Classifications

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  • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
  • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
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  • A61B90/90—Identification means for patients or instruments, e.g. tags
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  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
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  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/26—Accessories or devices or components used for biocidal treatment
  • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
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  • A61B17/07292—Reinforcements for staple line, e.g. pledgets
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  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
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  • A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
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  • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
  • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
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  • A61B2017/00473—Distal part, e.g. tip or head
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  • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
  • A61B2017/07214—Stapler heads
  • A61B2017/07271—Stapler heads characterised by its cartridge
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  • A61B2018/00172—Connectors and adapters therefor
  • A61B2018/00178—Electrical connectors
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  • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
  • A61B2018/00922—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device by switching or controlling the treatment energy directly within the hand-piece
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  • A61B90/08—Accessories or related features not otherwise provided for
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  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
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  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/20—Targets to be treated
  • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

• the present invention relates to surgical instruments and, in various arrangements, to surgical stapling and cutting instruments and staple cartridges for use therewith that are designed to staple and cut tissue.
• the present disclosure provides a modular surgical instrument system that comprises a handle assembly.
• the handle assembly comprises a disposable outer housing configured to define a sterile barrier.
• the disposable outer housing comprises a first housingportion and a second housing-portion movable relative to the first housing-portion between an open configuration and a closed configuration.
• the handle assembly further comprises a control inner core receivable inside the disposable outer housing in the open configuration.
• the disposable outer housing is configured to isolate the control inner core in the closed configuration.
• the modular surgical instrument system further comprises a primary wired interface configured to transmit at least one of data and power between the control inner core and at least one of modular components of the modular surgical instrument system, a secondary interface comprising a sensor located within the outer housing, and a control circuit configured to confirm a primary connection through the primary wired interface based on at least one reading of the sensor.
• the present disclosure provides a handle assembly for use with a modular surgical system.
• the handle assembly comprises a disposable outer housing configured to define a sterile barrier.
• the disposable outer housing comprises a first housingportion and a second housing-portion movable relative to the first housing-portion between an open configuration and a closed configuration.
• the handle assembly further comprises a control inner core receivable inside the disposable outer housing in the open configuration, wherein the disposable outer housing is configured to isolate the control inner core in the closed configuration.
• the handle assembly further comprises 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, and a control circuit configured to assess a proper assembly of the disposable outer housing with the control inner core based on at least one reading of the first sensor and at least one reading of the second sensor.
• the present disclosure provides a handle assembly for use with a modular surgical system.
• the handle assembly comprises an outer surface, a sensor array comprising sensors secured into the outer surface in predetermined zones of the handle assembly, and a disposable outer housing configured to define a sterile barrier.
• the disposable outer housing comprises a re-sterilization-detection circuit that detects a re-sterilization status of each of the zones based on readings from the sensors.
• FIG. 1 illustrates a perspective view of a surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 2 illustrates a perspective view of handle assembly of the surgical instrument system of FIG. 1 in a disassembled 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 an end effector of the surgical instrument system of FIG. 1 and the inner core of FIG. 2.
• FIG. 4 is a logic flow diagram of a process depicting a control program or a logic configuration for electrically connecting an inner core of a surgical instrument system with a staple cartridge or an end effector, in accordance with at least one aspect of the present disclosure.
• FIG. 5 is a graph illustrating drive member travel on the x-axis and drive member speed on the y-axis, in accordance with at least one aspect of the present disclosure.
• FIG. 6 is a graph illustrating 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. 7 is a partial elevational view of a surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 8 is a partial elevational 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 a nozzle portion of the surgical instrument system of FIG. 8.
• FIG. 10 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. 11 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. 12 is a graph illustrating resistance identifiers of various potential modular components of the modular surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 13 is a logic flow diagram of a process depicting a control program or a logic configuration for detecting and/or authenticating a modular configuration of a modular surgical instrument system or assembly.
• FIG. 14 is a logic flow diagram of a process depicting a control program or a logic configuration for detecting and/or authenticating a modular configuration of a modular surgical instrument system or assembly.
• FIG. 15 is a perspective view of a handle assembly of a modular surgical instrument system, the handle assembly 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 assessing proximity and alignment of the disposable outer housing and the inner core of FIG. 15 in an assembled configuration.
• FIG. 17 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 nozzle portion of a shaft assembly of the surgical instrument system of FIG. 17.
• FIG. 19 is a partial exploded view of components of the surgical instrument system of FIG. 17.
• FIG. 20 is a partial cross-sectional view of components of the surgical instrument system of FIG. 17.
• FIG. 21 is a logic flow diagram of a process depicting a control program or a logic configuration for disabling an inner core of a handle assembly of a surgical instrument system at an end-of-life event.
• FIGS. 22-25 illustrate safety mechanisms for disabling a disposable outer housing of a handle assembly after usage in a surgical procedure, in accordance with at least one aspect of the present disclosure.
• FIGS. 26-29 illustrate safety mechanisms for disabling a disposable outer housing of a handle assembly after usage in a surgical procedure, in accordance with at least one aspect of the present disclosure.
• FIG. 30 is a perspective view of a surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 31 is a partial cross-sectional view of an outer wall of a handle assembly of the surgical instrument system of FIG. 30.
• FIG. 32 is a simplified representation of a sterilization-detection circuit of the handle assembly of the surgical instrument system FIG. 30.
• FIG. 33 is a top view of the handle assembly of the surgical instrument system of FIG. 30 showing a light-emitting diode (LED) display thereof.
• LED light-emitting diode
• FIG. 34 is an expanded view of the LED display of FIG. 33.
• FIG. 35 is a graph illustrating sensor readings of a hydrogen peroxide sensor, in accordance with at least one aspect of the present disclosure.
• FIG. 36 is a logic flow diagram of a process depicting a control program or a logic configuration for detecting an end of a lifecycle of a re-serializable component of a surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 37 illustrates a process of re-sterilizing a handle assembly of a surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 38 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.
• FIG. 39 illustrates the re-serialization system of FIG. 38 in a closed configuration.
• FIG. 40 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.
• FIG. 41 is a primary electrical interface for use with a surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 42 is an actuator for use with a surgical instrument system, in accordance with at least one aspect of the present disclosure.
• FIG. 43 illustrates the actuator of FIG. 42 in different configurations yielding different closure forces, in accordance with at least one aspect of the present disclosure.
• FIG. 44 is a graph illustrating different closure positions of an end effector and corresponding closure forces as determine based on the different configurations of FIG. 43.
• FIG. 45 is a perspective view of a disposable outer housing and an inner core of a handle assembly, in accordance with at least one aspect of the present disclosure.
• FIG. 46 is a partial cross-sectional view of an actuator of the handle assembly of FIG. 45.
• FIG. 47 is a perspective view of a disposable outer housing and an inner core of a handle assembly, in accordance with at least one aspect of the present disclosure.
• FIG. 48 is a partial cross-sectional view of an actuator of the handle assembly of FIG. 47.
• FIG. 49 is a graph vibrations, on the Y-axis, as a function of time on the x-axis.
• FIG. 50 is a partial exploded view of a handle assembly, in accordance with at least one aspect of the present disclosure.
• FIG. 51 is a partial cross-sectional view of an actuator of the handle assembly of FIG. 50.
• FIG. 52 is a partial exploded view of a handle assembly, in accordance with at least one aspect of the present disclosure.
• FIG. 53 is a partial exploded view of an actuator of a handle assembly, in accordance with at least one aspect of the present disclosure.
• FIG. 54 is a partial cross-sectional view of the actuator of FIG. 53.
• Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures.
• the various methods and devices disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures.
• the reader will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc.
• the working portions or end effector portions of the instruments can be inserted directly into a patient’s body or can be inserted through an access device that has a working channel through which the end effector and elongate shaft of a surgical instrument can be advanced.
• a surgical instrument system such as, for example, an electromechanical surgical instrument system 8500.
• System 8500 includes a handle assembly 8520, a plurality of types of adapter or shaft assemblies such as, for example, shaft assembly 8530, and a plurality of types of loading units or end effectors such as, for example, end effector 8540.
• Handle assembly 8520 is configured for selective attachment thereto with any one of a number of shaft assemblies, for example, shaft assembly 8530 and, in turn, each unique shaft assembly 8530 is configured for selective connection with any number of surgical loading units or end effectors, such as, for example, end effector 8540.
• End effector 8540 and shaft assembly 8530 are configured for actuation and manipulation by handle assembly 8520.
• the handle assembly 8520 includes an inner core 8522 and a disposable outer housing 8524 configured to selectively receive and encase inner core 8522 to establish a sterile barrier 8525 (FIG. 3) around the inner core 8522.
• Inner core 8522 is motor operable and configured to drive an operation of a plurality of types of end effectors.
• Inner core 8522 has a plurality of sets of operating parameters (e.g., speed of operation of motors of inner core 8522, an amount of power to be delivered by motors of inner core 8522 to a shaft assembly, selection of motors of inner core 8522 to be actuated, functions of an end effector to be performed by inner core 8522, or the like).
• Each set of operating parameters of inner core 8522 is designed to drive the actuation of a specific set of functions unique to respective types of end effectors when an end effector is coupled to inner core 8522.
• inner core 8522 may vary its power output, deactivate or activate certain buttons thereof, and/or actuate different motors thereof depending on the type of end effector that is coupled to inner core 8522.
• the inner core 8522 defines an inner housing cavity therein in which a power-pack 8526 is situated.
• Power-pack 8526 is configured to control the various operations of inner core 8522.
• Power-pack 8526 includes a plurality of motors operatively engaged thereto. The rotation of motors function to drive shafts and/or gear components of shaft assembly 8530, for example, in order to drive the various operations of end effectors attached thereto, for example, end effector 8540.
• motors of power-pack 8526 are configured to drive shafts and/or gear components of the shaft assembly 8530 in order to selectively effect a firing motion, a closure motion, and/or an articulation motion at the end effector 8540, for example.
• the disposable outer housing 8524 includes two housing portions 8524a, 8524b releasably attached to one another to permit assembly with the inner core 8522.
• the housing portion 8524b is movably coupled to the housing portion 8524a by a hinge 8525 located along an upper edge of housing portion 8524b. Consequently, the housing portions 8524a, 8524b are pivotable relative to one another between a closed, fully coupled configuration, as shown in FIG. 1 , and an open, partially detached configuration, as shown in FIG. 2.
• the housing portions 8524a, 8524b define a cavity therein in which inner core 8522 may be selectively situated.
• the inner core 8522 includes a control circuit 8560.
• the control circuit 8560 is disposed on an inner wall of the disposable outer housing 8524, and is releasably couplable to the inner core 8522 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.
• the control circuit 8560 includes a processor 8562 and a storage medium such as, for example, a memory unit 8564.
• the control circuit 8560 can be powered by the power-pack 8526, for example.
• the memory unit 8564 may store program instructions, which when executed by the processor 8562, may cause the processor 8562 to adjust/perform various control functions of the surgical instrument system 8500.
• control circuit 8560 is releasably couplable to the inner core 8522.
• the inner core 8522 is assembled with the outer housing 8524, an electrical connection is established between the inner core 8522 and the control circuit 8560.
• the control circuit 8560 is incorporated into the inner core 8522.
• the memory unit 8564 may be non-volatile memories, such as, for example, electrically erasable programmable read-only memories.
• the memory unit 8564 may have stored therein discrete operating parameters of inner core 8522 that correspond to the operation of one type of end effector, for example, end effectors such as, for example end effector 8540 and/or one type of adapter assembly such as, for example, shaft assembly 8530.
• the operating parameter(s) stored in memory 8564 can be at least one of: a speed of operation of motors of inner core 8522; an amount of power to be delivered by motors of inner core 8522 during operation thereof; which motors of inner core 8522 are to be actuated upon operating inner core 8522; types of functions of end effectors to be performed by inner core 8522; or the like.
• the surgical instrument system 8500 includes an electrical interface assembly 8570 configured to transmit at least one of data signal and power between the inner core 8522 and the end effector 8540.
• the electrical interface assembly 8570 includes a first interface portion 8580 on a first side 8525a of the sterile barrier 8525 and a second interface portion 8590 on a second side 8525b of the sterile barrier 8525 opposite the first side.
• the first interface portion 8580 is configured to form a wireless electrical interface with the second interface portion 8590.
• the wireless electrical interface facilitates a wireless transmission of at least one of data signal and power between the inner core 8522 and the second interface portion 8590.
• the electrical interface assembly 8570 includes an exteriorly-mounted wiring connection 8600.
• the exteriorly-mounted wiring connection 8600 is separately-attachable to the second interface portion 8690 to facilitate a wired transmission of the at least one of data signal and power between the second interface portion 8590 and the end effector 8540.
• first interface portion 8580 and the second interface portion 8590 are configured to cooperatively form a wireless segment of an electrical pathway between the inner core 8522 and the end effector 8540.
• the exteriorly- mounted wiring connection 8600 forms a wired segment of the electrical pathway. At least one of data signal and power is transmitted between the inner core 8522 and the end effector 8540 through the electrical pathway.
• the exteriorly-mounted wiring connection 8600 includes a wire flex circuit 8601 terminating at an attachment member 8602 releasably couplable to the second interface portion 8590.
• the wire flex circuit 8601 is of sufficient length to permit the attachment member 8602 to exteriorly reach the second interface portion 8590.
• the attachment member 8602 is magnetically couplable to the second interface portion 8590.
• the attachment member 8602 includes magnetic elements 8606, 8608 disposed in the housing 8604.
• the first interface portion 8580 includes ferrous elements 8576, 8578 for magnetic attachment and proper alignment of the attachment member 8602 onto the outer housing 8524, as illustrated in FIG. 3.
• the ferrous elements 8576, 8578 are disposed on an outer housing 8523 of the inner core 8522 such that the ferrous elements 8576, 8578 and the magnetic elements 8606, 8608 are aligned when the inner core 8522 is properly positioned within the disposable outer housing 8524 and the attachment member 8602 is properly positioned against the second interface portion 8590.
• magnetic elements can be disposed on the outer housing 8523 of the inner core 8522, and the ferrous elements can be disposed on the housing 8604 of the attachment member 8602.
• corresponding magnetic elements can be disposed on both of the housings 8604, 8523.
• another exteriorly-mounted wiring connection 8611 connects the shaft assembly 8530 to the second interface portion 8590.
• the exteriorly-mounted wiring connection 8611 is similar in many respects to the exteriorly-mounted wiring connection 8600.
• the exteriorly-mounted wiring connection 8611 also includes a wire flex circuit 8612 that terminates in an attachment member 8613 that is similar to the attachment member 8602 of the exteriorly-mounted wiring connection 8600.
• the attachment member 8613 is also magnetically-couplable to the handle assembly 8520 to exteriorly transmit at least one of data and power between the shaft assembly 8530 and the inner core 8522.
• the electrical interface assembly 8570 utilizes inductive elements 8603, 8583 positionable on opposite sides of the sterile barrier 8525.
• the inductive elements 8603, 8583 are in the form of wound wire coils that are components of inductive circuits 8605, 8585, respectively.
• the wire coils of the inductive elements 8603, 8583 comprise a copper, or copper alloy, wire; however, the wire coils may comprise suitable conductive material, such as aluminum, for example.
• the wire coils can be wound around a central axis any suitable number of times.
• the wire coils of the inductive elements 8603, 8583 are properly aligned about a central axis extending therethrough.
• the proper alignment of the wire coils of the inductive elements 8603, 8583 improves the wireless transmission of the at least one of data and power therethrough.
• the inductive circuit 8585 is electrically coupled to the power-pack 8526 and the control circuit 8560.
• the inductive circuit 8605 is electrically couplable to a transponder 8541 in the end effector 8540.
• the inductive element 8603 is inductively coupled to the inductive element 8583.
• the transponder 8541 may use a portion of the power of the inductive signal received from the inductive element 8603 to passively power the transponder 8541 .
• the transponder 8541 may receive and transmit data to the control circuit 8560 in the handle assembly via the inductive coupling between the inductive circuits 8605, 8585.
• the transponder 8541 is located in the shaft portion 8542 of the end effector 8540. In other examples, the transponder 8541 can be disposed in the jaws of the end effector 8540. In the illustrated example, the end effector 8540 includes a staple cartridge 8543. In certain instances, the transponder 8541 can be located in the staple cartridge 8543.
• Internal wiring within the shaft portion 8542 connects the exteriorly- mounted wiring connection 8600 to the transponder 8541 .
• the exteriorly-mounted wiring connection 8600 includes an attachment member 8609 configured to connect the wire flex circuit 8601 to the shaft portion 8542. In certain instances, the attachment member 8609 is permanently connected to the shaft portion 8542. In other instances, the attachment member 8609 is releasably coupled to the shaft portion 8542.
• the control circuit 8560 may comprise an encoder for encoding the signals and a modulator for modulating the signals according to the modulation scheme.
• the control circuit 8560 may communicate with the transponder 8541 using any suitable wireless communication protocol and any suitable frequency (e.g., an ISM band).
• the control circuit 8560 through queries identification devices (e.g., radio frequency identification devices (RFIDs)), or cryptographic identification devices, can determine whether an attached staple cartridge and/or end effector is compatible with the surgical instrument system 8500.
• RFIDs radio frequency identification devices
• An identification chip and/or an interrogation cycle can be utilized to assess the compatibility of an attached staple cartridge and/or end effector.
• RFIDs radio frequency identification devices
• FIG. 4 is a logic flow diagram of a process 8610 depicting a control program or a logic configuration electrically connecting 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).
• the process 8610 includes detecting 8612 a compatible connection between the end effector 8540 and the inner core 8522, more specifically the control circuit 8560, through the electrical interface assembly 8570.
• the process 8610 further includes adjusting 8614 a signal parameter of a signal passing through the electrical interface assembly 8570 to improve a throughput of the at least one of data and power between the end effector 8540 and the inner core 8522.
• the process 8610 is implemented by the control circuit 8560.
• the memory unit 8564 may store program instructions, which when executed by the processor 8562, may cause the processor 8562 to perform one or more aspects of the process 8610.
• one or more aspects of the process 8610 can be implemented by a connection circuit separate from, but can be in communication with, the control circuit 8560.
• the connection circuit can incorporated into the disposable outer housing 8524 of the handle assembly 8520, for example.
• the end effector 8540 includes a memory unit that stores an identification code.
• the control circuit 8560 may assess whether a compatible connection exists between the end effector 8540 and the inner core 8522 based on the identification code retrieved from the memory unit through the electrical interface assembly 8570.
• the electrical interface assembly 8570 includes one or more sensors configured to detect, measure, and/or monitor aspects of the signal transmitted through the electrical interface assembly 8570.
• the control circuit 8560 may further adjust one or more aspects of the signal such as, for example, the signal strength, frequency, and/or bandwidth and/or adjust power levels to optimize the throughput of the at least one of data and power between the end effector 8540 and the inner core 8522 through the electrical interface assembly 8570.
• the control circuit 8560 can determine if the surgical instrument system 8500 is within an environment where one or more components or connections of the electrical interface assembly 8570 are shorted and/or the signal is lost.
• control circuit 8560 may adjust the signal frequency, signal strength, and/or signal repeat in order to improve data or power throughput. In at least one example, the control circuit 8560 may respond by turning off one or more connections in order to improve other connections of the electrical interface assembly 8570.
• the control circuit 8560 may set one or more operational parameter of the surgical instrument system 8500 based on an identifier received through the electrical interface assembly 8570.
• FIG. 5 depicts a graph 8620 that represents several control schemes (e.g. 8621 , 8622, 8623, 8624, 8625, 8626, 8627) that can be stored in the memory unit 8564, and can be selected by the processor 8562 based on the identifier received through the electrical interface assembly 8570.
• the 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 motivated by the motor(s) of the inner core 8522 to effect a closure and/or firing motion of the end effector 8540.
• the drive member is motivated by the mortar to advance an I-beam assembly along a predefined firing path to deploy staples from the staple cartridge 8543 into tissue and, optionally, advance a cutting member to cut the stapled tissue in a firing stroke.
• the drive member speed of motion and distance traveled from starting position represent the speed of motion of the I-beam assembly and the distance traveled by the I-beam assembly along the predefined firing pathway, respectively.
• the example control schemes (8621 , 8622, 8623, 8624, 8625, 8626, 8627) represented in the graph 8620 can be stored in the memory unit 8564 in any suitable form such as, for example, tables and/or equations.
• the control schemes (8621 , 8622, 8623, 8624, 8625, 8626, 8627) represent different types and sizes (e.g. 45mm, 60mm) of staple cartridges suitable for use with the surgical instrument system 8500 to treat different tissue types with different thicknesses.
• control scheme 8621 is for use with a cartridge type suitable for treating thin tissue and, as such, permits relatively faster speeds of motion of the drive member, which yields a higher inertia, which necessitates an earlier slowdown before the end of the firing stroke.
• control scheme 8627 is for use with a cartridge type suitable for treating thick tissue and, as such, permits slower speeds of motion of the drive member than the control scheme 8621 . Accordingly, the control scheme 8627 yields a lower inertia than the control scheme 8621 , which justifies a later slowdown before the end of the firing stroke compared to the control scheme 8621 .
• FIG. 6 depicts another graph 8720 representing additional control schemes (8721 , 8722, 8723, 8724).
• the graph 8720 illustrates 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 motor of the inner core 8522 to achieve a particular speed of the drive member varies depending on the cartridge type.
• the control circuit 8560 selects from the control schemes (8721 , 8722, 8723, 8724) based on the identifier received through the electrical interface assembly 8570 to ensure a current draw by the motor sufficient to achieve a desired speed as determined by the selected control scheme.
• a surgical instrument system 8800 is similar in many respects to the surgical instrument system 8500.
• the surgical instrument system 8800 also includes a handle assembly 8820 that includes an inner core 8822 which has a motor assembly for motivating a drive member configured to effect a closure motion and/or a firing motion in an end effector 8540.
• the inner core 8822 further includes an internal power pack 8826 that powers the motor assembly and a control circuit 8860.
• the power pack 8826 comprises one or more batteries, which can be rechargeable.
• the power pack 8826 can be releasably couplable to the inner core 8822.
• the control circuit 8860 includes a memory unit that stores program instructions.
• the program instructions when executed by the processor, cause the processor to control the motor assembly, a feedback system, and/or one or more sensors.
• the feedback system can be employed by the control circuit 8860 to perform a predetermined function such as, for example, issuing an alert when one or more predetermined conditions are met.
• the feedback systems may comprise one or more visual feedback systems such as display screens, backlights, and/or LEDs, for example.
• the feedback systems may comprise one or more audio feedback systems such as speakers and/or buzzers, for example.
• the feedback systems may comprise one or more haptic feedback systems, for example.
• the feedback systems may comprise combinations of visual, audio, and/or haptic feedback systems, for example.
• a wireless power transfer system 8850 is utilized to wirelessly transmit power across a sterile barrier created by a disposable outer housing 8824 disposed around the inner core 8822.
• the disposable outer housing 8824 is similar in many respects to the disposable outer housing 8524.
• the disposable outer housing 8824 may include two housing portions detachably couplable to one another to permit insertion of the inner core 8822 inside the disposable outer housing 8824.
• the inner core 8822 is sealed inside the disposable outer housing 8824, thereby creating the sterile barrier around the inner core 8822.
• the wireless power transfer system 8850 utilizes magnetic coupling of bearings to drive mechanical work to ultimately be converted to usable electrical energy.
• the wireless power transfer system 8850 includes an internal power transfer unit 8852 and an external disposable energy re DCVER/con verier 8854.
• the internal power transfer unit 8852 and the external disposable energy receiver/converter 8854 are positioned on opposite sides of the sterile barrier defined by the disposable outer housing 8824.
• the internal power transfer unit 8852 is positioned inside the disposable outer housing 8824, and is hardwired to the power pack 8826.
• the internal power transfer unit 8852 is attached to an inner wall of the disposable outer housing 8824, and is releasably connected to the power pack 8826.
• an external connector thereof is brought into a mating engagement with a corresponding connector of the internal power transfer unit 8852.
• the power pack 8826 and the internal power transfer unit 8852 become electrically connected.
• the inner core 8822 may include an external wiring that can be manually connected to the internal power transfer unit 8852.
• the internal power transfer unit 8852 is incorporated into the inner core 8822.
• the internal power transfer unit 8852 is positioned near an external housing of the inner core 8822 in such a manner that brings the internal power transfer unit 8852 into a proper operational alignment with the external disposable energy receiver/converter 8854 when the inner core 8822 is finally positioned within the disposable outer housing 8824.
• the internal power transfer unit 8852 includes a magnetic bearing 8856.
• the control circuit 8860 causes a current to drive the rotation of the magnetic bearing 8856.
• the mechanical energy is magnetically transmitted across the sterile barrier to the external disposable energy receiver/converter 8854, and is converted again to electrical energy via a linear alternator 8857.
• the external disposable energy receiver/converter 8854 includes a magnetic bearing 8858 configured to rotate with rotation of the magnetic bearing 8856. In operation, the magnetic bearing 8858 is synchronized to the rotation of the magnetic bearing 8856, which causes mechanical work to be generated externally in an outer power transfer unit 8854.
• the generated mechanical work is harnessed and converted to electrical energy via the linear alternator 8857 and is then available for utilization with an end effector 8540, for example.
• a gear assembly 8859 is utilized to transfer the mechanical energy from the magnetic bearing 8858 to the linear alternator 8857.
• power transfer across the sterile barrier can be achieved via a direct conductive connection is between the internal and external environments.
• a specific region of the outer disposable housing can be over-molded onto a metal strip that extends the thickness of the sterile barrier when implemented. The over-molding will allow for tight seals to remove the chance of contaminants getting through, and once the outer housing is transitioned to a closed configuration to create the sterile barrier, the metal strip will act as a conductive bridge allowing energy to be transferred directly to the external environment.
• a surgical instrument system 8900 is similar in many respects to the surgical instrument systems 8500, 8800.
• the surgical instrument system 8900 also includes a handle assembly 8920 that includes an inner core 8922 which has a motor assembly for motivating a drive member configured to effect a closure motion and/or a firing motion in an end effector 8940.
• the surgical instrument system 8900 includes a shaft 8930 with a nozzle portion 8930a and a shaft portion 8930b extending distally from the nozzle portion 8930a.
• the nozzle portion 8930a permits rotation of the end effector 8940 relative to the handle assembly 8920.
• a flex circuit 8934 is configured to transmit power to the end effector 8940 through the nozzle portion 8930a.
• the flex circuit 8934 comprises a proximal flex circuit segment 8934a disposed on the handle assembly 8920 and a distal flex circuit segment 8934c disposed on the shaft portion 8930b and the end effector 8940.
• the flex circuit 8934 includes a conductive metal segment 8934b frictionally connected to the proximal flex circuit segment 8934a and fixedly connected to the distal flex circuit segment 8934c.
• the conductive metal segment 8934b facilitates rotation of the shaft 8930 and the end effector 8940 relative to the handle assembly 8920 while maintaining an electrical connection between the handle assembly 8920 and the end effector 8940.
• the conductive metal segment 8934b includes a conductive ring 8935 frictionally attached to the proximal flex circuit segment 8934a.
• the flex circuit 8934 is configured to transmit power from an external power source 8926 to the end effector 8940.
• the external power source 8926 is disposed onto the disposable outer housing 8924.
• a connection between the external power source 8926 and the flex circuit 8934 can be protected from surrounding environment by being partially, or fully, embedded in the disposable outer housing 8924, for example.
• the external power source 8926 includes a connection port 8927 configured to receive a proximal end of the proximal flex circuit segment 8934a.
• the inner core 8922 may include an internal power pack that powers the motor assembly and a control circuit.
• the power pack electrically coupled to the flex circuit 8934 and/or the external power source 8926 by an electrical interface assembly 8570 in a similar manner to that described in connection with the surgical instrument system 8500.
• the external power source 8926 is fully replaced by the internal power pack of the inner core 8922. In such examples, power is transmitted to the flex circuit 8934 from the internal power pack through the sterile barrier via the electrical interface assembly 8570.
• the flex circuit 8934 may also include an end effector segment 8934d configured to connect the distal flex circuit segment 8934c to a staple cartridge 8944 releasably coupled to the end effector 8940.
• the end effector segment 8930d comprises sufficient slack to prevent over extension of the end effector segment 8930d, which can be caused by end effector motions.
• a surgical instrument system 9000 is similar in many respects to the surgical instrument system 8500.
• the surgical instrument system 9000 also includes a handle assembly 9020 that includes an inner core 9022 which has a motor assembly for motivating a drive member configured to effect a closure motion and/or a firing motion in an end effector (e.g. end effector 8540).
• a disposable outer housing 9024 defines a sterile barrier 9025 around the inner core 9022.
• the handle assembly 9020 further includes an electrical interface assembly 9070 configured to transmit at least one of data signal and power between the inner core 8922 and the end effector 8540 through the sterile barrier 9025 defined by the disposable outer housing 9024.
• the electrical interface assembly 9070 includes an internal piezoelectric transducer 9071 coupled to an internal power pack 9026 configured to energize the internal piezoelectric transducer 9071.
• the electrical interface assembly 9070 further includes a lens coupled to the internal piezoelectric transducer 9071 , and configured to focus ultrasound energy generated by the internal piezoelectric transducer 9071 through a gel-like membrane 9072 into an external piezoelectric transducer 9073.
• FIG. 11 depicts a modular surgical instrument system 9100 similar in many respects to the surgical instrument system 8500.
• the modular surgical instrument system 9100 also includes a handle assembly 9120, a shaft 9130, and a loading unit 9140 including a proximal shaft portion 9140a and an end effector 9140b.
• the loading unit 9140 is releasably connectable to a distal shaft portion 9130b of the shaft 9130.
• a nozzle portion 9130a of the shaft 9130 is also releasably connectable to the handle assembly 9120.
• a staple cartridge 9144 is releasably connectable to the end effector 9140b. In other instances, the staple cartridge is integrated with the end effector 9140b.
• the handle assembly 9120 includes an inner core 9122 and a disposable outer housing 9124 configured to selectively receive and encase the inner core 9122 to establish a sterile barrier 9125 around the inner core 9122.
• Inner core 9122 is motor operable and configured to drive an operation of a plurality of types of end effectors.
• Inner core 9122 has a plurality of sets of operating parameters (e.g., speed of operation of motors of inner core 9122, an amount of power to be delivered by motors of inner core 9122 to a shaft assembly, selection of motors of inner core 9122 to be actuated, functions of an end effector to be performed by inner core 9122, or the like).
• Each set of operating parameters of inner core 9122 is designed to drive the actuation of a specific set of functions unique to respective types of end effectors when an end effector is coupled to inner core 9122.
• inner core 9122 may vary its power output, deactivate or activate certain buttons thereof, and/or actuate different motors thereof depending on the type of end effector that is coupled to inner core 9122.
• the inner core 9122 defines an inner housing cavity that accommodates a power pack and one or more motors powered by the power pack.
• the rotation of motors function to drive shafts and/or gear components of the shaft 9130, for example, in order to drive the various operations of end effectors attached thereto, for example, end effector 9140.
• the outer housing 9124 includes two housing portions 9124a, 9124b releasably attached to one another to permit assembly with the inner core 9122.
• the housing portion 9124b is movably coupled to the housing portion 9124a by a hinge located along an upper edge of the housing portion 9124b. Consequently, the housing portions 9124a, 9124b are pivotable relative to one another between a closed, fully coupled configuration, as shown in FIG. 11 , and an open, partially detached configuration. When joined, the housing portions 9124a, 9124b define a cavity therein in which inner core 9122 may be selectively situated.
• the control circuit 9160 includes a memory unit that stores program instructions.
• the program instructions when executed by a processor, cause the processor to control the motor assembly, a feedback system, and/or one or more sensors, for example.
• the feedback system can be employed by the control circuit 9160 to perform a predetermined function such as, for example, issuing an alert when one or more predetermined conditions are met.
• the feedback systems may comprise one or more visual feedback systems or a visual interface such as display screens, backlights, and/or LEDs, for example.
• the feedback systems may comprise one or more audio feedback systems such as speakers and/or buzzers, for example.
• the feedback systems may comprise one or more haptic feedback systems, for example.
• the feedback systems may comprise combinations of visual, audio, and/or haptic feedback systems, for example.
• one or more sensors can be configured to detect or measure whether the disposable outer housing 9124 in an open configuration or a closed configuration.
• a Hall Effect sensor 9123 detects a transition of the housing portion 9124a, 9124b to a closed configuration or to an open configuration.
• the control circuit 9160 may receive an input signal indicative of whether the disposable outer housing 9124 is in the open configuration or closed configuration.
• other suitable sensors can be employed to detect the closed configuration and/or the open configuration such as, for example, other magnetic sensors, pressure sensors, inductive sensors, and/or optical sensor.
• the modular surgical instrument system 9100 includes an electrical interface assembly 9170 configured to transmit at least one of data signal and power across the sterile barrier 9125, outside the sterile barrier 9125, and/or within the sterile barrier 9125.
• the at least one of data signal and power is transmitted between one or more of the modular components of the modular surgical instrument system 9100.
• the electrical interface assembly 9170 includes a first interface portion 9180 on a first side (inside the disposable outer housing 9124) of the sterile barrier 9125 and a second interface portion 9190 on a second side (outside the disposable outer housing 9124) of the sterile barrier 9125 opposite the first side.
• the electrical interface assembly 9170 includes a wiring assembly 9171 that includes exteriorly-mounted wiring connections 9101 , 9102, 9103 that electrically couple the second interface portion 9190 to the loading unit 9140, a loading unit-to-shaft connection sensor 9141 , and the nozzle portion 9130a, respectively, and corresponding internally-mounted wiring connections 9101’, 9102’, 9103’ that couple the first interface portion 9180 to the control circuit 9160.
• the wiring connections 9101 , 9102, 9103, 9101 ’, 9102’, 9103’ cooperate with the interface portions 9180, 9190 to transmit signals between the control circuit 9160 and the loading unit 9140, the staple cartridge 9144, the loading unit-to-shaft connection sensor 9141 , and the nozzle portion 9130a, as discussed in greater detail below.
• a buttress is attached to the staple cartridge 9144.
• the wiring connections 9101 , 9101 ’ may facilitation the transmission of signals between the control circuit 9160 and a buttress-attachment sensor configured to detect a buttress unique identifier, for example, as discussed in greater detail below.
• the wiring assembly 9171 further includes internally-mounted wiring connections 9104, 9105, 9106, 9107 configured to electrically couple the control circuit 9160 to a handle assembly-to-shaft connection sensor 9131 , the first housing portion 9124a, the second housing portion, and an inner core-to-handle assembly connection sensor 9121 .
• one or more of the wiring connections of the wiring assembly 9161 comprise connector ends releasably couplable to corresponding connector ends of corresponding modular components of the modular surgical instrument system 9100.
• the handle assembly 9120 may include an electrical interface assembly that facilitates a wired connection through the sterile barrier 9125.
• Wire portions may be passed through the disposable outer housing 9124.
• the wire portions can be partially embedded in a handle assembly outer wall. Suitable insulation can be provided to prevent fluid leakage.
• modular surgical instrument system 9100 various possible modular components of the modular surgical instrument system 9100 are listed along with unique identifier resistances for each of the listed modular components.
• the listed modular components may facilitate surgical stapling, surgical ultrasonic energy treatment, surgical radio-frequency (RF) energy treatment, and various combinations thereof.
• RF radio-frequency
• the modular components include various types of inner cores, handle assemblies, shafts, loading units, staple cartridges with different types and sizes, and/or buttress attachments with different shapes and sizes, which can be assembled in various combinations to form a modular surgical instrument system 9100. Since each modular component comprises a unique identifier resistance, a total sensed resistance can be determined to identify a connected modular configuration based on the unique identifier resistances of its modular components.
• control circuit 9160 may compare an expected value of the total sensed resistance to a measured value of the total sensed resistance to verify, or confirm, the identity of the modular components in a modular configuration.
• control circuit 9160 may receive user input identifying components of modular configuration through a user interface, for example. Additionally, or alternatively, the control circuit 9160 may directly compare expected values of the identifier resistances to corresponding measured values of the identifier resistances to verify, or confirm, the identity of the modular components in a modular configuration, for example.
• control circuit 9160 may compare an expected value of the total sensed resistance to a measured value of the total sensed resistance to assess or detect irregularities in connected modular components of a modular configuration. Additionally, or alternatively, the control circuit 9160 may compare expected values to measured values for each of the modular components to assess or detect irregularities in the connected modular components of a modular configuration.
• a graph 9161 illustrates expected and measured, or detected, identifier resistance values. Based on a comparison of the expected and measured, or detected, resistant identifier values the control circuit 9160 determines that an inner core, a disposable outer housing, a shaft, an end effector, a cartridge, and a buttress with unique identifier resistances Ria, R2a, Rad, R4c, Rsb, Rec, respectively, are connected in a modular configuration.
• lines 9163, 9164 illustrate scenarios where an outer housing and a buttress, respectively, are either not connected or are not authentic. Additionally, lines 9165, 9166 illustrate scenarios where an outer housing and a buttress, respectively, are connected, but are not authentic. In such complex configurations, checking authenticity of the modular components ensures that the modular configuration will work properly
• a deviation between the expected and measured, or detected, resistant identifier values may indicate a not-connected status, a not-authentic status, or other irregularities.
• the amount of deviation dictates whether the control circuit 9160 determines a not-connected status, a not-authentic status, or a connected authentic status.
• the control circuit 9160 may calculate the deviation amount and compare the calculated deviation amount to a predetermined threshold to assess whether the deviation represents a not-connected status, a not-authentic status, or an authentic/connected status.
• a deviation magnitude selected from 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 range of greater than 0% to about 50% indicates a not-authentic status.
• a deviation indicative of a not-authentic status is less than a deviation indicative of a not-connected status.
• FIG. 13 is a logic flow diagram of a process 9150, depicting a control program or a logic configuration for detecting and/or authenticating a modular configuration of a modular surgical instrument system or assembly.
• One or more aspects of the process 9150 can be performed by a control circuit such as, for example, the control circuit 9160 of the modular surgical instruments system 9100.
• the process 9150 includes generating 9152 an interrogation signal to detect, or confirm identity, of modular components of an assembled modular configuration of a modular surgical instruments system 9100. In the event, the identities of the modular components are to be confirmed, the identities could be supplied through a user interface coupled to the control circuit 9160, for example.
• the interrogation signal can be transmitted to the modular components of the modular configuration through the wiring assembly 9171 and/or electrical interface assembly 9170.
• the interrogation signal may trigger a response signal from the 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, identity of the modular components in the modular configuration.
• each of the modular components available for use with the modular surgical instrument system 9100 includes an identifier resistance unique to the modular component.
• the control circuit 9160 may utilize the response signal to calculate the identifier resistances of the modular components of the modular configuration.
• the identities of the modular components of the modular configuration can then be detected 9154, or confirmed, based on the calculated identifier resistances. Confirmation of the identities of the modular components of the modular configuration can be achieved by the control circuit 9160 by comparing the identities entered through the user interface with the identities detected based on the response signal.
• control circuit 9160 causes a current to pass through the wiring assembly 9171 and the electrical interface assembly 9170 to the modular components of the modular configuration.
• the return current can then be sampled to calculate a total sensed resistance of the modular configuration. Since each of the individual modular components has a unique identifier resistance, the control circuit 9160 can determine the identities of the individual modular components based on the total sensed resistance of the modular configuration.
• control circuit 9160 compares an expected value of the total sensed resistance to a determined value of the total sensed resistance to confirm a proper assembly of a modular configuration.
• the expected value is stored in a memory unit, which is accessed by the control circuit 9160 to perform the comparison.
• a deviation between the expected value and the determined value with a magnitude equal to, or at least substantially equal to, the resistance identifier of one or more modular components causes the control circuit 9160 to conclude that the one or more modular components are not connected in the modular configuration.
• the control circuit 9160 may assign a not-connected status.
• the control circuit 9160 may also issue an alert 9151 regarding the one or more modular components through the user interface.
• the control circuit 9160 may further provide instructions for how to properly connect the deemed-unconnected modular components.
• the process 9150 may further include assessing 9155 authenticity of the modular configuration based on the response signal.
• the control circuit 9160 assesses the authenticity of the modular configuration based on a comparison between expected and determined values of the unique identifier resistances of the modular components.
• the control circuit 9160 may compare the magnitude of a detected deviation between expected and determined values of a unique identifier resistance to a predetermined threshold to assess 9155 authenticity of a detected modular component in a modular configuration.
• the predetermined threshold is a threshold range. If the magnitude of the detected deviation is beyond, the predetermined threshold, the control circuit 9160 may select a suitable security response 9156 such as, for example, assigning a non- authentic status to the modular component, issuing an alert through the user interface, and/or temporarily deactivating the surgical instrument system 9100.
• the threshold range is about ⁇ 1%, about ⁇ 2%, about ⁇ 3%, about ⁇ 4%, about ⁇ 5%, about ⁇ 10%, or about ⁇ 20% from the expected value, for example. Other ranges are contemplated by the present disclosure.
• FIG. 14 is a logic flow diagram of a process 9110, depicting a control program or a logic configuration for detecting and/or authenticating a modular configuration of a modular surgical instrument system or assembly.
• One or more aspects of the process 9110 can be performed by a control circuit such as, for example, the control circuit 9160 of the modular surgical instruments system 9100.
• the process 9110 includes detecting 9111 an identification signal of an assembled modular configuration of the modular surgical instrument system 9100.
• the identification signal is a combined response signal transmitted by modular components of the modular configuration in response to an interrogation signal generated by the control circuit 9160.
• control circuit 9160 may assess authenticity of the modular components of the modular configuration. If 9112 the identification signal is detected, the control circuit 9160 measures 9113 a characteristic of the modular configuration, determines 9114 an authentication key based on at least one measurement of the characteristic, and authenticates 9115 the identification signal based on the authentication key. If 9116 the control circuit 9160 determines that the modular configuration is not authentic, the control circuit 9160 may further generate a security response, as described in connection with the process 9150.
• control circuit 9160 is configured to determine the authentication key independently of the identification signal.
• the authentication key can be based on a characteristic common among individual modular components of the modular configuration.
• the common characteristic can be an environmental characteristic.
• the common characteristic can be a location, a radiofrequency (RF) intensity, a sound level, a light level, and/or a magnetic field strength.
• RF radiofrequency
• a modular component of the modular configuration measures the common characteristic, and generates the authentication key based on at least one measurement of the common characteristic.
• the modular component may further encode an identification signal based on the generated authentication key, and transmits the encoded identification signal to the control circuit 9160 through the wiring assembly 9171 and/or the electrical interface assembly 9170.
• the control circuit 9160 may independently measure the common characteristic, and determine the authentication key based on at least one measurement of the common characteristic.
• the control circuit 9160 may further utilize the authentication key to authenticate and/or decode the identification signal received from the modular component.
• the handle assembly 9120 generates a magnetic field with a strength measureable by each of the modular components in a modular configuration.
• the modular components can utilize the measured magnetic field strength to encode identification signals transmitted to the control circuit 9160 through the wiring assembly 9171 and/or the electrical interface assembly 9170.
• the control circuit 9160 separately determines the strength of the magnetic field.
• the control circuit 9160 sets the strength of the magnetic field.
• the control circuit 9160 measures the strength in a similar manner to modular components.
• the control circuit 9160 decodes the encoded identification signals based on an authentication key generated from one or more measurements of the strength of the magnetic field.
• Measuring the magnetic field can be accomplished by one or more sensors such as, for example, a magnetometer.
• the common characteristic is a radio-frequency (RF) intensity, a sound level, or a light level
• the control circuit 9160 employs an RF intensity sensor, an auditory sensor, or a photoelectric sensor, respectively, to measure the common characteristic.
• RF radio-frequency
• FIG. 15 illustrates a handle assembly 9220 of a modular surgical instrument 9200 similar in many respects to the modular surgical instruments 8500, 9100, which are not repeated herein in the same level of detail for brevity.
• the handle assembly 9220 includes an inner core 9222 and a disposable outer housing 9224 configured to selectively receive and encase inner core 9222 to establish a sterile barrier 9225 around the inner core 9222.
• Inner core 9222 is motor operable and configured to drive an operation of a plurality of types of end effectors.
• Inner core 9222 has a plurality of sets of operating parameters (e.g., speed of operation of motors of inner core 9222, an amount of power to be delivered by motors of inner core 9222 to a shaft assembly, selection of motors of inner core 9222 to be actuated, functions of an end effector to be performed by inner core 9222, or the like).
• Each set of operating parameters of inner core 9222 is designed to drive the actuation of a specific set of functions unique to respective types of end effectors when an end effector is operably coupled to inner core 9222.
• inner core 9222 may vary its power output, deactivate or activate certain buttons thereof, and/or actuate different motors thereof depending on the type of end effector that is operably coupled to inner core 9222.
• the outer housing 9224 includes two housing portions 9224a, 9224b releasably attached to one another to permit assembly with the inner core 9222.
• the housing portions 9224a, 9224b are movable relative to one another between a closed, fully coupled configuration, and an open, partially detached, or fully detached, configuration. When joined, the housing portions 9224a, 9224b define a cavity therein in which inner core 9222 may be selectively situated.
• the handle assembly 9220 includes a primary interface assembly 9270 configured to transmit at least one of data and power between the inner core 9222 and at least one of modular components of the modular surgical instrument system 9200.
• the primary interface assembly 9270 includes a first interface portion 9270a disposed onto the inner core 9222 and a second interface portion 9270b disposed on an inner wall of the disposable outer housing 9224.
• the interface portions 9270a, 9270b include corresponding electrical contacts that become electrically connected, or form an electrical connection, when the inner core 9222 is properly assembled with the disposable outer housing 9224.
• the primary interface assembly 9270 facilitates an electrical connection between a power pack 9226 of the inner core 9222 and an external charging system.
• the primary interface assembly 9270 also facilitates the detection of a modular configuration of the modular surgical instrument system 9200 by transmitting at least one of power and data therethrough between the inner core 9222 and the modular configuration.
• the electrical contacts comprise spring contacts such as, for example, leaf-spring contacts.
• the handle assembly 9220 includes a secondary interface 9262 including one or more sensors 9261 configured to detect the presence of the inner core 9222 in the disposable outer housing 9224.
• the control circuit 9260 is configured to confirm a primary connection through the primary interface assembly 9270 based on at least one reading of the sensor 9261 .
• Position and/or sensitivity of a sensor 9261 can be set to detect the inner core 9222 when the inner core 9222 is in the right position and alignment within the disposable outer housing to establish a wired connection between the interface portions 9270a, 9270b.
• readings from the sensor 9261 must be greater than, or equal, to a predetermined threshold to cause the control circuit 9260 to detect that the inner core 9222 is correctly inserted into the disposable outer housing 9224.
• the control circuit 9260 may continuously compare readings of the sensor 9261 to the predetermined threshold to determine whether the inner core 9222 is correctly inserted into the disposable outer housing 9224.
• the senor 9261 comprises 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.
• the control circuit 9260 is configured to identify/detect an inner core 9222 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.
• the control circuit 9260 is further configured to detect a closed configuration of the disposable outer housing 9224 of the handle assembly 9220.
• the control circuit 9260 may detect the closed configuration based on at least one reading of at least one sensor 9264 within the disposable outer housing 9224.
• the sensor 9264 is a proximity sensor.
• the sensor 9264 is a Hall Effect sensor.
• the sensor 9264 can be an inductive sensor, such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor.
• the control circuit 9260 may detect the closed configuration when an input signal is received from a closed-configuration detection circuit 9265.
• 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 becomes a closed-circuit when the disposable outer housing 9224 is in the closed configuration.
• the transition to the closed-circuit causes an electrical signal to be transmitted to the control circuit 9260, which causes the control circuit 9260 to detect/confirm the closed configuration.
• a graph 9280 is depicted. Distance (5) between the housing portions 9224a, 9224b is illustrated on the X-axis, and capacitance measured from the inner core 9222 to the disposable outer housing 9224 is depicted on the Y-axis.
• control circuit 9260 is configured to assess a proper assembly of the inner core 9222 with the disposable outer housing 9224 based on the distance between the housing portions 9224a, 9224b, and based on capacitance measured from the inner core 9222 to the disposable outer housing 9224.
• control circuit 9260 can be configured to assess the proper assembly of the inner core 9222 with the disposable outer housing 9224 based on the distance between the inner core 9222 and the disposable outer housing 9224, and based on capacitance measured from the inner core 9222 to the disposable outer housing 9224.
• a proper assembly of the inner core 9222 with the disposable outer housing 9224 is detected by the control circuit 9260 when two conditions are met, as represented by curved line 9281 of graph 9280.
• the first condition is that a detected distance (6) between a first datum on the first housing-portion 9224a and a corresponding second datum on the second housing-portion 9224b is less than or equal to a predetermined threshold distance.
• the second condition is that a detected value of the capacitance measured from the inner core 9222 to the disposable outer housing 9224 is within a predetermined capacitance range (pF min - F max) ⁇
• curved line 9281 represents a properly assembled handle assembly 9220, wherein the inner core 9222 is properly positioned within the disposable outer housing 9224, and wherein the housing portions 9224a, 9224b are properly sealed in the closed configuration.
• curve lines 9282, 9283, 9284 represent improperly assembled handle assemblies 9220.
• the curve line 9282 indicates that a closed configuration has not been achieved, and the curve line 9283 indicates that the inner core 9222 is not properly positioned with thin the disposable outer housing 9224.
• Capacitance can also be indicative of authenticity of the inner core 9222 and/or the disposable outer housing 9224.
• the predetermined capacitance range ( Fmin- pF max ) also represents a capacitance-based authentication range.
• curved lines 9281 , 9282 of graph 9280 represent an authentic inner core 9222 and/or disposable outer housing 9224, while the curved line 9283 on the graph 9280 illustrates non-authentic inner core 9222 and/or disposable outer housing 9224.
• the curved line 9284 indicates the absence of a capacitive identifier from the inner core 9222.
• a surgical instrument system 9300 is similar in many respects to other surgical instrument systems described elsewhere herein such as, for example, the surgical instrument systems 8500, 9100, 9200, which are not repeated herein at the same level of detail for brevity.
• the surgical instrument system 9300 includes a handle assembly 9320, a shaft assembly 9330, and a loading unit including an end effector 9340 that releasably accommodates a staple cartridge 9341.
• the handle assembly 9320 includes a disposable outer housing 9324 configured to define a sterile barrier 9325.
• An inner core is positionable within the disposable outer housing 9324. The inner core is configured to drive and/or control various functions of the surgical instrument system 9300, as described elsewhere herein with respect to other similar inner cores.
• the surgical instrument system 9300 includes an external power source 9326.
• the external power source 9326 is disposed on to an outer wall of the disposable outer housing 9324. In other examples, the external power source 9326 can be integrated into the disposable outer housing 9324.
• An electrical interface assembly 9328 is configured to transmit at least one of data and power from the handle assembly 9320 to the end effector 9340.
• the electrical interface assembly 9328 includes a flex circuit 9327 extending between, and coupled to, the external power source 9326 and a data communication band 9332 disposed in a nozzle portion 9331 of the shaft assembly 9330.
• the data communication band 9332 comprises an annular shape that permits rotation of the nozzle portion 9331 and other portions of the shaft assembly 9330 without wire entanglement.
• the shaft assembly 9330 includes concentric conductive rings 9337, 9338 that facilitate a transmission of the at least one of power and data therebetween without hindering notation of the shaft assembly 9330.
• the conductive ring 9337 is disposed on an outer surface of an inner portion 9335, and the conductive ring is disposed on an inner annular surface of an outer portion 9336.
• the inner portion 9335 is concentric with the outer portion 9336.
• FIG. 21 is a logic flow diagram of a process 9350 depicting a control program or a logic configuration for disabling an inner core of a handle assembly of a surgical instrument system at an end-of-life event.
• Using the inner core beyond its lifecycle poses a serious risk to the patient.
• Various circuits and other features of the inner core are carefully designed to ensure a safe operation of the inner core within its lifecycle. Beyond the predetermined lifecycle, however, the inner core may not function properly which, in many events, is not discovered until the handle assembly is actually used in surgery.
• the process 9350 can be performed by the handle assembly 9220 of the surgical instrument system 9200, for example.
• the process 9350 detects 9351 a proper assembly of the inner core 9222 with the disposable outer housing 9224.
• a control circuit performing one or more aspects of the process 9350 can be configured to detect the proper assembly based on at least one reading of at least one sensor within the outer housing 9224.
• one or more aspects of the process 9350 can be performed by the control circuit 9260 (FIG. 15).
• the control circuit 9260 can be configured to detect a proper assembly of the inner core 9222 with the disposable outer housing 9224 based on readings from the sensors 9261 , 9264, for example.
• control circuit 9260 is in communication with a counter configured to maintain a usage count of the inner core 9222. In certain instances, the control circuit 9260 is configured to store the usage in a memory unit, for example.
• the process 9355 further determines whether the inner core 9222 is disconnected from the disposable outer housing 9224.
• the disconnection indicates a termination of the usage, or completion of the procedure, that constitutes an end-of-life event based on the usage count. If 9355 it is so, the disconnection triggers a disabling event 9356 of the inner core 9222 to prevent unsafe usage beyond the predetermined end-of-life usage count. Normal operation 9357, however, is continued until the disconnection is detected.
• control circuit 9260 employees a current limiter to ensure that current within the inner core is maintained below a predetermined threshold during normal operation.
• the control circuit 9260 may remove, disable, or disconnect the current limiter, which causes excessive current to pass through the circuitry of the inner core 9222 thereby disabling the inner core. Disabling the inner core prevents unauthorized use thereof beyond a predetermined lifecycle carefully selected to ensure the safe operation of the handle assembly in surgery.
• the handle assembly 9420 is similar in many respects to other handle assemblies described elsewhere herein, which are not repeated herein for brevity.
• the disposable outer housing 9424 is configured to selectively receive and encase inner core 9422 to establish a sterile barrier around the inner core 9422.
• the outer housing 9424 includes two housing portions movable relative to one another between a closed, fully coupled configuration, and an open, partially detached, or fully detached, configuration to accommodate insertion of the inner core 9422 therein.
• the housing portions When joined, the housing portions define a cavity therein in which inner core 9222 may be selectively situated.
• the inner core 9422 includes a power source 9426 that can be in the form of one or more batteries.
• a power source 9426 that can be in the form of one or more batteries.
• connector wires 9427, 9428 electrically connect the inner core 9422 to the disposable outer housing 9424.
• the disposable outer housing 9424 includes one or more cutting members 9437, 9438 configured to cut, or several, one or both of the connector wires 9427, 9428 thereby permanently disconnecting a circuit electrically coupling the disposable outer housing 9424 to the inner core 9422, which disables the disposable outer housing 9424, as illustrated in FIG. 24.
• FIG. 24 In an alternative embodiment, as illustrated in FIG.
• connector wires 9447, 9448 which are similar to the connector wires 9427, 9428, include weekend, or tethering, portions 9457, 9458 that are severed when the housing portions of the disposable outer housing are transitioned to the open configuration.
• a connector wire of a disposable outer housing is coupled to an identifier 9429 of the disposable outer housing.
• the connector wire 9427 is coupled to an RFID chip that is disabled on the connector wire 9427 is cut by the cutting member 9437 during a transition of the disposable outer housing 9424 to an open configuration. Disabling the identifier 9429 prevents an inner core from establishing a successful connection with a used disposable outer housing.
• FIGS. 26-27 illustrate additional safety mechanisms for disabling a disposable outer housing 9524 of a handle assembly 9520 to protect against unsafe reuse of the disposable outer housing 9524 beyond its design capabilities.
• the handle assembly 9520 is similar in many respects to other handle assemblies described elsewhere herein, which are not repeated herein for brevity.
• the disposable outer housing 9524 is configured to selectively receive and encase inner core 9522 to establish a sterile barrier 9525 around the inner core 9522.
• the outer housing 9524 includes two housing portions 9524a, 9524b movable relative to one another between a closed, fully coupled configuration (FIG. 26), and an open, partially detached, or fully detached, configuration (FIG. 27) to accommodate insertion of the inner core 9522 therein.
• the handle assembly 9520 further includes an external power source 9526 connected via a connector wire 9527 extending through the sterile barrier 9525 to a control circuit 9560.
• the external power source 9526 is releasably mounted onto the disposable outer housing 9524, and the connector wire 9527 is severed when the external power source 9526 is released from the disposable outer housing 9524 after completion of the surgical procedure, which disables the disposable outer housing 9524 thereby preventing unsafe reuse thereof.
• a second wire connector 9528 extending between the housing portion 9524a, 9524b, can also be severed when the disposable outer handle 9524 is transitioned to the open configuration to prevent unsafe reuse of the disposable outer housing 9524.
• one or both of the housing portions 9524a, 9524b of a disposable outer housing 9524’ (FIG. 28), 9524” (FIG. 29) are equipped with a mechanical connector 9531 (FIG. 28), 9551 (FIG. 29) that maintains the housing portions 9524a, 9524b in a closed configuration, and is severed or broken when the housing portions 9524a, 9524b are pulled apart after completion of a surgical procedure to recover the inner core 9522, for example.
• a surgical instrument system 9600 is similar in many respects to the surgical instrument systems 8500, 8800.
• the surgical instrument system 9600 also includes a handle assembly 9620 that includes an inner core which has a motor assembly for motivating one or more drive members configured to effect a closure motion, an articulation motion, and/or a firing motion of an end effector 9640.
• a shaft assembly 9630 extends between the end effector 9640 and the handle assembly 9620 to transmit drive motion from the inner core to the end effector 9640 to deploy staples from a staple cartridge 9641.
• the handle assembly 9620 includes a power source 9626 that can be in the form of one or more batteries.
• a sterilization-detection circuit 9660 is coupled to the power source 9626 and to a receiver 9663 connected to a sensor array 9670 configured to monitor a sterilization status of the handle assembly 9620.
• the sensor array 9670 includes a number of sensors 9671 disposed onto an outer surface 9623 of the disposable outer housing 9624.
• the sensors 9671 are configured to detect the sterilization statuses of various portions, or zones, of the handle assembly 9620, which are then communicated to a microcontroller 9661 .
• the microcontroller 9661 causes a user interface 9662 to present the sterilization statuses, as illustrated in FIG. 34.
• the user interface 9662 is in the form of an LED display.
• a representation of the handle assembly 9620 is displayed onto the LED display.
• Each of the various portions, or zones, of the handle assembly 9620 is shown in one of two different visual indicators representing either an acceptable sterilization status or an unacceptable sterilization status.
• the 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, while zones 1 , 3, 4, 6 are assigned an acceptable sterilization status.
• a handle assembly such as, for example, the handle assembly 9620 is re-usable. Accordingly, the handle assembly 9620 is re-sterilized before each use to maintain a sterile surgical field while using the handle assembly 9620 in surgery.
• the handle assembly 9620 is sterilized by exposure to hydrogen peroxide (H2O2).
• H2O2 hydrogen peroxide
• a clinician may wipe the handle assembly 9620 with hydrogen peroxide wipes to sterilize the handle assembly 9620.
• other means of sterilizing the handle assembly 9620 via hydrogen peroxide can be employed, as described elsewhere in the present disclosure in greater detail.
• a handle assembly may include a disposable outer housing and a reusable inner core.
• the sensors 9671 can be disposed onto an outer surface of the inner core to evaluate sterilization statuses of various portions, or zones, of the inner core in a similar manner to that described in connection with the handle assembly 9620.
• 9670 are hydrogen peroxide sensors configured to detect the presence of hydrogen peroxide in each of the zones of the handle assembly 9620. Accordingly, the sensor readings of a sensor
• an acceptable sterilization status corresponds to a reading of the sensor 9671 that is greater than or equal to a predetermined threshold 9673.
• FIG. 36 is a logic flow diagram of a process 9680 depicting a control program or a logic configuration for detecting an end of a lifecycle of a re-serializable component of a surgical instrument system such, as for example, a handle assembly or an inner core.
• the process 9680 detects the end of the lifecycle by counting the number of times the component has been re-sterilized.
• the process 9680 can be implemented by the sterilizationdetection circuit 9660. If 9681 the microcontroller 9661 detects a sensor reading greater than or equal to the predetermined threshold 9673, the microcontroller 9661 increases a count kept by any suitable counter by one. In the event, the re-sterilization is performed by hydrogen peroxide, the sensor reading increases to reach a peak value, then decreases as the hydrogen peroxide begins to evaporate, as illustrated in FIG. 35. To avoid false counts, the microcontroller 9661 is configured to ignore 9683 sensor readings for a predetermined time period.
• a component of a surgical instrument system such as, for example, a handle assembly 9720 includes an outer surface 9723 coated with a coating that changes color upon exposure to a sterilization solution such as, for example, hydrogen peroxide.
• the coating provides a visual indicator of areas 9720a of the handle assembly 9720 that have been sufficiently exposed to hydrogen peroxide and areas 9720b that have not been sufficiently exposed to hydrogen peroxide. This gives the clinician a chance to ensure application of the sterilization solution to all portions of the handle assembly 9720 with sufficient quantities to yield a properly sterilized handle assembly 9720’.
• the resterilization system 9800 includes a receiving chamber 9801 configured to accommodate a reusable handle assembly 9820 of a surgical instrument system.
• the re-sterilization system 9800 can be configured to accommodate other components of a surgical instrument system such as, for example, an inner core a handle assembly.
• the re-sterilization system 9800 includes two portions 9800a, 9800b movable between an open configuration, FIG. 38, and a closed configuration, FIG. 39, to accommodate the re-usable handle assembly 9820.
• a receiving chamber 9801 is defined between the portions 9800a, 9800b of the re-sterilization system 9800.
• a number of irrigation ports 9806 are defined in the portion 9800b. Additionally, or alternatively, irrigation ports can be defined in the portion 9800a.
• the re-sterilization system 9800 includes a charging port 9804 and corresponding connectors 9805 configured to connect the handle assembly 9820 to a charging system while the handle assembly 9820 is in the receiving chamber.
• the irrigation ports 9802 are connected to a source of sterilization solution that is delivered through the irrigation ports 9802 into the receiving chamber 9801.
• a pump can be utilized to inject the sterilization solution through the irrigation ports 9802 and to remove it in a re-sterilization cycle.
• a resterilization system 9800’ includes a receiving chamber 9811 that includes an absorbent material or cloth 9812 saturated with a sterilization solution.
• a motor 9814 causes a driver 9813 to repeatedly move the cloth 9812 between a starting position and an end position relative to a handle assembly 9820 to re-sterilize the handle assembly.
• the motor 9814 may cause the driver 9813 to move the handle assembly 9820 between a starting position and an end position relative to the cloth 9812.
• the primary interface assembly 9270 includes a wireless electrical interface 9230 and a wired electrical interface 9240.
• the wireless electrical interface 9230 and the wired electrical interface 9240 are configured to transmit at least one of data and power through the sterile barrier 9225.
• the at least one of power and data can be transmitted between the inner core 9222 and an end effector and/or a shaft assembly of the surgical instrument system 9200.
• the first wireless interface portion 9231 and the second wireless interface portion 9232 are configured to cooperatively form a wireless segment of an electrical pathway between the inner core 9222 and the end effector and/or between the inner core 9222 and the shaft assembly.
• one or more flex circuits can be configured to define one or more segment of the electrical pathway.
• the wireless electrical interface 9230 includes a first wireless interface portion 9231 housed by the inner core 9222, and a second wireless interface portion 9232 releasably attachable to an outer wall 9227 of the disposable outer housing 9224.
• the second wireless interface portion 9232 is integrated with the outer wall 9227 of the disposable outer housing 9224.
• the first wireless interface portion 9231 is located within an outer wall 9229 of the inner core 9222. In other examples, however, the first wireless interface portion 9231 can be, at least partially, disclosed on an outer surface of the outer wall 9229.
• second wireless interface portion 9232 is magnetically couplable to the first wireless interface portion 9231 when the inner core 9222 is properly positioned within the disposable outer housing 9224.
• the second wireless interface portion 9232 includes attachment elements 9233’, 9234’ therefore magnetically couplable to corresponding attachment elements 9233, 9234 of the first wireless interface portion 9231.
• the attachment elements 9233’, 9234’ are magnetic elements, and the corresponding attachment elements 9233, 9234 are ferrous elements.
• the attachment elements 9233’, 9234’ are ferrous elements, and the corresponding attachment elements 9233, 9234 are magnetic elements.
• the attachment elements 9233’, 9234’ and the corresponding attachment elements 9233, 9234 are magnetic elements.
• the attachment elements 9233, 9234, 9233’, 9234’ cooperate to ensure a proper alignment between an inductive element 9235 of the first wireless interface portion 9231 and a corresponding inductive element 9235’ of the second wireless interface portion 9232, as illustrated in FIG. 41 .
• the inductive elements 9235, 9235’ are in the form of wound wire coils that are components of inductive circuits 9236, 9236’, respectively.
• the wire coils of the inductive elements 9235, 9235’ comprise a copper, or copper alloy, wire; however, the wire coils may comprise suitable conductive material, such as aluminum, for example.
• the wire coils can be wound around a central axis any suitable number of times.
• the wire coils of the inductive elements 9235, 9235’ are properly aligned about a central axis extending therethrough.
• the proper alignment of the wire coils of the inductive elements 9235, 9235’ improves the wireless transmission of the at least one of data and power therethrough.
• the wired electrical interface 9240 includes a first wired interface portion 9241 on the first side of the sterile barrier 9225, and a second wired interface portion 9242 on the second side of the sterile barrier 9225.
• the wired electrical interface 9240 further includes connectors 9243, 9243’ configured to cooperate with the first wired interface portion 9241 and second wired interface portion 9242 to facilitate a wired transmission of at least one data and power through the sterile barrier 9225 without contaminating the sterile environment protected by the sterile barrier 9225.
• the wired electrical interface 9240 defines two wired electrical pathways extending through the sterile barrier 9225. In other examples, however, the wired electrical interface 9240 may define more or less than two wired electrical pathways.
• the connectors 9243, 9243’ include bodies 9244, 9244’ that extend through the outer wall 9227 of the disposable outer housing 9224.
• the connectors 9243, 9243’ further include inner contacts 9245, 9245’ that are inside the disposable outer housing 9224, and outer contacts 9246, 9246’ that are outside the disposable outer housing 9224.
• the second wired interface portion 9242 includes flex circuits 9250, 9250’ terminating at connectors 9247, 9247’ configured to form a sealed connection with the outer contacts 9246, 9246’.
• the connectors 9247, 9247’ comprise insulative outer housings 9248, 9248’ configured to receive and guide the outer contacts 9246, 9246’ into an electrical engagement with corresponding electrical contacts of the flex circuit 9250, 9250’.
• the bodies 9244, 9244’ are tightly fitted through the outer wall 9227 of the disposable outer housing 9224 to prevent, or at least resist, fluid contamination.
• the insulative outer housings 9248, 9248’ comprise flush ends that rest against an outer surface of the outer wall 9227 to prevent, or at least resist, fluid contact with the outer contacts 9246, 9246’ in operation.
• the inner contacts 9245, 9245’ of the connectors 9243, 9243’ are configured to engage leaf spring contacts 9249, 9249’ when the inner core 9222 is properly assembled with the disposable outer housing 9224.
• the outer walls 9227, 9229 comprise portions that are flush with one another to facilitate the wireless connection between the first wireless interface portion 9231 and the second wireless interface portion 9232.
• the outer walls 9227, 9229 also comprise portions that are spaced apart to facilitate the wired connection between the inner contacts 9245, 9245’ and the leaf spring contacts 9249, 9249’.
• a portion of the outer wall 9227 is slightly raised, which forms an isolated chamber 9255 between the outer walls 9227, 9229.
• the isolated chamber 9255 has a predetermined depth that ensures a good electrical contact between the inner contacts 9245, 9245’ and the leaf spring contacts 9249, 9249’ in the assembled configuration, as illustrated in FIG 41.
• one or more of the surgical instrument systems of the present disclosure include a display for providing feedback to a user, which may include information about one or more characteristics of the tissue being treated and/or one or more parameters of the surgical instrument system.
• the display may provide the user with information regarding the size of a staple cartridge assembled was the surgical instrument system and/or a measured thickness of the tissue being treated.
• the display can be a flexible display, for example.
• a flexible display 9201 is incorporated into the disposable outer housing 9224.
• a microcontroller 9202 resides beneath the flexible display 9201 .
• the flexible display 9201 is configured to face the outside of the disposable outer housing 9224, while the microcontroller 9202 is configured to face the inside of the disposable outer housing 9224.
• the flexible display 9201 can connected through a wireless or a wired electrical interface to a suitable power source.
• the flexible display 9201 is powered by the power source 9226 of the inner core 9222.
• the flexible display 9201 is powered by an external power source attachable to the disposable outer housing 9224.
• the flexible display 9201 can be incorporated into a shaft of a surgical instrument system.
• the flexible display 9201 is bent to conform to, or at least substantially conform to, the cylindrical shape of the shaft.
• the flexible display 9201 is incorporated into an outer wall of the shaft.
• the flexible display 9201 is positioned underneath, or inside, the shaft, and is visible through a clear outer wall of the shaft. Positioning the flexible display 9201 on the disposable outer housing 9224, or within the shaft, helps against fog accumulation on the display which may occur if a display is located with the inner core 9222 inside the disposable outer housing 9224 due to the heat generated by the motor assembly of the inner core 9222.
• an actuator 10000 can be incorporated into a handle assembly of a surgical instrument system such as, 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.
• the actuator 10000 can be configured to cause an inner core 8522, for example, to produce drive motions to close, fire, and/or articulate the end effector 8540 that are proportional a mechanical pressure applied by a user, as detected by the actuator 10000.
• the actuator 10000 comprises a magnetostrictive transducer configured to change a magnetic field in response to the amount of force applied thereto.
• the actuator 10000 illustrates different actuation configurations of the actuator 10000, and the amount of strain produced from null magnetization (configuration 1) to full magnetization (configurations 1 , 5).
• the actuator 10000 is divided into discrete mechanical and magnetic attributes that are coupled in their effect on the magnetostrictive core strain and magnetic induction.
• a control circuit 8560 may adjust the drive motions produced by the inner core 8522, for example, based on readings of a magnetic sensor configured to measure the flux fields generated by the actuator 10000 in response to an actuation force applied by a user to the actuator 10000.
• FIG. 44 is a graph 10001 that illustrates changes in closure position (Y-axis) of the jaws of the end effector 8540, for example, in response to actuation force (X-axis) applied by a user, as detected by the actuator 10000.
• a fully closed configuration of the end effector 8540 corresponds to a predetermined actuation force threshold 10002, which corresponds to configuration 5 of the actuator 10000, as illustrated in FIG. 43.
• control circuit 8560 causes the drive motions to stop by deactivating one or more motors of the inner core 8522, for example. Furthermore, the control circuit 8560 may further reverse the direction of rotation of the motor to transition the end effector 8540 back to the open configuration.
• FIGS. 42-44 illustrate the utilization of the actuator 10000 as an end effector closure actuator.
• the actuator 10000 can be similarly utilized to effect and control a firing motion and/or an articulation motion of the end effector 8540, for example.
• a handle assembly 9920 is similar in many respects to other handle assemblies described elsewhere herein such as, for example, the handle assemblies 8520, 9120, 9220, which are not repeated herein for brevity.
• the handle assembly 9920 also includes an inner core 9922 which has a motor assembly for motivating one or more drive members configured to effect a closure motion, an articulation motion, and/or a firing motion in an end effector (e.g. end effector 8540).
• the handle assembly 9920 further includes a disposable outer housing 9924 that includes two housing portions 9924a, 9924b releasably attached to one another to permit assembly with the inner core 9922. When joined, the housing portions 9924a, 9924b define a cavity therein in which inner core 9922 may be selectively situated within a sterile barrier 9925 defined by an outer wall 9927 of the disposable outer housing 9924.
• the handle assembly 9920 includes an actuator 9901 configured to transform changes in an external actuation force (F) applied by a user to the actuator 9901 into changes in an internal magnetic field detectable by one or more magnetic field sensors 9902 within the handle assembly 9920.
• the actuator 9901 permits an accurate detection by the inner core 9922 of the changes in the external actuation force (F) without compromising the sterile barrier 9925.
• the housing portion 9924b includes a pressure-sensitive actuation member 9923 configured to detect the changes in the external actuation force (F).
• a stem 9905 extends from the pressure-sensitive actuation member 9923 inside the disposable outer housing 9924, and is configured to abut against a rigid surface 9906 of the inner core 9922 when the inner core 9922 is properly assembled with the disposable outer housing 9924, as illustrated in FIG. 46.
• a wire coil 9903 is wound around the stem 9905, and is configured to form a magnetic field when a current is passed therethrough.
• the wire coil 9903 is a part of a circuit powered by a power source 9926 of the inner core 9922, for example.
• the inner core 9922 includes a control circuit 9960 connected to the magnetic field sensor 9902.
• the control circuit 9960 is also connected to a motor assembly 9962 of the inner core 9922, and is configured to cause the motor assembly 9962 to adjust drive motions generated by the motor assembly 9962 in accordance with changes in the external actuation forces (F) as detected by the control circuit 9960 based on readings of the magnetic field sensor 9902.
• the drive motions are configured to close, fire, and/or articulate an end effector operably coupled to the hand assembly 9920.
• control circuit 9960 includes a storage medium such as, for example, a memory unit that stores one or more databases, formulas, and/or tables that can be utilized to select one or more parameters of the drive motions based on the readings of the magnetic field sensor 9902.
• a storage medium such as, for example, a memory unit that stores one or more databases, formulas, and/or tables that can be utilized to select one or more parameters of the drive motions based on the readings of the magnetic field sensor 9902.
• the wire coil 9903 comprise a copper, or copper alloy, wire; however, the wire coil 9903 may comprise suitable conductive material, such as aluminum, for example.
• the wire coil 9903 can be wound around the stem 9905 any suitable number of times.
• a handle assembly 11020 is similar in many respects to other handle assemblies described elsewhere herein such as, for example, the handle assemblies 9920, 8520, 9120, 9220, which are not repeated herein for brevity.
• the handle assembly 11020 also includes an inner core 11022 which has a motor assembly for motivating one or more drive members configured to effect a closure motion, an articulation motion, and/or a firing motion in an end effector (e.g. end effector 8540).
• the handle assembly 11020 further includes a disposable outer housing 11024 that includes two housing portions 11024a, 11024b releasably attached to one another to permit assembly with the inner core 11022. When joined, the housing portions 11024a, 11024b define a cavity therein in which inner core 11022 may be selectively situated within a sterile barrier 11025 defined by an outer wall 11027 of the disposable outer housing 11024.
• the handle assembly 11020 includes an actuator 11001 configured to detect an external compression force (F) applied by a user to the actuator 9901 and, in response, cause an electromechanical member 11023 to produce vibrations when the external actuation force (F) is greater than or equal to a predetermined threshold 11002, as illustrated in graph 11004 of FIG. 49.
• the electromechanical member 11023 is in the form of a piezoelectric film or, alternatively, a ceramic member.
• the electromechanical member 11023 is coupled to a power source 11026 of the inner core 11022 which supplies power to the electromechanical member 11023 when a conductive member 11003 closes a circuit connecting the electromechanical member 11023 to the power source 11026.
• a handle assembly 12020 is similar in many respects to other handle assemblies described elsewhere herein such as, for example, the handle assemblies 9920, 8520, 9120, 9220, 11020, which are not repeated herein for brevity.
• the handle assembly 12020 also includes an inner core 12022 which has a motor assembly for motivating one or more drive members configured to effect a closure motion, an articulation motion, and/or a firing motion in an end effector (e.g. end effector 8540).
• the handle assembly 12020 further includes a disposable outer housing 12024 that includes two housing portions releasably attached to one another to permit assembly with the inner core 12022. When joined, the housing portions define a cavity therein in which inner core 12022 may be selectively situated within a sterile barrier 12025 defined by an outer wall 12027 of the disposable outer housing 12024.
• the handle assembly 12020 includes an actuator 12001 configured to detect an external compression force (F) applied by a user to the actuator 12001 .
• the detection occurs across the sterile barrier 12025.
• the external compression force (F) is applied on a first side of sterile barrier 12025, and is detected on a second side, opposite the first side, of the sterile barrier 12025, without compromising the sterile barrier 12025.
• the actuator 12001 includes components on both sides of the sterile barrier 12025 that are capable of a magnetic interaction across the sterile barrier 12025.
• a ferromagnetic plate, or film, 12002 is positioned outside the disposable outer housing 12024, and a corresponding magnetic sensor 12003 is positioned inside the disposable outer housing 12024.
• a movement of the ferromagnetic plate 12002, in response to the external compression force (F), causes a change in the readings of the magnetic sensor 12003 commensurate with the change in position of the ferromagnetic plate 12002 caused by the external compression force (F).
• a control circuit 120060 of the handle assembly 12020 may include a microcontroller 120061 configured to adjust drive motions of a motor assembly 120062 in accordance with the readings of the magnetic sensor 12003.
• the drive motions may effect one or more of a closure motion, a firing motions, and an articulation motion of an end effector, for example.
• the ferromagnetic plate 12002 extends across a cavity 12031 defined in the outer wall 12027 of the disposable outer housing 12024. Edges of the ferromagnetic plate 12002 or attached to sidewalls of the cavity 12031 . In the illustrated example, form-in-place seals 12029, 12030 are configured to attach the edges of the ferromagnetic plate 12002 to the sidewalls of the cavity 12031 . However, in other examples, it is envisioned that other attachment mechanisms can be employed. 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 .
• the magnetic sensor 12003 protrudes through an outer wall 12028 of the inner core 12022, and is compressed by a spring 12004 against the outer wall 12027.
• the spring 12004 ensures that the magnetic sensor 12003 remains in sufficient proximity to the ferromagnetic plate 12002 to detect changes in the position of the ferromagnetic plate 12002 caused by the external compression force (F).
• the magnetic sensor 12003 and the ferromagnetic plate 12002 are aligned with each other on opposite sides of a wall portion of the outer wall 12027 that forms the cavity 12031 .
• the ferromagnetic plate 12002 is configured to move, or bend, toward the magnetic sensor 12003 in response to the external compression force (F).
• the movement of the ferromagnetic plate 12002 changes the readings of the magnetic sensor 12003 in accordance with the magnitude of the external compression force (F).
• FIGS. 52-54 alternative actuator embodiments are depicted.
• FIG. 52-54 alternative actuator embodiments are depicted.
• the handle assembly 13020 also includes an inner core 13022 which has a motor assembly for motivating one or more drive members configured to effect a closure motion, an articulation motion, and/or a firing motion in an end effector (e.g. end effector 8540).
• the handle assembly 13020 further includes a disposable outer housing 13024 that includes two housing portions releasably attached to one another to permit assembly with the inner core 13022. When joined, the housing portions define a cavity therein in which inner core 13022 may be selectively situated within a sterile barrier 13025 defined by an outer wall 13027 of the disposable outer housing 13024.
• the handle assembly 13020 includes an actuator 13001 similar in many respects to the actuator 12001 , which are not repeated for brevity.
• the actuator 13001 includes a ferromagnetic plate 13002 similar in many respects to the ferromagnetic plate 12002.
• the ferromagnetic plate 13002 is connected to the inner core 13022 via wire connectors 13023 that extend through an outer wall of the inner core 13022.
• an adhesive 13029 is configured to seemingly secure the ferromagnetic plate 13002 to an opening 13031 of the disposable outer housing 13024.
• the ferromagnetic plate 13002 defines a portion of the outer wall 13027.
• a flexible rubberized outer cover 13033 is disposed over the ferromagnetic plate 13002 forming a portion of the outer wall 13027.
• the flexible rubberized outer cover 13033 can be attached to the outer wall 13027 via a form-in- place seal and/or an adhesive 13034.
• the ferromagnetic plate 13002 and the flexible rubberized outer cover 13033 provide a double seal that ensures the integrity of the sterile barrier 13025.
• the surgical instrument systems described herein are motivated by an electric motor; however, the surgical instrument systems described herein can be motivated in any suitable manner. In certain instances, the motors disclosed herein may comprise a portion or portions of a robotically controlled system.
• an end effector in accordance with certain embodiments can apply vibrational energy to seal the tissue.
• Example 1 A modular surgical instrument system that comprises a handle assembly.
• the handle assembly comprises a disposable outer housing configured to define a sterile barrier.
• the disposable outer housing comprises a first housing-portion and a second housingportion movable relative to the first housing-portion between an open configuration and a closed configuration.
• the handle assembly further comprises a control inner core receivable inside the disposable outer housing in the open configuration.
• the disposable outer housing is configured to isolate the control inner core in the closed configuration.
• the modular surgical instrument system further comprises a primary wired interface configured to transmit at least one of data and power between the control inner core and at least one of modular components of the modular surgical instrument system, a secondary interface comprising a sensor located within the outer housing, and a control circuit configured to confirm a primary connection through the primary wired interface based on 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 Examples 1 , 2, or 3, herein the primary connection is detectable only when the control inner core is properly inserted into the disposable outer housing.
• Example 5 The modular surgical instrument system of Examples 1 , 2, 3, or 4, wherein the sensor is a first sensor, wherein 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 at least one reading of the second sensor.
• Example 7 The modular surgical instrument system of Examples 5 or 6, wherein the control circuit is configured to assess a 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.
• Example 8 The modular surgical instrument system of Examples 1 , 2, 3, 4, 5, 6, or 7, wherein the first housing-portion and the second-housing portion comprise electrical contacts of a closed-configuration detection circuit.
• Example 9 The modular surgical instrument system of Example 8, wherein the control circuit is configured to detect the closed configuration based on an electrical signal transmitted between the electrical contacts.
• Example 10 A handle assembly for use with a modular surgical system.
• the handle assembly comprises a disposable outer housing configured to define a sterile barrier.
• the disposable outer housing comprises 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 comprises a control inner core receivable inside the disposable outer housing in the open configuration, wherein the disposable outer housing is configured to isolate the control inner core in the closed configuration.
• the handle assembly further comprises 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, and a control circuit configured to assess a proper assembly of the disposable outer housing with the control inner core based on at least one reading of the first sensor and at least one reading of the second sensor.
• Example 11 The handle assembly of Example 10, wherein the control circuit is configured to detect the closed configuration based on a distance between the first housingportion and the second housing-portion.
• Example 12 The handle assembly of Example 11 , wherein the control circuit is configured to detect the closed configuration when the distance between the first housingportion and the second housing-portion is less than or equal to a predetermined distance.
• Example 13 The handle assembly of Examples 10, 11 , or 12, wherein the second sensor is a magnetic sensor.
• Example 14 The handle assembly of Examples 10, 11 , 12, or 13, wherein the first sensor is a capacitive sensor.
• Example 15 The handle assembly of Examples 10, 11 , 12, 13, or 14, wherein 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 a current limiter.
• Example 17 The handle assembly of Examples 10, 11 ,12, 13, 14, 15, or 16, wherein the disposable outer housing comprises a disabling mechanism for preventing re-use of the disposable outer housing.
• Example 18 The handle assembly of Example 17, wherein the disabling mechanism is activatable by transitioning the first housing-portion and the second housing-portion from the closed configuration to the open configuration.
• Example 19 A handle assembly for use with a modular surgical system.
• the handle assembly comprises an outer surface, a sensor array comprising sensors secured into the outer surface in predetermined zones of the handle assembly, and a disposable outer housing configured to define a sterile barrier.
• the disposable outer housing comprises a re-sterilization- detection circuit that detects a re-sterilization status of each of the zones based on readings from the sensors.
• Example 20 The handle assembly of Example 19, wherein the re-sterilization- detection circuit is configured to assess an end of a lifecycle of the handle assembly based on the readings of the sensors.
• Instructions used to program logic to perform various disclosed aspects can be stored within a memory in the system, such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Furthermore, the instructions can be distributed via a network or by way of other computer readable media.
• DRAM dynamic random access memory
• cache cache
• flash memory or other storage.
• the instructions can be distributed via a network or by way of other computer readable media.
• a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, compact disc, read-only memory (CD-ROMs), and magneto-optical disks, read-only memory (ROMs), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, flash memory, or a tangible, machine-readable storage used in the transmission of information over the Internet via electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.).
• a machine e.g., a computer
• control circuit includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
• control circuit may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including 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 array (FPGA)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof.
• DSP digital signal processor
• PLD programmable logic device
• PLA programmable logic array
• FPGA field programmable gate array
• the control circuit may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IO), an application-specific integrated circuit (ASIC), a system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smart phones, etc.
• IO integrated circuit
• ASIC application-specific integrated circuit
• SoC system on-chip
• control circuit includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes and/or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and/or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and/or electrical circuitry forming a communications device (e.g., a modem, communications switch, or optical-electrical equipment).
• a computer program e.g., a general purpose computer configured by a computer program which at least partially carries out processes and/or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and/or devices described herein
• electrical circuitry forming a memory device
• logic may refer to an app, software, firmware and/or circuitry configured to perform any of the aforementioned operations.
• Software may be embodied as a software package, code, instructions, instruction sets and/or data recorded on non-transitory computer readable storage medium.
• Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in memory devices.
• an “algorithm” refers to a self-consistent sequence of steps leading to a desired result, where a “step” refers to a manipulation of physical quantities and/or logic states which may, though need not necessarily, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common usage to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.
• a network may include a packet switched network.
• the communication devices may be capable of communicating with each other using a selected packet switched network communications protocol.
• One example communications protocol may include an Ethernet communications protocol which may be capable permitting communication using a Transmission Control Protocol/lnternet Protocol (TCP/IP).
• TCP/IP Transmission Control Protocol/lnternet Protocol
• the Ethernet protocol may comply or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) titled “IEEE 802.3 Standard”, published in December, 2008 and/or later versions of this standard.
• the communication devices may be capable of communicating with each other using an X.25 communications protocol.
• the X.25 communications protocol may comply or be compatible with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T).
• the communication devices may be capable of communicating with each other using a frame relay communications protocol.
• the frame relay communications protocol may comply or be compatible with a standard promulgated by Consultative Committee for International Circuit and Telephone (CCITT) and/or the American National Standards Institute (ANSI).
• the transceivers may be capable of communicating with each other using an Asynchronous T ransfer Mode (ATM) communications protocol.
• ATM communications protocol may comply or be compatible with an ATM standard published by the ATM Forum titled “ATM-MPLS Network Interworking 2.0” published August 2001 , and/or later versions of this standard.
• ATM-MPLS Network Interworking 2.0 published August 2001
• One or more components may be referred to herein as “configured to,” “configurable to,” “operable/operative to,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.
• “configured to” can generally encompass active-state components and/or inactive-state components and/or standby-state components, unless context requires otherwise.
• proximal and distal are used herein with reference to a clinician manipulating the handle portion of the surgical instrument.
• proximal refers to the portion closest to the clinician and the term “distal” refers to the portion located away from the clinician.
• distal refers to the portion located away from the clinician.
• spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings.
• surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
• any reference to “one aspect,” “an aspect,” “an exemplification,” “one exemplification,” and the like means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect.
• appearances of the phrases “in one aspect,” “in an aspect,” “in an exemplification,” and “in one exemplification” in various places throughout the specification are not necessarily all referring to the same aspect.
• the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects.
• any numerical range recited herein includes all sub-ranges subsumed within the recited range.
• a range of “1 to 10” includes all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10.
• all ranges recited herein are inclusive of the end points of the recited ranges.
• a range of “1 to 10” includes the end points 1 and 10.
• Any maximum numerical limitation recited in this specification is intended to include all lower numerical limitations subsumed therein, and any minimum numerical limitation recited in this specification is intended to include all higher numerical limitations subsumed therein. Accordingly, Applicant reserves the right to amend this specification, including the claims, to expressly recite any sub-range subsumed within the ranges expressly recited. All such ranges are inherently described in this specification.

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• 2021
  • 2021-11-29 EP EP21819595.6A patent/EP4081134A1/de not_active Withdrawn
  • 2021-11-29 WO PCT/IB2021/061047 patent/WO2022118159A1/en active Application Filing
  • 2021-11-29 JP JP2023533694A patent/JP2023551921A/ja active Pending

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