Surgical instrument system including RFID system
By using RFID technology and multiple RFID tags in surgical instruments to identify and verify the staple cartridge, the problem of difficulty in staple cartridge compatibility and status recognition in the prior art is solved, and the safety and accuracy of the surgery are improved.
Patent Information
- Application Number
- CN202080047316.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-06-30
- Filing Date
- 2020-06-18
- Publication Date
- 2025-01-17
- Estimated Expiration
- 2040-06-18
AI Technical Summary
It is difficult to effectively identify and verify the compatibility and status of the nail cartridge during use, resulting in the possibility of inappropriate suture or cutting operations, affecting the accuracy and safety of the surgery.
Using RFID technology and multiple RFID tags, the type and status of the staple cartridge is identified and verified through the RFID system, ensuring compatibility between the staple cartridge and surgical instruments, and locking or unlocking operations when necessary to avoid inappropriate use.
Improve the accuracy of identification and verification of staple cartridges in surgical procedures, ensure the safety and accuracy of the surgical process, and reduce errors caused by incompatibility of staple cartridges.
Smart Images

Figure CN114096204B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This patent application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application No. 62 / 868,457, filed on June 28, 2019, entitled “SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS,” the entire disclosure of which is hereby incorporated by reference into this document. Background Art
[0003] The present invention relates to surgical instruments and, in various embodiments, to surgical cutting and stapling instruments and staple cartridges thereof designed for cutting and stapling tissue. In various embodiments, RFID technology can be used to identify components of surgical instruments, such as, for example, staple cartridges. Examples of surgical systems using RFID technology can be found in U.S. Patent No. 7,959,050, entitled "ELECTRICALLY SELF-POWERED SURGICAL INSTRUMENT WITH MANUAL RELEASE," published on June 14, 2011, and U.S. Patent Application No. 2015 / 0053743, entitled "ERROR DETECTION ARRANGEMENTS FOR SURGICAL INSTRUMENT ASSEMBLIES," published on February 26, 2015, both of which are incorporated herein by reference in their entirety. BRIEF DESCRIPTION OF THE DRAWINGS
[0004] The features and advantages of the present invention and the manner in which they are achieved will become more apparent, and the invention itself may be better understood, by referring to the following description of embodiments of the present invention in conjunction with the accompanying drawings, in which:
[0005] Figure 1 is a perspective view of a surgical instrument including a handle, a shaft, and an articulatable end effector;
[0006] Figure 2 for Figure 1 A front view of a surgical instrument;
[0007] Figure 3 yes Figure 1 A plan view of surgical instruments;
[0008] Figure 4 yes Figure 1 A cross-sectional view of an end effector and a shaft of a surgical instrument;
[0009] Figure 5 Rotatable connection Figure 1A detailed view of the articulation joint of the shaft and end effector showing the end effector in a neutral or centered position;
[0010] Figure 6 yes Figure 1 A cross-sectional view of an articulation control of a surgical instrument in a neutral or centered position;
[0011] Figure 7 yes Figure 1 An exploded view of an end effector, an elongated shaft, and an articulation joint of a surgical instrument;
[0012] Figure 8 yes Figure 1 A cross-sectional view of an end effector, an elongated shaft, and an articulation joint of a surgical instrument;
[0013] Fig. 9 yes Figure 1 A perspective view of an end effector, an elongated shaft, and an articulation joint of a surgical instrument;
[0014] Fig.10 Shows Figure 1 The end effector of the surgical instrument articulates about the articulation joint;
[0015] Fig.11 is to perform joint movements to move Fig.12 The end effector is shown Figure 6 A cross-sectional view of a joint motion control;
[0016] Fig.12 is a perspective view of a surgical instrument including a handle, a shaft, and an articulatable end effector;
[0017] Fig.13 yes Fig.12 A side view of a surgical instrument;
[0018] Fig.14 is located in Fig.12 A perspective view of a firing member and a pinion gear within the handle;
[0019] Fig.15 yes Fig.14 A perspective view of a firing member and a pinion and a gear reducer assembly operably engaged with the pinion;
[0020] Fig.16 yes Fig.12 A perspective view of the handle with portions removed to show Fig.14 The firing member and pinion, Fig.15 a gear reducer assembly, and an electric motor configured to drive the firing member distally and / or proximally depending on the direction of rotation of the electric motor;
[0021] Fig.17 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 shown removed for purposes of illustration;
[0022] Fig.18 yes Fig.17 A cross-sectional view of a surgical instrument;
[0023] Fig.19 yes Fig.17 Exploded views of surgical instruments;
[0024] Fig. 20 yes Fig.17 A cross-sectional detail view of a surgical instrument showing an end effector in an open configuration, an articulation joint in an unlocked configuration, and an articulation lock actuator of a handle of the surgical instrument shown in an unlocked configuration;
[0025] Fig.21 yes Fig.17 A cross-sectional detail view of a surgical instrument showing an end effector in an articulated open configuration, an articulated joint in an unlocked configuration, and Fig.17 an articulation driver engaged with a firing member of the surgical instrument, wherein movement of the firing member can actuate the articulation driver and cause the end effector to articulate;
[0026] Fig. 22 yes Fig.17 a cross-sectional detail view of a surgical instrument showing an end effector in a closed configuration, an articulation joint in an unlocked configuration, and an end effector closure drive actuated to close the end effector and move the articulation lock actuator to a locked configuration;
[0027] Fig.22A is shown as being in reference Fig. 22 Describing the configuration Fig.17 A cross-sectional detail of a handle of a surgical instrument;
[0028] Fig.23 yes Fig.17 A cross-sectional detail view of a surgical instrument showing an end effector in a closed configuration and an articulation joint in a locked configuration, wherein an actuated closure drive prevents the articulation lock actuator from moving to Figure 20 to Figure 22 Unlocked configuration shown;
[0029] Fig.24A is shown in a locked configuration Fig.17 A plan view of an articulation joint of a surgical instrument;
[0030] Fig. 24B is shown in the unlocked configuration Fig.17 A plan view of an articulation joint of a surgical instrument;
[0031] Fig.25 yes Fig.17 A cross-sectional detail view of a handle of a surgical instrument showing an articulation drive disconnected from a closure drive and a firing member;
[0032] Fig.26 yes Fig.17 A cross-sectional detail view of a surgical instrument of showing a firing member in at least a partially fired position and an articulation drive disconnected from the firing member by a closure drive;
[0033] Fig. 27 yes Fig.17 A cross-sectional detail view of a surgical instrument showing an end effector in a closed configuration, an articulation joint and an articulation joint actuator in a locked configuration, and a firing member in a retracted position;
[0034] Fig.28 yes Fig.17 A cross-sectional detail view of a surgical instrument showing an end effector in an open configuration, an end effector closure drive in a retracted position, and an articulation joint in a locked configuration;
[0035] Fig.29 yes Fig.17 A cross-sectional detail view of a surgical instrument showing an end effector in an open configuration, and an articulation joint and an articulation joint actuator in an unlocked configuration, wherein the articulation drive can be reconnected to the firing drive and used to articulate the end effector;
[0036] Fig.30 is an exploded view of a shaft and end effector of a surgical instrument including an alternative articulation lock arrangement;
[0037] Fig.31 yes Fig.30 A cross-sectional front view of an end effector and a shaft of a surgical instrument showing the end effector in an unlocked configuration;
[0038] Fig.32 yes Fig.30 A cross-sectional front view of an end effector and a shaft of a surgical instrument of , showing the end effector in a locked configuration;
[0039] Fig.33 is an assembled view of one form of a surgical system including a surgical instrument and a plurality of interchangeable shaft assemblies;
[0040] Fig.34is a perspective view of a surgical instrument handle coupled to an interchangeable shaft assembly;
[0041] Fig.35 yes Fig.34 An exploded perspective view of a surgical instrument handle;
[0042] Fig.36 yes Fig.35 A side elevation view of the handle with a portion of the handle housing removed;
[0043] Fig.37 is an exploded perspective view of the interchangeable shaft assembly;
[0044] Fig.38 yes Fig.34 a side elevational assembly view of a handle and a portion of an interchangeable shaft assembly showing the alignment of these components prior to coupling together and with portions thereof omitted for clarity;
[0045] Fig.39 is a perspective view of a portion of an interchangeable shaft assembly prior to attachment to a handle of a surgical instrument;
[0046] Fig.40 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 attachment module of the handle;
[0047] Fig.41 yes Fig.40 Another side view of the interchangeable shaft assembly and handle of the embodiment of the present invention, wherein the locking yoke is in a disengaged or unlocked position;
[0048] Fig.42 is a top view of a portion of an interchangeable shaft assembly and handle prior to being coupled together;
[0049] Fig.43 are connected together Fig.42 Another top view of the interchangeable shaft assembly and handle;
[0050] Fig.44 is a side elevation view of an interchangeable shaft assembly aligned with a surgical instrument handle prior to being coupled together;
[0051] Fig.45 yes Fig.44 A front perspective view of an interchangeable shaft assembly and surgical instrument with portions thereof omitted for clarity;
[0052] Fig.46 is a side view of a portion of an interchangeable shaft assembly aligned with a portion of a surgical instrument handle prior to being coupled together, with portions thereof omitted for clarity;
[0053] Fig.47 yes Fig.46 another side elevation view of the interchangeable shaft assembly and handle, wherein the shaft assembly is partially coupled to the handle;
[0054] Fig.48 yes Fig.46 and Fig.47 Another side elevation view of the interchangeable shaft assembly and handle after being coupled together;
[0055] Fig.49 is another side elevation view of a portion of the interchangeable shaft assembly aligned with a portion of the handle prior to commencing a coupling process;
[0056] Fig.50 One embodiment of a logic diagram of a method of compensating for the spreading effect over the cross-sectional length in a flexible knife band is shown;
[0057] Fig.51 is a schematic diagram of a system for de-energizing an electrical connector of a surgical instrument handle when a shaft assembly is not coupled to the electrical connector;
[0058] Fig.52 is a schematic diagram of a system for controlling the speed of a motor and / or the speed of a drivable member of a surgical instrument disclosed herein;
[0059] Fig.53 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;
[0060] Fig.54 is a schematic diagram illustrating a control system for controlling various operations of various surgical instruments described herein according to various embodiments of the present disclosure;
[0061] Fig.54A yes Fig.54 A partial view of a schematic diagram of;
[0062] Fig.54B yes Fig.54 A partial view of a schematic diagram of;
[0063] Fig.55 is a schematic diagram showing a switching circuit for controlling a system according to various embodiments of the present disclosure;
[0064] Fig.56 is a schematic diagram showing a switching circuit for controlling a system according to various embodiments of the present disclosure;
[0065] Fig.57 is a schematic diagram illustrating a control system for controlling various operations of various surgical instruments described herein according to various embodiments of the present disclosure;
[0066] Fig.57A yes Fig.57 A partial view of a schematic diagram of;
[0067] Fig.57B yes Fig.57 A partial view of a schematic diagram of;
[0068] Fig.58 is a schematic diagram illustrating a control system for controlling various operations of various surgical instruments described herein according to various embodiments of the present disclosure;
[0069] Fig.59 is a diagram showing various embodiments according to the present disclosure Fig.58 Schematic diagram of various sub-operations of the cross-cutting operation;
[0070] Fig.60 is a diagram showing various embodiments according to the present disclosure Fig.59 Schematic diagram of various sub-operations of the firing operation near a hard obstacle;
[0071] Fig.61 is a front view of a surgical instrument including a handle, a shaft, and an articulatable end effector according to at least one embodiment;
[0072] Fig.62 is a top view of a staple cartridge according to at least one embodiment;
[0073] Fig.63 According to at least one embodiment, a staple cartridge such as Fig.62 The structure of the serial number generated by the nail bin;
[0074] Fig.64 yes Fig.62 A front view of a nail magazine;
[0075] Fig.65 yes Fig.62 The plan view of the nail warehouse;
[0076] Fig.66 is constructed to receive Fig.62 A sectional plan view of the jaws of the nail magazine;
[0077] Fig.67 is a perspective view of an RFID tag according to at least one embodiment;
[0078] Fig.68 yes Fig.62 A partial cross-sectional view of a cartridge body of a staple cartridge;
[0079] Fig.69 yes Fig.62 A cross-sectional view of a sliding member of a nail magazine;
[0080] Fig.70 yes Fig.62 A perspective view of a removable cover of a staple cartridge;
[0081] Fig.71 is a cross-sectional view of a slide according to at least one embodiment;
[0082] Fig.72 According to at least one embodiment, Fig.70 A front view of the end effector of the slide;
[0083] Fig.72A yes Fig.72 A front view of the end effector showing Fig.70 The slider is advanced distally during the nail firing stroke;
[0084] Fig.72B yes Fig.72 A front view of the end effector showing the end of the nail firing stroke Fig.70 Sliding parts;
[0085] Fig.73A is embedded in Fig.70 A detailed view of an RFID tag in a slide;
[0086] Fig.73B is a detail of the RFID tag cut at the end of the nail firing stroke;
[0087] Fig.74 Two nail magazines are shown;
[0088] Fig.75 An end effector is shown, wherein Fig.74 One of the staple cartridges is compatible with the end effector and the other staple cartridge is incompatible with the end effector;
[0089] Fig.76 An algorithm for controlling a system according to at least one embodiment is shown;
[0090] Fig.77 A flexible circuit including an RFID scanner according to at least one embodiment is shown;
[0091] Fig.78 is a perspective view of a surgical staple cartridge package, wherein the package includes identification features of a surgical staple cartridge contained therein;
[0092] Fig.79 When Fig.78 A partial cross-sectional view of an RFID system integrated with the package when the package is in a sealed configuration;
[0093] Fig.80 When the package is in the unsealed configuration Fig.79A partial cross-sectional view of an RFID system;
[0094] Fig.81 is a perspective view of a retainer for use with a surgical staple cartridge, wherein the retainer includes an integrated RFID tag;
[0095] Fig.82 Removed from surgical staple cartridge Fig.81 A perspective view of a retainer;
[0096] Fig.83 When the retainer is removed from the surgical staple cartridge Fig.81 and Fig.82 Detailed diagram of the RFID tag;
[0097] Fig.84 is a partial perspective view of a surgical staple cartridge including an RFID system including an elongated antenna, wherein a portion of the elongated antenna traverses a cutting path of a tissue cutting member;
[0098] Fig.85 is an RFID system comprising an RFID tag, a first RFID scanner integrated into a first flexible circuit layer, and a second RFID scanner integrated into a second flexible circuit layer;
[0099] Fig.86 Before the nail firing stroke Fig.85 Representation of the communication path of the RFID system;
[0100] Fig.87 During and after the nail firing stroke Fig.85 Representation of the communication path of the RFID system;
[0101] Fig.88 is a partial perspective view of a nail firing lockout system in an unlocked configuration;
[0102] Fig.88A It is in unlocked configuration Fig.88 A perspective view of a stop bolt assembly of a nail firing locking system;
[0103] Fig.89 is in locked configuration Fig.88 A partial perspective view of a nail firing locking system;
[0104] Fig.89A is in locked configuration Fig.88A A perspective view of a blocking bolt assembly;
[0105] Fig.90 Yes Figures 88 to 89A A motor control circuit diagram of a surgical instrument having a cartridge locking assembly;
[0106] Fig.91 is a schematic diagram of a manufacturing process configured to facilitate assembly and packaging of a staple cartridge using an encryption protocol; and
[0107] Fig.92 is a flow chart representing a decryption protocol for authentication of a staple cartridge for use with a surgical system.
[0108] Corresponding reference characters indicate corresponding parts throughout the several views.The exemplification described herein illustrates certain embodiments of the invention, in one form, and such exemplification should not be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION
[0109] The applicant of the present application owns the following U.S. patent applications filed on the same date as the present application and each of which is incorporated herein by reference in its entirety:
[0110] - Attorney Docket No. END9145USNP1 / 190235-1M entitled “METHOD FOR AUTHENTICATING THE COMPATIBILITY OF A STAPLECARTRIDGE WITH A SURGICAL INSTRUMENT”;
[0111] - Attorney Docket No. END9147USNP1 / 190237, entitled “SURGICAL INSTRUMENT COMPRISING AN RFID SYSTEM FOR TRACKING AMOVABLE COMPONENT”;
[0112] - Attorney Docket No. END9148USNP1 / 190238, entitled “SURGICAL INSTRUMENT COMPRISING AN ALIGNED RFID SENSOR”;
[0113] - Attorney Docket No. END9123USNP1 / 190239 entitled “SURGICAL STAPLING SYSTEM HAVING AN INFORMATION DECRYPTIONPROTOCOL”;
[0114] - Attorney Docket No. END9124USNP1 / 190240 entitled “SURGICAL STAPLING SYSTEM HAVING AN INFORMATION ENCRYPTIONPROTOCOL”;
[0115] -Agent docket number is END9125USNP1 / 190241, titled "SURGICAL STAPLING SYSTEMHAVING A LOCKOUT MECHANISM FOR AN INCOMPATIBLE CARTRIDGE";
[0116] - Attorney Docket No. END9126USNP1 / 190242 entitled “SURGICAL STAPLING SYSTEM HAVING A FRANGIBLE RFID TAG”; and
[0117] - Attorney Docket No. END9127USNP1 / 190243 entitled “PACKAGING FOR A REPLACEABLE COMPONENT OF A SURGICAL STAPLING SYSTEM”.
[0118] The applicant of the present application owns the following U.S. patent applications filed on the same date as the present application and each of which is incorporated herein by reference in its entirety:
[0119] - Attorney Docket No. END9119USNP1 / 190245-1M entitled “METHOD OF USING MULTIPLE RFID CHIPS WITH A SURGICAL ASSEMBLY”;
[0120] - Attorney Docket No. END9120USNP1 / 190246 titled “MECHANISMS FOR PROPER ANVIL ATTACHMENT SURGICAL STAPLING HEADASSEMBLY”;
[0121] - Attorney Docket No. END9121USNP1 / 190247 entitled “MECHANISMS FOR MOTOR CONTROL ADJUSTMENTS OF A MOTORIZED SURGICAL INSTRUMENT”;
[0122] - Attorney Docket No. END9122USNP1 / 190248 titled “SURGICAL INSTRUMENT WITH BATTERY COMPATIBILITY VERIFICATIONFUNCTIONALITY”;
[0123] - Attorney Docket No. END9131USNP1 / 190249 entitled “SURGICAL SYSTEM WITH RFID TAGS FOR UPDATING MOTOR ASSEMBLY PARAMETERS”;
[0124] - Attorney Docket No. END9132USNP1 / 190250 entitled “SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS”;
[0125] - Attorney Docket No. END9149USNP1 / 190251 entitled “RFID IDENTIFICATION SYSTEMS FOR SURGICAL INSTRUMENTS”;
[0126] - Attorney Docket No. END9150USNP1 / 190252 entitled “RFID IDENTIFICATION SYSTEMS FOR SURGICAL INSTRUMENTS”;
[0127] - Attorney Docket No. END9151USNP1 / 190253, entitled “SURGICAL RFID ASSEMBLIES FOR DISPLAY AND COMMUNICATION”;
[0128] - Attorney Docket No. END9152USNP1 / 190254, entitled “SURGICAL RFID ASSEMBLIES FOR COMPATIBILITY DETECTION”; and
[0129] - Attorney Docket No. END9153USNP1 / 190255 entitled “SURGICAL RFID ASSEMBLIES FOR INSTRUMENT OPERATIONAL SETTING CONTROL”.
[0130] The applicant of this application owns the following U.S. patent applications filed on May 1, 2018, each of which is incorporated herein by reference in its entirety:
[0131] - U.S. Provisional Patent Application Serial No. 62 / 665,129, entitled “SURGICAL SUTURING SYSTEMS”;
[0132] - U.S. Provisional Patent Application Serial No. 62 / 665,139, entitled “SURGICAL INSTRUMENTS COMPRISING CONTROL SYSTEMS”;
[0133] - U.S. Provisional Patent Application Serial No. 62 / 665,177, entitled “SURGICAL INSTRUMENTS COMPRISING HANDLE ARRANGEMENTS”;
[0134] - U.S. Provisional Patent Application Serial No. 62 / 665,128, entitled “MODULAR SURGICAL INSTRUMENTS”;
[0135] - U.S. Provisional Patent Application Serial No. 62 / 665,192, entitled “SURGICAL DISSECTORS”; and
[0136] - U.S. Provisional Patent Application Serial No. 62 / 665,134, entitled “SURGICAL CLIP APPLIER.”
[0137] The applicant of the present application owns the following U.S. patent applications filed on August 24, 2018, each of which is incorporated herein by reference in its entirety:
[0138] - U.S. Patent Application Serial No. 16 / 112,129, entitled “SURGICAL SUTURING INSTRUMENT CONFIGURED TO MANIPULATE TISSUEUSING MECHANICAL AND ELECTRICAL POWER”;
[0139] - U.S. Patent Application Serial No. 16 / 112,155, entitled "SURGICAL SUTURING INSTRUMENT COMPRISING A CAPTURE WIDTH WHICHIS LARGER THAN TROCAR DIAMETER";
[0140] - U.S. Patent Application Serial No. 16 / 112,168, entitled “SURGICAL SUTURING INSTRUMENT COMPRISING A NON-CIRCULARNEEDLE”;
[0141] - U.S. Patent Application Serial No. 16 / 112,180, entitled “ELECTRICAL POWER OUTPUT CONTROL BASED ON MECHANICAL FORCES”;
[0142] - U.S. Patent Application Serial No. 16 / 112,193, entitled “REACTIVE ALGORITHM FOR SURGICAL SYSTEM”;
[0143] - U.S. Patent Application Serial No. 16 / 112,099, entitled “SURGICAL INSTRUMENT COMPRISING AN ADAPTIVE ELECTRICAL SYSTEM”;
[0144] - U.S. Patent Application Serial No. 16 / 112,112, entitled “CONTROL SYSTEM ARRANGEMENTS FOR A MODULAR SURGICALINSTRUMENT”;
[0145] - U.S. Patent Application Serial No. 16 / 112,119, entitled “ADAPTIVE CONTROL PROGRAMS FOR A SURGICAL SYSTEM COMPRISING MORE THAN ONE TYPE OF CARTRIDGE”;
[0146] - U.S. Patent Application Serial No. 16 / 112,097, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING BATTERY ARRANGEMENTS”;
[0147] - U.S. Patent Application Serial No. 16 / 112,109, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING HANDLE ARRANGEMENTS”;
[0148] - U.S. Patent Application Serial No. 16 / 112,114, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING FEEDBACK MECHANISMS”;
[0149] - U.S. Patent Application Serial No. 16 / 112,117, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING LOCKOUT MECHANISMS”;
[0150] - U.S. Patent Application Serial No. 16 / 112,095, entitled “SURGICAL INSTRUMENTS COMPRISING A LOCKABLE END EFFECTORSOCKET”;
[0151] - U.S. Patent Application Serial No. 16 / 112,121, entitled “SURGICAL INSTRUMENTS COMPRISING A SHIFTING MECHANISM”;
[0152] - U.S. Patent Application Serial No. 16 / 112,151, entitled “SURGICAL INSTRUMENTS COMPRISING A SYSTEM FOR ARTICULATION ANDROTATION COMPENSATION”;
[0153] - U.S. Patent Application Serial No. 16 / 112,154, entitled “SURGICAL INSTRUMENTS COMPRISING A BIASED SHIFTING MECHANISM”;
[0154] - U.S. Patent Application Serial No. 16 / 112,226, entitled “SURGICAL INSTRUMENTS COMPRISING AN ARTICULATION DRIVE THAT PROVIDES FOR HIGH ARTICULATION ANGLES”;
[0155] - U.S. Patent Application Serial No. 16 / 112,062, entitled “SURGICAL DISSECTORS AND MANUFACTURING TECHNIQUES”;
[0156] - U.S. Patent Application Serial No. 16 / 112,098, entitled “SURGICAL DISSECTORS CONFIGURED TO APPLY MECHANICAL AND ELECTRICAL ENERGY”;
[0157] - U.S. Patent Application Serial No. 16 / 112,237, entitled “SURGICAL CLIP APPLIER CONFIGURED TO STORE CLIPS IN A STOREDSTATE”;
[0158] - U.S. Patent Application Serial No. 16 / 112,245, entitled “SURGICAL CLIP APPLIER COMPRISING AN EMPTY CLIP CARTRIDGE LOCKOUT”;
[0159] - U.S. Patent Application Serial No. 16 / 112,249, entitled “SURGICAL CLIP APPLIER COMPRISING AN AUTOMATIC CLIP FEEDING SYSTEM”;
[0160] - U.S. Patent Application Serial No. 16 / 112,253, entitled “SURGICAL CLIP APPLIER COMPRISING ADAPTIVE FIRING CONTROL”; and
[0161] - U.S. Patent Application Serial No. 16 / 112,257, entitled "SURGICAL CLIP APPLIER COMPRISING ADAPTIVE CONTROL IN RESPONSETO A STRAIN GAUGE CIRCUIT."
[0162] The applicant of the present application owns the following U.S. patent applications filed on October 26, 2018, each of which is incorporated herein by reference in its entirety:
[0163] - U.S. Patent Application Serial No. 16 / 172,130, entitled “CLIP APPLIER COMPRISING INTERCHANGEABLE CLIP RELOADS”;
[0164] - U.S. Patent Application Serial No. 16 / 172,066, entitled “CLIP APPLIER COMPRISING A MOVABLE CLIP MAGAZINE”;
[0165] - U.S. Patent Application Serial No. 16 / 172,078, entitled “CLIP APPLIER COMPRISING A ROTATABLE CLIP MAGAZINE”;
[0166] - U.S. Patent Application Serial No. 16 / 172,087, entitled “CLIP APPLIER COMPRISING CLIP ADVANCING SYSTEMS”;
[0167] - U.S. Patent Application Serial No. 16 / 172,094, entitled “CLIP APPLIER COMPRISING A CLIP CRIMPING SYSTEM”;
[0168] - U.S. Patent Application Serial No. 16 / 172,128, entitled “CLIP APPLIER COMPRISING A RECIPROCATING CLIP ADVANCING MEMBER”;
[0169] - U.S. Patent Application Serial No. 16 / 172,168, entitled “CLIP APPLIER COMPRISING A MOTOR CONTROLLER”;
[0170] - U.S. Patent Application Serial No. 16 / 172,164, entitled “SURGICAL SYSTEM COMPRISING A SURGICAL TOOL AND A SURGICALHUB”; and
[0171] - U.S. Patent Application Serial No. 16 / 172,303 entitled "METHOD FOR OPERATING A POWERED ARTICULATING MULTI-CLIP APPLIER."
[0172] The applicant of this patent application owns the following U.S. patent applications filed on December 4, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:
[0173] - U.S. Patent Application Serial No. 16 / 209,385, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY”;
[0174] - U.S. Patent Application Serial No. 16 / 209,395, entitled “METHOD OF HUB COMMUNICATION”;
[0175] - U.S. Patent Application Serial No. 16 / 209,403, entitled “METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB”;
[0176] - U.S. Patent Application Serial No. 16 / 209,407, entitled “METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL”;
[0177] - U.S. Patent Application Serial No. 16 / 209,416, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS”;
[0178] - U.S. Patent Application Serial No. 16 / 209,423, entitled “METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS”;
[0179] - U.S. Patent Application Serial No. 16 / 209,427, entitled “METHOD OF USING REINFORCED FLEXIBLE CIRCUITS WITH MULTIPLESENSORS TO OPTIMIZE PERFORMANCE OF RADIO FREQUENCY DEVICES”;
[0180] - U.S. Patent Application Serial No. 16 / 209,433, entitled “METHOD OF SENSING PARTICULATE FROM SMOKE EVACUATED FROM APATIENT, ADJUSTING THE PUMP SPEED BASED ON THE SENSED INFORMATION, AND COMMUNICATING THE FUNCTIONAL PARAMETERS OF THE SYSTEM TO THE HUB”;
[0181] - U.S. Patent Application Serial No. 16 / 209,447, entitled “METHOD FOR SMOKE EVACUATION FOR SURGICAL HUB”;
[0182] - U.S. Patent Application Serial No. 16 / 209,453, entitled “METHOD FOR CONTROLLING SMART ENERGY DEVICES”;
[0183] - U.S. Patent Application Serial No. 16 / 209,458, entitled “METHOD FOR SMART ENERGY DEVICE INFRASTRUCTURE”;
[0184] - U.S. Patent Application Serial No. 16 / 209,465, entitled “METHOD FOR ADAPTIVE CONTROL SCHEMES FOR SURGICAL NETWORKCONTROL AND INTERACTION”;
[0185] - U.S. Patent Application Serial No. 16 / 209,478, entitled “METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON ASENSED SITUATION OR USAGE”;
[0186] - U.S. Patent Application Serial No. 16 / 209,490, entitled “METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION”; and
[0187] - U.S. Patent Application Serial No. 16 / 209,491 entitled "METHOD FOR CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON SITUATIONAL AWARENESS."
[0188] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of the structure, function, manufacture and use of the apparatus and methods disclosed herein. One or more examples of these embodiments are shown in the accompanying drawings. It will be appreciated by those of ordinary skill in the art that the apparatus and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the various embodiments of the present invention is limited only by the claims. The features shown or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
[0189] References throughout this specification to "various embodiments", "some embodiments", "one embodiment" or "an embodiment" etc. mean that a specific feature, structure or characteristic described in conjunction with an embodiment is included in at least one embodiment. Therefore, phrases "in various embodiments", "in some embodiments", "in one embodiment" or "in an embodiment" etc. appearing throughout this specification do not necessarily all refer to the same embodiment. In addition, in one or more embodiments, specific features, structures, or characteristics may be combined in any suitable manner. Therefore, without limitation, specific features, structures, or characteristics shown or described in conjunction with one embodiment may be combined in whole or in part with features, structures, or characteristics of one or more other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
[0190] The terms "proximal" and "distal" are used herein relative to a clinician manipulating the 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 positioned away from the clinician. It should also be understood that for brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in conjunction with the accompanying drawings. However, surgical instruments are used in many orientations and positions, and these terms are not restrictive and / or absolute.
[0191] Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, one of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein can be used in many surgical procedures and applications, including, for example, in combination with open surgical procedures. Continuing to refer to this detailed description, one of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into the body in any manner, such as through a natural cavity, through an incision or puncture formed in tissue, etc. The working portion or end effector portion of the instrument can be inserted directly into the patient's body or can be inserted through an access device having a working channel, and the end effector and elongated shaft of the surgical instrument can be advanced through the working channel.
[0192] The surgical stapling system may include an axis and an end effector extending from the axis. The end effector includes a first jaw and a second jaw. The first jaw includes a staple cartridge. The staple cartridge can be inserted into the first jaw and can be removed from the first jaw; however, other embodiments are envisioned in which the staple cartridge cannot be removed from the first jaw or can at least be easily replaced from the first jaw. The second jaw includes an anvil configured to deform the staples ejected from the staple cartridge. The second jaw can pivot relative to the first jaw about a closed axis; however, other embodiments are envisioned in which the first jaw can pivot relative to the second jaw. The surgical stapling system also includes an articulated joint configured to allow the end effector to rotate or articulate relative to the axis. The end effector can rotate around an articulated axis extending through the articulated joint. Other embodiments are envisioned that do not include an articulated joint.
[0193] The staple cartridge comprises a cartridge body. The cartridge body comprises a proximal end, a distal end and a platform extending between the proximal end and the distal end. In use, the staple cartridge is positioned on a first side of a tissue to be sutured, and the anvil is positioned on a second side of the tissue. The anvil moves toward the staple cartridge to compress the tissue and clamp it against the platform. The staples removably stored in the cartridge body can then be deployed into the tissue. The cartridge body comprises a staple cavity defined in the cartridge body, wherein the staples are removably stored in the staple cavity. 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 are also possible.
[0194] The nail is supported by a nail driver in the magazine body. The driver can move between a first or non-firing position and a second or firing position to eject the nail from the nail magazine. The driver is retained in the magazine body by a retainer, which extends around the bottom of the magazine body and includes a resilient member configured to grip the magazine body and retain the retainer to the magazine body. The driver can move between its non-firing position and its firing position by a slide. The slide can move between a proximal position adjacent to the proximal end and a distal position adjacent to the distal end. The slide includes a plurality of ramp surfaces that are configured to slide under the driver toward the anvil and lift the driver, and the nail is supported on the driver.
[0195] In addition to the above, the slider can also move distally through the firing member. The firing member is configured to contact the slider and push the slider toward the distal end. The longitudinal slot defined in the magazine body is configured to receive the firing member. The anvil also includes a slot configured to receive the firing member. The firing member also includes a first cam engaging the first jaw and a second cam engaging the second jaw. As the firing member advances distally, the first cam and the second cam can control the distance or tissue gap between the platform of the nail magazine and the anvil. The firing member also includes a knife configured to cut into the tissue captured between the nail magazine and the anvil. It is desired that the knife is positioned at least partially close to the ramp surface so that the nail is ejected before the knife.
[0196] Figures 1 to 3 An exemplary surgical instrument 100 is shown, which includes a handle 103, a shaft 104, and an articulated end effector 102 pivotally connected to the shaft 104 at an articulated joint 110. An articulation control 112 is provided to enable rotation of the end effector 102 about the articulated joint 110. The end effector 102 includes an endoscopic cutter for clamping, cutting, and stapling tissue; however, it should be understood that various embodiments may include end effectors configured to be capable of being used 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, etc. The handle 103 of the instrument 100 includes a closing trigger 114 and a firing trigger 116 for actuating the end effector 102. It should be understood that instruments with end effectors related to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating the end effector. The end effector 102 is connected to the handle 103 by the shaft 104. The clinician may articulate the end effector 102 relative to the shaft 104 by utilizing the articulation control 112 , as described in greater detail further below.
[0197] It should be understood that spatial terms such as vertical, horizontal, right, left, etc. are given herein with reference to the accompanying drawings assuming that the longitudinal axis of the surgical instrument 100 is coaxial with the central axis of the shaft 104, and the triggers 114, 116 extend downward at an acute angle from the bottom of the handle 103. However, in actual practice, the surgical instrument 100 can be oriented at various angles, and therefore these spatial terms are used relative to the surgical instrument 100 itself. In addition, proximal is used to represent the perspective of a clinician behind the handle 103, who places the end effector 102 distally or away from him or herself. As used herein, the phrase "substantially transverse to the longitudinal axis" refers to a direction that is almost perpendicular to the longitudinal axis, where the "longitudinal axis" is the axis of the shaft. However, it should be understood that some directions that deviate from perpendicular to the longitudinal axis are also substantially transverse to the longitudinal axis.
[0198] Various embodiments disclosed herein are directed to instruments having articulation joints driven by curved cables or bands. Figure 4 and Figure 5 A cross-sectional top view of an elongated shaft 104 and an end effector 102 is shown, the end effector including a band 205 that is mechanically coupled to a boss 206 extending from the end effector 102. The band 205 may include band portions 202 and 204 extending proximally from the boss 206 along the elongated shaft 104 and passing through the joint motion control 112. The band 205 and the band portions 202, 204 may have a fixed length. The band 205 may be mechanically coupled to the boss 206, such as using any suitable fastening method, including, for example, gluing, welding, etc. In various embodiments, each band portion 202, 204 may be provided as a separate band, wherein each separate band has one end that is mechanically coupled to the boss 206 and another end that extends through the shaft 104 and the joint motion control 112. The separate bands may be mechanically coupled to the boss 206 as described above.
[0199] In addition to the above, the strap portions 202, 204 may extend from the boss 206 through the articulation joint 110 and along the shaft 104 to the articulation control 112, such as Figure 6 As shown. The articulation control 112 may include an articulation slide 208, a frame 212, and a housing 218. The strap portions 202, 204 may pass through the articulation slide 208 through slots 210 or other apertures, but it should be understood that the strap portions 202, 204 may be coupled to the slide 208 in any suitable manner. The articulation slide 208 may be integral, such as Figure 6 As shown, or may include two components, the joint between the two components defining a slot 210. In one non-limiting embodiment, the articulation slide 208 may include a plurality of slots, for example, each slot being configured to receive one of the band portions 202, 204. The housing 218 may cover the various components of the articulation control 112 to prevent debris from entering the articulation control 112.
[0200] See again Figure 6 , the band portions 202, 204 can be anchored to the frame 212 at connection points 214, 216, respectively, located proximal to the slot 210. It should be understood that the band portions 202, 204 can be anchored anywhere in the instrument 10 proximal to the slot 210, including the handle 103. Figure 6 The non-limiting embodiment of shows that the strap portions 202, 204 may include 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 strap portions 202, 204 are straight.
[0201] Figures 7 to 9A view showing the end effector 102 and the elongated shaft 104 of the instrument 100 is shown, including Figure 5 The articulation joint 110 is shown. Figure 7 An exploded view of the end effector 102 and the elongated shaft 104 is shown, including various internal components. In at least one embodiment, the end effector frame 150 and the shaft frame 154 are configured to engage at the articulation joint 110. The boss 206 can be integral with the end effector frame 150, and the band 205 interfaces with the boss 206, as shown. The shaft frame 154 may include a distally directed handle 302 defining a hole 304. The hole 304 can be positioned to interface with an articulation pin (not shown) included in the end effector frame 150, thereby allowing 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 be Fig. 9 and Fig.10 The articulation axis 306 is shown pivoting about the articulation joint 110 .
[0202] Figure 7 Anvil 120 is also shown. In this non-limiting embodiment, anvil 120 is coupled to elongated channel 198. For example, hole 199 can be defined in elongated channel 198, which can receive pin 152 extending from anvil 120 and allow anvil 120 to pivot from an open position to a closed position relative to elongated channel 198 and staple cartridge 118. In addition, Figure 7 A firing rod 172 is shown that is configured to be able to translate longitudinally through the shaft frame 154, through the flexible closure device and the pivot frame articulation joint 110, and through the firing slot 176 in the distal frame 150 into the end effector 102. The firing rod 172 can be composed of a solid part, or in various embodiments, can include a laminate material that includes, for example, a stack of steel plates. It should be understood that the firing rod 172 made of a laminate material can reduce the force required to articulate the end effector 102. In various embodiments, a spring clip 158 can be installed in the end effector frame 150 to bias the firing rod 172 downward. The distal square hole 164 and the proximal square hole 168 formed on the top of the end actuator frame 150 can define a clamp rod 170 therebetween, which receives the upper arm 162 of the spring clamp 158, and the distally extending lower arm 160 of the spring clamp exerts a downward force on the raised portion 174 of the firing rod 172, as described below.
[0203] The distal protruding end of the firing rod 172 can be attached to an E-shaped crossbeam 178, which can (among other things) help to space the anvil 120 from the staple cartridge 118 positioned in the elongated channel 198 when the anvil 120 is in the closed position. The E-shaped crossbeam 178 can also include a sharp cutting edge 182, which can be used to cut tissue when the E-shaped crossbeam 178 is advanced distally by the firing rod 172. In operation, the E-shaped crossbeam 178 can also actuate or fire the staple cartridge 118. The staple cartridge 118 can include a molded cartridge body 194 that holds a plurality of staples 191, which are disposed on staple drivers 192, which are located in staple cavities 195 that open upwardly, respectively. The wedge-shaped slide 190 is driven distally by the E-shaped crossbeam 178, thereby sliding on a cartridge tray 196, which holds the various components of the replaceable staple cartridge 118 together. Wedge sled 190 cams staple drivers 192 upward to extrude staples 191 into deforming contact with anvil 120 while cutting surface 182 of E-beam 178 severs the clamped tissue.
[0204] In addition to the above, the E-shaped beam 178 may include an upper pin 180 that engages the anvil 120 during firing. The E-shaped beam 178 may also include an intermediate pin 184 and a bottom foot 186, which may 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, the slot 193 defined in the cartridge body 194 may be aligned with the slot 197 defined in the cartridge tray 196 and the slot 189 defined in the elongated channel 198. In use, the E-shaped beam 178 may slide through the aligned slots 193, 197, and 189, wherein as shown in FIG. Figure 7 As shown, the bottom base 186 of the E-shaped crossbar 178 can engage the groove extending along the bottom surface of the channel 198 along the length of the slot 189, the middle 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 this case, when the firing rod 172 moves distally to fire staples from the staple cartridge 118 and / or cut into the tissue trapped between the anvil 120 and the staple cartridge 118, the E-shaped crossbar 178 can separate or limit the relative movement between the anvil 120 and the staple cartridge 118. Then, the firing rod 172 and the E-shaped crossbar 178 can be retracted proximally, thereby allowing the anvil 120 to be opened to release the two stapled and cut tissue portions (not shown).
[0205] Figures 7 to 9 Also shown is a dual pivot closure sleeve assembly 121 according to various embodiments. Figure 7, the double pivot closure sleeve assembly 121 includes a shaft closure tube segment 128 having an upper shank 146 and a lower shank 148 protruding distally. The end effector closure tube segment 126 includes a horseshoe-shaped hole 124 and a tab 123 for engaging the opening tab 122 on the anvil 120. When the anvil 120 is opened, the horseshoe-shaped hole 124 and the tab 123 engage the tab 122. The closure tube segment 126 is shown as having an upper shank 144 and a lower shank (not visible) protruding proximally. The upper double pivot connector 130 includes an upwardly protruding distal pivot pin 134 and a proximal pivot pin 136, which respectively engage an upper distal pin hole 138 in the proximally protruding upper shank 144 and an upper proximal pin hole 140 in the distally protruding upper shank 146. The lower dual pivot connection 132 includes a distal pivot pin and a proximal pivot pin ( Figure 7 Not shown but Figure 8 ), these pivot pins respectively engage the lower distal pin hole in the proximally protruding lower shank foot and the lower proximal pin hole 142 in the distally protruding lower shank foot 148.
[0206] In use, the closure tube assembly 121 is translated distally to close the anvil 120, for example in response to actuation of the closure trigger 114. By translating the closure tube segment 126 distally and thus the sleeve assembly 121 distally, it strikes the left side of the insert 122. Fig. 9 A, thereby closing the anvil 120. Figure 8 and Fig. 9 As more clearly shown in FIG. 1 , the anvil 120 is opened by translating the tube segment 126 and the sleeve assembly 121 toward the proximal side, causing the insert 123 and the horseshoe-shaped hole 124 to contact and push the insert 122 to lift the anvil 120. In the anvil open position, the double pivot closure sleeve assembly 121 moves to its proximal position.
[0207] In operation, the 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 laterally. From the neutral position, the clinician can provide a lateral force to the left side of the control 112 to articulate the end effector 102 to the left relative to the shaft 104. In response to the force, the articulation slide 208 can be at least partially pushed into the frame 212. When the slide 208 is pushed into the frame 212, the slot 210 and the band portion 204 can translate across the elongated shaft 104 in a lateral direction (e.g., a direction substantially transverse to or perpendicular to the longitudinal axis of the shaft 104). Thus, a force is applied to the band portion 204, causing it to elastically bend and / or shift from its initial pre-bent position toward the opposite side of the shaft 104. At the same time, the band portion 202 relaxes from its initial pre-bent position. This movement of the strap portion 204, along with the straightening of the strap portion 202, can apply a counterclockwise rotational force at the boss 206, which in turn causes the boss 206 and the end effector 102 to pivot about the articulation pivot 110 to a desired angle relative to the axis of the shaft 104, such as Fig.12 As shown. The relaxation of the strap portion 202 reduces the tension on this strap portion, thereby allowing the strap portion 204 to articulate the end effector 102 without significant interference from the strap portion 202. It should be understood that the clinician can also articulate the end effector 102 to the right relative to the axis 104 by providing a lateral force to the right side of the control 112. This causes the cable portion 202 to bend, thereby causing a clockwise rotational force at the boss 206, which in turn causes the boss 206 and the end effector to pivot to the right about the articulation pivot 110. Similar to the above, the strap portion 204 can be relaxed at the same time to allow such movement.
[0208] Fig.12 and Fig.13 A motor-driven surgical cutting and fastening instrument 310 is shown. The illustrated embodiment shows an endoscopic instrument, and generally speaking, the instrument 310 is described herein as an endoscopic surgical cutting and fastening instrument; however, it should be noted that the present invention is not limited thereto, and according to other embodiments, any instrument disclosed herein may include a non-endoscopic surgical cutting and fastening instrument. Fig.12 and Fig.13The surgical instrument 310 shown in FIG. 3 includes a handle 306, a shaft 308, and an end effector 312 connected to the shaft 308. In various embodiments, the end effector 312 can be articulated relative to the shaft 308 about an articulation joint 314. Various devices for articulating the end effector 312 and / or devices for allowing the end effector 312 to articulate relative to the shaft 308 are disclosed in U.S. Pat. No. 7,753,245, entitled “SURGICAL STAPLING INSTRUMENTS”, issued on July 13, 2010, and U.S. Pat. No. 7,670,334, entitled “SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR”, issued on March 2, 2010, the entire disclosures of which are incorporated herein by reference. Various other devices for articulating the end effector 312 are discussed in more detail below. Similar to the above, the end effector 312 is configured to act as a linear cutter for clamping, severing and / or stapling tissue, but in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices such as graspers, cutters, staplers, clip applicators, access devices, drug / gene therapy devices, ultrasonic, RF and / or laser devices, etc. Several RF devices can be found in U.S. Patent No. 5,403,312, entitled "ELECTROSURGICAL HEMOSTATIC DEVICE", issued on April 4, 1995, and U.S. Patent Application Serial No. 12 / 031,573, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RFELECTRODES", filed on February 14, 2008, the complete disclosures of which are incorporated by reference in their entirety.
[0209] It should be understood that the terms "proximal" and "distal" as used herein are relative to a clinician grasping the handle 306 of the instrument 310. Thus, the end effector 312 is located distally relative to the more proximal handle portion 306. It should also be understood that spatial terms such as "vertical" and "horizontal" are used herein in conjunction with the illustrations for convenience and clarity. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
[0210] For example, the end effector 312 may include a staple channel 322 and a clamping member that can pivotally translate, such as an anvil 324. The handle 306 of the instrument 310 may include a closing trigger 318 and a firing trigger 320 for actuating the end effector 312. It should be understood that instruments with end effectors related to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating the end effector 312. The handle 306 may include a downwardly extending pistol grip 326, toward which the clinician pivotally pulls the closing trigger 318 to clamp or close the anvil 324 toward the staple channel 322 of the end effector 312, thereby clamping the tissue positioned between the anvil 324 and the channel 322. In other embodiments, different types of clamping members may be used in addition to or in place of the anvil 324. The handle 306 may also include a lock that may be configured to releasably hold the closing trigger 318 in its closed position. More detailed information regarding embodiments of exemplary closure systems for closing (or clamping) the anvil 324 of the end effector 312 by retracting the closure trigger 318 is provided in U.S. Pat. No. 7,000,818, issued on Feb. 21, 2006, entitled “SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS,” U.S. Pat. No. 7,422,139, issued on Sep. 9, 2008, entitled “MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK,” and U.S. Pat. No. 7,422,139, issued on Dec. 16, 2008, entitled “ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVILALIGNMENT COMPONENTS" are provided in U.S. Patent 7,464,849, the entire disclosure of which is incorporated herein by reference.
[0211] Once the clinician is satisfied with the positioning of the end effector 312, the clinician can retract the closure trigger 318 to its fully closed, locked position proximate the pistol grip 326. The trigger 320 can then be actuated or fired. In at least one such embodiment, the firing trigger 320 can be located farther outboard of the closure trigger 318, wherein the closing of the closure trigger 318 can cause the firing trigger 320 to move or rotate toward the pistol grip 326, allowing the operator to reach the firing trigger 320 using one hand in various situations. Thereafter, the operator can pivotally pull the firing trigger 320 toward the pistol grip 312 to staple and sever the clamped tissue in the end effector 312. Thereafter, after the clinician relaxes or releases the force applied to the firing trigger 320, the firing trigger 320 can return to its unactuated or unfired position (e.g., Figure 1 and Figure 2 31). When pressed, the release button on the handle 306 can release the locked closure trigger 318. The release button can be implemented in various forms, such as, for example, those disclosed in published U.S. Patent Application Publication No. 2007 / 0175955, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM," filed on January 31, 2006, the entire disclosure of which is incorporated herein by reference in its entirety.
[0212] In addition to the above, the end effector 312 may include, for example, a cutting instrument, such as a knife, for cutting the tissue clamped in 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, for example, a device for fastening the tissue cut by the cutting instrument, such as a nail, an RF electrode and / or an adhesive. The longitudinally movable drive shaft located in the shaft 308 of the instrument 310 can drive / actuate the cutting instrument and the fastening device in the end effector 312. The electric motor located in the handle 306 of the instrument 310 can be used to drive the drive shaft, as further described herein. In various embodiments, the motor may be a DC brush drive motor with a maximum speed of, for example, about 25,000 RPM. In other embodiments, the motor may include 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 pack") such as, for example, a lithium-ion battery may be provided in the pistol grip 26 of the handle 6 adjacent to the motor, wherein the battery can supply power to the motor via a motor control circuit. According to various embodiments, a plurality of battery cells connected in series may be used as a power source to power the motor. In addition, the power source may be replaceable and / or rechargeable.
[0213] As outlined above, the electric motor in the handle 306 of the instrument 310 can be operably engaged with a longitudinally movable drive member located within the shaft 308. Referring now to Figures 14 to 16 , the electric motor 342 can be mounted to the pistol grip portion 326 of the handle 306 and located within the pistol grip portion. The electric motor 342 may include a rotatable shaft operably connected to a gear reducer assembly 370, wherein the gear reducer assembly 370 may include a housing 374 and an output pinion 372, among other things. In certain embodiments, the output pinion 372 may be directly operably engaged with a longitudinally movable drive member 382, or alternatively may be operably engaged with the drive member 382 via one or more intermediate gears 386. In at least one such embodiment, the intermediate gear 386 may be meshingly engaged with a set or row of drive teeth 384 defined in the drive member 382. In use, the electric motor 342 may drive the drive member distally, as indicated by arrow D ( Fig.15 ) and / or driving the drive member proximally, indicated by arrow D ( Fig.16 ) indication, depending on the direction in which the electric motor 342 rotates the intermediate gear 386. In use, the polarity of the voltage provided by the battery can operate the electric motor 342 in a clockwise direction, wherein the polarity of the voltage applied by the battery to the electric motor can be reversed to operate the electric motor 342 in a counterclockwise direction. The handle 306 may include a switch that can be configured to reverse the polarity applied by the battery to the electric motor 342. The handle 306 may also include a sensor 330 that is configured to detect the position of the drive member 382 and / or the direction in which the drive member 382 moves.
[0214] As described above, the surgical instrument 310 can include an articulation joint 314 about which the end effector 312 can be articulated. The instrument 310 can also include an articulation lock that can be configured and operated to selectively lock the end effector 312 in place. In at least one such embodiment, the articulation lock can extend from the proximal end of the shaft 308 to the distal end of the shaft 308, wherein the distal end of the articulation lock can engage the end effector 312 to lock the end effector 312 in place. See again Fig.12 and Fig.13, the instrument 310 may also include an articulation control 316 that may engage with the proximal end of the articulation lock and may be configured to enable the articulation lock to operate between a locked state and an unlocked state. In use, the articulation control 316 may be pulled proximally to unlock the end effector 312 and allow the end effector 312 to rotate about the articulation joint 314. After the end effector 312 has been properly articulated, the articulation control 316 may be moved distally to re-lock the end effector 312 in place. In at least one such embodiment, the handle 306 may also include a spring and / or other suitable biasing elements configured to bias the articulation control 316 distally and the articulation lock into a locked configuration with the end effector 312. If the clinician desires, the clinician may again pull the articulation control 316 back or proximally to unlock the end effector 312, articulate the end effector 312, and then move the articulation control 316 back to its locked state. In this locked state, the end effector 312 may not be articulated relative to the shaft 308 .
[0215] As outlined above, the surgical instrument 310 may include an articulation lock configured to hold the end effector 312 in position relative to the shaft 308. As described above, when the articulation lock is in its unlocked state, the end effector 312 may be rotated or articulated relative to the shaft 308. In this unlocked state, the end effector 312 may be positioned and urged against, for example, soft tissue and / or bone surrounding a surgical site in a patient's body to articulate the end effector 312 relative to the shaft 308. In certain embodiments, the articulation control 316 may include an articulation switch, or may be configured to operate an articulation switch, which may selectively allow and / or prevent the firing trigger 320 from operating the electric motor 342. For example, such an articulation switch may be placed in series with the electric motor 342 and a firing switch operably associated with the firing trigger 320, wherein the articulation switch may be in a closed state when the articulation control 316 is in the 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 and the operation of the electric motor 342. In such circumstances, the firing drive of the instrument 310 cannot be fired when the end effector 312 is in the unlocked state and can be articulated relative to the shaft 308. When the articulation control 316 returns to its 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 serial number 12 / 647,100, entitled “MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY,” filed on December 24, 2009, which was published as U.S. patent application publication 2011 / 0155785 on June 30, 2011, now U.S. Patent 8,220,688, the entire disclosure of which is incorporated herein by reference.
[0216] Now go to Figures 17 to 29 , the surgical instrument 400 may include a handle 403, a shaft 404 extending from the handle 403, and an end effector 402 extending from the shaft 404. As the reader will note, for purposes of illustration, portions of the handle 403 have been removed; however, the handle 403 may include a handle similar to, for example, Figure 1The closure trigger 114 and the firing trigger 116 are shown as a closure trigger and a firing trigger. As will be described in more detail below, the firing trigger 116 can be operably coupled to a firing drive including a firing member 470 extending through the shaft 404, wherein operation of the firing trigger 116 can cause the firing member 470 to be advanced distally toward the end effector 402. As will also be described in more detail below, the surgical instrument 400 can also include an articulation drive that can be selectively coupled to the firing member 470 so that when the firing member 470 is actuated by the firing trigger 116 and / or by, for example, a separate articulation trigger and / or button, the articulation drive can be driven by the firing member 470, and the articulation drive can, in turn, cause the end effector 402 to articulate about the articulation joint 410.
[0217] Now go to Fig.17 , the reader will note that the end effector 402 of the surgical instrument 400 is shown in an open configuration. More specifically, the first jaw of the end effector 402, including the anvil 420, is shown in an open position relative to the channel 498 of the second jaw of the end effector 402. Similar to the above, the channel 498 can be configured to receive and secure a staple cartridge therein. Turning now to Fig. 20 , which also shows the end effector 420 in an open configuration, the handle 403 of the surgical instrument 400 may include an articulation lock actuator 409 that is movable between a distal or locked position, in which the end effector 402 is locked in place relative to the shaft 404, and a proximal or unlocked position, in which the end effector 402 is articulated relative to the shaft 404 about an articulation joint 410. Although the end effector 402 and the shaft 404 are in an open configuration, the end effector 402 and the shaft 404 are in an open configuration. Fig. 20 404, but the articulation lock actuator 409 is shown in its retracted, unlocked position and the end effector 402 can therefore be articulated relative to the shaft 404. Fig.19 , Fig.24A and Fig. 24B , joint motion lock actuator 409 ( Fig.21 ) can be operably coupled to the articulation lock 443, wherein the articulation lock actuator 409 can cause the articulation lock 443 to be in a distal position ( Fig.24A ) and proximal position ( Fig. 24B), in which the articulation lock 443 is engaged with the proximal lock member 407 of the end effector 402, and in which the articulation lock 443 is disengaged from the end effector 402. As the reader will appreciate, the distal locked position of the articulation lock actuator 409 corresponds to the distal position of the articulation lock 443, and the proximal unlocked position of the articulation lock actuator 409 corresponds to the proximal position of the articulation lock 443. Turning now to Fig.19 The articulation lock 443 is coupled to the articulation lock actuator 409 via an articulation lock rod 440, which includes a distal end 442 (eg, Fig.24A ), and a proximal end 441 (as more clearly seen in FIG. 4 ) that engages with the articulation lock actuator 409. Fig. 22 more clearly seen in Fig.24A and Fig. 24B As shown, the articulation lock 443 may include one or more teeth 445 that may be configured to meshingly engage, for example, one or more teeth 446 defined around the perimeter of the proximal lock member 407. Fig.19 , the shaft 404 may further include a biasing member such as, for example, a spring 444, which may be configured to bias the teeth 445 of the articulation 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 cavity 488 ( Fig.23 ) so that the biasing member can push the articulation lock actuator 409 toward its distal locking position.
[0218] like Fig.17 As shown, the articulation lock actuator 409 may be comprised of two nozzle halves or portions, 411a and 411b, wherein, as the reader will note, the nozzle halves or portions 411a and 411b have been removed for purposes of illustration. Figures 18 to 27 The nozzle portion 411b is removed. Fig.17 As shown, the articulation lock actuator 409 may include a plurality of finger hooks 413 that may be grasped by a surgeon or other clinician in order to retract the articulation lock actuator 409 into its proximal unlocked configuration. Fig. 20 , the articulation lock actuator 409 may further include a stopper assembly 452 which may be configured to bias a stopper 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, wherein the stopper assembly 452 may be configured to bias a stopper member 457 against the shaft frame 454. See Fig.19, the shaft frame 454 may include a stop channel 453 defined therein, which can be aligned with the stop member 457 so that the stop member 457 can slide within the stop channel 453 when the articulation lock actuator 409 slides between its locked position and unlocked position. Fig. 20 , the stop assembly 452 may include a fixed frame portion 458, which may define a threaded hole configured to receive an adjustable threaded member 459. The adjustable threaded member 459 may include an internal hole, wherein at least a portion of the stop member 457 may be located within the internal hole, and wherein the stop member 457 may be biased to an end of the internal hole by a spring, such as located intermediate the stop member 457 and the closed end of the internal hole. Fig.19 As shown, the proximal end of the stop channel 453 may include a stop seat 455, which may be configured to removably receive a stop member 457 when the articulation lock actuator 409 has reached its proximal unlocked position. In various circumstances, the stop member 457, the stop seat 455, and the bias spring located in the adjustable threaded member 459 may be sized and configured so that the stop assembly 452 can releasably retain the articulation lock actuator 409 in its proximal unlocked position. As described in more detail below, the articulation lock actuator 409 may remain in its proximal unlocked position until the end effector 402 has been properly articulated. At this point, the articulation lock actuator 409 may be pushed forward to disengage the stop member 457 from the stop seat 455. As the reader will appreciate, referring primarily to Fig. 20 , the adjustable threaded member 459 can be rotated downward toward the shaft frame 454 to increase the force required to disengage the stop member 457 from the stop seat 455, and the adjustable threaded member 459 can be rotated upward away from the shaft frame 454 to reduce the force required to disengage the stop member 457 from the stop seat 455. Fig. 20 As shown, the articulation lock actuator 409 may include an access port 418 that may be used to access and rotate the threaded member 459 .
[0219] As described above, the articulation lock actuator 409 is Fig. 20 In the retracted unlocked position, and the end effector 402 is in the unlocked configuration, such as Fig. 24B Now see Fig.19 and Fig. 20 , the surgical instrument 400 also includes an articulation driver 460 that can be pushed distally to rotate the end effector 402 about the articulation joint 410 in a first direction, and pulled proximally to rotate the end effector 402 about the articulation joint in a second or opposite direction, such as Fig.21 As shown in the comparison Fig. 20 and Fig.21, the reader will note that the articulation driver 460 has been pulled proximally by the firing member 470. More specifically, the intermediate portion 475 of the firing member 470 may include a notch or slot 476 defined therein, which may 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 may also pull the articulation driver 460 proximally. Similarly, when the firing member 470 is pushed distally, the firing member 470 may push the articulation driver 460 distally. Similarly, Fig. 20 and Fig.21 As shown, the articulation driver 460 may include a distal end 462 engaged with a protrusion 414 extending from the proximal lock member 407, which may be configured to transmit proximal and distal articulation of the articulation driver 460 to the end effector 102, for example. Figures 18 to 20 , the handle 404 may also include a proximal firing member portion 482 of the firing member 470, the proximal firing member portion including a distal end 481 engaged with the proximal end 477 of the intermediate portion 475 of the firing member 470. Similar to the above, the handle 403 may include an electric motor including an output shaft and a gear operably engaged with the output shaft, wherein the gear may be capable of operably engaging with a set of longitudinal teeth 484 defined on the surface of the firing member portion 482. In use, in addition to the above, the electric motor may 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 may also include a switch that may be in a first state to operate the electric motor in its first direction, in a second state to operate the electric motor in its second direction, and / or in a neutral state, when the electric motor is not operated in either direction. In at least one such embodiment, the switch can include at least one biasing member, such as, for example, a spring, which can be configured to, for example, bias the switch to its neutral state. Also, in at least one such embodiment, a first state of the articulation switch can include a first position of the switch toggle being on a first side of a neutral position, and a second state of the articulation switch can include a second position of the switch toggle being on a second or opposite side of the neutral position.
[0220] In various circumstances, in addition to the above, the articulation switch can be used to make small adjustments in the position of the end effector 402. For example, the surgeon can move the articulation switch in a first direction to rotate the end effector 402 about the articulation joint in a first direction, 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 until the end effector 402 is positioned in the desired position. Fig.19 , Fig.24A and Fig. 24B , the articulation joint 410 may include a pivot pin 405 extending from the shaft frame member 451, and further includes a hole 408 defined in the proximal lock member 407, which is configured to receive the pivot pin 405 tightly therein so that the rotation of the end effector 402 is limited to, for example, rotation about the articulation axis 406. Fig.19 , the distal end of the shaft frame 454 may include a recess 456 configured to receive the shaft frame member 451 therein. As will be described in more detail below, the shaft 404 may include an outer sleeve that can slide relative to the shaft frame 454 to close the anvil 420. See mainly Figures 19 to 21 , the outer sleeve of the shaft 410 may include a proximal portion 428 and a distal portion 426, which may be connected to each other via articulation links 430 and 432. When the outer sleeve slides relative to the articulation joint 410, the articulation link 430 may accommodate the angular relative movement between the distal portion 426 and the proximal portion 428 of the outer sleeve when the end effector 402 has been articulated, such as Fig.21 In various circumstances, the articulation links 430 and 432 may provide two or more degrees of freedom at the articulation joint 410 to accommodate the articulation of the end effector 402. The reader will also note that the articulation joint 410 may also include a guide 401 that may be configured to receive the distal cutting portion 472 of the firing member 470 therein and guide the distal cutting portion 472 as it is advanced distally and / or retracted proximally within and / or relative to the articulation joint 410.
[0221] As outlined above, the firing member 470 can be advanced distally to advance the articulation driver 460 distally and thereby rotate the end effector 402 in a first direction, and similarly, the firing member 470 can be retracted proximally to retract the articulation driver 460 proximally and thereby rotate the end effector 402 in an opposite direction. However, in some circumstances, it may be undesirable to move, or at least substantially move, the distal cutting portion 472 of the firing member 470 while the end effector 402 is articulated using the firing member 470. Turning now to Figures 19 to 21 , the middle portion 475 of the firing member 470 may include a longitudinal slot 474 defined in the distal end thereof, which may be configured to receive the proximal end 473 of the distal cutting portion 472. The longitudinal slot 474 and the proximal end 473 may be sized and configured to allow relative movement therebetween and may include a sliding joint 471. The sliding joint 471 may allow the middle portion 475 of the firing drive 470 to move to allow the end effector 402 to articulate without moving or at least substantially moving the distal cutting portion 472. Once the end effector 402 has been properly oriented, the middle portion 475 may be advanced distally until the proximal sidewall of the longitudinal slot 474 contacts the proximal end 473 so as to advance the distal cutting portion 472 and fire the staple cartridge located within the channel 498, as further described in greater detail below. See primarily Fig.19 The shaft frame 454 may include a longitudinal slot 469 defined therein which may be configured to slidably receive the joint motion driver 460, and similarly, the proximal portion 428 of the outer shaft sleeve may include a longitudinal opening 425 configured to accommodate relative movement between the above-mentioned joint motion driver 460 and the outer sleeve of the shaft 404.
[0222] Further to the above, the articulation lock actuator 409 can be configured to bias the proximal portion 461 of the articulation driver 460 toward the drive member 470 when the articulation lock actuator 409 is in its proximal unlocked position. More specifically, in at least one such embodiment, an inner surface of the articulation lock actuator 409 can include a cam that can engage a side 466 of the proximal portion 461 and bias 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 moved back to its distal locked position, the articulation lock actuator 409 can no longer bias the proximal portion 461 inwardly toward the drive member 470. In at least one such embodiment, the handle 403 and / or the shaft 404 may include a resilient member, such as, for example, a spring, which may be configured to bias the proximal portion 461 outwardly away from the firing member 470 so that the proximal portion 461 is not operably 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 its unlocked position, as described above. In various circumstances, the proximal portion 461 and the slot 476 may include a force limiting clutch.
[0223] Once the end effector 402 has been articulated into the desired orientation, in addition to the above, the closure trigger 114 may be actuated to move the anvil 420 toward its closed position, such as Fig. 22 As shown. More specifically, the closing trigger 114 can advance the outer sleeve of the shaft 410 distally so that the distal portion 426 of the outer sleeve can, for example, push the anvil 420 distally and downwardly. The anvil 420 may include protrusions 497 extending from opposite sides of the anvil 420, each of which may be configured to slide and rotate within an elongated slot 499 defined in a cartridge channel 498. The anvil 420 may also include a protrusion 496 extending upward therefrom, which may be located within a hole 495 defined in the distal portion 426 of the outer sleeve, wherein the side wall of the hole 495 may contact the protrusion 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 closing drive device can also cause the articulation lock actuator 409 to move from its proximal unlocked position ( Figure 20 to Figure 22 ) to its distal locking position ( Fig.23 ). More specifically, the closure drive can be configured to distally advance the closure drive bracket 415, which can contact the bushing 450 mounted within the articulation actuator 409, such as Fig. 22 As shown. Fig.19 and Fig. 22As shown, the collar 450 may include opposing portions or halves that may be assembled together such that opposing portions of the collar 450 may surround the shaft 404. The collar 450 may also support the stop assembly 452 discussed above, and may include a mounting portion that engages the proximal end 441 of the articulation lock rod 440, also discussed above. Regardless, the closure drive bracket 415 may contact the collar 450 and slide the articulation lock actuator 409 distally, and in addition to the above, remove the stop member 457 from the stop seat 455 (see Fig.19 ) is displaced into the stop channel 453 so that the articulation lock actuator 409 can be pushed into its locked position and the articulation lock 443 can be moved into engagement with the proximal lock portion 407 to lock the end effector 402 in place, as shown. Fig.23 At this point, the closure drive yoke 415 can prevent the end effector 402 from unlocking and articulating until the closure drive and anvil 420 are reopened and the closure drive yoke 415 is moved proximally, as further described in greater detail below.
[0224] See now Fig.25 , actuation of the closure drive by the closure drive actuator 114 and distal advancement of the outer sleeve 428 of the shaft 410 may also operably disengage the articulation drive 460 from the firing drive 470. Fig. 20 and Fig.21424. The reader will note that the outer sleeve 428 includes a window 424 defined therein, in which a rotatable cam member 465 can be positioned. The cam member 465 can include a first end that is rotatably pinned or coupled to the shaft frame 454, and a second end that is configured to rotate relative to the pinned end of the cam member 465. In other embodiments, the cam member 465 can include 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 can be in a first position that allows the proximal end 461 of the articulation driver 460 to engage with the slot 476 defined in the firing member 470; however, when the outer sleeve 428 is advanced distally, the sidewall of the window 424 can engage the cam member 465 and lift the second end of the cam member 465 away from the shaft frame 454 into the second position. In this second position, the cam member 465 can 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 has been actuated to close the anvil 420, the closure drive can urge the articulation lock actuator 409 into its distal locked configuration, the articulation lock actuator 409 can urge the articulation lock 445 into a locked configuration with the end effector 402, and in addition, the closure drive can operably disconnect the articulation driver 460 from the firing drive 470. At this point in the operation of the surgical instrument 400, actuation of the firing drive 470 will not articulate the end effector 402, and the firing drive 470 can move independently of the articulation driver 460.
[0225] Now go to Fig.26 , as described above, the firing drive 470 can be advanced distally to eject the staples from the staple cartridge located within the channel 498 of the end effector 402 and to deform the staples against the anvil 420. As outlined above, the firing drive 470 can also include a cutting member which 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 distally advance the firing member 470, wherein in 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 position within the staple cartridge. Regardless, the rotation of the electric motor can be reversed to retract the firing member 470 proximally, such as Fig. 27As shown. In various circumstances, the electric motor can retract the proximal drive portion 482 and the intermediate portion 475 until the 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 this point, further retraction of the proximal drive portion 482 and the intermediate portion 475 will retract the distal cutting member 472 proximally. In various circumstances, the electric motor can 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; however, when the closure sleeve 428 is still in the distally advanced position, the cam member 465 can still bias the articulation driver 460 out of engagement with the firing member 470. To allow the articulation driver 460 to reengage with the firing member 470, in such circumstances, the closure drive will have to be reopened 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 its first position. In various circumstances, the articulation driver 460 can be resiliently bent out of engagement with the firing member 470 so that when the cam member 465 is allowed to move back to its first position, the articulation driver 460 can be resiliently bent 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 also include a biasing member that can be configured to bias the proximal portion 461 back into engagement with the intermediate portion 475.
[0226] The reader will note that the middle portion 475 of the firing member 470 is Fig. 27 The intermediate portion 475 has been retracted proximally such that the slot 476 defined in the intermediate portion 475 is located proximally relative to the proximal portion 461 of the articulation driver 460. In such circumstances, the proximal portion 461 may therefore be inoperably reconnected to the firing member 470 until the intermediate portion 475 is advanced distally to align the slot 476 with the proximal portion 461. Such circumstances may occur due to relative sliding between the intermediate portion 475 and the cutting member portion 472 of the firing member 470 caused by the sliding joint 471, which may be resolved by, for example, immediately re-actuating the electric motor in the first direction.
[0227] See again Fig. 27 , the firing member 470 may be in a retracted or reset position, however, the closure drive is still in an actuated or closed configuration, which prevents the anvil 420 from reopening and the end effector 402 from articulating again. When the closure drive is released, now see Fig.28, the closure actuator carriage 415 can be retracted to a proximal position, in which the closure sleeve including portions 426 and 428 is also pulled proximally. Fig.19 , the proximal sleeve portion 428 may include a proximal end 417 that can engage with the closure drive bracket 415 so that the proximal sleeve portion 428 and the closure drive bracket 415 move together in the distal direction and / or the proximal direction. In any case, in addition to the above, the proximal movement of the distal sleeve portion 426 can cause the distal side wall of the hole 495 to engage with the protrusion 496 extending from the anvil 420 to pivot the anvil 420 to its open position, such as Fig.29 In addition, proximal movement of the closure drive carriage 415 may unlock the articulation lock actuator 409, allowing the articulation lock actuator 409 to move to its proximal unlocked position, thereby pulling the articulation lock 443 proximally to compress the spring 444 and unlock the end effector 402. As described above, the end effector 402 may then be articulated about the articulation joint 410, and the operation of the surgical instrument 400 described above may be repeated. Figures 18 to 20 , the handle 404 may further include a switch 408 mounted to the handle frame 480, which may be configured to detect whether the articulation lock actuator 409 is in its proximal unlocked position. In some embodiments, the switch 408 may be operably coupled to an indicator in the handle 404, such as, for example, a light, which may indicate to an operator of the surgical instrument 400 that the end effector 402 is in an unlocked state and that the operator may utilize the articulation switch to, for example, articulate the end effector 402.
[0228] As above combined Fig.17 As described in the embodiment of the present invention, the surgical instrument 400 may include an articulation lock system configured to lock and unlock the end effector 402, and a closure drive device configured to open and close the anvil 420 of the end effector 402. Although these two systems of the surgical instrument 400 interact with each other in several aspects, which are described above, these systems can be actuated independently of each other in other aspects. 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 device operates independently to close the anvil 420. Now turning to Figure 30 to Figure 32 , the surgical instrument 400 may include an alternative arrangement in which the closure drive is actuated to: (i) close the anvil 420, and (ii) lock the end effector 402 in place. Fig.31 and Fig.32 , the shaft 404 may include an articulation locking bar 540 that may be in a proximal unlocked position ( Fig.31 ) and distal locking position ( Fig.32), in the proximal unlocked position, the end effector 402 can be articulated about the articulation joint 410, and in the distal locked position, the end effector 402 can be locked in place. Similar to the articulation lock bar 440, the articulation lock bar 540 can include a distal end 542 operably engaged with the articulation lock 443, so that when the articulation lock bar 540 is pulled proximally, the articulation lock 443 can be pulled proximally. Similarly, when the articulation lock bar 540 is pushed distally, the articulation lock 443 can be pushed distally. Compared to the articulation lock bar 440 that is pushed distally and pulled proximally by the articulation lock actuator 409, the articulation lock bar 540 can be pushed distally and pulled proximally by the closure sleeve 428, as described above. More specifically, the proximal end 541 of the articulation lock bar 540 may include a hook 547 that can catch a portion of the closure sleeve 428 and be pulled proximally with the closure sleeve 428 when the closure sleeve 428 is pulled proximally. In such cases, the sleeve 428 can pull the articulation lock bar 540 to an unlocked state. As the reader will note, the closure sleeve 428 can include a window 549 in which the proximal end 541 of the articulation lock bar 540 can be positioned. When the closure sleeve 428 is pushed distally, in addition to the above, the proximal sidewall 548 of the window 549 can contact the proximal end 541 and push the articulation lock bar 540 and the articulation lock 443 distally to lock the end effector 402 in place.
[0229] As described herein, it may be desirable to employ surgical systems and devices that may include reusable portions that are configured for use with interchangeable surgical components. Fig.33, for example, at least one form of surgical system, generally designated 1000, is shown, which includes a surgical instrument 1010 that may or may not be reusable. The surgical instrument 1010 may be employed with a plurality of interchangeable shaft assemblies 1200, 1200', 1200". The interchangeable shaft assemblies 1200, 1200', 1200" may have surgical end effectors 1300, 1300', 1300" operably coupled thereto, the surgical end effectors being configured to perform one or more surgical tasks or procedures. For example, each of the surgical end effectors 1300, 1300', 1300" may include a surgical cutting and fastening device configured to operably support a surgical staple cartridge therein. Each of the shaft assemblies may employ end effectors adapted to support staple cartridges of different sizes and types, having different shaft lengths, sizes and types, and the like. Although the drawings of the present invention illustrate end effectors configured to cut and suture tissue, various aspects of the surgical system 1000 may also be effectively employed with surgical instruments configured to apply other motion and energy forms (such as, for example, radio frequency (RF) energy, ultrasonic energy, and / or motion) to interchangeable shaft-mounted end effector arrangements used in various surgical applications and procedures. In addition, the end effectors, shaft assemblies, handles, surgical instruments, and / or surgical instrument systems may utilize any suitable fasteners to fasten tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein may be removably inserted into and / or attached to the end effector of the shaft assembly. In various cases, the shaft assembly may be selected to be attached to the handle of the surgical instrument, and the fastener cartridge may be selected to be attached to the shaft assembly.
[0230] Fig.33The surgical instrument 1010 shown includes a housing 1040 consisting of a handle 1042 configured to be grasped, manipulated and actuated by a clinician. Continuing with this specific embodiment, it should be understood that various unique and novel arrangements of various forms of interchangeable shaft assemblies disclosed herein can also be effectively used in conjunction with robotically controlled surgical systems. Therefore, 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 that is configured to generate and apply at least one control action that can be used to actuate the interchangeable shaft assemblies disclosed herein and their corresponding 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 employed with various robotic systems, instruments, components and methods disclosed in U.S. Patent Application Publication No. 2012 / 0298719. US Patent Application Serial No. 13 / 118,241 (now US Patent Application Publication No. 2012 / 0298719), entitled “SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS,” is incorporated herein by reference in its entirety.
[0231] Fig.34 A surgical instrument 1010 is shown with an interchangeable shaft assembly 1200 operably coupled thereto. In the illustrated form, the surgical instrument includes a handle 1042. In at least one form, the handle 1042 may include a pair of interconnectable housing segments 1044, 1046 that may be interconnected by screws, snap features, adhesives, etc. See Fig.35 In the illustrated arrangement, the handle housing segments 1044, 1046 cooperate to form a pistol grip 1048 that can be grasped and manipulated by a clinician. As will be discussed in further detail below, the handle 1042 operably supports a plurality of drive systems therein that are configured to generate and apply various control actions to corresponding portions of the interchangeable shaft assembly operably attached thereto.
[0232] The handle 1042 may also include a frame 1080 that operably supports a plurality of drive systems. For example, the frame 1080 may operably support a first or closed drive system, generally designated 1050, that may be used to apply closing and opening motions to an operably attached or coupled interchangeable shaft assembly 1200. In at least one form, the closed drive system 1050 may include an actuator in the form of a closed trigger 1052 pivotally supported by the frame 1080. More specifically, as Fig.35 As shown, the closure trigger 1052 can be pivotally supported by the frame 1080 so that when the clinician grasps the pistol grip 1048 of the handle 1042, the closure trigger 1052 can be easily pivoted from the starting or unactuated position to the actuated position, and more specifically, to the fully compressed or fully actuated position. The closure trigger 1052 can be biased to the unactuated position by a spring or other biasing arrangement (not shown). In various forms, the closure drive system 1050 also includes a closure linkage assembly 1060 pivotally coupled to the closure trigger 1052. As shown in FIG. Fig.35 As can be seen in FIG. 1 , the closure linkage assembly 1060 may include a closure trigger 1052 that is pivotally coupled to a closure link 1064 having a pair of laterally extending attachment lugs or portions 1066 protruding therefrom. The closure link 1064 may also be referred to herein as an "attachment member."
[0233] Still see Fig.35 , it can be observed that the closure trigger 1052 can have a locking wall 1068 thereon that is configured to cooperate with a closure release assembly 1070 pivotally coupled to the frame 1080. In at least one form, the closure release assembly 1070 can include a release button assembly 1072 having a distally projecting cam follower arm 1074 formed thereon. The release button assembly 1072 can be pivoted in a counterclockwise direction by a release spring 1076. When the clinician presses the closure trigger 1052 from its unactuated position toward the pistol grip 1048 of the handle 1042, the closure link 1062 pivots upward to a point where the cam follower arm 1072 falls into engagement with the locking wall 1068 on the closure link 1062, thereby preventing the closure trigger 1052 from returning to the unactuated position. Thus, the closure release assembly 1070 is used to lock the closure trigger 1052 in the fully actuated position. When the clinician desires to unlock the closure trigger 1052 to allow it to 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. When the cam follower arm 1074 has moved out of engagement with the closure trigger 1052, the closure trigger 1052 can be pivoted back to the unactuated position. Other closure trigger locking arrangements and release arrangements may also be employed.
[0234] In at least one form, the handle 1042 and the frame 1080 are operably supported by another drive system referred to herein as a firing drive system 1100, which is configured to be able to apply a firing action 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 positioned in the pistol grip 1048 of the handle 1042. In various forms, the motor 1102 may be a DC brushed drive motor having a maximum speed of, for example, about 25,000 RPM. In other arrangements, 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 (i.e., a "power source" or "power pack") such as a lithium-ion battery may be coupled to the handle 1042 to provide power to the control circuit board assembly 1106 and ultimately to the motor 1102. Fig.34 A battery pack housing 1104 is shown that is configured to be releasably mounted to the handle 1042 for supplying control power to the surgical instrument 1010. Multiple battery cells connected in series can be used as a power source to power the motor. In addition, the power source can be replaceable and / or rechargeable.
[0235] As outlined above with respect to the other various forms, the electric motor 1102 may include a rotatable shaft (not shown) operably interfaced with a gear reducer assembly 1108, which is mounted on a longitudinally movable drive member 1110 in meshing engagement with a set or rack of drive teeth 1112. In use, the polarity of the voltage provided by the battery can operate the electric motor 1102 in a clockwise direction, wherein the polarity of the voltage applied to the electric motor by the battery can be reversed so as to operate the electric motor 1102 in a counterclockwise direction. When the electric motor 1102 rotates in one direction, the drive member 1110 will be driven axially in the distal direction "D". When the motor 1102 is driven in the opposite rotational direction, the drive member 1110 will be driven axially in the proximal direction "P". See, e.g. Fig.35 The handle 1042 may include a switch that may be configured to reverse the polarity applied by the battery to the electric motor 1102. As with other forms 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 moving.
[0236] Actuation of the motor 1102 can be controlled by a firing trigger 1120 that is pivotally supported on the handle 1042. The firing trigger 1120 can pivot between an unactuated position and an actuated position. The firing trigger 1120 can be biased to the unactuated position by a spring (not shown) or other biasing structure, so that when the clinician releases the firing trigger 1120, it can be pivoted to or otherwise returned to the unactuated position by the spring or biasing structure. In at least one form, the firing trigger 1120 can be positioned "outside" of the closing trigger 1052, as discussed above. In at least one form, the firing trigger safety button 1122 can be pivotally mounted to the closing trigger 1052. For example, as shown in FIG. Fig.35 and Fig.36 As can be seen in FIG. 1 , the safety button 1122 can be positioned between the firing trigger 1120 and the closing trigger 1052 and has a pivot arm 1124 protruding therefrom. Fig.38 As shown, when the closure trigger 1052 is in the unactuated position, the safety button 1122 is housed in the handle housing, and the clinician may not be able to easily reach the button or move the button between the safety position that prevents actuation of the firing trigger 1120 and the firing position in which the firing trigger 1120 can be fired. When the clinician depresses the closure trigger 1052, the safety button 1122 and the firing trigger 1120 pivot downward and can then be manipulated by the clinician.
[0237] As described above, in at least one form, the longitudinally movable drive member 1110 has teeth 1112 of a rack formed thereon for meshing engagement with a corresponding drive gear 1114 of the gear reducer assembly 1108. At least one form also includes a manually actuatable "panic" assembly 1130 that is configured to enable a clinician to manually retract the longitudinally movable drive member 1110 in the event that the motor is disabled. The panic assembly 1130 may include a lever or panic handle assembly 1132 that is configured to be manually pivoted into ratcheting engagement with the teeth 1112 in the drive member 1110. Thus, the clinician can manually retract the drive member 1110 by using the panic handle assembly 1132 to ratchet the drive member in the proximal direction "P". U.S. Patent Application Publication No. US2010 / 0089970 (now U.S. Patent No. 8,608,045) discloses emergency arrangements and other components, arrangements and systems that may also be used with the various apparatus disclosed herein. U.S. Patent Application Serial 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 incorporated by reference in its entirety.
[0238] Fig.34 and Fig.37 One form of an interchangeable shaft assembly 1200 is shown, which has, for example, a surgical end effector 1300 that can be operably attached thereto. The end effector 1300 shown in these figures can be configured to cut and staple tissue in various ways disclosed herein. For example, the end effector 1300 may include a channel 1302 configured to support a surgical staple cartridge 1304. The staple cartridge 1304 may include a removable staple cartridge 1304 so that it can be replaced when it is used up. However, in other arrangements, the staple cartridge may be configured so that once installed in the channel 1302, it is not intended to be removed from the channel. The channel 1032 and the staple cartridge 1304 can be collectively referred to as the "first jaw portion" of the end effector 1300. In various forms, 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 ways discussed herein.
[0239] The interchangeable shaft assembly 1200 may also include a shaft 1210 including a shaft frame 1212 coupled to a shaft attachment module or shaft attachment portion 1220. In at least one form, a proximal end 1214 of the shaft frame 1212 may extend through a hollow collar portion 1222 formed on and rotatably attached to the shaft attachment module 1220. For example, an annular groove 1216 may be provided in the proximal end 1214 of the shaft frame 1212 for engaging with a U-shaped retainer 1226 extending through a slot 1224 in the shaft attachment module 1220. This arrangement enables the shaft frame 1212 to rotate relative to the shaft attachment module 1220.
[0240] The shaft assembly 1200 may also include a hollow outer sleeve or closure tube 1250 through which the shaft frame 1212 extends. The outer sleeve 1250 may also be referred to herein as a "first shaft" and / or a "first shaft assembly." The outer sleeve 1250 has a proximal end 1252 adapted to be rotatably coupled to a closure tube attachment yoke 1260. Fig.37 , the proximal end 1252 of the outer cannula 1250 is configured to be received within a bracket 1262 in the closure tube attachment yoke 1260. A U-shaped connector 1266 extends through a slot 1264 in the closure tube attachment yoke 1260 to be received in an annular groove 1254 in the proximal end 1252 of the outer cannula 1250. This arrangement is used to rotatably couple the outer cannula 1250 to the closure tube attachment yoke 1260 so that the outer cannula 1250 can rotate relative to the closure tube attachment yoke.
[0241] like Fig.38 and 39 As can be seen in FIG. 1 , the proximal end 1214 of the shaft frame 1214 protrudes proximally from the proximal end 1252 of the outer sleeve 1250 and is supported by the U-shaped retainer 1226 ( Fig.38 1260 is rotatably coupled to the shaft attachment module 1220. The closure tube attachment yoke 1260 is configured to be slidably received within a channel 1268 in the shaft attachment module 1220. This arrangement allows the outer sleeve 1250 to move axially relative to the shaft attachment module 1220 on the shaft frame 1212 in the proximal direction "P" and the distal direction "D", as will be discussed in further detail below.
[0242] In at least one form, the interchangeable shaft assembly 1200 may also include an articulation joint 1350. However, other interchangeable shaft assemblies may not be able to articulate. Fig.37As can be seen, for example, the articulation joint 1350 includes 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 a distally protruding upper shank 1356 and a lower shank 1358. The end effector closure sleeve assembly 1354 includes a horseshoe-shaped hole 1360 and a tab 1362 for engaging an opening tab on the anvil 1310. As described above, when the anvil 1310 is opened, the horseshoe-shaped hole 1360 and the tab 1362 engage the anvil tab. The upper dual pivot connection 1364 includes an upwardly protruding distal pivot pin and a proximal pivot pin, which respectively engage an upper distal pin hole in the proximally protruding upper shank 1356 on the outer sleeve 1250 and an upper proximal pin hole in the distally protruding upper shank 1256. The lower dual pivot connection 1366 includes a downwardly projecting distal pivot pin and a proximal pivot pin that respectively engage a lower distal pin hole in the proximally projecting lower shank 1358 and a lower proximal pin hole in the distally projecting lower shank 1258 .
[0243] 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, therefore, the shaft closure sleeve assembly 1354 distally so that it strikes the proximal surface on the anvil 1310 in the manner described above. Also as described above, the anvil 1310 is opened by translating the outer sleeve 1250 and the shaft closure sleeve assembly 1354 proximally so that the tab 1362 and the horseshoe-shaped hole 1360 contact and push against the anvil tab to lift the anvil 1310. In the anvil open position, the shaft closure sleeve assembly 1352 moves to its proximal position.
[0244] In at least one form, the interchangeable shaft assembly 1200 also includes a firing member 1270 supported for axial travel within the shaft frame 1212. The firing member 1270 includes an intermediate firing shaft portion 1272 configured for attachment to the distal cutting portion 1280. The firing member 1270 may also be referred to herein as a "second shaft" and / or a "second shaft assembly." Fig.37, the intermediate firing shaft portion 1272 may include a longitudinal slot 1274 in its distal end that may be configured to receive a proximal end 1282 of a distal cutting portion 1280. The longitudinal slot 1274 and the proximal end 1282 may be sized and configured to allow relative movement therebetween and may include a sliding joint 1276. The sliding joint 1276 may allow the intermediate firing shaft portion 1272 of the firing drive 1270 to move so as to articulate the end effector 1300 without moving, or at least substantially moving, the distal cutting portion 1280. Once the end effector 1300 has been properly oriented, the intermediate firing shaft portion 1272 may be advanced distally until the proximal sidewall of the longitudinal slot 1272 contacts the proximal end 1282 so as to advance the distal cutting portion 1280 and fire the staple cartridge located within the channel 1302, as described herein. Fig.37 As can be further seen in the figure, the shaft frame 1212 has an elongated opening or window 1213 therein to facilitate the assembly and insertion of the intermediate firing shaft portion 1272 into the shaft frame 1212. Once the intermediate firing shaft portion 1272 has been inserted therein, the top frame segment 1215 can be engaged with the shaft frame 1212 to enclose the intermediate firing shaft portion 1272 and the distal cutting portion 1280 therein. The reader will also note that the articulation joint 1350 can also include a guide 1368, which can be configured to receive the distal cutting portion 1280 of the firing member 1270 therein and guide the distal cutting portion 1280 as it is advanced distally and / or retracted proximally within and / or relative to the articulation joint 1350.
[0245] like Fig.37 As can be seen in FIG. 1 , the shaft attachment module 1220 may further include a latch actuator assembly 1230 that may be removably attached to the shaft attachment module via a cap screw (not shown) or other suitable fastener. The latch actuator assembly 1230 is configured to cooperate with a locking yoke 1240 that is pivotally coupled to the shaft attachment module 1220 for selective pivotal travel relative to the shaft attachment module. See FIG. Fig.41 . See Fig.39 The locking yoke 1240 may include two proximal-protruding locking lugs 1242 ( Fig.37), the two locking lugs being configured for releasably engaging with corresponding locking detents or grooves 1086 formed in the frame attachment module portion 1084 of the frame 1080. The locking yoke 1240 is substantially U-shaped and is installed over the latch actuator assembly 1230 after the latch actuator assembly 1230 has been coupled to the shaft attachment 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 arcuate body portion between a latched position and an unlatched position.
[0246] In various forms, the locking yoke 1240 is biased in the proximal direction by a spring or biasing member (not shown). In other words, the locking yoke 1240 is biased to the latched position ( Fig.40 ) and can be pivoted to an unlatched position ( Fig.41 ). For example, in at least one arrangement, the latch button 1236 is slidably retained within the latch housing portion 1235 and is biased in the proximal direction "P" by a latch spring or biasing member (not shown). As will be discussed in further detail below, the latch button 1236 has a distally projecting release lug 1237 that is designed to engage the locking yoke 1240 and pivot the locking yoke from the latched position to the released position when the latch button 1236 is actuated. Fig.41 Shown in unlatched position.
[0247] The interchangeable shaft assembly 1200 may also include a nozzle assembly 1290 rotatably supported on the shaft attachment 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 features, adhesives, and the like. When mounted on the shaft attachment module 1220, the nozzle assembly 1290 may interface with the outer sleeve 1250 and the shaft frame 1212 to enable a clinician to selectively rotate the shaft 1210 relative to the shaft attachment module 1220 about a shaft axis SA-SA, which may be defined, for example, by the axis of the firing member assembly 1270. In particular, a portion of the nozzle assembly 1290 may extend through the window 1253 in the outer sleeve to engage the recess 1218 in the shaft frame 1212. See Fig.37 Thus, rotation of the nozzle assembly 1290 will cause the shaft frame 1212 and outer sleeve 1250 to rotate relative to the shaft attachment module 1220 about the axis AA.
[0248] See now Fig.42 and Fig.43, the reader will observe that the frame attachment module portion 1084 of the frame 1080 is formed with two inwardly facing dovetail receiving slots 1088. Each dovetail receiving slot 1088 may be tapered, or in other words, slightly V-shaped. See, e.g. Fig.36 and Fig.38 (Only one of the slots 1088 is shown.) The dovetail receiving slot 1088 is configured to releasably receive a corresponding tapered attachment or lug portion 1229 of the proximally extending connector portion 1228 of the shaft attachment module 1220. Figure 37 to Figure 39 As further seen in the figure, the shaft attachment lug 1278 is formed on the proximal end 1277 of the intermediate firing shaft 1272. As will be discussed in further detail below, when the interchangeable shaft assembly 1200 is coupled to the handle 1042, the shaft attachment lug 1278 is received in the firing shaft attachment bracket 1113 formed in the distal end 1111 of the longitudinal drive member 1110. In addition, the closure tube attachment yoke 1260 includes a proximally extending yoke portion 1265 that includes two capture slots 1267 that open downwardly to capture the attachment lugs 1066 on the closure attachment rod 1064.
[0249] Now refer to Figures 44 to 48 The operation of attaching the interchangeable shaft assembly 1220 to the handle 1042 is described. In various forms, at least one of the frame 1080 or the drive system defines an actuation axis AA-AA. For example, the actuation axis AA-AA can be defined by the axis of the longitudinally movable drive member 1110. Thus, when the intermediate firing shaft 1272 is operably coupled to the longitudinally movable drive member 1110, the actuation axis AA-AA is coaxial with the shaft axis SA-SA, as shown in FIG. Fig.48 shown.
[0250] To begin the coupling process, the clinician may position the shaft attachment module 1220 of the interchangeable shaft assembly 1200 over or near the frame attachment module portion 1084 of the frame 1080 such that the attachment lugs 1229 formed on the connector portion 1228 of the shaft attachment module 1220 are aligned with the dovetail slots 1088 in the attachment module portion 1084, as shown in FIG. Fig.45 As shown. The clinician can then move the shaft attachment module 1220 along the installation axis IA-IA that is substantially transverse to the actuation axis AA-AA. In other words, the shaft attachment module 1220 is moved in the installation direction "ID" that is substantially transverse to the actuation axis AA-AA until the attachment lugs 1229 of the connector portion 1228 are positioned to be "operably engaged" with the corresponding dovetail receiving slots 1088. See Fig.44 and Fig.46 . Fig.47The position of the shaft attachment module 1220 is shown before the shaft attachment lug 1278 on the intermediate firing shaft 1272 enters the bracket 1113 in the longitudinally movable drive member 1110 and the attachment lug 1066 on the closing attachment rod 1064 enters the corresponding slot 1267 in the yoke portion 1265 of the closing tube attachment yoke 1260. Fig.48 The position of the shaft attachment module 1220 is shown after the attachment process has been completed. As can be seen in this figure, the lugs 1066 (only one lug is shown) are positioned to be operably engaged in their corresponding slots 1267 in the yoke portion 1265 of the closure tube attachment yoke 1260. As used herein, the term "operably engaged" in the context of two components means that the two components are sufficiently engaged with each other so that once an actuation action is applied thereto, the components can perform their intended action, function and / or procedure.
[0251] As discussed above, see again Figures 44 to 49, at least five systems of the interchangeable shaft assembly 1200 can be operably coupled to at least five corresponding systems of the handle 1042. The first system can include a frame system that couples and / or aligns the frame of the shaft assembly 1200 with the frame of the handle 1042. As outlined above, the connector portion 1228 of the shaft assembly 1200 can engage with the attachment module portion 1084 of the handle frame 1080. The second system can include a closure drive system that can operably connect the closure trigger 1052 of the handle 1042 to the closure tube 1250 and the anvil 1310 of the shaft assembly 1200. As outlined above, the closure tube attachment yoke 1260 of the shaft assembly 1200 can engage with the attachment lug 1066 of the handle 1042. The third system can include a firing drive system that can operably connect the firing trigger 1120 of the handle 1042 to the intermediate firing shaft 1272 of the shaft assembly 1200. As outlined above, the shaft attachment lugs 1278 can be operably connected to the bracket 1113 of the longitudinal drive member 1110. The fourth system can include an electrical system that is capable of: (i) sending a signal to a controller (such as, for example, the microcontroller 7004) in the handle 1042 to indicate that a shaft assembly (such as, for example, the shaft assembly 1200) has been operably engaged with the handle 1042, and / or (ii) conducting power and / or transmitting signals between the shaft assembly 1200 and the handle 1042. For example, the shaft assembly 1200 can include six electrical contacts, and the electrical connector 4000 can also include six electrical contacts, wherein each electrical contact on the shaft assembly 1200 is paired and mated with an electrical contact on the electrical connector 4000 when the shaft assembly 1200 is assembled to the handle 1042. The shaft assembly 1200 can also include a latch 1236, which can be part of a fifth system, such as a locking system, that releasably locks the shaft assembly 1200 to the handle 1042. In various circumstances, for example, when the latch 1236 is engaged with the handle 1042, the latch 1236 can close a circuit in the handle 1042.
[0252] In addition to the above, the frame system, closed drive system, firing drive system and electrical system of the shaft assembly 1200 can be assembled to the corresponding system of the handle 1042 in the lateral direction (i.e., along the axis IA-IA). In various cases, the frame system, closed drive system and firing drive system of the shaft assembly 1200 can be connected to the corresponding system of the handle 1042 at the same time. In some cases, both of the frame system, closed drive system and firing drive system of the shaft assembly 1200 can be connected to the corresponding system of the handle 1042 at the same time. In at least one case, the frame system can be connected at least initially before the closed drive system and the firing drive system are connected. In such cases, the frame system can be configured to align their corresponding components before the closed drive system and the firing drive system are connected as outlined above. In various cases, the electrical system portion of the housing assembly 1200 and the handle 1042 can be configured to be connected at the same time so that the frame system, the closed drive system and / or the firing drive system are finally or completely placed. In some cases, the electrical system portions of the housing assembly 1200 and 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 completely positioned. In some cases, the electrical system portions of the housing assembly 1200 and the handle 1042 may be configured to be coupled after the frame system has been at least partially coupled but before the closure drive system and / or the firing drive system have been coupled. In various cases, the locking system may be configured so that it is the last system to be engaged, i.e., after the frame system, the closure drive system, the firing drive system, and the electrical system have all been engaged.
[0253] As outlined above, see again Figures 44 to 49 , the electrical connector 4000 of the handle 1042 may include a plurality of electrical contacts. Fig.51 , the electrical connector 4000 may 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. Although the illustrated embodiment utilizes six contacts, other embodiments are contemplated that may utilize more than six contacts or less than six contacts. Fig.51As shown, the first contact 4001a can be electrically connected to the transistor 4008, the contacts 4001b to 4001e can be electrically connected to the microcontroller 7004, and the sixth contact 4001f can be electrically connected to the ground. The microcontroller 7004 is discussed in more detail below. In some cases, one or more of the electrical contacts 4001b to 4001e can be electrically connected to one or more output channels of the microcontroller 7004, and can be powered when the handle 1042 is in the powered state, or have a voltage potential applied thereto. In some cases, one or more of the electrical contacts 4001b to 4001e can be electrically connected to one or more input channels of the microcontroller 7004, and the microcontroller 7004 can be configured to detect when a voltage potential is applied to such electrical contacts when the handle 1042 is in the powered state. When the shaft assembly (such as the shaft assembly 1200) is assembled to the handle 1042, the electrical contacts 4001a to 4001f may not be connected to each other. However, when the shaft assembly is not assembled to the handle 1042, the electrical contacts 4001a to 4001f of the electrical connector 4000 may be exposed, and in some cases, one or more of the contacts 4001a to 4001f may accidentally be electrically connected to each other. For example, such a situation may occur when one or more of the contacts 4001a to 4001f come into contact with a conductive material. When this occurs, for example, the microcontroller 7004 may receive an erroneous input and / or the shaft assembly 1200 may receive an erroneous output. To address this issue, in various cases, when the shaft assembly (such as the shaft assembly 1200) is not attached to the handle 1042, the handle 1042 may not be powered. In other cases, the handle 1042 may be powered when the shaft assembly (such as the shaft assembly 1200) is not attached thereto. In this case, for example, the microcontroller 7004 may be configured to disregard input or voltage potentials applied to contacts that are in electrical communication with the microcontroller 7004 (i.e., contacts 4001b to 4001e) before the shaft assembly is attached to the handle 1042. Although the microcontroller 7004 may be powered to operate other functions of the handle 1042 in this case, the handle 1042 may be in a powered-down state. To the extent that the voltage potential applied to the electrical contacts 4001b to 4001e may not affect the operation of the handle 1042, the electrical connector 4000 may be in a powered-down state. The reader will appreciate that even though the contacts 4001b to 4001e may be in a powered-down state, the electrical contacts 4001a and 4001f that are not in electrical communication with the microcontroller 7004 may or may not be in a powered-down state. For example, regardless of whether the handle 1042 is in a powered-up state or a powered-down state, the sixth electrical contact 4001f may remain in electrical communication with the ground.In addition, transistor 4008 and / or any other suitable structure of transistors (such as transistor 4010) and / or switches may be configured to control the supply of power from a power source 4004 (such as, for example, battery 1104) within the handle 1042 to the first electrical contact 4001a, as outlined above, regardless of whether the handle 1042 is in a powered-on or powered-off state. In various cases, for example, the latch 1236 of the shaft assembly 1200 may be configured to change the state of the transistor 4008 when the latch 1236 is engaged with the handle 1042. In various cases, as described elsewhere herein, the latch 1236 may be configured to close the circuit when engaging the handle 1042, and thus affect the state of the transistor 4008. In some cases, in addition to the following, the Hall effect sensor 4002 may be configured to switch the state of the transistor 4010, and thus the state of the transistor 4008, ultimately supplying power from the power source 4004 to the first contact 4001a. Thus, in addition to the above, both the power circuit and the signal circuit coupled to the connector 4000 may be powered down when the shaft assembly is not mounted to the handle 1042 , and may be powered up when the shaft assembly is mounted to the handle 1042 .
[0254] In each case, see again Fig.51 , the handle 1042 may include, for example, a Hall effect sensor 4002, which may be configured to detect a detectable element, such as a magnetic element, located on the shaft assembly (such as, for example, the shaft assembly 1200) when the shaft assembly is coupled to the handle 1042. The Hall effect sensor 4002 may be powered by a power source 4006, such as a battery, which may in effect amplify the detection signal of the Hall effect sensor 4002 and transmit it to the sensor via a power source 4006. Fig.51The circuit shown is in communication with an input channel of the microcontroller 7004. Once the microcontroller 7004 receives an input indicating that the shaft assembly has been at least partially coupled to the handle 1042 and that the electrical contacts 4001a to 4001f are no longer exposed, the microcontroller 7004 may enter its normal or powered-up operating state. In such an operating state, the microcontroller 7004 will evaluate signals transmitted from the shaft assembly to one or more contacts 4001b-4001e and / or transmit signals to the shaft assembly through one or more contacts 4001b-4001e in their normal use state. In various cases, the shaft assembly 1200 may have to be fully seated in order for the Hall effect sensor 4002 to detect the magnetic element. For example, while the Hall effect sensor 4002 may be used to detect the presence of the shaft assembly 1200, any suitable system of sensors and / or switches may be used to detect whether the shaft assembly has been assembled to the handle 1042. Thus, in addition to the above, both the power circuit and the signal circuit coupled to the connector 4000 may be powered down when the shaft assembly is not mounted to the handle 1042 , and may be powered up when the shaft assembly is mounted to the handle 1042 .
[0255] In various embodiments, for example, any number of magnetic sensing elements may be used to detect whether the shaft assembly has been assembled to the handle 1042. For example, technologies for magnetic field sensing include search coils, fluxgates, optical pumps, nuclear spinning, superconducting quantum interference devices (SQUIDs), Hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetosensitive diodes, magnetosensitive transistors, optical fibers, magneto-optics, and micro-electromechanical system-based magnetic sensors, among others.
[0256] After the interchangeable shaft assembly 1200 has been operably coupled to the handle 1042, actuation of the closure trigger 1052 will cause the outer sleeve 1250 and the shaft closure sleeve assembly 1354 coupled thereto to be axially advanced distally to actuate the anvil 1310 in the various manners disclosed herein. Fig.48 1042, the firing member 1270 in the interchangeable shaft assembly 1200 is coupled to the longitudinally movable drive member 1110 in the handle 1042. More specifically, the shaft attachment lug 1278 formed on the proximal end 1277 of the intermediate firing shaft 1272 is received in the firing shaft attachment bracket 1113 formed in the distal end 1111 of the longitudinally movable drive member 1110. Therefore, actuation of the firing trigger 1120, which causes power to be supplied to the motor 1102 to axially advance the longitudinally movable drive member 1110, will also cause the firing member 1270 to axially move within the shaft frame 1212. This action will cause the distal cutting portion 1280 to advance through the tissue clamped in the end effector 1300 in the various manners disclosed herein. Although in Fig.481080, but those of ordinary skill in the art will also understand that when in the coupled position shown in this figure, the attachment lug portions 1229 of the shaft attachment module 1220 are seated within their corresponding dovetail receiving slots 1088 in the attachment module portion 1084 of the frame 1080. Thus, the shaft attachment module 1220 is coupled to the frame 1080. In addition, although Fig.48 Not shown (but in Fig.40 ), when the shaft attachment module 1220 has been coupled to the frame 1080, the locking lugs 1242 on the locking yoke 1240 are seated in their corresponding locking grooves 1086 in the attachment module portion 1084 of the frame 1080 ( Fig.40 Only one is shown) to releasably maintain the shaft attachment module 1220 in operable engagement with the coupled frame 1080.
[0257] To separate the interchangeable shaft assembly 1220 from the frame 1080, the clinician pushes the latch button 1236 in the distal direction "D" to pivot the locking yoke 1240, as shown in FIG. Fig.41 This pivoting movement of the locking yoke 1240 causes the locking lug 1242 thereon to disengage from the state of being engaged with the locking groove 1086. The clinician can then move the shaft attachment module 1220 away from the handle in the disconnecting direction "DD", as shown. Fig.49 shown.
[0258] It will be understood by one of ordinary skill in the art that the shaft attachment module 1220 can also remain stationary and the handle 1042 can be moved along the mounting axis IA-IA that is substantially transverse to the shaft axis SA-SA to position the lugs 1229 on the connector portion 1228 to engage the dovetail slot 1088. It should also be understood that the shaft attachment module 1220 and the handle 1042 can be simultaneously moved toward each other along the mounting axis IA-IA that is substantially transverse to the shaft axis SA-SA and the actuation axis AA-AA.
[0259] As used herein, the phrase "substantially transverse to the actuation axis and / or shaft axis" refers to a direction that is nearly perpendicular to the actuation axis and / or shaft axis. However, it should be understood that some deviations from perpendicular to the actuation axis and / or shaft axis are also substantially transverse to these axes.
[0260] Using the physical properties of the device disclosed herein, we now turn to Fig.52 and Fig.53, a controller (such as, for example, microcontroller 7004) can be designed to simulate the response of the actual system of the instrument in the controller's software. The simulated response is compared to the (noisy discrete) measured response of the actual system to obtain an "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that balances the smooth continuous nature of the simulated response with the measured response, which can detect external influences on the system. See Fig.52 and Fig.53 , the firing element or cutting element in the end effector 1300 of the shaft assembly 1200 can be moved at or close to a target rate (or speed). Fig.52 and Fig.53 The system disclosed in the invention moves the cutting element at a target rate. The system may include a feedback controller 4200, which may be one of any feedback controllers, including but not limited to, for example, PID, state feedback, LQR, and / or adaptive controllers. The system may also include a power supply. The power supply may convert a signal from the feedback controller 4200 into, for example, a physical input to the system, in this case, a voltage. Other examples include, but are not limited to, for example, pulse width modulated (PWM) voltage, frequency modulated voltage, current, torque, and / or force.
[0261] Continue to see Fig.52 and Fig.53 , wherein the physical system referred to is the actual drive system of the instrument that is configured to drive the firing member or cutting member. One example is a brushed DC motor with a gear box and a mechanical link to the articulation and / or knife system. Another example is the motor 1102 disclosed herein that operates, for example, the firing member 10060 and the articulation driver 10030 of an interchangeable shaft assembly. Fig.52 and Fig.53 The external influences 4201 referred to in (for example) are the unmeasured, unpredictable effects of things such as tissue, surrounding objects, and friction on the physical system. Such external influences may be referred to as drag and may be represented, for example, by motor 4202, which acts opposite to motor 1102. In various cases, external influences such as drag are the main reason why the simulation of the physical system deviates from the actual physical system. Fig.52 and Fig.53 The system shown in and described further below can resolve differences between the predicted behavior of a firing member or cutting member and the actual behavior of the firing member or cutting member.
[0262] Continue to see Fig.52 and Fig.53, wherein the discrete sensors mentioned measure the physical parameters of the actual physical system. One embodiment of such a discrete sensor may include the absolute positioning sensor 7102 and system described herein. Since the output of such discrete sensors may be a digital signal (or connected to a digital data acquisition system), its output may have a limited resolution and sampling frequency. The output of the discrete sensor may be provided to a microcontroller (such as, for example, microcontroller 7004). In various cases, the microcontroller may merge the simulated or estimated response with the measured response. In some cases, it may be useful to use enough measured responses to ensure that external influences are taken into account without making the observed response uselessly noisy. Examples of algorithms that perform this operation include weighted averages and / or theoretical control loops, which, for example, drive the simulated response toward the measured response. Ultimately, in addition to the above, the simulation of the physical system takes into account characteristics such as mass, inertia, viscous friction and / or inductance resistance to predict the state and output of the physical system by knowing the input. Fig.53 Shown is an additional evaluation and measurement of the current provided by the operating actual system, which is yet another parameter that can be evaluated for use in controlling, for example, the speed of the cutting member or firing member of the shaft assembly 1200. In some cases, in addition to or instead of measuring voltage, by measuring current, the physical system can be made more accurate. Nevertheless, the ideas disclosed herein can be extended to the measurement of other state parameters of other physical systems.
[0263] Control systems such as Fig.54 and / or Fig.57 The control system shown in the figure can be used to control any surgical instrument disclosed herein. In various cases, the control system may include a microcontroller, such as, for example, microcontroller 7004, which can be configured to operate various systems of the surgical instrument. In addition to the above, the control system may include an assembly detection device for detecting whether a shaft assembly, such as, for example, shaft assembly 1200, has been assembled or at least partially assembled to handle 1042. Such assembly detection devices may include, for example, the Hall effect sensor 4002 described above, and a device for keeping the handle 1042 in a power-off state when the shaft assembly is not assembled to the handle 1042, and a device for keeping the handle 1042 in a power-on state when the shaft assembly is assembled to the handle 1042 (in addition to the above). As outlined above, for example, microcontroller 7004 may include such devices. The control system may also include a power transmission device for transmitting power to and / or from the shaft assembly, and / or a signal communication device for transmitting communication signals to and / or from the shaft assembly. Such power transfer means and signal communication means may include, for example, electrical connector 4000, a corresponding electrical connector on the shaft assembly, and / or microcontroller 7004.
[0264] See also Fig.54 and Fig.57 , the control system may also include at least one closed trigger switch and at least one closed trigger circuit, which may be configured to transmit to the microcontroller 7004 that the trigger 1052 has been closed and / or to be explained to it by the microcontroller 7004 that the trigger has been closed. Various switches may include, for example, potentiometers and / or Hall effect sensors. The control system may also include an unclosed operating device for operating the surgical instrument in an unclosed operating state when the closed trigger 1052 is in an unclosed position, and a closed operating device for operating the surgical instrument in a closed operating state when the closed trigger 1052 is in a closed position. The control system may include a power source such as, for example, a battery 1104, and a device for distributing the power of the power source throughout the control system. The control system may include a motor (such as, for example, a motor 1102), a motor power switch (such as, for example, a firing trigger 1120), and a motor operating device for operating the motor 1102 in a desired manner, as described elsewhere herein. In some cases, such a motor operating device may be configured to control the motor 1102, for example, using pulse width modulation (PWM) voltage control. In addition, PWM voltage control can be used to control, for example, the speed of the firing members 1272 and 1280. In the unclosed operating state of the surgical instrument, in some cases, the battery 1104 can be disconnected from the motor 1102, and in some cases, the motor controller can be configured to prevent the operation of the motor 1102 until the microcontroller 7004 detects the closure of the closing trigger 1052, even if power can be supplied to the motor 1102. In such cases, the microcontroller 7004 can then operate the surgical instrument in its closed operating state. In the closed operating state, power can be supplied to the motor 1102, and the motor controller can be configured to operate the motor 1102 in response to the operation of the firing trigger 1120. Figures 58 to 60 Various operations for operating, for example, the motor 1102 and the firing members 1272 and 1280 are shown.
[0265] See also Fig.54 and Fig.57, the control system may include, for example, a 12-bit magnetic rotary encoder, and may be configured to monitor the position of the firing members 1272 and 1280. In various cases, the control system may include an absolute positioning sensor 7102 and the above-mentioned sensing system to monitor the position of the firing members 1272 and 1280. The control system may also include a manual drive device for manually moving the firing members 1272 and 1280, and / or a device for operating another system of the surgical instrument according to the operation of the manual drive device. For example, the manual drive device may include, for example, a manually actuated emergency assembly 1130 as described above. In addition, for example, the operation of the manual drive device may electrically deactivate the motor 1102. In some cases, the operation of the manual drive device may disconnect the battery 1104 from the motor 1102. In some cases, the operation of the manual drive device may be detected by a motor controller, which may be configured to prevent the operation of the motor 1102, even if power may be supplied to the motor 1102. In various cases, the motor controller may include, for example, a microcontroller 7004.
[0266] See also Fig.54 and Fig.57 , the control system may also include a communication device for communicating with the operator of the instrument. In various cases, the communication device may include, for example, one or more light emitting diode (LED) lights on the handle 1042, which may be configured to, for example, notify the operator of the surgical instrument that the surgical instrument is in a specific operating state. In at least one case, the handle 1042 may include, for example, a green LED light, which, when lit, may indicate that the surgical instrument is in, for example, an assembled, closed, and powered state. In such cases, the lit green LED light may indicate that the surgical instrument is ready for use. The handle 1042 may include, for example, a red LED light, which, when lit, may indicate that the surgical instrument is in an unassembled, unclosed, and / or powered-off state. In such cases, the lit red LED light may indicate that the surgical instrument is not ready for use. In addition to the above, the LED light may be electrically connected to an output channel of the microcontroller 7004, wherein the microcontroller 7004 may be configured to, for example, determine and / or set the operating state of the surgical instrument and notify the state through the LED light. In some cases, the communication device may include, for example, a display screen on the handle 1042, which may be configured to transmit information to the operator of the surgical instrument. In addition to the above, the microcontroller 7004 may be electrically connected to the display screen to, for example, transmit the operating status of the surgical instrument.
[0267] See also Fig.54 and Fig.57 , and see also Fig.55 and Fig.56, the control system may include, for example, a plurality of switches electrically connected to the microcontroller 7004. These switches may include the switches discussed above and / or any system and / or subsystem in conjunction with the surgical instruments described herein. These switches may include a switch array that may be included in a switch circuit electrically connected to, for example, the microcontroller 7004. In some cases, the switch circuit may include, for example, a 16-bit I / O encoder that can communicate with the microcontroller 7004. In addition, the switch circuit may include a bus electrically connected to the microcontroller 7004 and one or more contacts in the electrical connector 4000. Ultimately, the switch circuit and the switch array may span, for example, the handle 1042 and the shaft assembly 1200. In various cases, the microcontroller 7004 may be configured to identify the shaft assembly attached to the handle 1042 and adjust the length of the firing stroke applied to, for example, the firing members 1272 and 1280. The entire disclosure of U.S. Patent 9,629,629, entitled “CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS,” issued on April 25, 2017, is incorporated herein by reference.
[0268] 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 includes a handle 18100, a shaft 18200 extending from the handle 18100, and an end effector 18300 extending from the shaft 18200. The end effector 18300 includes a first jaw 18310 and a second jaw 18320, wherein the first jaw 18310 is movable between an open clamping position and a closed clamping position to clamp tissue between the first jaw 18310 and the second jaw 18320. In addition, the end effector 18300 is rotatably attached to the shaft assembly 18200 about an articulation joint 18400. The handle 18100 includes a frame 18110 and a housing 18120. The handle 18100 also includes a grip 18130, a closure actuator 18140 operable to actuate an end effector closure system, and a firing actuator 18150 operable to actuate a nail firing system. The handle 18100 also includes an articulation actuator operable to actuate an end effector articulation system. The second jaw 18320 includes a replaceable nail magazine 18500 including nails removably stored therein, and the first jaw 18310 includes an anvil configured to deform the nails. The surgical instrument 18000 also includes an electric motor configured to drive the nail firing system of the surgical instrument 18000. Various staple firing systems are disclosed in U.S. Patent 7,000,818, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS," issued on February 21, 2006, and incorporated herein by reference.
[0269] See now Fig.62 , the nail magazine 18500 includes a magazine body 18510, which includes a longitudinal slot 18520, a proximal end 18530 and a distal end 18540. The nail magazine 18500 also includes a plurality of nail cavities 18222 defined in the magazine body 18510 and nails that can be removably stored in the nail cavities. The nail magazine 18500 also includes a sliding member 18550 ( Fig.69 ), during the nail firing stroke, the nail firing system enables the slide to move distally to drive the nail upward out of the nail cavity 18222 and into the patient's tissue. The nail magazine 18500 also includes a removable nail magazine retainer or cover 18570 ( Fig.70 ), which extends over the nail cavity and protects the nail. Fig.70, the cover includes an elongated body, a flexible latch arm 18574 extending from the body to releasably clamp the cartridge body 18510, and a longitudinal fin 18572 extending into the longitudinal slot 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 cases, the staple cartridge cover 18570 allows the clinician to place, for example, their thumb on the top of the staple cartridge 18500 to seat the staple cartridge 18500 in the second jaw 18320 without contacting the staples. Once the staple cartridge 18500 has been seated in the second jaw 18320, the cartridge cover 18570 can be 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 has been installed, the cartridge cover 18570 will prevent the staples from properly contacting the anvil of the first jaw 18310.
[0270] The surgical instrument 18000 also includes a controller including a microprocessor. The surgical instrument 18000 also includes an RFID system that communicates with the controller. The RFID system includes one or more RFID readers and one or more RFID tags, as will be discussed in more detail below. In various embodiments, the RFID system is configured to determine whether the nail magazine is positioned in the surgical instrument and / or whether the nail magazine is an appropriate nail magazine for use with the surgical instrument. Such an RFID system can also determine whether the nail magazine includes the correct components intended for the nail magazine. If the controller determines that the nail magazine is appropriate and the components in the nail magazine are correct, the surgical instrument 18000 can be used as expected. If the controller determines that the nail magazine is not suitable or one or more components in the nail magazine are incorrect, the controller can limit the operation of the surgical instrument in some way. In such cases, for example, the controller can allow the end effector to open and close, and / or allow the end effector to perform joint movement, but prevent the execution of the nail firing stroke. The RFID system can also be used to determine whether the nail magazine has been correctly positioned in the nail magazine support. For example, the RFID system may indicate whether the proximal end of the staple cartridge and / or the distal end of the staple cartridge are properly positioned in the staple cartridge channel, and if one of these ends of the staple cartridge has not been fully positioned, the controller may prevent the execution of the nail firing stroke. In addition, the RFID system may indicate whether the staple cartridge positioned in the surgical instrument is an unused staple cartridge, or whether the staple cartridge has been used or otherwise used. If the controller determines that the staple cartridge has been used, the controller prevents the execution of the nail firing stroke until the used staple cartridge has been 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.
[0271] Radio frequency identification (RFID) is used in a variety of industries to track and identify objects. RFID relies on radio waves to transmit digitally stored information from an RFID tag to an RFID reader or a receiver configured to receive the information. RFID technology uses an RFID tag (sometimes called a chip) containing electronically stored information, and an RFID reader for identification and communication using the RFID tag. There are two different types of RFID systems: active RFID systems and passive RFID systems. Active RFID systems include RFID tags that have an onboard power source to broadcast their signals. Active RFID tags can include a battery within the RFID tag, which allows active RFID tags to operate independently of the RFID reader. Therefore, RFID tags in active RFID systems do not need to wait to receive a signal from an RFID reader before sending information. Instead, active RFID tags are free to continuously send out signals or beacons. Many commercially available active RFID systems typically operate within one of two main frequency ranges (433 MHz and 915 MHz), but any suitable frequency range may be used. Typically, an RFID tag must be located within a specific distance or frequency range in order to be recognized by its corresponding RFID reader.
[0272] Passive RFID systems include RFID tags that do not have an onboard power supply, but receive the energy required for operation from an RFID reader. In contrast to active RFID tags, RFID tags in passive RFID systems do not actively send out signals before receiving a prompt. Instead, passive RFID tags wait to receive information from an RFID reader before sending out a signal. Many commercially available passive RFID systems typically operate in three frequency ranges, namely low frequency ("LF"), high frequency ("HF"), near field communication ("NFC"), and ultra-high frequency ("UHF"). The LF bandwidth is 125-134KHz, and includes longer wavelengths and a short read range of approximately one centimeter to ten centimeters. The HF and NFC bandwidths are 13.56MHz, and include medium wavelengths and a typical read range of one centimeter to one meter. The UHF bandwidth is 865-960MHz, and includes a high energy short wavelength of one meter, which translates to a long read range. As described above, any suitable frequency can be used.
[0273] There are various RFID systems including RFID tags of different sizes. However, some are more suitable for use in the field of technology where very small objects need to be tracked. For example, Hitachi Chemical Co. Ltd. is a leading manufacturer in the field of RFID technology. The ultra-small size UHF RFID tags manufactured by Hitachi Chemical Co. Ltd. are generally no larger than 1.0 mm to 13 mm, and enable communication between the RFID tag and the RFID reader at a distance of several centimeters or more. Due to its compact nature, the Hitachi RFID tag is 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 seals the IC chip and the antenna. Because the Hitachi RFID tag combines the antenna and the IC chip in a single unit, the Hitachi RFID tag is convenient enough and can be easily attached to any small object using, for example, an adhesive or tape.
[0274] The Hitachi RFID tag includes a square stainless steel plate and a metal antenna. The antenna includes an LC resonant circuit or any other suitable circuit and is electrically connected to the board. After the board and the antenna are connected to each other, the antenna and the board are sealed together using a sealing material in a single unit. The sealing material is mainly composed of epoxy resin, carbon and silicon dioxide to enhance the heat resistance of the Hitachi RFID tag. That is, the heat resistance of the RFID tag basically depends on the heat resistance of the sealing material. The sealing material has a high heat resistance temperature and can withstand up to 250 to 300°C in a shorter period of time and up to 150°C in a longer period of time. Therefore, the Hitachi RFID tag has higher heat resistance than conventional RFID tags and can also operate normally at high temperatures. Additional information about the Hitachi RFID tag can be found in U.S. Patent No. 9,171,244, entitled "RFIDTAG", published on October 27, 2015, which is incorporated herein by reference.
[0275] As described above, surgical instrument system 18000 includes an RFID system that includes one or more RFID readers and one or more RFID tags. In various embodiments, see Fig.62 The RFID system includes a first RFID tag 18560a, a second RFID tag 18560b and a third RFID tag 18560c. Fig.67A Hitachi ultra-small package UHF RFID tag 18900 is shown that can be used for RFID tags 18560a, 18560b, and 18560c, although any suitable RFID tag can be used. Tag 18900 includes dimensions of, for example, 2.5 mm×2.5 mm×0.4 mm. Tag 18900 includes a substrate or base 18910, a microchip 18920 mounted to substrate 18910, and an antenna 18930 mounted to substrate 18910 in a circumferential pattern that communicates with an output channel or pin of microchip 18920. Additional details about RFID tag 18900 are disclosed in U.S. Pat. No. 9,171,244, which is incorporated herein by reference in its entirety. That is, any suitable RFID tag can be used.
[0276] See also Fig.62 , Figure 64 to Figure 66 and Fig.68 , the first RFID tag 18560a is attached to the bin body 18510 at a first position A. The second RFID tag 18560b is attached to a slide 18550 that can be slidably positioned in the bin body 18510, such as Fig.69 As shown, and a third RFID tag 18560c is attached to the cover 18570, as Fig.70 See also 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 in the surgical instrument handle 18100 and a second jaw 18320. The first RFID reader 18600 includes a first induction coil or sensor 18620, which is aligned with the first RFID tag 18560a when the nail magazine 18500 is placed in the second jaw 18320. Similarly, the second RFID reader 18700 includes a flexible circuit extending between the controller in the surgical instrument handle 18100 and the second jaw 18320. The second RFID reader 18700 includes a second induction coil or sensor 18720 ( Fig.62 ), when the staple cartridge 18500 is placed in the second jaw 18320, the second inductive coil or sensor is aligned with the second RFID tag 18560b. Likewise, similarly, the third RFID reader 18600 includes a flexible circuit extending between the controller in the surgical instrument handle 18100 and the second jaw 18320. The third RFID reader 18800 includes a third inductive coil or sensor 18820 ( Fig.62), when the nail magazine 18500 is placed in the second jaw 18320, the third induction coil or sensor is aligned with the third RFID tag 18560c.
[0277] RFID tags 18560a, 18560b, and 18560c can be active and / or passive. When RFID tags 18560a, 18560b, and 18560c are active RFID tags, they each transmit a signal 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 beacon signal, the second beacon signal, and the third beacon signal can all be transmitted at the same frequency or at different frequencies. If the beacon signals are transmitted at the same frequency, the range of the beacon signals and / or the position 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 power from their corresponding power supplies or batteries. Typically, the range of the beacon signal is proportional to the transmitted power of the signal. If the beacon signals are transmitted at different frequencies, the range of the signal and the relative positioning of the RFID sensors 18620, 18720 and 18820 can be more flexible. In such embodiments, the controller includes one or more signal filters, such as, for example, low-pass filters and / or high-pass filters, which can be used to ensure that the signals and data received from the RFID tags 18560a, 18560b and 18560c are received on the correct input line or RFID reader. For example, a low pass filter may be used to filter out the second and third beacon signals on the first RFID reader 18600, a high pass filter may be used to filter out the first and second beacon signals on the third RFID reader 18800, and both the low pass filter and the high pass filter may be used to filter out the first and third beacon signals on the second RFID reader 18700. In any event, once the staple cartridge 18500 is seated in the second jaw 18320, the RFID readers 18600, 18700, and 18800 receive data from their respective RFID tags 18560a, 18560b, and 18560c. Notably, as the staple cartridge 18500 is seated and / or when the staple cartridge 18500 is aligned with the second jaw 18320 and is to be seated, the RFID tags 18560a, 18560b, and 18560c may begin communicating with their respective RFID readers.
[0278] When the RFID tags 18560a, 18560b, and 18560c are passive RFID tags, the RFID tags 18560a, 18560b, and 18560c do not transmit signals until they receive signals from their respective RFID scanners 18600, 18700, and 18800. For example, the first RFID tag 18560a does not transmit a signal until it is stimulated by a signal transmitted from the first sensor 18620 of the RFID scanner 18600. In this way, the first sensor 18620 acts as a transmitting antenna that broadcasts a first signal, and when the first signal is received by the first RFID tag 18560a, the first RFID tag 18560a transmits a first return signal that is received by the first sensor 18620. Therefore, the first sensor 18620 acts as both a transmitting antenna and a receiving antenna. That is, the first RFID scanner 18600 may include a transmitting antenna as part of a transmitting circuit and a separate receiving antenna as part of a receiving circuit. Similarly, the second RFID tag 18560b does not transmit a signal until it is stimulated by a signal transmitted from the second sensor 18720 of the RFID scanner 18700. In this way, the first sensor 18720 acts as a transmitting antenna that broadcasts the second signal, and when the second signal is received by the second RFID tag 18560b, the second RFID tag 18560b transmits a second return signal received by the second sensor 18720. Therefore, the second sensor 18720 acts as both a transmitting antenna and a receiving antenna. That is, the second RFID scanner 18700 may include a transmitting antenna as part of the transmitting circuit and a separate receiving antenna as part of the receiving circuit. Likewise, similarly, the third RFID tag 18560c does not transmit a signal until it is stimulated by a signal transmitted from the third sensor 18820 of the RFID scanner 18800. In this way, the third sensor 18820 acts as a transmitting antenna that broadcasts the third signal, and when the third signal is received by the third RFID tag 18560c, the third RFID tag 18560c transmits a third return signal that is received by the third sensor 18820. Therefore, the third sensor 18820 acts as both a transmitting antenna and a receiving antenna. That is, the third RFID scanner 18800 may include a transmitting antenna as part of the transmitting circuit and a separate receiving antenna as part of the receiving circuit.
[0279] As described above, the first RFID tag 18560a is attached 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 adhesives. That is, the first RFID tag 18560a can be attached to the cartridge body 18510 in any suitable manner. For example, see Fig.68, during the injection molding process, the first RFID tag 18560a can be integrally molded with the bin body 18510. In such cases, at least a portion of the first RFID tag 18560a is embedded in the bin body 18510. That is, embodiments are contemplated in which the entire first RFID tag 18560a is embedded in the bin body 18510. In addition, embodiments are contemplated in which the wall of the bin body 18510 defines a recess or pit and the first RFID tag 18560a is positioned in the recess. In various cases, the perimeter of the RFID tag 18560a matches the perimeter of the recess in the bin body 18510.
[0280] When the first RFID scanner 18600 receives the first signal from the first RFID tag 18560a and the first signal or data from the first signal is transmitted to the controller of the surgical instrument 18000, the controller determines that the nail magazine is present in the second jaw 18520. In various embodiments, the controller performs an authentication assessment to determine that the data received from the first RFID tag 18560a matches the data from the acceptable nail magazine. The data about the acceptable nail magazine can be stored in a memory device of the controller and / or can be stored in, for example, an off-machine controller and / or a cloud environment. If the controller determines that the nail magazine is present in the second jaw 18320 and the nail magazine is compatible, the controller will perform additional checks using the second RFID tag 18560b and the third RFID tag 18560c of the RFID system, as discussed in more detail below. That is, such an embodiment is envisioned in which the first RFID tag 18560a is the only RFID tag in the RFID system, and once the presence of a compatible nail magazine is verified via the first RFID tag 18560a, the controller can unlock the nail firing system.
[0281] As described above, the second RFID tag 18560b is attached to the slider 18550 of the staple cartridge 18500. The second RFID tag 18560b is attached to the slider 18550 using one or more adhesives. That is, the second RFID tag 18560b can be attached to the slider 18550 in any suitable manner. For example, see Fig.69, during the injection molding process, the second RFID tag 18560b can be integrally molded with the slider 18550. In such cases, at least a portion of the second RFID tag 18560b can be embedded in the slider 18550. That is, embodiments are contemplated in which the entire second RFID tag 18560b is embedded in the slider 18550. In addition, embodiments are contemplated in which the wall of the slider 18550 defines a recess or pit and the second RFID tag 18560b is positioned in the recess. In various cases, the perimeter of the RFID tag 18560b matches the perimeter of the recess in the slider 18550.
[0282] When the second RFID scanner 18700 receives the second signal from the second RFID tag 18560b and the second signal or data from the second signal is transmitted to the controller of the surgical instrument 18000, the controller determines that the slider is present in the nail magazine in its proximal unfired position. Using this information, the controller can determine that the nail magazine is in an unused state. If the slider 18550 is not in its proximal unfired position, the second RFID tag 18560b will not be within the range of the second RFID scanner 18700, and the controller will determine that the nail magazine positioned in the second jaw 18320 has been at least partially used. In such a case, the controller will not unlock the nail firing system until the nail magazine has been replaced with a compatible unused nail magazine.
[0283] In various embodiments, the controller performs an authentication evaluation to determine that the data received from the second RFID tag 18560b matches the data corresponding to the staple cartridge identified by the first RFID scanner 18600. If the controller determines via the data from the second RFID tag 18560b that the slide 18550 is the proper component of the staple cartridge present in the second jaw 18320, the controller will perform an additional check using the third RFID tag 18560c of the RFID system, as discussed in more detail below. That is, embodiments are contemplated in which the third RFID tag 18560c is not included, and once the presence of a compatible unfired staple cartridge is verified via the first RFID tag 18560a and the second RFID tag 18560b, as described above, the controller can unlock the staple firing system.
[0284] As mentioned above, see Fig.70 , the third RFID tag 18560c is attached 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 adhesives. That is, the third RFID tag 18560c can be attached to the cover 18570 in any suitable manner. For example, see Fig.70, during the injection molding process, the third RFID tag 18560c can be integrally molded with the cover 18570. In such cases, at least a portion of the third RFID tag 18560c can be embedded in the cover 18570. That is, embodiments are contemplated in which the entire third RFID tag 18560c is embedded in the cover 18570. In addition, embodiments are contemplated in which the wall of the cover 18570 defines a recess or pit and the third RFID tag 18560c is positioned in the recess. In various cases, the perimeter of the RFID tag 18560c matches the perimeter of the recess in the cover 18570.
[0285] When the third RFID scanner 18800 receives the third signal from the third RFID tag 18560c and the third signal or data from the third signal is transmitted to the controller of the surgical instrument 18000, the controller determines that the cover 18570 is attached to the nail magazine. Using this information, the controller can determine that the clinician inserted the nail magazine into the surgical instrument 18000 with the cover 18570 present and therefore did not interfere with the nails stored in the magazine body 18510. If the cover 18570 is not detected on the magazine body 18510, the controller will determine that the nail magazine may be damaged. In such a case, the controller will not unlock the nail firing system until the nail magazine has been replaced with a compatible, unused and undamaged nail magazine.
[0286] In various embodiments, the controller performs an authentication evaluation to determine that the data received from the third RFID tag 18560c matches the data corresponding to the staple cartridge identified by the third RFID scanner 18700. If the controller determines via the data from the third RFID tag 18560c that the cover 18570 is the proper component for the staple cartridge present in the second jaw 18320, the controller unlocks the staple firing system. Additional RFID tags and RFID tag scanners can be used to evaluate the presence, status, and / or compatibility of a staple cartridge positioned in a surgical instrument.
[0287] As described 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. If not, the controller cannot assess the position of the sled 18550 because it is not within the communication range of the second RFID 18700 scanner. That is, the surgical instrument may include more than one RFID scanner that is used by the controller of the surgical instrument to assess the position of the sled 18500 and, therefore, the progress of the nail firing stroke. See again Fig.66, the first RFID scanner 18600 and the third RFID scanner 18800 of the surgical instrument 18000 can be used to track the position of the slider 18500. As the slider 18500 moves distally during the nail firing stroke, the second RFID tag 18560b passes through the transmission range 18610 of the first RFID scanner 18600 and the 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 slider 18550 is in the adjacent position A. Similarly, when the second signal of the second RFID tag 18560b is detected by the third RFID scanner 18800, the controller determines that the slider 18550 is in the adjacent position C. In various embodiments, the RFID system may include an RFID scanner adjacent to the distal end of the nail cartridge that communicates with the controller to detect when the slider 18550 has reached the end of the nail firing stroke.
[0288] Many commercially available staple cartridges are sold in standard lengths. For example, Johnson & Johnson subsidiary Ethicon sells staple cartridges configured to apply 30mm long staple patterns, staple cartridges configured to apply 45mm long staple patterns, and staple cartridges configured to apply 60mm long staple patterns, etc. 30mm, 45mm, and 60mm lengths do not represent the total length of the staple cartridge; on the contrary, these lengths represent the lengths of the staple patterns to which these staple cartridges are applicable. That is, Ethicon also sells surgical staplers configured to receive 30mm staple cartridges. Such surgical staplers include anvils configured to deform the staples in the 30mm pattern. Ethicon also sells surgical staplers configured to receive 45mm staple cartridges and surgical staplers configured to receive 60mm staple cartridges, and has anvils configured to deform the 45mm staple pattern and the 60mm staple pattern, respectively. If other factors are not considered, the anvil designed to produce a 30mm long staple pattern will not be able to deform all the staples of the 60mm staple pattern. In various embodiments, further to the above, a surgical instrument can include an RFID system configured to evaluate whether a nail magazine that has been inserted into the surgical instrument has a nail pattern that matches a nail pattern that can be deformed by an anvil of the surgical instrument, as described in more detail below.
[0289] In addition to the above, see Fig.74 and Fig.75, the end effector 18300' of the surgical instrument includes a first jaw 18310 and a second jaw 18320, wherein the second jaw 18320 is 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 the staples stored in the staple cartridge 19700 matches the pattern of the staple forming recesses defined in the anvil of the first jaw 18310. Fig.74 Another staple cartridge 19600 is shown in FIG. Similar to staple cartridge 19700, staple cartridge 19600 can be inserted into second jaw 18320; however, staple cartridge 19600 produces a staple pattern of a different length or shorter length than the staple pattern produced by staple cartridge 19700. Therefore, staple cartridge 19600 is not suitable or appropriate for use with a surgical instrument, while staple cartridge 19700 is suitable or appropriate for use with a surgical instrument. The surgical instrument includes an RFID system that communicates with a controller of the surgical instrument, which is used to prevent the surgical instrument from performing a staple firing stroke when an incorrect staple cartridge (such as, for example, staple cartridge 19600) or no staple cartridge is positioned in second jaw 18320. Correspondingly, the controller is configured to allow the stapling instrument to be used to perform a staple firing stroke when the correct staple cartridge (such as staple cartridge 19700) is positioned in second jaw 18320 and recognized by the controller.
[0290] The end effector 18300' includes a first RFID scanner including a first sensor located at the proximal end of the second jaw 18320 and a second RFID scanner including a second sensor located at the distal end of the second jaw 18320. The staple cartridge 19700 includes a cartridge body 19710, a first RFID tag 19760a mounted to the proximal end of the cartridge body 19710, and a second RFID tag 19760b mounted to the distal end of the cartridge body 19710. When the staple cartridge 19700 is placed 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 a case, when the two RFID scanners detect the presence of their respective RFID tags, the controller of the surgical instrument can verify the presence of the correct staple cartridge in the second jaw 18320. As discussed herein, the controller can be configured to authenticate whether the signal and / or data received from the RFID tag matches a set of signals and / or data corresponding to a compatible nail magazine. In any case, the controller is configured to unlock the nail firing system once the controller determines that the correct nail magazine disposed in the second jaw 18320 exists.
[0291] In addition to the above, the staple cartridge 19600 includes a cartridge body 19610, a first RFID tag 19660a mounted to the proximal end of the cartridge body 19610, and a second RFID tag 19660b mounted to the distal end of the cartridge body 19610. When the staple cartridge 19600 is positioned in the second jaw 18320, the second RFID tag 19660b is aligned with the sensor of the second RFID scanner; however, see 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. Therefore, the controller can receive a signal from the second RFID tag 19660b, but cannot receive a signal from the first RFID tag 19660a. In such a case, the controller is configured to determine that a nail magazine with an incorrect length has been placed in the second jaw 18320. In other words, due to the detection of the second RFID tag 19660b by the second RFID scanner, the controller can determine that the nail magazine is present in the second jaw 18320, but due to the lack of a signal detected by the first RFID scanner, the nail magazine has an inappropriate length. The controller is configured to keep the nail firing system in a locked state until the controller has determined that the correct nail magazine is placed in the second jaw 18320. In at least one such embodiment, the controller does not respond to the firing actuator input and does not power the electric motor of the nail firing system until the correct nail magazine is detected in the second jaw 18320.
[0292] Fig.76 It is shown in Fig.74 and Fig.75The algorithm 16000 of the controller of the embodiment of the present invention. At step 16100, the controller uses the second RFID scanner to evaluate the presence of the second RFID tag 19660b. If the controller does not receive a signal from the second RFID scanner, the controller determines that there is no nail magazine in the second jaw 18320, and indicates to the clinician at step 16110 that there is no nail magazine. In various cases, the surgical instrument includes a display screen in communication with the controller, which is used to communicate the absence of the nail magazine to the clinician. In such cases, the algorithm 16000 returns to step 16100 and waits for the nail magazine to be inserted into the second jaw 18320 that can communicate with the second RFID scanner. If the controller receives a signal from the second RFID scanner at step 16100, the controller uses the first RFID scanner to evaluate the presence of the first tag 19660a at step 16200. If the controller does not receive a signal from the first RFID scanner, the controller determines that an incompatible nail magazine is present in the second jaw 18320, indicating this situation to the clinician at step 16210. This indication may be provided to the clinician via, for example, a display screen. In such cases, the algorithm 16000 returns to step 16100 and waits for a compatible staple cartridge to be inserted into the second jaw 18320 that can communicate with the first and second RFID scanners. If the controller receives a signal from the first RFID scanner at step 16200, the controller authenticates the authenticity of the first and / or second RFID tags at step 16300. In various cases, the controller includes multiple sets of data stored in a memory chip or memory device that can be used to authenticate data received from the first RFID tag 19660a and the second RFID tag 19660b. For example, if the data from the first RFID signal and the second RFID signal match the data set stored in the memory chip regarding the first RFID signal and the second RFID signal, then at step 16300 the controller may determine that the staple cartridge positioned in the second jaw 18320 is authentic. If the received data does not match the stored data at step 16300, then at step 16310 the controller indicates to the clinician, for example via a display screen, that an inauthentic staple cartridge is present in the second jaw 18320. In such an event, the algorithm 16000 returns to step 16100 and waits for a compatible real nail magazine to be inserted into the second jaw 18320.
[0293] Once the controller determines that the actual nail magazine is positioned in the second jaw 18320, the controller enables the nail firing system at step 16400. At this point, the controller responds to input from the nail firing actuator at step 16500 and applies a voltage potential to the electric motor of the nail firing system at step 16600 upon receipt of the input, assuming that all other conditions for executing the nail firing stroke have been met. For example, the controller is configured not to respond to input from the nail firing actuator when the first jaw 18310 is in the open position. However, when the first jaw 18310 is closed, the controller may respond to input from the nail firing actuator at steps 16500 and 16600. If no input is received from the nail firing actuator, the controller waits for such input at step 16510.
[0294] In various embodiments, further to the above, the staple cartridge 19700 and / or the second jaw 18320 include features that create 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. This snap fit arrangement securely holds the staple cartridge 19700 in the second jaw 18320, but still allows the staple cartridge 19700 to be removed from the second jaw 18320. In some instances, it may be relatively easy to seat the distal end of the staple cartridge 19700 in the second jaw 18320, while seating the proximal end of the staple cartridge 19700 may be somewhat difficult due to the proximity of the first jaw 18310. In various embodiments, an RFID system may be used to determine whether 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 seated in the second jaw 18320, the controller will detect the presence of the staple cartridge 19700 due to the signal received from the first RFID reader, but will determine 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 a case, the controller can communicate this situation to the clinician, for example, via a display, and provide the clinician with instructions on how to fix the problem. 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 a case, the controller can identify the staple cartridge 19700 as an unseated but still correct staple cartridge by authenticating a partial data set from the second RFID tag 19760b, or at least assume that the staple cartridge 19700 is the correct staple cartridge. In any case, if the controller determines that the ends of the nail magazine 19700 have not been fully seated, the controller will prevent the nail firing stroke from being actuated. Once both ends of the nail magazine 19700 have been fully seated, the controller responds to the input from the firing system actuator, assuming that all conditions for executing the nail firing stroke have been met.
[0295] As described above, a nail magazine includes nails removably stored therein, which are ejected from the nail magazine by a slide and / or firing member that moves through the nail magazine during the nail firing stroke. In various embodiments, the slide directly contacts the nails, while in other embodiments, the slide contacts the nail drivers, which support the nails and drive the nails out of the nail magazine during the nail firing stroke. The magazine body, slide and / or nail drivers of the nail magazine often experience significant stresses and strains during the nail firing stroke, and in such circumstances, it may not be desirable to reuse or reload a spent nail magazine with new nails. Accordingly, various embodiments are contemplated in which one or more features of the nail magazine are intentionally destroyed during and / or after the nail firing stroke to prevent the nail magazine from being reused. See. Fig.72 The nail magazine 19500 includes a magazine body 19510, nails removably stored in the magazine body 19510, nail drivers that can be movably stored in the magazine body 19510, and a sliding member 18550'( Fig.71 ), the slide is configured to be able to move in a proximal position ( Fig.72 ) and distal position ( Fig.72B ) between. Similar to the slide 18550, the slide 18550' includes an RFID tag 18560b mounted thereon, and similarly to the above, the RFID system of the surgical instrument 18000 is configured to verify that the slide 18550' is in its proximal unfired position ( Fig.72 ). When the nail magazine 19500 has not been fired before, see Fig.73A , the RFID system can communicate with the RFID tag 18560b and allow the nail firing stroke to be performed. However, at the end of the nail firing stroke, the RFID tag 18560b of the slide 18550' contacts the knife 19590 positioned at the distal end of the cartridge body 19510 and is cut by the knife, such as Fig.73B When RFID tag 18560b is cut in this manner, RFID tag 18560b is no longer able to transmit a signal, and even if slider 18550' is pushed back or reset to its proximal unfired position to reload staple cartridge 19500, the reloaded staple cartridge 19500 may not pass the certification test performed by the RFID system of surgical instrument 18000 due to the damaged RFID tag 18560b. Therefore, surgical instrument 18000 will not be able to perform a staple firing stroke with the reloaded staple cartridge 19500 positioned therein.
[0296] See again Fig.71, the RFID tag 18560b is mounted to the central or longitudinal portion 18552 of the slide 18550', which slides within the longitudinal slot of the nail magazine 19500. The RFID tag 18560b is partially embedded in the central portion 18552, and a portion of the RFID tag 18560b is exposed. More specifically, a portion of the RFID antenna is exposed. That is, the RFID tag 18560b can be mounted to the slide 18550' at any suitable position, such as on the track 18554 of the slide 18550'. The exposed portion of the RFID tag 18560b faces the distal end of the slide 18550', so that the RFID tag 18560b contacts the magazine knife 19590 at the end of the nail firing stroke. That is, an embodiment is envisioned in which the RFID tag 18560b on the slide 18550' is destroyed at the beginning of the nail firing stroke. In addition, an embodiment is envisioned in which the RFID tag of other nail magazine components is intentionally destroyed and / or disabled during use. A such embodiment is further discussed below, wherein when removing from the nail bin, the RFID tag of the nail bin cover is destroyed and / or disabled. In this case, the used nail bin cover may not be attached to the nail bin to pass the certification test performed by the RFID system.
[0297] As described above, the RFID system of surgical instrument 18000 includes three RFID readers, each of which is capable of communicating with and / or receiving signals from a corresponding RFID tag. Also as described above, the RFID reader may include, for example, a flexible circuit extending into the end effector 18300 of surgical instrument 18000. In such cases, see Fig.66 , the flexible circuit can be mounted to the wall of the second jaw 18320 and can be sized and configured to accommodate a staple cartridge disposed in the second jaw 18320. Fig.66 , the second jaw 18320 includes a bottom wall or support 18322 and two lateral side walls 18324 extending upward from the bottom wall 18322, and the two side walls are configured to receive a nail magazine therebetween. Two RFID flexible circuits are mounted to one side wall, and another RFID flexible circuit is mounted to the other side wall. In various cases, the RFID flexible circuits are mounted to the side walls using, for example, one or more adhesives. In addition to or in lieu of the above, fasteners can be used to mount the RFID flexible circuits to the walls of the second jaw 18320. In various alternative embodiments, see Fig.77 , the RFID scanner can be part of a flexible circuit. In at least one such embodiment, the RFID scanner includes a subcircuit of the flexible circuit.
[0298] See again Fig.77, the flexible circuit 19900 includes a flexible substrate and a conductor embedded in the flexible substrate. For example, the flexible substrate is composed of an insulating or non-conductive material (such as, for example, plastic), and the conductor is composed of, for example, copper. The flexible circuit 19900 is mounted to the bottom wall 18322 of the second jaw 18320, and includes a first RFID scanner 19100, a second RFID scanner 19200, and a third RFID scanner 19300. The first RFID scanner 19100 includes a sensor circuit that includes two conductors and a first sensor coil or array 19120. One of the conductors includes a coil portion defined in the first sensor 19120, and a conductive connector that connects the 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 the first side wall 18324 of the second jaw 18320. Similarly, the second RFID scanner 19200 includes a sensor circuit that includes 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 connecting the end of the coil portion to another conductor to complete the circuit of the second RFID scanner 19200. The second sensor 19220 is mounted to the second side wall 18324 of the second jaw 18320. Likewise, similarly, the third RFID scanner 19300 includes a sensor circuit that includes 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 connecting the end of the coil portion to another conductor to complete the circuit of the third RFID scanner 19300. The third sensor 19320 is mounted to the bottom wall 18322 of the second jaw 18320.
[0299] See again Fig.66, when a staple cartridge, such as, for example, staple cartridge 18500, is placed 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 includes 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 flat. The sensor 18620 of the first RFID scanner 18600 (similar to the sensor 19220 of the RFID scanner 19200) also includes a substantially planar configuration that appears flat. When the staple cartridge 18500 is placed in the second jaw 18320, the first RFID tag 18560a is parallel to or at least substantially parallel to the first sensor 18620. When there is an angle of about 10 degrees or less between the two planes of the first RFID tag 18560a and the first sensor 18620, they are substantially parallel to each other.
[0300] Furthermore, in addition to the above, the tag antenna of the first RFID tag 18560a extends circumferentially around the tag antenna axis TA ( Fig.67 ), the tag antenna axis is orthogonal or at least substantially orthogonal to the plane defined by the first RFID tag 18560a. When there is an angle of approximately 80 to 100 degrees between the tag antenna axis TA and the plane defined by the first RFID tag 18560a, the tag antenna axis TA is orthogonal to the first RFID tag 18560a. Similarly, the reader antenna of the first sensor 18620 extends circumferentially around the reader antenna axis SA ( Fig.77 ), the reader antenna axis is orthogonal or at least substantially orthogonal to the plane defined by the first sensor 18620. When there is an angle of approximately 80 to 100 degrees between the reader antenna axis SA and the plane defined by the first reader antenna 18620, the reader antenna axis SA is orthogonal to the first reader antenna 18620. When the staple cartridge 18500 is positioned in the second jaw 18320, the tag antenna axis TA is aligned with the reader antenna axis SA. In various cases, the tag antenna axis TA is colinear with the reader antenna axis SA. A similar arrangement may be implemented between the second RFID tag 18560b and the antenna 18720 of the second RFID reader 18700. In addition, a similar arrangement may be implemented between the third RFID tag 18560c and the antenna 18820 of the third RFID reader 18800.
[0301] See again Fig.66, the first RFID tag 18560a, the second RFID tag 18560b, and the third RFID tag 18560c are not longitudinally aligned in the second jaw 18320. More specifically, the second RFID tag 18560b is positioned proximally relative to the first RFID tag 18560a, and furthermore 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 so that they do not overlap. Furthermore, 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 furthermore the third sensor 18820 of the third RFID reader 18800 is positioned distally relative to the first sensor 18620. Similarly, Fig.66 As shown, the second transmission range 18710 of the second sensor 18720 is near the first transmission range 18610 of the first sensor 18620 and does not overlap therewith, and in addition, the third transmission range 18810 of the third sensor 18820 is far from the first transmission range 18610 of the first sensor 18620 and does not overlap therewith.
[0302] In addition to the above, see Figure 64 to Figure 66 , the first RFID tag 18560a and the second RFID tag 18560b are not laterally aligned in the second jaw 18320. More specifically, the first RFID tag 18560a is positioned in the lateral sidewall 18514 of the cartridge body 18510, and the second RFID tag 18560b is positioned in the longitudinal slot 18520. Additionally, the first RFID tag 18560a and the third RFID tag 18560c are not laterally aligned in the second jaw 18320. More specifically, the first RFID tag 18560a is positioned in the lateral sidewall 18514 of the cartridge body 18510, and the third RFID tag 18560c is positioned in the longitudinal slot 18520.
[0303] As discussed herein, a controller of a surgical instrument such as, for example, surgical instrument 18000 is configured to prevent or allow a nail firing stroke to be executed based on feedback from an RFID system. That is, the controller may be configured to change the operation of the surgical instrument in one or more other ways based on feedback from the RFID system. For example, the controller may be configured to change the speed of the nail firing stroke based on feedback from the RFID system. In at least one such embodiment, the controller may use data obtained from an RFID tag and / or data stored in a memory device to cause the electric motor of the nail firing system to operate at a desired speed for a nail magazine placed in the surgical instrument. In at least one case, the data indicates that the electric motor operates at a slower speed during the nail firing stroke. This arrangement may be useful when the nail magazine includes an implantable appendage that is releasably attached to the platform of the nail magazine. For example, when the nail magazine includes a long nail or a nail with a height between about 2.5 mm and about 5.0 mm before deforming against the anvil, this arrangement may also be useful. In other cases, the data indicates that the electric motor operates at a faster speed during the nail firing stroke. When the nail magazine does not include an implantable appendage that can be releasably attached to the platform of the nail magazine, this arrangement can be useful.For example, when the nail magazine includes short nails or nails with a height of less than about 2.5 mm before deforming against the anvil, this arrangement can also be useful.
[0304] During various surgical procedures, surgical instruments that include at least one replaceable component are used. It is important that such replaceable components are replaced with functional and / or compatible components. Various identification systems described in more detail herein verify compatibility with components of the surgical instrument and / or verify the operating status of the component. For example, the identification system can be used to, for example, ensure that the packaging containing the replaceable component has not been damaged and / or tampered with, warn the clinician that the component is compatible or incompatible with the surgical instrument before opening the product packaging, and / or remind the clinician if there is a recall on a specific manufacturing batch or type of the replaceable component.
[0305] Identification system as described herein can be an active system or a passive system. In various embodiments, a combination of an active identification system and a passive identification system is used. Passive systems can include, for example, bar codes, quick response (QR) codes and / or radio frequency identification (RFID) tags. Passive systems do not include an internal power supply, and passive systems as described herein need a reader to send a first signal, such as, for example, an inquiry signal.
[0306] The implementation of bar codes requires the use of an optical bar code reader and / or scanner. The bar code needs to be properly oriented relative to the scanner, and the scanner needs to have an unobstructed view of the bar code in order to properly scan the bar code. For at least these reasons, bar codes are typically printed onto paper or plastic. The scanner decodes the bars of the bar code, which typically represent a series of numbers. The decoded information is sent to a computer or controller, which interprets what has been read. The information may include data about, for example, 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 the surgical instrument.
[0307] Another passive identification system includes a Quick Response (QR) code. A QR code is a matrix barcode. A QR code typically includes data pointing to a locator, identifier, or tracker of a website or an application for use on a mobile device. Qr codes use four standardized encoding modes to efficiently store data. These four standardized encoding modes include numbers, alphanumerics, bytes / binary, and Japanese kanji. A QR code consists of black squares arranged in a square grid on a white background, which can be read by an imaging device such as a camera. The captured image is processed using Reed-Solomon error correction until the captured image can be properly interpreted. The desired data is then extracted from the pattern that exists in the horizontal and vertical components of the image. The desired data may include, for example, the manufacturer of the replaceable component, the type or model of the replaceable component, and / or the compatibility information of the replaceable component with the surgical instrument.
[0308] 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, for example, a microchip, that stores information about replaceable parts and / or surgical instruments with which the replaceable parts are compatible. Although the chip may contain only a basic identification number, in various cases, the chip may store additional information, such as, for example, manufacturing data, shipping data, and / or maintenance history. Each RFID tag includes a radio antenna that allows the RFID tag to communicate with the RFID scanner. The radio antenna extends the range at which the RFID tag can receive signals from the RFID scanner and send response signals back to the RFID scanner. In a passive RFID system, the RFID scanner also includes its own antenna that transmits a radio signal that activates an RFID tag located within a predetermined range. The RFID scanner is configured to receive a response signal that "bounces back" from the RFID tag, thereby allowing the RFID scanner to capture identification information representing the replaceable part. In various cases, the one or more response signals include the same signal as the interrogation signal. In various cases, the one or more response signals include a modified signal from the interrogation signal. In various cases, the RFID scanner can also write or encode information directly onto the RFID tag. In any case, the software on the RFID scanner can pass information about the replaceable component to a controller, such as a control system for the surgical instrument, a surgical hub, and / or a remote surgical system. Various surgical hubs are described in U.S. patent application serial number 16 / 209,395, entitled "METHOD OF HUB COMMUNICATION," filed on December 4, 2018, which is hereby incorporated by reference in its entirety. The RFID scanner is configured to read multiple RFID tags at a time because the RFID tags are activated by radio signals.
[0309] Active radio frequency identification (RFID) systems also include RFID tags and RFID scanners. However, the RFID tags in active RFID systems include an internal power source. Active RFID systems utilize battery-powered RFID tags that are configured to continuously broadcast their own signals. One type of active RFID tag is generally referred to as a "beacon." Such beacon RFID tags do not wait to receive a first signal from an RFID scanner. Instead, the beacon RFID tag continuously transmits its stored information. For example, a beacon can send its information at intervals of 3-5 seconds. Another type of active RFID tag includes a transponder. In such a system, the RFID scanner first transmits a signal. The RFID transponder tag then sends a signal back to the RFID scanner with relevant information. Such RFID transponder tag systems are effective because they save battery life when, for example, the RFID tag is out of range of the RFID scanner. In various cases, active RFID tags include onboard sensors to track environmental parameters. For example, onboard sensors can track moisture content, temperature, and / or other data that may be relevant.
[0310] The replacement staple cartridge is contained in a sealed package after manufacture until the package is opened in the operating room. Various forms of packaging include, for example, paper and plastic bags, woven and / or nonwoven material wrappings, and rigid containers. Fig.78 An example of a sealed package 25000 is shown. The package 25000 shown is a paper plastic bag. The package 25000 includes a first layer 25010 and a second layer 25020. The first layer 25010 and the second layer 25020 form a protective barrier around the staple cartridge 25100, which can be used with surgical instruments. The adhesive bonds the first layer 25010 and the second layer 25020 together to form an airtight and / or fluid-tight seal and / or bag around the article. The adhesive forms a seal without creases, wrinkles and / or gaps. For example, the seal created by the adhesive prevents contaminants from contacting the staple cartridge 25100 and / or prevents the components of the staple cartridge 25100 from being misplaced. In various cases, the staple cartridge 25100 is hermetically sealed within the package 25000. In various cases, the package 25000 provides a completely fluid-tight seal. In various cases, the package provides a complete fluid-tight and airtight seal.
[0311] 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. The clinician can expose the sealed staple cartridge 25100 by peeling the first layer 25010 away from the second layer 25020. In various circumstances, the 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 in a direction away from the second layer 25021, although any suitable opening method can be used.
[0312] The first layer 25010 and the second layer 25020 are made of materials such as 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 cases, the first layer 25010 and the second layer 25020 are made of plastic. The first layer 25010 and the second layer 25020 can be made of a material with a certain transparency to allow a clinician to observe the contents of the package 25000, for example. As described above, any suitable material or combination of materials can be used for the first layer 25010 and / or the second layer 25020.
[0313] The package 25000 includes various identification systems that facilitate the surgical instrument and / or clinician to select 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 indicate the contents of the package 25000 in some manner. For example, Fig.78 As shown, the name 25012 of the product contained within the package 25000 is printed or otherwise displayed on the first layer 25010.
[0314] The package 25000 also includes one or more passive identification systems displayed on the first layer 25010. For example, the package 25000 includes a QR code 25014. The QR code 25014 can assist, for example, in sorting and / or tracking the status of the package 25000. The QR code 25014 can also be scanned before breaking the seal of the package 25000 to ensure that the contents are suitable for use with a particular instrument and / or during a particular surgical procedure.
[0315] In addition to the name 25012 of the contents of the package 25000 displayed on the first layer 25010, the package 25000 includes a serial number 25016, which can, for example, provide more detailed information that a clinician can use before deciding whether to open the package 25000. For example, the serial number 25016 may include an alphanumeric symbol that is specific to the surgical system and / or unique to the surgical system. Each alphanumeric symbol may represent a component of a compatible assembled surgical system. For example, the alphanumeric symbol may represent a staple cartridge, an end effector, an axis assembly, a surgical instrument, etc. The serial number 25016 may represent additional factors, such as a manufacturing batch, a manufacturing date, etc. In various cases, the serial number 25016 may include encrypted information as described in more detail herein.
[0316] It is contemplated that package 25000 may include some or all of the various forms of identification systems discussed herein.
[0317] Fig.79 and Fig.80 An RFID system 25200 integrated with a package 25000 is shown. The RFID system 25200 includes an RFID tag 25210 and an insulator 25220. The RFID tag 25210 includes 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 cases, the chip includes a basic identification number. This basic identification can be assigned to a chip that can transmit the presence of the chip to an RFID scanner. In various cases, the chip includes additional information, such as, for example, manufacturing data, shipping data, and / or compatibility data. The RFID tag 25210 also includes a radio antenna configured to facilitate communication between the RFID tag 25210 and the RFID scanner.
[0318] 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 to or otherwise connected to the RFID tag 25210. The RFID tag 25210 is part of an active RFID system 25200, including an internal power source that is activated when the package 25000 is opened. Before the package 25000 is opened, the joint between the insulator 25220 and the RFID tag 25210 prevents the power source from providing power to the RFID tag 25210. In such a case, the RFID tag 25210 cannot transmit 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 separated 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 powered on. Fig.80 As shown, the RFID tag 25210 begins to transmit a signal 25215 when powered on. The RFID tag 25210 is configured to transmit the signal 25215 at any suitable frequency and / or any suitable duration. For example, the RFID tag 25210 may continuously transmit the signal 25215, or the RFID tag 25210 may transmit the signal 25215 every 3-5 seconds. The signal 25215 includes some or all of the information stored on the chip. In various cases, the signal 25215 can be used to alert the surgical instrument that the package 25000 has been tampered with during transportation and / or storage or simply that the package 25000 has been opened.
[0319] The RFID tag 25210 is configured to communicate with an RFID scanner. Once the insulator 25220 has been removed, the internal power source of the RFID tag 25210 allows the RFID tag 25210 to transmit a signal 25215 before receiving a first signal (such as an interrogation signal) from the RFID scanner. The RFID scanner includes a scanner antenna configured to transmit and / or receive a radio signal 25215 from the RFID tag 25210. In various cases, the RFID scanner includes a read capability and a write capability. The software on the RFID scanner is then able to pass the collected information from the RFID tag 25210 to the controller of the surgical instrument for further interpretation. The RFID scanner is located within a predetermined range of the RFID tag 25210, which allows the RFID scanner to receive the transmission signal 25215 emitted by the RFID tag 25210. Depending on the application, the RFID scanner may be located on the surgical instrument, on the contents of the package, or remotely located 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 a surgical instrument or a remote console.
[0320] In various embodiments, an RFID system including an RFID tag mounted to a staple cartridge 25100 may be used. In addition to the above, the RFID tag includes an internal power source located within the staple cartridge 25100. Suitable locations for the RFID tag include, for example, on a slide of the staple cartridge, on a side wall of the staple cartridge, or on a retainer of a staple cartridge assembly. An insulator similar to insulator 25220 is attached to the package 25000, and 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, and the circuit between the power source and the RFID tag is kept open. The joint between the insulator 25220 and the RFID tag prevents the power source from activating the RFID tag, and the RFID tag cannot transmit a signal. When the clinician breaks the seal of the package 25000 by peeling off the first layer 25010, for example, disconnecting or otherwise separating the insulator 25220 from the RFID tag, the circuit between the power source and the RFID tag is closed. At this point, the RFID tag is powered on and begins to transmit a signal.
[0321] In various cases, the RFID system 25200 also includes a transponder. The transponder is configured to receive a first signal from the RFID scanner. In various cases, the first signal from the RFID scanner fully powers the transponder so that the transponder communicates with the RFID tag. In various cases, the transponder is powered on before receiving the first signal from the RFID scanner. In any 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 power supply of the RFID tag powers on the RFID tag upon receiving the second signal from the transponder, and the RFID tag is able to respond to the first signal of the RFID scanner by transmitting a third signal to the RFID scanner. The transponder maintains the battery life of the RFID tag 25210 until, for example, the RFID tag 25210 is within the range of the RFID scanner.
[0322] As described in more detail herein, it is valuable to enable a clinician to verify the compatibility of a staple cartridge used with a particular surgical instrument and / or during a particular surgical procedure. It is also valuable to enable a clinician to ensure that a surgical staple cartridge has not been previously used and / or tampered with for a variety of reasons. The clinician may also wish to confirm, for example, that the surgical staple cartridge is not contaminated, that the staple retaining member has not been removed, and / or that a firing member, such as a slide, is positioned in the cartridge body.
[0323] Figure 81 to Figure 83 A staple cartridge assembly 26000 is shown. The staple cartridge assembly 26000 includes a staple cartridge 26100, and a staple retaining member or retainer 26200 attached to the staple cartridge 26100. The retainer 26200 is positioned alongside the staple cartridge 26100 to facilitate attachment of the staple cartridge 26100 to a surgical instrument and / or retain the staples within their respective staple cavities in the staple cartridge 26100. The retainer 26200 includes a longitudinal projection 26210 configured to be received by an elongated slot defined in the staple cartridge 26100. The longitudinal projection 26210 projects from a bottom surface 26206 of the retainer 26200 and extends from a proximal end 26202 of the retainer 26200 toward a distal end 26204 of the retainer 26200. The retainer 26200 also includes a set of proximal external projections 26240 and a set of distal external projections 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 protrusion 26210 and the external protrusions 26220, 26240 are used, for example, to retain the retainer 26200 to the staple cartridge 26100. 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.
[0324] When the retainer 26200 is attached to the staple cartridge 26100, the bottom surface 26206 of the retainer 26200 is located next to the platform surface 26106 of the staple cartridge 26100. In various cases, the bottom surface 26206 does not contact the platform surface 26106 of the staple cartridge 26100 until a push force is applied to the top of the fixture 25200. In other cases, the bottom surface 20206 contacts the platform surface 26106. To remove the retainer 26200 from the staple cartridge 26100, and thus facilitate attachment of the staple cartridge 26100 to the surgical instrument, the clinician pulls or lifts the thumb protrusion 26230 in a direction away from the staple cartridge 26100. The retainer 26200 is made of a material such as, for example, plastic that provides a degree of flexibility to the retainer 26200. As the thumb tab 26230 is lifted off the staple cartridge 26100, the exterior tabs 26220, 26240 provide an opposing force in an effort to maintain the connection between the retainer 26200 and the staple cartridge 26100. In order to remove the retainer 26200, the clinician must apply a force to the thumb tab 26230 that is strong enough to overcome the opposing retaining force created by the exterior tabs 26220, 26240. As the thumb tab 26230 is pulled off 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.
[0325] The retainer 26200 also includes an RFID tag 26250. The RFID tag 26250 includes a chip, such as, for example, a microchip, that stores information about the staple cartridge assembly 26000. Figure 81 to Figure 83As shown, the RFID tag 26250 is molded into the retainer 26200. However, the RFID tag 26250 can be embedded in the retainer 26200, mounted to the retainer and / or attached to the retainer by any suitable method. In the depicted embodiment, the RFID tag 26250 is molded into the distal portion of the longitudinal protrusion 26210. The RFID tag 26250 is located at a structurally weak position in the retainer 26200. The structurally weak position can be any portion of the retainer 26200 that is bent and / or flexed in response to the upward pull of the thumb protrusion 26230 and / or the removal of the retainer 26200 from the nail magazine 26100. The RFID tag 26250 is attached to the retainer 26200 in a manner and position that promotes the physical destruction of the RFID tag 26250 during the retainer removal process. The first end 26252 of the RFID tag 26250 is attached to the first portion 26212 of the holder 26200, and the second end 26254 of the RFID tag 26250 is attached to the second portion 26214 of the holder 26200. As the holder 26200 begins to bend in response to pulling upward on the thumb protrusion 26230, the first portion 26212 of the holder 26200 and the second portion 26214 of the holder flex away from each other. The first end 26252 of the RFID tag 26250 is pulled by the first portion 26212 of the holder 26200, and the second end 26254 of the RFID tag 26250 is pulled in the opposite direction by the second portion 26214 of the holder 26200. The RFID tag 26250 is pulled apart and / or otherwise damaged due to the stretching and / or flexing. The RFID tag 26250 is fragile, brittle and / or fragile, and is not configured to be able to stretch significantly. It is contemplated that the RFID tag 26250 may be positioned at 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 attached to the retainer 26200 in any suitable manner that renders the RFID tag 26250 inoperable during / after removal of the retainer 26200 from the staple cartridge 26100. In various embodiments, the RFID tag 26250 may separate or disengage from the retainer 26200 during this removal process.
[0326] In various cases, it is undesirable to destroy the components of the surgical system. However, the destruction of the RFID tag 26250 in the retainer 26200 prevents the clinician from reusing the retainer 26200 with an incompatible or in other words 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. This signal indicates to the controller that the retainer 26200 remains connected to the staple cartridge 26100. In various cases, the signal may also indicate that the staple cartridge 26100 is compatible or incompatible with the surgical instrument. In the absence of receiving the signal and / or receiving an incompatible signal, various functions of the surgical instrument are unavailable. In various cases, and as described below, the RFID tag 26250 in the retainer 26200 must lose the ability to send and / or transmit a signal using an RFID scanner. The RFID tag 26250 may lose the ability to communicate by the RFID tag 26250 being physically destroyed and / or positioned outside the range of the RFID scanner. Regardless, 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 the clinician cannot reuse the retainer 26200 on an incompatible staple cartridge. In various cases, the staple cartridge 26100 includes an RFID tag within the communication range of the RFID scanner. When the controller receives information detected from the staple cartridge RFID tag but not 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 is removed.
[0327] The RFID tag 26250 in the holder 26200 provides a lockout for the surgical instrument. If the information stored on the RFID tag 26250 is not received by the controller of the surgical instrument, the surgical instrument will not perform a nail firing stroke. In various cases, when the RFID tag 26250 is still communicating with the RFID scanner, the surgical instrument will not perform a nail firing stroke. This lockout prevents the surgical instrument from performing a nail firing stroke when the nail cartridge 26100 has been improperly placed in the surgical instrument while the holder 26200 is still attached.
[0328] In various cases, the staple cartridge 26100 and the retainer 26200 are assembled into the staple cartridge assembly 26000 by the manufacturer. In such cases, 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, the staple cartridge assembly 26000 has been tampered with, and / or there is a manufacturing defect that inhibits proper attachment. Separation and / or physical destruction of the RFID tag 26250 prevents, for example, the retainer 26200 from being placed on a used and / or otherwise inappropriate staple cartridge 26100.
[0329] As mentioned in more detail herein, a 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 within a predetermined range of the RFID scanner. The RFID scanner then receives one or more response signals that "bounce back" from the RFID tag. In various cases, the one or more response signals include the same signal as the interrogation signal. In various cases, the one or more response signals include a modified signal from the interrogation signal. In various cases, the RFID scanner includes a read capability and a write capability. The software on the RFID scanner is then able to pass the collected information from the RFID tag to the controller for further interpretation. The controller may be positioned in a surgical instrument, a remote console, or in any suitable location. The RFID scanner and / or the controller may include a stored set of information corresponding to a surgical suturing assembly that is compatible with a specific surgical instrument and / or used during a specific surgical procedure.
[0330] 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 may be present in various locations. For example, the RFID scanner may be located in the staple cartridge 26100. In various cases, the RFID scanner may be located in the jaws of the end effector of the surgical instrument, in an alternative location within the surgical system, and / or any other suitable location that allows 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 the RFID tag 26250 are powered so that the signal it transmits can only be detected within a limited radius. The RFID scanner and the RFID tag 26250 are close enough to facilitate communication when the retainer 26200 is attached to the staple cartridge 26100, but are not close enough to prevent communication when the retainer 26200 is removed from the staple cartridge 26100. That is, when the retainer 26200 is removed from the staple cartridge 26100, the RFID tag 26250 is inoperable by, for example, physical destruction or separation. When the RFID tag 26250 is inoperable, it does not respond to a signal (such as an interrogation signal) sent by an RFID scanner.
[0331] If a used retainer with a damaged RFID tag 26250 is attached to another nail magazine, the RFID scanner and the damaged RFID tag 26250 will not be able to communicate. In such cases, the nail magazine verification system of the surgical instrument will not be able to allow the surgical instrument to perform a nail firing stroke. If the RFID scanner receives a response to an inquiry signal that is not found in a stored set of compatible suturing components, the controller of the surgical instrument is programmed to communicate the error to the clinician. Similarly, if the RFID scanner does not receive a response to the inquiry signal, the controller of the surgical instrument is programmed to communicate the error to the clinician. In various cases, the controller detects an error that can prevent the surgical instrument from being used with a specific nail magazine. In various cases, the detected error can prevent the surgical instrument from performing a nail firing stroke and / or a tissue cutting stroke. In various cases, the surgical instrument also includes a manual override control that can be activated to allow the clinician to override any system lockout in an emergency and utilize the operating functions of the surgical instrument. As described above, the controller is configured to remind the clinician that an error has been detected. Such reminders may be transmitted through various forms of feedback, including, for example, tactile feedback, audio feedback, and / or visual feedback. In at least one case, the feedback includes audio feedback, and the surgical instrument may include a speaker that emits a sound such as, for example, a beep when an error is detected. In some cases, the feedback includes visual feedback, and the surgical instrument may include a light emitting diode (LED), for example, which flashes when an error is detected. In various cases, the feedback includes tactile feedback, and the surgical instrument may include an electric motor that includes an eccentric element that vibrates when an error is detected. The reminder may be specific or general. For example, the reminder may specifically indicate that the RFID tag 26250 on the retainer 26200 cannot be detected, or the reminder may specifically indicate that the RFID tag 26250 includes information indicating an incompatible and / or defective staple cartridge assembly 26000.
[0332] Fig.84A staple cartridge assembly 27000 is shown. The staple cartridge assembly includes a staple cartridge 27100. The staple cartridge 27100 includes 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 in 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 the passage of a firing and / or cutting member such as a mover 27125 therethrough during a staple firing stroke. Channels 27120 are defined in 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 slider 27125. The nail magazine 27100 also includes several rows of longitudinal nail cavities defined in the magazine body, and nails removably stored in the nail cavities. During the nail firing stroke, the sliding member 27125 ejects nails from the nail magazine 27100.
[0333] The staple cartridge assembly 27000 also includes an RFID system 27200. The RFID system 27200 includes an RFID tag 27250 mounted to the staple cartridge assembly 27000 and an RFID scanner 27300 mounted 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 cases, the chip includes a basic identification number of the staple cartridge 27100. In various cases, the chip includes additional information, such as, for example, manufacturing data, shipping data, and / or compatibility data. The RFID tag 27250 also includes a radio antenna configured to receive an interrogation signal from the RFID scanner 27300 and to send a response signal to the RFID scanner. The RFID scanner 27300 is configured to communicate with the RFID tag 27250 when the staple cartridge 27100 is placed in the surgical instrument. The RFID scanner 27300 includes a scanner antenna that is configured to, for example, transmit and receive radio signals. That is, the RFID system 27200 can use any suitable frequency. Since electromagnetic waves have different performances at various frequencies, the desired frequency is selected based on the specific application. In various cases, the RFID system 27200 can utilize low frequency, high frequency and / or ultra-high frequency. The radio signal activates the RFID tag within the predetermined range of the RFID scanner 27300. The RFID scanner 27300 then receives one or more response signals that "bounce back" from the RFID tag. In various cases, the one or more response signals include the same signal as the interrogation signal. In various cases, the one or more response signals include a modified signal from the interrogation signal. In various cases, the RFID scanner 27300 includes reading and writing capabilities. The software on the RFID scanner 27300 is then able to pass the collected information from the RFID tag to the controller for further interpretation. The controller can be located in the surgical instrument, on the remote console, or in any suitable location. The RFID scanner and / or the controller may include a stored set of information corresponding to a surgical suturing assembly compatible with a specific surgical instrument and / or a specific surgical procedure.
[0334] As described above, the RFID scanner 27300 in the surgical instrument is configured to interact with the RFID tag 27250 positioned on the staple cartridge 27100. Fig.84As shown, the RFID tag 27250 is attached to one of the side walls 27102 of the staple cartridge 27100, and the RFID scanner 27300 is installed in the surgical instrument. As described above, the RFID tag 27250 includes a radio antenna 27252 and a chip 27254. In the depicted embodiment, the radio antenna 27252 and the chip 27254 are positioned in the RFID tag 27250. In various cases, the radio antenna 27252 is positioned on the outer surface of the RFID tag 27250. When the staple cartridge 27100 is placed in the surgical instrument, the RFID tag 27250 is positioned to be a distance "D" from the RFID scanner 27300. It is worth noting that the distance "D" can be, for example, about 1 / 4 of the length of the staple cartridge 27100, 1 / 3 of the length of the staple cartridge 27100, or 1 / 2 of the length of the staple cartridge 27100. In the depicted embodiment, the communication range 27255 of the radio antenna of the RFID tag and the antenna of the RFID scanner spans, for example, about 1 centimeter (cm). The distance "D" is greater than 1 cm and is therefore outside the communication range 27255 between the RFID scanner 27300 and the radio antenna 27252 of the RFID tag 27250. Therefore, the RFID tag 27250 cannot receive the interrogation signal and will not respond to the interrogation signal from the RFID scanner 27300.
[0335] To facilitate communication with the RFID scanner 27300, Fig.84The RFID tag system 27200 depicted in the figure also includes an extended antenna 27260 that communicates with the RFID tag 27250. The extended antenna 27260 is used to expand the communication range of the RFID tag 27250, for example, compared to the radio antenna 27252. The extended antenna 27260 extends along the side wall 27102, is attached to the side wall and spans a portion of the base 27104 of the nail magazine 27100. At least a portion of the extended antenna 27260 crosses the elongated slot 27110. In the depicted embodiment, the communication range 27265 of the extended antenna 27260 spans, for example, about 2 centimeters (cm). As previously described, the RFID scanner 27300 is positioned at a distance "D" from the RFID tag 27250. Although the distance "D" is greater than 1 cm, the distance "D" is less than 2 cm and is therefore within the communication range 27265 of the extended antenna 27260 and the RFID scanner antenna. With the extended antenna 27260, the RFID tag 27250 is able to receive and respond to interrogation signals from the RFID scanner 27300. However, without the extended antenna 27260, the RFID tag 27250 may not communicate with the RFID scanner 27300. The RFID tag 27250 and the extended antenna 27260 may be attached to the staple cartridge 27100 in any suitable manner, including, for example, mounted on the staple cartridge 27100, embedded in the staple cartridge, and / or fixed to the staple cartridge. In addition, 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 the platform surface 27106.
[0336] As previously described, at least a portion of the extended antenna 27260 crosses the elongated slot 27110 of the nail magazine 27100. During the nail firing stroke, the tissue cutting and / or nail firing member is configured to be able to longitudinally translate through the elongated slot 27110 during the nail firing stroke and cross-cut or otherwise damage the extended antenna 27260 in the process. The portion of the extended antenna 27260 that crosses the elongated slot 27110 is positioned at a position proximal to the most proximal nail cavity. Therefore, the extended antenna 27260 only works before the nail firing stroke begins. Any distal movement of the tissue cutting and / or nail firing member that causes the firing of the nail makes the extended antenna 27260 inoperable. Any suitable method can be used to make the extended antenna 27260 inoperable. For example, the extended antenna 27260 can be cut by the tissue cutting member and thus physically destroyed. In various circumstances, the extended antenna 27260 can be detached from the RFID tag 27250 and / or the staple cartridge 27100 in response to the forces applied by the tissue cutting and staple firing components. Notably, the staple firing stroke does not damage the radio antenna 27252 of the RFID tag 27250. However, the range of the radio antenna 27252 is insufficient to facilitate communication between the RFID tag 27250 and the RFID scanner 27300. Thus, the detachment of the extended antenna 27260 can change 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.
[0337] Destroying the extended antenna 27260 in this manner does not adversely affect the operation of the surgical instrument. In other words, the extended antenna 27260 is not destroyed until after the staple cartridge 271000 has been authenticated. Thus, the staple firing stroke can be performed after the extended antenna 27260 has been destroyed. That is, once the extended antenna 27260 has been destroyed and the staple cartridge 27100 has been removed from the surgical instrument, relocating the staple cartridge 27100 into the surgical instrument will not reauthenticate the staple cartridge 27100 because the RFID scanner will no longer communicate with the RFID tag 27250. Such an arrangement serves to use a used cartridge lock, etc.
[0338] As described above, in the case where the extended antenna 27260 is inoperable, the RFID scanner 27300 does not receive a response to its interrogation signal. When the RFID scanner 27300 does not receive a response to the interrogation signal, the controller of the surgical instrument is programmed to identify an error. In the case where the RFID scanner 27300 receives a response to its interrogation signal that cannot be identified and / or does not represent a compatible nail magazine assembly 27000, the controller of the surgical instrument is also programmed to identify an error. In various cases, the controller detects an error that can make the surgical instrument unable to be used with the nail magazine assembly 27000. In various cases, the detected error can prevent the surgical instrument from performing a nail firing stroke and / or a tissue cutting stroke when the nail magazine assembly 27000 is attached to the surgical instrument. The manual override control can be activated to allow the clinician to override any system lockout in an emergency and utilize the operating function of the surgical instrument. In various cases, the controller is configured to remind the clinician that an error has been detected. Such a reminder can be transmitted by various forms of feedback, including, for example, tactile feedback, sound feedback, and / or visual feedback. The reminder can be specific or universal. 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 an incompatible and / or defective staple cartridge assembly 27000 .
[0339] The portion of the extended antenna 27260 that crosses the elongated slot 27110 can be located at any suitable position along the elongated slot 27110. For example, the extended antenna 27260 can cross the elongated slot 27110 at a position aligned with or slightly proximal to the distal-most nail cavity. In such an embodiment, when the tissue cutting and nail firing stroke is completed, the extended antenna 27260 is rendered inoperable. When the RFID scanner 27300 is unable to communicate with the RFID tag 27250 in this case, the clinician will be able to, for example, confirm that the entire nail firing stroke is completed. In addition, the RFID tag 27250 can be positioned at any suitable position on the nail magazine 27100, such as, for example, on the base 27104 and / or the platform surface 27106 of the nail magazine 27100.
[0340] In various cases, the extended antenna 27260 includes a first antenna configured to traverse the elongated slot 27110 of the nail magazine 27100, and a second antenna that does not traverse the elongated slot 27110 of the nail magazine 27100. In other words, the second antenna is not cross-cut by the firing member during the nail firing stroke. When the first antenna is cross-cut 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 improved by using the first antenna that is not cross-cut by the firing member during the nail firing stroke.
[0341] Fig.85An exemplary RFID system 28200 is shown that can be incorporated into a surgical instrument such as, for example, the surgical instrument 400 discussed herein. The RFID system 28200 can 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 are similar to the RFID tags discussed herein, such as, for example, the RFID tags 26250, 27250. The RFID scanner system 28300 includes a first RFID scanner 28310 and a second RFID scanner 28320. The functions of the RFID scanners 28310, 28320 are similar to the other RFID scanners discussed herein, such as, for example, the RFID scanner 27300.
[0342] The RFID tag 28250 includes a chip, such as, for example, a microchip, that stores information about replaceable components within the surgical system. In various cases, the chip includes an identification number of the staple cartridge. In various cases, the chip includes additional information, such as, for example, manufacturing data, shipping data, and / or other compatibility data of the staple cartridge. The RFID tag 28250 also includes a radio antenna configured to receive an interrogation signal from one and / or both of the RFID scanners 28310, 28320.
[0343] Each RFID scanner 28310, 28320 includes a scanner antenna configured to transmit a radio signal. The radio signal activates an RFID tag 28250 located within a predetermined range of the RFID scanner 28310. The RFID scanner 28310 then receives one or more response signals that "bounce back" from the RFID tag 28250. In various cases, the one or more response signals include the same signal as the interrogation signal. In various cases, 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.
[0344] In various cases, the RFID scanner 28310 includes both read and write capabilities. The software on the RFID scanner 28310 can then pass the collected information from the RFID tag 28250 to the controller for further interpretation. The controller can be located in the surgical instrument, on a remote console, or in any suitable location. A second RFID scanner 28320 can also be used in this manner.
[0345] The RFID scanner system 28300 includes a flexible circuit, wherein the flexible circuit includes a first layer and a second layer. The first layer acts as a first RFID scanner 28310, and the second layer acts as a second RFID scanner 28320. The RFID scanners 28310, 28320 also include an RF amplifier that determines the power of the signal to be transmitted by the RFID scanners 28310, 28320 and amplifies the interrogation signal to the required power level. When powered on, the first layer 28310 is configured to transmit a signal 2815 using a power of about 1 watt or less. When powered on, the second layer 28320 is configured to transmit a signal 28325 using a power of more than 1 watt. In practice, the amplifier communicates with the controller of the surgical instrument and, as described in more detail below, can transmit the signal of the second RFID scanner 28320 using a power far exceeding 1 watt.
[0346] Before the nail firing stroke, the first RFID scanner 28310 is powered on. Fig.86 As shown, the first RFID scanner 28310 sends an interrogation signal 28315 to the RFID tag 28250. The RFID tag 28250 receives the energy or interrogation signal 28315 using the radio antenna of the RFID tag 28250. The received energy travels through the antenna of the tag, and a portion of the received energy is used to activate the chip and prepare for the transmission of data based on the command received from the first RFID scanner 28310. The activation of the chip allows the chip to modulate the received energy with the information stored in the RFID tag 28250 and "reflect" the remaining energy back in the form of a response signal 28255. The chip transmits a response signal 28255 that is the same and / or different from the interrogation signal back to the RFID scanner 28310. The response signal 28255 is received by the antenna of the first RFID scanner so that the first RFID scanner 28310 recovers the information stored on the RFID tag 28250.
[0347] After the nail firing stroke begins, the second RFID scanner 28320 is powered on in addition to and / or in place of the first RFID scanner 28310. Fig.87As shown, both the first RFID scanner 28310 and the second RFID scanner 28320 simultaneously send interrogation signals 28315, 28325 to the RFID tag 28250. The RFID tag 28250 receives energy from the two interrogation signals 28315, 28325 using the radio antenna of the RFID tag 28250. The received energy totals, for example, about 2 watts of power and exceeds the operating power threshold of the RFID tag 28250, for example, 1 watt. The RFID tag 28250 is inoperable when it receives the interrogation signals 28315, 28325 from both the first RFID scanner 28310 and the second RFID scanner 28320. In various cases, the RFID tag 28250 overheats due to exceeding the operating 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.
[0348] 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 after the staple cartridge has been authenticated by the surgical instrument. Instead, once the staple cartridge has been authenticated, the surgical instrument can be used to perform staple firing strokes and other functions. After the staple firing stroke and / or after the staple cartridge is removed from the surgical instrument, the surgical instrument cannot re-authenticate the staple cartridge, and the staple cartridge cannot therefore be reused. The system uses a used cartridge lock, etc.
[0349] In any case, in the inoperable configuration, the RFID tag 28250 cannot receive signals from the RFID scanner and / or transmit signals to the RFID scanner. When the first RFID scanner 28310 does not receive a response to its query signal 28315, the controller of the surgical instrument is configured to communicate the error to the clinician. In the case where the first RFID scanner 28310 receives a response to its query signal 28315 that cannot be identified and / or does not represent a compatible nail magazine assembly, the controller of the surgical instrument is also programmed to communicate the error to the clinician. In various cases, the detected error transmitted from the controller can make the surgical instrument inoperable when the nail magazine assembly is attached. In various cases, the detected error can prevent the surgical instrument from performing a nail firing stroke and / or a tissue cutting stroke when the nail magazine assembly is attached. A manual override control can be activated to allow the clinician to override any system lockout in an emergency and utilize the operating function of the surgical instrument. In various cases, the controller is configured to remind the clinician that an error has been detected. Such a reminder can be transmitted by various forms of feedback, including, for example, tactile feedback, sound feedback, and / or visual feedback. The reminder can be specific or general. For example, the reminder can specifically indicate that the RFID tag 28250 cannot be detected, or the reminder can specifically indicate that the RFID tag 28250 includes information indicating an incompatible and / or defective staple cartridge assembly.
[0350] As described above, the first RFID scanner 28310 can 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 can be used to destroy the RFID tag 28250. Alternatively, the first RFID scanner 28310 can be used to communicate with the RFID tag 28250, and the second RFID scanner 28320 can be used to destroy the RFID tag 28250. In this embodiment, the first RFID scanner 28310 uses a power below a threshold, and the second RFID scanner 28320 uses a power above the threshold. In addition, alternatively, the second RFID scanner may not be used because both the communication and destruction functions can be performed by a single scanner. In at least one such case, a signal amplifier is used to transmit a signal below a power threshold for communication, and to transmit a signal above the power threshold for destruction.
[0351] Figures 88 to 89A A cartridge lockout system 29000 is shown. The cartridge lockout system 29000 is configured to prevent the surgical instrument from executing a nail firing stroke when an incompatible and / or used nail cartridge is detected. When an unused compatible nail cartridge is detected, the controller of the surgical instrument allows the execution of a nail firing stroke. One such compatible nail cartridge includes, for example, nail cartridge 29100.
[0352] The staple cartridge 29100 includes a cartridge body including a cartridge platform 29106, a base 29104, and a sidewall 29108 extending between the cartridge platform 29106 and the base 29104. A plurality of staple cavities 29107 are defined in the cartridge body. The staple cavities 29107 are arranged in a longitudinal row, and a staple is removably supported in each staple cavity 29107. The staple cartridge 29100 also includes 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 nail firing stroke. The staple cartridge 29100 also includes a wedge-shaped slide 29125 and a channel 29120 defined in the cartridge body. The wedge-shaped slide 29125 is configured to drive the staples out of the cartridge body and toward the anvil during the nail firing stroke. The channel 29120 is configured to receive the ramp of the wedge sled 29125 as the wedge sled 29125 translates through the staple cartridge 29100 during the staple firing stroke. Stops are formed on the inside of the channel 29120 to interface with the ramp of the wedge sled 29125 and control the lateral position of the wedge sled 29125 within the channel 29120. In at least one embodiment, a rib can be used to releasably retain the wedge sled 29125 in the proximal unfired position.
[0353] The staple cartridge 29100 also includes an RFID tag 29250. The RFID tag 29250 includes a chip, such as, for example, a microchip, that stores information about the staple cartridge 29100. In various cases, the chip includes a basic identification number. In various cases, the chip includes additional information, such as, for example, manufacturing data, shipping data, and / or compatibility data. The RFID tag 26250 also includes a radio antenna configured to receive an interrogation signal from an RFID scanner. Fig.88 and Fig.89 As shown, the RFID tag 29250 is attached 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 and / or attached to the staple cartridge 29100 in any suitable manner and / or at any suitable location.
[0354] The surgical system also includes an RFID scanner. The RFID scanner includes a scanner antenna configured to transmit a radio signal. The radio signal activates an RFID tag within a predetermined transmission range of the RFID scanner. The RFID scanner then receives one or more response signals 29255 that "bounce back" from the RFID tag. In various cases, the one or more response signals include the same signal as the interrogation signal. In various cases, the one or more response signals include a modified signal from the interrogation signal. The RFID scanner can be positioned in various locations, such as, for example, a staple cartridge 29100, an end effector of a surgical instrument, and / or a console remotely positioned relative to the surgical instrument. In other words, the RFID scanner can be positioned in any suitable position that allows the RFID scanner to communicate with the RFID tag 29250 when the staple cartridge 29100 is placed in the end effector of the surgical instrument and / or once the staple cartridge 29100 is placed in the end effector of the surgical instrument. In various cases, the RFID scanner includes a read capability and a write capability. The software on the RFID scanner is capable of transmitting the collected information 29255 from the RFID tag 29250 to the controller for further interpretation. The controller may be positioned in the surgical instrument or in any suitable location.The RFID scanner and / or the controller may include a stored set of information corresponding to the staple cartridges compatible with a particular surgical instrument and / or used during a particular surgical procedure.
[0355] Based on the information 29255 collected from the RFID tag 29250, the controller can maintain, activate and / or deactivate a cartridge lock assembly, such as, for example, the cartridge lock assembly 29000. The cartridge lock assembly 29000 includes a lock rod 29300. The lock rod 29300 includes a proximal end 29302 and a distal end 29304. The distal end 29304 of the lock rod 29300 is configured to interface with the wedge slide 29125 when the staple cartridge 29100 is seated in the jaws of the end effector. The lock rod 29300 is sized to fit within one of the channels 29120 formed in the cartridge body. The proximal end 29302 of the lock rod 29300 includes a lateral protrusion or flange 29310. The proximal end 29302 of the lockout bar 29300 engages with the firing bar 29200 of the nail firing drive so that the lockout bar 29300 and the firing bar 29200 move together. The firing bar 29200 includes a groove 29225 that receives the lateral protrusion 29310 of the lockout bar 29300.
[0356] The bin lock assembly 29000 also includes a blocking bolt assembly 29400. In the depicted embodiment, the blocking bolt assembly 29400 includes a solenoid. The blocking bolt assembly 29400 includes a locking bolt 29410, an elastic member 29420, and an induction coil 29430. Figures 88 to 89AIn the embodiment depicted in , the resilient member 29420 is a spring, but any resilient member may be used. The blocking bolt assembly 29400 can be configured to be in an unlocked configuration and a locked configuration. The locking bolt 29410 and the resilient member 29420 are positioned in the housing 29405 of the blocking bolt assembly 29400. The resilient member 29240 biases the locking bolt 29410 into its locked configuration. In the locked configuration, a portion of the locking bolt 29410 extends outside the housing 29405. In the unlocked configuration, the locking bolt 29410 is entirely positioned within the housing 29405.
[0357] When the controller has detected a compatible staple cartridge 29100, the blocking bolt assembly 29400 is placed in an unlocked configuration by the controller. A compatible staple cartridge 29100 is detected when the RFID tag 29250 emits a signal 29255 corresponding to a set of information stored in the RFID scanner and / or the controller, and / or when the clinician overrides the controller. In such cases, the controller is configured to activate the induction coil 29430 of the blocking bolt assembly 29400. The controller applies a voltage source to the coil 29430 to activate the coil 29430. Activating the induction coil 29430 generates a magnetic field that pulls the locking bolt 29410 into the housing 29405. To this end, the locking bolt 29410 is constructed of iron, nickel, and / or any suitable magnetic material. That is, the elastic member 29420 is compressed due to the movement of the locking bolt 29410, and thus the elastic member 29240 obstructs the movement of the locking bolt 29410. In any case, the locking bolt 29410 is retracted enough to leave the path of the locking rod 29300. At this point, the nail firing stroke can be performed. If the nail cartridge 29100 is removed from the surgical instrument, the controller will deactivate the induction coil 29430, allowing the elastic member 29240 to re-extend the locking bolt 29410.
[0358] When the staple cartridge 29100 is placed into the jaws of the end effector, in addition to the above, the distal end 29304 of the lockout rod 29300 comes into contact with the slider 29125 of the staple cartridge 29100. If the locking bolt 29410 has been retracted, when the clinician attempts to place the staple cartridge 29100 in the jaws, the proximal end 29302 of the lockout rod 29300 is pushed proximally by the slider 29125 of the staple cartridge 29100. In such cases, the lockout rod 29300 is configured to be able to freely translate in the proximal direction. The lack of resistance to the proximal movement of the lockout rod 29300 allows the lockout rod 29300 to move without displacing the wedge-shaped slider 29125 in the staple cartridge 29100. In other words, the retaining force exerted by the stop within the channel 29120 on the wedge sled 29125 is sufficient to maintain the wedge sled 29125 in its current position while pushing the lockout bar 29300 when the staple cartridge 29100 is seated in the surgical instrument.
[0359] As described above, when an incompatible staple cartridge 29100' has been detected, the blocking bolt assembly 29400 is in a locked configuration. Fig.89As shown, an incompatible staple cartridge 29100' is detected when the RFID tag 29250 emits a signal 29255' that does not correspond to a set of information stored in the RFID scanner and / or controller. In various cases, when the RFID scanner cannot detect a signal from the RFID tag, the staple cartridge 29100' is considered incompatible with the controller of the surgical instrument. When the emitted signal 29255' or the lack of a signal indicates an incompatible staple cartridge 29100', the induction coil 29430 of the blocking bolt assembly 29400 is not activated by the controller. Without activating the induction coil 29430, the biasing member 29420 maintains a portion of the locking bolt 29410 extending outside the housing 29405. When the staple cartridge 29100' is placed into the jaws of the end effector and the locking bolt 29410 is extended, the distal end 29304 of the locking rod 29300 becomes in contact with the slider 29125 of the staple cartridge 29100'. The lockout rod 29300 is blocked from translating in the proximal direction because the locking bolt 29410 is in its path. In such cases, the resistance provided by the locking bolt 29410 against the lockout rod 29300 exceeds the retention force provided by the stop in the channel 29120 that holds the wedge slide 29125 in place. Therefore, when the nail cartridge 29100' is installed and the locking bolt 29410 is not retracted, the wedge slide 29125 is displaced distally from its unfired position. The distal movement of the wedge slide 29125 from its unfired position causes the nail cartridge 29100' to be spent, even if no nails are fired from the nail cartridge 29100'.The firing lockout systems disclosed in the following U.S. patents, the disclosures of which are incorporated herein by reference in their entirety, will mechanically prevent the execution of the nail firing stroke under such circumstances: U.S. Patent 7,143,923, issued on December 5, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL"; U.S. Patent 7,044,352, issued on May 16, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING"; U.S. Patent 7,000,818, issued on February 21, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS"; U.S. Patent 7,000,818, issued on January 24, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS" ASPENT CARTRIDGE LOCKOUT"; and U.S. Patent No. 6,978,921, issued on December 27, 2005, "SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM".
[0360] Fig.90A motor control circuit 30000 is shown for controlling the cartridge lockout assembly 29000. Various details of the motor control circuit 30000 are described in more detail in U.S. Patent Application Publication No. 2010 / 0075474, entitled "MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT," the disclosure of which is incorporated by reference in its entirety. A battery or other suitable power source 30064 powers an electric motor 30065. When the clinician initially pulls the firing trigger of the surgical instrument, the run motor (or firing) switch 30110 is closed. When the run motor switch 30110 is closed, the safety switch is closed, and the lockout switch is opened, and current flows through the safety switch, through the lockout indicator 30244, and to the motor 30065. When the end of the nail firing stroke is reached, the end of stroke or direction switch 30130 is switched to reverse the direction of the motor 30065. The circuit 30000 may also include a manual return switch 30348. If a firing member, such as the firing member 29210, is only partially fired, the clinician can manually flip this switch 30348. Toggling the manual return switch 30348 causes the motor 30065 to rotate in reverse, thereby returning the firing member to its initial or home position.
[0361] The motor control circuit 30000 also includes a cartridge lockout switch 30300. When the controller 30310 determines that a compatible staple cartridge is positioned in the end effector by receiving a signal from an RFID tag, such as the RFID tag 29250, the induction coil 30320 is energized. Energization of the induction coil 30320 closes the cartridge lockout switch 30300 and allows a compatible staple cartridge to be positioned in the end effector without displacing the wedge slide of the staple cartridge. When the controller 30310 determines that an incompatible staple cartridge is positioned in the end effector by receiving a signal from an RFID tag, such as the RFID tag 29250, the induction coil 30320 is not energized. The inactivated induction coil 30320' allows the cartridge lockout switch 30300 to remain open. The cartridge lockout, such as the cartridge lockout 29000, then causes the wedge slide to be displaced distally within the incompatible surgical cartridge. The surgical instrument is then unable to perform a staple firing stroke when an incompatible surgical cartridge is attached.
[0362] Various surgical instruments are composed of replaceable parts that need to be replaced before and / or during the start of 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 need to replace the staple cartridge for various reasons, such as, for example, the type of surgical procedure performed, the thickness of the tissue processed during the surgical procedure, and / or the state of the staple cartridge. The state of the staple cartridge corresponds to, for example, whether the staple cartridge has been used, i.e., whether one or more staples from within the staple cartridge have been ejected during the staple firing stroke.
[0363] 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. Fig.91 As shown, a first RFID tag 31560a is positioned on the cartridge body 31510 of the staple cartridge 31500, a second RFID tag 31560b is positioned on the wedge-shaped slide 31550 of the staple cartridge 31500, and a third RFID tag 31560c is positioned on the retainer 31570 of the staple cartridge 31500. Each RFID tag includes a chip that stores information related to the status of the staple cartridge assembly, the identification of the staple cartridge, and / or the compatibility of the staple cartridge assembly with a specific surgical instrument. For purposes such as ensuring patient safety and the correct assembly of components within the surgical system, the information stored on each chip is encrypted. Encryption of the information on the chip allows only authorized parties to access the stored information, while unauthorized parties cannot access the information. In other words, if the information stored on the chip cannot be decrypted, the surgical system will not be able to assemble incompatible assembly components, and / or when incompatible assembly components are attached, one or more operating parameters of the surgical system will be unavailable and / or modified. The encryption key is stored in the controller of the surgical system and / or in an external storage medium to decrypt information collected from the RFID tags by one or more RFID scanners. In various cases, all of the RFID tags include encrypted information. In other cases, only one of the RFID tags includes encrypted information, such as, for example, an RFID tag positioned on a staple cartridge. However, it is contemplated that any suitable combination of RFID tags may include a chip with encrypted information. In various cases, one or more encryption keys are stored in a memory on the surgical instrument, however, any suitable storage location is also contemplated.
[0364] The data stored on the RFID tag of the staple cartridge may be encrypted using an encryption protocol during the manufacturing process of the staple cartridge. This information may be encrypted to, for example, prevent the use of a duplicated staple cartridge without authorization and / or with inferior components. Such unauthorized copies of the staple cartridge 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 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.
[0365] 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 related to 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 include unencrypted or unprotected data related to the wedge slide 31550 and the retainer 31570, respectively. Such data may include, for example, manufacturing data and / or identification data.
[0366] 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 includes 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 reflecting the various components of the staple cartridge 31500 with RFID tags. For example, the unprotected data stored on the first RFID tag 31560a is encrypted with a first value 31202. The unprotected data stored on the second RFID tag 31560b is encrypted with a second value 31204, and the unprotected data stored on 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. This encryption process is performed on each staple cartridge manufactured. See also Fig.63 .
[0367] After the cloud storage medium 31150 completes the encryption protocol, the manufacturing controller 31100 rewrites the RFID tags 31560a, 31560b, and 31560c with the encrypted data. The manufacturing controller 31100 directs the RFID scanner to send a first rewrite signal 31110a to the first RFID tag 31560a. The first rewrite signal 31110a is used to delete the unprotected data stored on 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 rewrite signal 31110b is used to delete the unprotected data stored on the second RFID tag 31560b and replace the unprotected data with new protected data 31204. The third rewrite signal 31110c is used to delete the unprotected data stored on the third RFID tag 31560c and replace the unprotected data with the new protected data 31206. At this time, the RFID tags 31560a, 31560b, 31560c only include encrypted data, and only the cloud storage medium 31150 can obtain the unprotected unencrypted data through the decryption protocol. As described above, the RFID reader is configured to transmit signals to and receive signals from the RFID tag. In such a case, the RFID reader includes both read capability and write capability.
[0368] When 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 cartridge 31500 and the associated encryption keys. The list 31250 may be updated in real time and / or may be 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 directs the packaging printer 31600 to print the unique serial number 31200 on the packaging for the staple cartridge 31500.
[0369] When the staple cartridge 31500 is required to be attached to the surgical instrument, the clinician needs to scan the packaging of the staple cartridge 31500. The controller of the surgical instrument and / or the remote controller in the operating room transmits the scanned packaging data to the cloud storage medium 31150. The remote controller transmits the scanned packaging data to the cloud storage medium 31150 for decryption, for example. The cloud storage medium 31150 performs a decryption protocol on the scanned packaging data and compares the received data with the list 31250 of compatible or otherwise acceptable staple cartridges. If the cloud storage medium 31150 identifies the scanned packaging data as being usable with the surgical instrument, the cloud storage medium 31150 transmits an approval signal to the remote controller. The remote controller transmits the approval signal to the controller on the surgical instrument, and the surgical instrument is able to perform, for example, a staple firing stroke. If the cloud storage medium 31150 cannot recognize the scanned packaging data, the cloud storage medium 31150 transmits an error to the remote controller. The remote controller transmits an error to the controller on the surgical instrument, and the surgical instrument cannot perform a staple firing stroke. In various cases, the surgical instrument includes an override input that the clinician can activate, but only after the clinician has been adequately alerted that the staple cartridge has failed the authentication protocol.
[0370] As previously described, the packaging of modular components (such as packaging 25000) includes one or more identification systems related to the contents of the packaging. The manufacturing controller and packaging printer 31600 use the encrypted information discussed above to create the identification system. Various techniques can be used to mark the packaging. Such techniques include, for example, laser printing, pad printing, thermal printing, and / or chip programming. For example, laser printing can be used to print QR codes and / or bar codes on product packaging. Chip programming can be used to change the information stored in an RFID system (such as, for example, RFID system 25200).
[0371] Fig.92A decryption protocol 32000 operated by a controller of a surgical instrument is shown. For example, the controller uses an automatically delivered incremental 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 includes a memory. The memory stores a default internal key 32010 that allows the controller to decrypt a first RFID tag. The first RFID tag is positioned on a staple cartridge package, and the first RFID tag includes 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 issues a second internal key 32040 upon successful decryption of the first RFID tag. If the controller determines that the package is not authentic, if the controller cannot decrypt the information stored on the first RFID tag, and / or if the information stored on the first RFID tag is not recognizable, the second internal key 32040 is not issued, and the decryption protocol 32000 cannot proceed to the next step. The RFID scanner may rescan the first RFID tag, or may scan a new package 32020. Without proceeding to 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.
[0372] The staple cartridge includes a second RFID tag positioned on the cartridge body, and the second RFID tag includes a second set of encrypted information. The second set of encrypted information can only be decrypted by the controller using a second internal key 32040. The decryption protocol 32000 releases a third internal key 32070 when the second RFID tag data is successfully decrypted. If the controller determines that the staple cartridge is not authentic, if the controller cannot decrypt the information stored on the second RFID tag and / or if the information stored on the second RFID tag is not recognizable, the third internal key 32070 is not released, and the decryption protocol 32000 cannot proceed to the next step. The RFID scanner can rescan the second RFID tag, or a new staple cartridge 32050 can be scanned. Without proceeding to 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.
[0373] As described above, the nail magazine previously included in the package includes a passive second RFID tag. The second RFID tag is positioned at any suitable location in the nail magazine. The clinician can bring an RFID scanner into range of the second RFID tag, wherein the RFID scanner transmits a signal to scan 32050 the second RFID tag of the nail magazine. In response to the transmission signal of the RFID scanner, the second RFID tag is configured to transmit its encrypted information back to the RFID scanner. The software on the RFID scanner is configured to transmit the transmitted information to the controller for decryption using the internal key 32040 that is released and / or unlocked. Once the received information is decrypted, the controller is configured to determine whether the nail magazine includes authentic parts 32060 that are compatible with the surgical instrument. In other words, the information stored by the second RFID tag allows the clinician to confirm that the package does contain an authentic nail magazine. In various cases, the controller is also configured to determine whether the nail magazine has been tampered with, has been used previously, and / or is a counterfeit form of an originally compatible nail magazine. If the controller determines that the nail magazine is not authentic, the controller cannot decrypt the information stored on the second RFID tag, and / or the information stored on the second RFID tag cannot be recognized. The RFID scanner may then rescan the staple cartridge, or may scan a new staple cartridge 32050. If the controller determines that the staple cartridge is authentic, the controller issues and / or unlocks the third internal key 32070 for use in detecting the presence of a retainer on the staple cartridge assembly. Without issuing and / or unlocking the third internal key 32070, the clinician is unable to complete the protocol 32000 and, in various circumstances, is unable to activate a surgical instrument with an inauthentic component, if there is no override input as described above.
[0374] The staple cartridge includes a third RFID tag positioned on the retainer, and the third RFID tag includes 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 representing a compatible staple cartridge, the decryption protocol 32000 issues a fourth internal key and / or the decryption protocol 32000 ends successfully. If the controller determines that the staple cartridge is not authentic, if the controller cannot decrypt the information stored on the third RFID tag and / or if the information stored on the third RFID tag is not recognizable, the next or fourth internal key is not issued, and the decryption protocol 32000 cannot proceed to the next step. The RFID scanner can rescan the third RFID tag, or a new retainer 32080 can be scanned. Without issuing and / or unlocking the fourth internal key, the controller cannot complete the protocol 32000, and in various cases, the surgical instrument may not be activated with an inauthentic component. In various cases, the retainer is the last modular component evaluated in the protocol 32000. However, in other cases, another modular component includes an RFID tag with encrypted information, and the component needs to be authenticated before use with the surgical system.
[0375] 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 conjunction with protocol 32000.
[0376] Various aspects of the subject matter described herein are illustrated in the following examples:
[0377] Example set 1
[0378] Embodiment 1. A method for authenticating compatibility of a staple cartridge with a surgical instrument, the method comprising inserting a staple cartridge into a surgical instrument. The method further comprises 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 further comprises comparing the first signal and the second signal to a set of stored data for compatible staple cartridges, and unlocking a staple firing system of the surgical instrument if the first signal and the second signal match the set of stored data for compatible staple cartridges.
[0379] Embodiment 2. The method of embodiment 1, wherein the comparing step comprises comparing the first signal and the second signal to more than one set of stored data for compatible staple cartridges.
[0380] Embodiment 3. The method of Embodiment 1 or 2, wherein the first RFID tag and the second RFID tag comprise active RFID tags.
[0381] Embodiment 4. The method of embodiments 1 to 3 further comprising the step of interrogating the first RFID tag using the RFID reader system prior to the step of transmitting the first signal from the first RFID tag.
[0382] Embodiment 5. The method of embodiments 1 to 4 further comprising the step of interrogating the second RFID tag using the RFID reader system prior to the step of transmitting a second signal from the second RFID tag.
[0383] Embodiment 6. The method according to embodiments 1 to 5 further includes a step of operating the nail firing system to perform a nail firing stroke after the unlocking step.
[0384] Embodiment 7. The method of embodiments 1 to 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.
[0385] Embodiment 8. The method of Embodiment 7, wherein the step of transmitting the second signal to the RFID reader system can only occur when the slide is in its proximal unfired position.
[0386] Embodiment 9. The method of embodiments 1 to 8, wherein the first component comprises a cartridge body and the second component comprises a cover removably attached to the cartridge body.
[0387] Embodiment 10. The method of Embodiment 9, wherein the step of transmitting the second signal to the RFID reader system can only occur when the lid is attached to the bin body.
[0388] Embodiment 11. A method for authenticating compatibility of a staple cartridge with a surgical instrument, the method comprising inserting a staple cartridge into a surgical instrument. The method further comprises receiving, using an RFID reader system, a first signal from a first RFID tag on a first component of the staple cartridge, and receiving, using the RFID reader system, a second signal from a second RFID tag on a second component of the staple cartridge. The method further comprises comparing the first signal and the second signal to stored data for a compatible staple cartridge, and if the first signal and the second signal do not match the stored data for a compatible staple cartridge, locking a staple firing system of the surgical instrument.
[0389] Embodiment 12. The method of Embodiment 11, wherein the comparing step comprises comparing the first signal and the second signal to stored data for more than one compatible staple cartridge.
[0390] Embodiment 13. The method of Embodiments 11 and 12, wherein the first RFID tag and the second RFID tag comprise active RFID tags.
[0391] Embodiment 14. The method of embodiments 11 to 13, further comprising the step of interrogating the first RFID tag using the RFID reader system prior to the step of receiving the first signal from the first RFID tag.
[0392] Embodiment 15. The method of embodiments 11 to 14, further comprising the step of interrogating the second RFID tag using the RFID reader system prior to the step of receiving a second signal from the second RFID tag.
[0393] Embodiment 16. The method according to embodiments 11 to 15 further includes the step of operating the nail firing system to perform a nail firing stroke without the locking step occurring.
[0394] Embodiment 17. The method of embodiments 11 to 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.
[0395] Embodiment 18. The method of Embodiment 17, wherein the step of receiving the second signal with the RFID reader system occurs only when the slide is in its proximal unfired position.
[0396] Embodiment 19. The method of embodiments 11 to 18, wherein the first component comprises a cartridge body and the second component comprises a cover removably attached to the cartridge body.
[0397] Embodiment 20. The method of Embodiment 19, wherein the step of receiving the second signal with the RFID reader system can only occur when the lid is attached to the bin body.
[0398] Example Set 2
[0399] Embodiment 1. A surgical instrument comprising a firing system configured to perform a firing motion, an end effector, and an RFID reader system. The end effector comprises an anvil, a staple cartridge support, and a staple cartridge positioned in the staple cartridge support. The staple cartridge comprises 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 further comprises a staple removably stored in the staple cavity, a cover releasably attached to the cartridge body, wherein when the cover is attached to the cartridge body, the cover extends over the staple cavity. The staple cartridge further comprises a slide capable of moving from a proximal unfired position to a distal fired position during the firing motion, a first RFID tag attached to the cartridge body at a first longitudinal position, and a second RFID tag attached to the slide, wherein the proximal unfired position of the slide is at a second longitudinal position different from the first longitudinal position. The staple cartridge further comprises a third RFID tag attached to the cover at a third longitudinal position different from 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.
[0400] Embodiment 2. The stapling instrument of embodiment 1, wherein the RFID reader system comprises a first RFID reader, a second RFID reader, and a third RFID reader.
[0401] Embodiment 3. A suturing instrument according to Embodiment 2, wherein the first RFID reader system includes a first antenna adjacent to the first longitudinal position, wherein the second RFID system includes a second antenna adjacent to the second longitudinal position, and wherein the third RFID system includes a third antenna adjacent to the third longitudinal position.
[0402] Embodiment 4. A suturing instrument according to embodiments 1 to 3, wherein the first RFID tag is configured to transmit the first signal in a first range, wherein the first antenna is positioned in the first range and is configured to receive the first signal, wherein the second RFID tag is configured to transmit the second signal in a second range, wherein the second RFID tag is configured to transmit a second range, wherein the second antenna is positioned in the second range and is configured to receive the second signal, wherein the third RFID tag is configured to transmit the third signal in a third range, and wherein the third antenna is positioned in the third range and is configured to receive the third signal.
[0403] Embodiment 5. The suturing instrument according to embodiment 4, wherein the first range does not overlap with the second range and the third range, and wherein the second range does not overlap with the first range and the third range.
[0404] Embodiment 6. A suturing instrument according to embodiments 2 to 5, wherein the first RFID reader system includes a first induction coil sensor adjacent to the first longitudinal position, wherein the second RFID system includes a second induction coil sensor adjacent to the second longitudinal position, and wherein the third RFID system includes a third induction coil sensor adjacent to the third longitudinal position.
[0405] Example 7. A suturing instrument according to Example 6, wherein the first RFID tag is configured to transmit the first signal in a first range, wherein the first induction coil sensor is positioned in the first range and is configured to receive the first signal, wherein the second RFID tag is configured to transmit the second signal in a second range, wherein the second induction coil sensor is positioned in the second range and is configured to receive the second signal, wherein the third RFID tag is configured to transmit the third signal in a third range, and wherein the third induction coil sensor is positioned in the third range and is configured to receive the third signal.
[0406] Embodiment 8. The suturing instrument according to embodiments 6 and 7, wherein the first range does not overlap with the second range and the third range, and wherein the second range does not overlap with the first range and the third range.
[0407] Embodiment 9. The suturing apparatus of embodiments 1 to 8, wherein the first RFID tag comprises an active RFID tag, wherein the second RFID tag comprises an active RFID tag, and wherein the third RFID tag comprises an active RFID tag.
[0408] Embodiment 10. The stapling apparatus of embodiments 1 to 8, wherein the first RFID tag comprises a passive RFID tag, wherein the second RFID tag comprises a passive RFID tag, and wherein the third RFID tag comprises a passive RFID tag.
[0409] Embodiment 11. The stapling instrument of embodiments 1 to 10, wherein the staple cartridge comprises a lateral width, and wherein the first longitudinal position, the second longitudinal position, and the third longitudinal position are not laterally aligned across the lateral width.
[0410] Embodiment 12. A suturing instrument according to embodiments 1 to 11, further comprising a controller that communicates with the RFID reader system and the firing system, wherein the controller is 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.
[0411] Example 13. The suturing instrument of Examples 1 to 12, further comprising a controller in communication with the RFID reader system and the firing system, wherein the controller comprises at least one set of data stored in a memory device, wherein the controller is configured to compare data from the first signal, the second signal, and the third signal with a set of data, wherein the controller is configured to disable the firing system if data from at least one of the first signal, the second signal, and the third signal is inconsistent with the set of data.
[0412] Embodiment 14. A nail magazine assembly, the nail magazine assembly comprising a magazine body defining a longitudinal axis, a longitudinal slot defined in the magazine body, and a nail cavity defined in the magazine body. The nail magazine assembly also includes a nail removably stored in the nail cavity, a cover releasably attached to the magazine body, wherein when the cover is attached to the magazine body, the cover extends above the nail cavity. The nail magazine assembly also includes a sliding member capable of moving from a proximal unfired position to a distal fired position during the firing motion, a first RFID tag attached to the magazine body at a first longitudinal position, a second RFID tag attached to the sliding member, and a third RFID tag attached to the cover at a third longitudinal position, wherein the proximal unfired position of the sliding member is in a second longitudinal position different from the first longitudinal position, and the third longitudinal position is not in the first longitudinal position and the second longitudinal position.
[0413] Embodiment 15. A surgical instrument comprising a firing system configured to perform a firing motion, an end effector, an RFID reader system, and a controller. The end effector comprises an anvil, a staple cartridge support, and a staple cartridge positionable in the staple cartridge support. The staple cartridge comprises a cartridge body having a proximal end and a distal end, a longitudinal slot defined in the cartridge body, and a staple cavity defined in the cartridge body. The staple cartridge further comprises a staple removably stored in the staple cavity, and a slide capable of moving from a proximal unfired position to a distal fired position during the firing motion. The staple cartridge further comprises a first RFID tag attached to the cartridge body at the proximal end, and a second RFID tag attached 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 communicates with the RFID reader system and the firing system, wherein the controller is configured to disable operation of the firing system if the controller receives one of the first signal and the second signal but does not receive the other.
[0414] Example 16. The surgical instrument of Example 15 further includes a feedback system in communication with the controller, wherein the controller is configured to activate the feedback system when the controller disables operation of the firing system.
[0415] Example 17. A surgical instrument according to Example 15 or 16, wherein the controller includes a set of data stored in a memory device, wherein the controller is configured to compare data from the first signal and the second signal with a set of data, and wherein the controller is configured to disable the firing system if the data from one of the first signal and the second signal is inconsistent with the set of data.
[0416] Embodiment 18. A staple cartridge, comprising a cartridge body, the cartridge body comprising a proximal end and a distal end. The staple cartridge further comprises 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 further comprises a slide capable of moving from a proximal unfired position to a distal fired position during the firing motion, the first RFID tag attached to the cartridge body at the proximal end, and a second RFID tag attached to the cartridge body at the distal end.
[0417] Example Set 3
[0418] Embodiment 1. A surgical instrument, comprising a nail firing system, an end effector, a first RFID reader, a second RFID reader, and a controller. The end effector comprises an anvil, a nail magazine channel, and a nail magazine positioned in the nail magazine channel. The nail magazine comprises a magazine body having a longitudinal axis, a nail cavity defined in the magazine body, and a nail removably stored in the nail cavity. The nail magazine also comprises a sliding member capable of being moved between a proximal unfired position and a distal fired position by the nail firing system, a first RFID tag attached to the magazine body, and a second RFID tag attached to the sliding member. 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. The controller communicates with the first RFID reader, the second RFID reader, and the nail firing system, wherein the controller verifies the presence of the nail magazine in the nail magazine channel upon receiving the first signal from the first RFID tag, and wherein the controller verifies that the nail magazine is an unfired nail magazine upon receiving the second signal from the second RFID tag.
[0419] Example 2. The surgical instrument of Example 1, wherein the controller is configured to disable the staple firing system if the controller receives the first signal but does not receive the second signal.
[0420] Embodiment 3. The surgical instrument of embodiments 1 and 2, wherein the controller is configured to unlock the nail firing system when the controller receives the first signal and the second signal.
[0421] Embodiment 4. A surgical instrument according to embodiments 1 to 3, wherein the first RFID tag includes a first operating range, and the second RFID tag includes a second operating range, and wherein when the sliding member is in the proximal unfired position, the first operating range and the second operating range do not overlap.
[0422] Embodiment 5. The surgical instrument of embodiments 1 to 4, wherein the first RFID reader comprises a first operating range and the second RFID reader comprises a second operating range, and wherein the first operating range and the second operating range do not overlap.
[0423] Embodiment 6. The surgical instrument according to embodiments 1 to 5 further includes a third RFID reader in communication with the controller, and wherein the third RFID reader is configured to detect the second signal from the second RFID tag when the slide is in the distal firing position.
[0424] Embodi...
Claims
1. A surgical instrument comprising: a firing system configured to execute a firing motion; An end effector, the end effector comprising: Anvil; a staple cartridge support; and A nail magazine, the nail magazine is positioned in the nail magazine support, and the nail magazine includes: a cartridge body defining a longitudinal axis; a longitudinal slot defined in the bin body; a nail cavity, the nail cavity being defined in the cartridge body; a staple, the staple being removably stored in the staple cavity; a cover releasably attached to the cartridge body, wherein the cover extends over the staple cavities when the cover is attached to the cartridge body; a slide movable from a proximal unfired position to a distal fired position during a firing motion; a first RFID tag attached to the bin body at a first longitudinal position; a second RFID tag attached to the slider, wherein the proximal unfired position of the slider is in a second longitudinal position different from the first longitudinal position; and a third RFID tag attached to the cover at a third longitudinal position different from the first longitudinal position and the second longitudinal position; and An 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.
2. The surgical instrument of claim 1, wherein the RFID reader system comprises a first RFID reader, a second RFID reader, and a third RFID reader.
3. The surgical instrument of claim 2, wherein the first RFID reader comprises a first antenna adjacent to the first longitudinal position, wherein the second RFID reader comprises a second antenna adjacent to the second longitudinal position, and wherein the third RFID reader comprises a third antenna adjacent to the third longitudinal position.
4. The surgical instrument according to claim 3, wherein the first RFID tag is configured to transmit the first signal in a first range, wherein the first antenna is positioned in the first range and is configured to receive the first signal, wherein the second RFID tag is configured to transmit the second signal in a second range, wherein the second antenna is positioned in the second range and is configured to receive the second signal, wherein the third RFID tag is configured to transmit the third signal in a third range, and wherein the third antenna is positioned in the third range and is configured to receive the third signal. 5 . The surgical instrument according to claim 4 , wherein the first range does not overlap with the second range and the third range, and wherein the second range does not overlap with the first range and the third range.
6. The surgical instrument of claim 2, wherein the first RFID reader comprises a first induction coil sensor adjacent to the first longitudinal position, wherein the second RFID reader comprises a second induction coil sensor adjacent to the second longitudinal position, and wherein the third RFID reader comprises a third induction coil sensor adjacent to the third longitudinal position.
7. The surgical instrument according to claim 6, wherein the first RFID tag is configured to transmit the first signal in a first range, wherein the first induction coil sensor is positioned in the first range and is configured to receive the first signal, wherein the second RFID tag is configured to transmit the second signal in a second range, wherein the second induction coil sensor is positioned in the second range and is configured to receive the second signal, wherein the third RFID tag is configured to transmit the third signal in a third range, and wherein the third induction coil sensor is positioned in the third range and is configured to receive the third signal.
8. The surgical instrument of claim 7, wherein the first range does not overlap with the second range and the third range, and wherein the second range does not overlap with the first range and the third range.
9. The surgical instrument of claim 1, wherein the first RFID tag comprises an active RFID tag, wherein the second RFID tag comprises an active RFID tag, and wherein the third RFID tag comprises an active RFID tag.
10. The surgical instrument of claim 1, wherein the first RFID tag comprises a passive RFID tag, wherein the second RFID tag comprises a passive RFID tag, and wherein the third RFID tag comprises a passive RFID tag.
11. The surgical instrument of Claim 1, wherein said staple cartridge comprises a lateral width, and wherein said first longitudinal position, said second longitudinal position, and said third longitudinal position are not laterally aligned across said lateral width.
12. The surgical instrument according to claim 1 further includes a controller that communicates with the RFID reader system and the firing system, wherein the controller is 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 reader system.
13. The surgical instrument according to claim 1 further includes a controller that communicates with the RFID reader system and the firing system, wherein the controller includes at least one set of data stored in a memory device, wherein the controller is configured to compare data from the first signal, the second signal, and the third signal with a set of data, wherein the controller is configured to disable the firing system if the data from at least one of the first signal, the second signal, and the third signal is inconsistent with the set of data.
14. A staple cartridge assembly, comprising: a cartridge body defining a longitudinal axis; a longitudinal slot defined in the bin body; a nail cavity, the nail cavity being defined in the cartridge body; a staple, the staple being removably stored in the staple cavity; a cover releasably attached to the cartridge body, wherein the cover extends over the staple cavities when the cover is attached to the cartridge body; a slide movable from a proximal unfired position to a distal fired position during a firing motion; a first RFID tag attached to the bin body at a first longitudinal position; a second RFID tag attached to the slider, wherein the proximal unfired position of the slider is in a second longitudinal position different from the first longitudinal position; and A third RFID tag is attached to the cover at a third longitudinal position different from the first longitudinal position and the second longitudinal position.
15. A surgical instrument comprising: a firing system configured to execute a firing motion; An end effector, the end effector comprising: Anvil; a staple cartridge support; and A staple cartridge capable of being positioned in the staple cartridge support, the staple cartridge comprising: a cartridge body, the cartridge body comprising a proximal end and a distal end; a longitudinal slot defined in the bin body; a nail cavity, the nail cavity being defined in the cartridge body; a staple, the staple being removably stored in the staple cavity; a slide movable from a proximal unfired position to a distal fired position during a firing motion; a first RFID tag attached to the cartridge body at the proximal end; and a second RFID tag attached to the cartridge body at the distal end; an RFID reader system comprising a first RFID reader disposed at a proximal end of the staple cartridge support and a second RFID reader disposed at a distal end of the staple cartridge support, wherein the first RFID reader is configured to receive a first signal from the first RFID tag and the second RFID reader is configured to receive a second signal from the second RFID tag; and A controller is in communication with the RFID reader system and the firing system, wherein the controller is configured to disable operation of the firing system if the controller receives one of the first signal and the second signal but does not receive the other.
16. The surgical instrument of claim 15, further comprising a feedback system in communication with the controller, wherein the controller is configured to activate the feedback system when the controller disables operation of the firing system.
17. A surgical instrument according to claim 15, wherein the controller includes a set of data stored in a memory device, wherein the controller is configured to compare data from the first signal and the second signal with a set of data, and wherein the controller is configured to disable the firing system if the data from one of the first signal and the second signal is inconsistent with the set of data.
18. A nail magazine, comprising: a cartridge body, the cartridge body comprising a proximal end and a distal end; a longitudinal slot defined in the bin body; a nail cavity, the nail cavity being defined in the cartridge body; a staple, the staple being removably stored in the staple cavity; a slide movable from a proximal unfired position to a distal fired position during a firing motion; a first RFID tag attached to the cartridge body at the proximal end; and a second RFID tag attached to the cartridge body at the distal end; The nail magazine is configured to be positioned in a nail magazine support of a surgical instrument so that a first signal from the first RFID tag can be received by a first RFID reader at a proximal end of the nail magazine support, and a second signal from the second RFID tag can be received by a second RFID reader at a distal end of the nail magazine support, and a controller of the surgical instrument that communicates with the first RFID reader, the second RFID reader, and the firing system disables operation of the firing system when one of the first signal and the second signal is received but the other is not received.
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