JP2023551921A - Powered surgical instruments with external connectors - Google Patents

Abstract

A modular surgical instrument system comprising a handle assembly comprising a disposable outer housing configured to define a sterility 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 further includes a control inner core receivable within the disposable outer housing in an open configuration. The disposable outer housing is configured to isolate the control inner core in the closed configuration. The modular surgical instrument system includes a primary wired interface configured to transmit data and power between the control inner core and at least one of the modular components of the modular surgical instrument system; and a control circuit configured to confirm the primary connection through the primary wired interface based on the at least one sensor reading.

Description

The present invention relates to surgical instruments and to surgical stapling and cutting instruments, and staple cartridges for use therewith, designed for stapling and cutting tissue in a variety of devices.

In one aspect, the present disclosure provides a modular surgical instrument system that includes a handle assembly. The handle assembly includes a disposable outer housing configured to define a sterility 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 further includes a control inner core receivable within the disposable outer housing in an open configuration. The disposable outer housing is configured to isolate the control inner core in the closed configuration. The modular surgical instrument system includes a primary wired interface configured to transmit at least one of data and power between the control inner core and at least one of the modular components of the modular surgical instrument system. and a secondary interface comprising a sensor located within the outer housing, and a control circuit configured to verify the primary connection through the primary wired interface based on the at least one reading of the sensor. .

In another aspect, the present disclosure provides a handle assembly for use with a modular surgical system. The handle assembly includes a disposable outer housing configured to define a sterility 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 further includes a control inner core receivable within the disposable outer housing in an open configuration, and the disposable outer housing is configured to isolate the control inner core in a closed configuration. The handle assembly includes a first sensor configured to detect a control inner core within the disposable outer housing, a second sensor configured to detect a closed configuration of the disposable outer housing, and a second sensor configured to detect a closed configuration of the disposable outer housing. and a control circuit configured to assess proper assembly of the disposable outer housing and the control inner core based on the at least one reading of the disposable outer housing and the at least one reading of the second sensor.

In another aspect, the present disclosure provides a handle assembly for use with a modular surgical system. The handle assembly includes an outer surface, a sensor array comprising a sensor secured to the outer surface within a predetermined zone of the handle assembly, and a disposable outer housing configured to define a sterility barrier. The disposable outer housing includes a resterilization detection circuit that detects the resterilization status of each of the zones based on readings from the sensor.

Various features of the embodiments described herein, together with their advantages, can be understood from the following description in conjunction with the accompanying drawings.
1 illustrates a perspective view of a surgical instrument system according to at least one aspect of the present disclosure. FIG. 2 illustrates a perspective view of the handle assembly of the surgical instrument system of FIG. 1 in an exploded configuration, the handle assembly including an outer disposable housing and an inner core. FIG. 3 illustrates a cross-sectional view of an electrical interface for transmitting at least one of power and data between the end effector of the surgical instrument system of FIG. 1 and the inner core of FIG. 2; FIG. 1 is a logic flow diagram of a process illustrating a control program or logic for electrically connecting an inner core of a surgical instrument system to a staple cartridge or end effector in accordance with at least one aspect of the present disclosure. FIG. 3 is a graph illustrating drive member movement on the x-axis and drive member velocity on the y-axis in accordance with at least one aspect of the present disclosure; FIG. 3 is a graph showing drive member speed on the x-axis and motor current on the y-axis in accordance with at least one aspect of the present disclosure; FIG. 1 is a perspective view of a surgical instrument system in accordance with at least one aspect of the present disclosure; FIG. 1 is a perspective view of a surgical instrument system in accordance with at least one aspect of the present disclosure; FIG. 9 is a cross-sectional view of the nozzle portion of the surgical instrument system of FIG. 8; FIG. 1 is a cross-sectional view of a handle assembly of a surgical instrument system in accordance with at least one aspect of the present disclosure; FIG. 1 is a cross-sectional view of a modular configuration of a modular surgical instrument system in accordance with at least one aspect of the present disclosure; FIG. 3 is a graph illustrating resistance identifiers of various potential modular components of a modular surgical instrument system in accordance with at least one aspect of the present disclosure. FIG. 2 is a logical flow diagram of a process illustrating a control program or logic for detecting and/or authenticating the modular configuration of a modular surgical instrument system or assembly. FIG. 2 is a logical flow diagram of a process illustrating a control program or logic for detecting and/or authenticating the modular configuration of a modular surgical instrument system or assembly. 1 is a perspective view of a handle assembly of a modular surgical instrument system including a disposable outer housing and an inner core, in accordance with at least one aspect of the present disclosure; FIG. 16 is a graph for evaluating the proximity and alignment of the disposable outer housing and inner core of FIG. 15 in an assembled configuration; FIG. 1 is a perspective view of a surgical instrument system in accordance with at least one aspect of the present disclosure; FIG. 18 is a cross-sectional view of a portion of the handle assembly of the surgical instrument of FIG. 17; FIG. 18 is a partially exploded view of components of the surgical instrument assembly of FIG. 17; FIG. 18 is a partial cross-sectional view of components of the surgical instrument assembly of FIG. 17; FIG. FIG. 2 is a logic flow diagram of a process illustrating a control program or logic configuration for disabling the inner core of a handle assembly of a surgical instrument system in an end-of-life event. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 2 illustrates a safety mechanism for disabling a disposable outer housing of a handle assembly after use in a surgical procedure, in accordance with at least one aspect of the present disclosure; FIG. 1 is a perspective view of a surgical instrument system in accordance with at least one aspect of the present disclosure; FIG. 31 is a cross-sectional view of a portion of the handle assembly of the surgical instrument of FIG. 30; FIG. 31 is a simplified diagram of a sterility detection circuit for the handle assembly of the surgical instrument system of FIG. 30; FIG. 31 is a top view of the handle assembly of the surgical instrument system of FIG. 30, illustrating a light-emitting diode (LED) display of the handle assembly; FIG. 34 is an enlarged view of the LED display of FIG. 33. FIG. 3 is a graph illustrating sensor readings of a hydrogen peroxide sensor in accordance with at least one aspect of the present disclosure. FIG. 3 is a logical flow diagram of a process illustrating a control program or logic configuration for detecting the end of life of a reserializable component of a surgical instrument system in accordance with at least one aspect of the present disclosure. 4 illustrates a process for resterilizing a handle assembly of a surgical instrument system in accordance with at least one aspect of the present disclosure. 1 is a re-serialization system for re-sterilizing a handle assembly of a surgical instrument system in accordance with at least one aspect of the present disclosure. 39 shows the reserialization system of FIG. 38 in a closed configuration. 1 is a re-serialization system for re-sterilizing a handle assembly of a surgical instrument system in accordance with at least one aspect of the present disclosure. 1 is a primary electrical interface for use with a surgical instrument system according to at least one aspect of the present disclosure. 1 is an actuator for use with a surgical instrument system according to at least one aspect of the present disclosure. 43 illustrates the actuator of FIG. 42 in different configurations that generate different closing forces, according to at least one aspect of the present disclosure. FIG. 44 is a graph showing different closing positions of the end effector and corresponding closing forces as determined based on the different configurations of FIG. 43. FIG. 1 is a perspective view of a disposable outer housing and inner core of a handle system in accordance with at least one aspect of the present disclosure; FIG. 46 is a partial cross-sectional view of the handle assembly of FIG. 45; FIG. FIG. 3 is a perspective view of a disposable outer housing and inner core of a handle assembly in accordance with at least one aspect of the present disclosure. 48 is a partial cross-sectional view of the actuator of the handle assembly of FIG. 47; FIG. 2 is a graph of vibrations on the Y-axis as a function of time on the x-axis. FIG. 3 is an enlarged partial view of a handle assembly in accordance with at least one aspect of the present disclosure. 51 is a partial cross-sectional view of the actuator of the handle assembly of FIG. 50; FIG. FIG. 3 is an enlarged partial view of a handle assembly in accordance with at least one aspect of the present disclosure. FIG. 3 is a partially enlarged view of an actuator of a handle assembly in accordance with at least one aspect of the present disclosure. 54 is a partial cross-sectional view of the actuator of FIG. 53; FIG.

Corresponding reference characters indicate corresponding parts throughout the figures. The examples set forth herein are, as one form, illustrative of certain specific embodiments of the invention, and such illustrations should not be construed as limiting the scope of the invention in any way. isn't it.

The applicant of this application also owns the following United States patent applications filed on the same date as this application, each of which is incorporated herein by reference in its respective entirety: US Pat.
- United States patent application, title of invention "METHOD FOR TISSUE TREATMENT BY SURGICAL INSTRUMENT", attorney docket number END9291USNP1/200802-1M,
- United States patent application, title of invention "SURGICAL INSTRUMENTS WITH INTERACTIVE FEATURES TO REMEDY INCIDENTAL SLED MOVEMENTS", attorney docket number END9291USNP2/200802-2,
- U.S. patent application, title of invention "SURGICAL INSTRUMENTS WITH SLED LOCATION DETECTION AND ADJUSTMENT FEATURES", attorney docket number END9291USNP3/200802-3,
- United States patent application, title of invention "SURGICAL INSTRUMENT WITH CARTRIDGE RELEASE MECHANISMS", attorney docket number END9291USNP4/200802-4,
- U.S. patent application, title of invention "DUAL-SIDED REINFORCED RELOAD FOR SURGICAL INSTRUMENTS", attorney docket number END9291USNP5/200802-5,
- United States patent application, title of invention "SURGICAL SYSTEMS WITH DETACHABLE SHAFT RELOAD DETECTION", attorney docket number END9291USNP6/200802-6,
- U.S. patent application, title of invention “DEVICES AND METHODS OF MANAGING ENERGY DISSIPATED WITHIN STERILE BARRIERS OF SURGICAL INSTRUMENT HOUSINGS”, attorney docket number EN D9291USNP8/200802-8,
- United States patent application, title of invention "POWERED SURGICAL INSTRUMENTS WITH EXTERNAL CONNECTORS", attorney docket number END9291USNP9/200802-9,
- U.S. patent application, title of invention “POWERED SURGICAL INSTRUMENTS WITH SMART RELOAD WITH SEPARATELY ATTACHABLE EXTERIORLY MOUNTED WIRING CONNECTIONS” , agent docket number END9291USNP10/200802-10,
- United States patent application, title of the invention "POWERED SURGICAL INSTRUMENTS WITH COMMUNICATION INTERFACES THROUGH STERILE BARRIER," attorney docket number END9291USNP11/200802-11, and - U.S. patent application, title of invention “POWERED SURGICAL INSTRUMENTS WITH MULTI-PHASE TISSUE TREATMENT” , agent docket number END9291USNP12/200802-12.

The applicant of this application owns the following US patent applications filed on December 4, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
・U.S. Patent Application No. 16/209,385, title of invention "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY",
・U.S. Patent Application No. 16/209,395, title of invention "METHOD OF HUB COMMUNICATION",
・U.S. Patent Application No. 16/209,403, title of invention “METHOD OF CLOUDS BASED DATA ANALYTICS FOR USE WITH THE HUB”;
・U.S. Patent Application No. 16/209,407, title of invention "METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL";
・U.S. Patent Application No. 16/209,416, title of invention "METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS",
・U.S. Patent Application No. 16/209,423, title of invention “METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS”
・U.S. Patent Application No. 16/209,427, title of the invention: “METHOD OF USING REINFORCED FLEXIBLE CIRCUITS WITH MULTIPLE SENSORS TO OPTIMIZE PERFORMANCE OF RADI O FREQUENCY DEVICES”,
・U.S. Patent Application No. 16/209,433, title of invention: “METHOD OF SENSING PARTICULATE FROM SMOKE EVACUATED FROM A PATIENT, ADJUSTING THE PUMP SPEED BASED ON” THE SENSED INFORMATION, AND COMMUNICATION THE FUNCTIONAL PARAMETERS OF THE SYSTEM TO THE HUB"
・U.S. Patent Application No. 16/209,447, title of invention “METHOD FOR SMOKE EVACUATION FOR SURGICAL HUB”;
・U.S. Patent Application No. 16/209,453, title of invention “METHOD FOR CONTROLLING SMART ENERGY DEVICES”;
・U.S. Patent Application No. 16/209,458, title of invention “METHOD FOR SMART ENERGY DEVICE INFRASTRUCTURE”;
・U.S. Patent Application No. 16/209,465, title of invention "METHOD FOR ADAPTIVE CONTROL SCHEMES FOR SURGICAL NETWORK CONTROL AND INTERACTION",
・U.S. Patent Application No. 16/209,478, title of invention “METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE O” F ADJUSTING FUNCTION BASED ON A SENSED SITUATION OR USAGE”
・U.S. Patent Application No. 16/209,490, title of the invention “METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION,” and ・U.S. Patent Application No. 16/209,491, title of the invention “METHOD FOR CIRCULAR S TAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON SITUATIONAL AWARENESS”.

Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described herein and illustrated in the accompanying drawings. Ru. Well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described herein. The reader should understand that the embodiments described and illustrated herein are non-limiting examples, and therefore certain structural and functional details disclosed herein may be representative and exemplary. You will understand that. Variations and modifications may be made thereto without departing from the scope of the claims.

Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily appreciate that the various methods and devices disclosed herein can be used in many surgical procedures and applications, including, for example, those associated with open surgical procedures. . By continuing to read the Detailed Description herein, the reader will understand that the various instruments disclosed herein can be used, for example, through an incision made in tissue through a pre-existing opening. It will be further understood that it may be inserted into the body in any manner, such as through a vent or puncture. The working or end effector portions of these instruments can be inserted directly into the patient's body or through an access device having a working passageway through which the end effector and elongated shaft of the surgical instrument can be advanced. .

Referring to FIGS. 1-3, a surgical instrument system is provided, such as, for example, electromechanical surgical instrument system 8500. System 8500 includes a handle assembly 8520, multiple types of adapters or shaft assemblies, such as, for example, shaft assembly 8530, and multiple types of loading units or end effectors, such as, for example, end effector 8540. Handle assembly 8520 is configured to be selectively attached to any one of several shaft assemblies, e.g., shaft assembly 8530, with each unique shaft assembly 8530 being configured to attach to any one of a number of shaft assemblies, e.g., end effector 8540. The surgical loading unit or end effector is configured to be selectively connected to a number of surgical loading units or end effectors. End effector 8540 and shaft assembly 8530 are configured for actuation and manipulation by handle assembly 8520. Connecting one shaft assembly 8530, e.g., to a handle assembly 8520, and connecting one type of end effector, e.g., end effector 8540, to a selected shaft assembly 8530 causes a powered hand-held electromechanical surgical instrument to It is formed.

Various suitable loading units or end effectors for use with the surgical instrument system 8500 are discussed in U.S. Pat. , the disclosure of which is incorporated herein by reference in its entirety. Various handle assemblies for use with surgical instrument system 8500 are discussed in U.S. Pat. This disclosure is incorporated herein by reference in its entirety.

Handle assembly 8520 includes an inner core 8522 and a disposable outer housing 8524 configured to selectively receive and enclose inner core 8522 to establish a sterility barrier 8525 (FIG. 3) around inner core 8522. . Inner core 8522 is motor operable and configured to drive operation of multiple types of end effectors. The inner core 8522 is configured to operate at a plurality of sets of operating parameters (e.g., the operating speed of the inner core 8522 motor, the amount of power delivered to the shaft assembly by the inner core 8522 motor, the selection of the inner core 8522 motor to be operated, the inner end effector functions performed by core 8522). Each set of operating parameters of the inner core 8522 is designed to drive operation of a particular set of functions that are unique for each type of end effector when the end effector is coupled to the inner core 8522. . For example, inner core 8522 may vary its power output, deactivate or activate certain buttons, and/or operate different motors, depending on the type of end effector coupled to inner core 8522. It can be done.

Inner core 8522 defines an inner housing cavity therein within which a power pack 8526 is located. Power pack core assembly 8526 is configured to control various operations of inner core 8522. Power pack 8526 includes a plurality of motors operably engaged thereto. Rotation of the motor functions to drive the shaft and/or gear components of shaft assembly 8530, e.g., to drive various operations of an end effector attached to shaft assembly 8530, e.g., end effector 8540. .

The motor of power pack 8526 drives the shaft of shaft assembly 8530 to selectively effect firing, closing, and/or articulating motion in end effector 8540 when end effector 8540 is coupled to inner core 8522, for example. and/or configured to drive gear components.

In addition to the above, disposable outer housing 8524 includes two housing portions 8524a, 8524b that are releasably attached to each other to permit assembly with inner core 8522. In the illustrated example, housing portion 8524b is movably coupled to housing portion 8524a by a hinge 8525 located along a top edge of housing portion 8524b. As a result, housing portions 8524a, 8524b can be moved relative to each other between a closed, fully coupled configuration, as shown in FIG. 1, and an open, partially separated configuration, as shown in FIG. It can be pivoted against. Housing portions 8524a, 8524b, when joined, define a cavity therein within which inner core 8522 may be selectively located.

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

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

In various examples, memory unit 8564 can be non-volatile memory, such as, for example, electrically erasable programmable read-only memory. Memory unit 8564 stores discrete motions of inner core 8522 that correspond to motions of one type of end effector, e.g., end effector 8540, and/or one type of adapter assembly, e.g., shaft assembly 8530. Parameters may be stored therein. The operating parameters stored in memory 8564 include the operating speed of the motor in inner core 8522, the amount of power delivered by the motor during operation of the motor in inner core 8522, which of the motors in inner core 8522 the type of end effector function performed by the inner core 8522, and the like.

Still referring to FIGS. 1-3, surgical instrument system 8500 includes an electrical interface assembly 8570 configured to transmit at least one of data signals and power between inner core 8522 and end effector 8540. include. In the illustrated example, electrical interface assembly 8570 includes a first interface portion 8580 on a first side 8525a of sterility barrier 8525 and a first interface portion 8580 on a second side 8525b of sterility barrier 8525 opposite the first side. 2 interface portion 8590. In various aspects, first interface portion 8580 is configured to form a wireless electrical interface with second interface portion 8590. A wireless electrical interface facilitates wireless transmission of data signals and/or power between inner core 8522 and second interface portion 8590.

Further, electrical interface assembly 8570 includes externally mounted wiring connections 8600. In the illustrated example, the externally mounted wiring connection 8600 is connected to the second interface portion 8690 to facilitate wired transmission of data signals and/or power between the second interface portion 8690 and the end effector 8540. Can be separately attached to section 8590.

In various aspects, first interface portion 8580 and second interface portion 8590 are configured to cooperate to form a wireless segment of an electrical path between inner core 8522 and end effector 8540. Additionally, externally mounted wiring connections 8600 form wiring segments of the electrical path. At least one of data signals and power is transmitted between inner core 8522 and end effector 8540 through electrical paths.

Still referring to FIGS. 1-3, externally mounted wiring connection 8600 includes a wire flex circuit 8601 terminating in an attachment member 8602 releasably coupleable to a second interface portion 8590. Wire flex circuit 8601 is long enough to allow attachment member 8602 to access second interface portion 8590 from the outside.

Attachment member 8602 is magnetically coupled to second interface portion 8590. For example, attachment member 8602 includes magnetic elements 8606, 8608 disposed within housing 8604. First interface portion 8580 includes ferrous elements 8576, 8578 for magnetic attachment and proper alignment of attachment member 8602 onto outer housing 8524, as shown in FIG.

The ferrous elements 8576, 8578 are connected to the ferrous elements 8576, 8578 and the magnetic element when the inner core 8522 is properly positioned within the disposable outer housing 8523 and the attachment member 8602 is properly positioned relative to the second interface portion 8590. 8606, 8608 are disposed on the outer housing 8524 of the inner core 8522 such that they are aligned.

Alternatively, in certain examples, the magnetic element can be disposed on the outer housing 8523 of the inner core 8522 and the ferrous element can be disposed on the housing 8604 of the attachment member 8602. Alternatively, corresponding magnetic elements can be disposed on both housings 8604, 8523 in certain examples.

In addition to the above, another externally mounted wiring connection 8611 connects shaft assembly 8530 to second interface portion 8590. Externally mounted wiring connection 8611 is similar to externally mounted wiring connection 8600 in many respects. For example, externally mounted wiring connection 8611 also includes a wire flex circuit 8612 that terminates in an attachment member 8613 similar to attachment member 8602 of externally mounted wiring connection 8600. Attachment member 8613 is also magnetically coupled to handle assembly 8520 for externally transmitting data and/or power between shaft assembly 8530 and inner core 8522.

In addition to the above, electrical interface assembly 8570 utilizes guide elements 8603, 8583 that are positionable on either side of sterility barrier 8525. In the illustrated example, inductive elements 8603, 8583 are in the form of wire-wound coils that are components of inductive circuits 8605, 8585, respectively. The wire coils of the inductive elements 8603, 8583 include copper or copper alloy wire. However, the wire coil may include any suitable electrically conductive material, such as aluminum, for example. The wire coil can be wrapped around the central axis any suitable number of times.

As shown in FIG. 3, once proper magnetic attachment is established by elements 8608, 8606, 8576, 8578, the wire coils of inductive elements 8603, 8583 are properly aligned about the central axis extending therethrough. be done. Proper alignment of the wire coils of the inductive elements 8603, 8583 improves wireless transmission of data and/or power through the wire coils.

In various examples, inductive circuit 8585 is electrically coupled to power pack 8526 and control circuit 8560. In the illustrated example, inductive circuit 8605 is electrically coupled to transponder 8541 within end effector 8540. Inductive element 8603 is inductively coupled to inductive element 8583 for transmitting signals to and receiving signals from transponder 8541. Transponder 8541 may use a portion of the power of the guidance signal received from guidance element 8603 to passively power transponder 8541. When fully powered by the inductive signal, the transponder 8541 can send and receive data to and from the control circuit 8560 in the handle assembly via the inductive coupling between the inductive circuits 8605, 8585.

In various examples, as shown in FIG. 1, transponder 8541 is located within shaft portion 8542 of end effector 8540. In other examples, transponder 8541 may be disposed within the jaws of end effector 8540. In the illustrated example, end effector 8540 includes staple cartridge 8543. In certain instances, transponder 8541 may be located within staple cartridge 8543. Internal wiring within shaft portion 8542 connects externally mounted wiring connection 8600 to transponder 8541. In the illustrated example, externally mounted wiring connection 8600 includes a mounting member 8609 configured to connect wire flex circuit 8601 to shaft portion 8542. In certain instances, attachment member 8609 is permanently connected to shaft portion 8542. In other cases, attachment member 8609 is releasably coupled to shaft portion 8542.

To transmit the signal to the transponder 8541, the control unit 8560 may include an encoder for encoding the signal and a modulator for modulating the signal according to a modulation plan. Control unit 8560 may communicate with transponder 8541 using any suitable wireless communication protocol and any suitable frequency (eg, ISM frequency band).

In various examples, the control circuit 8560 may determine whether the attached staple cartridge and/or end effector is connected to the surgical instrument system through a query identification device (e.g., radio frequency identification device (RFID)) or cryptographic identification device. 8500 can be determined. Identification chips and/or interrogation cycles can be utilized to assess suitability of installed staple cartridges and/or end effectors. Various identification techniques are presented in a paper entitled ELECTRICALLY SELF-POWERED SURGICAL INSTRUMENT WITH CRYPTOGRAPHIC IDENTIFICATION OF INTERCHANGEABLE PART, January 1, 2014. It is described in U.S. Patent No. 8,672,995, issued on the 4th, which , incorporated herein by reference in its entirety.

FIG. 4 illustrates a control program or program that electrically connects an inner core 8522 of a surgical instrument system (e.g., surgical instrument system 8500) with a staple cartridge (e.g., staple cartridge 8543) or an end effector (e.g., end effector 8540). 8610 is a logical flow diagram of process 8610 showing the logical configuration. Process 8610 includes detecting 8612 a compatible connection between end effector 8540 and inner core 8522, and more specifically control circuitry 8560, through electrical interface assembly 8570. Process 8610 further includes adjusting 8614 signal parameters of signals passing through electrical interface assembly 8570 to improve at least one of data and power throughput between end effector 8540 and inner core 8522. include.

In the illustrated example, process 8610 is implemented by control circuit 8560. Memory unit 8564 may store program instructions that, when executed by processor 8562, may 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. The connection circuit can be incorporated into the disposable outer housing 8524 of the handle assembly 8520, for example.

In various aspects, end effector 8540 includes a memory unit that stores an identification code. Control circuit 8560 can evaluate whether a compatible connection exists between end effector 8540 and inner core 8522 based on the identification code retrieved from the memory unit through electrical interface assembly 8570.

In various aspects, electrical interface assembly 8570 includes one or more sensors configured to detect, measure, and/or monitor aspects of signals transmitted through electrical interface assembly 8570. Control circuitry 8560 further adjusts one or more aspects of the signal, such as signal strength, frequency, and/or bandwidth, and/or adjusts the power level, via electrical interface assembly 8570. The throughput of data and/or power between the end effector 8540 and the inner core 8522 can be optimized. In various aspects, the control circuit 8560 is configured to operate the surgical instrument system 8500 in an environment where one or more components or connections of the electrical interface assembly 8570 are shorted and/or the signal is lost. It is possible to determine whether the In response, control circuit 8560 can adjust signal frequency, signal strength, and/or signal repetition to improve data or power throughput. In at least one example, control circuit 8560 may respond by turning off one or more connections to improve other connections of electrical interface assembly 8570.

Referring primarily to FIGS. 5 and 6, control circuit 8560 may set one or more operating parameters of surgical instrument system 8500 based on an identifier received through electrical interface assembly 8570. FIG. 5 shows several control schemes (e.g., 8621, 8622, 8623, 8624, 8625) that can be stored in memory unit 8564 and selected by processor 8562 based on an identifier received through electrical interface assembly 8570. , 8626, 8627) is shown. Graph 8620 includes an x-axis representing drive member travel distance in millimeters (mm) and a y-axis representing drive member speed in millimeters per second (mm/sec).

The drive member is moved by the motor in the inner core 8522 to effect the closing and/or firing motion of the end effector 8540. In at least one example, the drive member is moved by the mortar to advance the I-beam assembly along a predetermined firing path to deploy staples from staple cartridge 8543 into tissue, and optionally, a firing stroke. A cutting member is advanced to cut the stapled tissue at. In such an example, 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.

The example control schemes (8621, 8622, 8623, 8624, 8625, 8626, 8627) represented in graph 8620 may be stored in memory unit 8564 in any suitable form, such as, for example, tables and/or equations. obtain. In various aspects, the control schemes (8621, 8622, 8623, 8624, 8625, 8626, 8627) have different Represents staple cartridges of type and size (e.g. 45mm, 60mm). For example, control scheme 8621 is intended for use with cartridge types suitable for treating thin tissue, and thus allows relatively high speeds of movement of the drive member, thereby providing higher inertia. necessitates faster deceleration before the end of the firing stroke. In contrast, control scheme 8627 is intended for use with cartridge types suitable for treating thick tissue, and thus allows for slower speeds of movement of the drive member than control scheme 8621. Therefore, control strategy 8627 provides lower inertia than control strategy 8621, which requires deceleration at a later time before the firing stroke ends compared to control strategy 8621.

FIG. 6 shows another graph 8720 representing additional control schemes (8721, 8722, 8723, 8724). Graph 8720 shows drive member speed on the x-axis and motor current (i) on the y-axis for different cartridge types suitable for different tissue types/thicknesses. The current draw of the inner core 8522 motor to achieve a particular speed of the drive member varies depending on the cartridge type. Accordingly, the control circuit 8560 uses the control scheme based on the identifier received through the electrical interface assembly 8570 to ensure sufficient current draw by the motor to achieve the desired speed determined by the selected control scheme. Select one of (8721, 8722, 8723, 8724).

Referring now to FIG. 7, surgical instrument system 8800 is similar to surgical instrument system 8500 in many respects. For example, surgical instrument system 8800 also includes a handle assembly 8820 that includes an inner core 8822 having a motor assembly for moving a drive member configured to perform a closing motion and/or a firing motion in end effector 8540. Inner core 8822 further includes an internal power pack 8826 that provides power to motor assembly and control circuitry 8860. In various aspects, power pack 8826 includes one or more batteries, and these batteries may be rechargeable. In certain aspects, power pack 8826 can be releasably coupled to inner core 8822.

Similar to control circuit 8560, control circuit 8860 includes a memory unit that stores program instructions. The program instructions, when executed by the processor, cause the processor to control a motor assembly, a feedback system, and/or one or more sensors. In various examples, the feedback system can be used by control circuitry 8860 to perform predetermined functions, such as, for example, issuing an alert when one or more predetermined conditions are met. In certain cases, the feedback system may include one or more visual feedback systems, such as a display screen, a backlight, and/or LEDs. In certain cases, the feedback system may include one or more audio feedback systems, such as speakers and/or buzzers. In certain cases, the feedback system may include, for example, one or more haptic feedback systems. In certain cases, the feedback system may include a combination of visual, audio, and/or tactile feedback systems, for example.

Still referring to FIG. 7, a wireless power transfer system 8850 is utilized to wirelessly transfer power across a sterility barrier formed by a disposable outer housing 8824 disposed around an inner core 8822. Disposable outer housing 8824 is similar to disposable outer housing 8524 in many respects. For example, disposable outer housing 8824 can include two housing portions that are removably connectable to each other to enable insertion of inner core 8822 within disposable outer housing 8824. Inner core 8822 is sealed within disposable outer housing 8824, thereby creating a sterile barrier around inner core 8822.

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

An internal power transfer unit 8852 is disposed within the disposable outer housing 8824 and is hardwired to a power pack 8826. In one example, internal power transfer unit 8852 is mounted to an interior wall of disposable outer housing 8824 and releasably connected to power pack 8826. Once the inner core 8822 is properly positioned within the disposable outer housing 8824, its outer connector is matingly engaged with the corresponding connector of the inner power transfer unit 8852. When the connectors are engaged, power pack 8826 and internal power transfer unit 8852 are electrically connected. However, in other examples, the inner core 8822 may include external wiring that can be manually connected to the internal power transfer unit 8852.

In other examples, internal power transfer unit 8852 is incorporated into inner core 8822. In such an example, the internal power transfer unit 8852 may properly operate the internal power transfer unit 8852 to the external disposable energy receiver/converter 8854 when the inner core 8822 is ultimately placed within the disposable outer housing 8824. The inner core 8822 is disposed proximate the outer housing for possible alignment.

In addition to the above, internal power transfer unit 8852 includes a magnetic bearing 8856. Control circuit 8860 causes the current to drive rotation of magnetic bearing 8856. The mechanical energy is magnetically transferred across the sterilization barrier to an external disposable energy receiver/transducer 8854 and converted back to electrical energy via a linear alternator 8857. External disposable energy receiver/transducer 8854 includes a magnetic bearing 8856 configured to rotate with rotation of magnetic bearing 8858. In operation, magnetic bearing 8858 is synchronized to the rotation of magnetic bearing 8856, which generates mechanical work in external outer power transfer unit 8854. The mechanical work generated is utilized and converted into electrical energy via linear alternator 8857 and then available for use by, for example, end effector 8540. In various aspects, gear assembly 8859 is utilized to transfer mechanical energy from magnetic bearing 8858 to linear alternator 8857.

In various instances, power transfer across the sterility barrier may be accomplished via a direct conductive connection between the interior and exterior environments. Certain areas of the outer disposable housing may be overmolded onto metal strips that extend the thickness of the sterility barrier when installed. The overmolding allows for a tight seal to eliminate the possibility of contaminants passing through, and once the outer housing is transitioned to the closed configuration to form a sterile barrier, the metal strip ensures that energy is transferred directly to the outside environment. Acts as a conductive bridge that enables

Referring now to FIGS. 8-9, surgical instrument system 8900 is similar to surgical instrument systems 8500, 8800 in many respects. For example, surgical instrument system 8900 also includes a handle assembly 8920 that includes an inner core 8922 having a motor assembly for moving a drive member configured to perform a closing motion and/or a firing motion in end effector 8940.

Additionally, surgical instrument system 8900 includes a shaft 8930 having a nozzle portion 8930a and a shaft portion 8930b extending distally from nozzle portion 8930a. Nozzle portion 8930a allows rotation of end effector 8940 relative to handle assembly 8920. Flex circuit 8934 is configured to transmit power through nozzle portion 8930a to end effector 8940. Flex circuit 8934 includes a proximal flex circuit segment 8934a disposed on handle assembly 8920 and a distal flex circuit segment 8934c disposed on shaft portion 8930b and end effector 8940.

In addition, flex circuit 8934 includes a conductive metal segment 8934b frictionally connected to proximal flex circuit segment 8934a and fixedly connected to distal flex circuit segment 8934c. Conductive metal segment 8934b facilitates rotation of shaft 8930 and end effector 8940 relative to handle assembly 8920 while maintaining electrical connection between handle assembly 8920 and end effector 8940. In the illustrated example, conductive metal segment 8934b includes a conductive ring 8935 frictionally attached to proximal flex circuit segment 8934a.

In addition to the above, flex circuit 8934 is configured to transfer power from external power source 8926 to end effector 8940. An external power source 8926 is disposed on the disposable outer housing 8924. The connection between external power source 8926 and flex circuit 8934 may be protected from the ambient environment, for example, by being partially or fully embedded within disposable outer housing 8924. In the illustrated example, external power source 8926 includes a connection port 8927 configured to receive the proximal end of proximal flex circuit segment 8934a.

Additionally, the inner core 8922 can include an internal power pack that powers the motor assembly and control circuitry. In various aspects, the power pack is electrically coupled to the flex circuit 8934 and/or the external power source 8926 by an electrical interface assembly 8570 in a manner similar to that described in connection with the surgical instrument system 8500. In one particular example, external power supply 8926 is completely replaced by an internal power pack of inner core 8922. In such an example, power is transferred from the internal power pack through the sterilization barrier to the flex circuit 8934 via the electrical interface assembly 8570.

In addition to the above, flex circuit 8934 may also include an end effector segment 8934d configured to connect distal flex circuit segment 8934c to staple cartridge 8944 releasably coupled to end effector 8940. End effector segment 893Od includes sufficient slack to prevent overextension of end effector segment 893Od that may be caused by movement of the end effector.

Referring now to FIG. 10, surgical instrument system 9000 is similar to surgical instrument system 8500 in many respects. For example, the surgical instrument system 9000 also includes a handle that includes an inner core 9022 having a motor assembly for moving a drive member configured to perform a closing motion and/or a firing motion in an end effector (e.g., end effector 8540). Includes assembly 9020. Disposable outer housing 9024 defines a sterility barrier 9025 around inner core 9022.

Handle assembly 9020 is an electrical interface assembly configured to transmit at least one of data signals and power between inner core 8922 and end effector 8540 through a sterile barrier 9025 defined by disposable outer housing 9024 9070. Electrical interface assembly 9070 includes an internal piezoelectric transducer 9071 that is coupled to an internal power pack 9026 that is configured to energize internal piezoelectric transducer 9071. Electrical interface assembly 9070 further includes a lens coupled to internal piezoelectric transducer 9071 and configured to focus ultrasound energy generated by internal piezoelectric transducer 9071 through gel-like membrane 9072 onto external piezoelectric transducer 9073 . Accordingly, electrical energy provided by power pack 9026 is converted to ultrasound energy that is transmitted across sterilization barrier 9025 and received by external piezoelectric transducer 9073. The ultrasound energy is then converted to electrical energy by an external piezoelectric transducer 9073. In certain cases, the flex circuit further transmits electrical energy to the end effector, for example.

FIG. 11 depicts a modular surgical instrument system 9100 that is similar in many respects to surgical instrument system 8500. For example, modular surgical instrument system 9100 also includes a handle assembly 9120, a shaft 9130, and a loading unit 9140 that includes a proximal shaft portion 9140a and an end effector 9140b. Loading unit 9140 is releasably connectable to distal shaft portion 9130b of shaft 9130. A nozzle portion 9130a of shaft 9130 is also releasably connectable to handle assembly 9120. Staple cartridge 9144 is releasably connectable to end effector 9140b. In other cases, the staple cartridge is integrated with end effector 9140b.

Similar to handle assembly 8520, 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 sterility barrier 9125 around the inner core 9122. including. Inner core 9122 is motor operable and configured to drive operation of multiple types of end effectors. The inner core 9122 is configured to operate at a plurality of sets of operating parameters (e.g., the operating speed of the inner core 9122 motor, the amount of power delivered to the shaft assembly by the inner core 9122 motor, the selection of the inner core 9122 motor to be operated, the inner (such as the end effector functions performed by the core 9122). Each set of operating parameters of the inner core 9122 is designed to drive operation of a particular set of functions that are unique for each type of end effector when the end effector is coupled to the inner core 9122. . For example, the inner core 9122 may vary its power output, deactivate or activate certain buttons, and/or operate its different motors depending on the type of end effector coupled to the inner core 9122. It can be done.

Inner core 9122 defines an inner housing cavity that houses a power pack and one or more motors powered by the power pack. Rotation of the motor functions, for example, to drive gear components of the shaft and/or shaft 9130 to drive various operations of an end effector attached thereto, such as end effector 9140.

In addition to the above, outer housing 9124 includes two housing portions 9124a, 9124b that are releasably attached to each other to permit assembly with inner core 9122. In the illustrated example, housing portion 9124b is movably coupled to housing portion 9124a by a hinge located along an upper edge of housing portion 9124b. As a result, housing portions 9124a, 9124b are pivotable relative to each other between a closed, fully coupled configuration, as shown in FIG. 11, and an open, partially separated configuration. . Housing portions 9124a, 9124b, when joined, define a cavity therein within which inner core 9122 may be selectively located.

Like control circuit 8560, control circuit 9160 includes a memory unit that stores program instructions. The program instructions, when executed by the processor, cause the processor to control, for example, a motor assembly, a feedback system, and/or one or more sensors. In various examples, the feedback system may be used by control circuitry 9160 to perform predetermined functions, such as, for example, issuing an alert when one or more predetermined conditions are met. In certain cases, the feedback system may include one or more visual feedback systems, such as a display screen, a backlight, and/or LEDs. In certain cases, the feedback system may include one or more audio feedback systems, such as speakers and/or buzzers. In certain cases, the feedback system may include, for example, one or more haptic feedback systems. In certain cases, the feedback system may include a combination of visual, audio, and/or tactile feedback systems, for example.

In various aspects, one or more sensors can be configured to detect or measure whether disposable outer housing 9124 is in an open or closed configuration. In the illustrated example, Hall effect sensors 9123 detect transitions of housing portions 9124a, 9124b to closed or open configurations. Control circuit 9160 may receive an input signal indicating whether disposable outer housing 9124 is in an open or closed configuration. In certain examples, other suitable sensors, such as, for example, other magnetic sensors, pressure sensors, inductive sensors, and/or optical sensors, may be used to detect the closed and/or open configurations. .

Still referring to FIG. 11, the modular surgical instrument system 9100 transmits at least one of a data signal and power across the sterile barrier 9125, external to the sterile barrier 9125, and/or within the sterile barrier 9125. and an electrical interface assembly 9170 configured to. At least one of data signals and power is transmitted between one or more of the modular components of modular surgical instrument system 9100. In the illustrated example, the electrical interface assembly 9170 includes a first interface portion 9180 on a first side of the sterility barrier 9125 (internal to the disposable outer housing 9124) and a first interface portion 9180 on the opposite side of the sterility barrier 9125. a second interface portion 9190 on a second side (outside of the disposable outer housing 9124).

Additionally, electrical interface assembly 9170 includes externally mounted wiring connections 9101, 9102, 9103 that electrically couple second interface portion 9190 to loading unit 9140, loading unit-shaft connection sensor 9141, and nozzle portion 9130a, respectively. a wiring assembly 9171 that includes corresponding internally mounted wiring connections 9101 ′, 9102 ′, 9103 ′ coupling interface portion 9180 of 1 to control circuit 9160 . Wiring connections 9101, 9102, 9103, 9101', 9102', 9103' cooperate with interface portions 9180, 9190 to connect control circuitry 9160, loading unit 9140, and staples, as discussed in more detail below. Signals are transmitted between cartridge 9144, loading unit-shaft connection sensor 9141, and nozzle portion 9130a. In one particular case, a buttress is attached to staple cartridge 9144. In such an example, the wiring connections 9101, 9101' are between the control circuit 9160 and a buttress mounted sensor configured to detect a buttress unique identifier, for example, as discussed in more detail below. can facilitate the transmission of signals.

In addition, wiring assembly 9171 is configured to electrically couple control circuit 9160 to handle assembly-shaft connection sensor 9131, first housing portion 9124a, second housing portion, and inner core-handle assembly connection sensor 9121. Further includes configured internal mounting wiring connections 9104, 9105, 9106, 9107. In at least one example, one or more of the wiring connections of wiring assembly 9161 are connectors releasably coupleable to corresponding connector ends of corresponding modular components of modular surgical instrument system 9100. with an end.

In certain examples, handle assembly 9120 may include an electrical interface assembly that facilitates wired connections through sterility barrier 9125. The wire portion may be passed through a 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.

Referring to FIG. 12, various possible modular components of modular surgical instrument system 9100 are listed with a unique identifier resistance for each of the listed modular components. The listed modular components may facilitate surgical stapling, surgical ultrasound energy therapy, surgical radio-frequency (RF) energy therapy, and various combinations thereof.

Modular components include different types of inner cores, handle assemblies, shafts, loading units, staple cartridges having different types and sizes, and/or buttress attachments having different shapes and sizes, allowing these components to be used in a variety of ways. They can be assembled in combination to form a modular surgical instrument system 9100. Since each module component includes a unique identifier resistance, the total sensed resistance can be determined to identify the connected module configuration based on that module component's unique identifier resistance.

In certain aspects, the control circuit 9160 may compare an expected value of total sensed resistance to a measured value of total sensed resistance to verify or confirm the identity of the module component within the module configuration. can. In at least one example, control circuit 9160 may receive user input identifying components of a module configuration, eg, through a user interface. Additionally or alternatively, the control circuit 9160 may directly compare the expected value of the identifier resistance to a corresponding measured value of the identifier resistance to verify or confirm the identity of the module component within the module configuration, for example. I can do it.

In other aspects, the control circuit 9160 compares an expected value of total sensed resistance to a measured value of total sensed resistance to evaluate or detect irregularities in connected module components of the module configuration. be able to. Additionally or alternatively, the control circuit 9160 can compare expected values to measured values for each of the module components to assess or detect irregularities in connected module components of the module configuration. .

In the illustrated example, graph 9161 shows expected identifier resistance values and measured or detected identifier resistance values. Based on the comparison of the expected resistance identifier values and the measured or detected resistance identifier values, the control circuit 9160 determines the unique identifier resistances R _1a , R _2a , R _3d , R _4c , R _5b , It is determined that the inner core, disposable outer housing, shaft, end effector, cartridge, and buttress, each having an R _6c , are connected in a modular configuration.

In the illustrated example, lines 9163, 9164 indicate a scenario where the outer housing and buttress are not connected or genuine, respectively. Additionally, lines 9165, 9166 illustrate a scenario where the outer housing and buttress are connected, respectively, but are not genuine. In such complex configurations, checking the authenticity of module components ensures that the module configuration functions properly.

A deviation between the expected resistance identifier value and the measured or detected resistance identifier value may indicate an unconnected status, non-authentic status, or other irregularity. The amount of deviation determines whether the control circuit 9160 determines an unconnected status, an inauthentic status, or a connected authentic status. In certain examples, the control circuit 9160 calculates an amount of deviation and compares the calculated amount of deviation to a predetermined threshold to determine whether the deviation represents an unconnected status, an inauthentic status, or an authentic/authentic status. It can be evaluated whether it represents the connection status.

In certain examples, a range of greater than 0% to about 10%, a range of greater than 0% to about 20%, a range of greater than 0% to about 30%, a range of greater than 0% to about 40%, or a deviation magnitude selected from a range of greater than 0% to about 50% indicates an inauthentic status. In certain examples, the deviation indicative of an inauthentic status is smaller than the deviation indicative of an unconnected status.

FIG. 13 is a logic flow diagram of a process 9150 illustrating a control program or logic for detecting and/or authenticating the modular configuration of a modular surgical instrument system or assembly. One or more aspects of process 9150 may be performed by a control circuit, such as control circuit 9160 of modular surgical instrument system 9100, for example. In various aspects, the process 9150 includes generating 9152 an interrogation signal to detect or verify the identity of a modular component of the assembled modular configuration of the modular surgical instrument system 9100. If the identity of the module component is verified, the identity may be provided through a user interface coupled to control circuitry 9160, for example.

In any event, the interrogation signal may be transmitted to the modular components of the modular configuration through wiring assembly 9171 and/or electrical interface assembly 9170. The interrogation signal can trigger response signals from modular components of the modular configuration. The response signal can be detected 9153 and utilized by the control circuit 9160 to detect 9154 or confirm the identity of the module component within the module configuration.

As described in more detail above, each of the modular components available for use with modular surgical instrument system 9100 includes an identifier resistance that is unique to the modular component. Accordingly, the control circuit 9160 can utilize the response signals to calculate the identifier resistances of the modular components of the module configuration. The identity of the module component of the module configuration can then be detected 9154 or verified based on the calculated identifier resistance. Verification of the identity of the modular component of the modular configuration may be accomplished by the control circuit 9160 by comparing the identity entered through the user interface with the identity detected based on the response signal.

In certain aspects, control circuitry 9160 directs electrical current through wiring assembly 9171 and electrical interface assembly 9170 to modular components of the modular configuration. The return current can then be sampled to calculate the total sensed resistance of the module configuration. Because each individual module component has a unique identifier resistance, the control circuit 9160 can determine the identity of the individual module component based on the sensed total resistance of the module configuration.

In certain aspects, the control circuit 9160 compares an expected value of total sensed resistance to a determined value of total sensed resistance to confirm proper assembly of the module configuration. In at least one form, the expected value is stored in a memory unit that is accessed by control circuit 9160 to perform the comparison.

Depending on the deviation between the decision point and the expected value having a magnitude equal to or at least substantially equal to the resistance identifier of one or more module components, control circuit 9160 may cause one or more We conclude that the module components of are not connected in the module configuration. In response, control circuit 9160 may assign an unconnected status. Control circuit 9160 may also issue alerts 9151 regarding one or more module components through the user interface. Control circuit 9160 may further provide instructions regarding how to properly connect module components that are deemed unconnected.

In certain instances, the process 9150 can further include evaluating 9155 the authenticity of the module configuration based on the response signal. In at least one example, the control circuit 9160 evaluates the authenticity of the module configuration based on a comparison of the expected value and the determined value of the unique identifier resistance of the module component. Control circuit 9160 compares the magnitude of the detected deviation between the expected and determined values of the unique identifier resistance to a predetermined threshold to assess the authenticity of the detected module component within the module configuration. (9155).

In at least one example, the predetermined threshold is a threshold range. If the magnitude of the detected deviation exceeds a predetermined threshold, the control circuit 9160 may, for example, assign an inauthentic status to the module component, issue a warning through a user interface, and/or cause the surgical instrument system 9100 to A suitable security response 9156 may be selected, such as temporarily deactivating. In various aspects, the threshold range is, for example, about ±1%, about ±2%, about ±3%, about ±4%, about ±5%, about ±10%, or about ±20% from the expected value. be. Other ranges are contemplated by this disclosure.

FIG. 14 is a logic flow diagram of a process 9110 illustrating a control program or logic for detecting and/or authenticating the modular configuration of a modular surgical instrument system or assembly. One or more aspects of process 9110 may be performed by a control circuit, such as control circuit 9160 of modular surgical instrument system 9100, for example. In various aspects, process 9110 includes detecting 9111 an identification signal of an assembled modular configuration of modular surgical instrument system 9100. In one particular example, the identification signal is a combined response signal transmitted by modular components of the modular configuration in response to an interrogation signal generated by control circuitry 9160.

Further, the control circuit 9160 can evaluate the authenticity of the modular components of the modular configuration. If an identification signal is detected 9112, the control circuit 9160 measures 9113 a characteristic of the module configuration, determines 9114 an authentication key based on the at least one measurement of the characteristic, and authenticates the identification signal based on the authentication key. 9115. If control circuitry 9160 determines 9116 that the module configuration is not authentic, control circuitry 9160 may further generate a security response as described in connection with process 9150.

In various aspects, control circuitry 9160 is configured to determine the authentication key independent of the identification signal. The authentication key may be based on common characteristics between individual module components of the module configuration. In at least one example, the common characteristic may be an environmental characteristic. In certain examples, the common characteristic may be location, radio frequency (RF) strength, sound level, light level, and/or magnetic field strength.

In various aspects, a modular component of a modular configuration measures a common characteristic and generates an authentication key based on the at least one measurement of the common characteristic. The module component can further encode an identification signal based on the generated authentication key and transmit the encoded identification signal to control circuitry 9160 through wiring assembly 9171 and/or electrical interface assembly 9170. Control circuit 9160 can independently measure the common characteristic and determine an authentication key based on the at least one measurement of the common characteristic. Control circuit 9160 can further utilize the authentication key to authenticate and/or decode identification signals received from module components.

In certain examples, handle assembly 9120 generates a magnetic field having a strength that is measurable by each of the modular components within the modular configuration. The modular components can utilize the measured magnetic field strength to encode identification signals that are transmitted to control circuitry 9160 through wiring assembly 9171 and/or electrical interface assembly 9170. Additionally, control circuit 9160 separately determines the strength of the magnetic field. In certain instances, control circuit 9160 sets the strength of the magnetic field. In other cases, the control circuit 9160 measures the intensity as well as the module components.

Control circuit 9160 decodes the encoded identification signal based on an authentication key generated from one or more measurements of magnetic field strength. Measurement of the magnetic field can be accomplished by one or more sensors, such as magnetometers, for example. In other cases, the common characteristic is radio frequency (RF) intensity, sound level, or light level, and the control circuit 9160 measures the common characteristic using an RF intensity sensor, an auditory sensor, or a photoelectric sensor, respectively. do.

FIG. 15 shows a handle assembly 9220 of a modular surgical instrument 9200 that is similar in many respects to modular surgical instruments 8500, 9100, and which are described herein as For the sake of brevity, the same level of detail will not be repeated. For example, handle assembly 9220 includes an inner core 9222 and a disposable outer housing 9224 configured to selectively receive and enclose inner core 9222 to establish a sterility barrier 9225 around inner core 9222. Inner core 9222 is motor operable and configured to drive operation of multiple types of end effectors. The inner core 9222 is configured to operate at a plurality of sets of operating parameters (e.g., the operating speed of the inner core 9222 motor, the amount of power delivered to the shaft assembly by the inner core 9222 motor, the selection of the inner core 9222 motor to be operated, the inner end effector functions performed by core 9222). Each set of operating parameters of the inner core 9222 is designed to drive actuation of a particular set of functions that are unique for each type of end effector when the end effector is operably coupled to the inner core 9222. be done. For example, the inner core 9222 may vary its power output, deactivate or activate certain buttons thereof, and/or cause its different The motor may be activated.

In addition to the above, outer housing 9224 includes two housing portions 9224a, 9224b that are releasably attached to each other to permit assembly with inner core 9222. In the illustrated example, housing portions 9224a, 9224b are movable relative to each other between a closed, fully coupled configuration and an open, partially separated or fully separated configuration. It is. Housing portions 9224a, 9224b, when joined, define a cavity therein within which inner core 9222 may be selectively located.

Further, the handle assembly 9220 is a primary interface assembly 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. Contains 9270. Primary interface assembly 9270 includes a first interface portion 9270a disposed on inner core 9222 and a second interface portion 9270b disposed on the inner wall of disposable outer housing 9224. Interface portions 9270a, 9270b include corresponding electrical contacts that are or form electrical connections when inner core 9222 is properly assembled with disposable outer housing 9224. In various aspects, primary interface assembly 9270 facilitates electrical connection between power pack 9226 of inner core 9222 and an external charging system. Primary interface assembly 9270 also facilitates detection of the modular configuration of modular surgical instrument system 9200 by transmitting power and/or data through primary interface assembly 9270 between inner core 9222 and the modular configuration. Make it. In at least one example, the electrical contacts include spring contacts, such as leaf spring contacts.

In various aspects, handle assembly 9220 includes a secondary interface 9262 that includes one or more sensors 9261 configured to detect the presence of inner core 9222 within disposable outer housing 9224. Control circuit 9260 is configured to verify the primary connection through primary interface assembly 9270 based on at least one reading of sensor 9261. The position and/or sensitivity of sensor 9261 is such that it detects inner core 9222 when it is aligned in the correct position within the disposable outer housing to establish a wired connection between interface portions 9270a, 9270b. Can be set to . In certain instances, the reading from sensor 9261 must be greater than or equal to a predetermined threshold in order for control circuit 9260 to detect that inner core 9222 is correctly inserted within disposable outer housing 9224. Control circuit 9260 may continuously compare sensor 9261 readings to a predetermined threshold to determine whether inner core 9222 is correctly inserted within disposable outer housing 9224.

In various aspects, sensor 9261 is a proximity sensor, such as, for example, a magnetic sensor such as a Hall effect sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor. including. In certain examples, the control circuit 9260 connects the inner core through the secondary interface 9262 based on a unique identifier 9263 of the inner core 9222, such as, for example, a QR code, a resistance identifier, a voltage identifier, and/or a capacitance identifier. 9222.

Still referring to FIG. 15, control circuit 9260 is further configured to detect a closed configuration of disposable outer housing 9224 of handle assembly 9220. Control circuit 9260 may detect the closed configuration based on at least one reading of at least one sensor 9264 within disposable outer housing 9224. In at least one example, sensor 9264 is a proximity sensor. In the illustrated example, sensor 9264 is a Hall effect sensor. In other cases, 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.

Additionally or alternatively, control circuit 9260 may detect a closed configuration when an input signal is received from closed configuration detection circuit 9265. The electrical contacts of the closed configuration detection circuit 9265 are disposed on the housing portions 9224a, 9224b such that the closed configuration detection circuit 9265 is a closed circuit when the disposable outer housing 9224 is in the closed configuration. Upon transition to a closed circuit, an electrical signal is transmitted to control circuit 9260, thereby causing control circuit 9260 to detect/verify the closed configuration.

Referring to FIG. 16, a graph 9280 is shown. The distance (δ) between housing portions 9224a, 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 connects the inner core 9222 and the disposable outer housing 9224 based on the distance between the housing portions 9224a, 9224b and based on the capacitance measured from the inner core 9222 to the disposable outer housing 9224. is configured to assess the proper assembly of the Alternatively, the control circuit 9260 connects the inner core 9222 and 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. Can be configured to assess proper assembly with outer housing 9224.

In various aspects, proper assembly of inner core 9222 and disposable outer housing 9224 is detected by control circuit 9260 when two conditions are met, as represented by curve 9281 of graph 9280. The first condition is that the detected distance (δ) between the first data on the first housing portion 9224a and the corresponding second data on the second housing portion 9224b is a predetermined threshold distance. The following must be met. The second condition is that the detected capacitance measured from the inner core 9222 to the disposable outer housing 9224 is within a predetermined capacitance range (μF _min −μF _max ).

In the illustrated example, curve 9281 represents a properly assembled handle assembly 9220, with an inner core 9222 properly disposed within a disposable outer housing 9224, and housing portions 9224a, 9224b properly assembled in a closed configuration. It is sealed. Conversely, curves 9282, 9283, 9284 represent an improperly assembled handle assembly 9220. Curve 9282 indicates that the closed configuration is not achieved, and curve 9283 indicates that the inner core 9222 is not properly positioned within the disposable outer housing 9224.

Capacitance can also indicate the authenticity of the inner core 9222 and/or the disposable outer housing 9224. In the illustrated example, the predetermined capacitance range (μF _min −μF _max ) also represents a capacitance-based certification range. For example, curves 9281, 9282 on graph 9280 represent an authentic inner core 9222 and/or disposable outer housing 9224, while curve 9283 on graph 9280 represents an inauthentic inner core 9222 and/or disposable outer housing 9224. show. Additionally, curve 9284 indicates that there is no capacity identifier present in inner core 9222.

17-20, surgical instrument system 9300 is similar to other surgical instrument systems described elsewhere herein, such as surgical instrument systems 8500, 9100, 9200, etc. are similar in that these surgical instrument systems will not be repeated at the same level of detail herein for the sake of brevity. For example, surgical instrument system 9300 includes a handle assembly 9320, a shaft assembly 9330, and a loading unit that includes an end effector 9340 that releasably houses a staple cartridge 9341. Handle assembly 9320 includes a disposable outer housing 9324 configured to define a sterility barrier 9325. The inner core is positionable within a 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 with respect to other similar inner cores.

In addition to the above, surgical instrument system 9300 includes an external power source 9326. In the illustrated example, external power source 9326 is disposed on the outer wall of disposable outer housing 9324. In other examples, external power source 9326 can be integrated into disposable outer housing 9324. Electrical interface assembly 9328 is configured to transmit at least one of data and power from handle assembly 9320 to end effector 9340. In the illustrated example, an electrical interface assembly 9328 extends between an external power source 9326 and a data communications band 9332 disposed within a nozzle portion 9331 of a shaft assembly 9330 and is connected to the external power source 9326 and the data communications band 9332. Includes coupled flex circuit 9327. In the illustrated example, data communications band 9332 includes an annular shape that allows rotation of nozzle portion 9331 and other portions of shaft assembly 9330 without entanglement of wires.

Additionally, shaft assembly 9330 includes concentric conductive rings 9337, 9338 that facilitate transmission of power and/or data therebetween without interfering with the representation of shaft assembly 9330. A conductive ring 9337 is disposed on the outer surface of the inner portion 9335 and a conductive ring is disposed on the inner annular surface of the outer portion 9336. In the illustrated example, inner portion 9335 is concentric with outer portion 9336.

FIG. 21 is a logic flow diagram of a process 9350 illustrating a control program or logic configuration for disabling the inner core of a handle assembly of a surgical instrument system in an end-of-life event. Using the inner core beyond its lifetime poses serious risks to the patient. Various circuits and other features of the inner core are carefully designed to ensure safe operation of the inner core during its lifetime. However, beyond a certain lifespan, the inner core may not function properly, which is often not discovered until the handle assembly is actually used in surgery.

In various aspects, process 9350 may be performed by handle assembly 9220 of surgical instrument system 9200, for example. Process 9350 detects 9351 proper assembly of inner core 9222 and disposable outer housing 9224. Control circuitry that performs one or more aspects of process 9350 can be configured to detect proper assembly based on at least one reading of at least one sensor within outer housing 9224. In at least one example, one or more aspects of process 9350 may be performed by control circuitry 9260 (FIG. 15). As discussed in more detail elsewhere herein, control circuit 9260 detects proper assembly of inner core 9222 and disposable outer housing 9224 based on, for example, readings from sensors 9261, 9264. may be configured to do so.

In any event, if proper assembly is detected (9352), the usage count for inner core 9222 is incremented by one (9353). In at least one example, control circuit 9260 communicates with a counter configured to maintain a usage count of inner core 9222. In certain instances, control circuitry 9260 is configured to store usage status, eg, in a memory unit.

Further, if the usage count equals a predetermined threshold number 9354, process 9355 further determines whether inner core 9222 has been disconnected from disposable outer housing 9224. Disconnection indicates the end of use or completion of a procedure, constituting an end-of-life event based on the usage count. When the use ends or the procedure is completed 9355, disconnection triggers a disable event 9356 of the inner core 9222 to prevent unsafe use beyond a predetermined lifetime use count. However, normal operation 9357 continues until a disconnection is detected.

Various suitable mechanisms may be used to disable inner core 9222 in an end-of-life event. In at least one example, control circuit 9260 uses a current limiter to ensure that the current in 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, thereby allowing excess current to pass through the circuitry of the inner core 9222. This disables the inner core. Disabling the inner core prevents tampering with the inner core beyond a predetermined life span that is carefully selected to ensure safe operation of the handle assembly in surgical procedures.

22-25 illustrate a safety mechanism for disabling the disposable outer housing 9424 of the handle assembly 9420 to protect against dangerous reuse of the disposable outer housing 9424 beyond its design capabilities. Handle assembly 9420 is similar in many respects to other handle assemblies described elsewhere herein, and a description of these handle assemblies will not be repeated herein for the sake of brevity. . For example, like disposable outer housing 9224, disposable outer housing 9424 is configured to selectively receive and encase inner core 9422 to establish a sterile barrier around inner core 9422.

Additionally, the outer housing 9424 can be configured in a closed, fully coupled configuration, and in an open, partially removed or fully removed configuration to accommodate insertion of the inner core 9422 therein. includes two housing portions movable relative to each other between. The housing portions, when joined, define a cavity therein within which the inner core 9222 may be selectively located.

Inner core 9422 includes a power source 9426, which can be in the form of one or more batteries. In the assembled configuration, connector wires 9427, 9428 electrically connect inner core 9422 to disposable outer housing 9424, as shown in FIG. In various aspects, as illustrated in FIG. 23, the disposable outer housing 9424 includes one or more cutting members 9437, 9438 configured to cut, or a number of connector wires 9427, 9428, thereby permanently disconnecting the circuit electrically coupling the disposable outer housing 9424 to the inner core 9422 and disabling the disposable outer housing 9424, as illustrated in FIG. become In an alternative embodiment, as shown in FIG. 25, connector wires 9447, 9448 similar to connector wires 9427, 9428 have a weekend or restraint portion 9457 that is severed when the housing portion of the disposable outer housing transitions to the open configuration. , 9458.

In one particular case, the disposable outer housing connector wire is coupled to the disposable outer housing identifier 9429. In the example illustrated in FIG. 24, connector wire 9427 is coupled to a deactivated RFID chip on connector wire 9427 that is severed by cutting member 9437 during transition of disposable outer housing 9424 to the open configuration. Disabling identifier 9429 prevents the inner core from successfully establishing a connection with a used disposable outer housing.

26-27 illustrate an additional safety mechanism for disabling the disposable outer housing 9524 of the handle assembly 9520 to protect it from hazardous reuse beyond the design capabilities of the disposable outer housing 9524. Handle assembly 9520 is similar in many respects to other handle assemblies described elsewhere herein, and a description of these handle assemblies will not be repeated herein for the sake of brevity. . For example, similar to disposable outer housing 9224, disposable outer housing 9524 is configured to selectively receive and encase inner core 9522 to establish a sterility barrier 9525 around inner core 9522.

Additionally, the outer housing 9524 can be configured in a closed and fully coupled configuration (FIG. 26), in an open and partially separated configuration, or in a fully disconnected configuration to accommodate insertion of the inner core 9522 therein. It includes two housing portions 9524a, 9524b that are movable relative to each other between separate configurations (FIG. 27). Handle assembly 9520 further includes an external power source 9526 connected via connector wire 9527 that extends through sterilization barrier 9525 to control circuitry 9560. In the illustrated example, external power source 9526 is releasably mounted on disposable outer housing 9524 housing, and connector wires 9527 are disconnected when external power source 9526 is released from disposable outer housing 9524 after completion of the surgical procedure. , thereby disabling the disposable outer housing 9524, thereby preventing its unsafe reuse. Additionally, a second wire connector 9528 extending between housing portions 9524a, 9524b can also be severed when the disposable outer handle 9524 transitions to the open configuration, preventing hazardous reuse of the disposable outer housing 9524. To prevent.

In addition to the above, in various aspects, as illustrated in FIGS. , mechanical connectors 9531 (FIG. 28), 9551 (FIG. 29) that maintain housing portions 9524a, 9524b in a closed configuration, e.g., after completion of a surgical procedure, When portions 9524a, 9524b are pulled apart, they are severed or broken and the inner core 9522 is recovered.

Referring now to FIGS. 30-34, surgical instrument system 9600 is similar to surgical instrument systems 8500, 8800 in many respects. For example, the surgical instrument system 9600 also includes an internal motor assembly having a motor assembly for moving one or more drive members configured to effect the closing, articulating, and/or firing motions of the end effector 9640. Includes a handle assembly 9620 that includes a core. Shaft assembly 9630 extends between end effector 9640 and handle assembly 9620 and transmits drive motion from the inner core to end effector 9640 to deploy staples from staple cartridge 9641.

Handle assembly 9620 includes a power source 9626, which can be in the form of one or more batteries. Sterilization-detection circuit 9660 is coupled to a power source 9626 and a receiver 9663 connected to a sensor array 9670 configured to monitor the sterilization status of handle assembly 9620. Sensor array 9670 includes a number of sensors 9671 disposed on outer surface 9623 of disposable outer housing 9624. Sensor 9671 is configured to detect the sterilization status of various portions or zones of handle assembly 9620, which is then communicated to microcontroller 9661. Microcontroller 9661 causes user interface 9662 to present sterilization status, as shown in FIG.

In the illustrated example, user interface 9662 is in the form of an LED display. A representation of handle assembly 9620 is displayed on the LED display. Each of the various portions or zones of handle assembly 9620 is indicated with one of two different visual indicators representing either an acceptable sterility status or an unacceptable sterility status. Microcontroller 9661 assigns one of the two visual indicators to each of the zones based on at least one reading of at least one of the sensors 9671 in such zone. In the illustrated example, zones 2, 5 are assigned an unacceptable sterilization status, and zones 1, 3, 4, 6 are assigned an acceptable sterilization status.

In certain instances, handle assemblies, such as handle assembly 9620, are reusable. Accordingly, handle assembly 9620 is resterilized before each use to maintain a sterile surgical field while using handle assembly 9620 in a surgical procedure. In the illustrated example, handle assembly 9620 is sterilized by exposure to hydrogen peroxide (H ₂ O ₂ ). In at least one example, a clinician can sterilize handle assembly 9620 by wiping handle assembly 9620 with a hydrogen peroxide wipe. In other examples, other means of sterilizing the handle assembly 9620 via hydrogen peroxide may be used, as described in more detail elsewhere in this disclosure.

In certain instances, the handle assembly may include a disposable outer housing and a reusable inner core. In such instances, sensors 9671 may be disposed on the outer surface of the inner core to assess the sterility status of various portions or zones of the inner core in a manner similar to that described in connection with handle assembly 9620. be able to.

If hydrogen peroxide is used, sensors 9671 of sensor array 9670 are hydrogen peroxide sensors configured to detect the presence of hydrogen peroxide within each of the zones of handle assembly 9620. Accordingly, the sensor reading of sensor 9671 can be indicative of the amount of hydrogen peroxide detected by sensor 9671 in the portion or zone of handle assembly 9620 where sensor 9671 is present. As shown in graph 9672 of FIG. 35, acceptable sterilization status corresponds to a sensor 9671 reading that is greater than or equal to a predetermined threshold 9673.

In addition to the above, FIG. 36 shows a logical flow of a process 9680 showing a control program or logic configuration for detecting the end of life of a reserializable component of a surgical instrument system, such as a handle assembly or an inner core. It is a diagram. Process 9680 detects end of life by counting the number of times the component has been resterilized.

In at least one example, process 9680 may be performed by sterility detection circuit 9660. If microcontroller 9661 detects a sensor reading greater than or equal to a predetermined threshold 9673 9681, microcontroller 9661 increments by one the count maintained by any suitable counter. When resterilization is performed with hydrogen peroxide, the sensor reading increases to a peak value and then decreases as the hydrogen peroxide begins to evaporate, as shown in FIG. 35. To avoid false counting, microcontroller 9661 is configured 9683 to ignore sensor readings for a predetermined period of time.

In certain instances, as shown in FIG. 37, a component of a surgical instrument system, such as handle assembly 9720, is coated with a coating that changes color when exposed to a sterile solution, such as hydrogen peroxide. includes an outer surface 9723. The coating provides a visual indicator of areas 9720a of handle assembly 9720 that have been sufficiently exposed to hydrogen peroxide, and areas 9720b that have not been sufficiently exposed to hydrogen peroxide. This provides the clinician with an opportunity to ensure that the sterilization solution is applied to all parts of the handle assembly 9720 in a sufficient amount to result in a properly sterilized handle assembly 9720'.

Referring now to FIGS. 38-40, a resterilization system 9800 is shown. Reserilization system 9800 includes a receiving chamber 9801 configured to receive a reusable handle assembly 9820 of a surgical instrument system. However, in other cases, resterilization system 9800 may be configured to accommodate other components of a surgical instrument system, such as, for example, an inner core handle assembly.

In the illustrated example, resterilization system 9800 includes two portions 9800a, 9800b movable between an open configuration (FIG. 38) and a closed configuration (FIG. 39) to accommodate a reusable handle assembly 9820. include. A receiving chamber 9801 is defined between portions 9800a and 9800b of resterilization system 9800. Additionally, a number of irrigation ports 9806 are defined in portion 9800b. Additionally or alternatively, an irrigation port may be defined in portion 9800a. Additionally, resterilization system 9800 includes a charging port 9804 and a corresponding connector 9805 configured to connect handle assembly 9820 to a charging system while handle assembly 9820 is within the receiving chamber.

In various embodiments, irrigation port 9802 is connected to a source of sterile solution that is delivered through irrigation port 9802 and into receiving chamber 9801. A pump can be utilized to inject sterile solution through irrigation port 9802 and remove the sterile solution in a resterilization cycle. In an alternative embodiment, as shown in FIG. 39, the resterilization system 9800' includes a receiving chamber 9811 containing an absorbent material or cloth 9812 saturated with a sterilization solution. Motor 9814 causes driver 9813 to repeatedly move cloth 9812 between starting and ending positions relative to handle assembly 9820 to resterilize the handle assembly. Alternatively, motor 9814 may cause driver 9813 to move handle assembly 9820 relative to fabric 9812 between a starting position and an ending position.

Referring now to FIGS. 15 and 41, in one particular case, primary interface assembly 9270 includes a wireless electrical interface 9230 and a wired electrical interface 9240. As shown in FIG. 41, wireless electrical interface 9230 and wired electrical interface 9240 are configured to transmit data and/or power through sterilization barrier 9225. At least one of power and data may be transmitted between inner core 9222 and an end effector and/or shaft assembly of surgical instrument system 9200. In various aspects, the first wireless interface portion 9231 and the second wireless interface portion 9232 cooperate to provide an electrical path between the inner core 9222 and the end effector and/or between the inner core 9222 and the shaft assembly. is configured to form a wireless segment of Additionally, one or more flex circuits may be configured to define one or more segments of the electrical path.

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

In addition to the above, second wireless interface portion 9232 can be magnetically coupled to first wireless interface portion 9231 when inner core 9222 is properly positioned within disposable outer housing 9224. In the illustrated example, the second wireless interface portion 9232 includes attachment elements 9233', 9234' and is therefore magnetically coupled to corresponding attachment elements 9233, 9234 of the first wireless interface portion 9231. In one particular case, the attachment elements 9233', 9234' are magnetic elements and the corresponding attachment elements 9233, 9234 are ferrous elements. In other cases, the attachment elements 9233', 9234' are ferrous elements and the corresponding attachment elements 9233, 9234 are magnetic elements. In other cases, the attachment elements 9233', 9234' and the corresponding attachment elements 9233, 9234 are magnetic elements.

The attachment elements 9233, 9234, 9233', 9234' cooperate to attach the guiding element 9235 of the first wireless interface part 9231 and the corresponding guiding element 9235' of the second wireless interface part 9232, as shown in FIG. Ensure proper alignment between the In the illustrated example, inductive elements 9235, 9235' are in the form of wire-wound coils that are components of inductive circuits 9236, 9236', respectively. The wire coils of the inductive elements 9235, 9235' include copper or copper alloy wire. However, the wire coil may include any suitable electrically conductive material, such as aluminum, for example. The wire coil can be wrapped around the central axis any suitable number of times.

As shown in FIG. 41, once proper magnetic attachment is established by elements 9233, 9234, 9233', 9234', the wire coils of inductive elements 9235, 9235' are properly aligned about the central axis extending therethrough. Aligned to . Proper alignment of the wire coils of the inductive elements 9235, 9235' improves the wireless transmission of data and/or power therethrough.

In addition to the above, wired electrical interface 9240 includes a first wired interface portion 9241 on a first side of sterility barrier 9225 and a second wired interface portion 9242 on a second side of sterility barrier 9225. include. In the example shown in FIG. 41, wired electrical interface 9240 cooperates with first wired interface portion 9241 and second wired interface portion 9242 to sterilize the environment without contaminating the sterile environment protected by sterile barrier 9225. Further includes connectors 9243, 9243' configured to facilitate wired transmission of at least one data and power through barrier 9225.

In the illustrated example, wired electrical interface 9240 defines two wired electrical paths extending through sterilization barrier 9225. However, in other examples, wired electrical interface 9240 may define more or less than two wired electrical paths.

Connector 9243, 9243' includes a body 9244, 9244' that extends through outer wall 9227 of disposable outer housing 9224. Connector 9243, 9243' further includes inner contacts 9245, 9245' that are internal to disposable outer housing 9224 and outer contacts 9246, 9246' that are external to disposable outer housing 9224. In the illustrated example, the second wired interface portion 9242 includes a flex circuit 9250, 9250' that terminates in a connector 9247, 9247' configured to form a sealed connection with an outer contact 9246, 9246'. In the illustrated example, the connectors 9247, 9247' are insulated and configured to receive and guide the outer contacts 9246, 9246' into electrical engagement with corresponding electrical contacts of the flex circuits 9250, 9250'. outer housings 9248, 9248'.

In various examples, the body 9244, 9244' fits snugly against the outer wall 9227 of the disposable outer housing 9224 to prevent or at least resist fluid contamination. In addition, the insulative outer housing 9248, 9248' includes a flush end that abuts the outer surface of the outer wall 9227 to prevent or at least resist fluid contact with the outer contacts 9246, 9246' during operation. .

Additionally, inner contacts 9245, 9245' of connectors 9243, 9243' are configured to engage leaf spring contacts 9249, 9249' when inner core 9222 is properly assembled with disposable outer housing 9224. In the illustrated example, the outer walls 9227, 9229 include portions that are flush with each other to facilitate wireless connection between the first wireless interface portion 9231 and the second wireless interface portion 9232. In addition, the outer walls 9227, 9229 also include spaced apart portions to facilitate a wired connection between the inner contacts 9245, 9245' and the leaf spring contacts 9249, 9249'. In the illustrated example, a portion of outer wall 9227 is slightly raised to form an isolated chamber 9255 between outer walls 9227, 9229. The isolated chamber 9255 has a predetermined depth that ensures good electrical contact between the inner contacts 9245, 9245' and the leaf spring contacts 9249, 9249' in the assembled configuration, as shown in FIG. have

In various aspects, one or more of the surgical instrument systems of the present disclosure include a display for providing feedback to a user, the feedback being one or more of the tissues being treated. and/or one or more parameters of the surgical instrument system. For example, the display may provide the user with information regarding the size of the staple cartridge assembled with the surgical instrument system and/or the measured thickness of the tissue being treated. In various aspects, the display can be, for example, a flexible display.

In the example shown in FIG. 41, flexible display 9201 is incorporated into a disposable outer housing 9224. Microcontroller 9202 resides below flexible display 9201. Flexible display 9201 is configured to face the exterior of disposable outer housing 9224 and microcontroller 9202 is configured to face the interior of disposable outer housing 9224. Flexible display 9201 can be connected to a suitable power source through a wireless or wired electrical interface. In at least one example, flexible display 9201 is powered by power supply 9226 in inner core 9222. In at least one example, flexible display 9201 is powered by an external power source attachable to disposable outer housing 9224.

In other examples, flexible display 9201 can be incorporated into the shaft of a surgical instrument system. In such an example, the flexible display 9201 is bent to conform, or at least substantially conform, to the cylindrical shape of the shaft. In certain cases, flexible display 9201 is incorporated into the outer wall of the shaft. However, in other cases, the flexible display 9201 is placed under or within 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 is generated by the motor assembly of the inner core 9222 when the display is located inside the disposable outer housing 9224 with the inner core 9222. Helps prevent fogging buildup on the display, which can occur due to heat.

Referring now to FIGS. 42-44, the actuator 10000 may include, for example, the handle assembly 8520 of the surgical instrument system 8500, the handle assembly 9220 of the surgical instrument system 9200, and/or the handle assembly 9120 of the surgical instrument system 9100, etc. may be incorporated into a handle assembly of a surgical instrument system. Actuator 10000 may be configured to cause inner core 8522 to generate drive movements that cause, for example, closing, firing, and/or articulating end effector 8540, and these drive movements are detected by actuator 10000. , proportional to the mechanical pressure applied by the user. In various aspects, actuator 10000 comprises a magnetostrictive transducer configured to change a magnetic field in response to the amount of applied force. FIG. 43 shows different operating configurations of actuator 10000 and the amount of strain produced from null magnetization (configuration 1) to full magnetization (configurations 1, 5). Actuator 10000 is divided into separate mechanical and magnetic attributes that are combined in their effects on magnetostrictive core strain and magnetic induction.

Still referring to FIG. 43, when no magnetic field is applied, the change in length is also zero along with the magnetic induction produced. Furthermore, the amount of magnetic field (H) is increased in configurations 1, 5 to its saturation limit (±Hsat). This increases the axial strain to a maximum value. Configurations 2, 4 represent a moderate increase in the value of magnetization, of a smaller magnitude (±H ₁ ) than configurations 1, 5. Maximum strain saturation and magnetic induction are obtained at the saturation limit (±Hsat). The magnetic flux lines associated with configurations 1 and 2 are in opposite directions to the magnetic flux lines of configurations 4 and 5. These generated magnetic flux fields are measured, for example, using the Hall effect principle, or by calculating the voltage generated in a conductor held at right angles to the generated magnetic flux. Ru. This value is proportional to the input strain or force.

Thus, for example, control circuit 8560 may, for example, based on readings of a magnetic sensor configured to measure a magnetic flux field generated by actuator 10000 in response to an actuation force applied to actuator 10000 by a user. The drive motion produced by the inner core 8522 can be adjusted. FIG. 44 is a graph 10001 illustrating changes in the closed position (Y-axis) of the jaws of end effector 8540 in response to an actuation force (X-axis) applied by, for example, a user, as detected by actuator 10000. In the illustrated example, the fully closed configuration of end effector 8540 corresponds to predetermined actuation force threshold 10002, which corresponds to configuration 5 of actuator 10000, as shown in FIG. If a predetermined actuation force threshold 10002 is detected by the control circuit 8560 based on the magnetic sensor readings, the control circuit 8560 may, for example, deactivate one or more motors of the inner core 8522. to stop the drive movement. Further, the control circuit 8560 can further reverse the direction of rotation of the motor to transition the end effector 8540 back to the open configuration.

The examples shown in FIGS. 42-44 illustrate the use of actuator 10000 as an end effector closure actuator. In other examples, actuator 10000 can be similarly utilized to create and control firing and/or articulating motion of end effector 8540, for example.

45 and 46, handle assembly 9920 is similar in many respects to other handle assemblies described elsewhere herein, such as, for example, handle assemblies 8520, 9120, 9220. As such, these handle assemblies will not be repeated herein for the sake of brevity. For example, handle assembly 9920 may also include a motor for moving one or more drive members configured to perform closing, articulating, and/or firing motions in an end effector (e.g., end effector 8540). Includes an inner core 9922 with an assembly. Handle assembly 9920 further includes a disposable outer housing 9924 that includes two housing portions 9924a, 9924b releasably attached to each other to permit assembly with inner core 9922. Housing portions 9924a, 9924b, when joined, define a cavity therein within which inner core 9922 is selectively positioned within sterility barrier 9925 defined by outer wall 9927 of disposable outer housing 9924. It is possible.

In addition to the above, the handle assembly 9920 is capable of detecting changes in the external actuation force (F) applied to the actuator 9901 by the user in an internal magnetic field detectable by one or more magnetic field sensors 9902 within the handle assembly 9920. It includes an actuator 9901 configured to convert into a change. Actuator 9901 allows changes in external actuation force (F) to be accurately detected by inner core 9922 without compromising sterility barrier 9925.

In the illustrated example, housing portion 9924b includes a pressure sensitive actuation member 9923 configured to detect changes in external actuation force (F). Stem 9905 extends from pressure sensitive actuation member 9923 within disposable outer housing 9924 and engages the rigid surface of inner core 9922 when inner core 9922 is properly assembled with disposable outer housing 9924, as shown in FIG. 9906. Wire coil 9903 is wrapped around stem 9905 and configured to create a magnetic field when electrical current passes through wire coil 9903. In at least one example, wire coil 9903 is part of a circuit powered by power supply 9926 of inner core 9922, for example. Similar to that described in connection with actuator 10000, changes in external actuation force (F) applied to pressure sensitive actuation member 9923 are generated by wire coil 9903, which corresponds to changes in external actuation force (F). causes a change in the magnetic field.

In the illustrated example, inner core 9922 includes control circuitry 9960 connected to magnetic field sensor 9902. Control circuit 9960 is also connected to motor assembly 9962 of inner core 9922 and causes motor assembly 9962 to operate the motor in response to changes in external actuation force (F) detected by control circuit 9960 based on readings of magnetic field sensor 9902. The assembly 9962 is configured to coordinate the drive motion produced by the assembly 9962. In various aspects, the drive motion is configured to cause an end effector operably coupled to hand assembly 9920 to close, fire, and/or articulate. In certain aspects, the control circuit 9960 includes one or more parameters that can be utilized to select one or more parameters of the drive motion based on, for example, readings of the magnetic field sensor 9902. It includes a storage medium such as a memory unit that stores databases, formulas, and/or tables.

In various aspects, wire coil 9903 comprises copper or copper alloy wire. However, wire coil 9903 may be made of any suitable electrically conductive material, such as aluminum, for example. Wire coil 9903 can be wrapped around shaft 9905 any suitable number of times.

47 and 48, 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 these handle assemblies will not be repeated herein for the sake of brevity. For example, handle assembly 11020 may also include a motor for moving one or more drive members configured to perform closing, articulating, and/or firing motions in an end effector (e.g., end effector 8540). Includes an inner core 11022 with an assembly. Handle assembly 11020 further includes a disposable outer housing 11024 that includes two housing portions 11024a, 11024b releasably attached to each other to permit assembly with inner core 11022. Housing portions 11024a, 11024b, when joined, define a cavity therein within which inner core 11022 is selectively positioned within sterility barrier 11025 defined by outer wall 11027 of disposable outer housing 11024. It is possible.

In addition to the above, the handle assembly 11020 detects an external compressive force (F) applied by a user to the actuator 11001 and, in response, an external actuation force (F), as shown in graph 11004 of FIG. An actuator 9901 is configured to generate vibrations in the electromechanical member 11023 when the predetermined threshold 11002 is greater than or equal to the predetermined threshold 11002. In at least one example, electromechanical member 11023 is in the form of a piezoelectric film, or alternatively a ceramic member. Electromechanical member 11023 is coupled to a power source 11026 of inner core 11022 that provides power to electromechanical member 11023 when conductive member 11003 closes a circuit connecting electromechanical member 11023 to power source 11026.

50 and 51, handle assembly 12020 is in many respects similar to other handle assemblies described elsewhere herein, such as, for example, handle assemblies 9920, 8520, 9120, 9220, 11020. are similar and these handle assemblies will not be repeated herein for the sake of brevity. For example, handle assembly 12020 may also include a motor for moving one or more drive members configured to perform closing, articulating, and/or firing motions in an end effector (e.g., end effector 8540). Includes an inner core 12022 with an assembly. Handle assembly 12020 further includes a disposable outer housing 12024 that includes two housing portions releasably attached to each other to permit assembly with inner core 12022. The housing portions, when joined, define a cavity therein within which the inner core 12022 may be selectively positioned within the sterility barrier 12025 defined by the outer wall 12027 of the disposable outer housing 12024.

In addition to the above, handle assembly 12020 includes an actuator 12001 configured to detect an external compressive force (F) applied to actuator 12001 by a user. Detection occurs across sterile barrier 12025. Stated another way, an external compressive force (F) is applied to a first side of the sterility barrier 12025 and a second side opposite the first side of the sterility barrier 12025 without compromising the sterility barrier 12025. detected on the side. In the illustrated example, actuator 12001 includes components on either side of sterility barrier 12025 that are capable of magnetic interaction across sterility barrier 12025. A ferromagnetic plate or film 12002 is placed on the exterior of the disposable outer housing 12024 and a corresponding magnetic sensor 12003 is placed on the interior of the disposable outer housing 12024. Movement of the ferromagnetic plate 12002 in response to the external compressive force (F) causes a change in the reading of the magnetic sensor 12003 that is proportional to the change in the position of the ferromagnetic plate 12002 caused by the external compressive force (F).

Furthermore, the control circuit 120060 of the handle assembly 12020 may include a microcontroller 120061 configured to adjust the drive movement of the motor assembly 120062 in response to the readings of the magnetic sensor 12003. The drive motion may, for example, result in one or more of a closing motion, a firing motion, and an articulation motion of the end effector.

In the illustrated example, ferromagnetic plate 12002 extends across a cavity 12031 defined in outer wall 12027 of disposable outer housing 12024. It is attached to the edge of the ferromagnetic plate 12002 or to the side wall of the cavity 12031. In the illustrated example, formed-in-place seals 12029, 12030 are configured to attach the edges of ferromagnetic plate 12002 to the sidewalls of cavity 12031. However, it is envisioned that other attachment mechanisms may be used in other examples. In at least one example, an adhesive can be utilized to attach the edges of the ferromagnetic plate 12002 to the sidewalls of the cavity 12031.

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

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. Ferromagnetic plate 12002 is configured to move or bend toward magnetic sensor 12003 in response to an external compressive force (F). Movement of the ferromagnetic plate 12002 changes the reading of the magnetic sensor 12003 depending on 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 in response to the reduction in the external compressive force (F). to change the reading value of the magnetic sensor 12003. As mentioned above, microcontroller 120061 communicates with magnetic sensor 12003. Therefore, a change in the reading of the magnetic sensor 12003 is translated into a change and drive movement of the motor assembly 120062.

Referring now to FIGS. 52-54, alternative actuator embodiments are shown. FIG. 52 depicts a handle assembly 13020 that is similar in many respects to handle assemblies described elsewhere herein, such as, for example, handle assemblies 9920, 8520, 9120, 9220, 11020, 12020. As such, these handle assemblies will not be repeated herein for the sake of brevity. For example, handle assembly 13020 may also include a motor for moving one or more drive members configured to perform closing, articulating, and/or firing motions in an end effector (e.g., end effector 8540). Includes an inner core 13022 with an assembly. Handle assembly 13020 further includes a disposable outer housing 13024 that includes two housing portions releasably attached to each other to permit assembly with inner core 13022. The housing portions, when joined, define a cavity therein within which the inner core 13022 may be selectively positioned within the sterility barrier 13025 defined by the outer wall 13027 of the disposable outer housing 13024.

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

In the example shown in FIGS. 53 and 54, a flexible rubberized outer cover 13033 is disposed over the ferromagnetic plate 13002 that forms part of the outer wall 13027. A flexible rubberized outer cover 13033 can be attached to the outer wall 13027 via a molded-in-place seal and/or adhesive 13034. Ferromagnetic plate 13002 and flexible rubberized outer cover 13033 provide a double seal that ensures the integrity of sterilization barrier 13025.

The surgical instrument systems described herein are operated by electric motors; however, the surgical instrument systems described herein can be driven in any suitable manner. In certain instances, the motors disclosed herein can comprise one or more parts of a robotically controlled system. For example, U.S. patent application Ser. Some of the systems discloses examples in more detail, the entire disclosure of which is incorporated herein by reference. International Publication No. 2017/083125 published on May 18, 2017, title of the invention "STAPLER WITH COMPOSITE CARDAN AND SCREW DRIVE", International Publication No. 2017/083126 published on May 18, 2017, title of the invention "STAPLE" PUSHER WITH LOST MOTION BETWEEN RAMPS”, International Publication No. 2015/153642 published on October 8, 2015, title of invention “SURGICAL INSTRUMENT WITH SHIFTABLE TRANSMISSION”, 2 U.S. Patent Application Publication No. 2017/, filed March 17, 2017 No. 0265954, title of the invention “STAPLER WITH CABLE-DRIVEN ADVANCEEABLE CLAMPING ELEMENT AND DUAL DISTAL PULLEYS”, U.S. Patent Application Publication No. 2017/026586, filed on February 15, 2017 No. 5, name of the invention “STAPLER WITH CABLE-DRIVEN ADVANCEABLE CLAMPING” ELEMENT AND DISTAL PULLEY" and U.S. Patent Application Publication No. 2017/0290586, filed March 29, 2017, entitled "STAPLING CARTRIDGE," are incorporated herein by reference in their entirety.

Although the surgical instrument systems described herein have been described in connection with staple deployment and deformation, the embodiments described herein are not so limited. Various embodiments are envisioned that deploy fasteners other than staples, such as, for example, clamps or tacks. Additionally, various embodiments are envisioned that utilize any suitable means for sealing tissue. For example, an end effector according to various embodiments may include an electrode configured to heat and seal tissue. Also, for example, an end effector according to certain embodiments can apply vibrational energy to seal tissue.

Various aspects of the subject matter described herein are illustrated in the numbered examples below.

Example 1 - Modular surgical instrument system with handle assembly. The handle assembly includes a disposable outer housing configured to define a sterility 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 further includes a control inner core receivable within the disposable outer housing in an open configuration. The disposable outer housing is configured to isolate the control inner core in the closed configuration. The modular surgical instrument system includes a primary wired interface configured to transmit at least one of data and power between the control inner core and at least one of the modular components of the modular surgical instrument system. and a secondary interface comprising a sensor located within the outer housing, and a control circuit configured to verify the primary connection through the primary wired interface based on the at least one reading of the sensor. .

Example 2 - The modular surgical instrument system of Example 1, wherein the sensor is a proximity sensor.

Example 3 - The modular surgical instrument system of Example 1, wherein the sensor is a magnetic sensor or a capacitive sensor.

Example 4 - The modular surgical instrument system of Example 1, 2, or 3, wherein the secondary connection is detectable only when the control inner core is properly inserted within the disposable outer housing.

Example 5 - The modular surgical instrument system of Example 1, 2, 3, or 4, wherein the sensor is a first sensor and the disposable outer housing comprises a second sensor.

Example 6 - The modular surgical instrument system of Example 5, wherein the control circuit is configured to detect a closed configuration of the disposable outer housing based on the at least one reading of the second sensor. .

Example 7 - An implementation in which the control circuit is configured to evaluate proper assembly of the handle assembly based on at least one reading of the first sensor and at least one reading of the second sensor. Modular surgical instrument system according to Example 5 or 6.

Example 8 - The modular surgical device of Example 1, 2, 3, 4, 5, 6, or 7, wherein the first housing portion and the second housing portion include electrical contacts of a closed configuration detection circuit. instrument system.

Example 9 - The modular surgical instrument system of Example 8, wherein the control circuit is configured to detect a closed configuration based on electrical signals transmitted between electrical contacts.

Example 10 - Handle assembly for use with a modular surgical system. The handle assembly includes a disposable outer housing configured to define a sterility 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 further includes a control inner core receivable within the disposable outer housing in an open configuration, and the disposable outer housing is configured to isolate the control inner core in a closed configuration. The handle assembly includes a first sensor configured to detect a control inner core within the disposable outer housing, a second sensor configured to detect a closed configuration of the disposable outer housing, and a second sensor configured to detect a closed configuration of the disposable outer housing. and a control circuit configured to assess proper assembly of the disposable outer housing and the control inner core based on the at least one reading of the disposable outer housing and the at least one reading of the second sensor.

Example 11 - The handle assembly of Example 10, wherein the control circuit is configured to detect a closed configuration based on a distance between the first housing portion and the second housing portion.

Example 12 - The control circuit is configured to detect a closed configuration when the distance between the first housing portion and the second housing portion is less than or equal to a predetermined distance. Handle assembly as described.

Example 13 - The handle assembly of Example 10, 11, or 12, wherein the second sensor is a magnetic sensor.

Example 14 - The handle assembly of Example 10, 11, 12, or 13, wherein the first sensor is a capacitive sensor.

Example 15 - The handle assembly of Example 10, 11, 12, 13, or 14, wherein the control circuit is configured to disable the control inner core after a predetermined number of uses.

Example 16 - The handle assembly of Example 15, wherein the control circuit is configured to disable the control inner core by removing the current limiter.

Example 17 - The handle assembly of Example 10, 11, 12, 13, 14, 15, or 16, wherein the disposable outer housing includes a disabling mechanism to prevent reuse of the disposable outer housing.

Example 18 - The handle assembly of Example 17, wherein the override mechanism is actuatable by transitioning the first housing portion and the second housing portion from a closed configuration to an open configuration.

Example 19 - Handle assembly for use with a modular surgical system. The handle assembly includes an outer surface, a sensor array comprising a sensor secured to the outer surface within a predetermined zone of the handle assembly, and a disposable outer housing configured to define a sterility barrier. The disposable outer housing includes a resterilization detection circuit that detects the resterilization status of each of the zones based on readings from the sensor.

Example 20 - The handle assembly of Example 19, wherein the resterilization detection circuit is configured to assess end of life of the handle assembly based on sensor readings.

While several forms have been shown and described, it is not the intention of the applicant to limit or limit the scope of the appended claims to such details. Many modifications, variations, changes, permutations, combinations and equivalents of these forms may be implemented and will occur to those skilled in the art without departing from the scope of this disclosure. Furthermore, the structure of each element associated with the described form may alternatively be described as a means for providing the functionality performed by that element. Also, although materials are disclosed with respect to certain components, other materials may be used. It is therefore intended that the foregoing description and appended claims cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms. I want you to understand. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

The detailed descriptions above have described various forms of apparatus and/or processes using block diagrams, flow diagrams, and/or example embodiments. To the extent such block diagrams, flow diagrams and/or implementations include one or more features and/or operations, those skilled in the art will appreciate that such block diagrams, flow diagrams and/or implementations include one or more features and/or operations. Each feature and/or operation included in an embodiment may be implemented individually and/or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will appreciate that all or part of some aspects of the forms disclosed herein can be implemented as one or more computer programs running on one or more computers ( For example, as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g. can equivalently be implemented on an integrated circuit (as one or more programs running on one or more microprocessors), as firmware, or virtually any combination thereof; It will be appreciated that designing and/or writing software and/or firmware code is within the skill of those skilled in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the features of the subject matter described herein can be distributed as one or more program products in a variety of forms, and The specific aspects of the subject matter described in 1. apply regardless of the particular type of signal-bearing medium used to actually effectuate the distribution.

The instructions used to program the logic to implement the various disclosed aspects reside in memory within the system, such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Can be remembered. Additionally, the instructions may be distributed over a network or by other computer-readable media. Thus, a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including floppy diskettes, optical disks, compact disks, read-only memory (compact disk, read-only memory (CD-ROM), as well as magneto-optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read -only memory, EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical card, flash memory or any other form of electrical, optical, acoustic or It is not limited to tangible machine-readable storage used in the transmission of information over the Internet via propagating signals (eg, carrier waves, infrared signals, digital signals, etc.). Thus, non-transitory computer-readable media includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used in any aspect herein, the term "control circuit" refers to, for example, hard-wired circuits, programmable circuits (e.g., computer processors containing one or more individual instruction processing cores, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate A field programmable gate array (FPGA)), a state machine circuit, firmware that stores instructions to be executed by a programmable circuit, and any combination thereof. Control circuits may be used collectively or individually, such as integrated circuits (ICs), application-specific integrated circuits (ASICs), system on-chip (SoCs), desktop It may be embodied as a circuit forming part of a larger system, such as a computer, laptop computer, tablet computer, server, smartphone, etc. Accordingly, as used herein, "control circuit" refers to an electrical circuit having at least one individual electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application-specific integrated circuit. a circuit, a general-purpose computing device configured with a computer program (e.g., a general-purpose computer configured with a computer program that at least partially executes a process and/or device described herein, or a process described herein) and/or an electrical circuit forming a memory device (e.g. in the form of a random access memory) and/or a communication device (e.g. a modem). , communications switches, or optical-electrical equipment). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.

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

As used in any aspect herein, the terms "component," "system," "module," etc. refer to any hardware, combination of hardware and software, software, or running software. can refer to any computer-related entity that is

As used in any aspect herein, "algorithm" refers to a self-consistent sequence of steps that leads to a desired result, and "steps" may include, but are not necessarily limited to, storing, transmitting, combining, Refers to the manipulation of physical quantities and/or logical states, which can take the form of electrical or magnetic signals, which can be compared, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities or are simply convenient labels applied to these quantities and/or conditions.

The network may include a packet switched network. The communication devices can communicate with each other using a selected packet-switched network communication protocol. One example communication protocol may include the Ethernet communication protocol, which may enable communication using Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol conforms to or is compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) entitled "IEEE 802.3 Standard" published December 2008, and/or any later version of this standard. It can be sexual. Alternatively or additionally, the communication device is configured to support X. can communicate with each other using the X.25 communication protocol. X. The T.25 communication protocols may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may communicate with each other using a frame relay communication protocol. The Frame Relay communication protocol is a protocol developed by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute ( may conform to or be compatible with standards promulgated by ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communications protocol shall comply with or be compatible with the ATM standard published by the ATM Forum in August 2001 under the title "ATM-MPLS Network Interworking 2.0" and/or with later versions of this standard. obtain. Of course, different and/or later developed connection-oriented network communication protocols are equally contemplated herein.

Unless explicitly stated otherwise, as is clear from the foregoing disclosure, the terms "processing," "computing," and "calculating" are used throughout the foregoing disclosure. , ``determining,'' ``displaying,'' and other terms, refers to the use of terms such as actions and processing of a computer system or similar electronic computing device that manipulate and convert such information into other data similarly represented as physical quantities in memories or registers or other storage, transmission, or display devices. I hope you understand what I'm referring to.

One or more components are herein defined as "configured to," "configurable to," "operable/as such." "operable/operative to", "adapted/adaptable", "able to", "conformable/conformed" may be referred to as "to)". Those skilled in the art will understand that "configured to" generally refers to an active component and/or an inactive component and/or a standby component, unless the context requires otherwise. will be understood to include.

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

Those skilled in the art will generally understand that the terms used herein, and particularly in the appended claims (e.g., the text of the appended claims), are generally intended as "open" terms. (For example, the term "including" should be interpreted as "including but not limited to," and the term "having" should be interpreted as "including but not limited to.") should be interpreted as “having at least” and the term “includes” should be interpreted as “includes but is not limited to.” should be done, etc.). Further, if a specific number is intended in an introduced claim recitation, such intent will be clearly stated in the claim, and if no such statement is made, no such intent exists. will be understood by those skilled in the art. For example, as an aid to understanding, the following appended claims incorporate the use of the introductory phrases "at least one" and "one or more." may be included to introduce the claims. However, the use of such phrases does not apply when a claim is introduced by the indefinite article "a" or "an," even if "one or more" or "at least one" are included in the same claim. Even if the introductory phrase and the indefinite article "a" or "an" are included, any particular claim containing such an introduced claim statement will be treated as a claim containing only one such statement. shall not be construed as suggesting limitation (e.g., "a" and/or "an" generally mean "at least one" or "one or more"). should be interpreted). The same applies when introducing claim statements using definite articles.

Additionally, even if a particular number is specified in an introduced claim statement, such statement is typically to be construed to mean at least the recited number. will be recognized by those skilled in the art (e.g., a mere statement of "two entries" with no other modifiers generally means at least two entries, or two or three entries). (means more than one item). Furthermore, in instances where notation similar to "at least one of A, B, and C, etc." is used, such construction is generally intended to have the meaning that a person skilled in the art would understand the notation ( For example, "a system having at least one of A, B, and C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C and/or all of A, B and C, etc.). In instances where notation similar to "at least one of A, B, or C, etc." is used, such construction is generally intended in the sense that a person skilled in the art would understand the notation (e.g., "A system having at least one of A, B, or C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C. and/or all of A, B and C, etc.). Further, typically any disjunctive words and/or phrases denoting two or more alternative terms are used in the specification unless the context requires otherwise. is intended to include the possibility of including one, either, or both of those terms, whether in the claims or in the drawings. It will be understood by those skilled in the art that this should be understood. For example, the phrase "A or B" will typically be understood to include the possibilities "A" or "B" or "A and B."

With reference to the appended claims, those skilled in the art will appreciate that the acts recited herein may generally be performed in any order. Additionally, while the flow diagrams of various operations are shown in sequence, it should be understood that the various operations may be performed in an order other than that shown, or may be performed simultaneously. be. Examples of such alternative orderings include overlapping, interleaving, interleaving, reordering, incremental, preliminary, additional, simultaneous, reverse or other different orderings, unless the context requires otherwise. May include. Additionally, terms such as "responsive to," "relating to," or other past tense adjectives generally exclude such variations unless the context requires otherwise. It's not intended.

Any reference to "an aspect," "an aspect," "an example," "an example," or the like includes a particular feature, structure, or characteristic described in connection with that aspect that is included in at least one aspect. The meaning of this is worth noting. Thus, the phrases "in one aspect," "in an aspect," "in an example," and "in one example" appearing in various places throughout this specification do not necessarily all refer to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

As used herein, unless otherwise indicated, the term "about" or "approximately" as used in this disclosure means a tolerance for a particular value as determined by one of ordinary skill in the art, unless otherwise specified. depends in part on the way the value is measured or determined. In certain embodiments, the term "about" or "approximately" means 1, 2, 3, or 4 standard deviations. In certain embodiments, the term "about" or "approximately" refers to 50%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5% of a given value or range. %, 4%, 3%, 2%, 1%, 0.5%, or within 0.05%.

In this specification, unless otherwise indicated, all numerical parameters are to be understood as being preceded and qualified in all instances by the term "about"; The underlying measurement method used to determine the At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter set forth herein shall be interpreted with regard to the reported significant figures and without ordinary rounding techniques. should at least be construed by applying.

Additionally, any numerical range recited herein includes all subranges subsumed within the recited range. For example, the range "1 to 10" includes all subranges between (and inclusive of) the stated minimum value of 1 and the stated maximum value of 10, i.e. All subranges with a minimum value greater than or equal to 1 and a maximum value less than or equal to 10 are included. Additionally, all ranges stated herein include the endpoints of the stated range. For example, the range "1-10" includes endpoints 1 and 10. Any maximum numerical limit recited herein is intended to include all lower numerical limits subsumed, and any minimum numerical limit recited herein is intended to include all subsumed subnumerical limits. is intended to include all higher numerical limits. Accordingly, applicant reserves the right to amend the specification, including the claims, to include any expressly stated subranges subsumed within the expressly stated scope. . All such ranges are originally described herein.

Any patent application, patent, non-patent publication, or other disclosure material referenced herein and/or listed in any application data sheet is incorporated by reference herein to the extent that the incorporated material is not inconsistent with this specification. , incorporated herein by reference. As such, and to the extent necessary, disclosure expressly set forth herein shall supersede any conflicting statements incorporated herein by reference. Any content, or portions thereof, that is cited as being incorporated herein by reference but is inconsistent with current definitions, views, or other disclosures set forth herein shall not be incorporated by reference. and are incorporated only to the extent that there is no conflict between them and the current disclosure.

In summary, many benefits have been described that result from using the concepts described herein. The above description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or limited to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The form or forms are illustrative of the principles and practical application, thereby enabling those skilled in the art to utilize the various forms, with various modifications, as appropriate for the particular application contemplated. It has been selected and written in order to make it possible. It is intended that the claims presented herewith define the overall scope.

[Mode of implementation]
(1) A modular surgical instrument system, comprising:
A handle assembly,
A disposable outer housing configured to define a sterility barrier, the disposable outer housing comprising:
a first housing portion;
a second housing portion movable relative to the first housing portion between an open configuration and a closed configuration;
a control inner core receivable within the disposable outer housing in the open configuration, the disposable outer housing configured to isolate the control inner core in the closed configuration; a handle assembly comprising;
a primary wired interface configured to transmit at least one of data and power between the control inner core and at least one of the modular components of the modular surgical instrument system;
a secondary interface comprising a sensor located within the outer housing;
a control circuit configured to confirm a primary connection through the primary wired interface based on a reading of at least one of the sensors.
(2) The modular surgical instrument system of embodiment 1, wherein the sensor is a proximity sensor.
3. The modular surgical instrument system of embodiment 1, wherein the sensor is a magnetic sensor or a capacitive sensor.
4. The modular surgical instrument system of claim 1, wherein the primary connection is detectable only when the control inner core is properly inserted within the disposable outer housing.
5. The modular surgical instrument system of embodiment 1, wherein the sensor is a first sensor and the disposable outer housing comprises a second sensor.

6. The modular surgical device of embodiment 5, wherein the control circuit is configured to detect a closed configuration of the disposable outer housing based on a reading of at least one of the second sensors. instrument system.
(7) the control circuit is configured to evaluate proper assembly of the handle assembly based on the at least one reading of the first sensor and the at least one reading of the second sensor; 7. The modular surgical instrument system of embodiment 6, wherein:
8. The modular surgical instrument system of embodiment 1, wherein the first housing portion and the second housing portion include electrical contacts of a closed configuration detection circuit.
9. The modular surgical instrument system of embodiment 8, wherein the control circuit is configured to detect the closed configuration based on electrical signals transmitted between the electrical contacts.
(10) A handle assembly for use with a modular surgical system, the handle assembly comprising:
A disposable outer housing configured to define a sterility barrier, the disposable outer housing comprising:
a first housing portion;
a second housing portion movable relative to the first housing portion between an open configuration and a closed configuration;
a control inner core receivable within the disposable outer housing in the open configuration, the disposable outer housing configured to isolate the control inner core in the closed configuration;
a first sensor configured to detect the control inner core within the disposable outer housing;
a second sensor configured to detect a closed configuration of the disposable outer housing;
a control configured to evaluate proper assembly of the disposable outer housing and the control inner core based on at least one reading of the first sensor and at least one reading of the second sensor; A handle assembly comprising a circuit.

11. The handle of embodiment 10, wherein the control circuit is configured to detect the closed configuration based on a distance between the first housing portion and the second housing portion. assembly.
(12) the control circuit is configured to detect the closed configuration when the distance between the first housing portion and the second housing portion is less than or equal to a predetermined distance; A handle assembly according to embodiment 11.
(13) The handle assembly according to embodiment 10, wherein the second sensor is a magnetic sensor.
(14) The handle assembly of embodiment 10, wherein the first sensor is a capacitive sensor.
15. The handle assembly of embodiment 10, wherein the control circuit is configured to disable the control inner core after a predetermined number of uses.

16. The handle assembly of claim 15, wherein the control circuit is configured to disable the control inner core by removing a current limiter.
17. The handle assembly of claim 10, wherein the disposable outer housing includes a disabling mechanism to prevent reuse of the disposable outer housing.
18. The handle assembly of claim 17, wherein the override mechanism is actuatable by transitioning the first housing portion and the second housing portion from the closed configuration to the open configuration.
(19) A handle assembly for use with a modular surgical system, the handle assembly comprising:
the exterior and
a sensor array comprising a sensor secured within the outer surface in a predetermined zone of the handle assembly;
a disposable outer housing configured to define a sterilization barrier and comprising a resterilization detection circuit configured to detect the resterilization status of each of the zones based on readings from the sensor; A handle assembly comprising: a disposable outer housing;
20. The handle assembly of claim 19, wherein the resterilization detection circuit is configured to assess end of life of the handle assembly based on the reading of the sensor.

Claims (20)

A modular surgical instrument system comprising:
A handle assembly,
A disposable outer housing configured to define a sterility barrier, the disposable outer housing comprising:
a first housing portion;
a second housing portion movable relative to the first housing portion between an open configuration and a closed configuration;
a control inner core receivable within the disposable outer housing in the open configuration, the disposable outer housing configured to isolate the control inner core in the closed configuration; a handle assembly comprising;
a primary wired interface configured to transmit at least one of data and power between the control inner core and at least one of the modular components of the modular surgical instrument system;
a secondary interface comprising a sensor located within the outer housing;
a control circuit configured to confirm a primary connection through the primary wired interface based on a reading of at least one of the sensors. The modular surgical instrument system of claim 1, wherein the sensor is a proximity sensor. The modular surgical instrument system of claim 1, wherein the sensor is a magnetic sensor or a capacitive sensor. The modular surgical instrument system of claim 1, wherein the primary connection is detectable only when the control inner core is properly inserted within the disposable outer housing. The modular surgical instrument system of claim 1, wherein the sensor is a first sensor and the disposable outer housing comprises a second sensor. The modular surgical instrument system of claim 5, wherein the control circuit is configured to detect a closed configuration of the disposable outer housing based on a reading of at least one of the second sensors. The control circuit is configured to evaluate proper assembly of the handle assembly based on the at least one reading of the first sensor and the at least one reading of the second sensor. 7. The modular surgical instrument system of claim 6. The modular surgical instrument system of claim 1, wherein the first housing portion and the second housing portion include electrical contacts of a closed configuration detection circuit. 9. The modular surgical instrument system of claim 8, wherein the control circuit is configured to detect the closed configuration based on electrical signals transmitted between the electrical contacts. A handle assembly for use with a modular surgical system, the handle assembly comprising:
A disposable outer housing configured to define a sterility barrier, the disposable outer housing comprising:
a first housing portion;
a second housing portion movable relative to the first housing portion between an open configuration and a closed configuration;
a control inner core receivable within the disposable outer housing in the open configuration, the disposable outer housing configured to isolate the control inner core in the closed configuration;
a first sensor configured to detect the control inner core within the disposable outer housing;
a second sensor configured to detect a closed configuration of the disposable outer housing;
a control configured to evaluate proper assembly of the disposable outer housing and the control inner core based on at least one reading of the first sensor and at least one reading of the second sensor; A handle assembly comprising a circuit. 11. The handle assembly of claim 10, wherein the control circuit is configured to detect the closed configuration based on a distance between the first housing portion and the second housing portion. 12. The control circuit is configured to detect the closed configuration when the distance between the first housing portion and the second housing portion is less than or equal to a predetermined distance. Handle assembly as described in. The handle assembly of claim 10, wherein the second sensor is a magnetic sensor. The handle assembly of claim 10, wherein the first sensor is a capacitive sensor. 11. The handle assembly of claim 10, wherein control circuitry is configured to disable the control inner core after a predetermined number of uses. 16. The handle assembly of claim 15, wherein the control circuit is configured to disable the control inner core by removing a current limiter. 11. The handle assembly of claim 10, wherein the disposable outer housing includes a disabling mechanism to prevent reuse of the disposable outer housing. 18. The handle assembly of claim 17, wherein the override mechanism is actuatable by transitioning the first housing portion and the second housing portion from the closed configuration to the open configuration. A handle assembly for use with a modular surgical system, the handle assembly comprising:
the exterior and
a sensor array comprising a sensor secured within the outer surface in a predetermined zone of the handle assembly;
a disposable outer housing configured to define a sterilization barrier and comprising a resterilization detection circuit configured to detect the resterilization status of each of the zones based on readings from the sensor; A handle assembly comprising: a disposable outer housing; 20. The handle assembly of claim 19, wherein the resterilization detection circuit is configured to assess end of life of the handle assembly based on the reading of the sensor.

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