21406 for an illustrative firing of a surgical instrument in accordance with at least one aspect of the present disclosure. In the following description of the sixth graph 21422, reference should also be made to fig. 95 and 99 to 101B. The exemplary firing described herein is intended to illustrate the concepts discussed above with reference to fig. 95 and 99-101B, and should not be construed as limiting in any way.

A sixth firing of the surgical instrument 21000 can be represented by a sixth FTC curve 21424 and a corresponding sixth speed curve 21424', which respectively show the FTC and closing speed over time during the course of the sixth firing. The sixth firing may represent, for example, firing of the surgical instrument 21000, including the control circuit 21002 performing the process 21200 shown in fig. 99. When the firing of the surgical instrument 21000 is initiated, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, thereby sharply increasing 21432 the closure velocity of the anvil 21014 until it reaches a particular closure velocity. As the anvil 21012 is closed, the FTC increases 21426 until a peak 21428 is reached at a particular time. In this particular example, the operator of the surgical instrument 21000 chooses to open the jaws 21013 of the surgical instrument 21000 in order to readjust the tissue therein. Thus, the closing speed drops 21434 until it reaches a negative closing speed, which indicates that the jaw 21013 is being opened, for example to easily allow the tissue to be readjusted within the jaw 21013. The closing speed is then returned 21436 to zero and the jaw 21013 stops. Accordingly, the FTC decreases 21430 to zero as the jaw 21013 is released from the tissue.

Fig. 106 illustrates a seventh graph 21438 depicting end effector FTC 21402 and closure velocity 21404 versus time 21406 for an illustrative firing of a surgical instrument, in accordance with at least one aspect of the present disclosure. In the following description of the seventh graph 21438, reference should also be made to fig. 95 and 99 to 101B. The exemplary firing described herein is intended to illustrate the concepts discussed above with reference to fig. 95 and 99-101B, and should not be construed as limiting in any way.

The seventh firing of the surgical instrument 21000 can be represented by a seventh FTC curve 21440 and a corresponding seventh speed curve 21440', which respectively show the FTC and closing speed over time during the course of the seventh firing. The seventh firing may represent, for example, firing of the surgical instrument 21000, including the control circuit 21002 performing the process 21200 shown in fig. 99. When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, thereby sharply increasing 21450 the closure velocity of the anvil 21014 to the first closure velocity v₁. As the anvil 21012 is closed, the FTC increases 21442 until time t₁. At time t₁Control circuit 21002 determining that Δ FTC has reached or exceeded a Δ FTC threshold Δ FTC_TWhich may be a default Δ FTC threshold or a Δ FTC threshold for a particular tissue type detected by the control circuitry 21002 according to the process 21200 shown in fig. 99. As another example, Δ FTC_TMay be set by another process performed by the control circuit 21002 and/or another control circuit of the surgical instrument 2100 in response to other sensed parameters or according to another algorithm. For example, if jaw closure is performed within the operating parameters of the procedure 21200 shown in fig. 99, but another sensor and/or procedure of the surgical instrument 21000 determines that the clamped tissue still deviates from the expected parameters in some way (e.g., the tissue is thicker or thinner than expected for a given tissue type), the time to close the jaws 21013, one or more closure thresholds, and other control parameters are set accordingly. In one example, the second sensor is at time t₁Where tissue is detected to be thinner than expected. Thus, control circuit 21002 sets a new Δ FTC_T(in this example, it is below the previous Δ FTC_T) The control circuit 21002 then determines at that time t₁The new value is reached or exceeded.

Thus, the control circuit 21002 controls the motor 21006 to decrease 21452 the closing speed of the anvil 21012 to the second closing speed v₂Wherein v is₁>v₂. From t₁Initially, the decrease in closing speed causes the FTC to increase 21444 at a slower rate. FTC is increased 21444 until it is at FTC threshold FTC_TThe peak 21446 is reached below and then falls. Due to the fact that at t₁Thereafter the seventh firing remains within all closure parameters, so the closure velocity remains 21454 at the second closure velocity v₂Until the tissue is fully clamped, at which point the control circuit 21002 controls the motor 21006 to stop the closure of the anvil 21012 and the closure speed drops 21456 to zero.

Fig. 107 illustrates a graph 21500 depicting impedance 21502 as a function of time 21504 to determine when jaws of a surgical instrument contact tissue and/or staples, in accordance with at least one aspect of the present disclosure. In the following description of the seventh graph 21438, reference should also be made to fig. 95. Configured to detect a signal from the end effector, as described above21008 the degree of compression of the clamped tissue and/or one or more sensors 21004 configured to be able to detect initial contact with the tissue may include, for example, impedance sensors. The impedance and/or rate of change of impedance of the tissue, as detected by one or more impedance sensors, may be used to determine the state of the clamped tissue. For example, if the detected impedance has stabilized at 21506, the impedance Z representing an open circuit condition_OCThen control circuitry 21002 coupled to the impedance sensor may determine that the jaws are open and/or not contacting tissue. As another example, when the detected impedance is initially from the open circuit impedance Z_OCUpon reduction 21508, control circuit 21002 coupled to the impedance sensor may determine that initial contact has been made with the tissue. As another example, when the detected impedance is from the open circuit impedance Z_OCUpon reducing 21510, the control circuit 21002 coupled to the impedance sensor may utilize the shape of the impedance curve over time and/or the rate of change of impedance detected to determine the rate of tissue compression and/or the degree of tissue compression. As another example, if the detected impedance drops 21512 to zero, the control circuit 21002 coupled to the impedance sensor can determine that the jaws of the end effector 21008 have contacted the staples, which shorts out the impedance detection system.

Examples

Various aspects of the subject matter described herein under the heading "control of a surgical instrument according to sensed closure parameters" are set forth in the following examples:

example 1-a surgical instrument comprising an end effector comprising jaws transitionable between an open configuration and a closed configuration. The surgical instrument also includes a motor operably coupled to the jaws. The motor is configured to transition the jaws between an open configuration and a closed configuration. The surgical instrument also includes a sensor configured to transmit at least one signal indicative of a tissue compression parameter associated with tissue between the jaws. The surgical instrument further includes a control circuit coupled to the sensor and the motor. The control circuit is configured to accept the at least one signal, determine a value of a tissue compression parameter based on the at least one signal when the jaws are transitioned from the open configuration to the closed configuration, cause the motor to increase a time to transition the jaws to the closed configuration as a function of whether the value of the tissue compression parameter is above a first threshold, and provide feedback as a function of whether the value of the tissue compression parameter is below a second threshold.

Example 2-the surgical instrument of example 1, wherein the tissue compression parameter comprises a force applied by the motor to transition the jaws to the closed configuration.

Example 3-the surgical instrument of example 1, wherein the tissue compression parameter comprises a time rate of change of a force applied by the motor to transition the jaws to the closed configuration.

Example 4-the surgical instrument of examples 1, 2, or 3, wherein the feedback comprises a recommendation for adjunct enhancement.

Example 5-the surgical instrument of examples 1, 2, 3, or 4, wherein the control circuit is configured to increase the time to transition the jaws to the closed configuration by decreasing a rate at which the motor transitions the jaws to the closed configuration.

Example 6-the surgical instrument of examples 1, 2, 3, or 4, wherein the control circuit is configured to increase the time to transition the jaws to the closed configuration by increasing a length of time that the motor is paused while transitioning the jaws to the closed configuration.

Example 7-the surgical instrument of examples 1, 2, 3, or 4, wherein the control circuit is configured to increase the time to transition the jaws to the closed configuration by decreasing a stability threshold to stop the motor when transitioning the jaws to the closed configuration.

Example 8-a surgical instrument comprising an end effector. The end effector includes jaws transitionable between an open configuration and a closed configuration, and one or more sensors disposed along a tissue contacting surface of each of the jaws. The one or more sensors are configured to be capable of detecting contact with tissue. The surgical instrument also includes a motor operably coupled to the jaws. The motor is configured to transition the jaws between an open configuration and a closed configuration. The surgical instrument also includes a control circuit coupled to the one or more sensors and the motor. The control circuit is configured to determine an initial point of contact of tissue contacting a tissue contacting surface of the jaws, determine a spacing between the jaws at the initial point of contact, determine a degree of contact between the tissue contacting surface and the tissue, cause the motor to transition the jaws to the closed configuration at a rate corresponding to the spacing between the jaws and the degree of contact between the tissue contacting surface and the tissue at the initial point of contact, and cause the motor to adjust the rate at which the jaws transition to the closed configuration as a function of whether a force applied by the motor to transition the jaws to the closed configuration exceeds a threshold. The threshold corresponds to the spacing between the jaws at the initial point of contact and the degree of contact between the tissue contacting surface and the tissue.

Example 9-the surgical instrument of example 8, wherein the one or more sensors comprise a pressure sensor.

Example 10-the surgical instrument of example 8, wherein the one or more sensors comprise an impedance sensor.

Example 11-the surgical instrument of examples 8, 9, or 10, wherein the spacing between the jaws comprises an angle between the jaws.

Example 12-the surgical instrument of examples 8, 9, or 10, wherein the spacing between the jaws comprises a gap between the jaws.

Example 13-a surgical instrument comprising an end effector. The end effector includes jaws configured to transition between an open configuration and a closed configuration to grasp tissue, and a contact sensor assembly configured to sense tissue against the contact sensor assembly. The surgical instrument also includes a position sensor configured to sense a configuration of the jaws and a motor coupled to the jaws. The motor is configured to transition the jaws between an open configuration and a closed configuration. The surgical instrument further includes a control circuit coupled to the contact sensor assembly, the position sensor, and the motor. The control circuit is configured to determine an initial point of contact at which tissue contacts the jaws, determine a configuration of the jaws at the initial point of contact via the position sensor, determine an amount of tissue contact between the tissue and the jaws at the initial point of contact via the contact sensor assembly, set a rate of closure at which the motor transitions the jaws to the closed configuration as a function of the configuration of the jaws at the initial point of contact and the amount of tissue contact, set a threshold of closure as a function of the configuration of the jaws at the initial point of contact and the amount of tissue contact, and control the motor to transition the jaws to the closed configuration relative to the threshold as a function of a force applied by the motor.

Example 14-the surgical instrument of example 13, wherein the sensor assembly comprises a pressure sensor.

Example 15-the surgical instrument of example 13, wherein the sensor assembly comprises an impedance sensor.

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

Example 17-the surgical instrument of examples 13, 14, or 15, wherein the configuration of the jaws corresponds to a gap between the jaws.

System for adjusting end effector parameters based on preoperative information

Aspects of the present disclosure are presented for adjusting a closure threshold and a closure rate achieved by a closure control procedure executed by a control circuit of a surgical instrument, where the adjustment is based on preoperative information. Adjusting the closure threshold may be one example of performing situational awareness by a computer-implemented interactive surgical system (including one or more surgical systems 102 and cloud-based analytical medical systems such as

clouds

104, 204, which are referred to as clouds 104 for clarity). For example, the closure threshold may be adjusted to a patient-specific closure threshold based on perioperative information received from the cloud 104 or determined by a surgical hub or surgical instrument. As used herein, perioperative information includes preoperative information, intraoperative information, and postoperative information.

Preoperative information refers to information received prior to performing a surgical procedure with a surgical instrument, while intraoperative information refers to information received during a surgical procedure (e.g., while performing a step of a surgical procedure). In particular, the computer-implemented interactive surgical system may determine or infer end effector closure parameters, such as appropriate end effector closure thresholds and closure rate algorithms, for a particular handheld intelligent surgical instrument. Such inference can be based on contextual information related to the surgical procedure to be performed and related to the corresponding patient. The contextual information may include or be determined based on perioperative information. The surgical instrument may be any suitable surgical instrument described in the present disclosure, such as

surgical instruments

112, 600, 700, 750, 790, 150010. For clarity, reference is made to surgical instrument 112.

Perioperative information, such as perioperatively diagnosed diseases and treatments, may affect the properties or characteristics of the tissue being treated by the surgical instrument 112. For example, a patient may have been previously diagnosed with cancer and received radiation therapy to treat the cancer. Thus, the preoperative information would indicate that the patient's tissue may have increased stiffness characteristics. However, currently applied closure control procedures may not address this increased stiffness. Thus, performing a surgical procedure according to a general closure rate algorithm using a closure control program may result in unnecessary trauma or injury to the tissue due to over-compression of the patient's tissue. In addition, during a surgical procedure, intraoperative information can be analyzed, such as by identifying which of a plurality of potential types of tissue is being processed. Different types of tissue may also have different tissue properties, such as tissue stiffness. Thus, changes in intraoperative information can be used to perform intraoperative adjustments, either in place of or in addition to perioperative adjustments. In summary, the closure control procedure may not take into account that different closure rate thresholds should be applied depending on perioperative information, such as tissue type, surgical procedure being performed and surgical steps already performed.

When performing a surgical operation with the surgical instrument 112, it may be desirable for the surgical instrument to account for the different tissue types and various characteristics of these different tissue types. In particular, it may be desirable for the surgical instrument 112 to efficiently determine the tissue type and characteristics of the tissue type prior to and during the performance of a surgical procedure with the surgical instrument by a clinician.

Thus, in some aspects, a cloud-based analytical medical system (e.g., computer-implemented interactive surgical system 100) is provided in which perioperative information can be considered to determine the type of tissue to be treated and the characteristics of the tissue treated prior to treatment. For example, the surgical procedure to be performed and other patient information may be examples of pre-operative information retrieved prior to performing the surgical procedure. Previously performed surgical procedure steps, other surgical histories, and changes in tissue type are examples of intraoperative information that may be considered. Generally, this perioperative information can be used in conjunction with sensor signals indicative of closure parameters to determine, infer, or adjust parameters (e.g., closure rate of change and closure threshold) of the end effector of the surgical instrument 112. The end effector may be any end effector described in this disclosure, such as

end effector

702, 151600, 150300, 151340, 152000, 152100, 152150, 152200, 152300, 152350, 152400, 153460, 153470, 153502. For clarity, reference is made to end effector 702.

Analyzing perioperative information to obtain closure rate-related situational awareness can be accomplished in a variety of ways. Based on the perioperative information, the control circuitry of the surgical instrument, such as

control circuitry

500, 710, 760, 150700 (discussed above with reference to fig. 12, 15, 17, and 29A-29B) may adjust the closure rate of change and closure threshold inputs used in the selected closure control procedure. For clarity, reference is made to control circuit 500. The control circuit 500 may also select different control programs based on perioperative information. Additionally or alternatively, a surgical hub, such as surgical hub 106, 206 (referred to as surgical hub 106 for clarity) may receive perioperative information from cloud 104 or surgical instruments 112. For example, the surgical hub 106 may receive an Electronic Medical Record (EMR) of the patient or an initial tissue thickness measurement determined based on tissue contact or pressure sensors of the surgical instrument 112 (e.g., as shown in fig. 24) from the cloud 104.

Surgical hub 106 may then analyze the received perioperative information. Based on the analysis, the surgical hub 106 may then transmit a signal to the surgical instrument 112 to adjust the closure rate of change and the closure threshold input used in the selected closure control procedure. The surgical hub 106 may also instruct the surgical instrument 112 to select a different closure control program, such as by the control circuit. The selection of the different control programs may be based on signals received from the hub 106 or updated control programs received by the surgical instrument 112 from the hub 106. The cloud 104 may also perform analysis for adjusting the closing rate and the maximum threshold used. In particular, the processors of the cloud 104 may analyze the perioperative information to determine, for example, the tissue type and characteristics used to change inputs to the closure control procedure or to select a different suitable closure control procedure to be performed by the surgical instrument.

As such, the cloud 104 may instruct (e.g., via the hub 106) the surgical instrument 112 to apply the appropriate closure rate algorithm and closure maximum threshold. The tissue type and characteristics may also be determined based on sensor signals indicative of closure parameters. The sensors may be tissue contact or pressure sensors, force sensors, motor current sensors, position sensors, load sensors or other suitable sensors, such as the

sensors

472, 474, 476, 630, 734, 736, 738, 744 a-744 e, 784, 788, 152408, 153102, 153112, 153118, 153126, 153200, 153438, 153448, 153450a, 153450b, 153474 described above. For clarity, reference is made to sensor 474. The sensor 474 is configured to transmit a sensor signal indicative of a parameter of the surgical instrument 112. Some types of perioperative information may be stored in the cloud 104 prior to determining tissue type and characteristics. For example, the patient EMR may be stored in a memory (e.g., a cloud database) of the cloud 104. In general, surgical instrument 112, hub 106, or cloud 104 can analyze perioperative information to determine tissue types and characteristics for situational awareness.

Thus, the tissue type and characteristics determined based on perioperative information can be used to actively adjust the closure rate and the maximum threshold used. That is, perioperative information can be used to predict more effective closure parameters (e.g., end effector 702 parameters) such that the closure control program applied by the surgical instrument 112 uses closure rates and thresholds that take into account patient-specific tissue characteristics and the type of tissue being treated. Thus, using closure rate and threshold situational awareness as described herein may advantageously enable the surgical instrument 112 to apply an adjusted closure rate and threshold without overcompressing the tissue to be treated. Over-compression may be based on the first and second jaw members of end effector 702. The first and second jaw members may be, for example, first and

second jaw members

152002, 152152, 152154, 152204, 152254, 152304, respectively. The first and second jaw members may also be referred to as anvils 716, 766 and

staple cartridges

718, 768. For clarity, the first jaw member is referred to as 152002, and the second jaw member is referred to as 152204. First jaw member 152002 and second jaw member 152004 can define an aperture of end effector 702 defined as the distance between first jaw member 152002 and second jaw member 152004.

For example, when the aperture of the end effector 702 is unnecessarily small, unnecessary tissue damage or trauma may occur due to over-compression. Reducing or preventing such over-compression may be accomplished by making adjustments using perioperative information and/or sensor signals from sensor 474. In addition, compression applied during initial closure parameter measurements can be minimized, such as based on the load sensor 474 (measuring the closure force) and the positioning sensor 474 (measuring the position of the first jaw member 152002 and the second jaw member 152004). In general, the sensor 474 may be configured to measure the closing force applied by the end effector 702 of the surgical instrument 112. In addition to proactively inferring tissue characteristics and types from perioperative information, one or more of surgical instrument 112, hub 106, and cloud 104 may use sensed measurements from sensor 474 (as shown in fig. 12) to verify or further adjust applied closure force, closure rate, and closure threshold as necessary. In particular, the contact sensor may be used to determine undeformed tissue thickness. Additionally, the load sensor 474, in combination with the position sensor 474, can be used to determine tissue thickness based on the applied closing force relative to the position of the first jaw member 152002 and the second jaw member 152004, respectively. These verifications or further adjustments may be performed preoperatively or intraoperatively.

Closed parameter situational awareness may be performed continuously. Thus, the clinician or surgeon may continue to use perioperative information to adjust the closure parameters (e.g., closure parameters of the closure control procedure) of the end effector 702 as appropriate (e.g., when performing a step of the surgical procedure). For example, perioperative information can be used to adjust the closure parameters of the end effector 702 when it is determined based on clinical history (e.g., the surgeon's routine) that the next step of the surgical procedure being performed involves vascular tissue. In this case, the situational aware surgical instrument 112 may apply the closing force at a constant rate of change of closure. Such perioperative information can be used in conjunction with sensor signals indicative of closure parameters of the surgical instrument 112 to adjust closure parameters (e.g., rate of closure change and closure thresholds of a control program) of the end effector 702. Perioperative information, such as intra-operative information, may indicate that the patient has been previously treated with radiation therapy.

Based on this information, the control circuit 500 can infer increased tissue stiffness, which is a tissue characteristic that can be considered throughout the steps of the surgical procedure. In one example, such increased tissue stiffness can be perioperative information to supplement sensor signals indicative of tissue thickness, such that adjustments to more appropriate end effector 702 closure parameter values can be achieved. The perioperative information may also indicate that the applied surgical procedure is a leaf resection that may be determined from data stored in the cloud 104. Based on knowledge of the lobectomy, it may be determined that the likely tissue types to be treated (e.g., sutured) include blood vessels, bronchial tissue, and parenchymal tissue.

Thus, based on perioperative information, the particular tissue type and characteristics of the tissue currently being treated by the surgical instrument 112 can be predicted or inferred prior to initiating the therapeutic treatment of the tissue. For example, consideration of an initial tissue thickness (measured when the tissue currently being treated first contacts the end effector 702) in conjunction with treatment, diagnosis, and patient information may enable inference that previously irradiated parenchymal tissue is being treated. Because the type and characteristics of the tissue being treated can be determined contextually prior to beginning the surgical procedure, the closing control procedure implemented by the control circuitry 500 of the surgical instrument 112 can be advantageously adjusted (e.g., by changing input parameters based on the inferred type or characteristics of tissue) or changed (e.g., by selecting a different control procedure) prior to beginning the treatment procedure. In particular, the maximum tissue closure threshold may be reduced to account for the substantial stiffness and fragility of the irradiated being treated. The maximum threshold may refer to a maximum closure force or a maximum rate of change of closure that may be applied. In addition, the closure algorithm of the closure control program may also be adjusted to identify a slower, more conservative rate of closure based on the substance being irradiated.

In addition, it may be determined whether the surgical instrument 112 is a suitable stapling surgical instrument 112, such as for irradiated parenchyma. If the perioperative information indicates that the selected surgical instrument 112 is not suitable for its intended use, an alert may be generated. For example, if it can be inferred based on perioperative information that the tissue currently being treated is bronchial tissue and an inappropriate vascular anastomosis surgical instrument 112 is selected, a warning will be generated to the clinician. In general, the surgical instrument 112 may generate an alert based on a determined, predicted, or inferred inconsistency between the surgical instrument type, the perioperative information, and the sensor signal. In addition, as described above, the intraoperative information can also be used to adjust throughout the surgical procedure. For example, the current step in the overall procedure operation may be to treat rigid bronchial tissue, which will typically result in a slower closure rate. Further adjustments may also be made after the initial adjustment. In particular, further adjustments may be made during operation, such as adjusting a slower closure rate to a faster closure rate when additional intraoperative information (e.g., sensed information) is analyzed and it is inferred that the closure force applied in the currently applied closure algorithm should be modified or adjusted. In some cases, such adjustments may also be made post-operatively.

Thus, the closure rate and threshold may be advantageously adjusted based on the determined tissue type, tissue characteristics, and perioperative information before or during the start of the treatment. Accordingly, such adjustment may advantageously avoid or minimize tissue damage caused by excessive strain and facilitate proper formation of staples from the stapling surgical instrument 112.

Fig. 108 and 109 are

graphs

22000, 22100 illustrating various end effector closure threshold functions that may be used based on perioperative information and illustratingAn adjusted end effector closure control algorithm is provided. Graph 22100 is an enlarged view of graph 22000. In fig. 108 and 109, a clamping or closing Force (FTC), which may be understood as a clamping force applied to the end effector 702, is indicated on the y-

axis

22002, 22102 of the

graphs

22000, 22100. The time elapsed or spanned a surgical cycle is indicated on the

x-axis

22004, 22104. For example, the x-axis 22004 of fig. 108 indicates the cycle span is 13 seconds. In contrast, the x-axis 22104 of fig. 109 spans slightly less than 2 seconds. As shown in FIG. 108, a default general tissue closure threshold function (denoted as FTC)_d22006) May be generally applied to control the closing of an end effector 702 of a surgical instrument 112 used in general surgery.

Also shown on

graphs

22000, 22100 are the default FTCs _d22006 other thresholds that are more conservative. However, less conservative thresholds may also be used. Such as FTC _L122008 and FTC _L222010, a more conservative closure threshold may be employed to reduce the closure force of the surgical instrument relative to a default closure force function. FTC _L122008 and FTC _L222010 may be thresholds stored in the memory of the surgical instrument 112, hub 106, or cloud 104. Additionally or alternatively, FTC _d22006 may be dynamically adjusted at a suitable point during the surgical cycle. Dynamic adjustment may be performed by control circuitry 500, corresponding hub 106, or cloud 104. Additionally,

graphs

22000, 22100 indicate different closing threshold functions FTC_d、FTC_L1And FTC _L222006. 22008, 22010. Since the occlusion threshold may vary as a function of time during the corresponding surgical cycle, the slope of the occlusion threshold may be constant throughout the surgical cycle or may vary as appropriate during the surgical cycle.

In other words, the instantaneous rate of change defined by a particular closure threshold function may vary between different time frames of the surgical cycle. For example, a particular closure threshold function may define a relatively slow rate of increase near the beginning of a surgical cycle and a relatively fast rate of increase near the middle of the surgical cycle. Closing threshold function Δ FTC_d、ΔFTC_L1And Δ FTC _L222106. 22108 and 22110 areFunction FTC_d、FTC_L1And FTC _L222006. 22008, 22010 and shows the corresponding slope of the closing threshold function. In the aspect of fig. 109, it can be seen that the slope is constant, although the slope may vary as appropriate. The rate of closure change may be adjusted according to a selected closure threshold function. One example of an adjustment is shown by an "x" in fig. 108 and 109, and is shown in larger size in the enlarged view of graph 22100. In this example, the closure rates as shown by

lines

22012, 22112 are adjusted such that they do not exceed Δ FTC _L222110。

In one aspect, a motor of the surgical instrument 112, such as motors 482, 704 a-704 e, 754, 150082, 150714, can move the first jaw member 152002 relative to the second jaw member 152004 of the end effector 702. For clarity, reference is made to motor 482. The motor 482 may move or close the end effector 702 according to the rate of change of closure represented by

lines

22012, 22112 and the selected closure threshold. To this end, the control circuit 500 may adjust the current drawn by the motor 482 to vary the speed or torque of the motor 482 based on a selected threshold. For example,

graphs

22000, 22100 illustrate how the control circuit 500 may adjust the motor 482 at point "x" (as shown on the graphs) such that the rate of change of closure parameter of the surgical instrument 112 changes to remain at the selected threshold FTC _L222010. FTC's that can be patient-specific thresholds can be selected and determined based on perioperative information _L222010。

FTC thresholds

22006, 22008, 22010 depicted in

graphs

22000, 22100 may be parameters of different or the same closing control procedures performed by the control circuit 500. These closure control programs may be stored locally on the memory of the surgical instrument 112 or remotely on the hub 106 or cloud 104. In general, the closure threshold function defines how the closure threshold changes as a function of time in a cycle, indicating an instantaneously applicable closure threshold at any point in time during the cycle. For example, the closure threshold may define a maximum closure force or a maximum rate of change of the closure force used that may be applied to close the jaws of the end effector. Fig. 108 shows the use of a threshold value as the maximum rate of change of the applied closing force. At a selected point in time on the

graph

22000, 22100, a

line

22012, 22112 plotted against time on the

x-axis

22004, 22104 and FTC on the y-

axis

22002, 22102 indicates the instantaneous force applied to close the

jaws

152002, 152004 at that point in time.

As shown by line 22012, the applied force progresses over time from time zero to time t₁But increases, then the rate of increase slows to zero and then to the rate of decrease of the force. At time t₂Shortly before, the rate of descent was much faster. At time t₂Thereafter, the force applied to close the jaws begins to transition to a zero rate and then decreases again at a non-zero rate. As shown by line 22112 of graph 22100, the closing force applied to close the

jaws

152002, 152004 increases between time zero to a time slightly before 0.5 seconds (shown on the x-axis 22104). At times corresponding to an "x" on graph 22100, the control circuit 500 may adjust the motor 482 to adjust the selected closing algorithm such that the rate of increase of closing is reduced. As such, the motor 482 may be controlled by the control circuitry 500 to remain at the selected patient specific threshold Δ FTC _L222110. Further, as shown in graph 22100, after the time corresponding to "x", the slower rate of increase of the applied closing force becomes a constant rate.

In one aspect, the same total amount of applied FTC may be applied during a surgical cycle. However, the force applied to close the end effector may be applied more gradually or immediately as the case may be. This is illustrated by the rate of change, which is represented by the rate of change of closure of a line, such as

lines

22012, 22112. Although FIG. 109 depicts three depicted thresholds Δ FTC_d、ΔFTC_L1And Δ FTC _L222106. 22108, 22110 are each shown as FTC_d、FTC_L1And FTC _L222006. 22008, 22010, but in some aspects, Δ FTC_d、ΔFTC_L1And Δ FTC _L222106. 22108, 22110 represent different closing threshold functions. In other words, control circuit 500 may slave threshold FTC_d、FTC_L1And FTC _L222006. 22008, 22010 to a threshold Δ FTC_d、ΔFTC_L1And Δ FTC _L222106. 22108, 22110, which in this case would be completely different thresholds.

As mentioned above, the slope of the closure threshold function may change during one surgical cycle. In this case, the dynamic slope may be adjusted consistently or individually throughout the surgical cycle. Generally, the closure threshold parameter adjustment may be implemented by changing a parameter of the current closure control program (e.g., by the control circuit 500 directly changing the closure threshold function implemented by the control circuit 500) or switching entirely to a new closure control program. The switching or adjusting may be performed by control circuitry 500, hub 106, or cloud 104 based on perioperative information. For example, the control circuit 500 may switch from the current control program to a second closed control program received from the cloud 104. A second closed control program may also be transmitted from cloud 104 to hub 106.

As described above, one or more of the surgical instrument 112, corresponding hub 106, and cloud 104 for treating tissue may be used to receive, infer, or determine perioperative information in order to determine, infer, or predict the type and characteristics of tissue currently being therapeutically treated. These closure situation awareness inferences and predictions may be used to adjust the closure rate threshold. Thus, in addition to FTC_d、ΔFTC_d22006. 22106,

graphs

22000, 21000 also show, for example, a second tissue closure rate of change threshold function FTC_L1、ΔFTC_L122008. 22108 the closure algorithm used by the surgical instrument 112 may automatically incorporate this function. That is, the surgical instrument 112 may adjust inputs to the current closure control program or adjust to a different control program to be executed by the control circuit 500. For example, situation aware surgical hub 106 may determine that the currently applied surgical procedure is a lung surgical procedure based on the target region located in the chest cavity. The chest cavity may then be inferred as the target region based on ventilation output from another device used in the operating room, for example. Thus, it is determined that the tissue type of treatment is lung tissue. Thus, the surgical instrument 112 may be calibrated from the previously used threshold FTC _d22006. 22106 Adjust to use a default closure threshold function FTC for Lung tissue _L122008. 22108. Such adjustments may be made inDuring the surgical cycle across the y-

axis

22004, 22104.

For example, the situational aware surgical hub 106 may predict that a patient's lungs will include relatively fragile tissue. Thus, as shown in fig. 108 and 109, the closing threshold function may be adjusted to a lower FTC threshold function. The closure threshold may be, for example, a maximum allowable FTC value or a maximum allowable FTC rate of change applied by the end effector. The inference of relatively high stiffness of lung tissue may be confirmed by other perioperative information. For example, the EMR of a patient stored in the cloud 104 may be analyzed to determine that the patient has been previously diagnosed with cancer and has been treated with radiation. This type of preoperative information can be used to infer tissue characteristics of lung tissue, including relatively high stiffness and significant fluid content (e.g., percentage of water in the tissue).

In addition to confirming the initial prediction, perioperative information may also be used to adjust for inaccurate initial predictions. For example, the surgical instrument 112 may apply a sub-optimal closure algorithm based on the incorrect assumption that tissue has greater flexibility than it actually has. In this case, the pre-patient medical history information can be used as part of the false hypothesis correction. Generally, perioperative information can be used in conjunction with sensor signals indicative of closure parameters. Advantageously, the perioperative information may identify an initial closure algorithm determined based on the sensor signals, or may be used to adjust the initial closure algorithm to a different, more suitable closure algorithm. For example, the sensor signal can indicate a relationship between the sensed applied closing force and the end effector 702 aperture position (e.g., the position of the first jaw 152002 relative to the second jaw 152004). Such signals can be used to determine tissue stiffness and can be used in conjunction with other perioperative information to adjust the closure algorithm prior to or during the surgical procedure.

Thus,

graphs

22000, 22100 of fig. 108 and 109 illustrate that the default lung tissue threshold function FTC may be further adjusted based on patient-specific tissue characteristics_L1. As shown in FIGS. 108 and 109, the surgical instrument can be slave to a threshold function FTC, for example, based on patient-specific perioperative information _L122008 further adjusted to FTC _L222010 or FTC _d22006. Thus, the adjustment may occur before the start of the surgery or during the surgery. Further, from FTC _d22006 Regulation to FTC _L222010, or the threshold function FTC may simply be implemented directly_L222010. It is possible to adjust between any available closure threshold functions based on perioperative information.

Although fig. 108 and 109 illustrate adjustments to the lower threshold, adjustments to the higher threshold are also possible. The threshold functions shown in fig. 108 and 109 may correspond to particular control procedures that may be implemented by particular closure control programs. Alternatively, the control process may correspond to a different closing control program. For example, the control circuit 500 may directly modify the selected closure control algorithm itself, or switch to a different closure control algorithm. That is, the particular closure control algorithm, e.g., represented by

lines

22012, 22112, or the particular closure threshold function of the rate of change of closure applied may be modified. Based on the perioperative information, closure threshold function modifications may be performed during the surgical procedure. In addition, the threshold function may also be a function of some other parameter, such as the staple size used, in addition to time.

Additionally or alternatively, the closure adjustment may include adjusting the input only to a closure threshold function. For example, if a tissue characteristic such as tissue thickness is an input to the closure threshold function, the perioperative information may be used to predictively or inferentially modify the input to modify the output closure threshold in accordance with the predicted or inferred tissue thickness input. Thus, the applied closure threshold function may be modified based on perioperative information. As described above, the applied closure threshold function is defined by the applied closure control algorithm. Additionally, the applied FTC or closing

force line

22012, 22112 may be adjusted based on perioperative information.

In one aspect, the FTC or

closure force line

22012, 22112 represents a closure rate of change parameter of a corresponding closure control procedure executed by the control circuit 500. The FTC lines 22012, 22112 are also defined by the applied closing control algorithm. In one aspect, as shown by "x" in fig. 108 and 109, the applied closing force can be dynamically adjusted during the cycle of the surgical procedure being performed. Such dynamic adjustment may also be a situational aware application. In other words, perioperative information can be incorporated to infer or predict adjustments to the threshold or threshold function during a surgical procedure. Thus, as shown in fig. 108 and 109, at one or more times corresponding to "x" indicated in fig. 108 and 109, the applied FTC is adjusted or modified to remain within the corresponding instantaneous closure threshold. In summary, the applied closure control algorithm may include a closure threshold function and a closure rate of change, both of which may be adjusted based on perioperative information.

In general, adjustments to different closure thresholds or different closure threshold functions may be performed based on a determined, inferred, or predicted characteristic or type of tissue being treated. As described above, tissue characteristics or types may be determined, inferred, or predicted based on perioperative information. Adjustment of another closure threshold may be understood as adjusting the maximum threshold with reference to the maximum torque generated by the motor 482 of the surgical instrument 112 or the rate of change of the motor speed. Various examples of perioperative information may be used to determine, infer or predict tissue types or tissue characteristics. For example, the amount of water, muscle properties, and vasculature of the tissue may affect the closure rate algorithm (including the closure threshold) to be applied. In one aspect, these properties, as well as other tissue type and tissue characteristic properties, are used to determine a default closure threshold FTC _D22006 or any other initial closing control program parameter.

Thus, a high vasculature may be a tissue characteristic used to infer a default closure threshold function with a relatively low slope. In addition to determining initial control procedure parameters, the rate of change of closure applied by the surgical instrument may be adjusted to be slower if pre-operative information such as the surgical procedure and the surgical history applied (e.g., a typical routine of a clinician performing a procedure with reference to a surgical step of the procedure) may be used to infer that vascular tissue having a high hemoglobin content is being targeted. Thus, these properties can be used to determine control procedure parameters pre-and intra-operatively. In addition, perioperative information can be used to confirm that the appropriate vascular stapler was used in the vascular tissue procedure.

Fig. 110 is a flowchart 22200 of aspects of the computer-implemented interactive surgical system 100 adjusting the closure rate algorithm according to an aspect of the present disclosure. At step 22202, a current closure algorithm is determined. This may refer to determining a closing control procedure currently being executed by the control circuit 500 of the surgical instrument 112. As described above in connection with fig. 108 and 109, the current closure algorithm or control program may include a closure threshold function (e.g., a closure threshold parameter) and an applied closure Force (FTC) function (e.g., a closure rate of change parameter). Flowchart 22200 next proceeds to step 22204 where the pre-operative information is received and analyzed. As described above, the pre-operative information may include an initial tissue thickness based on the tissue contact sensor 474, a patient history including previous diagnoses and treatments (e.g., listed on patient information EMR records stored in a hub or cloud), a clinical history such as a typical surgical routine of the surgeon, identified surgical instruments and related materials, and an identified current surgical procedure. At step 22206, the pre-operative information may be used to determine, infer or predict a tissue type or tissue characteristic.

For example, an undeformed initial tissue thickness as measured by the tissue contact sensor 474 may be used to determine an initial closure algorithm. Preoperative information such as a patient's lung medical history may be used to determine that the surgical procedure currently being performed is a thoracic procedure and the tissue type is lung tissue. This pre-operative information may also be used to determine adjustments to the initial closure algorithm. Additionally or alternatively, initial tissue stiffness measured by comparing non-therapeutic (or quasi-non-therapeutic) initial tissue compression measurements and closure member position measurements (e.g., the positions of the first and second jaws of the end effector) may also be used in conjunction with the pre-operative information. The pre-ventilatory information received from the surgical suite's ventilator may also be used to infer that the current procedure is a chest surgery. Other pre-operative information may also be used to further predict the particular thoracic procedure being performed. For example, based on the patient EMR record in the cloud indicating that the patient has cancer, it may be concluded at step 22206 that the thoracic procedure is a lobectomy to remove cancerous tissue in the lung lobes.

In addition, the patient EMR record may also indicate that the patient history indicates that the patient has previously received radiation therapy for the cancer.In this case, for example, it may be inferred or predicted that the lung tissue being illuminated will be rigid, but also susceptible to monopolar RF energy being applied by the surgical instrument 112. This would be one example of inferred organizational characteristics. In addition, the inference of performing a lobectomy may also be used to determine possible tissues for stapling by the surgical instrument 112 including blood vessels (PA/PV), bronchi, and parenchyma. At step 22208, an adjustment to the current closure algorithm is determined based on the pre-operative information and applied. As described above, the closure threshold and applied FTC may be adjusted based on the tissue type and tissue characteristics. For example, high tissue stiffness may require a slower and more conservative rate of change of the applied FTC (e.g., as represented by FTC wires 22012, 22112), and a closure threshold that typically outputs a lower maximum threshold (e.g., as represented by FTC wires 22012, 22112)_L222010 and Δ FTC _L222110 shows).

The maximum threshold value can indicate a threshold value at which the first jaw member 152002 and the second jaw member 152004 are in a position sufficient to fire staples in the surgical instrument 112. For example, relatively thicker tissue may correspond to a slower rate of change of closure force and a generally higher maximum closure threshold. Additionally, tissue type or structure may be inferred based on the determined surgical and clinical history for identifying other closure algorithm adjustments at step 22208. For example, the clinical history recorded by the attending surgeon may indicate the practice of treating a blood vessel first. It can be concluded that the tissue type and structure are vascular lung tissue with high blood content (i.e. high vasculature). Based on this inferred tissue type and characteristic information, it may be determined that an adjustment to the rate of change of the slower applied FTC would be beneficial. In summary, at step 22208, an adjustment to the current closure algorithm is determined based on the inferred information and applied. Thus, the current surgical procedure may be performed using the adjusted current closure algorithm and with the surgical instrument 112.

The flowchart 22200 then proceeds to decision operation 22210, where a determination is made as to whether any steps of the identified surgical procedure remain. If there are no remaining steps (i.e., the answer to decision operation 22210 is no), then flowchart 22200 terminates in some respects. However, if the answer to decision 22210 is yes, then there are additional steps for the remaining surgical procedure. Thus, the current state of flowchart 22200 is operational. In this case, the flow chart proceeds to step 22212 where the intraoperative information can be received and analyzed. For example, the intraoperative information may indicate that the type of tissue processed during this step of the surgical procedure is substantial. In particular, it may be inferred that the tissue is parenchymal, e.g., based on clinical history. This inference may be made in conjunction with the measurement of the tissue contact sensor 474 and the measurement of the closure member position by the load sensor 474. In addition, clinical history may indicate that the attending surgeon routinely completes the lung fissure (double fold of the pleura, i.e., inward fold to the parenchyma of the sheath lung) after dissection with monopolar RF energy surgical instruments. In this case, it can be inferred based on the previously completed monopolar RF anatomy that the current step of the surgical procedure is the lung parenchyma tissue.

In addition, for example, the surgical hub 106 may determine whether the surgical instrument 112 being used is an appropriate stapler for substantial firing. The measurements of initial tissue contact sensor 474 may indicate that the tissue is relatively thick, such as based on the tissue contacting the lengths of first jaw member 152002 and second jaw member 152004 when end effector 702 is fully open (at the maximum jaw aperture), which may be substantially consistent. Further, measurements of the closure member position by the load sensor 474 (as represented by a comparison of the closure member to the jaw aperture curve) may indicate a relatively high tissue stiffness. The hardness characteristic may be substantially consistent with being illuminated, which is a prediction that may be confirmed by reference to patient EMR data in the cloud. Thus, for example, at step 22212, the sensor signals and perioperative information may be used in combination.

Based on the received and analyzed intraoperative information, it may be determined at decision 22214 that further adjustments are needed. On the other hand, if the answer at decision operation 22214 is no, the flow chart will return to decision operation 22210. When the answer at decision operation 22214 is yes, the tissue type and tissue characteristics are inferred, such as determining parenchymal tissue structure and stiffness characteristics, similar to that described above at step 22206. Subsequently, an adjustment to the currently applied closure algorithm may be determined at step 22208, and the adjustment applied. In particular, inferences about handling rigid and fragile parenchymal tissue may result in adjustments to slower, more conservative rates of change of applied closure force.

Thus, the current closure algorithm may be adjusted to an algorithm that minimizes the closure threshold and rate of change. That is, the adjusted threshold may have a reduced maximum closing force threshold, a more gradual rate of change of the closing force, a reduced rate of change of the closing force threshold, or some combination or sub-combination of the above. For example, in the event that the clinician inadvertently exceeds the closure threshold, a wait time may be set. For example, exceeding a closure threshold may indicate that the compressed tissue or material is too thick for firing the staples, and thus this waiting time may be necessary. Thus, the wait time may enable some tissue material or fluid in the end effector 702 to be expelled or flow out. After a suitable wait time, it is determined that the tissue can be properly compressed to achieve the proper end effector 702 configuration so that the stapling surgical instrument 112 can fire the staples. Since the adjusted closing algorithm is more conservative, long latency may be used. However, the clinician may be able to override this long-latency or conservatively adjusted closure algorithm by manually selecting a faster clamping protocol usage on the surgical instrument 112.

Upon applying the modified closure algorithm to the parenchymal tissue at step 22208, the flow chart again proceeds to decision operation 22210. Here, the answer may likewise be "yes" because there are remaining steps of the surgical procedure. For example, a leaf resection may then proceed to a vascular anastomosis procedure. Likewise, at step 22212, intraoperative information is received and analyzed. For example, the surgical hub may determine that the clinician has selected a vascular stapler surgical instrument. Additionally, initial measurements from the tissue contact sensor 474 may indicate that tissue contact occurred almost immediately during closure. Further, tissue contact may be determined to encompass a small area of the vascular stapler 112 and be limited on the distal side of the stapler 112. The load cell 474 measurements may also indicate compliant tissue structure. In addition, it can be inferred that the tissue may have a relatively low stiffness, which may be consistent with pulmonary vessels. In addition, clinical history may indicate that the attending surgeon will typically apply the vascular stapler 112 to the blood vessel as a step after completion of the lung fissure. Thus, the intraoperative information in combination with, for example, closure parameter sensor signals can be used to infer tissue type and tissue characteristics. In particular, the vascular tissue may be predicted to be being treated based on the particular characteristics of the selected vascular stapler 112. For example, the measurements of the initial tissue contact and load sensor 474 may confirm the initial prediction.

Accordingly, it may be determined at decision operation 22214 that further adjustments are needed, which causes flowchart 22200 to proceed to step 22206. At step 22206, the tissue may be inferred as vascular tissue having a relatively low tissue thickness and stiffness. Thus, flowchart 22200 proceeds to step 22208 where the previously applied conservative closure algorithm is adjusted to the normal closure algorithm. The normal closure algorithm may include a constant rate of closure change. Additionally, the closure threshold may be higher than the threshold used in the control algorithm for parenchymal tissue. In other words, the normal closure algorithm may achieve a higher maximum applied closure force, and the rate of change of closure may be faster than parenchymal tissue. The surgical instrument may also notify the clinician of the adjustment to the normal closing algorithm via a suitable indicator, such as a Light Emitting Diode (LED) indicator displaying a particular color. In another example, it may be determined at step 22206 that the patient has a finished lung fissure. Thus, any staple firing of the parenchymal tissue has not been performed during the surgical procedure. In response to the determination, the surgical instrument can prompt the clinician, such as via a display of the surgical instrument, to confirm that the inference is correct. The clinician may then manually select an appropriate closure control algorithm for that step or stage of the surgical procedure. Additionally or alternatively, the surgical instrument 112 may default to a conservative closure algorithm, as the inference performed at step 22206 may not be conclusive. In any case, the adjusted closing algorithm is applied at step 22208.

Continuing with the lobectomy example, the flow chart proceeds to decision operation 22210. At decision operation 22210, it can be determined that there are remaining steps for the surgical procedure. Accordingly, at step 22212, intraoperative information is received and analyzed. Based on the intraoperative information, it can be inferred that the type of tissue being treated is bronchial tissue. Further, measurements of initial tissue contact sensor 474 may indicate that tissue grasped between end effector 702 nearly immediately contacts first jaw member 152002 and second jaw member 152004 during the initial closure of end effector 702, and that such contact corresponds to a small region of stapling surgical instrument 112. Additionally, such contact is limited on both sides of

jaw members

152002, 152004.

Thus, it is predicted that such tissue contact corresponds to bronchial tissue. As described above, the measurements of these initial tissue contact sensors 474 may be non-therapeutic or quasi-non-therapeutic. Further, measurements of the closure load sensor 474 (as represented by a comparison of the closure member to the jaw aperture curve) may indicate a rigid tissue structure consistent with bronchial tissue. The surgical history indicates that vascular stapler 112 has been used during surgery, which may also mean that substantial staple firing is likely to have occurred and significant monopolar RF energy use has occurred. For example, this surgical history, taken in conjunction with the clinical history, can be used to predict that the surgeon is treating bronchial tissue. This prediction would be consistent with the conventional practice of a surgeon suturing the bronchi as the last step in a leaf resection. Based on analyzing this type of information and other suitable intraoperative information at step 22212, it may be determined at decision 22214 that further adjustments are needed. Since the answer to decision operation 22214 is yes, the flowchart proceeds to step 22206 where it is inferred that the tissue being treated is bronchial tissue having normal tissue stiffness and thickness.

In one aspect, it can be readily ascertained that the tissue being treated is bronchial tissue, as the surgical instrument 112 is only configured for a particular tissue type. For example, the surgical instrument 112 may be adapted to fire staples only for the bronchi. Conversely, the surgical instrument 112 may be adapted to fire staples only for the parenchymal tissue. In this case, an alert may be generated by the surgical instrument 112 because the surgeon is attempting to treat the bronchial tissue with staples that are dedicated to the parenchymal tissue. The warning may be an audible warning, a visual warning, or some other suitable warning. In another example, if the vessel stapler 112 is selected for use with bronchial tissue, a warning may be provided by the vessel stapler 112. As described above, the tissue being treated may be determined to be bronchial tissue with the vascular stapler disabled based on perioperative information. Similarly, other perioperative information (such as closure load and cartridge selection) may be used to provide warnings when the surgical instrument 112 is used for tissue types or characteristics that are incompatible with them. As described above, inferences made using perioperative information can be made in conjunction with closure parameter sensor signals. In all cases, a safety check may be implemented to ensure that the surgical instrument 112 being used is safe for the tissue being treated.

Based on the inferred tissue type and characteristics, at step 22208, an adjustment is made to the current closure algorithm. Although a constant occlusion rate may be determined to be appropriate, the occlusion rate may be adjusted to be faster or slower depending, for example, on inferred bronchial tissue characteristics. The closing threshold may be modified in the same or similar manner. Further, the current closure algorithm may also be adjusted such that a longer wait time is automatically enabled or suggested if and when the surgical instrument 112 exceeds the momentarily applicable closure threshold. For example, the latency time for bronchial tissue may be longer than the latency time for parenchymal tissue. As described above, the surgeon is informed of the selected adjustment to the closure algorithm, for example, via an LED indicator. The clinician may also override a longer wait time so that the surgeon may be allowed to fire the stapler surgical instrument 112, if appropriate. Flowchart 22200 then proceeds to step 22212, where it may be determined that there are no additional steps for the remaining surgical procedure.

In one aspect, flowchart 22200 may be implemented by control circuitry. However, in other aspects, flowchart 22200 may be implemented by surgical hub 106 or cloud 104. Additionally, although

steps

22204 and 22212 are described in terms of preoperative information and intraoperative information, respectively, they are not limited in this manner. In particular, perioperative information may generally be received and analyzed, rather than specific preoperative or intraoperative information. As noted above, perioperative information encompasses preoperative, intraoperative, and postoperative information. Further, the sensor signals can be used in conjunction with perioperative information for contextual and inferential closure algorithm adjustments.

Examples

Various aspects of the subject matter described herein under the heading "system for adjusting end effector parameters based on preoperative information" are set forth in the following embodiments:

example 1-a surgical system comprising a surgical instrument. The surgical instrument includes an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument further includes a motor configured to move the first jaw relative to the second jaw as a function of the closure rate of change parameter and the closure threshold parameter. The surgical instrument further includes a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector. The surgical system also includes a control circuit communicatively coupled to the sensor. The control circuitry is configured to receive perioperative information, wherein the perioperative information includes one or more of perioperative disease, perioperative treatment, and type of surgical procedure. The control circuit is further configured to receive a sensor signal from the sensor and determine adjustments to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal.

Embodiment 2-the surgical system of embodiment 1, wherein the control circuit is further configured to determine a characteristic of tissue to be treated by the surgical instrument based on one or more of the perioperative information and the sensor signal.

Embodiment 3-the surgical system of embodiment 2, wherein the tissue characteristic comprises one or more of a tissue type characteristic, a muscle characteristic, a vessel characteristic, a water content characteristic, a stiffness characteristic, and a thickness characteristic.

Example 4-the surgical system of examples 1, 2, or 3, wherein the control circuit is further configured to vary the speed of the motor based on the determined adjustments to the closure rate of change parameter and the closure threshold parameter.

Example 5-the surgical system of examples 1, 2, 3, or 4, wherein the control circuit is further configured to generate an alert based on an inconsistency between the type of surgical instrument and one or more of the perioperative information and the sensor signal.

Example 6-the surgical system of examples 1, 2, 3, 4, or 5, wherein the perioperative information further comprises one or more of a type of tissue to be treated by the surgical instrument, a tissue characteristic, a clinical history, and a type of staple cartridge used with the surgical instrument.

Example 7-the surgical system of examples 1, 2, 3, 4, 5, or 6, wherein the closure threshold parameter is a maximum closure force threshold, and the control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closure force threshold.

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

Example 9-the surgical system of example 8, wherein the closure control procedure is a first closure control procedure, the surgical hub is further configured to transmit a second closure control procedure to the surgical instrument, and the second closure control procedure defines the adjustment to the rate of closure change parameter and the adjustment to the closure threshold parameter.

Example 10-the surgical system of example 9, wherein the cloud computing system is configured to transmit a second closure control procedure to the surgical hub, and the adjustment of the rate of closure change parameter and the adjustment of the closure threshold parameter of the second closure control procedure are adjusted based on the perioperative information.

Example 11-the surgical system of examples 8, 9, or 10, wherein the surgical instrument is configured to generate the alert based on an inconsistency between a type of the surgical instrument and one or more of the perioperative information and the sensor signal.

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

Example 13-the surgical system of examples 8, 9, 10, 11, or 12, wherein the perioperative information includes one or more of a perioperative disease, a perioperative treatment, a type of surgical procedure, a clinical history, a type of surgical instrument, a type of tissue being treated by the surgical instrument, and a characteristic of the tissue.

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

Example 15-a surgical instrument comprising an end effector comprising a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument further includes a motor configured to move the first jaw relative to the second jaw according to the closure rate of change parameter and the closure threshold parameter of the first closure control procedure received from the surgical hub. The surgical instrument further includes a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector, and a control circuit communicatively coupled to the sensor and the motor. The control circuit is configured to receive the sensor signal from the sensor and determine adjustments to the closure rate of change parameter and the closure threshold parameter based on the perioperative information and the sensor signal.

Example 16-the surgical system of example 15, wherein the surgical instrument is configured to generate the alert based on an inconsistency between a type of the surgical instrument and one or more of the perioperative information and the sensor signal.

Example 17-the surgical system of examples 15 or 16, wherein the control circuit is further configured to switch from the first closing control procedure to a second closing control procedure received from the cloud computing system and vary the speed of the motor based on the second closing control procedure.

Example 18-the surgical system of examples 15, 16, or 17, wherein the control circuitry is further configured to determine the characteristics and type of tissue to be treated by the surgical instrument based on one or more of the perioperative information and the sensor signal.

Example 19-the surgical system of examples 15, 16, 17, or 18, wherein the closure threshold parameter is a maximum closure force threshold.

Example 20-the surgical system of example 19, wherein the closure threshold parameter is a maximum closure force threshold.

In various aspects, sensors of a sensor array according to the present disclosure may be placed on a staple cartridge. The adhesive mask may be embedded with sensors at predetermined locations. In various aspects, the sensor is attached to a lug on the staple cartridge such that the sensor is positioned higher than a cartridge deck of the staple cartridge to ensure contact with tissue. For example, an adhesive mask may be formed in large quantities on a polyester substrate using screen printing techniques. The conductive pads may be printed to a common location.

In various examples, in addition to detecting proximity to cancerous tissue, the end effector of the present disclosure may be configured to target a particular cancer type in a particular tissue. As noted in Altenberg B and the journal publication by Greulich KO, Genomics, Vol.84, No. 2004, p.1014-1020, which is incorporated herein by reference in its entirety, certain cancers are characterized by overexpression of glycolytic genes, while other cancers are not characterized by overexpression of glycolytic genes. Thus, the end effector of the present disclosure may be equipped with an array of sensors with high specificity for certain cancer tissues characterized by overexpression of glycolytic genes, such as lung or liver cancer.

In various aspects, sensor readings of a sensor array according to the present disclosure are transmitted by a surgical instrument to a surgical hub (e.g., surgical hub 106, 206) for additional analysis and/or for situational awareness.

The foregoing detailed description has set forth various forms of the devices 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, in whole or in part, can 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 one or more program products in a variety of forms, and that an exemplary form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.

The instructions for programming logic to perform the various disclosed aspects may be stored within a memory within the system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Further, the instructions may be distributed via a network or through other computer readable media. Thus, a machine-readable medium may include a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, read-only memories (CD-ROMs), magneto-optical disks, read-only memories (ROMs), Random Access Memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memory, or a tangible, machine-readable storage device for use in transmitting information over the internet via electrical, optical, acoustical 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" can refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor that includes one or more separate 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 that stores instructions executed by programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry that forms part of a larger system, e.g., 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 smartphone, etc. 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 implements, at least in part, the methods and/or apparatus described herein, or a microprocessor configured by a computer program that implements, at least in part, 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, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in an 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 a software package, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) 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, either hardware, a combination of hardware and software, or software in execution.

An "algorithm," as used in any aspect herein, is a self-consistent sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states which may (but are not necessarily) take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. And are used to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or 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 communication using the transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with the ethernet standard entitled "IEEE 802.3 standard" promulgated by the Institute of Electrical and Electronics Engineers (IEEE) at 12 months 2008 and/or higher versions of this 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 telecommunication 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 entitled "ATM-MPLS network interworking 2.0" promulgated by the ATM forum at 8 months 2001 and/or higher versions of that standard. Of course, different and/or later-developed connection-oriented network communication protocols are also contemplated herein.

Unless specifically stated otherwise as apparent from the above discussion, 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 able," "configurable to be able," "operable/operable," "adapted/adaptable," "able," "conformable/conformal," or the like. Those skilled in the art will recognize that "configured to be able to" may generally encompass components in an active state and/or components in an inactive state and/or components in a standby state 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 be further appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" 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 especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within 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 claims. 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"); this also applies to the use of definite articles used to introduce claim recitations.

The term "comprises" (and any form of "comprising", such as "comprises" and "comprising)", "has" (and "has)", such as "has" and "has)", "contains" (and any form of "containing", such as "comprises" and "containing)", and "containing" (and any form of "containing", such as "containing" and "containing", are open-ended verbs. Thus, a surgical system, device, or apparatus that "comprises," "has," "contains," or "contains" one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, an element of a system, apparatus, or device that "comprises," "has," "includes," or "contains" one or more features has those one or more features, but is not limited to having only those one or more features.

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). Further, 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 to have a meaning that one of ordinary 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 a alone, B alone, C, A and B together alone, 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 to have a meaning that one of skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include but not be limited to systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). It will also be understood by those within the art that, in general, disjunctive words and/or phrases having two or more alternative terms, whether appearing 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 terms, unless the context indicates otherwise. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".

Those skilled in the art will appreciate from the appended claims that the operations recited therein may generally be performed in any order. In addition, while the various operational flow diagrams are presented in an order(s), it should be appreciated that the various operations may be performed in an order other than that shown, or may be performed concurrently. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, supplemental, simultaneous, reverse, or other altered orderings, unless context dictates otherwise. Furthermore, unless the context dictates otherwise, terms like "responsive," "related," or other past adjectives are generally not intended to exclude such variations.

It is worthy to note that any reference to "an aspect," "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" 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 applications, patents, non-patent publications or other published materials mentioned in this specification and/or listed in any application data sheet are herein incorporated by reference, to the extent that the incorporated materials are not inconsistent herewith. Thus, 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, a number of 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 are possible in light of the above teachings. The form or forms selected and described are to be illustrative of the principles and practical applications to thereby enable one of ordinary skill in the art to utilize the form or forms and various modifications as are suited to the particular use contemplated. The claims as filed herewith are intended to define the full scope.

Claims

1. A surgical system, comprising:

a surgical instrument, wherein the surgical instrument comprises:

an end effector, the end effector comprising:

a first jaw; and

a second jaw, wherein the first jaw is configured to move relative to the second jaw;

a motor configured to move the first jaw relative to the second jaw as a function of a closure rate of change parameter and a closure threshold parameter; and

a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector; and

a control circuit communicatively coupled to the sensor, wherein the control circuit is configured to:

receiving perioperative information, wherein the perioperative information includes one or more of perioperative disease, perioperative treatment, and type of surgical procedure;

receiving the sensor signal from the sensor; and

determining adjustments to the closure rate parameter and the closure threshold parameter based on the perioperative information and the sensor signal.

2. The surgical system of claim 1, wherein the control circuit is further configured to determine a characteristic of tissue to be treated by the surgical instrument based on one or more of the perioperative information and the sensor signal.

3. The surgical system of claim 2, wherein the tissue characteristic comprises one or more of a tissue type characteristic, a muscle characteristic, a vasculature characteristic, a water content characteristic, a stiffness characteristic, and a thickness characteristic.

4. The surgical system of claim 1, wherein the control circuit is further configured to vary a speed of the motor based on the determined adjustments to the closure rate of change parameter and closure threshold parameter.

5. The surgical system of claim 1, wherein the control circuit is further configured to generate an alert based on an inconsistency between the type of the surgical instrument and one or more of the perioperative information and the sensor signal.

6. The surgical system of claim 1, wherein the perioperative information further comprises one or more of a type of tissue to be treated by the surgical instrument, a tissue characteristic, a clinical history, and a type of staple cartridge used with the surgical instrument.

7. The surgical system of claim 1, wherein:

the closure threshold parameter is a maximum closure force threshold; and is

The control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closing force threshold.

8. A surgical system, comprising:

a surgical hub configured to receive perioperative information transmitted from a remote database of a cloud computing system, wherein the surgical hub is communicatively coupled to the cloud computing system; and

a surgical instrument communicatively coupled to the surgical hub, wherein the surgical instrument comprises:

an end effector, the end effector comprising:

a first jaw; and

a motor configured to move the first jaw relative to the second jaw according to a closure rate of change parameter and a closure threshold parameter of a closure control program received from the surgical hub; and

a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector; and is

Wherein the surgical hub is further configured to:

receiving the sensor signal from the sensor; and

9. The surgical system of claim 8, wherein:

the close control program is a first close control program;

the surgical hub is further configured to transmit a second closure control procedure to the surgical instrument; and is

The second closure control procedure defines an adjustment to the closure rate of change parameter and an adjustment to the closure threshold parameter.

10. The surgical system of claim 9, wherein:

the cloud computing system is configured to transmit the second closure control program to the surgical hub; and is

Adjusting the closure rate parameter adjustment and the closure threshold parameter adjustment of the second closure control procedure based on perioperative information.

11. The surgical system of claim 8, wherein the surgical instrument is configured to generate an alert based on an inconsistency between a type of the surgical instrument and one or more of the perioperative information and the sensor signal.

12. The surgical system of claim 8, wherein:

the closure threshold parameter is a maximum closure force threshold; and is

The surgical hub is further configured to disable the motor for a predetermined period of time based on reaching the maximum closure force threshold.

13. The surgical system of claim 12, wherein the perioperative information includes one or more of perioperative disease, perioperative treatment, type of surgical procedure, clinical history, type of the surgical instrument, type of tissue being treated by the surgical instrument, and characteristics of the tissue.

14. The surgical system of claim 9, wherein the surgical hub is further configured to vary a speed of the motor based on the determined adjustments to the closure rate of change parameter and closure threshold parameter.

15. A surgical instrument, comprising:

an end effector, the end effector comprising:

a first jaw; and

a motor configured to move the first jaw relative to the second jaw according to a closure rate of change parameter and a closure threshold parameter of a first closure control procedure received from a surgical hub; and

a control circuit communicatively coupled to the sensor and the motor, wherein the control circuit is configured to:

receiving the sensor signal from the sensor; and

determining adjustments to the closure rate parameter and the closure threshold parameter based on perioperative information and the sensor signal.

16. The surgical instrument of claim 15, wherein the surgical instrument is configured to generate an alert based on an inconsistency between a type of the surgical instrument and one or more of the perioperative information and the sensor signal.

17. The surgical instrument of claim 15, wherein the control circuit is further configured to:

Switching from the first closed control program to a second closed control program received from a cloud computing system; and

varying a speed of the motor based on the second closing control procedure.

18. The surgical instrument of claim 15, wherein the control circuit is further configured to determine a characteristic and a type of tissue to be treated by the surgical instrument based on one or more of the perioperative information and the sensor signal.

19. The surgical instrument of claim 15, wherein the closure threshold parameter is a maximum closure force threshold.

20. The surgical instrument of claim 19, wherein the control circuit is further configured to disable the motor for a predetermined period of time based on reaching the maximum closure force threshold.