Powered surgical instrument with smart reload having externally mounted wiring connectors with individual attachability

Abstract

A modular surgical instrument system is provided that includes a modular component and a control circuit electrically couplable to the modular component. The modular component includes a shaft and a handle assembly. The handle assembly includes a disposable outer housing. The disposable outer housing is movable between an open configuration and a closed configuration. The handle assembly further includes a control inner core that is receivable within an interior of the disposable outer housing in the open configuration. The disposable outer housing is configured to isolate the control inner core in the closed configuration. The modular component further includes a loading unit releasably couplable to the shaft and a staple cartridge releasably couplable to an end effector. The loading unit includes the end effector. The control circuit is configured to generate an interrogation signal, detect a response signal, determine a modular configuration of the modular surgical instrument system, and assess an authenticity of the modular configuration.

Description

Background Technology

[0001] This invention relates to surgical instruments, and in various arrangements, to surgical suturing and cutting instruments designed to suture and cut tissues, and staple cartridges used with them. Summary of the Invention

[0002] In one aspect, this disclosure provides a modular surgical instrument system including a modular component comprising a shaft and a handle assembly releasably coupled to the shaft. The handle assembly includes a disposable outer housing configured to define a sterile barrier. The disposable outer housing includes a first housing portion and a second housing portion movable relative to the first housing portion between an open configuration and a closed configuration. The handle assembly also includes a control core, which, in the open configuration, is accommodated within the disposable outer housing. The disposable outer housing is configured to isolate the control core in the closed configuration. The modular component also includes a loading unit releasably coupled to the shaft, wherein the loading unit includes an end effector. The modular component also includes a staple cartridge releasably coupled to the end effector. The modular surgical instrument system further includes control circuitry electrically coupled to the modular component. The control circuitry is configured to generate an interrogation signal, detect a response signal to the interrogation signal, determine a modular configuration of the modular surgical instrument system based on the response signal, and evaluate the authenticity of the modular configuration based on the response signal.

[0003] In another aspect, this disclosure provides a modular surgical instrument system comprising modular components characterized by a uniquely identified resistor. The modular component includes a shaft and a handle assembly releasably coupled to the shaft. The handle assembly includes a disposable outer housing configured to define a sterile barrier. The disposable outer housing includes a first housing portion and a second housing portion, the second housing portion being movable relative to the first housing portion between an open configuration and a closed configuration. The handle assembly also includes a control core, which, in the open configuration, is accommodated within the disposable outer housing. The disposable outer housing is configured to isolate the control core in the closed configuration. The modular component also includes a loading unit releasably coupled to the shaft, wherein the loading unit includes an end effector. The modular component also includes a staple cartridge releasably coupled to the end effector. The modular surgical instrument system further includes control circuitry electrically coupled to the modular component. The control circuitry is configured to detect the modular configuration of the modular surgical instrument system based on the uniquely identified resistor and to evaluate the authenticity of the modular configuration.

[0004] In another aspect, this disclosure provides a modular surgical instrument system comprising modular components characterized by a uniquely identified resistor. The modular components include a shaft and a handle assembly releasably coupled to the shaft. The handle assembly includes a disposable outer housing configured to define a sterile barrier. The disposable outer housing includes a first housing portion and a second housing portion, the second housing portion being movable relative to the first housing portion between an open configuration and a closed configuration. The handle assembly also includes a control core, which, in the open configuration, is accommodated within the disposable outer housing. The disposable outer housing is configured to isolate the control core in the closed configuration. The modular components also include a loading unit releasably coupled to the shaft, wherein the loading unit includes an end effector. The modular components also include a staple cartridge releasably coupled to the end effector. The modular surgical instrument system further includes control circuitry electrically coupled to the modular components. The control circuitry is configured to detect an identification signal of the modular configuration of the modular surgical instrument system, measure characteristics of the modular configuration, determine an authentication key based on at least one measurement of the characteristics of the modular configuration, and authenticate the identification signal based on the authentication key. Attached Figure Description

[0005] The various features and advantages of the implementation scheme described herein can be understood in conjunction with the following figures and the following description: Figure 1 A perspective view of a surgical instrument system according to at least one aspect of this disclosure is shown.

[0006] Figure 2 The disassembled configuration is shown. Figure 1 A perspective view of the handle assembly of a surgical instrument system, which includes a disposable outer shell and an inner core.

[0007] Figure 3 It shows the use of in Figure 1 End effectors of surgical instrument systems and Figure 2 A cross-sectional view of the electrical interface between the inner cores for transmitting at least one of the power and data.

[0008] Figure 4 The present disclosure provides a logical flowchart of a process according to at least one aspect of the present disclosure, which depicts a control program or logical configuration for electrically connecting the core of a surgical instrument system to a staple cartridge or end effector.

[0009] Figure 5 A graph according to at least one aspect of this disclosure is provided, which shows the travel of the drive member on the x-axis and the speed of the drive member on the y-axis.

[0010] Figure 6A graph according to at least one aspect of this disclosure is provided, which shows the speed of the drive member on the x-axis and the motor current on the y-axis.

[0011] Figure 7 A partial front view of a surgical instrument system according to at least one aspect of this disclosure.

[0012] Figure 8 A partial front view of a surgical instrument system according to at least one aspect of this disclosure.

[0013] Figure 9 for Figure 8 A cross-sectional view of the nozzle portion of a surgical instrument system.

[0014] Figure 10 A cross-sectional view of the handle assembly of a surgical instrument system according to at least one aspect of this disclosure.

[0015] Figure 11 A cross-sectional view of a modular configuration of a modular surgical instrument system according to at least one aspect of this disclosure.

[0016] Figure 12 A graph is provided according to at least one aspect of this disclosure, which illustrates the resistance identifiers of various potential modular components of a modular surgical instrument system.

[0017] Figure 13 A logic flowchart depicting the process of controlling the modular configuration of a modular surgical instrument system or component for testing and / or certifying the modular configuration.

[0018] Figure 14 A logic flowchart depicting the process of controlling the modular configuration of a modular surgical instrument system or component for testing and / or certifying the modular configuration.

[0019] Figure 15 A perspective view of a handle assembly of a modular surgical instrument system according to at least one aspect of the present disclosure, the handle assembly including a disposable outer housing and an inner core.

[0020] Figure 16 For evaluation of the assembly configuration Figure 15 A graph showing the proximity and alignment of the disposable outer shell and inner core.

[0021] Figure 17 A perspective view of a surgical instrument system according to at least one aspect of this disclosure.

[0022] Figure 18 for Figure 17 A cross-sectional view of the nozzle portion of the shaft assembly of a surgical instrument system.

[0023] Figure 19 for Figure 17 A partial exploded view of the components of a surgical instrument system.

[0024] Figure 20 for Figure 17 A partial cross-sectional view of the components of a surgical instrument system.

[0025] Figure 21 This is a logic flowchart depicting the process of controlling or configuring the inner core of the handle assembly of a surgical instrument system to disable it upon end-of-life events.

[0026] Figures 22 to 25 A safety mechanism for a disposable outer housing for disabling the handle assembly after use in surgical procedures is shown, according to at least one aspect of this disclosure.

[0027] Figures 26 to 29 A safety mechanism for a disposable outer housing for disabling the handle assembly after use in surgical procedures is shown, according to at least one aspect of this disclosure.

[0028] Figure 30 A perspective view of a surgical instrument system according to at least one aspect of this disclosure.

[0029] Figure 31 for Figure 30 A partial cross-sectional view of the outer wall of the handle assembly of a surgical instrument system.

[0030] Figure 32 for Figure 30 A simplified representation of the sterilization detection circuit of the handle assembly of a surgical instrument system.

[0031] Figure 33 for Figure 30 A top view of the handle assembly of a surgical instrument system, showing its light-emitting diode (LED) display.

[0032] Figure 34 for Figure 33 A magnified view of the LED display.

[0033] Figure 35 A graph showing sensor readings of a hydrogen peroxide sensor according to at least one aspect of this disclosure.

[0034] Figure 36 A logic flowchart depicting a control procedure or logic configuration process for detecting the end of the life cycle of a resterilable component of a surgical instrument system, according to at least one aspect of this disclosure.

[0035] Figure 37 The process of re-sterilizing the handle assembly of a surgical instrument system according to at least one aspect of this disclosure is illustrated.

[0036] Figure 38 A re-sterilization system for re-sterilizing the handle assembly of a surgical instrument system according to at least one aspect of this disclosure.

[0037] Figure 39 It shows a closed configuration. Figure 38 The re-sterilization system.

[0038] Figure 40 A re-sterilization system for re-sterilizing the handle assembly of a surgical instrument system according to at least one aspect of this disclosure.

[0039] Figure 41 This is a main electrical interface for use with a surgical instrument system, according to at least one aspect of this disclosure.

[0040] Figure 42 An actuator for use with a surgical instrument system, according to at least one aspect of this disclosure.

[0041] Figure 43 It is shown that at least one aspect of this disclosure is in different configurations, thereby generating different closing forces. Figure 42 The actuator.

[0042] Figure 44 To illustrate different closed positions of the end effector and based on Figure 43 The curves of the corresponding closing forces determined by different configurations.

[0043] Figure 45 A perspective view of a disposable outer housing and inner core of a handle assembly according to at least one aspect of this disclosure.

[0044] Figure 46 for Figure 45 A partial cross-sectional view of the actuator of the handle assembly.

[0045] Figure 47 A perspective view of a disposable outer housing and inner core of a handle assembly according to at least one aspect of this disclosure.

[0046] Figure 48 for Figure 47 A partial cross-sectional view of the actuator of the handle assembly.

[0047] Figure 49 A graph showing the vibration on the y-axis as a function of time on the x-axis.

[0048] Figure 50 This is a partial exploded view of the handle assembly according to at least one aspect of this disclosure.

[0049] Figure 51 for Figure 50 A partial cross-sectional view of the actuator of the handle assembly.

[0050] Figure 52 This is a partial exploded view of the handle assembly according to at least one aspect of this disclosure.

[0051] Figure 53 This is a partial exploded view of an actuator for a handle assembly according to at least one aspect of the present disclosure.

[0052] Figure 54 for Figure 53 A partial cross-sectional view of the actuator.

[0053] In several views, corresponding reference symbols indicate corresponding parts. The examples described herein illustrate certain embodiments of the invention in one form, and such examples should not be construed as limiting the scope of the invention in any way. Detailed Implementation

[0054] The applicant of this application also owns the following U.S. patent applications filed on the same date as this application, each of which is incorporated herein by reference in its entirety: - A U.S. patent application entitled "METHOD FOR TISSUE TREATMENT BY SURGICAL INSTRUMENT"; Agent's file number END9291USNP1 / 200802-1M; - U.S. patent application entitled "SURGICAL INSTRUMENTS WITH INTERACTIVE FEATURES TO REMEDY INCIDENTAL SLED MOVEMENTS"; Agent's file END9291USNP2 / 200802-2; - U.S. patent application entitled "SURGICAL INSTRUMENTS WITH SLED LOCATION DETECTION AND ADJUSTMENT FEATURES"; Agent's file END9291USNP3 / 200802-3; - U.S. patent application entitled "SURGICAL INSTRUMENT WITH CARTRIDGE RELEASE MECHANISMS"; Agent's file END9291USNP4 / 200802-4; - U.S. patent application entitled "DUAL-SIDED REINFORCED RELOAD FOR SURGICAL INSTRUMENTS"; Agent's file END9291USNP5 / 200802-5; - U.S. patent application entitled "SURGICAL SYSTEMS WITH DETACHABLE SHAFT RELOAD DETECTION"; Agent's file END9291USNP6 / 200802-6; - U.S. patent application entitled "SURGICAL INSTRUMENTS WITH ELECTRICAL CONNECTORS FOR POWERTRANSMISSION ACROSS STERILE BARRIER"; Agent's file END9291USNP7 / 200802-7; - U.S. patent application entitled "DEVICES AND METHODS OF MANAGING ENERGY DISSIPATED WITHINSTERILE BARRIERS OF SURGICAL INSTRUMENT HOUSINGS"; Agent's file END9291USNP8 / 200802-8; - U.S. patent application entitled "POWERED SURGICAL INSTRUMENTS WITH EXTERNAL CONNECTORS"; Agent's file END9291USNP9 / 200802-9; - U.S. patent application entitled "POWERED SURGICAL INSTRUMENTS WITH COMMUNICATION INTERFACESTHROUGH STERILE BARRIER"; Agent's File No. END9291USNP11 / 200802-11; and - U.S. patent application entitled “POWERED SURGICAL INSTRUMENTS WITH MULTI-PHASE TISSUETREATMENT”; Agent’s file END9291USNP12 / 200802-12.

[0055] The applicant of this patent application owns the following U.S. patent applications filed on December 4, 2018, the disclosure of each of which is incorporated herein by reference in its entirety: ● U.S. Patent Application Serial No. 16 / 209,385 entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY”; ● U.S. Patent Application Serial No. 16 / 209,395 entitled “METHOD OF HUB COMMUNICATION”; ● U.S. Patent Application Serial No. 16 / 209,403 entitled “METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB”; ● U.S. Patent Application Serial No. 16 / 209,407 entitled “METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, ANDCONTROL”; ● U.S. Patent Application Serial No. 16 / 209,416 entitled “METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUDANALYTICS”; ● U.S. Patent Application Serial No. 16 / 209,423 entitled “METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS”; ● U.S. Patent Application Serial No. 16 / 209,427 entitled “METHOD OF USING REINFORCED FLEXIBLE CIRCUITS WITH MULTIPLESENSORS TO OPTIMIZE PERFORMANCE OF RADIO FREQUENCY DEVICES”; ● U.S. Patent Application Serial No. 16 / 209,433 entitled “METHOD OF SENSING PARTICULATE FROM SMOKE EVACUATED FROM APATIENT, ADJUSTING THE PUMP SPEED BASED ON THE SENSED INFORMATION, AND COMMUNICATING THE FUNCTIONAL PARAMETERS OF THE SYSTEM TO THE HUB”; ● U.S. Patent Application Serial No. 16 / 209,447 entitled “METHOD FOR SMOKE EVACUATION FOR SURGICAL HUB”; ● U.S. Patent Application Serial No. 16 / 209,453 entitled “METHOD FOR CONTROLLING SMART ENERGY DEVICES”; ● U.S. Patent Application Serial No. 16 / 209,458 entitled “METHOD FOR SMART ENERGY DEVICE INFRASTRUCTURE”; ● U.S. Patent Application Serial No. 16 / 209,465 entitled “METHOD FOR ADAPTIVE CONTROL SCHEMES FOR SURGICAL NETWORKCONTROL AND INTERACTION”; ● U.S. Patent Application Serial No. 16 / 209,478 entitled “METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK ORSURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON ASENSED SITUATION OR USAGE”; ● U.S. Patent Application Serial No. 16 / 209,490, entitled “METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION”; and ● U.S. Patent Application Serial No. 16 / 209,491 entitled “METHOD FOR CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENTBASED ON SITUATIONAL AWARENESS”.

[0056] This document sets forth numerous specific details to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described in the specification and illustrated in the figures. Well-known operations, components, and elements are not described in detail to avoid obscuring the embodiments described in the specification. The reader will understand that the embodiments described and illustrated herein are non-limiting examples, and thus will recognize that the specific structural and functional details disclosed herein are representative and illustrative. Variations and changes may be made to these embodiments without departing from the scope of the claims.

[0057] Various exemplary apparatuses and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily understand that the various methods and apparatuses disclosed herein can be used in a wide range of surgical procedures and applications, including, for example, in combination with open surgery. Continuing to refer to this specific embodiment, the reader will further understand that the various instruments disclosed herein can be inserted into the body in any manner, such as through natural cavities, through incisions or puncture holes formed in tissue, etc. The working portion or end effector portion of the instrument can be inserted directly into the patient's body or through an access device having a working channel through which the end effector and elongated shaft of the surgical instrument can be advanced.

[0058] refer to Figures 1 to 3 A surgical instrument system, such as, for example, an electromechanical surgical instrument system 8500, is provided. System 8500 includes a handle assembly 8520, various types of adapters or shaft assemblies (such as, for example, shaft assembly 8530), and various types of loading units or end effectors (such as, for example, end effector 8540). The handle assembly 8520 is configured to selectively attach to any one of a plurality of shaft assemblies (such as, for example, shaft assembly 8530), and each unique shaft assembly 8530 is subsequently configured to selectively connect to any number of surgical loading units or end effectors (such as, for example, end effector 8540). The end effector 8540 and the shaft assembly 8530 are configured to be actuated and manipulated by the handle assembly 8520. When a shaft assembly 8530 is connected, for example, to the handle assembly 8520 and a type of end effector (such as, for example, end effector 8540) is connected to the selected shaft assembly 8530, a powered handheld electromechanical surgical instrument is formed.

[0059] Various suitable loading units or end effectors for use with the Surgical Instrument System 8500 are discussed in U.S. Patent No. 5,865,361, entitled “SURGICAL STAPLING APPARATUS,” published February 2, 1999, the entire disclosure of which is incorporated herein by reference. Various handle assemblies for use with the Surgical Instrument System 8500 are discussed in U.S. Patent No. 10,426,468, entitled “HANDHELD ELECTROMECHANICAL SURGICAL SYSTEM,” published October 1, 2019, the entire disclosure of which is incorporated herein by reference.

[0060] The handle assembly 8520 includes an inner core 8522 and a disposable outer shell 8524, the disposable outer shell being configured to selectively receive and enclose the inner core 8522 to establish a sterile barrier 8525 around the inner core 8522. Figure 3 The inner core 8522 is motor-operable and configured to drive the operation of various types of end effectors. The inner core 8522 has multiple sets of operating parameters (e.g., the operating speed of the motor in the inner core 8522, the amount of power delivered by the motor in the inner core 8522 to the shaft assembly, the selection of the motor to be actuated in the inner core 8522, the function of the end effector to be performed by the inner core 8522, etc.). Each set of operating parameters of the inner core 8522 is designed to drive a unique set of specific functions for the corresponding type of end effector when the end effector is coupled to the inner core 8522. For example, depending on the type of end effector coupled to the inner core 8522, the inner core 8522 can change its power output, deactivate or activate certain buttons, and / or actuate different motors.

[0061] The inner core 8522 defines an internal housing cavity therein, within which the power supply assembly 8526 is located. The power supply assembly 8526 is configured to control various operations of the inner core 8522. The power supply assembly 8526 includes a plurality of motors operably engaged thereto. Rotation of the motors, for example, drives the shaft and / or gear components of the shaft assembly 8530 to drive various operations of an end effector (e.g., end effector 8540) attached to the shaft assembly.

[0062] When the end effector 8540 is coupled to the inner core 8522, the motor of the power supply 8526 is configured to drive the shaft and / or gear components of the shaft assembly 8530 to selectively achieve, for example, firing motion, closing motion and / or articulation motion at the end effector 8540.

[0063] In addition to the above, the disposable outer housing 8524 includes two housing portions 8524a and 8524b, which are releasably attached to each other to allow assembly with the inner core 8522. In the illustrated example, housing portion 8524b is movably connected to housing portion 8524a by a hinge 8525 positioned along the upper edge of housing portion 8524b. Therefore, housing portions 8524a and 8524b are capable of being positioned relative to each other as follows: Figure 1 The closed, fully connected configuration shown and as Figure 2 The open, partially separated configurations shown pivot between each other. When engaged, housing portions 8524a, 8524b define cavities therein, in which the inner core 8522 may be selectively located.

[0064] In the illustrated example, the inner core 8522 includes control circuitry 8560. In other examples, control circuitry 8560 is disposed on the inner wall of the disposable outer housing 8524 and is releasably coupled to the inner core 8522, such that an electrical connection is established between the inner core 8522 and control circuitry 8560 when the inner core 8522 is assembled with the outer housing 8524. Control circuitry 8560 includes processor 8562 and storage medium, such as, for example, memory unit 8564. Control circuitry 8560 may be powered, for example, by power supply 8526. Memory unit 8564 may store program instructions that, when executed by processor 8562, enable processor 8562 to adjust / execute various control functions of surgical instrument system 8500.

[0065] In the illustrated example, the control circuitry 8560 can be releasably coupled to the inner core 8522. An electrical connection is established between the inner core 8522 and the control circuitry 8560 when the inner core 8522 is assembled with the outer housing 8524. However, in other examples, the control circuitry 8560 is incorporated into the inner core 8522.

[0066] In various examples, memory cell 8564 may be a non-volatile memory, such as, for example, an electrically erasable programmable read-only memory. Memory cell 8564 may store discrete operating parameters of the core 8522, corresponding to the operation of a type of end effector (e.g., an end effector such as end effector 8540) and / or a type of adapter assembly (e.g., shaft assembly 8530). The operating parameters stored in memory 8564 may be at least one of the following: the operating speed of the motor of the core 8522; the amount of power delivered by the motor of the core 8522 during its operation; which motors of the core 8522 will be actuated when operating the core 8522; the type of function of the end effector to be performed by the core 8522; etc.

[0067] See still Figures 1 to 3The surgical instrument system 8500 includes an electrical interface assembly 8570 configured to transmit at least one of a data signal and power between the inner core 8522 and the end effector 8540. In an illustrated example, the electrical interface assembly 8570 includes a first interface portion 8580 located on a first side 8525a of a sterile barrier 8525 and a second interface portion 8590 located on a second side 8525b of the sterile barrier 8525 opposite to the first side. In various aspects, the first interface portion 8580 is configured to form a radio interface with the second interface portion 8590. The radio interface facilitates the wireless transmission of at least one of a data signal and power between the inner core 8522 and the second interface portion 8590.

[0068] Furthermore, the electrical interface assembly 8570 includes an externally mounted wiring connector 8600. In the illustrated example, the externally mounted wiring connector 8600 can be separately attached to the second interface portion 8590 to facilitate wired transmission of at least one of data signals and power between the second interface portion 8590 and the end effector 8540.

[0069] In each aspect, the first interface portion 8580 and the second interface portion 8590 are configured to cooperatively form a wireless segment of an electrical path between the core 8522 and the end effector 8540. Additionally, an externally mounted wiring connector 8600 forms a wired segment of the electrical path. At least one of data signals and power is transmitted between the core 8522 and the end effector 8540 via the electrical path.

[0070] See still Figures 1 to 3 The externally mounted wiring connector 8600 includes a flexible conductor circuit 8601 that terminates in an attachment member 8602 capable of being releasably coupled to a second interface portion 8590. The flexible conductor circuit 8601 has sufficient length to allow the attachment member 8602 to reach the second interface portion 8590 from the outside.

[0071] The attachment member 8602 is magnetically coupled to the second interface portion 8590. For example, the attachment member 8602 includes magnetic elements 8606 and 8608 disposed within the housing 8604. Figure 3 As shown, the first interface portion 8580 includes iron-containing elements 8576 and 8578 for magnetically attaching and properly aligning the attachment member 8602 to the outer housing 8524.

[0072] Iron-containing elements 8576 and 8578 are disposed on the outer shell 8523 of the inner core 8522, such that when the inner core 8522 is correctly positioned inside the disposable outer shell 8524 and the attachment member 8602 is correctly positioned against the second interface portion 8590, the iron-containing elements 8576 and 8578 and the magnetic elements 8606 and 8608 are aligned.

[0073] Alternatively, in some examples, the magnetic element may be disposed on the outer housing 8523 of the inner core 8522, and the ferrous element may be disposed on the outer housing 8604 of the attachment member 8602. Alternatively, in some examples, the corresponding magnetic element may be disposed on both housings 8604 and 8523.

[0074] In addition to the above, another externally mounted wiring connector 8611 connects the shaft assembly 8530 to the second interface portion 8590. The externally mounted wiring connector 8611 is similar to the externally mounted wiring connector 8600 in many respects. For example, the externally mounted wiring connector 8611 also includes a flexible conductor circuit 8612 that terminates at an attachment member 8613, similar to the attachment member 8602 of the externally mounted wiring connector 8600. The attachment member 8613 is also magnetically coupled to the shank assembly 8520 to transmit at least one of data and power from the outside between the shaft assembly 8530 and the inner core 8522.

[0075] In addition to the above, the electrical interface assembly 8570 utilizes sensing elements 8603 and 8583 that can be positioned on opposite sides of the sterile barrier 8525. In the illustrated example, the sensing elements 8603 and 8583 are in the form of wound coils, serving as components of the sensing circuits 8605 and 8585, respectively. The coils of the sensing elements 8603 and 8583 comprise copper wire or copper alloy wire; however, the coils may comprise, for example, a suitable conductive material, such as aluminum. The coils may be wound around a central axis any suitable number of times.

[0076] When a suitable magnetic attachment is established by components 8608, 8606, 8576, and 8578, such as Figure 3 As shown, the coils of sensing elements 8603 and 8583 are correctly aligned about a central axis extending through them. This correct alignment of the coils of sensing elements 8603 and 8583 improves the wireless transmission of at least one of data and power therethrough.

[0077] In various examples, the sensing circuit 8585 is electrically coupled to the power supply group 8526 and the control circuit 8560. In the illustrated example, the sensing circuit 8605 is electrically coupled to the transponder 8541 in the end effector 8540. To send and receive signals to and from the transponder 8541, the sensing element 8603 is inductively coupled to the sensing element 8583. The transponder 8541 can be passively powered using a portion of the power of the induced signal received from the sensing element 8603. Once sufficiently powered by the induced signal, the transponder 8541 can receive data and transmit it to the control circuit 8560 in the handle assembly via the inductive coupling between the sensing circuits 8605 and 8585.

[0078] In various examples, such as Figure 1 As shown, repeater 8541 is located in the shaft portion 8542 of end effector 8540. In other examples, repeater 8541 may be disposed in the jaws of end effector 8540. In the illustrated example, end effector 8540 includes a staple cartridge 8543. In some cases, repeater 8541 may be located in staple cartridge 8543. Internal wiring within shaft portion 8542 connects an externally mounted wiring connector 8600 to repeater 8541. In the illustrated example, externally mounted wiring connector 8600 includes attachment member 8609 configured to connect a flexible wire circuit 8601 to shaft portion 8542. In some cases, attachment member 8609 is permanently attached to shaft portion 8542. In other cases, attachment member 8609 is releasably coupled to shaft portion 8542.

[0079] To transmit signals to repeater 8541, control circuitry 8560 may include an encoder for encoding the signals and a modulator for modulating the signals according to a modulation scheme. Control circuitry 8560 may communicate with repeater 8541 using any suitable wireless communication protocol and any suitable frequency (e.g., ISM band).

[0080] In various examples, control circuitry 8560 determines whether the attached staple cartridge and / or end effector is compatible with the surgical instrument system 8500 by querying an identification device (e.g., a radio frequency identification (RFID) device) or a cryptographic identification device. The compatibility of the attached staple cartridge and / or end effector can be evaluated using an identification chip and / or an interrogation cycle. Various identification techniques are described in U.S. Patent No. 8,672,995, entitled “ELECTRICALLY SELF-POWERED SURGICAL INSTRUMENT WITH CRYPTOGRAPHICIDENTIFICATION OF INTERCHANGEABLE PART,” published January 14, 2014, which is incorporated herein by reference in its entirety.

[0081] Figure 4This is a logic flowchart of process 8610, which depicts a control program or logic configuration for electrically connecting the inner core 8522 of a surgical instrument system (e.g., surgical instrument system 8500) to a staple cartridge (e.g., staple cartridge 8543) or an end effector (e.g., end effector 8540). Process 8610 includes detecting 8612 a compatible connection between the end effector 8540 and the inner core 8522 (more specifically, control circuitry 8560) via an electrical interface component 8570. Process 8610 also includes adjusting 8614 the signal parameters of the signals via the electrical interface component 8570 to improve the throughput of at least one of data and power between the end effector 8540 and the inner core 8522.

[0082] In the illustrated example, process 8610 is implemented by control circuitry 8560. Memory unit 8564 may store program instructions that, when executed by processor 8562, cause processor 8562 to perform one or more aspects of process 8610. In other examples, one or more aspects of process 8610 may be implemented by connection circuitry that is separate from but can communicate with control circuitry 8560. For example, the connection circuitry may be incorporated into a disposable outer housing 8524 of the handle assembly 8520.

[0083] In various aspects, the end effector 8540 includes a memory unit for storing an identification code. The control circuitry 8560 can assess whether a compatible connection exists between the end effector 8540 and the inner core 8522 based on the identification code retrieved from the memory unit via the electrical interface component 8570.

[0084] In various aspects, the electrical interface assembly 8570 includes one or more sensors configured to detect, measure, and / or monitor aspects of signals transmitted through the electrical interface assembly 8570. Control circuitry 8560 may further adjust one or more aspects of the signal (such as, for example, signal strength, frequency, and / or bandwidth) and / or adjust the power level to optimize the throughput of at least one of data and power between the end effector 8540 and the inner core 8522 via the electrical interface assembly 8570. In various aspects, control circuitry 8560 may determine whether the surgical instrument system 8500 is in an environment where one or more components or connections of the electrical interface assembly 8570 are short-circuited and / or signal is lost. In response, control circuitry 8560 may adjust the signal frequency, signal strength, and / or signal repetition to improve data or power throughput. In at least one example, control circuitry 8560 may respond by disconnecting one or more connections to improve other connections of the electrical interface assembly 8570.

[0085] See also Figure 5 and Figure 6The control circuit 8560 can set one or more operating parameters of the surgical instrument system 8500 based on the identifier received through the electrical interface component 8570. Figure 5 A graph 8620 depicts several control schemes (e.g., 8621, 8622, 8623, 8624, 8625, 8626, 8627), which can be stored in a memory unit 8564 and selected by a processor 8562 based on an identifier received via an electrical interface component 8570. The graph 8620 includes an x-axis representing the distance traveled by the drive member in millimeters (mm) and a y-axis representing the speed of the drive member in millimeters per second (mm / sec).

[0086] The drive member is actuated by a motor in the inner core 8522 to achieve the closing and / or firing motion of the end effector 8540. In at least one example, the drive member is actuated by a mortar to advance the I-beam assembly along a predetermined firing path to deploy staples from the staple cartridge 8543 into the tissue, and optionally advances a cutting member to cut the sutured tissue during the firing stroke. In such examples, the speed of movement of the drive member and the distance traveled from the starting position represent the speed of movement of the I-beam assembly and the distance traveled by the I-beam assembly along the predetermined firing path, respectively.

[0087] The exemplary control schemes (8621, 8622, 8623, 8624, 8625, 8626, 8627) shown in graph 8620 can be stored in memory unit 8564 in any suitable form (such as, for example, tables and / or equations). In various aspects, control schemes 8621, 8622, 8623, 8624, 8625, 8626, 8627 represent different types and sizes (e.g., 45 mm, 60 mm) of staple cartridges suitable for use with surgical instrument system 8500 to treat different tissue types with different thicknesses. For example, control scheme 8621 is used with cartridge types suitable for handling thin tissues and therefore allows for a relatively faster movement speed of the drive member, resulting in higher inertia, which necessitates earlier deceleration before the end of the firing stroke. Conversely, control scheme 8627 is used with cartridge types suitable for handling thick tissues and therefore allows for a slower movement speed of the drive member than that of control scheme 8621. Therefore, control scheme 8627 produces lower inertia compared to control scheme 8621, which demonstrates that the deceleration before the end of the firing stroke is later than that of control scheme 8621.

[0088] Figure 6Another graph 8720 depicts additional control schemes (8721, 8722, 8723, 8724). Graph 8720 shows the drive member speed on the x-axis and the motor current (i) on the y-axis for different compartment types with different tissue types / thicknesses. The current consumption of the motor in the inner core 8522, used to achieve a specific speed of the drive member, varies depending on the compartment type. Therefore, the control circuit 8560 selects from the control schemes (8721, 8722, 8723, 8724) based on identifiers received through the electrical interface component 8570 to ensure that the motor current consumption is sufficient to achieve the desired speed determined by the selected control scheme.

[0089] See now Figure 7 The surgical instrument system 8800 is similar to the surgical instrument system 8500 in many respects. For example, the surgical instrument system 8800 also includes a handle assembly 8820 that includes an inner core 8822 having a motor assembly for actuating a drive member, the motor assembly being configured to achieve a closing motion and / or a firing motion in the end effector 8540. The inner core 8822 also includes an internal power supply group 8826 for powering the motor assembly and control circuitry 8860. In various aspects, the power supply group 8826 includes one or more batteries, which may be rechargeable. In some aspects, the power supply group 8826 can be releasably coupled to the inner core 8822.

[0090] Similar to control circuit 8560, control circuit 8860 includes a memory unit storing program instructions. When executed by a processor, the program instructions cause the processor to control motor components, a feedback system, and / or one or more sensors. In various examples, control circuit 8860 may employ a feedback system to perform a predetermined function, such as, for example, issuing an alarm when one or more predetermined conditions are met. In some cases, the feedback system may include, for example, one or more visual feedback systems, such as a display screen, backlight, and / or LEDs. In some cases, the feedback system may include, for example, one or more audio feedback systems, such as speakers and / or buzzers. In some cases, the feedback system may include, for example, one or more haptic feedback systems. In some cases, the feedback system may include, for example, a combination of visual, audio, and / or haptic feedback systems.

[0091] See still Figure 7The wireless power transmission system 8850 is used to wirelessly transmit power across a sterile barrier formed by a disposable outer housing 8824 surrounding an inner core 8822. The disposable outer housing 8824 is similar to the disposable outer housing 8524 in many respects. For example, the disposable outer housing 8824 may include two housing portions that can be detachably coupled to each other to allow the inner core 8822 to be inserted into the disposable outer housing 8824. The inner core 8822 is sealed within the disposable outer housing 8824, thereby forming a sterile barrier around the inner core 8822.

[0092] The wireless power delivery system 8850 utilizes the magnetic coupling of bearings to drive mechanical work to ultimately convert it into usable electrical energy. The wireless power delivery system 8850 includes an internal power delivery unit 8852 and an external disposable energy receiver / converter 8854. In the illustrated example, the internal power delivery unit 8852 and the external disposable energy receiver / converter 8854 are positioned on opposite sides of a sterile barrier defined by a disposable outer housing 8824.

[0093] An internal power delivery unit 8852 is located inside a disposable outer housing 8824 and hardwired to a power supply unit 8826. In one example, the internal power delivery unit 8852 is attached to the inner wall of the disposable outer housing 8824 and releasably connected to the power supply unit 8826. When the inner core 8822 is properly positioned within the disposable outer housing 8824, its external connector engages with the corresponding connector of the internal power delivery unit 8852. When the connectors engage, the power supply unit 8826 and the internal power delivery unit 8852 become electrically connected. However, in other examples, the inner core 8822 may include external wiring that can be manually connected to the internal power delivery unit 8852.

[0094] In other examples, the internal power delivery unit 8852 is incorporated into the inner core 8822. In such examples, the internal power delivery unit 8852 is positioned near the outer housing of the inner core 8822 in such a way that when the inner core 8822 is finally positioned within the disposable outer housing 8824, the internal power delivery unit 8852 is correctly aligned with the external disposable energy receiver / converter 8854.

[0095] In addition to the above, the internal power transmission unit 8852 includes a magnetic bearing 8856. A control circuit 8860 causes current to drive the magnetic bearing 8856 to rotate. Mechanical energy is magnetically transferred across a sterile barrier to an external disposable energy receiver / converter 8854, and is then converted back into electrical energy via a linear alternator 8857. The external disposable energy receiver / converter 8854 includes a magnetic bearing 8858 configured to rotate in tandem with the rotation of the magnetic bearing 8856. In operation, the rotation of the magnetic bearing 8858 is synchronized with that of the magnetic bearing 8856, resulting in the generation of mechanical work from the outside in the external power transmission unit 8854. The generated mechanical work is utilized and converted into electrical energy via the linear alternator 8857, which can then be used, for example, by an end effector 8540. In various aspects, a gear assembly 8859 is used to transfer mechanical energy from the magnetic bearing 8858 to the linear alternator 8857.

[0096] In various scenarios, power transfer across sterile barriers can be achieved via a direct conductive connection between the internal and external environments. Specific areas of a disposable outer housing can be overmolded onto a metal strip that, during implementation, extends the thickness of the sterile barrier. This overmolding allows for a tight seal to eliminate the possibility of contaminant passage, and once the outer housing transitions to a closed configuration to form a sterile barrier, the metal strip acts as a conductive bridge, allowing energy to be transferred directly to the external environment.

[0097] See now Figure 8 and Figure 9 The surgical instrument system 8900 is similar to the surgical instrument systems 8500 and 8800 in many respects. For example, the surgical instrument system 8900 also includes a handle assembly 8920, which includes an inner core 8922 having a motor assembly for actuating a drive member, the motor assembly being configured to realize a closing motion and / or a firing motion in the end effector 8940.

[0098] Additionally, the surgical instrument system 8900 includes a shaft 8930 having a nozzle portion 8930a and a shaft portion 8930b extending distally from the nozzle portion 8930a. The nozzle portion 8930a allows the end effector 8940 to rotate relative to the shank assembly 8920. A flexible circuit 8934 is configured to transmit power to the end effector 8940 via the nozzle portion 8930a. The flexible circuit 8934 includes a proximal flexible circuit segment 8934a disposed on the shank assembly 8920 and a distal flexible circuit segment 8934c disposed on the shaft portion 8930b and the end effector 8940.

[0099] Additionally, the flexible circuit 8934 includes a conductive metal segment 8934b that is frictionally connected to the proximal flexible circuit segment 8934a and fixedly connected to the distal flexible circuit segment 8934c. The conductive metal segment 8934b facilitates rotation of the shaft 8930 and the end effector 8940 relative to the shank assembly 8920 while maintaining electrical connection between the shank assembly 8920 and the end effector 8940. In the illustrated example, the conductive metal segment 8934b includes a conductive ring 8935 frictionally attached to the proximal flexible circuit segment 8934a.

[0100] In addition to the above, the flexible circuit 8934 is configured to transmit power from an external power supply 8926 to the end effector 8940. The external power supply 8926 is disposed on a disposable outer housing 8924. The connection between the external power supply 8926 and the flexible circuit 8934 can be protected from environmental influences, for example, by being partially or completely embedded in the disposable outer housing 8924. In the illustrated example, the external power supply 8926 includes a connection port 8927 configured to receive a proximal end of a proximal flexible circuit segment 8934a.

[0101] Additionally, the inner core 8922 may include an internal power supply group for powering the motor assembly and control circuitry. In various aspects, the power supply group is electrically coupled to the flexible circuitry 8934 and / or the external power supply 8926 via an electrical interface assembly 8570 in a manner similar to that described in the surgical instrument system 8500. In some examples, the external power supply 8926 is entirely replaced by the internal power supply group of the inner core 8922. In such examples, power is transferred from the internal power supply group to the flexible circuitry 8934 via the electrical interface assembly 8570 through a sterile barrier.

[0102] In addition to the above, the flexible circuit 8934 may also include an end effector segment 8934d, which is configured to connect the distal flexible circuit segment 8934c to a staple cartridge 8944 releasably coupled to the end effector 8940. The end effector segment 8930d has sufficient slack to prevent overextension of the end effector segment 8930d, which could be caused by movement of the end effector.

[0103] See now Figure 10 The surgical instrument system 9000 is similar to the surgical instrument system 8500 in many respects. For example, the surgical instrument system 9000 also includes a handle assembly 9020 that includes an inner core 9022 having a motor assembly for actuating a drive member, the motor assembly being configured to achieve closing and / or firing movements in an end effector (e.g., end effector 8540). A disposable outer housing 9024 defines a sterile barrier 9025 surrounding the inner core 9022.

[0104] The handle assembly 9020 also includes an electrical interface assembly 9070 configured to transmit at least one of data signals and power between the inner core 8922 and the end effector 8540 through a sterile barrier 9025 defined by a disposable outer housing 9024. The electrical interface assembly 9070 includes an internal piezoelectric transducer 9071 coupled to an internal power supply group 9026 configured to power the internal piezoelectric transducer 9071. The electrical interface assembly 9070 also includes a lens coupled to the internal piezoelectric transducer 9071 and configured to focus the ultrasonic energy generated by the internal piezoelectric transducer 9071 onto an external piezoelectric transducer 9073 through a gel membrane 9072. Thus, the electrical energy supplied by the power supply group 9026 is converted into ultrasonic energy, which is transmitted across the sterile barrier 9025 for reception by the external piezoelectric transducer 9073. The ultrasonic energy is then converted into electrical energy via an external piezoelectric transducer 9073. In some cases, flexible circuitry may further transfer the electrical energy to an end effector.

[0105] Figure 11 A modular surgical instrument system 9100 is depicted that is similar in many respects to the surgical instrument system 8500. For example, the modular surgical instrument system 9100 also includes a handle assembly 9120, a shaft 9130, and a loading unit 9140, which includes a proximal shaft portion 9140a and an end effector 9140b. The loading unit 9140 can be releasably connected to the distal shaft portion 9130b of the shaft 9130. The nozzle portion 9130a of the shaft 9130 can also be releasably connected to the handle assembly 9120. Furthermore, the staple cartridge 9144 can be releasably connected to the end effector 9140b. In other cases, the staple cartridge and the end effector 9140b are integrated.

[0106] Similar to the handle assembly 8520, the handle assembly 9120 includes an inner core 9122 and a disposable outer housing 9124 configured to selectively receive and enclose the inner core 9122 to establish a sterile barrier 9125 around the inner core 9122. The inner core 9122 is motor-operable and configured to drive the operation of various types of end effectors. The inner core 9122 has multiple sets of operating parameters (e.g., operating speed of the motor of the inner core 9122, the amount of power delivered by the motor of the inner core 9122 to the shaft assembly, selection of the motor of the inner core 9122 to be actuated, the function of the end effector to be performed by the inner core 9122, etc.). Each set of operating parameters of the inner core 9122 is designed to drive a unique set of specific functions for the corresponding type of end effector when the end effector is coupled to the inner core 9122. For example, depending on the type of end effector connected to the inner core 9122, the inner core 9122 can change its power output, deactivate or activate certain of its buttons, and / or actuate its different motors.

[0107] The inner core 9122 defines an internal housing cavity that accommodates a power supply unit and one or more motors powered by the power supply unit. The rotation of the motors, for example, acts as a drive shaft and / or gear components of the shaft 9130 to drive various operations of an end actuator (e.g., end actuator 9140) attached to the shaft assembly.

[0108] In addition to the above, the outer housing 9124 includes two housing portions 9124a and 9124b, which are releasably attached to each other to allow assembly with the inner core 9122. In the illustrated example, housing portion 9124b is movably connected to housing portion 9124a by a hinge positioned along the upper edge of housing portion 9124b. Therefore, housing portions 9124a and 9124b are capable of being positioned relative to each other as follows: Figure 11 The diagram shows a pivot between a closed, fully connected configuration and an open, partially separated configuration. When engaged, housing portions 9124a, 9124b define cavities therein, in which the inner core 9122 may be selectively located.

[0109] Similar to control circuit 8560, control circuit 9160 includes a memory unit storing program instructions. For example, when executed by a processor, the program instructions cause the processor to control motor components, a feedback system, and / or one or more sensors. In various examples, control circuit 9160 may employ a feedback system to perform a predetermined function, such as, for example, issuing an alarm when one or more predetermined conditions are met. In some cases, the feedback system may include, for example, one or more visual feedback systems or visual interfaces, such as a display screen, backlight, and / or LEDs. In some cases, the feedback system may include, for example, one or more audio feedback systems, such as speakers and / or buzzers. In some cases, the feedback system may include, for example, one or more haptic feedback systems. In some cases, the feedback system may include, for example, a combination of visual, audio, and / or haptic feedback systems.

[0110] In various aspects, one or more sensors may be configured to detect or measure whether the disposable outer housing 9124 is in an open or closed configuration. In the illustrated example, a Hall effect sensor 9123 detects the transition of housing portions 9124a, 9124b to a closed or open configuration. Control circuitry 9160 may receive an input signal indicating whether the disposable outer housing 9124 is in an open or closed configuration. In some examples, other suitable sensors may be employed to detect the closed and / or open configurations, such as, for example, other magnetic sensors, pressure sensors, inductive sensors, and / or optical sensors.

[0111] See still Figure 11 The modular surgical instrument system 9100 includes an electrical interface assembly 9170 configured to transmit at least one of data signals and power across a sterile barrier 9125, outside the sterile barrier 9125, and / or within the sterile barrier 9125. At least one of the data signals and power is transmitted between one or more modular components of the modular surgical instrument system 9100. In the illustrated example, the electrical interface assembly 9170 includes a first interface portion 9180 located on a first side of the sterile barrier 9125 (inside a disposable outer housing 9124) and a second interface portion 9190 located on a second side of the sterile barrier 9125 opposite to the first side (outside the disposable outer housing 9124).

[0112] Furthermore, the electrical interface assembly 9170 includes a wiring assembly 9171, which includes externally mounted wiring connectors 9101, 9102, and 9103 that electrically couple the second interface portion 9190 to the loading unit 9140, the loading unit-to-axis connection sensor 9141, and the nozzle portion 9130a, respectively, and corresponding internally mounted wiring connectors 9101', 9102', and 9103' that couple the first interface portion 9180 to the control circuit 9160. The wiring connectors 9101, 9102, 9103, 9101', 9102, and 9103' cooperate with the interface portions 9180 and 9190 to transmit signals between the control circuit 9160 and the loading unit 9140, the staple cartridge 9144, the loading unit-to-axis connection sensor 9141, and the nozzle portion 9130a, as discussed in more detail below. In some cases, a support is attached to the staple cartridge 9144. In this case, wiring connectors 9101, 9101' can, for example, facilitate signal transmission between control circuit 9160 and support-attachment sensor, which is configured to detect a unique identifier of the support, as discussed in more detail below.

[0113] Additionally, the wiring assembly 9171 includes internally mounted wiring connectors 9104, 9105, 9106, and 9107, which are configured to electrically couple the control circuitry 9160 to the handle assembly-to-shaft connection sensor 9131, the first housing portion 9124a, the second housing portion, and the inner core-to-handle assembly connection sensor 9121. In at least one example, one or more wiring connectors of the wiring assembly 9161 include connector ends capable of being releasably coupled to corresponding connector ends of corresponding modular components of the modular surgical instrument system 9100.

[0114] In some examples, the handle assembly 9120 may include an electrical interface assembly that facilitates wired connection through a sterile barrier 9125. A portion of the wire may pass through the disposable outer housing 9124. For example, the wire portion may be partially embedded in the outer wall of the handle assembly. Suitable insulation may be provided to prevent fluid leakage.

[0115] See Figure 12 This document lists various possible modular components of the Modular Surgical Instrument System 9100, along with a unique identifier resistor for each of the listed modular components. The listed modular components facilitate surgical suturing, surgical ultrasound energy therapy, surgical radiofrequency (RF) energy therapy, and various combinations thereof.

[0116] Modular components include various types of cores, handle assemblies, shafts, loading units, staple cartridges of different types and sizes, and / or support attachments of different shapes and sizes, which can be assembled in various combinations to form a modular surgical instrument system 9100. Because each modular component includes a uniquely identified resistor, the total sensing resistance can be determined based on the uniquely identified resistor of its modular component to identify the connected modular configuration.

[0117] In some respects, control circuitry 9160 may compare the expected value of the total sense resistance with the measured value of the total sense resistance to verify or confirm the identity of modular components in a modular configuration. In at least one example, control circuitry 9160 may, for example, receive user input identifying components of the modular configuration via a user interface. Additionally or alternatively, for example, control circuitry 9160 may directly compare the expected value of an identifier resistor with the corresponding measured value of the identifier resistor to verify or confirm the identity of modular components in the modular configuration.

[0118] In other respects, control circuitry 9160 may compare a desired value of the total sense resistance with a measured value of the total sense resistance to assess or detect irregularities in the modular components of a modularly configured connection. Additionally or alternatively, control circuitry 9160 may compare a desired value with a measured value for each modular component in the modular configuration to assess or detect irregularities in the modular components of a modularly configured connection.

[0119] In the illustrated example, graph 9161 shows the expected and measured or detected identifier resistance values. Based on the comparison between the expected and measured or detected resistance identifier values, control circuit 9160 determines the resistor R with a unique identifier. 1a R 2a R 3d R 4c R 5b R 6c The inner core, disposable outer housing, shaft, end effector, chamber, and support are connected in a modular configuration.

[0120] In the illustrated example, lines 9163 and 9164 show cases where the outer shell and support are not connected or are not actually connected, respectively. Additionally, lines 9165 and 9166 show cases where the outer shell and support are connected but not actually connected. In such complex configurations, checking the authenticity of the modular components ensures that the modular configuration will function correctly.

[0121] The deviation between the expected and the measured or detected resistance identifier value can indicate an unconnected state, an inauthentic state, or other irregularities. The amount of deviation indicates whether the control circuit 9160 determines that it is an unconnected state, an inauthentic state, or an authentic connected state. In some examples, the control circuit 9160 may calculate the amount of deviation and compare the calculated amount of deviation with a predetermined threshold to assess whether the deviation indicates an unconnected state, an inauthentic state, or an authentic / connected state.

[0122] In some examples, a deviation selected from the range of greater than 0% to about 10%, greater than 0% to about 20%, greater than 0% to about 30%, greater than 0% to about 40%, or greater than 0% to about 50% indicates a non-real state. In some examples, the deviation indicating a non-real state is smaller than the deviation indicating a disconnected state.

[0123] Figure 13 A logic flowchart 9150 depicts a control procedure or logical configuration process for detecting and / or certifying a modular configuration of a modular surgical instrument system or component. One or more aspects of process 9150 may be executed by control circuitry, such as, for example, control circuitry 9160 of a modular surgical instrument system 9100. In each aspect, process 9150 includes generating an interrogation signal 9152 to detect or verify the identity of modular components in the assembled modular configuration of the modular surgical instrument system 9100. In this case, to verify the identity of the modular component, identification may be provided, for example, through a user interface coupled to control circuitry 9160.

[0124] In any case, an interrogation signal can be transmitted to a modular component in a modular configuration via wiring assembly 9171 and / or electrical interface assembly 9170. The interrogation signal can trigger a response signal from the modular component in the modular configuration. The response signal can be detected 9153 and used by control circuitry 9160 to detect 9154 or confirm the identity of the modular component in the modular configuration.

[0125] As described in more detail above, each modular component in the modular parts that can be used with the modular surgical instrument system 9100 includes a unique identifier resistor for the modular component. Therefore, the control circuit 9160 can use a response signal to calculate the identifier resistor of the modular components in the modular configuration. Then, based on the calculated identifier resistor, the identity of the modular component in the modular configuration can be detected 9154 or confirmed. Confirmation of the identity of the modular component in the modular configuration can be achieved by the control circuit 9160 by comparing the identity input through the user interface with the identity detected based on the response signal.

[0126] In some respects, control circuitry 9160 directs current through wiring assembly 9171 and electrical interface assembly 9170 to the modular components of the modular configuration. The return current can then be sampled to calculate the total sense resistance of the modular configuration. Since each individual modular component has a unique identifier resistor, control circuitry 9160 can determine the identity of each individual modular component based on the total sense resistance of the modular configuration.

[0127] In some respects, control circuitry 9160 compares the expected value of the total sense resistance with the determined value of the total sense resistance to confirm the correct assembly of the modular configuration. In at least one form, the expected value is stored in a memory cell, which is accessed by control circuitry 9160 to perform the comparison.

[0128] The deviation between the expected value and the determined value is equal to or at least substantially equal to the resistance identifier of one or more modular components, causing control circuit 9160 to infer that one or more modular components are not connected in the modular configuration. In response, control circuit 9160 can assign a disconnected state. Control circuit 9160 can also issue an alarm 9151 regarding one or more modular components via a user interface. Control circuit 9160 can also provide instructions on how to correctly connect the modular components deemed unconnected.

[0129] In some cases, process 9150 may also include evaluating the authenticity of the 9155 modular configuration based on the response signal. In at least one example, control circuitry 9160 evaluates the authenticity of the modular configuration based on a comparison between the expected and determined values ​​of the unique identifier resistor of the modular component. Control circuitry 9160 may compare the magnitude of a detected deviation between the expected and determined values ​​of the unique identifier resistor with a predetermined threshold to evaluate the authenticity of the detected modular component in the 9155 modular configuration.

[0130] In at least one example, the predetermined threshold is a threshold range. If the magnitude of the detected deviation exceeds the predetermined threshold, the control circuit 9160 may select an appropriate safety response 9156, such as, for example, assigning an unrealistic state to a modular component, issuing an alarm via a user interface, and / or temporarily disabling the surgical instrument system 9100. In various aspects, for example, the threshold range differs from the expected value by about ±1%, about ±2%, about ±3%, about ±4%, about ±5%, about ±10%, or about ±20%. This disclosure contemplates other ranges.

[0131] Figure 14A logic flowchart 9110 depicts a control procedure or logical configuration process for detecting and / or certifying a modular configuration of a modular surgical instrument system or component. One or more aspects of process 9110 may be executed by control circuitry, such as, for example, control circuitry 9160 of a modular surgical instrument system 9100. In various aspects, process 9110 includes an identification signal for detecting the assembled modular configuration of the modular surgical instrument system 9100. In some examples, the identification signal is a combined response signal sent by a modular component of the modular configuration in response to an interrogation signal generated by control circuitry 9160.

[0132] Furthermore, control circuit 9160 can evaluate the authenticity of the modular components of the modular configuration. If an identification signal is detected (9112), control circuit 9160 measures (9113) the characteristics of the modular configuration, determines (9114) an authentication key based on at least one measurement of these characteristics, and authenticates (9115) the identification signal based on this authentication key. If control circuit 9160 determines (9116) that the modular configuration is not authentic, control circuit 9160 can further generate a security response, as described in assembly process (9150).

[0133] In all aspects, the control circuitry 9160 is configured to determine the authentication key independently of the identification signal. The authentication key may be based on common characteristics among the various modular components of the modular configuration. In at least one example, the common characteristic may be an environmental characteristic. In some examples, the common characteristic may be location, radio frequency (RF) strength, sound level, light level, and / or magnetic field strength.

[0134] In each aspect, the modular components of the modular configuration measure common characteristics and generate an authentication key based on at least one measurement of these common characteristics. The modular components can also encode an identification signal based on the generated authentication key and transmit the encoded identification signal to control circuitry 9160 via wiring assembly 9171 and / or electrical interface assembly 9170. Control circuitry 9160 can independently measure the common characteristics and determine an authentication key based on at least one measurement of these common characteristics. Control circuitry 9160 can also use the authentication key to authenticate and / or decode identification signals received from the modular components.

[0135] In some examples, the handle assembly 9120 generates a magnetic field with a strength measurable by each modular component in the modular configuration. The modular components can utilize the measured magnetic field strength to encode an identification signal transmitted to the control circuitry 9160 via the wiring assembly 9171 and / or the electrical interface assembly 9170. Alternatively, the control circuitry 9160 independently determines the magnetic field strength. In some cases, the control circuitry 9160 sets the magnetic field strength. In other cases, the control circuitry 9160 measures the strength in a manner similar to that of the modular components.

[0136] The control circuit 9160 decodes the encoded identification signal based on an authentication key generated from one or more measurements of the magnetic field strength. Measuring the magnetic field can be accomplished using one or more sensors, such as a magnetometer. In other cases, the common characteristic is radio frequency (RF) strength, sound level, or light level, and the control circuit 9160 uses an RF strength sensor, an auditory sensor, or a photoelectric sensor to measure this common characteristic, respectively.

[0137] Figure 15 A handle assembly 9220 of a modular surgical instrument 9200, which is similar in many respects to modular surgical instruments 8500 and 9100, is shown. For the sake of brevity, these modular surgical instruments will not be repeated in the same level of detail herein. For example, the handle assembly 9220 includes an inner core 9222 and a disposable outer housing 9224 configured to selectively receive and enclose the inner core 9222 to establish a sterile barrier 9225 around the inner core 9222. The inner core 9222 is motor-operable and configured to drive the operation of various types of end effectors. The inner core 9222 has multiple sets of operating parameters (e.g., the operating speed of the motor of the inner core 9222, the amount of power delivered by the motor of the inner core 9222 to the shaft assembly, the selection of the motor of the inner core 9222 to be actuated, the function of the end effector to be performed by the inner core 9222, etc.). Each set of operating parameters of the inner core 9222 is designed to drive a unique set of specific functions for the corresponding type of end effector when the end effector is operably coupled to the inner core 9222. For example, depending on the type of end effector operably coupled to the inner core 9222, the inner core 9222 can change its power output, deactivate or activate certain buttons, and / or actuate different motors.

[0138] In addition to the above, the outer housing 9224 includes two housing portions 9224a and 9224b, which are releasably attached to each other to allow assembly with the inner core 9222. In the illustrated example, the housing portions 9224a and 9224b are movable relative to each other between a closed, fully engaged configuration and an open, partially or fully disengaged configuration. When engaged, the housing portions 9224a and 9224b define cavities in which the inner core 9222 can be selectively located.

[0139] Furthermore, the handle assembly 9220 includes a main interface assembly 9270 configured to transmit at least one of data and power between the inner core 9222 and at least one of the modular components of the modular surgical instrument system 9200. The main interface assembly 9270 includes a first interface portion 9270a disposed on the inner core 9222 and a second interface portion 9270b disposed on the inner wall of the disposable outer housing 9224. The interface portions 9270a and 9270b include corresponding electrical contacts that become electrically connected or form an electrical connection when the inner core 9222 and the disposable outer housing 9224 are properly assembled. In various respects, the main interface assembly 9270 facilitates electrical connection between the power supply group 9226 of the inner core 9222 and an external charging system. The main interface assembly 9270 also facilitates the detection of the modular configuration of the modular surgical instrument system 9200 by transmitting at least one of power and data passing through it between the inner core 9222 and the modular configuration. In at least one example, the electrical contact includes a spring contact, such as, for example, a leaf spring contact.

[0140] In various aspects, the handle assembly 9220 includes an auxiliary interface 9262 comprising one or more sensors 9261 configured to detect the presence of the inner core 9222 within the disposable outer housing 9224. Control circuitry 9260 is configured to confirm a primary connection via the main interface assembly 9270 based on at least one reading from sensor 9261. The position and / or sensitivity of sensor 9261 can be set to detect the inner core 9222 when it is correctly positioned and aligned within the disposable outer housing, establishing a wired connection between interface portions 9270a, 9270b. In certain circumstances, the reading from sensor 9261 must be greater than or equal to a predetermined threshold for control circuitry 9260 to detect that the inner core 9222 is correctly inserted into the disposable outer housing 9224. Control circuitry 9260 can continuously compare the readings from sensor 9261 to the predetermined threshold to determine whether the inner core 9222 is correctly inserted into the disposable outer housing 9224.

[0141] In various aspects, sensor 9261 includes proximity sensors, such as, for example, magnetic sensors (such as, for example, Hall effect sensors), inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors. In some examples, control circuitry 9260 is configured to identify / detect core 9222 via auxiliary interface 9262 based on a unique identifier 9263 of core 9222 (such as, for example, a QR code, a resistance identifier, a voltage identifier, and / or a capacitance identifier).

[0142] See still Figure 15The control circuit 9260 is also configured to detect a closed configuration of the disposable outer housing 9224 of the handle assembly 9220. The control circuit 9260 can detect the closed configuration based on at least one reading from at least one sensor 9264 within the disposable outer housing 9224. In at least one example, the sensor 9264 is a proximity sensor. In the illustrated example, the sensor 9264 is a Hall effect sensor. In other cases, the sensor 9264 can be an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor.

[0143] Alternatively or additionally, when an input signal is received from the closed configuration detection circuit 9265, the control circuit 9260 can detect a closed configuration. Electrical contacts of the closed configuration detection circuit 9265 are disposed on the housing portions 9224a and 9224b, such that when the disposable outer housing 9224 is in a closed configuration, the closed configuration detection circuit 9265 becomes a closed circuit. This transition to a closed circuit causes an electrical signal to be transmitted to the control circuit 9260, which then detects / confirms the closed configuration.

[0144] See Figure 16 The graph 9280 is shown. The distance (δ) between housing portions 9224a and 9224b is shown on the x-axis, and the capacitance measured from the inner core 9222 to the disposable outer housing 9224 is shown on the y-axis. In various aspects, the control circuit 9260 is configured to evaluate the correct assembly of the inner core 9222 with the disposable outer housing 9224 based on the distance between housing portions 9224a and 9224b and based on the capacitance measured from the inner core 9222 to the disposable outer housing 9224. Alternatively, the control circuit 9260 may be configured to evaluate the correct assembly of the inner core 9222 with the disposable outer housing 9224 based on the distance between the inner core 9222 and the disposable outer housing 9224 and based on the capacitance measured from the inner core 9222 to the disposable outer housing 9224.

[0145] In all aspects, the control circuit 9260 detects the correct assembly of the inner core 9222 and the disposable outer casing 9224 when two conditions are met, as represented by curve 9281 of graph 9280. The first condition is that the detection distance (δ) between the first reference surface on the first casing portion 9224a and the corresponding second reference surface on the second casing portion 9224b is less than or equal to a predetermined threshold distance. The second condition is that the detected value of the capacitance measured from the inner core 9222 to the disposable outer casing 9224 is within a predetermined capacitance range (µF). min - µF max )Inside.

[0146] In the illustrated example, curve 9281 represents a correctly assembled handle assembly 9220, where the inner core 9222 is correctly positioned within the disposable outer housing 9224, and where housing portions 9224a, 9224b are properly sealed in a closed configuration. Conversely, curves 9282, 9283, and 9284 represent an incorrectly assembled handle assembly 9220. Curve 9282 indicates that a closed configuration has not been achieved, and curve 9283 indicates that the inner core 9222 is not correctly positioned within the disposable outer housing 9224.

[0147] The capacitance can also indicate the authenticity of the inner core 9222 and / or the disposable outer casing 9224. In the illustrated example, a predetermined capacitance range (µF) is specified. min - µF max This also indicates the scope of certification based on capacitance. For example, curves 9281 and 9282 on graph 9280 represent the actual inner core 9222 and / or disposable outer casing 9224, while curve 9283 on graph 9280 shows a non-actual inner core 9222 and / or disposable outer casing 9224. Additionally, curve 9284 indicates that the inner core 9222 does not have a capacitance identifier.

[0148] See now Figures 17 to 20 The surgical instrument system 9300 is similar in many respects to other surgical instrument systems described elsewhere herein (such as, for example, surgical instrument systems 8500, 9100, and 9200), and for the sake of brevity, these surgical instrument systems will not be repeated here at the same level of detail. For example, the surgical instrument system 9300 includes a handle assembly 9320, a shaft assembly 9330, and a loading unit including an end effector 9340 that releasably accommodates a staple cartridge 9341. The handle assembly 9320 includes a disposable outer housing 9324 configured to define a sterile barrier 9325. An inner core is positionable within the disposable outer housing 9324. The inner core is configured to drive and / or control various functions of the surgical instrument system 9300, as described elsewhere herein regarding other similar inner cores.

[0149] In addition to the above, the surgical instrument system 9300 includes an external power supply 9326. In the illustrated example, the external power supply 9326 is disposed on the outer wall of the disposable outer housing 9324. In other examples, the external power supply 9326 may be integrated into the disposable outer housing 9324. An electrical interface assembly 9328 is configured to transmit at least one of data and power from the handle assembly 9320 to the end effector 9340. In the illustrated example, the electrical interface assembly 9328 includes a flexible circuit 9327 that extends between and couples to the external power supply 9326 and a data communication strip 9332 disposed in the nozzle portion 9331 of the shaft assembly 9330. In the illustrated example, the data communication strip 9332 includes an annular shape that allows the nozzle portion 9331 and other portions of the shaft assembly 9330 to rotate without wire entanglement.

[0150] Furthermore, the shaft assembly 9330 includes concentric conductive rings 9337 and 9338 that facilitate the transmission of at least one of power and data between them without interfering with the markings of the shaft assembly 9330. Conductive ring 9337 is disposed on the outer surface of the inner portion 9335, and conductive ring 9338 is disposed on the inner annular surface of the outer portion 9336. In the illustrated example, the inner portion 9335 and the outer portion 9336 are concentric.

[0151] Figure 21 Logic flowchart 9350 illustrates the process of controlling or configuring the core of a surgical instrument system's handle assembly to disable it at the end of its lifespan. Using a core beyond its intended lifespan poses serious risks to the patient. The core's various circuits and other features are carefully designed to ensure its safe operation throughout its lifespan. However, after its intended lifespan, the core may fail to function properly, and in many cases, this is not discovered until the handle assembly is actually used in surgical procedures.

[0152] In various aspects, for example, process 9350 may be performed by the handle assembly 9220 of the surgical instrument system 9200. Process 9350 detects the correct assembly of the inner core 9222 with the disposable outer housing 9224. Control circuitry executing one or more aspects of process 9350 may be configured to detect correct assembly based on at least one reading from at least one sensor within the outer housing 9224. In at least one example, one or more aspects of process 9350 may be performed by control circuitry 9260 ( Figure 15 As discussed in more detail elsewhere in this document, the control circuit 9260 can be configured to detect, for example, the correct assembly of the inner core 9222 with the disposable outer housing 9224 based on readings from sensors 9261, 9264.

[0153] In any case, if correct assembly of 9352 is detected, the usage count of core 9222 is incremented by 9353. In at least one example, control circuitry 9260 communicates with a counter configured to maintain the usage count of core 9222. In some cases, control circuitry 9260 is configured, for example, to store usage data in a memory cell.

[0154] Furthermore, if the usage count 9354 becomes equal to a predetermined threshold number, process 9355 further determines whether the inner core 9222 is disconnected from the disposable outer casing 9224. Disconnection indicates the termination of use or the completion of the process, which constitutes a lifecycle end event based on the usage count. If 9355 is disconnected, the disconnection triggers a disable event 9356 for the inner core 9222 to prevent unsafe use beyond the predetermined lifecycle end usage count. However, normal operation continues 9357 until a disconnection is detected.

[0155] Various suitable mechanisms can be employed to disable the inner core 9222 upon end-of-life event. In at least one example, the control circuit 9260 uses a current limiter to ensure that the current within the inner core remains below a predetermined threshold during normal operation. To disable the inner core 9222, the control circuit 9260 can remove, disable, or disconnect the current limiter, which causes excessive current to flow through the circuitry of the inner core 9222, thereby disabling the inner core. Disabling the inner core prevents unauthorized use of the inner core beyond its carefully selected predetermined lifespan, ensuring safe operation of the handle assembly during surgery.

[0156] Figures 22 to 25 A safety mechanism for disabling the disposable outer housing 9424 of the handle assembly 9420 is shown to prevent unsafe reuse of the disposable outer housing 9424 beyond its design capabilities. The handle assembly 9420 is similar in many respects to other handle assemblies described elsewhere herein, and will not be repeated for the sake of brevity. For example, similar to the disposable outer housing 9224, the disposable outer housing 9424 is configured to selectively receive and enclose the inner core 9422 to establish a sterile barrier around the inner core 9422.

[0157] Furthermore, the outer housing 9424 includes two housing portions that are movable relative to each other between a closed, fully engaged configuration and an open, partially or fully disengaged configuration to accommodate insertion of the inner core 9422 therein. When engaged, the housing portions define cavities therein in which the inner core 9222 may be selectively located.

[0158] The core 9422 includes a power supply 9426, which can be in the form of one or more batteries. In the assembled configuration, as... Figure 22As shown, connecting wires 9427 and 9428 electrically connect the inner core 9422 to the disposable outer housing 9424. In various aspects, such as... Figure 23 As shown, the disposable outer housing 9424 includes one or more cutting members 9437, 9438, which are configured to cut one or two or more of the connecting wires 9427, 9428, thereby permanently disconnecting the circuit electrically coupling the disposable outer housing 9424 to the inner core 9422. This disables the disposable outer housing 9424, as... Figure 24 As shown. In alternative implementations, such as Figure 25 As shown, similar to connecting lines 9427 and 9428, connecting lines 9447 and 9448 include tail or tether portions 9457 and 9458 that are cut off when the housing portion of the disposable outer housing is converted to the open configuration.

[0159] In some cases, the connection wires of the disposable outer housing are coupled to the identifier 9429 of the disposable outer housing. Figure 24 In the example shown, connector 9427 is coupled to the RFID chip. During the transition of the disposable outer housing 9424 to an open configuration, the RFID chip, disabled on connector 9427, is cut off by cutter 9437. Disable identifier 9429 prevents the inner core from establishing a successful connection with the used disposable outer housing.

[0160] Figures 26 to 27 Additional safety mechanisms for disabling the disposable outer housing 9524 of the handle assembly 9520 are shown to prevent unsafe reuse of the disposable outer housing 9524 beyond its design capabilities. The handle assembly 9520 is similar in many respects to other handle assemblies described elsewhere herein, and for the sake of brevity, will not be repeated. For example, similar to the disposable outer housing 9224, the disposable outer housing 9524 is configured to selectively receive and enclose the inner core 9522 to establish a sterile barrier 9525 around the inner core 9522.

[0161] Furthermore, the outer housing 9524 includes two housing portions 9524a and 9524b, which are capable of being in a fully connected closed configuration relative to each other. Figure 26 ) and open partially or completely separated configurations ( Figure 27The handle assembly 9520 moves between the two sections to accommodate the insertion of the inner core 9522 therein. The handle assembly 9520 also includes an external power supply 9526 connected to the control circuitry 9560 via a connecting wire 9527 extending through the sterile barrier 9525. In the illustrated example, the external power supply 9526 is releasably mounted to the disposable outer housing 9524, and the connecting wire 9527 is cut when the external power supply 9526 is released from the disposable outer housing 9524 after the surgical procedure, thus disabling the disposable outer housing 9524 and preventing its unsafe reuse. Furthermore, a second wire connector 9528 extending between the housing portions 9524a, 9524b can also be cut when the disposable outer handle 9524 is transformed into an open configuration to prevent unsafe reuse of the disposable outer housing 9524.

[0162] In addition to the above, in various aspects, such as Figures 28 to 29 As shown, disposable outer casing 9524' ( Figure 28 ), 9524" ( Figure 29 One or both of the housing portions 9524a and 9524b are equipped with a mechanical connector 9531. Figure 28 ), 9551 Figure 29 The mechanical connector holds the housing portions 9524a, 9524b in a closed configuration and is cut or destroyed, for example, when the housing portions 9524a, 9524b are pulled open after surgery to retrieve the inner core 9522.

[0163] See now Figures 30 to 34 The surgical instrument system 9600 is similar to the surgical instrument systems 8500 and 8800 in many respects. For example, the surgical instrument system 9600 also includes a shank assembly 9620 that includes an inner core having a motor assembly for actuating one or more drive members configured to achieve closing, articulating, and / or firing movements of the end effector 9640. A shaft assembly 9630 extends between the end effector 9640 and the shank assembly 9620 to transmit drive motion from the inner core to the end effector 9640, thereby deploying staples from the staple cartridge 9641.

[0164] The handle assembly 9620 includes a power supply 9626, which may be in the form of one or more batteries. A sterilization detection circuit 9660 is coupled to the power supply 9626 and a receiver 9663, which is coupled to a sensor array 9670 configured to monitor the sterilization status of the handle assembly 9620. The sensor array 9670 includes a plurality of sensors 9671 disposed on the outer surface 9623 of the disposable outer housing 9624. The sensors 9671 are configured to detect the sterilization status of various portions or areas of the handle assembly 9620, which is then transmitted to a microcontroller 9661. The microcontroller 9661 causes a user interface 9662 to display the sterilization status, such as... Figure 34 As shown.

[0165] In the illustrated example, the user interface 9662 is in the form of an LED display. The representation of the handle assembly 9620 is displayed on the LED display. Each portion or area of ​​the handle assembly 9620 is shown as one of two different visual indicators indicating an acceptable or unacceptable sterilization state. The microcontroller 9661 assigns one of the two visual indicators to each area based on at least one reading from at least one of the sensors 9671 in that area. In the illustrated example, areas 2 and 5 are assigned an unacceptable sterilization state, while areas 1, 3, 4, and 6 are assigned an acceptable sterilization state.

[0166] In some cases, the handle assembly (such as, for example, handle assembly 9620) is reusable. Therefore, the handle assembly 9620 is resterilized before each use to maintain a sterile surgical area when used in surgical procedures. In an illustrative example, the handle assembly 9620 is sterilized by exposure to hydrogen peroxide (H2O2). In at least one example, a clinician may sterilize the handle assembly 9620 by wiping it with a hydrogen peroxide swab. In other examples, other means of sterilizing the handle assembly 9620 via hydrogen peroxide may be employed, as described in more detail elsewhere in this disclosure.

[0167] In some cases, the handle assembly may include a disposable outer housing and a reusable inner core. In this case, sensor 9671 may be disposed on the outer surface of the inner core to assess the sterilization status of various portions or areas of the inner core in a manner similar to that described in conjunction with handle assembly 9620.

[0168] When using hydrogen peroxide, sensor 9671 of sensor array 9670 is a hydrogen peroxide sensor, configured to detect the presence of hydrogen peroxide in each region of handle assembly 9620. Therefore, the sensor reading of sensor 9671 indicates the amount of hydrogen peroxide detected by sensor 9671 in a portion or region of handle assembly 9620 where sensor 9671 is located. Figure 35 As shown in graph 9672, the acceptable sterilization state corresponds to the reading of sensor 9671, which is greater than or equal to a predetermined threshold 9673.

[0169] In addition to the above, Figure 36 This is a logic flowchart of process 9680, which depicts a control procedure or logic configuration for detecting the end of the lifecycle of a resterilable component (such as, for example, a handle assembly or core) of a surgical instrument system. Process 9680 detects the end of the lifecycle by counting the number of times the component has been resterilized.

[0170] In at least one example, process 9680 is implemented by sterilization detection circuit 9660. If microcontroller 9661 detects a sensor reading greater than or equal to a predetermined threshold 9673, microcontroller 9661 increments the count held by any suitable counter by 1. In this case, re-sterilization is performed with hydrogen peroxide, the sensor reading increases to a peak, and then decreases as the hydrogen peroxide begins to evaporate, as... Figure 35 As shown. To avoid false counting, the microcontroller 9661 is configured to ignore sensor readings from the 9683 for a predetermined time period.

[0171] In some cases, such as Figure 37 As shown, components of a surgical instrument system (such as, for example, handle assembly 9720) include an outer surface 9723 coated with a coating that changes color upon exposure to a sterilizing solution (such as, for example, hydrogen peroxide). This coating provides a visual indicator of the areas 9720a of the handle assembly 9720 that have been adequately exposed to hydrogen peroxide and the areas 9720b that have not yet been adequately exposed. This allows clinicians the opportunity to ensure that the sterilizing solution is applied in sufficient quantity to all portions of the handle assembly 9720 to produce a properly sterilized handle assembly 9720'.

[0172] See now Figures 38 to 40 The image depicts a re-sterilization system 9800. The re-sterilization system 9800 includes a receiving chamber 9801 configured to accommodate a reusable handle assembly 9820 of a surgical instrument system. However, in other cases, the re-sterilization system 9800 may be configured to accommodate other components of the surgical instrument system, such as, for example, the inner core or handle assembly.

[0173] In the illustrated example, the re-sterilization system 9800 includes two parts, 9800a and 9800b, which can be configured in an open configuration ( Figure 38 ) and closed configuration ( Figure 39 The re-sterilization system 9800 is movable between portions 9800a and 9800b to accommodate a reusable handle assembly 9820. A receiving chamber 9801 is defined between portions 9800a and 9800b of the re-sterilization system 9800. Additionally, a plurality of rinsing ports 9806 are defined in portion 9800b. Alternatively, the rinsing ports may be defined in portion 9800a. Furthermore, the re-sterilization system 9800 includes a charging port 9804 and a corresponding connector 9805 configured to connect the handle assembly 9820 to a charging system when it is in the receiving chamber.

[0174] In all aspects, the rinsing port 9802 is connected to a sterilization solution source, which is delivered to the receiving chamber 9801 via the rinsing port 9802. A pump can be used to inject the sterilization solution through the rinsing port 9802 and remove it during a resterilization cycle. In alternative embodiments, such as Figure 39 As shown, the re-sterilization system 9800' includes a receiving chamber 9811 containing an absorbent material or cloth 9812 filled with a sterilizing solution. A motor 9814 causes an actuator 9813 to repeatedly move the cloth 9812 relative to the handle assembly 9820 between a starting position and an ending position to re-sterilize the handle assembly. Alternatively, the motor 9814 can cause the actuator 9813 to move the handle assembly 9820 relative to the cloth 9812 between a starting position and an ending position.

[0175] See now Figure 15 and Figure 41 In some cases, the main interface component 9270 includes a radio interface 9230 and a wired interface 9240. For example... Figure 41 As shown, radio interface 9230 and wired electrical interface 9240 are configured to transmit at least one of data and power through sterile barrier 9225. At least one of power and data can be transmitted between the inner core 9222 and the end effector and / or shaft assembly of the surgical instrument system 9200. In various aspects, the first wireless interface portion 9231 and the second wireless interface portion 9232 are configured to cooperatively form wireless segments of an electrical path between the inner core 9222 and the end effector and / or between the inner core 9222 and the shaft assembly. Additionally, one or more flexible circuits can be configured to define one or more segments of the electrical path.

[0176] In the illustrated example, the radio interface 9230 includes a first radio interface portion 9231 housed by the inner core 9222 and a second radio interface portion 9232 releasably attachable to the outer wall 9227 of the disposable outer housing 9224. In other examples, the second radio interface portion 9232 is integral with the outer wall 9227 of the disposable outer housing 9224. In the illustrated example, the first radio interface portion 9231 is located within the outer wall 9229 of the inner core 9222. However, in other examples, the first radio interface portion 9231 may be at least partially disposed on the outer surface of the outer wall 9229.

[0177] In addition to the above, when the inner core 9222 is correctly positioned within the disposable outer casing 9224, the second wireless interface portion 9232 can be magnetically coupled to the first wireless interface portion 9231. In the illustrated example, the second wireless interface portion 9232 includes attachment elements 9233' and 9234', thereby enabling magnetic coupling of corresponding attachment elements 9233 and 9234 of the first wireless interface portion 9231. In some cases, attachment elements 9233' and 9234' are magnetic elements, and the corresponding attachment elements 9233 and 9234 are ferro-containing elements. In other cases, attachment elements 9233' and 9234' are ferro-containing elements, and the corresponding attachment elements 9233 and 9234 are magnetic elements. In still other cases, attachment elements 9233' and 9234' and their corresponding attachment elements 9233 and 9234 are magnetic elements.

[0178] Attachment elements 9233, 9234, 9233', and 9234' cooperate to ensure proper alignment between the sensing element 9235 of the first wireless interface portion 9231 and the corresponding sensing element 9235' of the second wireless interface portion 9232, such as... Figure 41 As shown. In the illustrated example, sensing elements 9235 and 9235' are in the form of wound coils, which are components of sensing circuits 9236 and 9236', respectively. The coils of sensing elements 9235 and 9235' comprise copper or copper alloy wire; however, the coils may comprise, for example, a suitable conductive material, such as aluminum. The coils may be wound around a central axis any suitable number of times.

[0179] When appropriate magnetic attachment is established by components 9233, 9234, 9233', and 9234', such as Figure 41 As shown, the coils of sensing elements 9235 and 9235' are correctly aligned about a central axis extending through them. Correct alignment of the coils of sensing elements 9235 and 9235' improves the wireless transmission of at least one of data and power therethrough.

[0180] In addition to the above, the wired interface 9240 includes a first wired interface portion 9241 located on a first side of the sterile barrier 9225 and a second wired interface portion 9242 located on a second side of the sterile barrier 9225. Figure 41 In the example shown, the wired electrical interface 9240 also includes connectors 9243, 9243', which are configured to cooperate with the first wired interface portion 9241 and the second wired interface portion 9242 to facilitate wired transmission of at least one of data and power through the sterile barrier 9225 without contaminating the sterile environment protected by the sterile barrier 9225.

[0181] In the illustrated example, the wired interface 9240 defines two wired pathways extending through the sterile barrier 9225. However, in other examples, the wired interface 9240 may define more or fewer than two wired pathways.

[0182] Connectors 9243, 9243' include bodies 9244, 9244' extending through the outer wall 9227 of the disposable outer housing 9224. Connectors 9243, 9243' also include internal contacts 9245, 9245' located inside the disposable outer housing 9224, and external contacts 9246, 9246' located outside the disposable outer housing 9224. In the illustrated example, the second wired interface portion 9242 includes flexible circuits 9250, 9250' terminating at connectors 9247, 9247', which are configured to form a hermetically sealed connection with the external contacts 9246, 9246'. In the illustrated example, connectors 9247, 9247' include insulating outer housings 9248, 9248', configured to receive the external contacts 9246, 9246' and guide them to electrically engage with corresponding electrical contacts of the flexible circuits 9250, 9250'.

[0183] In various examples, the bodies 9244, 9244' are tightly fitted by the outer wall 9227 of the disposable outer housing 9224 to prevent or at least block fluid contamination. Additionally, the insulating outer housings 9248, 9248' include flush ends abutting the outer surface of the outer wall 9227 to prevent or at least resist fluid contact with the external contacts 9246, 9246' during operation.

[0184] Furthermore, the internal contacts 9245 and 9245' of connectors 9243 and 9243' are configured to engage leaf spring contacts 9249 and 9249' when the inner core 9222 is properly assembled with the disposable outer housing 9224. In the illustrated example, the outer walls 9227 and 9229 include flush portions to facilitate wireless connectivity between the first wireless interface portion 9231 and the second wireless interface portion 9232. Additionally, the outer walls 9227 and 9229 also include spaced portions to facilitate wired connectivity between the internal contacts 9245 and 9245' and the leaf spring contacts 9249 and 9249'. In the illustrated example, a portion of the outer wall 9227 is slightly raised, forming an isolation chamber 9255 between the outer walls 9227 and 9229. Figure 41 As shown, the isolation chamber 9255 has a predetermined depth that ensures good electrical contact between the internal contacts 9245, 9245' and the leaf spring contacts 9249, 9249' in the assembled configuration.

[0185] In various aspects, one or more of the surgical instrument systems of this disclosure include a display for providing feedback to a user, which may include information about one or more characteristics of the tissue being treated and / or one or more parameters of the surgical instrument system. For example, the display may provide the user with information about the dimensions of the staple cartridge assembled with the surgical instrument system, the measured thickness of the surgical instrument system and / or the tissue being treated. In various aspects, the display may be, for example, a flexible display.

[0186] exist Figure 41 In the example shown, the flexible display 9201 is incorporated into a disposable outer housing 9224. A microcontroller 9202 is located below the flexible display 9201. The flexible display 9201 is configured to face the outside of the disposable outer housing 9224, while the microcontroller 9202 is configured to face the inside of the disposable outer housing 9224. The flexible display 9201 can be connected to a suitable power source via a wireless or wired interface. In at least one example, the flexible display 9201 is powered by a power supply 9226 within the inner housing 9222. In at least one example, the flexible display 9201 is powered by an external power source that can be attached to the disposable outer housing 9224.

[0187] In other examples, the flexible display 9201 may be incorporated into the shaft of a surgical instrument system. In such examples, the flexible display 9201 is bent to conform to, or at least substantially conform to, the cylindrical shape of the shaft. In some cases, the flexible display 9201 is incorporated into the outer wall of the shaft. However, in other cases, the flexible display 9201 is positioned below or inside the shaft and is visible through the transparent outer wall of the shaft. Positioning the flexible display 9201 on the disposable outer housing 9224 or within the shaft helps prevent fogging on the display, which could occur if the display is positioned inside the disposable outer housing 9224 along with the inner core 9222 due to heat generated by the motor assembly of the inner core 9222.

[0188] See now Figures 42 to 44 The actuator 10000 may be incorporated into the handle assembly of a surgical instrument system, such as, for example, the handle assembly 8520 of surgical instrument system 9100, the handle assembly 9220 of surgical instrument system 8500, and / or the handle assembly 9120 of surgical instrument system 9200. The actuator 10000 may be configured to cause the inner core 8522 to, for example, generate a driven motion to close, trigger, and / or articulate the end effector 8540, the driven motion being proportional to mechanical pressure applied by the user, as detected by the actuator 10000. In various aspects, the actuator 10000 includes a magnetostrictive transducer configured to change the magnetic field in response to the amount of force applied thereto. Figure 43 Different actuation configurations of actuator 10000 and the amount of strain produced from zero magnetization (configuration 1) to full magnetization (configurations 1, 5) are shown. Actuator 10000 is divided into discrete mechanical and magnetic properties, which are coupled in their effects on the strain and magnetic induction of the magnetostrictive core.

[0189] See still Figure 43 Without an applied magnetic field, the change in length will be zero due to the generated magnetic induction. Furthermore, the amount of magnetic field (H) increases to its saturation limit (±Hsat) in configurations 1 and 5. This results in an increase in axial strain to its maximum value. Configurations 2 and 4 represent intermediate increases in magnetization, but to a lesser extent than configurations 1 and 5 (±H1). Maximum strain saturation and magnetic induction are achieved at the saturation limit (±Hsat). The flux lines associated with configurations 1 and 2 are in the opposite direction to those in configurations 4 and 5. These generated magnetic flux fields can be measured, for example, using the Hall effect principle or by calculating the voltage generated in a conductor perpendicular to the generated magnetic flux. This value will be proportional to the input strain or force.

[0190] Therefore, for example, control circuit 8560 can adjust the drive motion generated by inner core 8522 based, for example, on the reading of a magnetic sensor configured to measure the magnetic flux field generated by actuator 10000 in response to the actuation force applied by the user to actuator 10000. Figure 44 This is graph 10001, which shows, for example, a change in the closed position (y-axis) of the jaws of the end effector 8540 in response to an actuation force (x-axis) applied by a user, as detected by the actuator 10000. In the illustrated example, the fully closed configuration of the end effector 8540 corresponds to a predetermined actuation force threshold 10002, which corresponds to configuration 5 of the actuator 10000, as shown... Figure 43 As shown. If the control circuit 8560 detects a predetermined actuation threshold 10002 based on the reading of the magnetic sensor, the control circuit 8560 stops the drive motion, for example, by disabling one or more motors in the inner core 8522. Furthermore, the control circuit 8560 can also reverse the rotation direction of the motors to return the end effector 8540 to an open configuration.

[0191] Figures 42 to 44 The example shown illustrates the use of actuator 10000 as a closing actuator for an end effector. In other examples, actuator 10000 may be similarly used to implement and control firing motion and / or joint motion, such as that of end effector 8540.

[0192] See now Figure 45 and Figure 46 The handle assembly 9920 is similar in many respects to other handle assemblies described elsewhere herein (such as, for example, handle assemblies 8520, 9120, 9220), and for the sake of brevity, will not be repeated herein. For example, the handle assembly 9920 also includes an inner core 9922 having a motor assembly for actuating one or more drive members configured to achieve closing movements, articulating movements, and / or firing movements in an end effector (e.g., end effector 8540). The handle assembly 9920 also includes a disposable outer housing 9924 comprising two housing portions 9924a, 9924b that are releasably attached to each other to allow assembly with the inner core 9922. When engaged, the housing portions 9924a, 9924b define cavities therein, wherein the inner core 9922 may selectively reside within a sterile barrier 9925 defined by an outer wall 9927 of the disposable outer housing 9924.

[0193] In addition to the above, the handle assembly 9920 includes an actuator 9901 configured to convert changes in external actuation force (F) applied by the user to the actuator 9901 into changes in an internal magnetic field detectable by one or more magnetic field sensors 9902 within the handle assembly 9920. The actuator 9901 allows the inner core 9922 to accurately detect changes in external actuation force (F) without compromising the sterile barrier 9925.

[0194] In the illustrated example, housing portion 9924b includes a pressure-sensitive actuator 9923 configured to detect changes in external actuation force (F). A rod 9905 extends from the pressure-sensitive actuator 9923 within the disposable outer housing 9924 and is configured to abut against a rigid surface 9906 of the inner core 9922 when the inner core 9922 is properly assembled with the disposable outer housing 9924, as shown. Figure 46 As shown. Coil 9903 is wound around rod 9905 and configured to generate a magnetic field when current passes through it. In at least one example, coil 9903 is, for example, part of a circuit powered by power supply 9926 of inner core 9922. In a manner similar to that described in conjunction with actuator 10000, a change in the external actuation force (F) applied to pressure-sensitive actuator 9923 causes a change in the magnetic field generated by coil 9903, which corresponds to the change in the external actuation force (F).

[0195] In the illustrated example, the inner core 9922 includes a control circuit 9960 connected to a magnetic field sensor 9902. The control circuit 9960 is also connected to a motor assembly 9962 of the inner core 9922 and is configured to adjust the drive motion generated by the motor assembly 9962 based on changes in external actuation force (F) detected by the control circuit 9960 based on readings from the magnetic field sensor 9902. In various aspects, the drive motion is configured to close, fire, and / or articulate an end effector operably coupled to the handle assembly 9920. In some aspects, the control circuit 9960 includes a storage medium, such as a memory unit storing, for example, one or more databases, formulas, and / or tables for selecting one or more parameters of the drive motion based on readings from the magnetic field sensor 9902.

[0196] In all respects, coil 9903 comprises copper wire or copper alloy wire. However, coil 9903 may comprise, for example, a suitable conductive material, such as aluminum. Coil 9903 may be wound around rod 9905 any suitable number of times.

[0197] See now Figure 47 and Figure 48The handle assembly 11020 is similar in many respects to other handle assemblies described elsewhere herein (such as, for example, handle assemblies 9920, 8520, 9120, 9220), and for the sake of brevity, will not be repeated herein. For example, the handle assembly 11020 also includes an inner core 11022 having a motor assembly for actuating one or more drive members configured to achieve closing movements, articulating movements, and / or firing movements in an end effector (e.g., end effector 8540). The handle assembly 11020 also includes a disposable outer housing 11024 comprising two housing portions 11024a, 11024b that are releasably attached to each other to allow assembly with the inner core 11022. When engaged, housing portions 11024a, 11024b define cavities therein, wherein the inner core 11022 is selectively located within a sterile barrier 11025 defined by the outer wall 11027 of the disposable outer housing 11024.

[0198] In addition to the above, the handle assembly 11020 includes an actuator 11001 configured to detect an external compressive force (F) applied by a user to the actuator 9901, and in response, to cause the electromechanical component 11023 to vibrate when the external actuating force (F) is greater than or equal to a predetermined threshold 11002. Figure 49 The curve is shown in graph 11004. In at least one example, the electromechanical component 11023 is in the form of a piezoelectric film, or alternatively a ceramic component. The electromechanical component 11023 is coupled to a power source 11026 of the inner core 11022, which supplies power to the electromechanical component 11023 when the conductive component 11003 closes the circuit connecting the electromechanical component 11023 to the power source 11026.

[0199] See now Figure 50 and Figure 51 The handle assembly 12020 is similar in many respects to other handle assemblies described elsewhere herein (such as, for example, handle assemblies 9920, 8520, 9120, 9220, 11020), and for the sake of brevity, will not be repeated herein. For example, the handle assembly 12020 also includes an inner core 12022 having a motor assembly for actuating one or more drive members configured to achieve closing movements, articulating movements, and / or firing movements in an end effector (e.g., end effector 8540). The handle assembly 12020 also includes a disposable outer housing 12024 comprising two housing portions releasably attached to each other to allow assembly with the inner core 12022. When engaged, the housing portions define cavities therein, wherein the inner core 12022 may selectively reside within a sterile barrier 12025 defined by an outer wall 12027 of the disposable outer housing 12024.

[0200] In addition to the above, the handle assembly 12020 includes an actuator 12001 configured to detect an external compressive force (F) applied by a user to the actuator 12001. Detection is performed across the sterile barrier 12025. In other words, the external compressive force (F) is applied to a first side of the sterile barrier 12025 and detected on a second side of the sterile barrier 12025 opposite to the first side without damaging the sterile barrier 12025. In the illustrated example, the actuator 12001 includes components located on both sides of the sterile barrier 12025 that are capable of magnetic interaction across the sterile barrier 12025. A ferromagnetic plate or membrane 12002 is positioned outside the disposable outer housing 12024, and a corresponding magnetic sensor 12003 is positioned inside the disposable outer housing 12024. The movement of the ferromagnetic plate 12002 in response to an external compressive force (F) causes a change in the reading of the magnetic sensor 12003, which is proportional to the change in the position of the ferromagnetic plate 12002 caused by the external compressive force (F).

[0201] Furthermore, the control circuitry 120060 of the handle assembly 12020 may include a microcontroller 120061 configured to adjust the drive motion of the motor assembly 120062 based on readings from the magnetic sensor 12003. The drive motion may realize one or more of, for example, the closing motion of an end effector, the firing motion, and the articulation motion.

[0202] In the illustrated example, the ferromagnetic plate 12002 extends across a cavity 12031 defined in the outer wall 12027 of the disposable outer housing 12024. The edge of the ferromagnetic plate 12002 is attached to the sidewall of the cavity 12031. In the illustrated example, in-situ formed seals 12029, 12030 are configured to attach the edge of the ferromagnetic plate 12002 to the sidewall of the cavity 12031. However, in other examples, other attachment mechanisms are contemplated. In at least one example, an adhesive may be used to attach the edge of the ferromagnetic plate 12002 to the sidewall of the cavity 12031.

[0203] In addition to the above, the magnetic sensor 12003 protrudes through the outer wall 12028 of the inner core 12022 and is pressed against the outer wall 12027 by the spring 12004. The spring 12004 ensures that the magnetic sensor 12003 remains sufficiently close to the ferromagnetic plate 12002 to detect changes in the position of the ferromagnetic plate 12002 caused by external compressive force (F).

[0204] When the inner core 12022 is properly assembled with the disposable outer housing 12024, the magnetic sensor 12003 and the ferromagnetic plate 12002 are aligned with each other on opposite sides of the wall portion of the outer wall 12027 forming the cavity 12031. The ferromagnetic plate 12002 is configured to move or bend toward the magnetic sensor 12003 in response to an external compressive force (F). The movement of the ferromagnetic plate 12002 changes the reading of the magnetic sensor 12003 according to the magnitude of the external compressive force (F). When the user releases the ferromagnetic plate 12002 or reduces the external compressive force (F), the ferromagnetic plate 12002 returns to its natural state and moves away from the magnetic sensor 12003, which changes the reading of the magnetic sensor 12003 according to the reduction of the external compressive force (F). As described above, the microcontroller 120061 communicates with the magnetic sensor 12003. Therefore, changes in the reading of the magnetic sensor 12003 are converted into changes in the motor assembly 120062 and drive motion.

[0205] See now Figures 52 to 54 Alternative actuator implementation schemes are described. Figure 52 A handle assembly 13020 is shown, which in many respects is similar to handle assemblies described elsewhere herein (such as, for example, handle assemblies 9920, 8520, 9120, 9220, 11020, 12020), and will not be repeated for the sake of brevity. For example, handle assembly 13020 also includes an inner core 13022 having a motor assembly for actuating one or more drive members configured to achieve closing movements, articulating movements, and / or firing movements in an end effector (e.g., end effector 8540). Handle assembly 13020 also includes a disposable outer housing 13024 comprising two housing portions releasably attached to each other to allow assembly with the inner core 13022. When engaged, the housing portions define cavities therein, wherein the inner core 13022 may selectively reside within a sterile barrier 13025 defined by an outer wall 13027 of the disposable outer housing 13024.

[0206] In addition to the above, the handle assembly 13020 includes an actuator 13001, which is similar in many respects to actuator 12001 and will not be repeated for the sake of simplicity. Actuator 13001 includes a ferromagnetic plate 13002, which is similar in many respects to ferromagnetic plate 12002. Furthermore, the ferromagnetic plate 13002 is connected to the inner core 13022 via a wire connector 13023 extending through the outer wall of the inner core 13022. Additionally, adhesive 13029 is configured to appear to secure the ferromagnetic plate 13002 to an opening 13031 of the disposable outer housing 13024. In the illustrated example, the ferromagnetic plate 13002 defines a portion of the outer wall 13027.

[0207] exist Figure 53 and Figure 54 In the example shown, a flexible rubber outer cover 13033 is disposed on a ferromagnetic plate 13002 forming part of an outer wall 13027. The flexible rubber outer cover 13033 can be attached to the outer wall 13027 via an in-situ formed seal and / or adhesive 13034. The ferromagnetic plate 13002 and the flexible rubber cover 13033 provide a double seal, which ensures the integrity of the sterile barrier 13025.

[0208] The surgical instrument systems described herein are actuated by electric motors; however, the surgical instrument systems described herein can be actuated in any suitable manner. In some instances, the motors disclosed herein may include one or more parts of a robot control system. For example, U.S. Patent Application Serial No. 13 / 118,241 (now U.S. Patent No. 9,072,535), entitled “SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLEDEPLOYMENT ARRANGEMENTS,” discloses several examples of robotic surgical instrument systems in more detail, the entire disclosure of which is incorporated herein by reference. International Patent Publication No. WO 2017 / 083125, entitled "STAPLER WITH COMPOSITE CARDAN AND SCREW DRIVE", published on May 18, 2017; International Patent Publication No. WO 2017 / 083126, entitled "STAPLE PUSHER WITH LOST MOTION BETWEEN RAMPS", published on May 18, 2017; International Patent Publication No. 2015 / 153642, entitled "SURGICAL INSTRUMENT WITH SHIFTABLE TRANSMISSION", published on October 8, 2015; U.S. Patent Application Publication No. 2017 / 0265954, entitled "STAPLER WITH CABLE-DRIVEN ADVANCEABLE CLAMPING ELEMENT AND DUAL DISTAL PULLEYS", filed on March 17, 2017; and U.S. Patent Application Publication No. WO 2017 / 083126, entitled "STAPLER WITH CABLE-DRIVEN ADVANCEABLE CLAMPING ELEMENT AND DUAL DISTAL PULLEYS", filed on February 15, 2017. The full text of the publications of U.S. Patent Application Publication No. 2017 / 0265865 entitled “Advanced Clampingement and Distal Pulley” and U.S. Patent Application Publication No. 2017 / 0290586 entitled “Stapping Cartridge”, filed on March 29, 2017, are incorporated herein by reference.

[0209] The surgical instrument system described herein has been described in conjunction with the deployment and variations of the staples; however, the embodiments described herein are not limited thereto. For example, various embodiments are contemplated for deploying fasteners other than staples, such as clamps or pins. Furthermore, various embodiments utilizing any suitable means for sealing tissue are contemplated. For example, the end effector according to various embodiments may include electrodes configured to heat and seal tissue. Additionally, for example, the end effector according to some embodiments may apply vibrational energy to seal tissue.

[0210] Example Various aspects of the subject matter described herein are set forth in the following numbered embodiments.

[0211] Example 1 - A modular surgical instrument system includes a modular component comprising a shaft and a handle assembly releasably coupled to the shaft. The handle assembly includes a disposable outer housing configured to define a sterile barrier. The disposable outer housing includes a first housing portion and a second housing portion movable relative to the first housing portion between an open configuration and a closed configuration. The handle assembly also includes a control core, in which the control core is accommodated within the disposable outer housing in the open configuration. The disposable outer housing is configured to isolate the control core in the closed configuration. The modular component also includes a loading unit releasably coupled to the shaft, wherein the loading unit includes an end effector. The modular component also includes a staple cartridge releasably coupled to the end effector. The modular surgical instrument system further includes control circuitry electrically coupled to the modular component. The control circuitry is configured to generate an interrogation signal, detect a response signal to the interrogation signal, determine a modular configuration of the modular surgical instrument system based on the response signal, and evaluate the authenticity of the modular configuration based on the response signal.

[0212] Example 2 - A modular surgical instrument system according to Example 1, wherein the control circuit is configured to determine the modular configuration by determining the total sense resistance based on the response signal, and wherein the total sense resistance indicates the modular configuration.

[0213] Example 3 - A modular surgical instrument system according to Example 2, wherein the control circuit is configured to evaluate the authenticity of the modular configuration based on a comparison between an expected value and a determined value of the total sense resistance.

[0214] Example 4 - A modular surgical instrument system according to Example 2 or 3, wherein the control circuit is configured to compare the magnitude of the deviation between the expected value and the determined value of the total sense resistance with a predetermined threshold.

[0215] Example 5 - A modular surgical instrument system according to Example 2, 3 or 4, wherein the control circuit is configured to select a safety response based on the magnitude of the deviation between the expected value and the determined value of the total sense resistance.

[0216] Example 6 - A modular surgical instrument system according to Example 5, wherein the safety response includes at least temporarily disabling at least one of power and communication within the modular configuration.

[0217] Example 7 - A modular surgical instrument system according to Examples 2, 3, 4, 5 or 6, wherein the control circuit is configured to determine at least one of the connection status and authentication status of at least one modular component of the modular configuration based on the magnitude of the deviation between the expected value and the determined value of the total sense resistance.

[0218] Example 8 - A modular surgical instrument system includes a modular component characterized by a uniquely identified resistor. The modular component includes a shaft and a handle assembly releasably coupled to the shaft. The handle assembly includes a disposable outer shell configured to define a sterile barrier. The disposable outer shell includes a first shell portion and a second shell portion, the second shell portion being movable relative to the first shell portion between an open configuration and a closed configuration. The handle assembly also includes a control core, in the open configuration being accommodated within the disposable outer shell. The disposable outer shell is configured to isolate the control core in the closed configuration. The modular component also includes a loading unit releasably coupled to the shaft, wherein the loading unit includes an end effector. The modular component also includes a staple cartridge releasably coupled to the end effector. The modular surgical instrument system further includes control circuitry electrically coupled to the modular component. The control circuitry is configured to detect the modular configuration of the modular surgical instrument system based on the uniquely identified resistor and to evaluate the authenticity of the modular configuration.

[0219] Example 9 - A modular surgical instrument system according to Example 8, wherein the control circuit is configured to evaluate the authenticity of the modular configuration based on a comparison between the expected value and the determined value of the unique identifier resistor.

[0220] Example 10 - A modular surgical instrument system according to Examples 8 and 9, wherein the control circuit is configured to compare the magnitude of the deviation between the expected value and the determined value of the unique identifier resistor.

[0221] Example 11 - A modular surgical instrument system according to Example 8, 9 or 10, wherein the control circuit is configured to determine at least one of the connection status and authentication status of at least one modular component of the modular configuration based on the magnitude of the deviation between the expected value and the determined value of the unique identifier resistor.

[0222] Example 12 - A modular surgical instrument system according to Examples 8, 9, 10 or 11, wherein the control circuit is configured to select a safety response based on the magnitude of the deviation between the expected value and the determined value of the unique identifier resistor.

[0223] Example 13 - A modular surgical instrument system according to Example 12, wherein the safety response includes the temporary deactivation of one or more aspects of the modular surgical instrument system.

[0224] Example 14 - A modular surgical instrument system includes a modular component characterized by a uniquely identified resistor. The modular component includes a shaft and a handle assembly releasably coupled to the shaft. The handle assembly includes a disposable outer housing configured to define a sterile barrier. The disposable outer housing includes a first housing portion and a second housing portion, the second housing portion being movable relative to the first housing portion between an open configuration and a closed configuration. The handle assembly also includes a control core, in the open configuration being releasable within the disposable outer housing. The disposable outer housing is configured to isolate the control core in the closed configuration. The modular component also includes a loading unit releasably coupled to the shaft, wherein the loading unit includes an end effector. The modular component also includes a staple cartridge releasably coupled to the end effector. The modular surgical instrument system further includes control circuitry electrically coupled to the modular component. The control circuitry is configured to detect an identification signal of the modular configuration of the modular surgical instrument system, measure characteristics of the modular configuration, determine an authentication key based on at least one measurement of the characteristics of the modular configuration, and authenticate the identification signal based on the authentication key.

[0225] Example 15 - A modular surgical instrument system according to Example 14, wherein the control circuit is configured to determine the authentication key independently of the identification signal.

[0226] Example 16 - A modular surgical instrument system according to Example 14 or 15, wherein the authentication key is based on common characteristics among the various modular components of the modular configuration.

[0227] Example 17 - A modular surgical instrument system according to Example 16, wherein the characteristic is an environmental characteristic.

[0228] Example 18 - A modular surgical instrument system according to Example 16, wherein the characteristics are selected from position, radio frequency (RF) intensity, sound level, light level, magnetic field intensity, and combinations thereof.

[0229] Example 19 - A modular surgical instrument system according to Examples 14, 15, 16, 17 or 18, wherein the control circuitry is configured to decode the identification signal using the authentication key.

[0230] Example 20 - A modular surgical instrument system according to Example 14 or 15, wherein the authentication key is based on the magnetic field strength measured by the modular configuration.

[0231] Although several forms have been illustrated and described, the applicant does not intend to limit or restrict the scope of the appended claims to such details. Many modifications, variations, alterations, substitutions, combinations, and equivalents of these forms can be made without departing from the scope of this disclosure, and those skilled in the art will recognize such modifications, variations, alterations, substitutions, combinations, and equivalents. Furthermore, alternatively, the structure of each element associated with a described form can be described as a device for providing the function performed by said element. Additionally, where materials for certain components are disclosed, other materials may also be used. Therefore, it should be understood that the foregoing detailed descriptions and the appended claims are intended to cover all such modifications, combinations, and variations falling within the scope of the forms disclosed in this invention. The appended claims are intended to cover all such modifications, variations, alterations, substitutions, modifications, and equivalents.

[0232] The specific embodiments described above have illustrated various forms of apparatus and / or methods using block diagrams, flowcharts, and / or examples. Wherever such block diagrams, flowcharts, and / or examples contain one or more functions and / or operations, those skilled in the art will understand that each function and / or operation in such block diagrams, flowcharts, and / or examples can be implemented individually and / or collectively by various hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein can be equivalently implemented in an integrated circuit, wholly or partially, 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 any combination thereof, and that designing circuit systems and / or writing software and / or hardware code according to this disclosure will be within the skill of those skilled in the art. Furthermore, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as one or more program products in various forms, and that the exemplary forms of the subject matter described herein apply regardless of the specific type of signal-bearing medium used for actual distribution.

[0233] Instructions used for programming logic to execute various disclosed aspects may be stored in the system's memory, such as dynamic random access memory (DRAM), cache, flash memory, or other memory. Furthermore, the instructions may be distributed via a network or through other computer-readable media. Therefore, machine-readable media may include any means for storing or transmitting information in a machine-readable (e.g., computer-readable) form, but are not limited to floppy disks, optical disks, optical disc read-only memory (CD-ROM), and magneto-optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic cards or optical cards, flash memory, or tangible machine-readable storage devices used for transmitting information over the Internet via electrical signals, optical signals, acoustic signals, or other forms of propagation signals (e.g., carrier waves, infrared signals, digital signals, etc.). Therefore, non-transitory computer-readable media include any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a machine-readable (e.g., computer-readable) form.

[0234] As used in any aspect of this document, the term "control circuitry" may refer to, for example, hardwired circuitry systems, programmable circuitry systems (e.g., computer processors including one or more individual instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, digital signal processors (DSPs), programmable logic devices (PLDs), programmable logic arrays (PLAs), field-programmable gate arrays (FPGAs)), state machine circuitry systems, firmware storing instructions executed by the programmable circuitry system, and any combination thereof. Control circuitry can be implemented collectively or individually as part of a larger system, such as integrated circuits (ICs), application-specific integrated circuits (ASICs), system-on-a-chip (SoCs), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. Therefore, as used herein, "control circuit" includes, but is not limited to, electronic circuits having at least one discrete circuit, electronic circuits having at least one integrated circuit, electronic circuits having at least one application-specific integrated circuit, electronic circuits forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially implements the methods and / or devices described herein, or a microprocessor configured by a computer program that at least partially implements the methods and / or devices described herein), electronic circuits forming a memory device (e.g., forming a random access memory), and / or electronic circuits 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 can be implemented in analog or digital modes, or some combination thereof.

[0235] As used in any aspect of this document, the term "logic" can refer to an application, software, firmware, and / or circuit system configured to perform any of the foregoing operations. Software can be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware can be embodied as hard-coded (e.g., non-volatile) code, instructions, or instruction sets and / or data in a memory device.

[0236] As used in any part of this document, the terms “component,” “system,” “module,” etc., can refer to computer-related entities, hardware, combinations of hardware and software, software, or software in execution.

[0237] As used in any aspect of this document, "algorithm" refers to a systematic sequence of steps that leads to a desired result, where "step" refers to the manipulation of physical quantities and / or logical states, which may (but not necessarily) take the form of electrical or magnetic signals that can be stored, transferred, combined, compared, and otherwise manipulated. These signals are commonly referred to as bits, values, elements, symbols, characters, terms, numbers, etc. These and similar terms may be associated with appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.

[0238] The network may include a packet-switched network. Communication devices may be able to communicate with each other using a selected packet-switched network communication protocol. An exemplary communication protocol may include an Ethernet communication protocol that may allow communication using Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and / or a higher version of this standard. Alternatively or additionally, communication devices may be able to communicate with each other using the X.25 communication protocol. The X.25 communication protocol may conform to or be compatible with standards published by the International Telecommunication Union Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, communication devices may be able to communicate with each other using the Frame Relay communication protocol. The Frame Relay communication protocol may conform to or be compatible with standards published by the International Telegraph and Telephone Consultative Committee (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, transceivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard entitled "ATM-MPLS Network Interworking 2.0" and / or a higher version of that standard, published by the ATM Forum in August 2001. Of course, this document also envisions different and / or subsequently developed connectivity-oriented network communication protocols.

[0239] Unless otherwise expressly stated in the foregoing disclosure, it is understood that in the foregoing disclosure, discussions using terms such as “processing,” “estimating,” “calculating,” “determining,” and “displaying” refer to the actions and processes of a computer system or similar electronic computing device that manipulate data represented as physical (electronic) quantities in the registers and memories of the computer system and convert them into other data similarly represented as physical quantities in the memory or registers of the computer system or other such information storage, transmission, or display devices.

[0240] One or more components may be referred to herein as “configured to be,” “configurable to be,” “operable / operationally,” “suitable / adaptable,” “capable,” “adaptable / fittable,” etc. Those skilled in the art will recognize that, unless the context otherwise requires, “configured to be” generally encompasses components in an active state and / or in an inactive state and / or in a standby state.

[0241] The terms "proximal" and "distal" are used herein in relation to the clinician manipulating the handle portion of the surgical instrument. "Proximal" refers to the portion closest to the clinician, and "distal" refers to the portion furthest from the clinician's position. It should also be understood that, for brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used in conjunction with accompanying drawings. However, surgical instruments are used in many orientations and locations, and these terms are not restrictive and / or absolute.

[0242] Those skilled in the art will recognize that, in general, the terminology used herein, and particularly in the appended claims (e.g., the text of the appended claims), is typically intended to be “open” terms (e.g., the term “comprising” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “at least having,” the term “including” should be interpreted as “comprising but not limited to,” etc.). Those skilled in the art will also understand that if a specific number of statements in the introduced claims is intended, such an intention will be explicitly stated in the claims, and if no such statement is present, such an intention does not exist. For example, to aid understanding, the appended claims below may contain the use of the introductory phrases “at least one” and “one or more” to introduce the claims. However, the use of such phrases should not be construed as implying that introducing a claim statement with the indefinite article "a" or "an" limits any particular claim containing such an introductory claim statement to a claim containing only one such statement, even when the same claim includes the introductory phrase "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); this also applies to the use of definite articles used to introduce a claim statement.

[0243] Furthermore, even when a specific number of claims is explicitly stated, those skilled in the art should recognize that such a statement should generally be interpreted as referring to at least the number stated (e.g., in the absence of other modifiers, a bare statement of "two statements" generally means at least two statements, or two or more statements). Moreover, in cases where conventions such as "at least one of A, B, and C" are used, such constructions are generally intended to have a meaning that those skilled in the art will understand (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In cases where conventions such as "at least one of A, B, or C" are used, such constructions are generally intended to have a meaning that those skilled in the art will understand (e.g., "a system having at least one of A, B, or C" should include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art should also understand that, generally, unless the context otherwise indicates, any transitional words and / or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to cover the possibility of including one of the terms, any one of the terms, or both of the terms. For example, the phrase "A or B" will generally be understood to include the possibility of "A" or "B" or "A and B".

[0244] With respect to the appended claims, those skilled in the art will understand that the operations described herein can generally be performed in any order. Furthermore, although various operation flowcharts are shown in one or more sequences, it should be understood that the various operations may be performed in other orders than those shown, or may be performed simultaneously. Unless the context otherwise requires, examples of such alternative orderings may include overlapping, interleaving, interruption, reordering, incremental, preparatory, supplementary, simultaneous, reverse, or other altered orderings. Moreover, unless the context otherwise requires, terms such as “in response to,” “related,” or other past tense adjectives are generally not intended to exclude such variations.

[0245] It is worth noting that any reference to "one aspect," "one aspect," "one example," or "one example" means that the specific feature, structure, or characteristic described in connection with said aspect is included in at least one aspect. Therefore, the phrases "in one aspect," "in one aspect," "in one example," and "in one example" appearing in various places throughout the specification do not necessarily refer to the same aspect. Furthermore, specific features, structures, or characteristics may be combined in one or more aspects in any suitable manner.

[0246] In this specification, unless otherwise stated, the terms "about" or "approximately" as used herein refer to an acceptable error in a particular value as determined by one of ordinary skill in the art, depending in part on how the value is measured or determined. In some embodiments, the terms "about" or "approximately" mean within 1, 2, 3, or 4 standard deviations. In some embodiments, the terms "about" or "approximately" mean within 50%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.05% of a given value or range.

[0247] In this specification, unless otherwise specified, all numerical parameters should in all cases be understood to be referred to by or modified by the term "about," whereby the numerical parameters have inherent differences in the underlying measurement techniques used to determine the parameter values. To a minimum, and without attempting to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter described herein should be interpreted at least according to the significant digits of the reported value and by applying customary rounding methods.

[0248] Any numerical ranges listed herein include all subranges covered by the listed range. For example, the range “1 to 10” includes all subranges between the listed minimum value 1 and the listed maximum value 10 (inclusive), that is, a minimum value equal to or greater than 1 and a maximum value equal to or less than 10. Furthermore, all ranges listed herein include the endpoints of the listed range. For example, the range “1 to 10” includes the endpoints 1 and 10. Any upper limit value listed in this specification is intended to include all smaller limits covered therein, and any lower limit value listed in this specification is intended to include all larger limits covered therein. Therefore, the applicant reserves the right to amend this specification (including the claims) to expressly list any subranges covered by the expressly listed ranges. All such ranges are inherently described in this specification.

[0249] Any patent application, patent, non-patent publication, or other public material mentioned in this specification and / or listed in any application data sheet is incorporated herein by reference, provided that the incorporated material is inconsistent with this specification. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein by reference that conflicts with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that the incorporated material does not conflict with existing public materials.

[0250] In summary, many beneficial effects resulting from employing the concepts described herein have been described. For illustrative and descriptive purposes, one or more of the specific embodiments described above have been provided. These embodiments are not intended to be exhaustive or limited to the precise forms disclosed in the invention. Modifications or variations may be made to the invention in accordance with the teachings above. The one or more forms chosen and described are intended to illustrate the principles and practical applications, thereby enabling those skilled in the art to utilize various forms and modifications suitable for the intended particular use. The claims filed herein are intended to define the full scope.

Claims

1. A modular surgical instrument system, comprising: Modular components, the modular components including: axis; A shank assembly releasably coupled to the shaft, wherein the shank assembly includes: A disposable outer housing configured to define a sterile barrier, the disposable outer housing comprising: First shell portion; and A second housing portion, the second housing portion being movable relative to the first housing portion between an open configuration and a closed configuration; and A control core, wherein the control core is receptive to the interior of the disposable outer housing in the open configuration, wherein the disposable outer housing is configured to isolate the control core in the closed configuration; A loading unit, releasably coupled to the shaft, wherein the loading unit includes an end effector; and A staple cartridge, the staple cartridge being releasably coupled to the end effector; and A control circuit capable of being electrically coupled to the modular component, the control circuit being configured to: Generate an inquiry signal; Detect the response signal to the interrogation signal; The modular configuration of the modular surgical instrument system is determined based on the response signal; and The authenticity of the modular configuration is evaluated based on the response signal.

2. The modular surgical instrument system according to claim 1, wherein, The control circuit is configured to determine the modular configuration by determining the total sense resistance based on the response signal, wherein the total sense resistance indicates the modular configuration.

3. The modular surgical instrument system according to claim 2, wherein, The control circuit is configured to evaluate the authenticity of the modular configuration based on a comparison between the expected and determined values ​​of the total sense resistance.

4. The modular surgical instrument system according to claim 2, wherein, The control circuit is configured to compare the magnitude of the deviation between the expected and determined values ​​of the total sense resistance with a predetermined threshold.

5. The modular surgical instrument system according to claim 2, wherein, The control circuit is configured to select a safety response based on the magnitude of the deviation between the expected value and the determined value of the total sense resistance.

6. The modular surgical instrument system according to claim 5, wherein, The security response includes at least temporarily disabling at least one of the power and communication capabilities within the modular configuration.

7. The modular surgical instrument system according to claim 2, wherein, The control circuit is configured to determine, based on the magnitude of the deviation between the expected and determined values ​​of the total sense resistance, at least one of the connection status and authentication status of at least one modular component in the modular configuration.

8. A modular surgical instrument system, comprising: A modular component characterized by a uniquely identified resistor, the modular component comprising: axis; A shank assembly releasably coupled to the shaft, wherein the shank assembly includes: A disposable outer housing configured to define a sterile barrier, the disposable outer housing comprising: First shell portion; and A second housing portion, the second housing portion being movable relative to the first housing portion between an open configuration and a closed configuration; and A control core, wherein the control core is receptive to the interior of the disposable outer housing in the open configuration, wherein the disposable outer housing is configured to isolate the control core in the closed configuration; A loading unit, releasably coupled to the shaft, wherein the loading unit includes an end effector; and A staple cartridge, the staple cartridge being releasably coupled to the end effector; and A control circuit capable of being electrically coupled to the modular component, the control circuit being configured to: Detecting the modular configuration of the modular surgical instrument system based on the unique identifier resistor; and Assess the authenticity of the modular configuration.

9. The modular surgical instrument system according to claim 8, wherein, The control circuit is configured to evaluate the authenticity of the modular configuration based on a comparison between the expected and determined values ​​of the unique identifier resistor.

10. The modular surgical instrument system according to claim 8, wherein, The control circuit is configured to compare the magnitude of the deviation between the expected value and the determined value of the unique identifier resistor.

11. The modular surgical instrument system according to claim 8, wherein, The control circuit is configured to determine, based on the magnitude of the deviation between the expected and determined values ​​of the unique identifier resistor, at least one of the connection status and authentication status of the modular components of the modular configuration.

12. The modular surgical instrument system according to claim 8, wherein, The control circuit is configured to select a safety response based on the magnitude of the deviation between the expected value and the determined value of the unique identifier resistor.

13. The modular surgical instrument system according to claim 12, wherein, The safety response includes the temporary deactivation of one or more aspects of the modular surgical instrument system.

14. A modular surgical instrument system, comprising: A modular component characterized by a uniquely identified resistor, the modular component comprising: axis; A shank assembly releasably coupled to the shaft, wherein the shank assembly includes: A disposable outer housing configured to define a sterile barrier, the disposable outer housing comprising: First shell portion; and A second housing portion, the second housing portion being movable relative to the first housing portion between an open configuration and a closed configuration; and A control core, wherein the control core is receptive to the interior of the disposable outer housing in the open configuration, wherein the disposable outer housing is configured to isolate the control core in the closed configuration; A loading unit, releasably coupled to the shaft, wherein the loading unit includes an end effector; and A staple cartridge, the staple cartridge being releasably coupled to the end effector; and A control circuit capable of being electrically coupled to the modular component, the control circuit being configured to: Detect the identification signal of the modular configuration of the modular surgical instrument system; Measure the characteristics of the modular configuration; The authentication key is determined based on at least one measurement of the characteristics of the modular configuration; and The identification signal is authenticated based on the authentication key.

15. The modular surgical instrument system according to claim 14, wherein, The control circuit is configured to determine the authentication key independently of the identification signal.

16. The modular surgical instrument system of claim 14, wherein, The authentication key is based on common characteristics among the modular components of the modular configuration.

17. The modular surgical instrument system of claim 16, wherein, The aforementioned characteristic is an environmental characteristic.

18. The modular surgical instrument system of claim 16, wherein, The characteristics are selected from location, radio frequency (RF) intensity, sound level, light level, magnetic field intensity, and combinations thereof.

19. The modular surgical instrument system of claim 14, wherein, The control circuit is configured to use the authentication key to decode the identification signal.

20. The modular surgical instrument system of claim 14, wherein, The authentication key is based on the magnetic field strength measured by the modular configuration.

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