Surgical stapling system having a frangible RFID tag - Patent application
Patent Information
- Application Number
- JP2021577527
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-06-30
- Filing Date
- 2020-06-18
- Publication Date
- 2025-03-04
- Estimated Expiration
- 2040-06-18
Smart Images

Figure 0007638914000001 
Figure 0007638914000002 
Figure 0007638914000003
Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62 / 868,457, filed June 28, 2019, entitled "SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS," the entire disclosure of which is incorporated herein by reference. [Background technology]
[0002] The present invention relates to surgical instruments, and in various embodiments to a surgical cutting and stapling instrument designed to cut and staple tissue, and a staple cartridge for the surgical cutting and stapling instrument. In various embodiments, RFID technology may be used to identify components of a surgical instrument, such as a staple cartridge. Examples of surgical systems using RFID technology may be found in U.S. Patent No. 7,959,050, issued June 14, 2011, entitled "ELECTRICALLY SELF-POWERED SURGICAL INSTRUMENT WITH MANUAL RELEASE," and U.S. Patent Application Publication No. 2015 / 0053743, published February 26, 2015, entitled "ERROR DETECTION ARRANGEMENTS FOR SURGICAL INSTRUMENT ASSEMBLIES," both of which are incorporated herein by reference in their entireties. [Brief description of the drawings]
[0003] The features and advantages of the present invention, as well as the manner in which they are accomplished, will become more apparent, and the invention itself will be better understood, by reference to the following description of embodiments of the invention in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a perspective view of a surgical instrument comprising a handle, a shaft, and an articulating end effector. [Diagram 2] FIG. 2 is an elevational view of the surgical instrument of FIG. [Diagram 3] FIG. 2 is a plan view of the surgical instrument of FIG. 1. [Figure 4] FIG. 2 is a cross-sectional view of the end effector and shaft of the surgical instrument of FIG. [Diagram 5] FIG. 2 is a detailed view of the articulation joint that rotatably connects the shaft and end effector of FIG. 1, the close-up showing the end effector in a neutral or centered position. [Figure 6] FIG. 2 is a cross-sectional view of the articulation control of the surgical instrument of FIG. 1 in a neutral or centered position. [Figure 7] FIG. 2 is an exploded view of the end effector, elongated shaft, and articulation joint of the surgical instrument of FIG. [Figure 8] FIG. 2 is a cross-sectional view of the end effector, elongated shaft, and articulation joint of the surgical instrument of FIG. [Figure 9] FIG. 2 is a perspective view of an end effector, elongated shaft, and articulation joint of the surgical instrument of FIG. [Figure 10] 2 illustrates the end effector of the surgical instrument of FIG. 1 articulated about an articulation joint; [Figure 11] FIG. 13 is a cross-sectional view of the articulation control of FIG. 6 actuated to move the end effector as shown in FIG. 12. [Figure 12] FIG. 1 is a perspective view of a surgical instrument comprising a handle, a shaft and an articulating end effector. [Figure 13] FIG. 13 is a side view of the surgical instrument of FIG. [Figure 14] FIG. 13 is a perspective view of a firing member and pinion gear positioned within the handle of FIG. 12; [Figure 15] FIG. 15 is a perspective view of the firing member and pinion gear of FIG. 14 and a gear reducer assembly operatively engaged with the pinion gear. [Figure 16]FIG. 13 is a perspective view of the handle of FIG. 12 with portions removed to show the firing member and pinion gear of FIG. 14, the gear reducer assembly of FIG. 15, and an electric motor configured to drive the firing member distally and / or proximally depending on the direction the electric motor is rotated. [Figure 17] FIG. 1 is a perspective view of a surgical instrument including a handle, a shaft, an end effector, and an articulation joint connecting the end effector to the shaft, with portions of the handle removed for purposes of illustration; [Figure 18] FIG. 18 is a cross-sectional view of the surgical instrument of FIG. [Figure 19] FIG. 18 is an exploded view of the surgical instrument of FIG. [Figure 20] FIG. 18 is a cross-sectional detail view of the surgical instrument of FIG. 17 shown with the end effector in an open configuration, the articulation joint in an unlocked configuration, and an articulation lock actuator on the surgical instrument handle in the unlocked configuration; [Figure 21] FIG. 18 is a cross-sectional detailed view of the surgical instrument of FIG. 17 showing the end effector in an articulated open configuration, the articulation joint in an unlocked configuration, and an articulation driver engaged with the firing member of the surgical instrument of FIG. 17, where movement of the firing member can move the articulation driver to articulate the end effector. [Figure 22] FIG. 18 is a cross-sectional detail view of the surgical instrument of FIG. 17 showing the end effector in a closed configuration, the articulation joint in an unlocked configuration, and the end effector closing drive being actuated to close the end effector and move the articulation lock actuator to the locked configuration. [Figure 22A] 23 is a detailed cross-sectional view of the handle of the surgical instrument of FIG. 17 shown in the configuration described in connection with FIG. 22. [Figure 23] FIG. 23 is a cross-sectional detailed view of the surgical instrument of FIG. 17 with the end effector in a closed configuration and the articulation joint in a locked configuration, where an actuated closure drive prevents the articulation lock actuator from being moved into the unlocked configuration shown in FIGS. 20-22. [Figure 24A]FIG. 18 is a top view of the articulation joint of the surgical instrument of FIG. 17 shown in a locked configuration. [Figure 24B] FIG. 18 is a top view of the articulation joint of the surgical instrument of FIG. 17 shown in the unlocked configuration. [Diagram 25] FIG. 18 is a cross-sectional detail view of the handle of the surgical instrument of FIG. 17 showing the articulation driver decoupled from the firing member by the closure drive. [Figure 26] 18 is a cross-sectional detail view of the surgical instrument of FIG. 17 showing the firing member in at least a partially fired position and the articulation driver decoupled from the firing member by the closure drive. [Figure 27] 18 is a cross-sectional detail view of the surgical instrument of FIG. 17 showing the end effector in a closed configuration, the articulation joint and the articulation joint actuator in a locked configuration, and the firing member in a retracted position. [Figure 28] 18 is a cross-sectional detail view of the surgical instrument of FIG. 17 showing the end effector in an open configuration, the end effector closure drive in a retracted position and the articulation joint in a locked configuration; [Figure 29] FIG. 18 is a cross-sectional detailed view of the surgical instrument of FIG. 17 showing the end effector in an open configuration and the articulation joint and articulation joint actuator in an unlocked configuration, where the articulation driver can be reconnected to the firing drive and utilized to re-articulate the end effector. [Diagram 30] FIG. 13 is an exploded view of a shaft and end effector of a surgical instrument having an alternative joint locking device. [Diagram 31] FIG. 31 is a cross-sectional elevation view of the end effector and shaft of the surgical instrument of FIG. 30, showing the end effector in an unlocked configuration; [Diagram 32] FIG. 31 is a cross-sectional elevation view of the end effector and shaft of the surgical instrument of FIG. 30, showing the end effector in a locked configuration; [Diagram 33] FIG. 1 is an assembled view of one form of a surgical system including a surgical instrument and a plurality of interchangeable shaft assemblies. [Diagram 34]FIG. 1 is a perspective view of a surgical instrument handle coupled to an interchangeable shaft assembly. [Diagram 35] FIG. 35 is an exploded perspective view of the surgical instrument handle of FIG. [Diagram 36] FIG. 36 is a side elevational view of the handle of FIG. 35 with a portion of the handle housing removed. [Figure 37] FIG. 2 is an exploded perspective view of the interchangeable shaft assembly. [Figure 38] FIG. 35 is an assembled side view of a portion of the handle and interchangeable shaft assembly of FIG. 34, with parts thereof omitted for clarity, showing the arrangement of the handle and interchangeable shaft assembly before they are coupled together. [Figure 39] FIG. 1 is a perspective view of a portion of an interchangeable shaft assembly prior to attachment to a handle of a surgical instrument. [Diagram 40] FIG. 13 is a side view of a portion of an interchangeable shaft assembly coupled to a handle with a locking yoke in a locked or engaged position with a portion of a frame mounted module of the handle. [Diagram 41] FIG. 41 is another side view of the interchangeable shaft assembly and handle of FIG. 40 with the locking yoke in the disengaged or unlocked position. [Diagram 42] FIG. 2 is a plan view of a portion of the interchangeable shaft assembly and handle before they are coupled together. [Diagram 43] FIG. 43 is another plan view of the interchangeable shaft assembly and handle of FIG. 42 coupled together. [Diagram 44] FIG. 13 is a side elevational view of an interchangeable shaft assembly aligned with a surgical instrument handle prior to being coupled together. [Diagram 45] FIG. 45 is a front perspective view of the interchangeable shaft assembly and surgical instrument handle of FIG. 44, portions of which have been removed for clarity; [Diagram 46] FIG. 1 is a side view of a portion of an interchangeable shaft assembly aligned with a portion of a surgical instrument handle prior to coupling together, with portions of the handle removed for clarity; [Figure 47]FIG. 47 is another side elevational view of the interchangeable shaft assembly and handle of FIG. 46, the shaft assembly being partially mated and engaged with the handle. [Figure 48] FIG. 48 is another side elevational view of the interchangeable shaft assembly and handle of FIGS. 46 and 47 after they have been joined together. [Figure 49] FIG. 13 is another side elevational view of a portion of the interchangeable shaft assembly aligned with a portion of the handle prior to beginning the bonding process. [Figure 50] 13 illustrates one embodiment of a logic diagram for how to correct for the effect of flexible knife band skewing on transection length. [Figure 51] 1 is a schematic diagram of a system for cutting off power to an electrical connector of a surgical instrument handle when the shaft assembly is not coupled to the surgical instrument handle. [Figure 52] 1 is a schematic diagram illustrating a system for controlling the speed of a motor and / or the speed of a drivable member of a surgical instrument disclosed herein. [Diagram 53] 1 is a schematic diagram illustrating another system for controlling the speed of a motor and / or the speed of a drivable member of a surgical instrument disclosed herein. [Figure 54] 1 is a schematic diagram illustrating a control system for controlling various operations of the various surgical instruments described herein, in accordance with various embodiments of the present disclosure. [Figure 54A] FIG. 55 is a partial view of the schematic diagram of FIG. 54. [Figure 54B] FIG. 55 is a partial view of the schematic diagram of FIG. 54. [Figure 55] 1 is a schematic diagram illustrating a switch circuit for a control system according to various embodiments of the present disclosure. [Figure 56] 1 is a schematic diagram illustrating a switch circuit for a control system according to various embodiments of the present disclosure. [Figure 57] 1 is a schematic diagram illustrating a control system for controlling various operations of the various surgical instruments described herein, in accordance with various embodiments of the present disclosure. [Figure 57A]FIG. 58 is a partial view of the schematic diagram of FIG. 57. [Figure 57B] FIG. 58 is a partial view of the schematic diagram of FIG. 57. [Figure 58] 1 is a schematic diagram illustrating a control system for controlling various operations of the various surgical instruments described herein, in accordance with various embodiments of the present disclosure. [Figure 59] 59A-59C are schematic diagrams illustrating various sub-procedures for the transverse incision procedure of FIG. 58, according to various embodiments of the present disclosure. [Figure 60] 60A-60C are diagrams illustrating various sub-procedures for the Fire Out Near Hard Stop procedure of FIG. 59, according to various embodiments of the present disclosure. [Figure 61] FIG. 1 is an elevational view of a surgical instrument comprising a handle, a shaft, and an articulating end effector in accordance with at least one embodiment. [Figure 62] FIG. 12 is a top view of a staple cartridge in accordance with at least one embodiment; [Figure 63] 63 illustrates a serial number structure that may be generated for a staple cartridge, such as the staple cartridge of FIG. 62, in accordance with at least one embodiment. [Figure 64] FIG. 63 is an elevational view of the staple cartridge of FIG. 62; [Figure 65] FIG. 63 is a top view of the staple cartridge of FIG. 62; [Figure 66] FIG. 63 is a cross-sectional plan view of a jaw configured to receive the staple cartridge of FIG. 62; [Figure 67] 1 is a perspective view of an RFID tag according to at least one embodiment. [Figure 68] A partial cross-sectional view of the cartridge body of the staple cartridge of Figure 62. [Figure 69] FIG. 63 is a cross-sectional view of the sled of the staple cartridge of FIG. 62; [Figure 70] FIG. 63 is a perspective view of a removable cover of the staple cartridge of FIG. 62; [Figure 71]FIG. 2 is a cross-sectional view of a sled according to at least one embodiment. [Figure 72] FIG. 71 is an elevational view of an end effector including the sled of FIG. 70 according to at least one embodiment. [Figure 72A] 73 is an elevational view of the end effector of FIG. 72 showing the sled of FIG. 70 being advanced distally during a staple firing stroke; [Fig. 72B] 73 is an elevational view of the end effector of FIG. 72 showing the sled of FIG. 70 at the end of a staple firing stroke. [Figure 73A] FIG. 71 is a detailed view of an RFID tag embedded in the sled of FIG. 70. [Figure 73B] FIG. 13 is a detailed view of an RFID tag being severed at the end of the staple firing stroke. [Figure 74] Two staple cartridges are shown. [Figure 75] An end effector is shown where one of the staple cartridges in FIG. 74 is compatible with the end effector and the other staple cartridge is not compatible with the end effector. [Figure 76] 1 illustrates an algorithm for a control system according to at least one embodiment. [Figure 77] 1 illustrates a flex circuit including an RFID scanner according to at least one embodiment. [Figure 78] 1 is a perspective view of a surgical staple cartridge package having an identification characteristic of a surgical staple cartridge contained therein; FIG. [Figure 79] FIG. 79 is a partial cross-sectional view of an RFID system integrated with the package of FIG. 78 when the package is in a sealed configuration. [Figure 80] FIG. 80 is a partial cross-sectional view of the RFID system of FIG. 79 when the package is in an unsealed configuration. [Figure 81] 1 is a perspective view of a retainer for use with a surgical staple cartridge, the retainer including an integrated RFID tag; [Figure 82]82 is a perspective view of the retainer of FIG. 81 being removed from the surgical staple cartridge; [Figure 83] 83 is a detailed view of the RFID tag of FIGS. 81 and 82 when the retainer is removed from the surgical staple cartridge. FIG. [Figure 84] 1 is a partial perspective view of a surgical staple cartridge with an RFID system with an extended antenna, a portion of the extended antenna traversing the cutting path of a tissue cutting member; [Figure 85] An RFID system including an RFID tag, a first RFID scanner integrated into a first flex circuit layer, and a second RFID scanner integrated into a second flex circuit layer. [Figure 86] 86 is a representation of the communication path of the RFID system of FIG. 85 prior to the staple firing stroke. [Figure 87] 86 is a representation of the communication path of the RFID system of FIG. 85 during and after the staple firing stroke. [Figure 88] FIG. 13 is a partial perspective view of the staple firing lockout system in an unlocked configuration; [Fig. 88A] FIG. 89 is a perspective view of the block bolt assembly of the staple firing lockout system of FIG. 88 in an unlocked configuration. [Figure 89] FIG. 89 is a partial perspective view of the staple firing lockout system of FIG. 88 in a locked configuration. [Figure 89A] FIG. 88B is a perspective view of the block bolt assembly of FIG. 88A in a locked configuration. [Figure 90] FIG. 89B is a motor control circuit diagram for a surgical instrument including the cartridge lockout assembly of FIGS. 88-89A. [Figure 91] 1 is a schematic representation of a manufacturing process configured to use an encryption protocol to facilitate assembly and packaging of a staple cartridge. [Figure 92] 13 is a flow chart depicting a decoding protocol for authenticating a staple cartridge for use with a surgical system.
[0004] Corresponding reference characters indicate corresponding parts throughout the several views. The examples described herein are illustrative of specific embodiments of the invention, in one form or another, and such examples should not be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0005] The applicant of this application has owned the following U.S. patent applications, filed on even date herewith, each of which is incorporated herein by reference in its entirety: -Attorney Docket No. END9145USNP1 / 190235-1M, Title of Invention: "METHOD FOR AUTHENTICATING THE COMPATIBILITY OF A STAPLE CARTRIDGE WITH A SURGICAL INSTRUMENT" -Attorney Docket No. END9146USNP1 / 192036, Title of Invention: "SURGICAL INSTRUMENT SYSTEM COMPRISING AN RFID SYSTEM"; -Attorney Docket No. END9147USNP1 / 190237, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN RFID SYSTEM FOR TRACKING A MOVABLE COMPONENT" -Attorney Docket No. END9148USNP1 / 190238, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN ALIGNED RFID SENSOR" -Attorney Docket No. END9123USNP1 / 192039, Title of Invention: "SURGICAL STAPLING SYSTEM HAVING AN INFORMATION DECRYPTION PROTOCOL" -Attorney Docket No. END9124USNP1 / 190240, Title of Invention: "SURGICAL STAPLING SYSTEM HAVING AN INFORMATION ENCRYPTION PROTOCOL" -Attorney Docket No. END9125USNP1 / 190241, entitled "SURGICAL STAPLING SYSTEM HAVING A LOCKOUT MECHANISM FOR AN INCOMPATIBLE CARTRIDGE"; and -Attorney Docket No. END9127USNP1 / 192043, Title of Invention: "PACKAGING FOR A REPLACEABLE COMPONENT OF A SURGICAL STAPLING SYSTEM."
[0006] The applicant of this application has owned the following U.S. patent applications, filed on even date herewith, each of which is incorporated herein by reference in its entirety: -Attorney Docket No. END9119USNP1 / 190245-1M, Title of Invention: "METHOD OF USING MULTIPLE RFID CHIPS WITH A SURGICAL ASSEMBLY" -Attorney Docket No. END9120USNP1 / 192046, Title of Invention: "MECHANISMS FOR PROPER ANVIL ATTACHMENT SURGICAL STAPLING HEAD ASSEMBLY"; -Attorney Docket No. END9121USNP1 / 192047, Title of Invention: "MECHANISMS FOR MOTOR CONTROL ADJUSTMENTS OF A MOTORIZED SURGICAL INSTRUMENT" -Attorney Docket No. END9122USNP1 / 190248, Title of Invention: "SURGICAL INSTRUMENT WITH BATTERY COMPATIBILITY VERIFICATION FUNCTIONALITY"; -Attorney Docket No. END9131USNP1 / 190249, Title of Invention: "SURGICAL SYSTEM WITH RFID TAGS FOR UPDATING MOTOR ASSEMBLY PARAMETERS" -Attorney Docket No. END9132USNP1 / 190250, Title of Invention: "SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS" -Attorney Docket No. END9149USNP1 / 190251, Title of Invention: "RFID IDENTIFICATION SYSTEMS FOR SURGICAL INSTRUMENTS" -Attorney Docket No. END9150USNP1 / 190252, Title of Invention: "RFID IDENTIFICATION SYSTEMS FOR SURGICAL INSTRUMENTS"; -Attorney Docket No. END9151USNP1 / 192053, Title of Invention: "SURGICAL RFID ASSEMBLIES FOR DISPLAY AND COMMUNICATION" -Attorney Docket No. END9152USNP1 / 190254, Title of Invention: "SURGICAL RFID ASSEMBLIES FOR COMPATIBILITY DETECTION" -Attorney Docket No. END9153USNP1 / 190255, invention title "SURGICAL RFID ASSEMBLIES FOR INSTRUMENT OPERATIONAL SETTING CONTROL".
[0007] The applicant of this application owns the following U.S. patent applications, filed on May 1, 2018, each of which is incorporated by reference in its entirety herein: - U.S. Provisional Patent Application No. 62 / 665,129, entitled "SURGICAL SUTURING SYSTEMS"; - U.S. Provisional Patent Application No. 62 / 665,139, entitled "SURGICAL INSTRUMENTS COMPRISING CONTROL SYSTEMS"; - U.S. Provisional Patent Application No. 62 / 665,177, entitled "SURGICAL INSTRUMENTS COMPRISING HANDLE ARRANGEMENTS"; - U.S. Provisional Patent Application No. 62 / 665,128, entitled "MODULAR SURGICAL INSTRUMENTS"; - U.S. Provisional Patent Application No. 62 / 665,192, entitled "SURGICAL DISSECTORS," and -U.S. Provisional Patent Application No. 62 / 665,134, entitled "SURGICAL CLIP APPLIER."
[0008] The applicant of this application owns the following U.S. patent applications, filed on August 24, 2018, each of which is incorporated by reference in its entirety herein: - U.S. Patent Application No. 16 / 112,129, entitled "SURGICAL SUTURING INSTRUMENT CONFIGURED TO MANIPULATE TISSUE USING MECHANICAL AND ELECTRICAL POWER"; - U.S. Patent Application No. 16 / 112,155, entitled "SURGICAL SUTURING INSTRUMENT COMPRISING A CAPTURE WIDTH WHICH IS LARGER THAN TROCAR DIAMETER"; - U.S. Patent Application No. 16 / 112,168, entitled "SURGICAL SUTURING INSTRUMENT COMPRISING A NON-CIRCULAR NEEDLE"; - U.S. Patent Application No. 16 / 112,180, entitled "ELECTRICAL POWER OUTPUT CONTROL BASED ON MECHANICAL FORCES"; - U.S. Patent Application No. 16 / 112,193, entitled "REACTIVE ALGORITHM FOR SURGICAL SYSTEM"; - U.S. Patent Application No. 16 / 112,099, entitled "SURGICAL INSTRUMENT COMPRISING AN ADAPTIVE ELECTRICAL SYSTEM"; - U.S. Patent Application No. 16 / 112,112, entitled "CONTROL SYSTEM ARRANGEMENTS FOR A MODULAR SURGICAL INSTRUMENT"; - U.S. Patent Application No. 16 / 112,119, entitled "ADAPTIVE CONTROL PROGRAMS FOR A SURGICAL SYSTEM COMPRISING MORE THAN ONE TYPE OF CARTRIDGE"; - U.S. Patent Application No. 16 / 112,097, entitled "SURGICAL INSTRUMENT SYSTEMS COMPRISING BATTERY ARRANGEMENTS"; - U.S. Patent Application No. 16 / 112,109, entitled "SURGICAL INSTRUMENT SYSTEMS COMPRISING HANDLE ARRANGEMENTS"; - U.S. Patent Application No. 16 / 112,114, entitled "SURGICAL INSTRUMENT SYSTEMS COMPRISING FEEDBACK MECHANISMS"; - U.S. Patent Application No. 16 / 112,117, entitled "SURGICAL INSTRUMENT SYSTEMS COMPRISING LOCKOUT MECHANISMS"; - U.S. Patent Application No. 16 / 112,095, entitled "SURGICAL INSTRUMENTS COMPRISING A LOCKABLE END EFFECTOR SOCKET"; - U.S. Patent Application No. 16 / 112,121, entitled "SURGICAL INSTRUMENTS COMPRISING A SHIFTING MECHANISM"; - U.S. Patent Application No. 16 / 112,151, entitled "SURGICAL INSTRUMENTS COMPRISING A SYSTEM FOR ARTICULATION AND ROTATION COMPENSATION"; - U.S. Patent Application No. 16 / 112,154, entitled "SURGICAL INSTRUMENTS COMPRISING A BIASED SHIFTING MECHANISM"; - U.S. Patent Application No. 16 / 112,226, entitled "SURGICAL INSTRUMENTS COMPRISING AN ARTICULATION DRIVE THAT PROVIDES FOR HIGH ARTICULATION ANGLES"; - U.S. Patent Application No. 16 / 112,062, entitled "SURGICAL DISSECTORS AND MANUFACTURING TECHNIQUES"; - U.S. Patent Application No. 16 / 112,098, entitled "SURGICAL DISSECTORS CONFIGURED TO APPLY MECHANICAL AND ELECTRICAL ENERGY"; - U.S. Patent Application No. 16 / 112,237, entitled "SURGICAL CLIP APPLIER CONFIGURED TO STORE CLIPS IN A STORED STATE"; - U.S. Patent Application No. 16 / 112,245, entitled "SURGICAL CLIP APPLIER COMPRISING AN EMPTY CLIP CARTRIDGE LOCKOUT"; - U.S. Patent Application No. 16 / 112,249, entitled "SURGICAL CLIP APPLIER COMPRISING AN AUTOMATIC CLIP FEEDING SYSTEM"; - U.S. Patent Application No. 16 / 112,253, entitled "SURGICAL CLIP APPLIER COMPRISING ADAPTIVE FIRING CONTROL"; and -U.S. Patent Application No. 16 / 112,257, entitled "SURGICAL CLIP APPLIER COMPRISING ADAPTIVE CONTROL IN RESPONSIBILITY TO A STRAIN GAUGE CIRCUIT."
[0009] The applicant of this application owns the following U.S. patent applications, filed on October 26, 2018, each of which is incorporated herein by reference in its entirety: - U.S. Patent Application No. 16 / 172,130, entitled "CLIP APPLIER COMPRISING INTERCHANGEABLE CLIP RELOADS"; - U.S. Patent Application No. 16 / 172,066, entitled "CLIP APPLIER COMPRISING A MOVABLE CLIP MAGAZINE"; - U.S. Patent Application No. 16 / 172,078, entitled "CLIP APPLIER COMPRISING A ROTATABLE CLIP MAGAZINE"; - U.S. Patent Application No. 16 / 172,087, entitled "CLIP APPLIER COMPRISING CLIP ADVANCING SYSTEMS"; - U.S. Patent Application No. 16 / 172,094, entitled "CLIP APPLIER COMPRISING A CLIP CRIMPING SYSTEM"; - U.S. Patent Application No. 16 / 172,128, entitled "CLIP APPLIER COMPRISING A RECIPROCATING CLIP ADVANCING MEMBER"; - U.S. Patent Application No. 16 / 172,168, entitled "CLIP APPLIER COMPRISING A MOTOR CONTROLLER"; - U.S. Patent Application No. 16 / 172,164, entitled "SURGICAL SYSTEM COMPRISING A SURGICAL TOOL AND A SURGICAL HUB"; and -U.S. Patent Application No. 16 / 172,303, entitled "METHOD FOR OPERATING A POWERED ARTICULATING MULTI-CLIP APPLIER."
[0010] The applicant of the present application owns the following U.S. patent applications, filed on December 4, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: - U.S. Patent Application No. 16 / 209,385, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY"; - U.S. Patent Application No. 16 / 209,395, entitled "METHOD OF HUB COMMUNICATION"; - U.S. Patent Application No. 16 / 209,403, entitled "METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB"; - U.S. Patent Application No. 16 / 209,407, entitled "METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL"; - U.S. Patent Application No. 16 / 209,416, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS"; - U.S. Patent Application No. 16 / 209,423, entitled "METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS"; - U.S. Patent Application No. 16 / 209,427, entitled "METHOD OF USING REINFORCED FLEXIBLE CIRCUITS WITH MULTIPLE SENSORS TO OPTIMIZE PERFORMANCE OF RADIO FREQUENCY DEVICES"; - U.S. Patent Application No. 16 / 209,433, entitled "METHOD OF SENSING PARTICULATE FROM SMOKE EVACUATED FROM A PATIENT, ADJUSTING THE PUMP SPEED BASED ON THE SENSED INFORMATION, AND COMMUNICATING THE FUNCTIONAL PARAMETERS OF THE SYSTEM TO THE HUB"; - U.S. Patent Application No. 16 / 209,447, entitled "METHOD FOR SMOKE EVACUATION FOR SURGICAL HUB"; - U.S. Patent Application No. 16 / 209,453, entitled "METHOD FOR CONTROLLING SMART ENERGY DEVICES"; - U.S. Patent Application No. 16 / 209,458, entitled "METHOD FOR SMART ENERGY DEVICE INFRASTRUCTURE"; - U.S. Patent Application No. 16 / 209,465, entitled "METHOD FOR ADAPTIVE CONTROL SCHEMES FOR SURGICAL NETWORK CONTROL AND INTERACTION"; - U.S. Patent Application No. 16 / 209,478, entitled "METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON A SENSED SITUATION OR USAGE"; - U.S. Patent Application No. 16 / 209,490, entitled "METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION"; -U.S. Patent Application No. 16 / 209,491, entitled "METHOD OF CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON SITUATIONAL AWARENESS."
[0011] Certain exemplary embodiments are described below to provide a general understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the devices and methods specifically described herein and shown in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the various embodiments of the present invention is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present invention.
[0012] Throughout this specification, "various embodiments," "some embodiments," "one embodiment," or "an embodiment," or the like, means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, phrases such as "various embodiments," "some embodiments," "one embodiment," or "in an embodiment" may appear in various places throughout this specification, but they do not necessarily all refer to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, a particular feature, structure, or characteristic illustrated or described with respect to one embodiment may be combined in whole or in part with the feature, structure, or characteristic of one or more other embodiments, without limitation. Such modifications and variations are intended to be within the scope of the present invention.
[0013] The terms "proximal" and "distal" are used herein with reference to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0014] Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, those skilled in the art will readily appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications, including, for example, those associated with open surgical procedures. As one proceeds through this Detailed Description, it will become more apparent to those skilled in the art that the various instruments disclosed herein can be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture made in tissue, etc. The working or end effector portion of the instrument may be inserted directly into the patient's body or through an access device having a working channel through which the end effector and elongate shaft of the surgical instrument may be advanced.
[0015] The surgical stapling system can include a shaft and an end effector extending from the shaft. The end effector includes a first jaw and a second jaw. The first jaw includes a staple cartridge. The staple cartridge is insertable into and removable from the first jaw, although other embodiments are contemplated in which the staple cartridge is not removable from the first jaw, or at least not easily replaceable from the first jaw. The second jaw includes an anvil configured to deform staples ejected from the staple cartridge. Other embodiments are contemplated in which the second jaw is pivotable relative to the first jaw about a closure axis, while the first jaw is pivotable relative to the second jaw. The surgical stapling system further includes an articulation joint configured to rotate or articulate the end effector relative to the shaft. The end effector is rotatable about an articulation axis extending through the articulation joint. Other embodiments are contemplated that do not include an articulation joint.
[0016] The staple cartridge comprises a cartridge body. The cartridge body includes a proximal end, a distal end, and a deck extending between the proximal and distal ends. In use, the staple cartridge is positioned on a first side of tissue to be stapled and the anvil is positioned on a second side of the tissue. The anvil is moved toward the staple cartridge to press and clamp the tissue against the deck. Staples removably stored within the cartridge body can then be deployed into the tissue. The cartridge body includes staple cavities defined therein, the staples being removably stored within the staple cavities. The staple cavities are arranged in six longitudinal rows. Three rows of staple cavities are positioned on a first side of the longitudinal slot and three rows of staple cavities are positioned on a second side of the longitudinal slot. Other arrangements of staple cavities and staples may be possible.
[0017] The staples are supported by staple drivers within the cartridge body. The drivers are movable between a first, or unfired, position and a second, or fired, position that ejects the staples from the staple cavities. The drivers are retained within the cartridge body by a retainer that extends around a bottom of the cartridge body and includes a resilient member configured to grip the cartridge body and hold the retainer against the cartridge body. The drivers are movable between their unfired and fired positions by a sled. The sled is movable between a proximal position adjacent a proximal end and a distal position adjacent a distal end. The sled includes a plurality of ramps configured to slide under the drivers and lift the drivers, on which the staples are supported, toward the anvil.
[0018] In addition to the above, the sled is moved distally by a firing member. The firing member is configured to contact the sled and push the sled toward the distal end. A longitudinal slot defined in the cartridge body is configured to receive the firing member. The anvil also includes a slot configured to receive the firing member. The firing member further includes a first cam engaging the first jaw and a second cam engaging the second jaw. When advancing the firing member distally, the first cam and the second cam can control the distance between the deck of the staple cartridge and the anvil, i.e., the tissue gap. The firing member also includes a knife configured to cut tissue captured intermediate the staple cartridge and the anvil. It is desirable for the knife to be positioned at least partially proximal to the ramp such that the staples are ejected forward of the knife.
[0019] 1-3 illustrate an exemplary surgical instrument 100 including a handle 103, a shaft 104, and an articulating end effector 102 pivotally coupled to the shaft 104 at an articulation joint 110. An articulation control 112 is provided to effect rotation of the end effector 102 about the articulation joint 110. The end effector 102 includes an endocutter for clamping, cutting, and stapling tissue, although it will be appreciated that various embodiments may include end effectors configured to function as other surgical devices including, for example, graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy delivery devices, ultrasound, RF, and / or laser energy devices, and the like. The handle 103 of the instrument 100 includes a closure trigger 114 and a firing trigger 116 for actuating the end effector 102. It will be appreciated that instruments having end effectors intended for different surgical tasks may have different numbers or types of triggers or other suitable controls for manipulating the end effectors. The end effector 102 is coupled to a handle 103 by a shaft 104. As will be described in more detail below, a clinician can articulate the end effector 102 relative to the shaft 104 by utilizing an articulation control 112.
[0020] As will be appreciated, spatial terms such as vertical, horizontal, right, left, etc. are used herein in relation to the figures, assuming that the longitudinal axis of the surgical instrument 100 is coaxial with the central axis of the shaft 104, with the triggers 114, 116 extending downward from the bottom of the handle 103 at an acute angle. In actual practice, however, the surgical instrument 100 may be oriented at various angles, and therefore these spatial terms are used with respect to the surgical instrument 100 itself. Additionally, proximal is used to indicate the view of a clinician who is rearward of the handle 103 and places the end effector 102 distally, i.e., away from him / her. As used herein, the phrase "substantially transverse to the longitudinal axis" (the "longitudinal axis" being the axis of the shaft) refers to a direction that is approximately perpendicular to the longitudinal axis. However, it is understood that a direction that deviates somewhat from perpendicular to the longitudinal axis is still a direction that is substantially transverse to the longitudinal axis.
[0021] Various embodiments disclosed herein relate to instruments having articulation joints actuated by bending cables or bands. Figures 4 and 5 are cross-sectional plan views of an elongated shaft 104 and an end effector 102 having a band 205 mechanically coupled to a boss 206 extending from the end effector 102. The band 205 may have band portions 202 and 204 that extend proximally from the boss 206, along the elongated shaft 104, and through the articulation control 112. The band 205 and band portions 202, 204 can have a fixed length. The band 205 can be mechanically coupled to the boss 206 as shown using any suitable fastening method including, for example, adhesives, welding, and the like. In various embodiments, each band portion 202, 204 may be provided as a separate band, with one end of each separate band mechanically coupled to the boss 206 and the other end extending through the shaft 104 and articulation control 112. Another band may be mechanically coupled to the boss 206 as described above.
[0022] Further to the above, the band portions 202, 204 may extend from the boss 206 through the articulation joint 110, along the shaft 104, to the articulation control 112 shown in FIG. 6. The articulation control 112 may include an articulation slide 208, a frame 212, and an enclosure 218. The band portions 202, 204 may pass through the articulation slide 208 through a slot 210 or other aperture, although it should be understood that the band portions 202, 204 may be coupled to the slide 208 by any suitable means. The articulation slide 208 may be one piece, as shown in FIG. 6, or may have two pieces, with the interface of the two pieces defining the slot 210. In one non-limiting embodiment, the articulation slide 208 may have multiple slots, for example, each slot configured to receive one of the band portions 202, 204. The enclosure 218 may cover various components of the articulation control 112 to prevent debris from entering the articulation control 112 .
[0023] 6, the band portions 202, 204 may each be anchored to the frame 212 at connection points 214, 216 located proximally from the slot 210. It should be understood that the band portions 202, 204 may be anchored anywhere on the instrument 10 proximally from the slot 210, including the handle 103. The non-limiting embodiment of FIG. 6 illustrates that the band portions 202, 204 may have a curved configuration between the connection points 214, 216 and the slot 210 located near the longitudinal axis of the shaft 104. Other embodiments are contemplated in which the band portions 202, 204 are straight.
[0024] 7-9 show views of the end effector 102 and elongate shaft 104 of the instrument 100, including the articulation joint 110 shown in FIG. 5. FIG. 7 shows an exploded view of the end effector 102 and elongate shaft 104, including various internal components. In at least one embodiment, the end effector frame 150 and the shaft frame 154 are configured to be joined at the articulation joint 110. A boss 206 may be integral with the end effector frame 150, and the band 205 interacts with the boss 206 as shown. The shaft frame 154 may include a distally directed tang 302 that defines an aperture 304. The aperture 304 is positioned to interact with an articulation pin (not shown) included in the end effector frame 150 to allow the end effector frame 150 to pivot relative to the shaft frame 154, and thus the end effector 102 to pivot relative to the shaft 104. When assembled, the various components can pivot about the articulation joint 110 at an articulation axis 306 shown in FIGS.
[0025] FIG. 7 also illustrates the anvil 120. In this non-limiting embodiment, the anvil 120 is coupled to an elongated channel 198. For example, an aperture 199 can be defined within the elongated channel 198 that can receive a pin 152 extending from the anvil 120 to allow the anvil 120 to pivot from an open position to a closed position relative to the elongated channel 198 and staple cartridge 118. Additionally, FIG. 7 illustrates a firing bar 172 that is configured to translate longitudinally through the shaft frame 154, through the flexible closure and pivot frame articulation joint 110, and through a firing slot 176 in the distal frame 150 to the end effector 102. The firing bar 172 may be constructed from one solid piece or, in various embodiments, may include a laminated material, including, for example, a stack of steel plates. As can be appreciated, a firing bar 172 made from a laminate can reduce the force required to articulate the end effector 102. In various embodiments, a spring clip 158 can be attached to the end effector frame 150 to bias the firing bar 172 downward. Distal and proximal rectangular apertures 164, 168 formed in the top of the end effector frame 150 can define therebetween a clip bar 170 that receives an upper arm 162 of the clip spring 158, with the lower distally extending arm 160 of the clip spring 158 exerting a downward force on a raised portion 174 of the firing bar 172 as discussed below.
[0026] The distally projecting end of the firing bar 172 can be attached to an E-beam 178 that can, among other things, assist in moving the anvil 120 away from the staple cartridge 118 positioned within the elongated channel 198 when the anvil 120 is in the closed position. The E-beam 178 can also include a sharp cutting edge 182 that can be used to cut tissue as the E-beam 178 is advanced distally by the firing bar 172. In operation, the E-beam 178 can also actuate or fire the staple cartridge 118. The staple cartridge 118 can include a shaped cartridge body 194 that holds a plurality of staples 191 mounted on staple drivers 192 within respective upwardly opening staple cavities 195. A wedge-shaped sled 190 is driven distally by the E-beam 178 to slide over a cartridge tray 196 that holds together the various components of the replaceable staple cartridge 118. The wedge-shaped sled 190 cams the staple driver 192 upwardly, expelling the staple 191 into deforming contact with the anvil 120 while the cutting surface 182 of the E-beam 178 cuts the clamped tissue.
[0027] Further to the above, the E-beam 178 can include an upper pin 180 that engages the anvil 120 during firing. The E-beam 178 can further include a center pin 184 and a lower foot 186 that can engage various portions of the cartridge body 194, the cartridge tray 196, and the elongated channel 198. When the staple cartridge 118 is positioned within the elongated channel 198, a slot 193 defined in the cartridge body 194 can be aligned with a slot 197 defined in the cartridge tray 196 and a slot 189 defined in the elongated channel 198. In use, the E-beam 178 can slide through the aligned slots 193, 197, and 189, and as shown in FIG. 7 , the lower foot 186 of the E-beam 178 can engage a groove running along the bottom surface of the channel 198 along the length of the slot 189, the central pin 184 can engage the top surface of the cartridge tray 196 along the length of the longitudinal slot 197, and the upper pin 180 can engage the anvil 120. In such a situation, the E-beam 178 can move the anvil 120 and the staple cartridge 118 apart or limit their relative movement as the firing bar 172 is moved distally to fire staples from the staple cartridge 118 and / or cut tissue captured between the anvil 120 and the staple cartridge 118. Thereafter, the firing bar 172 and E-beam 178 can be retracted proximally, thereby opening the anvil 120 and releasing the two stapled and cut tissue portions (not shown).
[0028] 7-9 also illustrate a dual pivot closure sleeve assembly 121 according to various embodiments. With particular reference to FIG. 7, the dual pivot closure sleeve assembly 121 includes a shaft closure tube section 128 having upper and lower distally protruding tangs 146, 148. The end effector closure tube section 126 includes a horseshoe shaped aperture 124 and a tab 123 for engaging an opening tab 122 on the anvil 120. The horseshoe shaped aperture 124 and tab 123 engage with the tab 122 when the anvil 120 is opened. The closure tube section 126 is shown with an upper proximal protruding tang 144 and a lower (not visible) proximal protruding tang. The upper double pivot link 130 includes upwardly projecting distal and proximal pivot pins 134, 136 that engage with upper distal pin holes 138 and 140, respectively, in an upper proximal protruding tang 144 and an upper proximal pin hole 140, respectively, in an upper proximal protruding tang 146. The lower double pivot link 132 includes downwardly projecting distal and proximal pivot pins (not shown in FIG. 7, but see FIG. 8) that engage with lower distal and lower proximal pin holes 142 and 142, respectively, in a lower proximal protruding tang 148 and an upper proximal protruding tang 146.
[0029] In use, the closure sleeve assembly 121 is translated distally to close the anvil 120, for example, in response to actuation of the closure trigger 114. The anvil 120 is closed by translating the closure tube section 126, and therefore the sleeve assembly 121, distally to impact with a proximal surface of the anvil 120 located to the left of the tab 122 in FIG. 9A. As shown more clearly in FIGS. 8 and 9, the anvil 120 is opened by translating the tube section 126, and therefore the sleeve assembly 121, proximally to contact the tab 123 and horseshoe aperture 124 with the tab 122 and lift the anvil 120 against the tab 122. In the anvil open position, the dual pivot closure sleeve assembly 121 is moved to its proximal position.
[0030] In operation, a clinician can articulate the end effector 102 of the instrument 100 about the pivot 110 relative to the shaft 104 by pushing the control 112 sideways. From a neutral position, a clinician can articulate the end effector 102 left relative to the shaft 104 by applying a lateral force to the left side of the control 112. In response to the force, the articulating slide 208 can be forced at least partially into the frame 212. As the slide 208 is forced into the frame 212, the slot 210 and the band portion 204 can be translated across the elongated shaft 104 in a transverse direction, e.g., substantially transverse or perpendicular to the longitudinal axis of the shaft 104. Thus, when a force is applied to the band portion 204, the band portion 204 will bend and / or displace elastically from its initial pre-bent position toward the opposite side of the shaft 104. As a result, the band portion 202 relaxes from its initial pre-bent position. Such movement of the band portion 204, coupled with the straightening of the band portion 202, can impart a counterclockwise rotational force to the boss 206, which in turn causes the boss 206 and the end effector 102 to pivot to the left about the articulation axis 110 to a desired angle relative to the axis of the shaft 104, as shown in FIG. 12. The relaxation of the band portion 202 reduces the tension thereon, allowing the band portion 204 to articulate the end effector 102 without substantial interference from the band portion 202. It will be appreciated that the clinician can also articulate the end effector 102 to the right relative to the shaft 104 by applying a lateral force to the right side of the control 112. This bends the cable portion 202, which in turn causes a clockwise rotational force to be applied to the boss 206, which in turn causes the boss 206 and the end effector to pivot to the right about the articulation axis 110. As above, band portion 204 is simultaneously relaxed to allow such movement.
[0031] 12 and 13 show a powered surgical cutting and fastening instrument 310. The illustrated embodiment shows an endoscopic instrument, and generally, the instrument 310 is described herein as an endoscopic cutting and fastening instrument. However, it should be noted that the invention is not so limited, and according to other embodiments, any of the instruments disclosed herein may include a non-endoscopic cutting and fastening instrument. The surgical instrument 310 shown in FIGS. 12 and 13 includes a handle 306, a shaft 308, and an end effector 312 coupled to the shaft 308. In various embodiments, the end effector 312 may be articulated relative to the shaft 308 about an articulation joint 314. Various means for articulating the end effector 312 and / or means for articulating the end effector 312 relative to the shaft 308 are disclosed in U.S. Patent No. 7,753,245, issued July 13, 2010 and entitled "SURGICAL STAPLING INSTRUMENTS," and U.S. Patent No. 7,670,334, issued March 2, 2010 and entitled "SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR," the entire disclosures of which are incorporated herein by reference. Various other means for articulating the end effector 312 are described in more detail below. Similar to above, the end effector 312 is configured to function as an endocutter for clamping, cutting, and / or stapling tissue, although in other embodiments, various types of end effectors may be used, such as end effectors for other types of surgical devices, graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy devices, ultrasound, RF, and / or laser devices, etc.Several RF devices can be found in U.S. Patent No. 5,403,312, issued April 4, 1995, entitled "ELECTROSURGICAL HEMOSTATIC DEVICE," and U.S. patent application Ser. No. 12 / 031,573, filed February 14, 2008, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES," the entire disclosures of which are incorporated herein by reference in their entireties.
[0032] It is understood that the terms "proximal" and "distal" are used herein with reference to a clinician grasping the handle 306 of the instrument 310. Thus, the end effector 312 is distal to the more proximal handle 306. It is further understood that for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein with reference to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
[0033] The end effector 312 may include, among other things, a staple channel 322 and a pivoting, translating clamping member, such as, for example, an anvil 324. The handle 306 of the instrument 310 may include a closure trigger 318 and a firing trigger 320 for actuating the end effector 312. It will be appreciated that instruments having end effectors intended for different surgical tasks may have a different number or type of triggers or other suitable controls for manipulating the end effector 312. The handle 306 may include a downwardly extending pistol grip 326 toward which the closure trigger 318 is pivotally drawn by the clinician to cause clamping or closure of the anvil 324 against the staple channel 322 of the end effector 312, thereby clamping tissue located between the anvil 324 and the channel 322. In other embodiments, various clamping members may be used in addition to or in place of the anvil 324. The handle 306 may further include a lock that may be configured to releasably hold the closure trigger 318 in a closed position. Further details regarding an exemplary closure system embodiment for closing (or clamping) the anvil 324 of the end effector 312 by retracting the closure trigger 318 are provided in U.S. Pat. No. 7,000,818, issued Feb. 21, 2006 and entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS," U.S. Pat. No. 7,422,139, issued Sep. 9, 2008 and entitled "MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK," and U.S. Pat. No. 7,464,849, issued Dec. 16, 2008 and entitled "ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVIL ALIGNMENT." No. 6,399,363, the disclosures of which are incorporated herein by reference in their entireties.
[0034] Once the clinician is satisfied with the positioning of the end effector 312, the clinician can pull the closure trigger 318 back to a fully closed and locked position proximate the pistol grip 326. The firing trigger 320 can then be actuated or fired. In at least one such embodiment, the firing trigger 320 can be further outboard of the closure trigger 318, and closing the closure trigger 318 can move or rotate the firing trigger 320 toward the pistol grip 326, thereby allowing the firing trigger 320 to be accessed by an operator with one hand under various circumstances. The operator can then pivotally pull the firing trigger 320 toward the pistol grip 312 to staple and sever tissue clamped within the end effector 312. The firing trigger 320 can then be returned to the unactuated or non-fired position (shown in FIGS. 1 and 2) after the clinician reduces or releases the force applied to the firing trigger 320. A release button on the handle 306 can be depressed to release the locked closure trigger 318. The release button may be embodied in a variety of forms, such as that disclosed in U.S. Patent Application Publication No. 2007 / 0175955, filed January 31, 2006, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM," the entire disclosure of which is incorporated herein by reference in its entirety.
[0035] In addition to the above, the end effector 312 may include a cutting instrument, such as a knife, for example, to cut tissue clamped within the end effector 312 when the firing trigger 320 is retracted by the user. In addition to the above, the end effector 312 may also include means for fastening tissue cut by the cutting instrument, such as, for example, staples, RF electrodes, and / or adhesives. A longitudinally movable drive shaft mounted within the shaft 308 of the instrument 310 may drive / actuate the cutting instrument and fastening means within the end effector 312. As will be further described herein, an electric motor mounted within the handle 306 of the instrument 310 may be used to drive the drive shaft. In various embodiments, the motor may be a brushed DC drive motor, for example, having a maximum rotational speed of about 25,000 RPM. In other embodiments, the motor may be a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. A battery (or "power source" or "power box"), such as a lithium ion battery, may be located adjacent to the motor within the pistol grip portion 26 of the handle 6 and may provide power to the motor via motor control circuitry. According to various embodiments, multiple battery cells connected in series may be used as a power source to power the motor. Additionally, the power source may be replaceable and / or rechargeable.
[0036] As generally described above, an electric motor within the handle 306 of the instrument 310 may be operatively engaged with a longitudinally movable drive member disposed within the shaft 308. Referring now to FIGS. 14-16, an electric motor 342 may be mounted and disposed within the pistol grip portion 326 of the handle 306. The electric motor 342 may have a rotatable shaft operatively coupled with a gear reducer assembly 370, which may include, among other things, a housing 374 and an output pinion gear 372. In certain embodiments, the output pinion gear 372 may be operatively engaged directly with the longitudinally movable drive member 382, or may alternatively be operatively engaged with the drive member 382 via one or more intermediate gears 386. The intermediate gears 386 may, in at least one such embodiment, be in meshing engagement with a set or rack of drive teeth 384 defined on the drive member 382. In use, the electric motor 342 can drive the drive member in a distal direction as indicated by arrow D (FIG. 15) and / or a proximal direction as indicated by arrow D (FIG. 16) depending on the direction in which the electric motor 342 rotates the intermediate gear 386. In use, the voltage polarity provided by the battery can cause the electric motor 342 to operate in a clockwise direction, however, the voltage polarity imparted to the electric motor by the battery can be reversed to cause the electric motor 342 to operate in a counterclockwise direction. The handle 306 can include a switch that can be configured to reverse the polarity imparted to the electric motor 342 by the battery. The handle 306 can also include a sensor 330 configured to detect the position of the drive member 382 and / or the direction in which the drive member 382 is being moved.
[0037] As indicated above, the surgical instrument 310 can have an articulation joint 314 about which the end effector 312 can be articulated. The instrument 310 can further have a joint lock that can be configured and operated to selectively lock the end effector 312 in position. In at least one such embodiment, the joint lock can extend from a proximal end of the shaft 308 to a distal end of the shaft 308, and a distal end of the joint lock can engage the end effector 312 to lock the end effector 312 in position. Referring again to FIGS. 12 and 13 , the instrument 310 can further have an articulation control 316 that can be engaged with a proximal end of the joint lock and configured to operate the joint lock between a locked state and an unlocked state. In use, the articulation control 316 can be pulled proximally to unlock the end effector 312 and rotate the end effector 312 about the articulation joint 314. After the end effector 312 is suitably articulated, the articulation control 316 can be moved distally to relock the end effector 312 in place. In at least one such embodiment, the handle 306 can further include a spring and / or other suitable biasing element configured to bias the articulation control 316 distally and to bias the articulation lock into a locked configuration with the end effector 312. If the clinician desires, the clinician can again pull the articulation control 316 rearward, i.e., proximally, to unlock the end effector 312 and articulate the end effector 312, and then move the articulation control 316 back to the locked state. In such a locked state, the end effector 312 cannot be articulated relative to the shaft 308.
[0038] As generally described above, the surgical instrument 310 can have a joint lock configured to hold the end effector 312 in a predetermined position relative to the shaft 308. Also, as generally described above, the end effector 312 can be rotated or articulated relative to the shaft 308 when the joint lock is in its unlocked state. In such an unlocked state, the end effector 312 can be adjacent to and pressed against soft tissue and / or bone surrounding a surgical site within a patient's body to articulate the end effector 312 relative to the shaft 308. In certain embodiments, the articulation control 316 can include a joint flexion switch or can be configured to operate a joint switch that can selectively permit and / or prevent the firing trigger 320 from operating the electric motor 342. For example, such a joint flexion switch can be disposed in series with the electric motor 342 and a firing switch operably associated with the firing trigger 320, and the joint flexion switch can be in a closed state when the articulation control 316 is in a locked state. When the articulation control 316 is moved to the unlocked state, the articulation control 316 can open the articulation switch, thereby electrically decoupling the operation of the firing trigger 320 from the operation of the electric motor 342. In such a situation, the firing drive of the instrument 310 cannot be fired while the end effector 312 is in the unlocked state and articulatable relative to the shaft 308. When the articulation control 316 is returned to the locked state, the articulation control 316 can reclose the articulation switch, which can then electrically couple the operation of the firing trigger 320 to the electric motor 342.Various details of one or more surgical stapling instruments are disclosed in U.S. patent application Ser. No. 12 / 647,100, entitled "MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY," filed Dec. 24, 2009, and published June 30, 2011 as U.S. Patent Application Publication No. 2011 / 0155785, now U.S. Patent No. 8,220,688, the disclosure of which is incorporated herein by reference in its entirety.
[0039] 17-29, a surgical instrument 400 can include a handle 403, a shaft 404 extending from the handle 403, and an end effector 402 extending from the shaft 404. The reader is reminded that, while portions of the handle 403 have been removed for illustrative purposes, the handle 403 can include a closure trigger and a firing trigger similar to the closure trigger 114 and firing trigger 116 shown in FIG. 1, for example. As described in more detail below, the firing trigger 116 can be operatively coupled to a firing drive having a firing member 470 extending through the shaft 404, such that operation of the firing trigger 116 can advance the firing member 470 distally towards the end effector 402. As described in more detail below, the surgical instrument 400 can further include an articulation drive that can be selectively coupled to the firing member 470 such that when the firing member 470 is actuated, for example, by the firing trigger 116 and / or by a separate articulation trigger and / or button, the articulation drive can be driven by the firing member 470 and can then articulate the end effector 402 about the articulation joint 410.
[0040] 17, the reader is reminded that the end effector 402 of the surgical instrument 400 is shown in an open configuration. More specifically, a first jaw of the end effector 402 with an anvil 420 is shown in an open position relative to a channel 498 of the second jaw of the end effector 402. As above, the channel 498 can be configured to receive and clamp a staple cartridge therein. Now referring to FIG. 20, which also shows the end effector 420 in an open configuration, the handle 403 of the surgical instrument 400 can have an articulation lock actuator 409 that can be moved between a distal or locked position where the end effector 402 is locked in place relative to the shaft 404, and a proximal or unlocked position where the end effector 402 can be articulated relative to the shaft 404 about an articulation joint 410. 20 as aligned in a straight configuration, the joint lock actuator 409 is shown in a retracted, unlocked position such that the end effector 402 can be articulated relative to the shaft 404. With reference to FIGS. 19, 24A and 24B, the joint lock actuator 409 (FIG. 21) can be operatively coupled to a joint lock 443 such that the joint lock actuator 409 can move the joint lock 443 between a distal position (FIG. 24A) in which the joint lock 443 is engaged with the proximal locking member 407 of the end effector 402 and a proximal position (FIG. 24B) in which the joint lock 443 is disengaged from the end effector 402. It should be understood by the reader that the distal locked position of the joint lock actuator 409 corresponds to the distal position of the joint lock 443 and the proximal unlocked position of the joint lock actuator 409 corresponds to the proximal position of the joint lock 443.19, the joint lock 443 is coupled to the joint lock actuator 409 by a joint lock bar 440 having a distal end 442 that is engaged with the joint lock 443 as best seen in FIG. 24A and a proximal end 441 that is engaged with the joint lock actuator 409 as best seen in FIG. 22. As shown in FIGS. 24A and 24B, the joint lock 443 can include one or more teeth 445 that can be configured, for example, to meshingly engage with one or more teeth 446 defined around the proximal lock member 407. Referring primarily to FIG. 19, the shaft 404 can further include a biasing member, such as, for example, a spring 444, that can be configured to bias the teeth 445 of the joint lock 443 into engagement with the teeth 446 of the proximal lock member 407 of the end effector 402. Similarly, the handle 403 may further include a biasing member positioned within a cavity 488 (FIG. 23) defined between the joint lock actuator 409 and the frame 480, such that the biasing member can urge the joint lock actuator 409 toward the distal locked position.
[0041] As shown in FIG. 17, the joint lock actuator 409 may be comprised of two nozzle halves or portions 411a and 411b, with the reader being reminded that the nozzle portion 411b has been removed from FIGS. 18-27 for illustrative purposes. Also as shown in FIG. 17, the joint lock actuator 409 may include a plurality of finger hooks 413 that may be grasped by a surgeon or other clinician to retract the joint lock actuator 409 to a proximal unlocked configuration. Referring again to FIG. 20, the joint lock actuator 409 may further include a detent assembly 452 that may be configured to bias a detent member 457 against a frame of the shaft 404 or a frame of the handle 403. More specifically, the shaft 404 may include a shaft frame 454 extending from a handle frame 480, and the detent assembly 452 may be configured to bias the detent member 457 against the shaft frame 454. 19, the shaft frame 454 can have a detent channel 453 defined therein that can be aligned with the detent member 457 such that the detent member 457 can slide within the detent channel 453 when the joint lock actuator 409 is slid between the locked and unlocked positions described above. The detent assembly 452, again referring to FIG. 20, can have a fixed frame portion 458 that can define a threaded aperture configured to receive the adjustable threaded member 459. The adjustable threaded member 459 can have an internal aperture, at least a portion of which can be positioned within the internal aperture, and the detent member 457 can be biased against an end of the internal aperture by, for example, a spring positioned intermediate the detent member 457 and a closed end of the internal aperture.As shown in FIG. 19 , the proximal end of the detent channel 453 can include a detent seat 455 that can be configured to releasably receive a detent member 457 when the articulation lock actuator 409 reaches a proximal unlocked position. Under various circumstances, the detent member 457, the detent seat 455, and the biasing spring positioned within the adjustable threaded member 459 can be sized and configured to enable the detent assembly 452 to releasably hold the articulation lock actuator 409 in the proximal unlocked position. As described in more detail below, the articulation lock actuator 409 can be held in the proximal unlocked position until the end effector 402 is suitably articulated. At such point, the articulation lock actuator 409 can be pushed forward to disengage the detent member 457 from the detent seat 455. 20, the reader should understand that the adjustable threaded member 459 can be rotated downwardly toward the shaft frame 454 to increase the force required to disengage the detent member 457 from the detent seat 455, while the adjustable threaded member 459 can be rotated downwardly away from the shaft frame 454 to decrease the force required to disengage the detent member 457 from the detent seat 455. As also shown in FIG. 20, the articulation lock actuator 409 can include an access port 418 that can be utilized to access and rotate the threaded member 459.
[0042] As discussed above, the articulation lock actuator 409 is in a retracted, unlocked position in Fig. 20, while the end effector 402 is in an unlocked configuration, as shown in Fig. 24B. Referring now to Figs. 19 and 20, the surgical instrument 400 further comprises an articulation driver 460 which, when pushed distally, can rotate the end effector 402 about the articulation joint 410 in a first direction, and when pulled proximally, can rotate the end effector 402 about the articulation joint in a second, opposite direction, as shown in Fig. 21. Comparing Figs. 20 and 21, the reader should note that the articulation driver 460 is being pulled proximally by the firing member 470. More specifically, the intermediate portion 475 of the firing member 470 can include a notch or slot 476 defined therein that can be configured to receive the proximal end 461 of the articulation driver 460 such that when the firing member 470 is pulled proximally, the firing member 470 can similarly pull the articulation driver 460 proximally. Similarly, when the firing member 470 is pushed distally, the firing member 470 can push the articulation driver 460 distally. As also shown in FIGS. 20 and 21 , the articulation driver 460 can include a distal end 462 that engages with a protrusion 414 extending from a proximal locking member 407, for example, that can be configured to transfer proximal and distal articulation motion of the articulation driver 460 to the end effector 102. 18-20 , the handle 404 can further include a proximal firing member portion 482 of the firing member 470 having a distal end 481 that engages the proximal end 477 of the intermediate portion 475 of the firing member 470. Similar to above, the handle 403 can include an electric motor with an output shaft and a gear operably engaged with the output shaft, the gear operably engaged with a longitudinal series of teeth 484 defined on a surface of the firing portion 482.In use, further to the above, the electric motor can be operated in a first direction to advance the firing member 470 distally and in a second or opposite direction to retract the firing member 470 proximally. Although not shown, the handle 403 can further include a switch that can be positioned in a first state to operate the electric motor in a first direction, a second state to operate the electric motor in a second direction, and / or a neutral state in which the electric motor is not operated in either direction. In at least one such embodiment, the switch can have at least one biasing member, such as, for example, a spring, that can be configured to bias the switch toward the neutral state. Also, in at least one such embodiment, the first state of the articulation switch can include, for example, a first position of a switch toggle that is on a first side of a neutral position, and the second state of the articulation switch can include a second position of a switch toggle that is on a second or opposite side of the neutral position.
[0043] In various circumstances, in addition to the above, the articulation switch may be used to make small adjustments to the position of the end effector 402. For example, the surgeon may move the articulation switch in a first direction to rotate the end effector 402 about the articulation joint in a first direction until the end effector 402 is placed in a desired position, and then reverse the movement of the end effector 402 by moving the articulation switch in a second direction, and / or any other suitable combination of movement in the first and second directions. Referring primarily to FIGS. 19, 24A, and 24B, the articulation joint 410 may have a pivot pin 405 extending from the shaft frame member 451, as well as an aperture 408 defined in the proximal locking member 407 that is configured to closely receive the pivot pin 405 therein such that rotation of the end effector 402 is constrained to rotation about the articulation axis 406, for example. 19, the distal end of the shaft frame 454 can have a recess 456 configured to receive the shaft frame member 451 therein. As described in more detail below, the shaft 404 can have an outer sleeve switch that can be slid relative to the shaft frame 454 to close the anvil 420. Referring primarily to FIGS. 19-21, the outer sleeve of the shaft 410 can include a proximal portion 428 and a distal portion 426 that can be coupled together by articulation links 430 and 432. When the outer sleeve is slid relative to the articulation joint 410, the articulation link 430 can accommodate oblique relative movement of the distal portion 426 and the proximal portion 428 of the outer sleeve when the end effector 402 is articulated, as shown in FIG. 21. Under various circumstances, the articulation links 430 and 432 can provide two or more degrees of freedom to the articulation joint 410 to accommodate articulation of the end effector 402.The reader should also note that the articulation joint 410 may further include a guide 401 that may be configured to receive the distal cutting portion 472 of the firing member 470 therein and to guide the distal cutting portion 472 as it is advanced distally and / or retracted proximally within and / or relative to the articulation joint 410.
[0044] As generally described above, the firing member 470 can be advanced distally to distally advance the articulation driver 460 and, consequently, rotate the end effector 402 in a first direction, and similarly, the firing member 470 can be retracted proximally to proximally retract the articulation driver 460 and, consequently, rotate the end effector 402 in an opposite direction. In some circumstances, however, it may be undesirable to move, or at least substantially move, the distal cutting portion 472 of the firing member 470 when the firing member 470 is utilized to articulate the end effector 402. Referring now to FIGS. 19-21 , the intermediate portion 475 of the firing member 470 can include a longitudinal slot 474 defined at a distal end thereof, which can be configured to receive the proximal end 473 of the distal cutting portion 472. The longitudinal slot 474 and the proximal end 473 can be sized and configured to permit relative movement therebetween and can include a slip joint 471. The slip joint 471 can move an intermediate portion 475 of the firing drive 470 to articulate the end effector 402 without moving, or at least substantially moving, the distal cutting portion 472. As described in more detail below, once the end effector 402 is suitably oriented, the intermediate portion 475 can be advanced distally until a proximal sidewall of the longitudinal slot 474 contacts the proximal end 473 to advance the distal cutting portion 472 and fire a staple cartridge positioned within the channel 498. Referring primarily to FIG. 19 , the shaft frame 454 can include a longitudinal slot 469 defined therein that can be configured to slidably receive the articulation driver 60, and similarly, the proximal portion 428 of the outer shaft sleeve can include a longitudinal opening 425 configured to accommodate relative movement between the articulation driver 460 and the outer sleeve of the shaft 404 described above.
[0045] Further to the above, the articulation lock actuator 409 can be configured to urge the proximal portion 461 of the articulation driver 460 toward the drive member 470 when the articulation lock actuator 409 is in the proximal unlocked position. More specifically, in at least one such embodiment, an inner surface of the articulation lock 409 can include a cam that can engage an outer side 466 of the proximal portion 461 and urge the proximal portion 461 into engagement with a slot 476 defined in an intermediate portion 475 of the drive member 470. When the articulation lock actuator 409 is again moved to the distal locked position, the articulation lock actuator 409 can no longer urge the proximal portion 461 inwardly toward the drive member 470. In at least one such embodiment, the handle 403 and / or shaft 404 can include a resilient member, such as a spring, that can be configured to bias the proximal portion 461 outwardly and away from the firing member 470 such that the proximal portion 461 is not operatively engaged with the slot 476 unless the biasing force of the resilient member is overcome by the articulation lock actuator 409 when the articulation lock actuator 409 is moved proximally to the unlocked position, as described above. Under various circumstances, the proximal portion 461 and the slot 476 can include a force limiting clutch.
[0046] Further to the above, once the end effector 402 is articulated in a desired orientation, the closure trigger 114 can be actuated to move the anvil 420 to a closed position, as shown in FIG. 22. More specifically, for example, the closure trigger 114 can distally advance the outer sleeve of the shaft 410 such that a distal portion 426 of the outer sleeve can push the anvil 420 distally and downwardly. The anvil 420 can include protrusions 497 extending from opposite sides of the anvil 420, each of which can be configured to slide and rotate within an elongated slot 499 defined in the cartridge channel 498. The anvil 420 may further include a projection 496 extending upwardly therefrom, the projection 496 may be positioned within an aperture 495 defined in the distal portion 426 of the outer sleeve, a sidewall of the aperture 495 may contact the projection 496 when the distal portion 426 is advanced distally to move the anvil 420 toward the cartridge channel 498. In addition to the above, actuation of the closure drive may also move the articulation lock actuator 409 from a proximal unlocked position (FIGS. 20-22) to a distal locked position (FIG. 23). More specifically, as shown in FIG. 22, the closure drive may be configured to distally advance a closure drive carriage 415, which may contact a collar 450 mounted within the articulation actuator 409. 19 and 22, the collar 450 can include opposing portions, or halves, that can be assembled together such that the opposing portions of the collar 450 can surround the shaft 404. The collar 450 can also support the detent assembly 452, discussed above, and can have a mounting portion that engages the proximal end 441 of the articulation lock bar 440, also discussed above.23, the closure drive carriage 415 can contact the collar 450 and slide the articulation lock actuator 409 distally, and in addition can displace the detent member 457 from the detent seat 455 into the detent channel 453 (see FIG. 19) so that the articulation lock actuator 409 can be pushed into a locked position and the articulation lock 443 can be moved to engage the proximal locking portion 407 to lock the end effector 402 in place. In such regard, the closure drive carriage 415 can prevent the end effector 402 from being unlocked and articulated until the closure drive and anvil 420 are again opened and the closure drive carriage 415 is moved proximally, as described in more detail below.
[0047] 25, actuation of the closure drive by the closure drive actuator 114 and distal advancement of the outer sleeve 428 of the shaft 410 can also operatively disengage the articulation driver 460 from the firing drive 470. Returning to FIGS. 20 and 21, the reader is reminded that the outer sleeve 428 has a window 424 defined therein in which a rotatable cam member 465 can be positioned. While the cam member 465 can include a first end that is rotatably pinned or coupled to the shaft frame 454 and a second end configured to rotate relative to the pinned end of the cam member 465, in other embodiments, the cam member 465 can have any suitable shape. When the outer sleeve 428 is in its proximal position and the anvil 420 is in its open configuration, the cam member 465 may be in a first position that may engage the proximal end 461 of the articulation driver 460 with a slot 476 defined in the firing member 470, but as the outer sleeve 428 is advanced distally, a side wall of the window 424 may engage the cam member 465 and lift the second end of the cam member 465 away from the shaft frame 454 to a second position. In this second position, the cam member 465 may move the proximal end 461 of the articulation driver 460 away from the firing drive 470 such that the proximal end 461 is no longer located within the slot 476 defined in the firing drive 470. Thus, when the closure drive is actuated to close the anvil 420, the closure drive can push the articulation lock actuator 409 into a distal locked configuration, the articulation lock actuator 409 can push the articulation lock 445 into a locked configuration with the end effector 402, and the closure drive can operatively decouple the articulation driver 460 from the firing drive 470. In such a manner, in operation of the surgical instrument 400, actuation of the firing drive 470 does not result in articulation of the end effector 402, and the firing drive 470 can move independently of the articulation driver 460.
[0048] 26, as described above, the firing drive 470 can be advanced distally to eject staples from the staple cartridge positioned within the channel 498 of the end effector 402 and deform the staples against the anvil 420. As generally described above, the firing drive 470 can further comprise a cutting member that can be configured to transect tissue captured within the end effector 402. Also as described above, the electric motor within the handle 403 can be operated by the firing actuator 116 to advance the firing member 470 distally, and under various circumstances, the electric motor can be operated until the distal cutting portion 472 of the firing member 470 reaches the distal end of the staple cartridge and / or any other suitable location within the staple cartridge. In any event, the rotation of the electric motor can be reversed to retract the firing member 470 proximally, as shown in FIG. 27. Under various circumstances, the electric motor may retract the proximal drive portion 482 and the intermediate portion 475 until a distal sidewall of the longitudinal slot 474 defined in the intermediate portion 475 contacts the proximal end 473 of the distal cutting member 472. At such point, further retraction of the proximal drive portion 482 and the intermediate portion 475 will cause the distal cutting member 472 to be proximally retracted. Under various circumstances, the electric motor may be operated until the slot 476 defined in the intermediate portion 475 of the firing member 470 is realigned with the proximal portion 461 of the articulation driver 460, but because the closure sleeve 428 is still in a distally advanced position, the cam member 465 may still urge the articulation driver 460 out of engagement with the firing member 470. In order to re-engage the articulation driver 460 with the firing member 470, under such circumstances, the closure drive must again be released to align the window 424 defined in the outer sleeve portion 428 with the cam member 465 so that the cam member 465 can pivot inwardly toward the shaft frame 454 to the first position.Under various circumstances, the articulation driver 460 can be resiliently flexed out of engagement with the firing member 470 such that when the cam member 465 is again free to move to the first position, the articulation driver 460 can be resiliently flexed inwardly toward the shaft frame 454 to reengage the proximal portion 461 of the articulation driver 460 with the slot 476 defined in the intermediate portion 475 of the drive member 470. In various embodiments, the surgical instrument 400 can further comprise a biasing member that can be configured to bias the proximal portion 461 into reengagement with the intermediate portion 475.
[0049] The reader is reminded that the intermediate portion 475 of the firing member 470 is retracted proximally in FIG. 27 such that the slot 476 defined in the intermediate portion 475 is positioned proximally relative to the proximal portion 461 of the articulation driver 460. Under such circumstances, the proximal portion 461 may not be operably recoupled to the firing member 470 until the intermediate portion 475 is advanced distally to align the slot 476 with the proximal portion 461. Such a situation may arise as a result of relative slip between the intermediate portion 475 and the cutting member portion 472 of the firing member 470 caused by the slip joint 471, which may be addressed, for example, by temporarily reactivating the electric motor in a first direction.
[0050] 27, the firing member 470 may be in a retracted or reset position, but the closure drive is still in an actuated or closed configuration, which may prevent the anvil 420 from being re-opened and the end effector 402 from being re-articulated. Now referring to FIG. 28, once the closure drive is released, the closure drive carriage 415 may be retracted to a proximal position where the closure sleeve, including portions 426 and 428, is also pulled proximally. Referring again to FIG. 19, the proximal sleeve portion 428 may have a proximal end 417 that may be engaged with the closure drive carriage 415, such that the proximal sleeve portion 428 and the closure drive carriage 415 move together in a distal and / or proximal direction. In any event, further to the above, proximal movement of the distal sleeve portion 426 may cause a distal sidewall of the aperture 495 to engage a protrusion 496 extending from the anvil 420 to pivot the anvil 420 to an open position, as shown in FIG. 29. Additionally, proximal movement of the closure drive carriage 415 may unlock the articulation lock actuator 409 such that it may be moved to a proximal unlocked position, which may result in the articulation lock 443 being pulled proximally to compress the spring 444 and unlock the end effector 402. As discussed above, the end effector 402 may then be articulated about the articulation joint 410 and the operations of the surgical instrument 400 described above may be repeated. 18-20 , the handle 404 can further include a switch 408 mounted to the handle frame 480, which can be configured to detect whether the articulation lock actuator 409 is in a proximal unlocked position. In some embodiments, the switch 408 can be operatively coupled to an indicator in the handle 404, such as a light, that can indicate to an operator of the surgical instrument 400, for example, that the end effector 402 is in an unlocked state and that the operator may utilize the articulation switch to articulate the end effector 402.
[0051] As described above in connection with the embodiment of FIG. 17, the surgical instrument 400 can include an articulation lock system configured to lock and unlock the end effector 402 and a closure drive configured to open and close the anvil 420 of the end effector 402. These two systems of the surgical instrument 400 interact in some respects as described above, but can be actuated independently of one another in other respects. For example, the articulation lock actuator 409 and the end effector lock 443 can be actuated without closing the anvil 420. In this embodiment of the surgical instrument 400, the closure drive is independently operated to close the anvil 420. Now referring to FIGS. 30-32, the surgical instrument 400 can have an alternative configuration in which the closure drive is actuated to (1) close the anvil 420 and (2) lock the end effector 402 in place. 31 and 32, the shaft 404 may include a joint lock bar 540 that may be moved between a proximal unlocked position (FIG. 31) in which the end effector 402 may be articulated about the articulation joint 410, and a distal locked position (FIG. 32) in which the end effector 402 may be locked in place. Similar to the joint lock bar 440, the joint lock bar 540 may have a distal end 542 operably engaged with a joint lock 443, such that when the joint lock bar 540 is pulled proximally, the joint lock 443 may be pulled proximally. Similarly, when the joint lock bar 540 is pushed distally, the joint lock 443 may be pushed distally as well. As described above, in contrast to the joint lock bar 440 that is pushed distally and pulled proximally by the joint lock actuator 409, the joint lock bar 540 may be pushed distally and pulled proximally by the closure sleeve 428. More specifically, the proximal end 541 of the joint locking bar 540 can include a hook 547 that can capture a portion of the closure sleeve 428 and be pulled proximally along with the closure sleeve 428 when the closure sleeve 428 is pulled proximally. Under such circumstances, the sleeve 428 can pull the joint locking bar 540 to the unlocked state.The reader is reminded that the closure sleeve 428 can have a window 549 within which the proximal end 541 of the joint lock bar 540 can be positioned. Further to the above, when the closure sleeve 428 is pulled distally, a proximal sidewall 548 of the window 549 can contact the proximal end 541 and push the joint lock bar 540 and joint lock 443 distally to lock the end effector 402 in place.
[0052] As described herein, it may be desirable to use surgical systems and devices that may include reusable parts configured for use with interchangeable surgical components. For example, referring to FIG. 33, a surgical system, generally designated 1000, is shown that, in at least one form, includes a surgical instrument 1010 that may or may not be reusable. The surgical instrument 1010 may be used with multiple interchangeable shaft assemblies 1200, 1200', 1200''. The interchangeable shaft assemblies 1200, 1200', 1200'' may have surgical end effectors 1300, 1300', 1300'' operably coupled thereto that are configured to perform one or more surgical tasks or procedures. For example, each of the surgical end effectors 1300, 1300', 1300'' may comprise a surgical cutting and fastening device configured to operably support a surgical staple cartridge therein. Each of the shaft assemblies may be adapted to support different sizes and types of staple cartridges and may use end effectors having different shaft lengths, sizes, types, and the like. While the present illustration depicts end effectors configured to cut and staple tissue, various aspects of the surgical system 1000 may also be effectively employed with surgical instruments configured to apply other motions and forms of energy, such as, for example, radio frequency (RF) energy, ultrasonic energy, and / or motion, in interchangeable shaft mounted end effector configurations used in a variety of surgical applications and procedures. Additionally, the end effectors, shaft assemblies, handles, surgical instruments, and / or surgical instrument systems may utilize any suitable fastener(s) to fasten tissue. For example, a fastener cartridge comprising a plurality of fasteners removably stored therein may be removably inserted and / or attached to the end effector of the shaft assembly.Under various circumstances, a shaft assembly can be selected to be mounted to the handle of a surgical instrument, and a fastener cartridge can be selected to be mounted to the shaft assembly.
[0053] The surgical instrument 1010 shown in FIG. 33 includes a housing 1040 consisting of a handle 1042 configured to be grasped, manipulated, and actuated by a clinician. However, as one proceeds through the detailed description, it will be understood that the various unique and novel configurations of the various forms of interchangeable shaft assemblies disclosed herein can be effectively used in conjunction with a robotically controlled surgical system. Thus, the term "housing" may also encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system configured to generate and apply at least one control motion that can be used to actuate the interchangeable shaft assemblies disclosed herein and their respective equivalents. The term "frame" may refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robotically controlled surgical instrument and / or a portion of a robotic system that can be used to operably control a surgical instrument. For example, the interchangeable shaft assemblies disclosed herein may be used with the various robotic systems, instruments, components and methods disclosed in U.S. Patent Application Serial No. 13 / 118,241, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," now U.S. Patent Application Serial No. 2012 / 0298719, is hereby incorporated by reference in its entirety.
[0054] FIG. 34 illustrates a surgical instrument 1010 having an interchangeable shaft assembly 1200 operably coupled thereto. In the illustrated form, the surgical instrument has a handle 1042. In at least one form, the handle 1042 can include a pair of interconnected housing segments 1044, 1046 that can be interconnected by screws, snap mechanisms, adhesives, or the like. See FIG. 35. In the illustrated device configuration, the handle housing segments 1044, 1046 cooperate to form a pistol grip portion 1048 that can be grasped and manipulated by a clinician. As described in more detail below, the handle 1042 operably supports a number of drive systems therein that are configured to generate and apply various control actions to corresponding portions of an interchangeable shaft assembly operably attached to the handle.
[0055] The handle 1042 may further include a frame 1080 that operably supports a number of drive systems. For example, the frame 1080 may operably support a first, or closure drive system, generally designated 1050, that may be used to effect closing and opening motions on an interchangeable shaft assembly 1200 that is operably attached or coupled to the handle 1042. In at least one form, the closure drive system 1050 may include an actuator in the form of a closure trigger 1052 that is pivotally supported by the frame 1080. More specifically, as shown in FIG. 35 , the closure trigger 1052 may be pivotally supported by the frame 1080 such that when a clinician grasps the pistol grip portion 1048 of the handle 1042, the closure trigger 1052 may be easily pivoted from a starting or unactuated position to an actuated position, more specifically to a fully compressed or fully actuated position. The closure trigger 1052 may be biased to the unactuated position by a spring or other biasing arrangement (not shown). In various configurations, the closure drive system 1050 further includes a closure linkage assembly 1060 pivotally coupled to the closure trigger 1052. As can be seen in Fig. 35, the closure linkage assembly 1060 may have the closure trigger 1052 pivotally coupled to a closure link 1064 having a pair of laterally extending mounting lugs or portions 1066 projecting therefrom. The closure link 1064 may also be referred to herein as an "attachment member."
[0056] Still referring to FIG. 35 , it can be seen that the closure trigger 1052 may have a locking wall 1068 configured to cooperate with a closure release assembly 1070 that is pivotally coupled to the frame 1080. In at least one form, the closure release assembly 1070 may include a release button assembly 1072 having a distally projecting cam follower arm 1074 formed thereon. The release button assembly 1072 may be pivoted in a counterclockwise direction by a release spring 1076. When the clinician depresses the closure trigger 1052 from the unactuated position toward the pistol grip portion 1048 of the handle 1042, the closure link 1062 pivots upwardly to a point where the cam follower arm 1072 moves into retaining engagement with the locking wall 1068 on the closure link 1062, thereby preventing the closure trigger 1052 from returning to the unactuated position. The closure release assembly 1070 thus acts to lock the closure trigger 1052 in a fully actuated position. When the clinician desires to unlock the closure trigger 1052 so that it can be biased to the unactuated position, the clinician simply pivots the closure release button assembly 1072 so that the cam follower arm 1074 moves out of engagement with the locking wall 1068 on the closure trigger 1052. Once the cam follower arm 1074 is moved out of engagement with the closure trigger 1052, the closure trigger 1052 can again be pivoted to the unactuated position. Other closure trigger lock and release configurations may be used.
[0057] In at least one form, the handle 1042 and frame 1080 may operatively support another drive system, referred to herein as a firing drive system 1100, configured to apply a firing motion to a corresponding portion of an interchangeable shaft assembly attached thereto. The firing drive system may also be referred to herein as a "second drive system." The firing drive system 1100 may employ an electric motor 1102 located within a pistol grip portion 1048 of the handle 1042. In various forms, the motor 1102 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In other device configurations, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. A battery 1104 (or "power source" or "power pack"), such as, for example, a lithium ion battery, may be coupled to the handle 1042 to power the control circuit board assembly 1106 and ultimately the motor 1102. 34 shows a battery pack housing 1104 configured to be releasably attached to the handle 1042 to provide control power to the surgical instrument 1010. Multiple batteries connected in series may be used as a power source to power the motor. Additionally, the power source may be replaceable and / or rechargeable.
[0058] As generally described above in relation to various other configurations, the electric motor 1102 may include a rotatable shaft (not shown) that operably interfaces with a gear reducer assembly 1108 mounted in meshing engagement with a set or rack of drive teeth 1112 on the longitudinally movable drive member 1110. In use, the voltage polarity provided by the battery may cause the electric motor 1102 to operate in a clockwise direction, but the voltage polarity imparted to the electric motor by the battery may be reversed to cause the electric motor 1102 to operate in a counterclockwise direction. When the electric motor 1102 is rotated in one direction, the drive member 1110 is driven axially in a distal direction "D". When the motor 1102 is driven in the opposite rotational direction, the drive member 1110 is driven axially in a proximal direction "P". See, for example, FIG. 35. The handle 1042 may include a switch that may be configured to reverse the polarity imparted to the electric motor 1102 by the battery. As with other configurations described herein, the handle 1042 may also include a sensor configured to detect the position of the drive member 1110 and / or the direction in which the drive member 1110 is being moved.
[0059] Actuation of the motor 1102 may be controlled by a firing trigger 1120 pivotally supported on the handle 1042. The firing trigger 1120 may pivot between an inactivated position and an activated position. The firing trigger 1120 may be biased to the inactivated position by a spring (not shown) or other biasing arrangement such that when the clinician releases the firing trigger 1120, the firing trigger 1120 may be pivoted or otherwise returned to the inactivated position by the spring or biasing arrangement. In at least one form, the firing trigger 1120 may be located "outside" the closure trigger 1052, as described above. In at least one form, the closure trigger 1052 may have a firing trigger safety button 1122 pivotally attached thereto. As seen in FIGS. 35 and 36, for example, the safety button 1122 may have a pivot arm 1124 positioned between the firing trigger 1120 and the closure trigger 1052 and projecting from the safety button 1122. 38, when the closure trigger 1052 is in the unactuated position, the safety button 1122 is constrained within the handle housing and cannot be easily accessed by a clinician to move the safety button 1122 between a safety position that prevents actuation of the firing trigger 1120 and a firing position in which the firing trigger 1120 can be fired. When the clinician presses the closure trigger 1052, the safety button 1122 and firing trigger 1120 pivot down, allowing them to then be operated by the clinician.
[0060] As shown above, in at least one form, the longitudinally movable drive member 1110 has a rack of teeth 1112 formed thereon for meshing engagement with a corresponding drive gear 1114 of the gear reducer assembly 1108. Also included in at least one form may be a manually actuated "escape" assembly 1130 configured to allow a clinician to manually retract the longitudinally movable drive member 1110 in the event of a motor failure. This escape assembly 1130 may have a lever or escape handle assembly 1132 configured to be manually pivoted into ratcheting engagement with the teeth 1112 in the drive member 1110. Thus, a clinician may manually retract the drive member 1110 by using the escape handle assembly 1132 to ratchet the drive member in the proximal direction "P". U.S. Patent Application Publication No. 2010 / 0089970, now U.S. Patent No. 8,608,045, discloses escape devices, as well as other components, devices, and systems that may be used with the various instruments disclosed herein. U.S. Patent Application No. 12 / 249,117, now U.S. Patent Application Publication No. 2010 / 0089970, now U.S. Patent No. 8,608,045, entitled "POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM," is hereby incorporated by reference in its entirety.
[0061] 34 and 37, for example, illustrate one form of the interchangeable shaft assembly 1200 having a surgical end effector 1300 operably attached thereto. The end effector 1300 as illustrated in these figures may be configured to cut and staple tissue in a variety of manners as disclosed herein. For example, the end effector 1300 may have a channel 1302 configured to support a surgical staple cartridge 1304. The staple cartridge 1304 may comprise a removable staple cartridge 1304 so that it may be replaced after use. However, staple cartridges of other configurations may be configured such that once installed within the channel 1302, it is not intended to be removed from the channel 1302. The channel 1032 and staple cartridge 1304 may be collectively referred to as the "first jaw portion" of the end effector 1300. In various configurations, the end effector 1300 may have a “second jaw portion” in the form of an anvil 1310 that is movably or pivotally supported on the channel 1302 in various manners as discussed herein.
[0062] The interchangeable shaft assembly 1200 may further include a shaft 1210 having a shaft frame 1212 coupled to a shaft mounting module or portion 1220. In at least one form, a proximal end 1214 of the shaft frame 1212 may extend through and be rotatably mounted to a hollow collar portion 1222 formed on the shaft mounting module 1220. For example, an annular groove 1216 may be provided on the proximal end 1214 of the shaft frame 1212 for engaging a U-shaped retainer 1226 extending through a slot 1224 of the shaft mounting module 1220. Such a configuration allows the shaft frame 1212 to rotate relative to the shaft mounting module 1220.
[0063] The shaft assembly 1200 may further comprise a hollow outer sleeve or closure tube 1250 through which the shaft 1212 extends. The outer sleeve 1250 may also be referred to herein as the "first shaft" and / or the "first shaft assembly." The outer sleeve 1250 has a proximal end 1252 adapted to be rotatably coupled to a closure tube mounting yoke 1260. As can be seen in FIG. 37, the proximal end 1252 of the outer sleeve 1250 is configured to be received within a cradle 1262 within the closure tube mounting yoke 1260. A U-shaped connector 1266 extends through a slot 1264 within the closure tube mounting yoke 1260 to be received within an annular groove 1254 of the proximal end 1252 of the outer sleeve 1250. Such an arrangement serves to rotatably couple the outer sleeve 1250 to the closure tube mounting yoke 1260 such that the outer sleeve 1250 can rotate relative to the closure tube mounting yoke 1260 .
[0064] 38 and 39, the proximal end 1214 of the shaft frame 1214 projects proximally from the proximal end 1252 of the outer sleeve 1250 and is rotatably coupled to the shaft mounting module 1220 by a U-shaped retainer 1226 (shown in FIG. 38). The closure tube mounting yoke 1260 is configured to be slidably received within a passageway 1268 of the shaft mounting module 1220. Such a configuration allows the outer sleeve 1250 to be moved axially in a proximal direction "P" and a distal direction "D" on the shaft frame 1212 relative to the shaft mounting module 1220, as discussed in further detail below.
[0065] In at least one form, the interchangeable shaft assembly 1200 may further include an articulation joint 1350. However, other interchangeable shaft assemblies may not be articulatable. As seen in FIG. 37, for example, the articulation joint 1350 has a dual pivot closure sleeve assembly 1352. According to various forms, the dual pivot closure sleeve assembly 1352 includes a shaft closure sleeve assembly 1354 having upper and lower distally projecting tangs 1356, 1358. The end effector closure sleeve assembly 1354 has a horseshoe shaped aperture 1360 and a tab 1362 for engaging an opening tab on the anvil 1310 in the manner described above. As described above, the horseshoe shaped aperture 1360 and the tab 1362 engage the anvil tab when the anvil 1310 is open. The upper double pivot link 1364 has upwardly projecting distal and proximal pivot pins which engage with upper distal and proximal pin holes, respectively, of the upper proximal protruding tang 1356 on the outer sleeve 1250. The lower double pivot link 1366 has downwardly projecting distal and proximal pivot pins which engage with lower distal and proximal pin holes, respectively, of the lower proximal protruding tang 1358.
[0066] In use, the closure sleeve assembly 1354 is translated distally (direction "D") to close the anvil 1310, for example, in response to actuation of the closure trigger 1052. The anvil 1310 is closed by translating the outer sleeve 1250, and thus the shaft closure sleeve assembly 1354, distally to impact a proximal surface of the anvil 1310 in the manner described above. As also described above, the anvil 1310 is opened by translating the outer sleeve 1250 and the shaft closure sleeve assembly 1354 proximally to contact and press the tabs 1362 and horseshoe shaped aperture 1360 against the anvil tabs to lift the anvil 1310. In the anvil open position, the shaft closure sleeve assembly 1352 is moved to its proximal position.
[0067] In at least one form, the interchangeable shaft assembly 1200 further includes a firing member 1270 that is supported for axial movement within the shaft frame 1212. The firing member 1270 includes an intermediate firing shaft portion 1272 configured to be attached to a distal cutting portion 1280. The firing member 1270 may also be referred to herein as a "second shaft" and / or a "second shaft assembly." As can be seen in FIG. 37 , the intermediate firing shaft portion 1272 may have a longitudinal slot 1274 at its distal end, which may be configured to receive a proximal end 1282 of the distal cutting portion 1280. The longitudinal slot 1274 and the proximal end 1282 may be sized and configured to permit relative movement therebetween and may include a slip joint 1276. The slip joint 1276 allows the intermediate firing shaft portion 1272 of the firing drive 1270 to move to articulate the end effector 1300 without moving, or at least substantially moving, the distal cutting portion 1280. Once the end effector 1300 is properly oriented as described herein, the intermediate firing shaft portion 1272 can be advanced distally until the proximal sidewall of the longitudinal slot 1272 contacts the proximal end 1282 to advance the distal cutting portion 1280 and fire a staple cartridge positioned within the channel 1302. As can be further seen in FIG. 37 , the shaft frame 1212 has an elongated opening or window 1213 to facilitate assembly and insertion of the intermediate firing shaft portion 1272 into the shaft frame 1212. When the mid-firing shaft portion 1272 is inserted into the shaft frame 1212, the top frame section 1215 can be engaged with the shaft frame 1212 to enclose the mid-firing shaft portion 1272 and the distal cutting portion 1280 therewithin.The reader will also note that the articulation joint 1350 may further include a guide 1368 that may be configured to receive the distal cutting portion 1280 of the firing member 1270 therein and to guide the distal cutting portion 1280 as it is advanced distally and / or retracted proximally within and / or relative to the articulation joint 1350.
[0068] As can be seen in FIG. 37, the shaft mounting module 1220 may further include a latch actuator assembly 1230, which may be removably mounted to the shaft mounting module by a cap screw (not shown) or other suitable fastener. The latch actuator assembly 1230 is configured to cooperate with a locking yoke 1240, which is pivotally coupled to the shaft mounting module 1220 for selective pivotal movement relative to the shaft mounting module 1220. See FIG. 41. With reference to FIG. 39, as discussed in more detail below, the locking yoke 1240 may have two proximally protruding locking lugs 1242 (FIG. 37) that are configured to releasably engage corresponding locking detents or grooves 1086 formed in a frame mounting module portion 1084 of the frame 1080. The locking yoke 1240 is substantially U-shaped and is installed onto the latch actuator assembly 1230 after the latch actuator assembly 1230 is coupled to the shaft mounting module 1220. The latch actuator assembly 1230 may have an arcuate body portion 1234 that provides sufficient clearance for the locking yoke 1240 to pivot relative to the latch actuator assembly 1230 between the latched and unlatched positions.
[0069] In various forms, the lock yoke 1240 is biased in a proximal direction by a spring or biasing member (not shown). In other words, the lock yoke 1240 is biased to a latched position (FIG. 40) and can be pivoted to an unlatched position (FIG. 41) by a latch button 1236 movably supported on the latch actuator assembly 1230. In at least one configuration, for example, the latch button 1236 is slidably retained within the latch housing portion 1235 and biased in a proximal direction "P" by a latch spring or biasing member (not shown). As discussed in more detail below, the latch button 1236 has a distally protruding release lug 1237 that is designed to engage the lock yoke 1240 when the latch button 1236 is actuated to pivot the lock yoke 1240 from the latched position to the unlatched position shown in FIG. 41.
[0070] The interchangeable shaft assembly 1200 may further include a nozzle assembly 1290 rotatably supported on the shaft mounting module 1220. In at least one form, for example, the nozzle assembly 1290 may be comprised of two nozzle halves or portions 1292, 1294 that may be interconnected by screws, snap mechanisms, adhesives, or the like. When mounted on the shaft mounting module 1220, the nozzle assembly 1290 may interface with the outer sleeve 1250 and the shaft frame 1212, thereby allowing a clinician to selectively rotate the shaft 1210 relative to the shaft mounting module 1220 about a shaft axis SA-SA, which may be defined, for example, in the axis of the firing member assembly 1270. In particular, a portion of the nozzle assembly 1290 may extend through a window 1253 in the outer sleeve to engage a notch 1218 in the shaft frame 1212. See FIG. 37. Thus, rotation of the nozzle assembly 1290 results in rotation of the shaft frame 1212 and outer sleeve 1250 relative to the shaft mounting module 1220 about axis AA.
[0071] 42 and 43, the reader will see that the frame mounting module portion 1084 of the frame 1080 is formed with two inwardly facing dovetail shaped receiving slots 1088. Each dovetail receiving slot 1088 may be tapered, or in other words, somewhat V-shaped. See, for example, FIGS. 36 and 38 (only one of each slot 1088 is shown). The dovetail receiving slots 1088 are configured to releasably receive corresponding tapered mounting or lug portions 1229 of the proximally extending connector portion 1228 of the shaft mounting module 1220. As can be further seen in FIGS. 37-39, a shaft mounting lug 1278 is formed on the proximal end 1277 of the intermediate launch shaft 1272. As will be described in more detail below, when the interchangeable shaft assembly 1200 is coupled to the handle 1042, the shaft mounting lugs 1278 are received in a firing shaft mounting cradle 1113 formed on the distal end 1111 of the longitudinal drive member 1110. The closure tube mounting yoke 1260 also has a proximally extending yoke portion 1265 having two downwardly opening capture slots 1267 for capturing the mounting lugs 1066 of the closure mounting bar 1064.
[0072] The attachment of the interchangeable shaft assembly 1220 to the handle 1042 will now be described with reference to Figures 44-48. In various configurations, at least one of the frame 1080 or drive system defines an actuation axis AA-AA. For example, the actuation axis AA-AA may be defined by the axis of the longitudinally movable drive member 1110. Thus, when the intermediate firing shaft 1272 is operatively coupled to the longitudinally movable drive member 1110, the actuation axis AA-AA is coaxial with the shaft axis SA-SA, as shown in Figure 48.
[0073] To begin the coupling process, the clinician can position the shaft mounting module 1220 of the interchangeable shaft assembly 1200 on or adjacent to the frame mounting module portion 1084 of the frame 1080 such that the mounting lugs 1229 formed on the connector portion 1228 of the shaft mounting module 1220 are aligned with the dovetail slots 1088 of the mounting module portion 1084, as shown in FIG. 45. The clinician can then move the shaft mounting module 1220 along an installation axis IA-IA substantially perpendicular to the actuation axis AA-AA. In other words, the shaft mounting module 1220 is moved in an installation direction "ID" substantially perpendicular to the actuation axis AA-AA until the mounting lugs 1229 of the connector portion 1228 are seated in "operable engagement" with the corresponding dovetail receiving slots 1088. See FIGS. 44 and 46. FIG. 47 shows the position of the shaft mounting module 1220 before the shaft mounting lugs 1278 on the intermediate launch shaft 1272 enter the cradle 1113 of the longitudinally movable drive member 1110 and the mounting lugs 1066 on the closure mounting bar 1064 enter the corresponding slots 1267 in the yoke portion 1265 of the closure tube mounting yoke 1260. FIG. 48 shows the position of the shaft mounting module 1220 after the mounting process is completed. As can be seen in this figure, the lugs 1066 (only one shown) are seated in operative engagement in the corresponding slots 1267 in the yoke portion 1265 of the closure tube mounting yoke 1260. As used herein, the term "operative engagement" in the context of two components means that the two components are sufficiently engaged with one another such that the components may perform their intended function, function, and / or procedure upon application of an actuation motion thereto.
[0074] As discussed above, and referring again to FIGS. 44-49 , at least five systems of the interchangeable shaft assembly 1200 may be operably coupled to at least five corresponding systems of the handle 1042. A first system may include a frame system that couples and / or aligns a frame of the shaft assembly 1200 with a frame of the handle 1042. As generally described above, the connector portion 1228 of the shaft assembly 1200 may be engaged with the mounting module portion 1084 of the handle frame 1080. A second system may include a closure drive system that may operably connect the closure trigger 1052 of the handle 1042, the closure tube 1250, and the anvil 1310 of the shaft assembly 1200. As generally described above, the closure tube mounting yoke 1260 of the shaft assembly 1200 may be engaged with the mounting lugs 1066 of the handle 1042. The third system may include a firing drive system that may operably connect the firing trigger 1120 of the handle 1042 with the intermediate firing shaft 1272 of the shaft assembly 1200. As generally described above, the shaft mounting lug 1278 may be operably connected with the cradle 1113 of the longitudinal drive member 1110. The fourth system may include an electrical system that may (1) communicate to a controller in the handle 1042, such as, for example, the microcontroller 7004, that a shaft assembly, such as, for example, the shaft assembly 1200, is operably engaged with the handle 1042, and / or (2) transmit power and / or communication signals between the shaft assembly 1200 and the handle 1042. For example, the shaft assembly 1200 may have six electrical contacts and the electrical connector 4000 may also have six electrical contacts, where each electrical contact of the shaft assembly 1200 may be paired and mated with an electrical contact of the electrical connector 4000 when the shaft assembly 1200 is assembled to the handle 1042. The shaft assembly 1200 can also have a latch 1236 , which may be part of a fifth system, such as a locking system, that can releasably lock the shaft assembly 1200 to the handle 1042 .Under various circumstances, the latch 1236 can close a circuit within the handle 1042 , for example, when the latch 1236 is engaged with the handle 1042 .
[0075] In addition to the above, the frame system, closure drive system, firing drive system, and electrical system of the shaft assembly 1200 can be assembled to the corresponding systems of the handle 1042, for example, transversely, i.e., along the axis IA-IA. Under various circumstances, the frame system, closure drive system, and firing drive system of the shaft assembly 1200 can be coupled to the corresponding systems of the handle 1042 simultaneously. Under certain circumstances, two of the frame system, closure drive system, and firing drive system of the shaft assembly 1200 can be coupled to the corresponding systems of the handle 1042 simultaneously. Under at least one circumstance, the frame system can be coupled at least initially before the closure drive system and the firing drive system are coupled. Under such circumstances, the frame system can be configured to align the corresponding components of the closure drive system and the firing drive system before they are coupled as outlined above. Under various circumstances, the housing assembly 1200 and the electrical system portion of the handle 1042 can be configured to be coupled at the same time that the frame system, the closure drive system, and / or the firing drive system are finally or fully seated. Under certain circumstances, the housing assembly 1200 and the electrical system portion of the handle 1042 may be configured to be coupled before the frame system, the closure drive system, and / or the firing drive system are finally or fully seated. Under some circumstances, the housing assembly 1200 and the electrical system portion of the handle 1042 may be configured to be coupled after the frame system is at least partially coupled and before the closure drive system and / or the firing drive system are coupled. Under various circumstances, the locking system may be configured to be the last system engaged, i.e., engaged after the frame system, the closure drive system, the firing drive system, and the electrical system are all engaged.
[0076] As generally described above, and referring again to Figs. 44-49, the electrical connector 4000 of the handle 1042 can include a number of electrical contacts. Referring now to Fig. 51, the electrical connector 4000 can include, for example, a first contact 4001a, a second contact 4001b, a third contact 4001c, a fourth contact 4001d, a fifth contact 4001e, and a sixth contact 4001f. While the illustrated embodiment utilizes six contacts, other embodiments are envisioned that may utilize more than six contacts or less than six contacts. As shown in Fig. 51, the first contact 4001a can be in electrical communication with a transistor 4008, the contacts 4001b-4001e can be in electrical communication with a microcontroller 7004, and the sixth contact 4001f can be in electrical communication with ground. The microcontroller 7004 is discussed in more detail below. Under certain circumstances, when the handle 1042 is in a powered state, one or more of the electrical contacts 4001b-4001e may be in electrical communication with one or more output channels of the microcontroller 7004 and may be powered or have a potential applied to them. In some circumstances, one or more of the electrical contacts 4001b-4001e may be in electrical communication with one or more input channels of the microcontroller 7004, and the microcontroller 7004 may be configured to detect when a potential is applied to such electrical contacts when the handle 1042 is in a powered state. When a shaft assembly, such as the shaft assembly 1200, is assembled to the handle 1042, the electrical contacts 4001a-4001f may not be in communication with one another. However, when the shaft assembly is not assembled to the handle 1042, the electrical contacts 4001a-4001f of the electrical connector 4000 may be exposed, and under some circumstances, one or more of the contacts 4001a-4001f may inadvertently be placed into electrical communication with one another. Such a situation may arise, for example, when one or more of the contacts 4001a-4001f come into contact with a conductive material. When this occurs, for example, the microcontroller 7004 may receive an error input and / or the shaft assembly 1200 may receive an error output.To address this issue, in various circumstances, the handle 1042 may be unpowered when, for example, a shaft assembly, such as the shaft assembly 1200, is not attached to the handle 1042. In other circumstances, the handle 1042 may be powered when, for example, a shaft assembly, such as the shaft assembly 1200, is not attached to the handle 1042. In such circumstances, the microcontroller 7004 may be configured to ignore inputs or potentials applied to contacts in electrical communication with the microcontroller 7004, i.e., contacts 4001b-4001e, for example, until a shaft assembly is attached to the handle 1042. The microcontroller 7004 may be powered to operate other functions of the handle 1042 under such circumstances, but the handle 1042 may be in an unpowered state. In a sense, the electrical connector 4000 may be in a depowered state, since potentials applied to the electrical contacts 4001b-4001e may not affect the operation of the handle 1042. The reader will understand that the contacts 4001b-4001e may be in an unpowered state, while the electrical contacts 4001a and 4001f that are not in electrical communication with the microcontroller 7004 may or may not be in an unpowered state. As an example, the sixth contact 4001f may remain in electrical communication with ground regardless of whether the handle 1042 is in a powered or unpowered state. Additionally, the transistor 4008 and / or any other suitable transistor configuration, such as, for example, the transistor 4010, and / or switch, may be configured to control the supply of power from the power source 4004, such as, for example, the battery 1104 in the handle 1042, to the first electrical contact 4001a, regardless of whether the handle 1042 is in a powered or unpowered state, as outlined above. Under various circumstances, the latch 1236 of the shaft assembly 1200 may be configured to change the state of the transistor 4008, for example, when the latch 1236 is engaged with the handle 1042. In various circumstances, as described elsewhere herein, the latch 1236 can be configured to close a circuit when engaged with the handle 1042, thereby affecting the state of the transistor 4008.Under certain circumstances, the Hall effect sensor 4002 can be configured to switch the state of the transistor 4010, which in turn can switch the state of the transistor 4008 and ultimately provide power from the power source 4004 to the first contact 4001a. In this manner, both the power and signal circuits to the connector 4000 can be de-energized when the shaft assembly is not installed in the handle 1042 and can be powered when the shaft assembly is installed in the handle 1042.
[0077] Referring again to FIG. 51, under various circumstances, the handle 1042 can have, for example, a Hall effect sensor 4002 configured to detect a detectable element, for example, a magnetic element, on a shaft assembly, for example, shaft assembly 1200, when the shaft assembly is coupled to the handle 1042. The Hall effect sensor 4002 can be powered by a power source 4006, for example, a battery, which can actually amplify the detection signal of the Hall effect sensor 4002 and communicate it to an input channel of the microcontroller 7004 via the circuitry shown in FIG. 51. When the microcontroller 7004 receives an input indicating that the shaft assembly is at least partially coupled to the handle 1042, and as a result, the electrical contacts 4001a-4001f are no longer exposed, the microcontroller 7004 can enter a normal, or powered, operating state. In such an operating state, the microcontroller 7004, during its normal use, evaluates a signal transmitted from the shaft assembly to one or more of the contacts 4001b-4001e and / or transmits a signal to the shaft assembly through one or more of the contacts 4001b-4001e. Under various circumstances, the shaft assembly 1200 may have to be fully seated before the Hall effect sensor 4002 can sense the magnetic element. While the Hall effect sensor 4002 may be utilized to detect the presence of the shaft assembly 1200, any suitable system of sensors and / or switches may be utilized to detect, for example, whether the shaft assembly is assembled to the handle 1042. In this manner, in addition to the above, both the power and signal circuits to the connector 4000 may be de-energized when the shaft assembly is not installed in the handle 1042 and may be energized when the shaft assembly is installed in the handle 1042.
[0078] In various embodiments, any number of magnetic sensing elements may be used to detect, for example, whether or not the shaft assembly is assembled to the handle 1042. For example, technologies used for magnetic field sensing include search coils, fluxgates, optical pumping, nuclear perturbation, SQUID, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, fiber optics, magneto-optical, and microelectromechanical systems based magnetic sensors, among others.
[0079] After the interchangeable shaft assembly 1200 is operably coupled to the handle 1042, actuation of the closure trigger 1052 results in axial distal advancement of the outer sleeve 1250 and associated shaft closure sleeve assembly 1354 to actuate the anvil 1310 in various manners disclosed herein. As can also be seen in FIG. 48 , a firing member 1270 in the interchangeable shaft assembly 1200 is coupled to a longitudinally movable drive member 1110 in the handle 1042. More specifically, a shaft mounting lug 1278 formed on a proximal end 1277 of the intermediate firing shaft 1272 is received within a firing shaft mounting cradle 1113 formed on a distal end 1111 of the longitudinally movable drive member 1110. Thus, actuation of the firing trigger 1120 results in energizing the motor 1102 to axially advance the longitudinally movable drive member 1110, which in turn causes the firing member 1270 to move axially within the shaft frame 1212. Such action advances the distal cutting portion 1280 through tissue clamped to the end effector 1300 in various manners as disclosed herein. Not visible in FIG. 48, but as would also be understood by one of ordinary skill in the art, when in the coupled position shown in FIG. 48, the attachment lug portion 1229 of the shaft attachment module 1220 is seated within respective dovetail receiving slots 1088 of the attachment module portion 1084 of the frame 1080. In this manner, the shaft attachment module 1220 is coupled to the frame 1080. Additionally, although not shown in FIG. 48 (but can be seen in FIG. 40), when the shaft mounting module 1220 is coupled to the frame 1080, the locking lugs 1242 on the locking yoke 1240 are seated within corresponding locking grooves 1086 (only one shown in FIG. 40) in the mounting module portion 1084 of the frame 1080 to releasably maintain the shaft mounting module 1220 in coupled and operative engagement with the frame 1080.
[0080] To unload the interchangeable shaft assembly 1220 from the frame 1080, the clinician presses the latch button 1236 in a distal direction "D" to pivot the locking yoke 1240 as shown in FIG. 41. Such pivoting movement of the locking yoke 1240 moves the locking lugs 1242 on the locking yoke 1240 out of retaining engagement with the locking grooves 1086. The clinician then moves the shaft attachment module 1220 away from the handle in the uncoupling direction "DD" as shown in FIG.
[0081] It will be appreciated by those skilled in the art that the shaft mounting module 1220 may also be held stationary and the handle 1042 may be moved along an installation axis IA-IA, substantially perpendicular to the shaft axis SA-SA, to bring the lug 1229 of the connector portion 1228 into seating engagement with the dovetail slot 1088. It will be further appreciated that the shaft mounting module 1220 and the handle 1042 may be moved simultaneously toward one another along an installation axis IA-IA, substantially perpendicular to the shaft axis SA-SA and the actuation axis AA-AA.
[0082] As used herein, the phrase "substantially perpendicular to the actuation axis and / or to the shaft axis" refers to a direction that is approximately perpendicular to the actuation axis and / or shaft axis, however, it should be understood that a direction that deviates somewhat from perpendicular to the actuation axis and / or shaft axis is also substantially perpendicular to those axes.
[0083] 52 and 53, using the physics of the tool disclosed herein, a controller, such as a microcontroller 7004, can be designed to simulate the response of the tool's actual system in the controller's software. The simulated response is compared to the measured response of the actual system (noisy and discrete) to obtain an "observed" response, which is used to determine the actual feedback. The observed response is a suitable adjusted value that balances the smooth and continuous nature of the simulated response with the measured response, which can detect external influences on the system. With reference to FIGS. 52 and 53, the firing or cutting element of the end effector 1300 of the shaft assembly 1200 can be moved at or near a target speed or velocity. The system disclosed in FIGS. 52 and 53 can be utilized to move the cutting element at a target speed. The system can include a feedback controller 4200, which can be one of any feedback controller, including, but not limited to, a PID, state feedback, LQR, and / or adaptive controller. The system may further include a power source, which may, for example, convert a signal from the feedback controller 4200 into a physical input to the system, in this case a voltage. Other examples include, but are not limited to, a pulse width modulated (PWM) voltage, a frequency modulated voltage, a current, a torque, and / or a force.
[0084] Continuing with reference to Figs. 52 and 53, the physical system referred to therein is the actual drive system of the instrument configured to drive the firing member or cutting member. One example is a brushed DC motor with a gearbox and mechanical link to the articulation and / or knife system. Another example is the motor 1102 disclosed herein, which operates, for example, the firing member 10060 and the articulation driver 10030 of the interchangeable shaft assembly. The external influence 4201 referred to in Figs. 52 and 53 is the unlimited and unpredictable influence that things such as, for example, the tissue surrounding the body and friction have on the physical system. Such an external influence may be called a drag force and can be represented, for example, by a motor 4202 acting against the motor 1102. Under various circumstances, external influences such as drag forces are a major source of deviation between a simulation of a physical system and an actual physical system. The system shown in Figures 52 and 53, and discussed further below, can accommodate differences between the expected behavior of a firing or cutting member and the actual behavior of the firing or cutting member.
[0085] With continued reference to Fig. 52 and Fig. 53, the individual sensors referenced therein measure physical parameters of an actual physical system. One embodiment of such individual sensors may include an absolute positioning sensor 7102 and the system described herein. The output of such individual sensors is a digital signal (or may be connected to a digital data acquisition system), so that the output has a finite resolution and sampling frequency. The output of the individual sensors may be fed to a microcontroller, such as, for example, microcontroller 7004. In various circumstances, the microcontroller may combine a simulated or estimated response with a measured response. In certain circumstances, it may be useful to fully utilize the measured response to ensure that external influences are taken into account without making the observed response noisy and unusable. Examples of algorithms that do this include, for example, weighted averages and / or theoretical control loops that approximate the simulated response to the measured response. Finally, in addition to the above, the simulation of the physical system may take into account properties such as mass, inertia, viscous friction, and / or inductive resistance, for example, to predict what the state and output of the physical system will be knowing the inputs. 53 illustrates the addition of evaluation and measurement of the current supplied to operate the actual system, which is yet another parameter that may be evaluated to control, for example, the speed of the cutting or firing member of the shaft assembly 1200. In certain circumstances, measuring the current in addition to or instead of measuring the voltage can make the physical system more accurate. Nevertheless, the concepts disclosed herein can be extended to measuring other state parameters for other physical systems.
[0086] A control system, such as the control system shown in FIG. 54 and / or FIG. 57, may be utilized to control, for example, any of the surgical instruments disclosed herein. In various circumstances, the control system may include a microcontroller, such as, for example, microcontroller 7004, which may be configured to operate various systems of the surgical instrument. In addition to the above, the control system may include assembly detection means for detecting whether a shaft assembly, such as shaft assembly 1200, has been assembled or at least partially assembled to, for example, handle 1042. Such assembly detection means may include, for example, Hall effect sensor 4002, as described above, and means for maintaining handle 1042 in an unpowered state when the shaft assembly is not assembled to handle 1042, and means for maintaining handle 1042 in an energized state when the shaft assembly is not assembled to handle 1042. As outlined above, microcontroller 7004, for example, may include such means. The control system may further comprise power transfer means for transferring power to and / or from the shaft assembly and / or signal communication means for communicating communication signals to and / or from the shaft assembly. Such power transfer means and signal communication means may comprise, for example, the electrical contacts 4000, corresponding electrical contacts on the shaft assembly, and / or the microcontroller 7004.
[0087] 54 and 57, the control system may further include at least one closure trigger switch and at least one closure trigger circuit that may be configured to communicate to the microcontroller 7004 and / or be interpreted by the microcontroller 7004 that the closure trigger 1052 is closed as described above. The various switches may include, for example, potentiometers and / or Hall effect sensors. The control system may further include an unclosed operating means for operating the surgical instrument in an unclosed operating state when the closure trigger 1052 is in an unclosed position, and a closed operating means for operating the surgical instrument in a closed operating state when the closure trigger 1052 is in a closed position. The control system may include a power source, such as, for example, a battery 1104, and means for distributing power from the power source throughout the control system. The control system may include a motor, such as, for example, the motor 1102, For example, a motor power switch such as the firing trigger 1120; and motor operating means, as described elsewhere herein, for operating the motor 1102 in a desired manner. Such motor operating means may, in certain circumstances, be configured to control the motor 1102 utilizing, for example, pulse width modulation (PWM) voltage control. Further, PWM voltage control may be utilized, for example, to control the speed of the firing members 1272 and 1280. In a closed operating state of the surgical instrument, in some circumstances: The battery 1104 may be decoupled from the motor 1102, while in certain circumstances, even if power is provided to the motor 1102, the motor controller may be configured to prevent operation of the motor 1102 until the microcontroller 7004 detects closure of the closure trigger 1052. In such circumstances, the microcontroller 7004 may then operate the surgical instrument in its closed operating state. In the closed operating state, power may be provided to the motor 1102 and the motor controller may be configured to operate the motor 1102 in response to actuation of the firing trigger 1120. FIGS. 58-60, for example, illustrate various operations for operating the motor 1102 and firing members 1272 and 1280.
[0088] 54 and 57, for example, the control system can include a 12-bit magnetic rotary encoder and can be configured to monitor the position of the firing members 1272 and 1280. In various circumstances, the control system can include: The control system may include the absolute positioning sensor 7102 and detection system described above. The control system may also include a manual drive means for manually moving the firing members 1272 and 1280, and / or a means for operating another system of the surgical instrument in consideration of the operation of the manual drive means. For example, the manual drive means may include, for example, the manually actuable escape assembly 1130 described above. Also, for example, operation of the manual drive means may electrically deactivate the motor 1102. In some circumstances, operation of the manual drive means may decouple the battery 1104 from the motor 1102. In certain circumstances, operation of the manual drive means may be detected by a motor controller, which may be configured to prevent operation of the motor 1102 even if power may be provided to the motor 1102. In various circumstances, for example, the motor controller may include a microcontroller 7004.
[0089] With further reference to FIGS. 54 and 57, the control system can further include a communication means for communicating with an operator of the instrument. In various situations, the communication means can include one or more light emitting diode (LED) lights, for example, on the handle 1042, which can be configured to communicate, for example, that the surgical instrument is in a particular operational state to an operator of the surgical instrument. In at least one situation, the handle 1042 can include, for example, a green LED light that, when illuminated, can indicate, for example, that the surgical instrument is in an assembled, closed, and powered state. In such a situation, an illuminated green LED light can indicate that the surgical instrument is ready for use. The handle 1042 can include a red LED light, For example, the red LED light, when illuminated, can indicate that the surgical instrument is either in an unassembled, unoccluded, or unpowered state. In such circumstances, an illuminated red LED light can indicate that the surgical instrument is not ready for use. In addition to the above, the LED light can be in electrical communication with an output channel of the microcontroller 7004, which can be configured to determine and / or set the operating condition of the surgical instrument and communicate that condition, for example, via the LED light. In some circumstances, the communication means can include a display screen, for example, on the handle 1042, which can be configured to communicate information to an operator of the surgical instrument. In addition to the above, the microcontroller 7004 can communicate, for example, the operating condition of the surgical instrument by electrically communicating with the display screen.
[0090] With further reference to FIGS. 54 and 57, and with additional reference to FIGS. 55 and 56, the control system can include, for example, a number of switches in electrical communication with the microcontroller 7004. The switches can include the switches described above and / or in connection with any of the systems and / or subsystems of the surgical instrument described herein. The switches can include a switch array, which can be included in a switch circuit in electrical communication with the microcontroller 7004, for example. In certain circumstances, the switch circuit can include, for example, a 16-bit I / O encoder that can communicate with the microcontroller 7004. Furthermore, the switch circuit can include a bus in electrical communication with the microcontroller 7004 and one or more contacts of the electrical connector 4000. Finally, the switch circuit and switch array can then span, for example, the handle 1042 and the shaft assembly 1200. In various circumstances, the microcontroller 7004 can be configured to identify the shaft assembly attached to the handle 1042 and, for example, adjust the length of the firing stroke applied to the firing members 1272 and 1280. The entire disclosure of U.S. Patent No. 9,629,629, entitled "CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS," issued April 25, 2017, is incorporated herein by reference.
[0091] The surgical instrument 18000 is shown in FIG. 61. The surgical instrument 18000 is similar in many respects to the surgical instrument 400. The surgical instrument 18000 comprises a handle 18100, a shaft assembly 18200 extending from the handle 18100, and an end effector 18300 extending from the shaft 18200. The end effector 18300 comprises a first jaw 18310 and a second jaw 18320, the first jaw 18310 being movable between an open clamping position and a closed clamping position to clamp tissue between the first jaw 18310 and the second jaw 18320. Further, the end effector 18300 is rotatably attached to the shaft assembly 18200 about an articulation joint 18400. The handle 18100 comprises a frame 18110 and a housing 18120. The handle 18100 also includes a grip 18130, a closure actuator 18140 operable to actuate the end effector closure system, and a firing actuator 18150 operable to actuate the staple firing system. The handle 18100 also includes an articulation actuator operable to actuate the end effector articulation system. The second jaw 18320 includes a replaceable staple cartridge 18500 including staples removably stored therein, and the first jaw 18310 includes an anvil configured to deform the staples. The surgical instrument 18000 also includes an electric motor configured to drive the staple firing system of the surgical instrument 18000. Various staple firing systems are disclosed in U.S. Pat. No. 7,000,818, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS," which issued Feb. 21, 2006, and is incorporated herein by reference.
[0092] 62, the staple cartridge 18500 comprises a cartridge body 18510 comprising a longitudinal slot 18520, a proximal end 18530, and a distal end 18540. The staple cartridge 18500 further comprises a plurality of staple cavities 18222 defined within the cartridge body 18510 and staples removably stored within the staple cavities. The staple cartridge 18500 further comprises a sled 18550 (FIG. 69) distally movable by the staple firing system during a staple firing stroke to drive the staples upwardly from the staple cavities 18222 and into the patient's tissue. The staple cartridge 18500 further comprises a removable staple cartridge retainer or cover 18570 (FIG. 70) extending over the staple cavities to protect the staples. 70, the cover includes an elongated body, flexible latch arms 18574 extending from the body that releasably grip the cartridge body 18510, and longitudinal fins 18572 that extend into the longitudinal slots 18520. In many cases, the staple cartridge cover 18570 acts as a protective barrier between the clinician and the staples of the staple cartridge 18500. In various examples, the staple cartridge cover 18570 allows the clinician to place their thumbs on top of the staple cartridge 18500, for example, to seat the staple cartridge 18500 in the second jaw 18320 without contacting the staples. Once the staple cartridge 18500 is seated in the second jaw 18320, the cartridge cover 18570 is removed and the surgical instrument 18000 can then be inserted into the patient. However, if the cartridge cover 18570 is not removed after the staple cartridge 18500 is installed, the cartridge cover 18570 will prevent the staples from properly contacting the anvil of the first jaw 18310.
[0093] The surgical instrument 18000 further comprises a controller including a microprocessor. The surgical instrument 18000 also comprises an RFID system in communication with the controller. The RFID system comprises one or more RFID readers and one or more RFID tags, as discussed in more detail below. In various embodiments, the RFID system is configured to determine whether a staple cartridge is positioned within the surgical instrument and / or whether the staple cartridge is an appropriate staple cartridge for use with the surgical instrument. Such an RFID system can also determine whether the staple cartridge includes the correct components intended for that staple cartridge. If the controller determines that the staple cartridge is appropriate and that the components within the staple cartridge are correct, the surgical instrument 18000 may be used as intended. If the controller determines that the staple cartridge is not appropriate or that one or more of the components within the staple cartridge are inappropriate, the controller can limit the operation of the surgical instrument in several ways. In such an example, for example, the controller may allow the end effector to be opened and closed and / or articulated, but may prevent a staple firing stroke from being performed. The RFID system may also be used to determine whether a staple cartridge is properly positioned within the staple cartridge support. For example, the RFID system may indicate whether a proximal end of the staple cartridge and / or a distal end of the staple cartridge are properly seated within the staple cartridge channel, and if one of the ends of the staple cartridge is not fully seated, the controller may prevent a staple firing stroke from being performed. Additionally, the RFID system may indicate whether a staple cartridge positioned within the surgical instrument is an unused staple cartridge, or whether the staple cartridge has already been used or otherwise used.If the controller determines that the staple cartridge has been used, the controller prevents a staple firing stroke from being performed until the used staple cartridge is replaced with an unused staple cartridge. The RFID system may also be capable of tracking the movement of the movable components of the staple cartridge, which will be discussed in more detail below.
[0094] Radio Frequency Identification (RFID) is used in various industries to track and identify objects. RFID utilizes radio waves to transfer digitally stored information from an RFID tag to an RFID reader or receiver configured to receive the information. RFID technology utilizes RFID tags, sometimes called chips, that contain electronically stored information and RFID readers that serve to identify and communicate with the RFID tags. There are two different types of RFID systems: active RFID systems and passive RFID systems. Active RFID systems include RFID tags with an on-board power source to broadcast their signals. Active RFID tags may include a battery within the RFID tag, which allows them to function independently of an RFID reader. Thus, RFID tags in active RFID systems do not have to wait to receive a signal from an RFID reader before transmitting information. Rather, active RFID tags continuously transmit signals or beacons at will. Many commercially available active RFID systems often operate in one of two main frequency ranges, 433 MHz and 915 MHz, although any suitable frequency range may be used. Typically, an RFID tag must be within a particular distance or frequency range in order to be identified by its corresponding RFID reader.
[0095] Passive RFID systems include RFID tags that do not have an on-board power source, but instead receive the energy required to operate from an RFID reader. In contrast to active RFID tags, RFID tags in passive RFID systems do not actively transmit signals before receiving a prompt. Rather, passive RFID tags wait to receive information from an RFID reader before transmitting a signal. Many commercially available passive RFID systems often operate within three frequency ranges: low frequency ("LF"), high frequency ("HF") and near field communication ("NFC"), and ultra-high frequency ("UHF"). The LF bandwidth is 125-134 KHz and includes longer wavelengths with a short read range of approximately 1-10 centimeters. The HF and NFC bandwidths are 13.56 KHz and include medium wavelengths with a typical read range of 1 centimeter to 1 meter. The UHF bandwidth is 865-960 MHz and includes short, high energy wavelengths with a long read range of 1 meter. As stated above, any suitable frequency may be used.
[0096] There are various RFID systems with different sized RFID tags. However, some are more suitable for use in technology areas that require tracking of very small objects. For example, Hitachi Chemical Co. Ltd. is a leading manufacturer in the technology field of RFID. Ultra-small UHF RFID tags manufactured by Hitachi Chemical Co. Ltd. are typically no larger than 1.0-13 mm, allowing communication between the RFID tag and the RFID reader at distances of a few centimeters or more. Due to their compact nature, Hitachi RFID tags are suitable for very small products that need to be identified. Each Hitachi RFID tag includes an antenna, an IC chip connected to the antenna, and a sealing material that encapsulates the IC chip and the antenna. Because Hitachi RFID tags incorporate the antenna and IC chip in a single unit, Hitachi RFID tags are convenient enough to be easily fixed to any small object using, for example, glue or tape.
[0097] The Hitachi RFID tag comprises a square stainless steel plate and a metal antenna. The antenna comprises an LC resonant circuit or any other suitable circuit and is electrically connected to the plate. After the plate and antenna are connected to each other, the antenna and plate are sealed together in a single unit using a sealing material. The sealing material is mainly composed of epoxy, carbon, and silica to enhance the heat resistance capability of the Hitachi RFID tag. That is, the heat resistance of the RFID tag substantially depends on the heat resistance capability of the sealing material. The sealing material has a high degree of heat resistance, withstanding temperatures of up to 250-300°C for shorter periods, such as a few seconds, and is resistant to heat of up to 150°C for longer periods. Thus, the Hitachi RFID tag has higher heat resistance than conventional RFID tags and can still operate normally at high temperatures. Further information regarding Hitachi RFID tags may be found in the entire disclosure of U.S. Pat. No. 9,171,244, entitled "RFID TAG," issued Oct. 27, 2015, and incorporated herein by reference.
[0098] As described above, the surgical tool system 18000 includes an RFID system including one or more RFID readers and one or more RFID tags. Referring to FIG. 62, in various embodiments, the RFID system includes a first RFID tag 18560a, a second RFID tag 18560b, and a third RFID tag 18560c. FIG. 67 shows a Hitachi Ultra Small Package UHF RFID tag 18900 that may be used for the RFID tags 18560a, 18560b, and 18560c, although any suitable RFID tag may be used. The tag 18900 may, for example, have a size of 2.5mm×2.5mm×0.4mm. The tag 18900 comprises a substrate or base 18910, a microchip 18920 attached to the substrate 18910, and an antenna 18930 mounted to the substrate 18910 in a circumferential pattern that communicates with output channels or pins of the microchip 18920. Further details regarding the RFID tag 18900 are disclosed in U.S. Patent No. 9,171,244, which is incorporated herein by reference in its entirety. However, any suitable RFID tag may be used.
[0099] 62, 64-66, and 68, a first RFID tag 18560a is attached to the cartridge body 18510 at a first position A. A second RFID tag 18560b is attached to a sled 18550 slidably positioned within the cartridge body 18510 as shown in FIG. 69, and a third RFID tag 18560c is attached to a cover 18570 as shown in FIG. 70. Referring primarily to FIG. 66, the surgical instrument 18000 includes a first RFID reader 18600, a second RFID reader 18700, and a third RFID reader 18800. The first RFID reader 18600 includes a flexible circuit extending between a controller of the surgical instrument handle 18100 and the second jaw 18320. The first RFID reader 18600 includes a first inductive coil or sensor 18620 that is aligned with the first RFID tag 18560a when the staple cartridge 18500 is seated in the second jaw 18320. Similarly, the second RFID reader 18700 includes a flexible circuit that extends between the controller of the surgical instrument handle 18100 and the second jaw 18320. The second RFID reader 18700 includes a second inductive coil or sensor 18720 at position B ( FIG. 62 ) that is aligned with the second RFID tag 18560b when the staple cartridge 18500 is seated in the second jaw 18320. Also similarly, the third RFID reader 18600 includes a flexible circuit that extends between the controller of the surgical instrument handle 18100 and the second jaw 18320. The third RFID reader 18800 includes a third induction coil or sensor 18820 at position C ( FIG. 62 ) that is aligned with the third RFID tag 18560c when the staple cartridge 18500 is seated in the second jaw 18320.
[0100] The RFID tags 18560a, 18560b, and 18560c may be active and / or passive. When the RFID tags 18560a, 18560b, and 18560c are active RFID tags, they each emit a signal that is received by their corresponding RFID reader. For example, the first RFID sensor 18620 receives a first beacon signal from the first RFID tag 18560a, the second RFID sensor 18720 receives a second beacon signal from the second RFID tag 18560b, and the third RFID sensor 18820 receives a third beacon signal from the third RFID tag 18560c. The first, second, and third beacon signals may all be emitted at the same frequency or different frequencies. If the beacon signals are emitted at the same frequency, the range of the beacon signals and / or the location of the RFID sensors must be controlled so that there is no "crosstalk" between the RFID tags 18560a, 18560b, and 18560c and their corresponding RFID reader sensors 18620, 18720, and 18820. The range of the RFID beacon signals is determined by the power used to transmit the beacon signals and the availability of that power from their respective power sources or batteries. In general, the range of the beacon signals is proportional to the transmission power of the signal. If the beacon signals are emitted at different frequencies, the range of the signals and the relative locations of the RFID sensors 18620, 18720, and 18820 can be more flexible. In such an embodiment, the controller comprises one or more signal filters, such as, for example, a low pass filter and / or a high pass filter, that can be used to ensure that signals and data received from the RFID tags 18560a, 18560b, and 18560c are received on the correct input lines or RFID readers. For example, a low-pass filter may be used to filter the second and third beacon signals on the first RFID reader 18600, a high-pass filter may be used to filter the first and second beacon signals on the third RFID reader 18800, and both a low-pass filter and a high-pass filter may be used to filter the first and third beacon signals on the second RFID reader 18700.In any event, RFID readers 18600, 18700, and 18800 receive data from their corresponding RFID tags 18560a, 18560b, and 18560c as soon as the staple cartridge 18500 is seated in the second jaw 18320. Notably, RFID tags 18560a, 18560b, and 18560c can begin to communicate with their corresponding RFID readers when the staple cartridge 18500 is seated and / or when the staple cartridge 18500 is aligned with and about to be seated in the second jaw 18320.
[0101] When the RFID tags 18560a, 18560b, and 18560c are passive RFID tags, the RFID tags 18560a, 18560b, and 18560c do not emit signals until they receive signals from their corresponding RFID scanners 18600, 18700, and 18800. For example, the first RFID tag 18560a does not emit signals until it is energized by a signal emitted from the first sensor 18620 of the RFID scanner 18600. In this manner, the first sensor 18620 acts as a transmitting antenna that broadcasts a first signal, which, when received by the first RFID tag 18560a, causes the first RFID tag 18560a to emit a first return signal that is received by the first sensor 18620. Thus, the first sensor 18620 acts as both a transmitting antenna and a receiving antenna. That said, the first RFID scanner 18600 may include a transmit antenna as part of the transmission circuit and a separate receive antenna as part of the reception circuit. Similarly, the second RFID tag 18560b does not emit a signal until it is energized by a signal emitted from the second sensor 18720 of the RFID scanner 18700. In this way, the first sensor 18720 acts as a transmit antenna that broadcasts a second signal, which when received by the second RFID tag 18560b, causes the second RFID tag 18560b to emit a second return signal that is received by the second sensor 18720. Thus, the second sensor 18720 acts as both a transmit antenna and a receive antenna. That said, the second RFID scanner 18700 may include a transmit antenna as part of the transmission circuit and a separate receive antenna as part of the reception circuit. Similarly, the third RFID tag 18560c does not emit a signal until it is energized by a signal emitted from the third sensor 18820 of the RFID scanner 18800. In this manner, the third sensor 18820 acts as a transmitting antenna that broadcasts a third signal which, when received by the third RFID tag 18560c, causes the third RFID tag 18560c to emit a third return signal that is received by the third sensor 18820.Thus, the third sensor 18820 acts as both a transmitting antenna and a receiving antenna. That said, the third RFID scanner 18800 may include a transmitting antenna as part of the transmitting circuitry and a separate receiving antenna as part of the receiving circuitry.
[0102] As described above, the first RFID tag 18560a is affixed to the cartridge body 18510 of the staple cartridge 18500. The first RFID tag 18560a is attached to the cartridge body 18510 using one or more types of adhesive. That said, the first RFID tag 18560a may be affixed to the cartridge body 18510 in any suitable manner. For example, with reference to FIG. 68, the first RFID tag 18560a may be integrally molded with the cartridge body 18510 during an injection molding process. In such an example, at least a portion of the first RFID tag 18560a is embedded within the cartridge body 18510. That said, embodiments are envisioned in which the entirety of the first RFID tag 18560a is embedded in the cartridge body 18510. Further, embodiments are contemplated in which the walls of the cartridge body 18510 define a recess or pocket and the first RFID tag 18560a is positioned within the recess. In various examples, the perimeter of the RFID tag 18560a coincides with the perimeter of the recess in the cartridge body 18510.
[0103] When the first RFID scanner 18600 receives a first signal from the first RFID tag 18560a and the first signal or data from the first signal is communicated to the controller of the surgical instrument 18000, the controller determines that a staple cartridge is present in the second jaw 18520. In various embodiments, the controller performs an authentication evaluation to determine that the data received from the first RFID tag 18560a matches data from an acceptable staple cartridge. Data regarding acceptable staple cartridges may be stored in a memory device of the controller and / or may be stored, for example, in an off-board controller and / or cloud environment. If the controller determines that a staple cartridge is present in the second jaw 18320 and that the staple cartridge is compatible, the controller performs additional checks with the second and third RFID tags 18560b and 18560c of the RFID system, as discussed in more detail below. That said, embodiments are envisioned in which the first RFID tag 18560a is the only RFID tag in the RFID system and the controller may unlock the staple firing system when the presence of a matching staple cartridge is verified via the first RFID tag 18560a.
[0104] As described above, the second RFID tag 18560a is affixed to the cartridge body 18550 of the staple cartridge 18500. The second RFID tag 18560a is attached to the sled 18550 using one or more types of adhesive. That said, the second RFID tag 18560b may be affixed to the sled 18550 in any suitable manner. For example, with reference to FIG. 69, the second RFID tag 18560b may be integrally molded with the sled 18550 during an injection molding process. In such an example, at least a portion of the second RFID tag 18560b may be embedded in the sled 18550. That said, embodiments are envisioned in which the entirety of the second RFID tag 18560b is embedded in the sled 18550. Additionally, embodiments are envisioned in which the walls of the sled 18550 define a recess or pocket and the second RFID tag 18560b is positioned within the recess. In various examples, the perimeter of the RFID tag 18560b matches the perimeter of a recess in the sled 18550.
[0105] When the second RFID scanner 18700 receives a second signal from the second RFID tag 18560b and the second signal or data from the second signal is communicated to the controller of the surgical instrument 18000, the controller determines that the sled is present in its proximal, unfired position within the staple cartridge. With this information, the controller can determine that the staple cartridge is in an unused state. If the sled 18550 is not in its proximal, unfired position, the second RFID tag 18560b will be located out of range of the second RFID scanner 18700, and the controller determines that the staple cartridge positioned within the second jaw 18320 is at least partially used. In such an example, the controller will not unlock the staple firing system until the staple cartridge is replaced with a matching, unused staple cartridge.
[0106] In various embodiments, the controller performs an authentication evaluation to determine that the data received from the second RFID tag 18560b matches data corresponding to the staple cartridge identified by the first RFID scanner 18600. If the controller determines that the sled 18550 is a suitable component of a staple cartridge present in the second jaw 18320 via the data from the second RFID tag 18560b, the controller performs an additional check with a third RFID tag 18560c of the RFID system, as discussed in more detail below. That said, embodiments are contemplated that do not include a third RFID tag 18560c, and where the presence of a matching unfired staple cartridge is verified via the first and second RFID tags 18560a and 18560b, the controller may unlock the staple firing system, as described above.
[0107] As discussed above, with reference to FIG. 70, the third RFID tag 18560c is affixed to the removable cover 18570 of the staple cartridge 18500. The third RFID tag 18560c is attached to the cover 18570 using one or more types of adhesive. That said, the third RFID tag 18560c may be affixed to the cover 18570 in any suitable manner. For example, with reference to FIG. 70, the third RFID tag 18560c may be integrally molded with the cover 18570 during an injection molding process. In such an example, at least a portion of the third RFID tag 18560c may be embedded in the cover 18570. That said, embodiments are envisioned in which the entirety of the third RFID tag 18560c is embedded in the cover 18570. Additionally, embodiments are contemplated in which a wall of the cover 18570 defines a recess or pocket and the third RFID tag 18560c is positioned within the recess. In various examples, the perimeter of the RFID tag 18560c coincides with the perimeter of the recess in the cover 18570.
[0108] When the third RFID scanner 18800 receives a third signal from the third RFID tag 18560c and the third signal or data from the third signal is communicated to the controller of the surgical instrument 18000, the controller determines that the cover 18570 is attached to the staple cartridge. With this information, the controller can determine that the clinician inserted the staple cartridge into the surgical instrument 18000 with the cover 18570 and therefore did not disturb the staples stored in the cartridge body 18510. If the cover 18570 is not detected on the cartridge body 18510, the controller determines that the staple cartridge may be damaged. In such an example, the controller will not unlock the staple firing system until the staple cartridge is replaced with a matching unused and undamaged staple cartridge.
[0109] In various embodiments, the controller performs an authentication evaluation to determine that the data received from the third RFID tag 18560c matches data corresponding to the staple cartridge identified by the third RFID scanner 18700. If the controller determines that the cover 18570 is an appropriate component of the staple cartridge present in the second jaw 18320 via the data from the third RFID tag 18560c, the controller unlocks the staple firing system. Additional RFID tags and RFID tag scanners may be used to evaluate the presence, condition, and / or suitability of a staple cartridge positioned within the surgical instrument.
[0110] As mentioned above, the second RFID scanner 18700 is used by the controller of the surgical instrument 18000 to assess whether the sled 18550 is in its proximal, unfired position. In the absence of the second RFID scanner 18700, the controller cannot assess the position of the sled 18550 unless it is within communication range of the second RFID 18700 scanner. That being said, the surgical instrument may include two or more RFID scanners that may be used by the controller of the surgical instrument to assess the position of the sled 18500 and thus the progress of the staple firing stroke. Referring again to FIG. 66, the first RFID scanner 18600 and the third RFID scanner 18800 of the surgical instrument 18000 may be used to track the position of the sled 18500. As the sled 18500 is moved distally during the staple firing stroke, the second RFID tag 18560b passes through a transmission range 18610 of the first RFID scanner 18600 and a transmission range 18810 of the third RFID scanner. When the second signal of the second RFID tag 18560b is detected by the first RFID scanner 18600, the controller determines that the sled 18550 is adjacent position A. Similarly, the controller determines that the sled 18550 is adjacent position C when the second signal of the second RFID tag 18560b is detected by the third RFID scanner 18800. In various embodiments, the RFID system may include an RFID scanner adjacent a distal end of the staple cartridge in communication with the controller to detect when the sled 18550 has reached the end of the staple firing stroke.
[0111] Many commercially available staple cartridges are sold in standard lengths. For example, Ethicon, a subsidiary of Johnson & Johnson, sells, among others, staple cartridges configured to apply a 30 mm long staple pattern, a 45 mm long staple pattern, and a 60 mm long staple pattern. These lengths of 30 mm, 45 mm, and 60 mm do not represent the overall length of the staple cartridge, but rather, these lengths represent the length of the staple pattern that these staple cartridges can apply. That said, Ethicon also sells a surgical stapler that is configured to receive a 30 mm staple cartridge. Such a surgical stapler includes an anvil that is configured to deform the staples in a 30 mm pattern. Ethicon also sells a surgical stapler configured to receive a 45 mm staple cartridge, as well as a surgical stapler configured to receive a 60 mm staple cartridge and have an anvil configured to deform the 45 mm staple pattern and the 60 mm staple pattern, respectively. Barring other considerations, an anvil designed to create a 30 mm long staple pattern will not be able to deform all of the staples in a 60 mm staple pattern. In various embodiments, further to the above, the surgical instrument may include an RFID system configured to evaluate whether a staple cartridge inserted into the surgical instrument has a staple pattern that matches a staple pattern that the anvil of the surgical instrument is capable of deforming, as described in more detail below.
[0112] In addition to the above, and with reference to FIGS. 74 and 75 , an end effector 18300′ of a surgical instrument includes a first jaw 18310 and a second jaw 18320 configured to receive a replaceable staple cartridge 19700 therein. The staple cartridge 19700 is similar in many respects to the staple cartridge 18500 and includes a plurality of staples removably stored therein. The pattern of staples stored in the staple cartridge 19700 matches the pattern of staple forming pockets defined in the anvil of the first jaw 18310. Another staple cartridge 19600 is shown in FIG. 74 . Similar to the staple cartridge 19700, the staple cartridge 19600 can be inserted into the second jaw 18320, but the staple cartridge 19600 creates a staple pattern that is different or shorter in length than the staple pattern created by the staple cartridge 19700. Thus, the staple cartridge 19600 is inappropriate for or suitable for use with the surgical instrument, while the staple cartridge 19700 is appropriate for or suitable for use with the surgical instrument. The surgical instrument includes an RFID system in communication with a controller of the surgical instrument that is used to prevent the surgical instrument from performing a staple firing stroke when an incorrect staple cartridge, such as staple cartridge 19600, is positioned in the second jaw 18320 or when no staple cartridge is positioned in the second jaw 18320. Correspondingly, the controller is configured to enable the stapling instrument to be used to perform a staple firing stroke when an appropriate staple cartridge, such as staple cartridge 19700, is positioned in the second jaw 18320 and recognized by the controller.
[0113] The end effector 18300' includes a first RFID scanner with a first sensor at a proximal end of the second jaw 18320 and a second RFID scanner with a second sensor at a distal end of the second jaw 18320. The staple cartridge 19700 includes a cartridge body 19710, a first RFID tag 19760a mounted at a proximal end of the cartridge body 19710 and a second RFID tag 19760b mounted at a distal end of the cartridge body 19710. When the staple cartridge 19700 is seated in the second jaw 18320, the first RFID tag 19760a is aligned with the sensor of the first RFID scanner and the second RFID tag 19760b is aligned with the sensor of the second RFID scanner. In such an example, the controller of the surgical instrument can verify the presence of the appropriate staple cartridge in the second jaw 18320 when both RFID scanners detect the presence of their corresponding RFID tags. As discussed herein, the controller can be configured to authenticate whether the signals and / or data received from the RFID tags match a set of signals and / or data corresponding to a compatible staple cartridge. In any case, the controller is configured to unlock the staple firing system upon determining the presence of an appropriate staple cartridge seated in the second jaw 18320.
[0114] Further to the above, the staple cartridge 19600 comprises a cartridge body 19610, a first RFID tag 19660a mounted at a proximal end of the cartridge body 19610, and a second RFID tag 19660b mounted at a distal end of the cartridge body 19610. When the staple cartridge 19600 is seated in the second jaw 18320, the second RFID tag 19660b is aligned with a sensor of the second RFID scanner, but, referring to FIG. 75, the first RFID tag 19660a is not aligned with the first RFID scanner. In fact, the first RFID tag 19660a is not positioned within the transmission or communication range of the first RFID scanner. As a result, the controller can receive signals from the second RFID tag 19660b, but cannot receive signals from the first RFID tag 19660a. In such an example, the controller is configured to determine that a staple cartridge having an improper length is seated in the second jaw 18320. Stated another way, the controller can determine that a staple cartridge is present in the second jaw 18320 due to detection of the second RFID tag 19660b by the second RFID scanner, but can determine that the staple cartridge is of an incorrect length due to a lack of a signal detected by the first RFID scanner. The controller is configured to maintain the staple firing system in a locked out state until the controller determines that a proper staple cartridge is seated in the second jaw 18320. In at least one such embodiment, the controller is not responsive to firing actuator inputs and does not provide power to an electric motor of the staple firing system until the presence of a proper staple cartridge is detected in the second jaw 18320.
[0115] The algorithm 16000 of the controller for the embodiment of Figures 74 and 75 is shown in Figure 76. In step 16100, the controller evaluates the presence of the second RFID tag 19660b using the second RFID scanner. If the controller does not receive a signal from the second RFID scanner, the controller determines that a staple cartridge is not present in the second jaw 18320 and the absence of a staple cartridge is indicated to the clinician in step 16110. In various examples, the surgical instrument includes a display screen in communication with the controller that is used to communicate the absence of a staple cartridge to the clinician. In such examples, the algorithm 16000 returns to step 16100 and waits for a staple cartridge to be inserted into the second jaw 18320 which may be in communication with the second RFID scanner. If the controller receives a signal from the second RFID scanner in step 16100, the controller evaluates the presence of the first tag 19660a using the first RFID scanner in step 16200. If the controller does not receive a signal from the first RFID scanner, the controller determines that a non-compatible staple cartridge is present in the second jaw 18320 and this is indicated to the clinician at step 16210. This indication may be provided to the clinician, for example, via a display screen. In such an example, the algorithm 16000 returns to step 16100 to wait for a compatible staple cartridge to be inserted into the second jaw 18320 which may be in communication with the first and second RFID scanners. If the controller receives a signal from the first RFID scanner at step 16200, the controller verifies the authenticity of the first and / or second RFID tags at step 16300. In various examples, the controller includes a set of data stored in a memory chip or memory device that may be used to authenticate data received from the first and second RFID tags 19660a and 19660b.For example, if the data from the first RFID signal and the second RFID signal matches a set of data for the first and second RFID signals stored in the memory chip, the controller can determine at step 16300 that the staple cartridge positioned in the second jaw 18320 is authentic. If the received data at step 16300 does not match the stored data, the controller at step 16310 indicates to the clinician, for example, via a display screen, that an unauthorized staple cartridge is present in the second jaw 18320. In such an example, the algorithm 16000 returns to step 16100 to wait for a matching authentic staple cartridge to be inserted into the second jaw 18320.
[0116] If the controller determines that a genuine staple cartridge is in place within the second jaw 18320, then in step 16400 the controller enables the staple firing system. At such time, the controller responds to an input from the staple firing actuator in step 16500 and, assuming all other conditions for performing a staple firing stroke are met, applies a potential to an electric motor of the staple firing system in step 16600 if an input is received. For example, the controller is configured not to respond to an input from the staple firing actuator while the first jaw 18310 is in the open position. However, when the first jaw 18310 is closed, the controller can respond to an input from the staple firing actuator in steps 16500 and 16600. If no input is received from the staple firing actuator, then the controller waits for such input in step 16510.
[0117] In various embodiments, further to the above, the staple cartridge 19700 and / or the second jaw 18320 include a mechanism that creates a snap fit between the staple cartridge 19700 and the second jaw 18320 when the staple cartridge 19700 is seated in the second jaw 18320. Such a snap fit arrangement holds the staple cartridge 19700 securely in the second jaw 18320, but still allows the staple cartridge 19700 to be removed from the second jaw 18320. In some instances, it is relatively easy to seat the distal end of the staple cartridge 19700 in the second jaw 18320, but seating the proximal end of the staple cartridge 19700 may be somewhat more difficult due to the proximity of the first jaw 18310. In various embodiments, an RFID system may be used to determine if the staple cartridge is fully seated in the second jaw 18320. For example, if the proximal end of the staple cartridge 19700 is fully seated in the second jaw 18320 and the distal end of the staple cartridge 19700 is not fully seated in the second jaw 18320, the controller detects the presence of the staple cartridge 19700 by a signal received from the first RFID reader, but determines that the distal end of the staple cartridge 19700 is not fully seated due to the absence of a signal from the second RFID reader. In such an example, the controller can communicate this condition to the clinician, for example, via a display, and provide instructions to the clinician on how to resolve the issue. The controller can also be configured to determine that the proximal end of the staple cartridge is not fully seated in the second jaw 18320 when the second RFID reader receives a signal from the second RFID tag 19760b and the first RFID reader does not receive a signal from the first RFID tag 19760a.In such an example, the controller may verify that the staple cartridge 19700 is the proper staple cartridge despite being unseatable, or may at least presume that the staple cartridge 19700 is the correct staple cartridge by authenticating a partial set of data from the second RFID tag 19760b. In either case, if the controller determines that the ends of the staple cartridge 19700 are not fully seated, the controller prevents the staple firing stroke from being actuated. Once both ends of the staple cartridge 19700 are fully seated, the controller responds to inputs from the firing system actuators assuming that all conditions have been met to perform a staple firing stroke.
[0118] As discussed above, a staple cartridge includes staples removably stored therein that are ejected from the staple cartridge by a sled and / or firing member that is moved through the staple cartridge during a staple firing stroke. In various embodiments, the sled directly contacts the staples, while in other embodiments, the sled contacts a staple driver that supports and drives the staples out of the staple cartridge during the staple firing stroke. The cartridge body, sled, and / or staple driver of the staple cartridge are often subjected to significant stresses and strains during the staple firing stroke, and in such cases, it may be undesirable to reuse a spent staple cartridge or to reload a spent staple cartridge with new staples. With this in mind, various embodiments are envisioned in which one or more features of the staple cartridge are intentionally destroyed during and / or after the staple firing stroke to prevent the staple cartridge from being reused. 72, the staple cartridge 19500 includes a cartridge body 19510, staples removably stored within the cartridge body 19510, a staple driver movably stored within the cartridge body 19510, and a sled 18550' (FIG. 71) configured to move between a proximal position (FIG. 72) and a distal position (FIG. 72B) during a staple firing stroke. Like the sled 18550, the sled 18550' includes an RFID tag 18560b attached thereto, and similarly to above, the RFID system of the surgical instrument 18000 is configured to verify the presence of the sled 18550' in its proximal, unfired position (FIG. 72) when the staple cartridge 19500 is loaded into the surgical instrument 18000. Referring to FIG. 73A, when the staple cartridge 19500 has not yet been fired, the RFID system can communicate with the RFID tag 18560b to enable the staple firing stroke to be performed.However, at the end of the staple firing stroke, the RFID tag 18560b of the sled 18550' contacts and is severed by the knife 19590 positioned at the distal end of the cartridge body 19510, as shown in FIG. 73B. Once the RFID tag 18560b is so severed, the RFID tag 18560b can no longer emit a signal, and even if the sled 18550' is pushed back or reset to its proximal, unfired position to reload the staple cartridge 19500, the reloaded staple cartridge 19500 will not be able to pass the certification test performed by the RFID system of the surgical instrument 18000 due to the damaged RFID tag 18560b. As a result, the surgical instrument 18000 cannot perform a staple firing stroke with the reloaded staple cartridge 19500 positioned therein.
[0119] 71 , the RFID tag 18560b is mounted to a central or longitudinal portion 18552 of the sled 18550′ that slides within a longitudinal slot of the staple cartridge 19500. The RFID tag 18560b is partially embedded in the central portion 18552, leaving a portion of the RFID tag 18560b exposed. More specifically, a portion of the RFID antenna is exposed. That being said, the RFID tag 18560b may be mounted to the sled 18550′ in any suitable location, such as, for example, on a rail 18554 of the sled 18550′. The exposed portion of the RFID tag 18560b faces the distal end of the sled 18550′ such that the RFID tag 18560b contacts the cartridge knife 19590 at the end of the staple firing stroke. That being said, embodiments are contemplated in which the RFID tag 18560b on the sled 18550' is destroyed early in the staple firing stroke. Additionally, embodiments are contemplated in which the RFID tags on other staple cartridge components are intentionally destroyed and / or disabled during use. One such embodiment is discussed further below in which the RFID tag on the staple cartridge cover is destroyed and / or disabled when the staple cartridge cover is removed from the staple cartridge. In such an example, a used staple cartridge cover cannot be attached to the staple cartridge in order to pass the certification testing performed by the RFID system.
[0120] As discussed above, the RFID system of the surgical instrument 18000 includes three RFID readers, each capable of communicating with and / or receiving signals from a corresponding RFID tag. Also as discussed above, the RFID readers may include, for example, a flex circuit extending into the end effector 18300 of the surgical instrument 18000. In such an example, with reference to FIG. 66, the flex circuit may be attached to a wall of the second jaw 18320 and may be sized and configured to accommodate a staple cartridge seated within the second jaw 18320. In particular, with reference again to FIG. 66, the second jaw 18320 includes a bottom wall or support 18322 and two lateral side walls 18324 extending upwardly from the bottom wall 18322 configured to receive a staple cartridge therebetween. Two of the RFID flex circuits are attached to one of the side walls and the other RFID flex circuit is attached to the other side wall. In various examples, the RFID flex circuits are attached to the side walls using, for example, one or more types of adhesive. Additionally or alternatively, fasteners may be used to attach the RFID flex circuits to the walls of the second jaw 18320. In various alternative embodiments, referring to FIG. 77, the RFID scanner may be part of one flex circuit. In at least one such embodiment, the RFID scanner comprises a sub-circuit of the flex circuit.
[0121] Referring again to FIG. 77, the flex circuit 19900 comprises a flexible substrate and conductors embedded in the flexible substrate. The flexible substrate is made of an insulating or non-conductive material, such as plastic, and the conductors are made of copper, for example. The flex circuit 19900 is mounted to the bottom wall 18322 of the second jaw 18320 and comprises a first RFID scanner 19100, a second RFID scanner 19200, and a third RFID scanner 19300. The first RFID scanner 19100 comprises a sensor circuit including two conductors and a first sensor coil or array 19120. One of the conductors comprises a coil portion defined in the first sensor 19120 and a conductive connector that connects an end of the coil portion to the other conductor to complete the circuit of the first RFID scanner 19100. The first sensor 19120 is mounted to a first sidewall 18324 of the second jaw 18320. Similarly, the second RFID scanner 19200 includes a sensor circuit including two conductors and a second sensor coil or array 19220. One of the conductors includes a coil portion defined in the second sensor 19220 and a conductive connector 19222 that connects an end of the coil portion to the other conductor to complete the circuit of the second RFID scanner 19200. The second sensor 19220 is mounted to a second sidewall 18324 of the second jaw 18320. Similarly, the third RFID scanner 19300 includes a sensor circuit including two conductors and a third sensor coil or array 19320. One of the conductors includes a coil portion defined in the third sensor 19320 and a conductive connector that connects an end of the coil portion to the other conductor to complete the circuit of the third RFID scanner 19300. The third sensor 19320 is mounted to a base wall 18322 of the second jaw 18320.
[0122] 66, when a staple cartridge, such as, for example, staple cartridge 18500, is seated in the second jaw 18320, the first RFID tag 18560a is aligned with the sensor 18620 of the first RFID scanner 18600. In various embodiments, the first RFID tag 18560a comprises a substantially planar configuration. More specifically, the base, microchip, and tag antenna of the first RFID tag 18560a are arranged in a manner that appears visually flat. The sensor 18620 of the first RFID scanner 18600, similar to the sensor 19220 of the RFID scanner 19200, also comprises a substantially planar configuration that appears visually flat. When the staple cartridge 18500 is seated in the second jaw 18320, the first RFID tag 18560a is parallel, or at least substantially parallel, to the first sensor 18620. The first RFID tag 18560a and the first sensor 18620 are substantially parallel to each other if the angle between their two planes is about 10 degrees or less.
[0123] Further to the above, the tag antenna of the first RFID tag 18560a extends in a circumferential direction about a tag antenna axis TA (FIG. 67) that is orthogonal or at least substantially orthogonal to a plane defined by the first RFID tag 18560a. The tag antenna axis TA is orthogonal to the first RFID tag 18560a when the angle between the tag antenna axis TA and the plane defined by the first RFID tag 18560a is about 80-100 degrees. Similarly, the reader antenna of the first sensor 18620 extends in a circumferential direction about a reader antenna axis SA (FIG. 77) that is orthogonal or at least substantially orthogonal to a plane defined by the first sensor 18620. The reader antenna axis SA is orthogonal to the first reader antenna 18620 when the angle between the reader antenna axis SA and the plane defined by the first reader antenna 18620 is about 80-100 degrees. When the staple cartridge 18500 is seated in the second jaw 18320, the tag antenna axis TA is aligned with the reader antenna axis SA. In various examples, the tag antenna axis TA is collinear with the reader antenna axis SA. A similar arrangement can be achieved between the second RFID tag 18560b and the antenna 18720 of the second RFID reader 18700. A similar arrangement can be achieved between the third RFID tag 18560c and the antenna 18820 of the third RFID reader 18800.
[0124] 66, the first RFID tag 18560a, the second RFID tag 18560b, and the third RFID tag 18560c are not longitudinally aligned within the second jaw 18320. More specifically, the second RFID tag 18560b is positioned proximally relative to the first RFID tag 18560a, and the third RFID tag 18560c is positioned distally relative to the first RFID tag 18560a. If the first RFID tag 18560a, the second RFID tag 18560b, and the third RFID tag 18560c are active RFID tags, the transmission ranges of the RFID tags 18560a, 18560b, and 18560c may be established to be non-overlapping. Further, the second sensor 18720 of the second RFID reader 18700 is positioned proximally relative to the first sensor 18620 of the first RFID reader 18600, and the third sensor 18820 of the third RFID reader 18800 is positioned distally relative to the first sensor 18620. As also shown in FIG. 66 , the second transmission range 18710 of the second sensor 18720 is proximal to and does not overlap with the first transmission range 18610 of the first sensor 18620, and the third transmission range 18810 of the third sensor 18820 is distal to and does not overlap with the first transmission range 18610 of the first sensor 18620.
[0125] In addition to the above, with reference to FIGS. 64-66, the first RFID tag 18560a and the second RFID tag 18560b are not aligned laterally within the second jaw 18320. More specifically, the first RFID tag 18560a is positioned within the lateral sidewall 18514 of the cartridge body 18510, and the second RFID tag 18560b is positioned within the longitudinal slot 18520. Furthermore, the first RFID tag 18560a and the third RFID tag 18560c are not aligned laterally within the second jaw 18320. More specifically, the first RFID tag 18560a is positioned within the lateral sidewall 18514 of the cartridge body 18510, and the third RFID tag 18560c is positioned within the longitudinal slot 18520.
[0126] As discussed herein, the controller of a surgical instrument, such as, for example, the surgical instrument 18000, is configured to prevent a staple firing stroke from being performed or to allow a staple firing stroke to be performed based on feedback from the RFID system. That being said, the controller may be configured to modify the operation of the surgical instrument in one or more other manners based on feedback from the RFID system. For example, the controller may be configured to vary the speed of the staple firing stroke based on feedback from the RFID system. In at least one such embodiment, the controller may use data obtained from the RFID tag and / or data stored in the memory device to operate an electric motor of the staple firing system at a speed desired for a staple cartridge seated within the surgical instrument. In at least one example, the data instructs the electric motor to operate at a slower speed during the staple firing stroke. Such an apparatus configuration may be useful when the staple cartridge includes an implantable appendage releasably attached to the deck of the staple cartridge. Such device configurations may also be useful when the staple cartridge includes, for example, tall staples, i.e., staples having a height of about 2.5 mm to about 5.0 mm before being deformed against the anvil. In another example, the data instructs the electric motor to run at a faster speed during the staple firing stroke. Such device configurations may also be useful when the staple cartridge does not include an implantable appendage releasably attached to the deck of the staple cartridge. Such device configurations may also be useful when the staple cartridge includes, for example, short staples, i.e., staples having a height of less than about 2.5 mm before being deformed against the anvil.
[0127] During various surgical procedures, surgical instruments are used that include at least one replaceable component. It is important that such replaceable components are replaced with functional and / or compatible components. Various identification systems, described in more detail herein, among other things, verify the compatibility of a component with a surgical instrument and / or verify the operational status of the component. By way of example, an identification system may act to ensure that a package containing a replaceable component has not been destroyed and / or tampered with, alert a clinician if a component is compatible or incompatible with a surgical instrument prior to opening a product package, and / or alert a clinician if there is a recall for a particular manufacturing batch or type of replaceable component.
[0128] The identification systems described herein can be either active or passive systems. In various embodiments, a combination of active and passive identification systems is used. Passive systems can include, for example, barcodes, Quick Response (QR) codes, and / or radio frequency identification (RFID) tags. Passive systems do not include an internal power source, and the passive systems described herein require a reader to transmit a first signal, such as, for example, an interrogation signal.
[0129] Implementation of barcodes requires the use of an optical barcode reader and / or scanner. The barcode must be properly oriented relative to the scanner, and the scanner must have an unobstructed view of the barcode in order to properly scan it. For at least these reasons, barcodes are typically printed on paper or plastic. The scanner decodes the bars of the barcode, which generally represent a series of numbers. The decoded information is transmitted to a computer or controller, which interprets what has been read. This information may include, for example, data regarding the manufacturer of the replaceable component, the type or model of the replaceable component, and / or compatibility information of the replaceable component for use with a surgical instrument.
[0130] Another passive identification system includes the Quick Response (QR) Code. A QR Code is a type of matrix barcode. QR Codes often contain locator, identifier, or tracker data that points to a website or an application for use on a mobile device. QR Codes use four standardized encoding modes to efficiently store data. The four standardized encoding modes include numeric, alphanumeric, byte / binary, and Kanji. QR Codes consist of black squares arranged as a square grid on a white background that can be read, for example, by an imaging device such as a camera. The captured image is processed using Reed-Solomon error correction until it can be properly interpreted. The desired data is then extracted from the patterns present in both the horizontal and vertical components of the image. This desired data can include, for example, the manufacturer of the replaceable component, the type or model of the replaceable component, and / or compatibility information between the replaceable component and the surgical instrument.
[0131] Passive radio frequency identification (RFID) systems read information by using radio frequencies. Such passive RFID systems include an RFID scanner and an RFID tag that does not have an internal power source. The RFID tag is powered by electromagnetic energy transmitted from the RFID scanner. Each RFID tag includes a chip, such as a microchip, that stores information about the replaceable component and / or the surgical instrument that is compatible with the replaceable component. The chip may contain only a basic identification number, but in various examples, the chip can store additional information, such as manufacturing data, shipping data, and / or maintenance history. Each RFID tag includes a wireless antenna that allows the RFID tag to communicate with the RFID scanner. The wireless antenna extends the range over which the RFID tag can receive signals from the RFID scanner and transmit a response signal back to the RFID scanner. In a passive RFID system, the RFID scanner, which also includes its own antenna, transmits a wireless signal that activates RFID tags positioned within a predetermined range. The RFID scanner is configured to receive a response signal "bounced back" from the RFID tag, which allows the RFID scanner to capture identification information representative of the replaceable component. In various examples, the one or more response signals include the same signal as the interrogation signal. In various examples, the one or more response signals include a modified signal from the interrogation signal. In various examples, the RFID scanner can also write or encode information directly onto the RFID tag. In either case, software on the RFID scanner can pass information about the replaceable component to a controller, such as a surgical instrument, a surgical hub, and / or a control system for a remote surgical system. Various surgical hubs are further described in U.S. Patent Application Serial No. 16 / 209,395, filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety. Because the RFID tags are activated by radio signals, the RFID scanner is configured to read multiple RFID tags at once.
[0132] Active radio frequency identification (RFID) systems also include RFID tags and RFID scanners. However, the RFID tags of active RFID systems include an internal power source. Active RFID systems utilize battery-powered RFID tags that are configured to continuously broadcast their own signal. One type of active RFID tag is what is commonly referred to as a "beacon." Such beacon RFID tags do not wait to receive a first signal from an RFID scanner. Instead, a beacon RFID tag continuously transmits its stored information. For example, a beacon may transmit its information at intervals of every 3-5 seconds. Another type of active RFID tag includes a transponder. In such a system, the RFID scanner transmits a signal first. The RFID transponder tag then transmits a signal back to the RFID scanner with the relevant information. Such RFID transponder tag systems are efficient because they conserve battery life, for example, when the RFID tag is out of range of the RFID scanner. In various examples, the active RFID tag includes on-board sensors for tracking environmental parameters. For example, on-board sensors may track moisture levels, temperature, and / or other data that may be relevant.
[0133] The replacement staple cartridge is stored in a sealed package after it is manufactured until the package is opened in the operating room. Various forms of packaging include, for example, peel-away pouches, woven and / or nonwoven wrappers, and rigid containers. FIG. 78 shows an example of a sealed package 25000. The depicted package 25000 is a peel-away pouch. The package 25000 comprises a first outer layer 25010 and a second outer layer 25020. The first layer 25010 and the second layer 25020 form a protective barrier surrounding the staple cartridge 25100 that can be used with a surgical instrument. An adhesive bonds the first layer 25010 and the second layer 25020 together to form an air-tight and / or liquid-tight seal and / or pouch around the article. The adhesive forms a seal without folds, wrinkles, and / or gaps. The seal created by the adhesive, for example, prevents contaminants from contacting the staple cartridge 25100 and / or prevents components of the staple cartridge 25100 from being misplaced. In various examples, the staple cartridge 25100 is hermetically sealed within the package 25000. In various examples, the package 25000 provides a completely liquid-tight seal. In various examples, the package provides a completely liquid-tight and air-tight seal.
[0134] The first layer 25010 includes a first corner 25011 positioned outside of the seal and the second layer 25020 includes a second corner 25021 positioned outside of the seal. A clinician can expose the sealed staple cartridge 25100 by peeling the first layer 25010 away from the second layer 25020. In various examples, a clinician can expose the sealed staple cartridge 25100 by holding the first corner 25011 and the second corner 25021 in separate hands and pulling the first corner 25011 away from the second layer 25021, although any suitable opening method may be used.
[0135] The first layer 25010 and the second layer 25020 are constructed from a material such as, for example, paper having a laminated inner surface. The laminated inner surface provides a barrier to prevent contaminants from entering the sealed portion of the package 25000. In various examples, the first layer 25010 and the second layer 25020 are constructed from plastic. The first layer 25010 and the second layer 25020 may be constructed from a material having a certain degree of transparency, for example, to allow a clinician to observe the contents of the package 25000. Although mentioned above, any suitable material or combination of materials may be used for the first layer 25010 and / or the second layer 25020.
[0136] The package 25000 includes various identification systems that assist the surgical instrument and / or clinician in selecting a staple cartridge 25100 that is compatible with a particular surgical instrument and / or a particular surgical procedure. The first layer 25010 of the package 25000 includes various visual indicators that represent the contents of the package 25000 in some manner. For example, as shown in FIG. 78 , the name 25012 of the product contained within the package 25000 is printed or otherwise displayed on the first layer 25010.
[0137] The package 25000 further comprises one or more passive identification systems displayed on the first layer 25010. For example, the package 25000 comprises a QR code 25014. The QR code 25014 may, for example, assist in sorting and / or tracking the status of the package 25000. The QR code 25014 may also be scanned prior to breaking the seal of the package 25000 to ensure that the contents are appropriate for use with a particular instrument and / or during a particular surgical procedure.
[0138] In addition to the name 25012 of the contents of the package 25000 being displayed on the first layer 25010, the package 25000 includes a serial number 25016 that may provide more detailed information that a clinician may utilize before deciding whether to open the package 25000, for example. For example, the serial number 25016 may include alphanumeric symbols that are unique and / or specific to the surgical system. Each alphanumeric symbol may represent a component of the matching assembled surgical system. For example, the alphanumeric symbols may represent a staple cartridge, an end effector, a shaft assembly, a surgical instrument, etc. The serial number 25016 may represent additional elements such as a manufacturing lot, a manufacturing date, etc. In various examples, the serial number 25016 may include encrypted information, as described in more detail herein.
[0139] It is envisioned that package 25000 may include some or all of the various forms of identification systems discussed herein.
[0140] 79 and 80 show an RFID system 25200 integrated with a package 25000. The RFID system 25200 comprises an RFID tag 25210 and an insulator 25220. The RFID tag 25210 comprises a chip, such as, for example, a microchip, that stores information about the package 25000 and / or the contents of the package 25000. In various examples, the chip comprises a base identification number. Such a base identification may be assigned to the chip that may communicate the presence of the chip to an RFID scanner. In various examples, the chip comprises additional information, such as, for example, manufacturing data, shipping data, and / or compatibility data. The RFID tag 25210 further comprises a wireless antenna configured to facilitate communication between the RFID tag 25210 and an RFID scanner.
[0141] The insulator 25220 is attached to the first layer 25010 of the package 25000 and the RFID tag 25210 is attached to the second layer 25020 of the package 25000. When the package is in a sealed configuration, the insulator 25220 is attached or otherwise connected to the RFID tag 25210. The RFID tag 25210 is part of an active RFID system 25200 with an internal power source that is activated when the package 25000 is opened. Before the package 25000 is opened, the interface between the insulator 25220 and the RFID tag 25210 prevents the power source from providing power to the RFID tag 25210. In such an example, the RFID tag 25210 cannot emit a signal. When the clinician breaks the seal of the package 25000 by peeling the first layer 25010 from the second layer 25020, the insulator 25220 is disconnected or otherwise decoupled from the RFID tag 25210. When the insulator 25220 is separated from the RFID tag 25210, the circuit between the power source and the RFID tag 25210 is closed and the RFID tag 25210 is energized. As shown in FIG. 80, the RFID tag 25210 begins emitting a signal 25215 when energized. The RFID tag 25210 is configured to emit the signal 25215 at any suitable frequency and / or for any suitable duration. For example, the RFID tag 25210 can emit the signal 25215 continuously, or the RFID tag 25210 can emit the signal 25215 every 3-5 seconds. The signal 25215 includes some or all of the information stored on the chip. In various examples, the signal 25215 can serve to alert a surgical instrument, for example, that the package 25000 has been tampered with during shipping and / or storage, or simply that the package 25000 is not sealed.
[0142] The RFID tag 25210 is configured to communicate with an RFID scanner. When the insulator 25220 is removed, an internal power source of the RFID tag 25210 allows the RFID tag 25210 to emit a signal 25215 before receiving a first signal, such as an interrogation signal, from the RFID scanner. The RFID scanner comprises a scanner antenna configured to transmit and / or receive a radio signal 25215 from the RFID tag 25210. In various examples, the RFID scanner comprises read and write capabilities. The RFID scanner's software can then pass the collected information from the RFID tag 25210 to the controller of the surgical instrument for further interpretation. The RFID scanner is positioned within a predetermined range of the RFID tag 25210 allowing the RFID scanner to receive the emitted signal 25215 transmitted by the RFID tag 25210. Depending on the application, the RFID scanner may be positioned on the surgical instrument, on the contents of the package, or remotely installed on a console, such as a remote surgical system, that communicates with the surgical instrument. In addition, the controller may be located in any suitable location, such as, for example, on the surgical instrument or on a remote console.
[0143] In various embodiments, an RFID system may be used that includes an RFID tag attached to the staple cartridge 25100. In addition to the above, the RFID tag includes an internal power source positioned within the staple cartridge 25100. Suitable locations for the RFID tag include, for example, on the threads of the staple cartridge, on a sidewall of the staple cartridge, or on a retainer of the staple cartridge assembly. An insulator similar to the insulator 25220 is attached to the package 25000 such that when the package 25000 is opened, the RFID tag on the staple cartridge 25100 is activated. The insulator is attached to or otherwise associated with the first layer 25010 and / or the second layer 25020 of the package 25000. When the package is in a sealed configuration, the insulator 25220 is attached to or otherwise connected to the RFID tag in the staple cartridge 25100, opening the circuit between the power source and the RFID tag. The interface between the insulator 25220 and the RFID tag prevents the power source from activating the RFID tag, and the RFID tag cannot emit a signal. When the clinician breaks the seal of the package 25000, for example, by peeling away the first layer 25010, the insulator 25220 is disconnected or otherwise decoupled from the RFID tag, and the circuit between the power source and the RFID tag is closed. At such point, the RFID tag is energized and begins to emit a signal.
[0144] In various aspects, the RFID system 25200 further comprises a transponder. The transponder is configured to receive a first signal from the RFID scanner. In various examples, the first signal from the RFID scanner energizes the transponder sufficiently for the transponder to communicate with the RFID tag. In various examples, the transponder is energized prior to receiving the first signal from the RFID scanner. In either case, the transponder is configured to automatically transmit a second signal to the RFID tag upon hearing or otherwise receiving the first signal from the RFID scanner. The RFID tag's power source energizes the RFID tag upon receiving the second signal from the transponder, and the RFID tag can respond to the RFID scanner's first signal by transmitting a third signal to the RFID scanner. The transponder preserves the battery life of the RFID tag 25210, for example, until the RFID tag 25210 is within range of the RFID scanner.
[0145] As described in more detail herein, it is valuable for a clinician to be able to verify the suitability of a staple cartridge for use with a particular surgical instrument and / or for use during a particular surgical procedure. For a variety of reasons, it may also be useful for a clinician to be able to ensure that a surgical staple cartridge has not been previously used and / or tampered with. A clinician may also wish to verify, for example, that the surgical staple cartridge has not been contaminated, that the staple holding members have not been removed, and / or that a firing member, such as a sled, is positioned within the cartridge body.
[0146] 81-83 illustrate a staple cartridge assembly 26000. The staple cartridge assembly 26000 includes a staple cartridge 26100 and a staple holding member or retainer 26200 attached to the staple cartridge 26100. The retainer 26200 is positioned along the staple cartridge 26100 to, among other things, facilitate attachment of the staple cartridge 26100 to a surgical instrument and / or to retain staples within corresponding staple cavities within the staple cartridge 26100. The retainer 26200 includes a longitudinal protrusion 26210 configured to be received by an elongated slot defined in the staple cartridge 26100. The longitudinal protrusions 26210 protrude from a bottom surface 26206 of the retainer 26200 and extend from a proximal end 26202 of the retainer 26200 toward a distal end 26204 of the retainer 26200. The retainer 26200 further comprises a proximal set of external protrusions 26240 and a distal set of external protrusions 26220. The external protrusions 26220, 26240 are configured to wrap around a portion of the side wall 26102 of the staple cartridge 26100. The longitudinal protrusions 26210 and the external protrusions 26220, 26240 function to retain the retainer 26200 to the staple cartridge 26100, for example. The retainer 26200 includes a thumb protrusion 26230 extending from the distal end 26204 to facilitate removal of the retainer 26200 from the staple cartridge 26100, for example.
[0147] When the retainer 26200 is attached to the staple cartridge 26100, the bottom surface 26206 of the retainer 26200 is positioned along the deck surface 26106 of the staple cartridge 26100. In various examples, the bottom surface 26206 does not contact the deck surface 26106 of the staple cartridge 26100 until a pushing force is applied to the top of the retainer 25200. In other examples, the bottom surface 26206 contacts the deck surface 26106. To remove the retainer 26200 from the staple cartridge 26100, thereby facilitating attachment of the staple cartridge 26100 to the surgical instrument, the clinician pulls or lifts the thumb projection 26230 away from the staple cartridge 26100. The retainer 26200 is manufactured from a material, such as, for example, plastic, that provides the retainer 26200 with some flexibility. As the thumb protrusion 26230 is lifted from the staple cartridge 26100, the exterior protrusions 26220, 26240 provide an opposing force in an attempt to maintain the coupling between the retainer 26200 and the staple cartridge 26100. To remove the retainer 26200, the clinician must exert a force on the thumb protrusion 26230 that is strong enough to overcome the opposing retention force created by the exterior protrusions 26220, 26240. As the thumb protrusion 26230 is pulled away from the staple cartridge 26100, the retainer 26200 begins to flex and / or bend, and such bending of the retainer 26200 can be used to deactivate an RFID tag, as described below.
[0148] The retainer 26200 further comprises an RFID tag 26250. The RFID tag 26250 comprises a chip, such as, for example, a microchip, that stores information regarding the staple cartridge assembly 26000. As shown in FIGS. 81-83, the RFID tag 26250 is molded into the retainer 26200. However, the RFID tag 26250 can be embedded into, attached to, and / or attached to the retainer 26200 by any suitable method. In the illustrated embodiment, the RFID tag 26250 is molded into a distal portion of the longitudinal projection 26210. The RFID tag 26250 is positioned within the retainer 26200 at a location of structural weakness. The location of structural weakness may be any portion of the retainer 26200 that bends and / or flexes in response to the thumb projection 26230 being pulled upward and / or the retainer 26200 being removed from the staple cartridge 26100. The RFID tag 26250 is affixed to the retainer 26200 in a manner and location that facilitates physical destruction of the RFID tag 26250 during the retainer removal process. A first end 26252 of the RFID tag 26250 is attached to the first portion 26212 of the retainer 26200 and a second end 26254 of the RFID tag 26250 is attached to the second portion 26214 of the retainer 26200. As the retainer 26200 begins to bend in response to pulling upward on the thumb projection 26230, the first portion 26212 of the retainer 26200 and the second portion 26214 of the retainer flex away from each other. The first end 26252 of the RFID tag 26250 is pulled by the first portion 26212 of the retainer 26200 and the second end 26254 of the RFID tag 26250 is pulled in the opposite direction by the second portion 26214 of the retainer 26200. As a result of the stretching and / or bending, the RFID tag 26250 is pulled apart and / or otherwise destroyed. The RFID tag 26250 is frangible, brittle, and / or weak and is not configured to stretch significantly.It is envisioned that the RFID tag 26250 may be positioned in any suitable location on the retainer 26200 that experiences sufficient bending and flexing during the removal process of the retainer 26200 from the staple cartridge 26100 to cause destruction of the RFID tag 26250. The RFID tag 26250 may be affixed to the retainer 26200 in any suitable manner that renders the RFID tag 26250 inoperative during and / or after removal of the retainer 26200 from the staple cartridge 26100. In various embodiments, the RFID tag 26250 may detach or be removed from the retainer 26200 during the removal process.
[0149] In various examples, it is undesirable to destroy components of the surgical system. However, destruction of the RFID tag 26250 in the retainer 26200 will prevent a clinician from reusing the retainer 26200 with an incompatible or otherwise inappropriate staple cartridge. Before enabling at least one operating parameter of the surgical instrument, the controller of the surgical instrument must receive a signal from the RFID tag 26250 on the retainer 26200. Such a signal indicates to the controller that the retainer 26200 remains connected to the staple cartridge 26100. In various examples, the signal may also indicate whether the staple cartridge 26100 is compatible or incompatible with the surgical instrument. Without receiving the signal and / or receiving the incompatible signal, various functions of the surgical instrument are unavailable. In various examples, and as described below, the RFID tag 26250 in the retainer 26200 must lose the ability to transmit and / or send signals to and from the RFID scanner. The RFID tag 26250 may lose the ability to communicate by being physically destroyed and / or by positioning the RFID tag 26250 out of range of the RFID scanner. In either case, the inability of the RFID tag 26250 to communicate with the RFID scanner indicates to the controller of the surgical instrument that the retainer 26200 is no longer connected to the staple cartridge 26100. The physical destruction of the RFID tag 26250 on the retainer 26200 ensures that a clinician cannot reuse the retainer 26200 on an incompatible staple cartridge. In various examples, the staple cartridge 26100 includes an RFID tag that is within communication range of the RFID scanner. When the controller receives information detected from the staple cartridge RFID tag but not from the retainer RFID tag 26250, the controller is configured to recognize that the staple cartridge 26100 remains attached to the surgical instrument, but the retainer 26200 has been removed.
[0150] The RFID tag 26250 in the retainer 26200 provides a lockout of the surgical instrument. The surgical instrument will not perform a staple firing stroke if the information stored in the RFID tag 26250 is not received by the controller of the surgical instrument. In various examples, the surgical instrument will not perform a staple firing stroke while the RFID tag 26250 is still in communication with the RFID scanner. Such a lockout prevents the surgical instrument from performing a staple firing stroke when the staple cartridge 26100 is improperly seated within the surgical instrument with the retainer 26200 still attached.
[0151] In various examples, the staple cartridge 26100 and the retainer 26200 are assembled into the staple cartridge assembly 26000 by a manufacturer. In such circumstances, the retainer 26200 is removed from the staple cartridge 26100 only when the staple cartridge 26100 has been inserted for use with a surgical instrument and the staple cartridge assembly 26000 has been tampered with and / or has a manufacturing defect that prevents proper installation. Separation and / or physical destruction of the RFID tag 26250 prevents the retainer 26200 from being placed on a used staple cartridge 26100 and / or an otherwise inappropriate staple cartridge 26100, for example.
[0152] As described in more detail herein, the surgical instrument may include an RFID scanner configured to communicate with a nearby RFID tag. The RFID scanner includes a scanner antenna configured to transmit a radio signal. The radio signal activates an RFID tag located within a predetermined range of the RFID scanner. The RFID scanner then receives one or more response signals "bounced back" from the RFID tag. In various examples, the one or more response signals include the same signal as the interrogation signal. In various examples, the one or more response signals include a modified signal from the interrogation signal. In various examples, the RFID scanner includes read and write capabilities. Software in the RFID scanner may then pass the collected information from the RFID tag to a controller for further interpretation. The controller may be located in the surgical instrument, a remote console, or any suitable location. The RFID scanner and / or controller may include a stored set of information corresponding to a surgical stapling assembly that is compatible with a particular surgical instrument and / or is for use during a particular surgical procedure.
[0153] More specifically, the surgical system includes an RFID scanner configured to interact with an RFID tag 26250 molded into the retainer 26200. The RFID scanner can be in a variety of locations. For example, the RFID scanner can be located within the staple cartridge 26100. In various examples, the RFID scanner can be located in the jaws of an end effector of a surgical instrument, in an alternative location within the surgical system, and / or in any other suitable location that allows for communication between the RFID tag 26250 and the RFID scanner when the retainer 26200 is properly attached to the staple cartridge 26100. The RFID scanner and / or RFID tag 26250 are powered such that the signal(s) they emit can only be detected within a limited radius. The RFID scanner and RFID tag 26250 are in sufficient proximity to communicate when the retainer 26200 is attached to the staple cartridge 26100, but are not in sufficient proximity to communicate when the retainer 26200 is removed from the staple cartridge 26100. That being said, when the retainer 26200 is removed from the staple cartridge 26100, the RFID tag 26250 is rendered inoperative, for example, by physical destruction or separation. When the RFID tag 26250 is inoperative, signals such as interrogation signals transmitted by the RFID scanner are not answered.
[0154] If a used retainer with a destroyed RFID tag 26250 is attached to another staple cartridge, the RFID scanner and the destroyed RFID tag 26250 will not be able to communicate. In such an example, the staple cartridge verification system of the surgical instrument will not be able to enable the surgical instrument to perform a staple firing stroke. If the RFID scanner receives a response to the interrogation signal that is not found in the stored set of matching stapling assemblies, the controller of the surgical instrument is programmed to communicate an error to the clinician. Similarly, if the RFID scanner does not receive a response to the interrogation signal, the controller of the surgical instrument is programmed to communicate an error to the clinician. In various examples, detection of an error by the controller may render the surgical instrument inoperative for use with that particular staple cartridge. In various examples, the detected error may prevent the surgical instrument from performing a staple firing stroke and / or a tissue cutting stroke. In various examples, the surgical instrument further comprises a manual override that may be activated to enable the clinician to override any system lockout and utilize the operating functions of the surgical instrument in an emergency. As discussed above, the controller is configured to alert the clinician that an error has been detected. Such an alert may be communicated via various forms of feedback, including, for example, tactile, auditory, and / or visual feedback. In at least one example, the feedback includes audio feedback, where the surgical instrument may include a speaker that emits a sound, such as a beep, when an error is detected. In a particular example, the feedback includes visual feedback, where the surgical instrument may include a light emitting diode (LED), for example, that flashes when an error is detected. In various examples, the feedback includes tactile feedback, where the surgical instrument may include an electric motor with an eccentric element that vibrates when an error is detected. The alert may be specific or general.For example, the alert may specifically indicate that the RFID tag 26250 on the retainer 26200 cannot be detected, or the alert may specifically indicate that the RFID tag 26250 contains information indicative of a mismatched and / or defective staple cartridge assembly 26000.
[0155] 84 illustrates a staple cartridge assembly 27000. The staple cartridge assembly includes a staple cartridge 27100. The staple cartridge 27100 comprises a staple cartridge body including a base 27104, a deck surface 27106, and a sidewall 27102 extending between the base 27104 and the deck surface 27106. An elongated slot 27110 is defined within the staple cartridge 27100 and extends from a proximal end 27101 toward a distal end of the staple cartridge 27100. The elongated slot 27100 is sized to facilitate passage therethrough of a firing and / or cutting member, such as a sled 27125, during a staple firing stroke. A channel 27120 is defined within the staple cartridge 27100 extending from the proximal end 27101 toward a distal end of the staple cartridge 27100. Each channel 27120 is configured to receive a ramp of a sled 27125. The staple cartridge 27100 further includes a vertical row of staple cavities defined within the cartridge body and staples removably stored within the staple cavities. The staples are ejected from the staple cartridge 27100 by the sled 27125 during a staple firing stroke.
[0156] The staple cartridge assembly 27000 further includes an RFID system 27200. The RFID system 27200 includes an RFID tag 27250 attached to the staple cartridge assembly 27000 and an RFID scanner 27300 attached to the surgical instrument. The RFID tag 27250 includes a chip, such as, for example, a microchip, that stores information about the staple cartridge assembly 27000. In various examples, the chip includes a base identification number for the staple cartridge 27100. In various examples, the chip includes additional information, such as, for example, manufacturing data, shipping data, and / or compatibility data. The RFID tag 27250 further includes a wireless antenna configured to receive an interrogation signal from the RFID scanner 27300 and transmit a response signal to the RFID scanner 27300. The RFID scanner 27300 is configured to communicate with the RFID tag 27250 when the staple cartridge 27100 is seated within the surgical instrument. The RFID scanner 27300 includes, for example, a scanner antenna configured to transmit and receive radio signals. That being said, the RFID system 27200 may use any suitable frequency. As electromagnetic waves behave differently at various frequencies, the desired frequency is selected based on the particular application. In various examples, the RFID system 27200 may utilize low, high, and / or very high frequencies. The radio signals activate RFID tags positioned within a predetermined range of the RFID scanner 27300. The RFID scanner 27300 then receives one or more response signals "bounced back" from the RFID tag. In various examples, the one or more response signals include the same signal as the interrogation signal. In various examples, the one or more response signals include modified signals from the interrogation signal. In various examples, the RFID scanner 27300 includes read and write capabilities. The software of the RFID scanner 27300 may then pass the collected information from the RFID tag to a controller for further interpretation. The controller may be located on the surgical instrument, on a remote console, or in any suitable location.The RFID scanner and / or controller may include a stored set of information corresponding to a particular surgical instrument and / or a surgical stapling assembly compatible with a particular surgical procedure.
[0157] As discussed above, the RFID scanner 27300 in the surgical instrument is configured to interact with the RFID tag 27250 positioned on the staple cartridge 27100. As shown in FIG. 84 , the RFID tag 27250 is affixed to one of the side walls 27102 of the staple cartridge 27100 and the RFID scanner 27300 is mounted within the surgical instrument. As discussed above, the RFID tag 27250 includes a wireless antenna 27252 and a chip 27254. In the illustrated embodiment, the wireless antenna 27252 and the chip 27254 are positioned within the RFID tag 27250. In various examples, the wireless antenna 27252 is positioned on an exterior surface of the RFID tag 27250. The RFID tag 27250 is positioned a distance "D" away from the RFID scanner 27300 when the staple cartridge 27100 is seated within the surgical instrument. In particular, the distance "D" can be, for example, about ¼ the length of the staple cartridge 27100, ⅓ the length of the staple cartridge 27100, or ½ the length of the staple cartridge 27100. In the illustrated embodiment, the communication range 27255 of the RFID tag's wireless antenna and the RFID scanner's antenna spans, for example, about 1 centimeter (cm). The distance "D" is greater than 1 cm and is therefore outside the range of communication 27255 between the RFID scanner 27300 and the wireless antenna 27252 of the RFID tag 27250. Thus, if only the RFID tag 27250 were present, the RFID tag 27250 would not be able to receive and respond to the interrogation signal from the RFID scanner 27300.
[0158] To facilitate communication with the RFID scanner 27300, the RFID tag system 27200 shown in FIG. 84 further includes an extension antenna 27260 in communication with the RFID tag 27250. The extension antenna 27260 functions to extend the communication range of the RFID tag 27250, for example, as compared to the wireless antenna 27252. The extension antenna 27260 extends along and is attached to the sidewall 27102 and is mounted across a portion of the base 27104 of the staple cartridge 27100. At least a portion of the extension antenna 27260 traverses the elongated slot 27110. In the illustrated embodiment, the communication range 27265 of the extension antenna 27260 spans, for example, approximately 2 centimeters (cm). As previously discussed, the RFID scanner 27300 is positioned a distance "D" from the RFID tag 27250. While the distance "D" is greater than 1 cm, the distance "D" is less than 2 cm and is therefore within range of communication 27265 by the extension antenna 27260 and the RFID scanner antenna. With the extension antenna 27260, the RFID tag 27250 is able to receive and respond to interrogation signals from the RFID scanner 27300. However, without the extension antenna 27260, the RFID tag 27250 is unable to communicate with the RFID scanner 27300. The RFID tag 27250 and extension antenna 27260 may be attached to the staple cartridge 27100 in any suitable manner including, for example, mounted on, embedded within, and / or affixed to the staple cartridge 27100. Additionally, the RFID tag 27250 may be positioned in any suitable location on the staple cartridge 27100, such as, for example, on the base 27104 and / or deck surface 27106.
[0159] As discussed above, at least a portion of the extended antenna 27260 traverses the elongated slot 27110 of the staple cartridge 27100. During a staple firing stroke, a tissue cutting and / or staple firing member is configured to translate longitudinally through the elongated slot 27110 during the staple firing stroke and traverse or otherwise destroy the extended antenna 27260 during the procedure. The portion of the extended antenna 27260 that traverses the elongated slot 27110 is positioned at a location proximal to the proximal-most staple cavity. Thus, the extended antenna 27260 is functional only prior to the initiation of a staple firing stroke. Any distal movement of the tissue cutting and / or staple firing member that results in the firing of a staple renders the extended antenna 27260 inoperative. The extended antenna 27260 can be rendered inoperative in any suitable manner. For example, the extended antenna 27260 can be cut and thus physically destroyed by the tissue cutting member. In various examples, the extended antenna 27260 can detach from the RFID tag 27250 and / or the staple cartridge 27100 in response to the tissue cutting and forces exerted by the staple firing member. Notably, the staple firing stroke does not damage the wireless antenna 27252 of the RFID tag 27250. However, the range of the wireless antenna 27252 is insufficient to facilitate communication between the RFID tag 27250 and the RFID scanner 27300. Thus, detachment of the extended antenna 27260 can alter the communication range 27265 of the RFID tag 27250 and remove the ability of the RFID tag 27250 to communicate with the RFID scanner 27300.
[0160] Destroying the extended antenna 27260 in this manner does not adversely affect the operation of the surgical instrument. Stated another way, the extended antenna 27260 is not destroyed until the staple cartridge 271000 is authenticated. Thus, a staple firing stroke may be performed after the extended antenna 27260 is destroyed. That being said, once the extended antenna 27260 is destroyed and the staple cartridge 27100 is removed from the surgical instrument, reseating the staple cartridge 27100 within the surgical instrument will not re-authenticate the staple cartridge 27100 because the RFID scanner can no longer communicate with the RFID tag 27250. Such an apparatus configuration functions, among other things, as a lockout of a used cartridge.
[0161] As described above, if the extension antenna 27260 is inoperative, the RFID scanner 27300 will not receive a response to its interrogation signal. If the RFID scanner 27300 does not receive a response to its interrogation signal, the controller of the surgical instrument is programmed to recognize an error. If the RFID scanner 27300 receives a response to its interrogation signal, but the response is unrecognizable and / or does not represent a compatible staple cartridge assembly 27000, the controller of the surgical instrument is also programmed to recognize an error. In various examples, detection of an error by the controller can render the surgical instrument inoperative for use with the staple cartridge assembly 27000. In various examples, a detected error can prevent the surgical instrument from performing a staple firing stroke and / or a tissue cutting stroke when the staple cartridge assembly 27000 is attached to the surgical instrument. A manual override can be activated to allow a clinician to override any system lockout and utilize the operating functions of the surgical instrument in an emergency. In various examples, the controller is configured to alert the clinician that an error has been detected. Such an alert may be communicated via various forms of feedback, including, for example, tactile, auditory, and / or visual feedback. The alert may be specific or general. For example, the alert may specifically indicate that the RFID tag 27250 cannot be detected, or the alert may specifically indicate that the RFID tag 27250 includes information indicative of a mismatched and / or defective staple cartridge assembly 27000.
[0162] The portion of the extended antenna 27260 that traverses the elongated slot 27110 may be positioned at any suitable location along the elongated slot 27110. For example, the extended antenna 27260 may traverse the elongated slot 27110 at a location that is coincident with or slightly proximal to the distal-most staple cavity. In such an embodiment, the extended antenna 27260 is disabled once the tissue cutting and staple firing stroke is complete. If the RFID scanner 27300 is unable to communicate with the RFID tag 27250 in this scenario, the clinician would be able to confirm, for example, that the entire staple firing stroke has been completed. Additionally, the RFID tag 27250 may be positioned at any suitable location on the staple cartridge 27100, such as, for example, on the base 27104 and / or deck surface 27106 of the staple cartridge 27100.
[0163] In various examples, the extended antenna 27260 comprises a first antenna configured to traverse the elongated slot 27110 of the staple cartridge 27100 and a second antenna that does not traverse the elongated slot 27110 of the staple cartridge 27100. In other words, the second antenna is not traversed by the firing member during the staple firing stroke. When the first antenna is traversed by the firing member, the communication range of the RFID tag 27250 is reduced. However, the communication range of the RFID tag 27250 can be increased using the first antenna that was not traversed by the firing member during the staple firing stroke.
[0164] FIG. 85 illustrates an exemplary RFID system 28200 that may be incorporated into a surgical instrument, such as, for example, the surgical instrument 400 discussed herein. The RFID system 28200 may be integrated into, for example, a staple cartridge, an end effector jaw, and / or any other suitable location within a surgical instrument. The RFID system 28200 includes an RFID tag 28250 and an RFID scanner system 28300. The structure and function of the RFID tag 28250 is similar to the RFID tags discussed herein, such as, for example, RFID tags 26250, 27250. The RFID scanner system 28300 includes a first RFID scanner 28310 and a second RFID scanner 28320. The function of the RFID scanners 28310, 28320 is similar to other RFID scanners discussed herein, such as, for example, RFID scanner 27300.
[0165] The RFID tag 28250 comprises a chip, such as, for example, a microchip, that stores information regarding replaceable components within the surgical system. In various examples, the chip includes an identification number for the staple cartridge. In various examples, the chip includes additional information, such as, for example, manufacturing data, shipping data, and / or other compatibility data for the staple cartridge. The RFID tag 28250 further comprises a wireless antenna configured to receive interrogation signals from one and / or both of the RFID scanners 28310, 28320.
[0166] Each RFID scanner 28310, 28320 includes a scanner antenna configured to transmit a radio signal. The radio signal activates an RFID tag 28250 positioned within a predetermined range of the RFID scanner 28310. The RFID scanner 28310 then receives one or more response signals "bounced back" from the RFID tag 28250. In various examples, the one or more response signals include the same signal as the interrogation signal. In various examples, the one or more response signals include a modified signal from the interrogation signal. The second RFID scanner 28320 is also configured to transmit a signal to the RFID tag 28250.
[0167] In various examples, the RFID scanner 28310 includes read and write capabilities. The RFID scanner 28310 software can then pass the collected information from the RFID tag 28250 to a controller for further interpretation. The controller may be located on the surgical instrument, a remote console, or any suitable location. A second RFID scanner 28320 may also be used in this manner.
[0168] The RFID scanner system 28300 comprises a flex circuit, the flex circuit including a first layer and a second layer. The first layer functions as a first RFID scanner 28310 and the second layer functions as a second RFID scanner 28320. The RFID scanners 28310, 28320 further comprise RF amplifiers that determine the power of the signal transmitted by the RFID scanners 28310, 28320 and amplify the interrogation signal to a desired power level. When energized, the first layer 28310 is configured to transmit a signal 2815 at a power of about 1 watt or less. When energized, the second layer 28320 is configured to transmit a signal 28325 at a power of more than 1 watt. In practice, the amplifiers communicate with a controller of the surgical instrument, and as described in more detail below, the signal of the second RFID scanner 28320 can be transmitted at a power well above 1 watt.
[0169] Prior to the staple firing stroke, the first RFID scanner 28310 is energized. As shown in FIG. 86, the first RFID scanner 28310 transmits an interrogation signal 28315 to the RFID tag 28250. The RFID tag 28250 receives the energy or interrogation signal 28315 using the RFID tag 28250's radio antenna. The received energy travels through the tag's antenna and a portion of the received energy is used to activate the chip and prepare for transmission of data based on a command received from the first RFID scanner 28310. Activation of the chip allows the chip to use information stored in the RFID tag 28250 to condition the received energy and to "reflect" the remaining energy in the form of a response signal 28255. The chip transmits a response signal 28255 to the RFID scanner 28310 that is the same and / or different from the interrogation signal. The response signal 28255 is received by the antenna of the first RFID scanner 28310 to allow the first RFID scanner to recover the information stored in the RFID tag 28250.
[0170] After the staple firing stroke is initiated, the second RFID scanner 28320 is energized in addition to and / or in place of the first RFID scanner 28310. As shown in FIG. 87, both the first RFID scanner 28310 and the second RFID scanner 28320 simultaneously transmit interrogation signals 28315, 28325 to the RFID tag 28250. The RFID tag 28250 receives energy from both interrogation signals 28315, 28325 using the RFID tag 28250's radio antenna. The received energy may total, for example, about 2 watts of power, and may exceed, for example, the RFID tag 28250's operating power threshold of 1 watt. The RFID tag 28250 is disabled upon receiving the interrogation signals 28315, 28325 from both the first RFID scanner 28310 and the second RFID scanner 28320. In various examples, the RFID tag 28250 overheats due to exceeding an operational power threshold. The increase in heat can, for example, burn a fuse within the RFID tag, melt a portion of the RFID tag, and / or otherwise render the RFID tag 28250 inoperable.
[0171] Destroying the RFID tag 28250 in this manner does not adversely affect the operation of the surgical instrument. In other words, destruction of the RFID tag 28250 does not occur until the staple cartridge is authenticated by the surgical instrument. Instead, once the staple cartridge is authenticated, the surgical instrument may be used to perform a staple firing stroke, among other functions. After the staple firing stroke and / or after the staple cartridge is removed from the surgical instrument, the staple cartridge cannot be re-authenticated by the surgical instrument, and therefore the staple cartridge cannot be reused. This system functions, among other things, as a lockout of a used cartridge.
[0172] In any event, the RFID tag 28250 cannot receive signals from and / or transmit signals to the RFID scanner in the inoperative configuration. If the first RFID scanner 28310 does not receive a response to its interrogation signal 28315, the controller of the surgical instrument is configured to communicate an error to the clinician. If the RFID scanner 28310 receives a response to its interrogation signal 28315, but the response is unrecognizable and / or does not represent a compatible staple cartridge assembly, the controller of the surgical instrument is also programmed to communicate an error to the clinician. In various examples, communicating a detected error from the controller can cause the surgical instrument to be inoperative when the staple cartridge assembly is attached. In various examples, a detected error can prevent the surgical instrument from performing a staple firing stroke and / or a tissue cutting stroke while the staple cartridge assembly is attached. A manual override can be activated to allow the clinician to override any system lockout and utilize the operating functions of the surgical instrument in an emergency. In various examples, the controller is configured to alert the clinician that an error has been detected. Such an alert may be communicated via various forms of feedback, including, for example, tactile, auditory, and / or visual feedback. The alert may be specific or general. For example, the alert may specifically indicate that the RFID tag 28250 cannot be detected, or the alert may specifically indicate that the RFID tag 28250 includes information indicative of a mismatched and / or defective staple cartridge assembly.
[0173] As discussed above, the first RFID scanner 28310 may be used to communicate with the RFID tag 28250, and the combined operation of the first RFID scanner 28310 and the second RFID scanner 28320 may be used to destroy the RFID tag 28250. Alternatively, the first RFID scanner 28310 may be used to communicate with the RFID tag 28250, and the second RFID scanner 28320 may be used to destroy the RFID tag 28250. In this embodiment, the first RFID scanner 28310 uses power below a threshold and the second RFID scanner 28320 uses power above a threshold. Also, alternatively, a second RFID scanner may not be used, as both the communication and destruction functions may be performed by a single scanner. In at least one such example, a signal amplifier is used to transmit signals below a power threshold for communication and above a power threshold for destruction.
[0174] 88-89A illustrate a cartridge lockout system 29000. The cartridge lockout system 29000 is configured to prevent a surgical instrument from performing a staple firing stroke when a mismatched and / or used staple cartridge is detected. When an unused, matched staple cartridge is detected, a controller of the surgical instrument is enabled to perform a staple firing stroke. One such matched staple cartridge includes, for example, staple cartridge 29100.
[0175] The staple cartridge 29100 comprises a cartridge body including a cartridge deck 29106, a base 29104, and a sidewall 29108 extending between the cartridge deck 29106 and the base 29104. A plurality of staple cavities 29107 are defined within the cartridge body. The staple cavities 29107 are arranged in a longitudinal row, with a staple removably supported within each staple cavity 29107. The staple cartridge 29100 comprises a proximal end 29102 and a distal end. An elongated slot 29110 extends from the proximal end 29102 toward the distal end and is configured to receive a firing member 29210 during a staple firing stroke. The staple cartridge 29100 further comprises a wedge sled 29125 and a channel 29120 defined within the cartridge body. The wedge sled 29125 is configured to drive staples from the cartridge body toward the anvil during a staple firing stroke. The channel 29120 is configured to receive a ramp of the wedge sled 29125 as the wedge sled 29125 is translated through the staple cartridge 29100 during a staple firing stroke. Detents are formed on the inside of the channel 29120 to, among other things, interface with the ramp of the wedge sled 29125 and to control a lateral position of the wedge sled 29125 within the channel 29120. In at least one example, a rib may be used to releasably retain the wedge sled 29125 in a proximal, unfired position.
[0176] The staple cartridge 29100 further comprises an RFID tag 29250. The RFID tag 29250 comprises a chip, such as, for example, a microchip, that stores information regarding the staple cartridge 29100. In various examples, the chip comprises a base identification number. In various examples, the chip comprises additional information, such as, for example, manufacturing data, shipping data, and / or compatibility data. The RFID tag 26250 further comprises a wireless antenna configured to receive an interrogation signal from an RFID scanner. As shown in FIGS. 88 and 89 , the RFID tag 29250 is affixed to one of the side walls 29108 of the staple cartridge 29100. However, it is contemplated that the RFID tag 29250 may be embedded within the staple cartridge 29100 and / or attached to the staple cartridge 29100 in any suitable manner and / or at any suitable location.
[0177] The surgical system further comprises an RFID scanner. The RFID scanner comprises a scanner antenna configured to transmit a radio signal. The radio signal activates an RFID tag located within a predetermined transmission range of the RFID scanner. The RFID scanner then receives one or more response signals 29255 "bounced back" from the RFID tag. In various examples, the one or more response signals include the same signal as the interrogation signal. In various examples, the one or more response signals include a modified signal from the interrogation signal. The RFID scanner may be located in various locations, such as, for example, the staple cartridge 29100, the end effector of the surgical instrument, and / or a console located remotely relative to the surgical instrument. In other words, the RFID scanner may be located in any suitable location that allows the RFID scanner to communicate with the RFID tag 29250 when the staple cartridge 29100 is seated in the end effector of the surgical instrument and / or after the staple cartridge 29100 is seated in the end effector of the surgical instrument. In various examples, the RFID scanner includes read and write capabilities. The RFID scanner's software can pass the collected information 29255 from the RFID tag 29250 to a controller for further interpretation. The controller can be located within the surgical instrument or in any suitable location. The RFID scanner and / or controller can include a stored set of information corresponding to the staple cartridge that is compatible with a particular surgical instrument and / or is intended for use during a particular surgical procedure.
[0178] Based on the information 29255 collected from the RFID tag 29250, the controller can maintain, activate, and / or deactivate a cartridge lockout assembly, such as, for example, the cartridge lockout assembly 29000. The cartridge lockout assembly 29000 includes a lockout bar 29300. The lockout bar 29300 includes a proximal end 29302 and a distal end 29304. The distal end 29304 of the lockout bar 29300 is configured to interface with a wedge sled 29125 when the staple cartridge 29100 is seated within the jaws of the end effector. The lockout bar 29300 is sized to fit within one of the channels 29120 formed within the cartridge body. The proximal end 29302 of the lockout bar 29300 includes a lateral protrusion or flange 29310. The proximal end 29302 of the lockout bar 29300 is engaged with the firing bar 29200 of a staple firing driver such that the lockout bar 29300 and the firing bar 29200 move together. The firing bar 29200 includes a groove 29225 that receives the lateral projection 29310 of the lockout bar 29300.
[0179] The cartridge lockout assembly 29000 further includes a block bolt assembly 29400. In the illustrated embodiment, the block bolt assembly 29400 includes a solenoid. The block bolt assembly 29400 includes a lock bolt 29410, a resilient member 29420, and an induction coil 29430. In the embodiment shown in FIGS. 88-89A, the resilient member 29420 is a spring, although any resilient member may be used. The block bolt assembly 29400 is configurable in an unlocked configuration and a locked configuration. The lock bolt 29410 and the resilient member 29420 are positioned within a housing 29405 of the block bolt assembly 29400. The resilient member 29240 biases the lock bolt 29410 into its locked configuration. In the locked configuration, a portion of the lock bolt 29410 extends outside of the housing 29405. In the unlocked configuration, the locking bolt 29410 is positioned fully within the housing 29405.
[0180] The block bolt assembly 29400 is placed in the unlocked configuration by the controller when a matching staple cartridge 29100 is detected by the controller. The matching staple cartridge 29100 is detected when the RFID tag 29250 emits a signal 29255 corresponding to a set of stored information in the RFID scanner and / or controller and / or when the clinician disables the controller. In such an example, the controller is configured to activate the induction coil 29430 of the block bolt assembly 29400. The controller applies a voltage source to the coil 29430 to activate the coil 29430. Activating the induction coil 29430 will generate a magnetic field that draws the lock bolt 29410 into the housing 29405. To this end, the lock bolt 29410 is constructed of iron, nickel, and / or any suitable magnetic material. That being said, the resilient member 29420 is compressed by the movement of the locking bolt 29410, and therefore the resilient member 29240 opposes the movement of the locking bolt 29410. In either case, the locking bolt 29410 is retracted a sufficient amount to clear the path of the lockout bar 29300. At such point, a staple firing stroke can be performed. When the staple cartridge 29100 is removed from the surgical instrument, the controller deactivates the induction coil 29430, thereby allowing the resilient member 29240 to re-extend the locking bolt 29410.
[0181] Further to the above, when the staple cartridge 29100 is seated into the jaws of the end effector, the distal end 29304 of the lockout bar 29300 contacts the threads 29125 of the staple cartridge 29100. If the locking bolt 29410 is retracted, the proximal end 29302 of the lockout bar 29300 is pushed proximally by the threads 29125 of the staple cartridge 29100 when the clinician attempts to seat the staple cartridge 29100 into the jaws. In such an example, the lockout bar 29300 is configured to freely translate in the proximal direction. The lack of resistance to proximal movement of the lockout bar 29300 allows the lockout bar 29300 to move without displacing the wedge threads 29125 in the staple cartridge 29100. In other words, the retaining force exerted on the wedge sled 29125 by the detent in the channel 29120 is sufficient to maintain the wedge sled 29125 in its current position while pushing against the lockout bar 29300 when the staple cartridge 29100 is seated within the surgical instrument.
[0182] As discussed above, the block bolt assembly 29400 is in the locked configuration when a mismatched staple cartridge 29100' is detected. As shown in FIG. 89, a mismatched staple cartridge 29100' is detected when the RFID tag 29250 emits a signal 29255' that does not correspond to a set of stored information in the RFID scanner and / or controller. In various examples, the staple cartridge 29100' is deemed mismatched by the controller of the surgical instrument when the RFID scanner is unable to detect a signal from the RFID tag. If the emitted signal 29255', or lack of a signal, indicates a mismatched staple cartridge 29100', the induction coil 29430 of the block bolt assembly 29400 is not activated by the controller. Without activating the induction coil 29430, the biasing member 29420 retains a portion of the lock bolt 29410 and extends outside the housing 29405. When the staple cartridge 29100' is seated into the jaws of the end effector and the locking bolt 29410 is extended, the distal end 29304 of the lockout bar 29300 contacts the threads 29125 of the staple cartridge 29100'. The lockout bar 29300 is prevented from translating in a proximal direction because the locking bolt 29410 is in its path. In such a case, the resistance provided by the locking bolt 29410 against the lockout bar 29300 exceeds the retaining force provided by the detents in the channel 29120 that hold the wedge threads 29125 in place. Thus, the wedge threads 29125 are displaced distally from their unfired position when the staple cartridge 29100' is seated and the locking bolt 29410 is not retracted. Distal movement of the wedge sled 29125 from its unfired position consumes the staple cartridge 29100' even though no staples have been fired from the staple cartridge 29100'.No. 7,143,923, entitled "SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL," issued December 5, 2006; U.S. Patent No. 7,044,352, entitled "SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING," issued May 16, 2006; U.S. Patent No. 7,000,818, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS," issued February 21, 2006; and U.S. Patent No. 6,988,649, entitled "SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE," issued February 21, 2006, the disclosures of which are incorporated herein by reference in their entireties. No. 6,978,921, entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM," issued on January 24, 2006, and U.S. Pat. No. 6,978,921, entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM," issued on December 27, 2005, mechanically prevent the staple firing stroke from being performed in such cases.
[0183] 90 illustrates a motor control circuit 30000 for use in controlling the cartridge lockout assembly 29000. Various details of the motor control circuit 30000 are described in further detail in U.S. Patent Application Publication No. 2010 / 0075474, entitled "MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT," the disclosure of which is incorporated herein by reference in its entirety. A battery or other suitable power source 30064 powers an electric motor 30065. When the clinician first pulls the firing trigger of the surgical instrument, an operating motor (or firing) switch 30110 is closed. When the operating motor switch 30110 is closed, a safety switch is closed and a lockout switch is opened, allowing current to flow through the safety switch, through the lockout indicator 30244, and to the motor 30065. When the end of the staple firing stroke is reached, an end of stroke or direction switch 30130 is toggled, reversing the direction of the motor 30065. The circuit 30000 may also include a manual return switch 30348. A clinician can manually flip this switch 30348 if a firing member, such as the firing member 29210, is only partially fired. Toggling the manual return switch 30348 will reverse the rotation of the motor 30065, returning the firing member to its original or home position.
[0184] The motor control circuit 30000 further comprises a cartridge lockout switch 30300. When the controller 30310 determines, through a received signal from an RFID tag, such as RFID tag 29250, that a matching staple cartridge is seated within the end effector, the induction coil 30320 is energized. Energization of the induction coil 30320 closes the cartridge lockout switch 30300, resulting in a matching staple cartridge being seated within the end effector without displacement of the staple cartridge's wedge sleds. When the controller 30310 determines, through a received signal from an RFID tag, such as RFID tag 29250, that a non-matching staple cartridge is seated within the end effector, the induction coil 30320' is not energized. The inactive induction coil 30320' allows the cartridge lockout switch 30300 to remain open. A cartridge lockout, such as cartridge lockout 29000, then causes distal displacement of the wedge sled in the mismatched surgical cartridge. The surgical instrument is then unable to perform a staple firing stroke while the mismatched surgical cartridge is installed.
[0185] Various surgical instruments are comprised of replaceable components that need to be replaced before the start of a surgical procedure and / or during a surgical procedure. For example, a surgical stapling instrument, such as surgical stapling instrument 400, includes a replaceable staple cartridge. A clinician may desire and / or require replacing a staple cartridge for a variety of reasons, such as, for example, the type of surgical procedure being performed, the thickness of the tissue being treated during the surgical procedure, and / or the condition of the staple cartridge. The condition of the staple cartridge corresponds, for example, to whether the staple cartridge has been used, i.e., whether one or more of the staples within the staple cartridge have been ejected during the staple firing stroke.
[0186] As described in more detail herein, various identification systems, such as, for example, RFID tags, QR codes, and / or bar codes, may be located throughout the surgical system. For example, as shown in FIG. 91, a first RFID tag 31560a is located on the cartridge body 31510 of the staple cartridge 31500, a second RFID tag 31560b is located on the wedge sled 31550 of the staple cartridge 31500, and a third RFID tag 31560c is located on the retainer 31570 of the staple cartridge 31500. Each RFID tag includes a chip that stores, among other things, information related to the status of the staple cartridge assembly, the identity of the staple cartridge, and / or compatibility of the staple cartridge assembly with a particular surgical instrument. The information stored on each chip is encrypted to ensure, among other things, patient safety and proper assembly of the components within the surgical system. Encryption of the information on the chip ensures that the stored information can only be accessed by authorized parties and not by unauthorized parties. In other words, if the information stored on the chip cannot be decrypted, the surgical system will not be able to assemble an incompatible assembly component and / or one or more operating parameters of the surgical system will be unavailable and / or modified when an incompatible assembly component is attached. To decrypt the information collected from the RFID tags by the one or more RFID scanners, an encryption key is stored in the controller of the surgical system and / or in an external storage medium. In various examples, all of the RFID tags contain encrypted information. In other examples, only one of the RFID tags, such as the RFID tag located on the staple cartridge, contains encrypted information. However, it is contemplated that any suitable combination of RFID tags may include a chip with encrypted information. In various examples, one or more of the encryption keys are stored in a memory on the surgical instrument, although any suitable storage location is contemplated.
[0187] The data stored on the RFID tag of the staple cartridge may be encrypted during the manufacturing process of the staple cartridge using an encryption protocol. The information may be encrypted, for example, to prevent, among other things, the use of staple cartridges that have been copied without authorization and / or with inferior components. Such unauthorized copies of staple cartridges may not be manufactured to the same specifications and / or dimensions as a compatible staple cartridge. If an incompatible staple cartridge is used with a surgical instrument, the incompatible staple cartridge may not perform the surgical function(s) in the same manner as a compatible staple cartridge, thereby exposing the patient to increased risk when the incompatible staple cartridge is used with a surgical instrument.
[0188] During the manufacturing process, the RFID scanner transmits a first interrogation signal to interrogate the first RFID tag 31560a of the staple cartridge 31500. The first RFID tag 31560a transmits a first signal 31580a in response to the first interrogation signal. The first response signal 31580a includes unencrypted or unprotected data associated with the staple cartridge 31500. Such data may include, for example, manufacturing data and / or cartridge identification data. The RFID scanner transmits a second interrogation signal and a third interrogation signal to interrogate the second RFID tag 31560b and the third RFID tag 31560c, respectively. The second RFID tag 31560b transmits a second signal 31580b in response to the second interrogation signal, and the third RFID tag 31560c transmits a third signal 31580c in response to the third interrogation signal. The second response signal 31580b and the third response signal 31580c each include unencrypted or unprotected data related to the wedge sled 31550 and the retainer 31570. Such data may include, for example, manufacturing data and / or identification data.
[0189] The RFID scanner transmits the response signals 31580a, 31580b, 31580c to the manufacturing controller 31100. The manufacturing controller 31100 accesses the cloud storage medium 31150 to, for example, encrypt the received data. The cloud storage medium 31150 comprises an encryption protocol configured to encrypt the data contained in the response signals 31580a, 31580b, 31580c. Using the encryption protocol, the cloud storage medium 31150 creates an encrypted serial number that reflects the various components of the staple cartridge 31500 having an RFID tag. For example, the unprotected data stored in the first RFID tag 31560a is encrypted with a first value 31202. The unprotected data stored in the second RFID tag 31560b is encrypted with a second value 31204, and the unprotected data stored in the third RFID tag 31560c is encrypted with a third value 31206. The first value 31202, the second value 31204, and the third value 31026 are combined to form a unique serial number 31200 that reflects the identity of the staple cartridge 31500. Such an encryption process is performed for each manufactured staple cartridge. See also FIG.
[0190] After the cloud storage medium 31150 completes the encryption protocol, the manufacturing controller 31100 rewrites the encrypted data to the RFID tags 31560a, 31560b, 31560c. The manufacturing controller 31100 instructs the RFID scanner to transmit a first rewrite signal 31110a to the first RFID tag 31560a. The first rewrite signal 31110a serves to delete the unprotected data stored in the first RFID tag 31560a and replace the unprotected data with new protected data 31202. The RFID scanner transmits a second rewrite signal 31110b to the second RFID tag 31560b and a third rewrite signal 31110c to the third RFID tag 31560c. The second re-write signal 31110b serves to delete the unprotected data stored in the second RFID tag 31560b and replace the unprotected data with new protected data 31204. The third re-write signal 31110c serves to delete the unprotected data stored in the third RFID tag 31560c and replace the unprotected data with new protected data 31206. At this point, the RFID tags 31560a, 31560b, 31560c contain only encrypted data and only the cloud storage medium 31150 has access to the unprotected unencrypted data via the decryption protocol. As mentioned above, the RFID reader is configured to transmit signals to and receive signals from the RFID tags. In such a case, the RFID reader has both read and write capabilities.
[0191] Since the data stored on each staple cartridge 31500 is encrypted, the cloud storage medium 31150 creates a list 31250 of unique serial numbers 31200 of the staple cartridges 31500 along with the associated encryption key. The list 31250 may be updated in real time and / or created after each RFID tag 31560a, 31560b, 31560c is programmed with the encrypted information. The manufacturing controller 31100 is configured to access the list 31250 of unique serial numbers 31200 from the cloud storage medium 31150. During the packaging process, the manufacturing controller 31100 instructs the package printer 31600 to print the unique serial numbers 31200 on the packaging of the staple cartridges 31500.
[0192] When a staple cartridge 31500 is required for attachment to a surgical instrument, the clinician is requested to scan the staple cartridge 31500 packaging. The controller of the surgical instrument and / or a remote controlled in the operating room communicates the scanned package data to the cloud storage medium 31150. The remote controller, for example, communicates the scanned package data to the cloud storage medium 31150 for decoding. The cloud storage medium 31150 performs a decoding protocol on the scanned package data and compares the received data to a list 31250 of matching or otherwise acceptable staple cartridges. If the cloud storage medium 31150 recognizes the scanned package data as acceptable for use with the surgical instrument, the cloud storage medium 31150 communicates an approval signal to the remote controller. The remote controller communicates an approval signal to a controller on the surgical instrument, and the surgical instrument can perform, for example, a staple firing stroke. If the cloud storage medium 31150 is unable to recognize the scanned package data, it communicates an error to the remote controller. The remote controller communicates the error to a controller on the surgical instrument and the surgical instrument is prevented from performing a staple firing stroke. In various examples, the surgical instrument is equipped with an override input that the clinician may activate only after the clinician has been properly alerted that the staple cartridge has not passed the authentication protocol.
[0193] As previously described, a package, such as modular component package 25000, includes one or more identification systems for the contents of the package. The manufacturing controller and package printer 31600 creates the identification systems using the encrypted information described above. Various techniques may be used to label the package. Such techniques include, for example, laser printing, pad printing, thermal printing, and / or chip programming. For example, laser printing may be used to print a QR code and / or a bar code on the product package. Chip programming may be used, for example, to change information stored in an RFID system, such as RFID system 25200.
[0194] 92 illustrates a decryption protocol 32000 operated by a controller of a surgical instrument. The controller uses an auto-incrementing encryption key to facilitate assembly and / or use of a surgical instrument, such as, for example, the surgical instrument described above. The surgical instrument controller comprises a memory. The memory stores a default internal key 32010 that enables the controller to decrypt a first RFID tag. The first RFID tag is located on a staple cartridge package, the first RFID tag containing a first set of encrypted information. The first set of encrypted information can only be decrypted by the controller using the default internal key 32010. The decryption protocol 32000 releases a second internal key 32040 upon successful decoding of the first RFID tag. If the controller determines that the packaging is not authentic, if the controller is unable to decode the information stored in the first RFID tag, and / or if the information stored in the first RFID tag cannot be recognized, the second internal key 32040 is not released and the decryption protocol 32000 cannot proceed. The first RFID tag may be rescanned or a new package may be scanned by the RFID scanner 32020. Without continuing with the next authentication step of the decryption protocol 32000, the controller of the surgical instrument prevents the surgical instrument from performing a staple firing stroke.
[0195] The staple cartridge includes a second RFID tag positioned on the cartridge body, the second RFID tag including a second set of encrypted information. The second set of encrypted information can only be decrypted by the controller using the second internal key 32040. The decryption protocol 32000 releases the third internal key 32070 upon successful decoding of the second RFID tag data. If the controller determines that the staple cartridge is not authentic, if the controller is unable to decrypt the information stored in the second RFID tag, and / or if the information stored in the second RFID tag cannot be recognized, the third internal key 32070 is not released and the decryption protocol 32000 cannot proceed forward. The second RFID tag may be rescanned or a new staple cartridge may be scanned by the RFID scanner 32050. Without continuing with the next authentication step of the decryption protocol 32000, the controller of the surgical instrument prevents the surgical instrument from performing a staple firing stroke.
[0196] The staple cartridge pre-packaged in the package as described above includes a passive second RFID tag. The second RFID tag is positioned in any suitable location within the staple cartridge. The clinician can bring an RFID scanner within range of the second RFID tag, and the RFID scanner emits a signal to scan (32050) the second RFID tag of the staple cartridge. In response to the RFID scanner's emitted signal, the second RFID tag is configured to transmit its encrypted information back to the RFID scanner. Software on the RFID scanner is configured to transmit the communicated information to the controller and decrypt it using the released and / or unlocked internal key 32040. Once the received information is decoded, the controller is configured to determine whether the staple cartridge includes authentic components that are compatible with the surgical instrument 32060. In other words, the information stored by the second RFID tag allows the clinician to confirm that the package did not contain an authentic staple cartridge. In various examples, the controller is also configured to determine whether the staple cartridge has been tampered with, whether it has been previously used, and / or whether it is an incorrect form of an otherwise compatible staple cartridge. If the controller determines that the staple cartridge is not authentic, the controller is unable to decode the information stored in the second RFID tag and / or the information stored in the second RFID tag cannot be recognized. The staple cartridge may then be rescanned or a new staple cartridge may be scanned by the RFID scanner 32050. If the controller determines that the staple cartridge is authentic, the controller releases and / or unlocks the third internal key 32070 for use in detecting the presence of a retainer on the staple cartridge assembly.Without releasing and / or unlocking the third internal key 32070, the clinician cannot complete the protocol 32000 and, in various examples, cannot activate the surgical instrument with an inauthentic component(s) unless there is an override input as described above.
[0197] The staple cartridge includes a third RFID tag positioned on the retainer, the third RFID tag including a third set of encrypted information. The third set of encrypted information can only be decrypted by the controller using the third internal key 32070. If the encrypted information includes data representative of a matching staple cartridge, the decryption protocol 32000 releases the fourth internal key and / or the decryption protocol 32000 is successfully completed. If the controller determines that the staple cartridge is not authentic, if the controller is unable to decrypt the information stored in the third RFID tag, and / or if the information stored in the third RFID tag cannot be recognized, the next or fourth key is not released and the decryption protocol 32000 cannot proceed forward. The third RFID tag may be rescanned or a new retainer may be scanned by the RFID scanner 32080. Without releasing and / or unlocking the fourth internal key, the controller cannot complete protocol 32000 and, in various examples, may not be able to activate the surgical instrument with the inauthentic component(s). In various examples, the retainer is the last modular component evaluated in protocol 32000. However, in other examples, additional modular components include RFID tags with encrypted information that require authentication before use with the surgical system.
[0198] It is contemplated that any of the identification systems described herein may be used in place of the active and / or passive RFID tags described in connection with protocol 32000.
[0199] Various aspects of the subject matter described herein are illustrated in the following examples.
[0200] Example Set 1 Example 1. A method for authenticating compatibility of a staple cartridge with a surgical instrument includes inserting the staple cartridge into the surgical instrument. The method also includes transmitting a first signal from a first RFID tag on a first component of the staple cartridge to an RFID reader system and transmitting a second signal from a second RFID tag on a second component of the staple cartridge to the RFID reader system. The method also includes comparing the first signal and the second signal to a set of stored data of a compatible staple cartridge, and unlocking a staple firing system of the surgical instrument if the first signal and the second signal match the set of stored data of the compatible staple cartridge.
[0201] Example 2. The method of example 1, wherein the comparing step includes comparing the first signal and the second signal to two or more sets of stored data of a matching staple cartridge.
[0202] Example 3. The method of example 1 or 2, wherein the first RFID tag and the second RFID tag comprise active RFID tags.
[0203] Example 4. The method of any one of Examples 1-3, further comprising the step of interrogating the first RFID tag with an RFID reader system prior to the step of transmitting the first signal from the first RFID tag.
[0204] Example 5. The method of any one of Examples 1-4, further comprising the step of interrogating the second RFID tag with an RFID reader system prior to the step of transmitting the second signal from the second RFID tag.
[0205] Example 6. The method of any one of Examples 1-5, further comprising the step of operating the staple firing system to perform a staple firing stroke after the unlocking step.
[0206] Example 7. The method of Examples 1-6, wherein the first component comprises a cartridge body and the second component comprises a sled movable from a proximal unfired position to a distal fired position during a staple firing stroke.
[0207] Example 8. The method of example 7, wherein the step of transmitting a second signal to the RFID reader system can occur only when the sled is in its proximal unfired position.
[0208] Example 9. The method of any one of Examples 1-8, wherein the first component comprises a cartridge body and the second component comprises a cover removably attached to the cartridge body.
[0209] Example 10. The method of example 9, wherein the step of transmitting a second signal to the RFID reader system can occur only when the cover is attached to the cartridge body.
[0210] Example 11. A method for authenticating compatibility of a staple cartridge with a surgical instrument includes inserting the staple cartridge into the surgical instrument. The method also includes receiving a first signal from a first RFID tag on a first component of the staple cartridge by an RFID reader system, and receiving a second signal from a second RFID tag on a second component of the staple cartridge by the RFID reader system. The method also includes comparing the first signal and the second signal to stored data of a compatible staple cartridge, and locking a staple firing system of the surgical instrument if the first signal and the second signal do not match the stored data of the compatible staple cartridge.
[0211] Example 12. The method of example 11, wherein the comparing step includes comparing the first signal and the second signal with stored data of two or more compatible staple cartridges.
[0212] Example 13. The method of examples 11 and 12, wherein the first RFID tag and the second RFID tag comprise active RFID tags.
[0213] Example 14. The method of any of Examples 11-13, further comprising interrogating the first RFID tag with an RFID reader system prior to the step of receiving the first signal from the first RFID tag.
[0214] Example 15. The method of any of Examples 11-14, further comprising interrogating the second RFID tag with an RFID reader system prior to the step of receiving the second signal from the second RFID tag.
[0215] Example 16. The method of any one of Examples 11-15, further comprising the step of operating the staple firing system to perform a staple firing stroke if the locking step does not occur.
[0216] Example 17. The method of any one of Examples 11-16, wherein the first component comprises a cartridge body and the second component comprises a sled movable from a proximal unfired position to a distal fired position during a staple firing stroke.
[0217] Example 18. The method of example 17, wherein the step of receiving a second signal by the RFID reader system can occur only when the sled is in its proximal unfired position.
[0218] Example 19. The method of any of Examples 11-18, wherein the first component comprises a cartridge body and the second component comprises a cover removably attached to the cartridge body.
[0219] Example 20. The method of example 19, wherein the step of receiving the second signal by the RFID reader system can occur only when the cover is attached to the cartridge body.
[0220] Example Set 2 Example 1. A surgical instrument includes a firing system configured to perform a firing motion, an end effector, and an RFID reader system. The end effector includes an anvil, a staple cartridge support, and a staple cartridge positioned within the staple cartridge support. The staple cartridge includes a cartridge body defining a longitudinal axis, a longitudinal slot defined within the cartridge body, and a staple cavity defined within the cartridge body. The staple cartridge also includes staples removably stored in the staple cavities and a cover releasably attached to the cartridge body, the cover extending over the staple cavities when the cover is attached to the cartridge body. The staple cartridge also includes a sled movable from a proximal unfired position to a distal fired position during a firing motion, a first RFID tag affixed to the cartridge body at a first longitudinal position, and a second RFID tag affixed to the sled, the proximal unfired position of the sled being at a second longitudinal position that is not at the first longitudinal position. The staple cartridge also includes a third RFID tag affixed to the cover at a third longitudinal position that is not at the first longitudinal position and the second longitudinal position. The RFID reader system is configured to receive a first signal from the first RFID tag at the first longitudinal position, a second signal from the second RFID tag at the second longitudinal position, and a third signal from the third RFID tag at the third longitudinal position.
[0221] Example 2. The stapling instrument of example 1, wherein the RFID reader system comprises a first RFID reader, a second RFID reader, and a third RFID reader.
[0222] Example 3. The stapling instrument of Example 2, wherein the first RFID reader system comprises a first antenna adjacent to the first longitudinal position, the second RFID system comprises a second antenna adjacent to the second longitudinal position, and the third RFID system comprises a third antenna adjacent to the third longitudinal position.
[0223] Example 4. The stapling instrument of Examples 1-3, wherein a first RFID tag is configured to emit a first signal in a first range, a first antenna is positioned within the first range and configured to receive the first signal, a second RFID tag is configured to emit a second signal in a second range, a second antenna is positioned within the second range and configured to receive the second signal, and a third RFID tag is configured to emit a third signal in a third range, and a third antenna is positioned within the third range and configured to receive the third signal.
[0224] Example 5. The stapling instrument of example 4, wherein the first range does not overlap with the second range and the third range, and the second range does not overlap with the first range and the third range.
[0225] Example 6. The stapling instrument of Examples 2-5, wherein the first RFID reader system includes a first inductive coil sensor adjacent to the first longitudinal position, the second RFID system includes a second inductive coil sensor adjacent to the second longitudinal position, and the third RFID system includes a third inductive coil sensor adjacent to the third longitudinal position.
[0226] Example 7. The stapling instrument of Example 6, wherein the first RFID tag is configured to emit a first signal in a first range, the first inductive coil sensor is positioned within the first range and configured to receive the first signal, the second RFID tag is configured to emit a second signal in a second range, the second inductive coil sensor is positioned within the second range and configured to receive the second signal, and the third RFID tag is configured to emit a third signal in a third range, and the third inductive coil sensor is positioned within the third range and configured to receive the third signal.
[0227] Example 8. The stapling instrument of Examples 6 and 7, wherein the first range does not overlap with the second range and the third range, and the second range does not overlap with the first range and the third range.
[0228] Example 9. The stapling instrument of any one of Examples 1-8, wherein the first RFID tag comprises an active RFID tag, the second RFID tag comprises an active RFID tag, and the third RFID tag comprises an active RFID tag.
[0229] Example 10. The stapling instrument of any one of Examples 1-8, wherein the first RFID tag comprises a passive RFID tag, the second RFID tag comprises a passive RFID tag, and the third RFID tag comprises a passive RFID tag.
[0230] Example 11. A stapling instrument as described in Examples 1-10, wherein the staple cartridge has a lateral width, and the first longitudinal position, the second longitudinal position, and the third longitudinal position are not laterally aligned across the lateral width.
[0231] Example 12: A stapling instrument as described in Examples 1 to 11, further comprising a controller in communication with the RFID reader system and the firing system, the controller being configured to prevent operation of the firing system if at least one of the first signal, the second signal, and the third signal is not received by the RFID system.
[0232] Example 13. A stapling instrument as described in Examples 1 to 12, further comprising a controller in communication with the RFID reader system and the firing system, the controller having at least one set of data stored in a memory device, the controller configured to compare data from the first signal, the second signal, and the third signal with the set of data, and the controller configured to disable the firing system if data from at least one of the first signal, the second signal, and the third signal does not match the set of data.
[0233] Example 14. A staple cartridge assembly includes a cartridge body defining a longitudinal axis, a longitudinal slot defined in the cartridge body, and a staple cavity defined in the cartridge body. The staple cartridge assembly also includes staples removably stored in the staple cavities and a cover releasably attached to the cartridge body, the cover extending over the staple cavities when the cover is attached to the cartridge body. The staple cartridge assembly also includes a sled movable from a proximal unfired position to a distal fired position during a firing movement, a first RFID tag attached to the cartridge body at a first longitudinal position, a second RFID tag attached to the sled, the proximal unfired position of the sled being at a second longitudinal position that is not at the first longitudinal position, and a third RFID tag attached to the cover at a third longitudinal position that is not at the first longitudinal position and the second longitudinal position.
[0234] Example 15. A surgical instrument includes a firing system configured to perform a firing motion, an end effector, an RFID reader system, and a controller. The end effector includes an anvil, a staple cartridge support, and a staple cartridge positionable within the staple cartridge support. The staple cartridge includes a cartridge body with a proximal end and a distal end, a longitudinal slot defined within the cartridge body, and a staple cavity defined within the cartridge body. The staple cartridge also includes a staple removably stored within the staple cavity, and a sled movable from a proximal unfired position to a distal fired position during a firing motion. The staple cartridge also includes a first RFID tag affixed to the cartridge body at the proximal end and a second RFID tag affixed to the cartridge body at the distal end. The RFID reader system is configured to receive a first signal from the first RFID tag and a second signal from the second RFID tag. The controller is in communication with the RFID reader system and the launch system, and is configured to disable operation of the launch system when one of the first signal and the second signal is received by the controller but not the other.
[0235] Example 16. The surgical instrument of Example 15, further comprising a feedback system in communication with the controller, the controller configured to activate the feedback system when the controller disables operation of the firing system.
[0236] Example 17. A surgical instrument as described in Example 15 or 16, wherein the controller has at least one set of data stored in a memory device, the controller is configured to compare data from the first signal and the second signal with the set of data, and the controller is configured to disable the firing system if the data from one of the first signal and the second signal does not match the set of data.
[0237] Example 18. A staple cartridge comprises a cartridge body having a proximal end and a distal end. The staple cartridge also includes a longitudinal slot defined in the cartridge body, a staple cavity defined in the cartridge body, and a staple removably stored in the staple cavity. The staple cartridge also includes a sled movable from a proximal unfired position to a distal fired position during a firing movement, a first RFID tag affixed to the cartridge body at the proximal end, and a second RFID tag affixed to the cartridge body at the distal end.
[0238] Example Set 3 Example 1. A surgical instrument includes a staple firing system, an end effector, a first RFID reader, a second RFID reader, and a controller. The end effector includes an anvil, a staple cartridge channel, and a staple cartridge positioned within the staple cartridge channel. The staple cartridge includes a cartridge body with a longitudinal slot, a staple cavity defined within the cartridge body, and a staple removably stored within the staple cavity. The staple cartridge also includes a sled movable between a proximal unfired position and a distal fired position by the staple firing system, a first RFID tag affixed to the cartridge body, and a second RFID tag affixed to the sled. The first RFID reader is configured to detect a first signal from the first RFID tag and the second RFID reader is configured to detect a second signal from the second RFID tag. A controller is in communication with the first RFID reader, the second RFID reader, and the staple firing system, where the controller verifies the presence of a staple cartridge in the staple cartridge channel upon receiving a first signal from the first RFID tag, and where the controller verifies that the staple cartridge is an unfired staple cartridge upon receiving a second signal from the second RFID tag.
[0239] Example 2. The surgical instrument of example 1, wherein the controller is configured to disable the staple firing system if it receives the first signal but does not receive the second signal.
[0240] Example 3. The surgical instrument of examples 1 and 2, wherein the controller is configured to unlock the staple firing system upon receiving the first signal and the second signal.
[0241] Example 4. The surgical instrument of examples 1-3, wherein the first RFID tag has a first range of motion and the second RFID tag has a second range of motion, the first range of motion and the second range of motion do not overlap when the sled is in the proximal unfired position.
[0242] Example 5. The surgical instrument of any one of examples 1-4, wherein the first RFID reader has a first operating range and the second RFID reader has a second operating range, the first operating range and the second operating range not overlapping.
[0243] Example 6. The surgical instrument of Examples 1-5, further comprising a third RFID reader in communication with the controller, the third RFID reader configured to detect a second signal from the second RFID tag when the sled is in the distal firing position.
[0244] Example 7. The surgical instrument of example 6, wherein the second RFID reader is unable to detect the second signal when the sled is in the distal fired position and the third RFID reader is unable to detect the second signal when the sled is in the proximal unfired position.
[0245] Example 8. A surgical instrument as described in Examples 1-7, wherein the controller comprises a set of data stored in a memory device, the controller is configured to compare data from the first signal and the second signal with the set of data, and the controller is configured to disable the staple firing system if the data from one of the first signal and the second signal does not match the set of data.
[0246] Example 9. The surgical instrument described in Examples 1-8, wherein the staple cartridge further comprises a removable cover releasably attached to the cartridge body, the removable cover having a third RFID tag attached thereto, the third RFID tag configured to emit a third signal, and the surgical instrument further comprises a third RFID reader configured to receive the third signal when the removable cover is attached to the cartridge body, the third RFID reader being unable to receive the third signal when the removable cover is removed from the cartridge body.
[0247] Example 10. The surgical instrument of any one of examples 1-9, wherein the first RFID tag comprises an active RFID tag and the second RFID tag comprises an active RFID tag.
[0248] Example 11. The surgical instrument of any one of Examples 1-9, wherein the first RFID tag comprises a passive RFID tag and the second RFID tag comprises a passive RFID tag.
[0249] Example 12. A surgical instrument includes a staple firing system, an end effector, a first RFID reader, a second RFID reader, and a controller. The end effector includes an anvil, a staple cartridge support, and a staple cartridge positioned within the staple cartridge support. The staple cartridge includes a cartridge body with a longitudinal slot, a staple cavity defined within the cartridge body, and a staple removably stored within the staple cavity. The staple cartridge also includes a sled movable between a proximal unfired position and a distal fired position by the staple firing system, a first RFID tag attached to the cartridge body, and a second RFID tag attached to the sled. The first RFID reader is configured to receive a first signal from the first RFID tag. The second RFID reader is configured to receive a second signal from the second RFID tag. A controller is in communication with the first RFID reader, the second RFID reader, and the staple firing system, where the controller verifies the presence of a staple cartridge in the staple cartridge channel ...
Claims
1. 1. A surgical system comprising:
1. A surgical instrument comprising an end effector, the end effector comprising: The first Joe, a surgical instrument comprising: a replaceable staple cartridge configured to be seated within the first jaw, A proximal end portion; A distal end portion. a cartridge body having a cartridge deck; an elongated slot extending from the proximal end toward the distal end; A staple removably stored in the cartridge body; a sled configured to translate along the elongated slot during a staple firing stroke to drive the staples out of the cartridge body; an RFID tag with stored information; an RFID scanner configured to transmit a first signal to the RFID tag and configured to receive a second signal from the RFID tag in response to the first signal; a controller that prevents at least one operation of the surgical instrument when the RFID scanner does not receive the second signal from the RFID tag in response to the first signal; a retainer releasably attached to the replaceable staple cartridge, the retainer extending along the cartridge deck; the RFID tag is positioned on the retainer; A surgical system, wherein the RFID tag is physically destroyed and rendered inoperable when the retainer is removed from the replaceable staple cartridge.
2. The surgical system of claim 1 , wherein the at least one motion of the surgical instrument includes the staple firing stroke.
3. 1. A surgical system comprising:
1. A surgical instrument comprising an end effector, the end effector comprising: The first Joe, a surgical instrument comprising: a replaceable staple cartridge configured to be seated within the first jaw, A proximal end portion; A distal end portion. a cartridge body having a cartridge deck; an elongated slot extending from the proximal end toward the distal end; A staple removably stored in the cartridge body; a sled configured to translate along the elongated slot during a staple firing stroke to drive the staples out of the cartridge body; An RFID tag; an RFID scanner configured to transmit a first signal to the RFID tag and configured to receive a second signal from the RFID tag in response to the first signal; a controller that prevents at least one operation of the surgical instrument when the controller determines that the second signal comprises information corresponding to a non-compatible replaceable staple cartridge; The RFID tag comprises: a first antenna having a first communication range, the RFID scanner being positioned outside the first communication range; The replaceable staple cartridge comprises: a second antenna having a second communication range, the second antenna communicating with the RFID tag, the RFID scanner being positioned within the second communication range; wherein a portion of the second antenna traverses a proximal portion of the elongated slot, and the thread destroys the portion of the second antenna as it translates distally through the elongated slot, and the RFID tag is unable to communicate with the RFID scanner after the portion of the second antenna is destroyed.
4. The surgical system of claim 3 , wherein the at least one motion of the surgical instrument includes the staple firing stroke.
Citation Information
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