SURGICAL STAPLE CARTRIDGE HAVING INTEGRATED AUTHENTICATION KEY - Patent application
The authentication key mechanism in the staple cartridge ensures compatibility and prevents accidental firing in surgical stapling devices, addressing the challenge of improper stapling or tissue cutting with incompatible or used cartridges.
Patent Information
- Application Number
- JP2021576978
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-06-26
- Filing Date
- 2020-06-08
- Publication Date
- 2025-05-08
- Estimated Expiration
- 2040-06-08
AI Technical Summary
Existing surgical stapling devices face challenges in preventing accidental firing with incompatible or used staple cartridges, which can lead to improper stapling or tissue cutting without stapling.
The implementation of a staple cartridge with an authentication key mechanism that interacts with the surgical stapling device's lockout system, ensuring that only compatible and unfired cartridges can be used, thereby preventing accidental firing.
This solution effectively prevents the stapling device from firing with incompatible or used cartridges, ensuring safe and proper stapling procedures, thereby reducing the risk of surgical errors and complications.
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Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a continuation of U.S. Provisional Patent Application No. 62 / 866,208, filed June 25, 2019, entitled "STAPLE CARTRIDGES WITH FEATURES FOR DEFEATING LOCKOUTS IN SURGICAL STAPLING DEVICES," U.S. Provisional Patent Application No. 62 / 807,310, filed February 19, 2019, entitled "METHODS FOR CONTROLLING A POWERED SURGICAL STAPLER THAT HAS SEPARATE ROTARY CLOSURE AND FIRING SYSTEMS," and U.S. Provisional Patent Application No. 62 / 807,319, filed February 19, 2019, entitled "SURGICAL STAPLING DEVICES WITH IMPROVED LOCKOUT This application claims the benefit of U.S. Provisional Patent Application No. 62 / 807,309, filed February 19, 2019, entitled "SURGICAL STAPLING DEVICES WITH IMPROVED ROTARY DRIVEN CLOSURE SYSTEMS," which are hereby incorporated by reference in their entireties. [Background technology]
[0002] The present invention relates to surgical instruments, and to surgical stapling and severing instruments and staple cartridges for use therewith, designed for stapling and severing tissue in a variety of situations. [Brief explanation of the drawings]
[0003] The various features of the embodiments described herein, together with their advantages, may be understood from the following description taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a perspective view of a powered surgical stapling system. [Figure 2]FIG. 2 is a perspective view of an interchangeable surgical shaft assembly of the powered surgical stapling system of FIG. 1; [Figure 3] FIG. 2 is an exploded view of a portion of a handle assembly of the powered surgical stapling system of FIG. 1; [Figure 4] FIG. 3 is an exploded view of the interchangeable surgical shaft assembly of FIG. 2. [Figure 5] FIG. 5 is another exploded view of a portion of the interchangeable surgical shaft assembly of FIG. 4. [Figure 6] FIG. 1 is an exploded perspective assembly view of a surgical stapling device and staple cartridge of a surgical stapling assembly; [Figure 7] FIG. 7 is a perspective view of a first lockout spring of the surgical stapling device of FIG. 6; [Figure 8] FIG. 7 is a partial side elevational view of a portion of the surgical stapling device of FIG. 6 showing the first lockout spring in retaining engagement with its firing member prior to insertion of a surgical staple cartridge into the first jaw of the surgical stapling device; [Figure 9] FIG. 9 is a top view of a portion of the surgical stapling device of FIG. 8; [Figure 10] FIG. 9 is an exploded view of a portion of the surgical stapling device of FIG. 8 illustrating the initial insertion of a cartridge assembly including a retainer attached to the staple cartridge where an authentication key on the retainer engages a first lockout spring of the surgical stapling device. [Figure 11] FIG. 11 is a perspective view of an authentication key of the retainer of FIG. [Figure 12] FIG. 12 is a top view of the authentication key of the retainer of FIG. [Figure 13] FIG. 12 is a side view of the authentication key of the retainer of FIG. [Figure 14] FIG. 10 is another top view of a portion of the surgical stapling device of FIG. 8 illustrating the initial insertion of the cartridge assembly of FIG. 8 into the first jaw of the surgical stapling device; [Figure 15]FIG. 15 is another top view of the portion of the surgical stapling device of FIG. 14 after the retainer has been removed from the staple cartridge operatively seated in the first jaw of the surgical stapling device; [Figure 16] FIG. 7 is a side view of a portion of the surgical stapling device of FIG. 6 showing a spent staple cartridge seated in the first jaw and the firing member in a starting position; [Figure 17] FIG. 17 is another side elevation view of the surgical stapling device and used staple cartridge of FIG. 16, showing the second firing member lockout in a locked position, preventing the firing member from moving distally during a staple firing stroke. [Figure 18] FIG. 7 is a side elevational view of a portion of the surgical stapling device of FIG. 6 showing an unfired staple cartridge seated in the first jaw and the firing member in a starting position; [Figure 19] FIG. 19 is another side elevation view of the surgical stapling device and unfired staple cartridge of FIG. 18 showing the second firing member lockout in an unlocked position with the thread in the staple cartridge in unlocking engagement with the firing member; [Figure 20] FIG. 10 is an exploded perspective assembly view of a surgical stapling device and staple cartridge of another surgical stapling assembly; [Figure 21] FIG. 21 is a partial side elevational view of a portion of the surgical stapling device of FIG. 20 during initial insertion of a cartridge assembly with a retainer attached to a staple cartridge into the surgical stapling device; [Figure 22] FIG. 22 is another partial side view of the surgical stapling device of FIG. 21 after the cartridge assembly is seated in the first jaw of the surgical stapling device but prior to removal of the retainer from the staple cartridge; [Figure 23]FIG. 23 is another partial side view of the surgical stapling assembly of FIG. 22 after the retainer has been removed from the staple cartridge; [Figure 24] FIG. 10 is a perspective view of the proximal end of another staple cartridge; [Figure 25] FIG. 25 is a partial side elevational view illustrating the initial insertion of the staple cartridge of FIG. 24 into a surgical stapling device with a first firing member lockout of the surgical stapling device in an engaged or locked position; [Figure 26] FIG. 26 is another partial side view of the surgical stapling device of FIG. 25 showing the staple cartridge of FIG. 24 operably seated within the surgical stapling device and the first firing member lockout in a disengaged or unlocked position; [Figure 27] FIG. 10 is an exploded perspective assembly view of a surgical stapling device and staple cartridge of another surgical stapling assembly; [Figure 28] FIG. 28 is a partial side elevational view of a portion of the surgical stapling device of FIG. 27 illustrating the first lockout arm of the first lockout in the jaw-locked position; [Figure 29] FIG. 30 is a top view of a portion of the surgical stapling device of FIG. 28 showing the first lockout arm in the jaw-locked position; [Figure 30] FIG. 30 is another top view of the portion of the surgical stapling device of FIG. 29 showing the first lockout arm in the jaw closed position; [Figure 31] FIG. 30 is a partial bottom perspective view of the surgical stapling device of FIG. 29 showing the first lockout arm in the jaw-locked position; [Figure 32] FIG. 11 is a partial perspective view of the proximal end of the cartridge assembly including an alternative retainer attached to the staple cartridge; [Figure 33] FIG. 33 is a bottom perspective view of the proximal end portion of the retainer of FIG. 32. [Figure 34] FIG. 34 is a top view of the proximal end of the retainer of FIG. 33. [Figure 35] FIG. 35 is a side view of the proximal end of the retainer of FIG. 34. [Figure 36] FIG. 33 is another top view of the portion of the surgical stapling device of FIG. 29 during initial insertion of the cartridge assembly of FIG. 32 into the surgical stapling device; [Figure 37] FIG. 37 is another top view of the portion of the surgical stapling device of FIG. 36 after the cartridge assembly is seated in the surgical stapling device; [Figure 38] FIG. 38 is another top view of the portion of the surgical stapling device of FIG. 37 after the retainer has been removed from the staple cartridge seated in the surgical stapling device; [Figure 38A] FIG. 38 is a top view of a portion of the surgical stapling device of FIG. 37 showing another cartridge assembly seated in the surgical stapling device; [Figure 39] FIG. 10 is a partial perspective view of another staple cartridge showing an authentication key folded into the cartridge pan of the staple cartridge; [Figure 40] FIG. 40 is a top view of another surgical stapling device illustrating the initial insertion of the staple cartridge of FIG. 39 into the surgical stapling device; [Figure 41] FIG. 41 is a side elevational view of the surgical stapling device and staple cartridge of FIG. 40; [Figure 42] FIG. 41 is another top view of the surgical stapling device of FIG. 40 showing the surgical staple cartridge of FIG. 39 operatively seated therein; [Figure 43] FIG. 10 is a partial perspective view of another staple cartridge showing an authentication key folded into the cartridge pan of the staple cartridge; [Figure 44] 44 is a partial perspective view showing the staple cartridge of FIG. 43 operably seated in another surgical stapling device; [Figure 45]FIG. 45 is a side elevational view of the surgical stapling device and staple cartridge of FIG. 44 showing the first lockout arm of the stapling device held in the jaw closed position; [Figure 46] FIG. 45 is another perspective view of the surgical stapling device and staple cartridge of FIG. 44 during the initial insertion of the staple cartridge into the surgical stapling device; [Figure 47] FIG. 10 is a partial perspective view of another staple cartridge showing an authentication key folded into the cartridge pan of the staple cartridge; [Figure 48] FIG. 10 is an exploded perspective assembly view of a surgical stapling device and staple cartridge of another surgical stapling assembly; [Figure 49] FIG. 49 is a side elevational view of the surgical stapling device of FIG. 48 showing the first lockout arm of the surgical stapling device held in the jaw-locked position; [Figure 50] FIG. 50 is a top view of the surgical stapling device of FIG. 49 showing the first lockout arm in the jaw-locked position; [Figure 51] FIG. 50 is a side view of the surgical stapling device of FIG. 49 showing the first lockout arm in the jaw closed position and the anvil of the surgical stapling device in the closed position; [Figure 52] FIG. 50 is another top view of the surgical stapling device of FIG. 49 illustrating the initial insertion of a cartridge assembly including a retainer attached to a staple cartridge into the surgical stapling device; [Figure 53] FIG. 53 is a partial perspective view of the proximal end of the retainer of the cartridge assembly of FIG. 52; [Figure 54] FIG. 54 is a top view of the proximal end of the retainer of FIG. 53. [Figure 55] FIG. 55 is a side view of the proximal end of the retainer of FIG. 54. [Figure 56]FIG. 53 is a top view of another surgical stapling device showing the first lockout arm supported on the opposite side of the surgical stapling device during initial insertion of the cartridge assembly of FIG. 52 into the surgical stapling device; [Figure 57] FIG. 10 is an exploded perspective assembly view of a surgical stapling device and staple cartridge of another surgical stapling assembly; [Figure 58] FIG. 58 is a perspective view of a first lockout spring of the surgical stapling device of FIG. 57; [Figure 59] FIG. 58 is a partial side view of the surgical stapling device of FIG. 57 illustrating a first lockout spring of the surgical stapling device in locking engagement with a firing member of the surgical stapling device; [Figure 60] FIG. 60 is a top view of the surgical stapling device of FIG. 59 showing the first lockout spring in the engaged or locked position; [Figure 61] FIG. 61 is an exploded view of a portion of the surgical stapling device of FIG. 60 showing the initial insertion of a cartridge assembly with a retainer attached to the staple cartridge, with an authentication key on the retainer engaging the first lockout spring of the surgical stapling device. [Figure 62] 62 is a top view of the surgical stapling device of FIG. 60 illustrating the initial insertion of the cartridge assembly of FIG. 61 into the surgical stapling device; [Figure 63] FIG. 63 is another top view of the surgical stapling device of FIG. 62 after the retainer has been removed from the staple cartridge seated in the surgical stapling device; [Figure 64] FIG. 1 is an exploded view of the surgical system. [Figure 64A] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64B]10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64C] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64D] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64E] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64F] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64G] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64H] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64I] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64J] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64K] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64L]10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64M] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64N] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64O] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64P] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64Q] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64R] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64S] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64T] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64U] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64V]10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64W] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64X] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64Y] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64Z] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 64ZZ] 10 illustrates examples of the varying amounts of space available for authentication key placement on various staple cartridges used in connection with different surgical stapling devices. [Figure 65] FIG. 10 is an exploded perspective assembly view of a surgical stapling device and staple cartridge of another surgical stapling assembly; [Figure 66] FIG. 66 is a partial perspective view of the surgical staple cartridge of FIG. 65; [Figure 67] FIG. 66 is a perspective view of a proximal end portion of a first jaw of the surgical stapling instrument of FIG. 65; [Figure 68] FIG. 66 is a top view of the surgical stapling device of FIG. 65 showing the first lockout arm of the surgical stapling device in the jaw-locked position; [Figure 69] FIG. 69 is a side view of the surgical stapling device of FIG. 68 showing the first lockout arm in the jaw-locked position; [Figure 70]FIG. 70 is another side elevational view of the surgical stapling device of FIG. 69 showing the first lockout arm in the jaw closed position and the anvil of the surgical stapling device in the closed position; [Figure 71] FIG. 1 is an end elevation view of a portion of a surgical stapling device showing a first lockout arm of the surgical stapling device in a jaw-locked position; [Figure 72] FIG. 66 is a perspective view of a staple cartridge that may be used in connection with the surgical stapling device of FIG. 65; [Figure 73] FIG. 73 is a top view of a portion of the first lockout arm of the surgical stapling device of FIG. 65 illustrating the initial insertion of the staple cartridge of FIG. 72 into the surgical stapling device; [Figure 74] FIG. 10 is another top view of the first lockout arm engaged with the upper ramp mechanism of the staple cartridge authentication key. [Figure 75] FIG. 73 is another top view of the first lockout arm of the surgical stapling device of FIG. 65 during further insertion of the staple cartridge of FIG. 72 into the surgical stapling device; [Figure 76] FIG. 66 is another top view of the first lockout arm of the surgical stapling device of FIG. 65 shown in a jaw closed position after the staple cartridge is operatively seated in the surgical stapling device; [Figure 77] 77 is a partial perspective view of a portion of the first lockout arm of FIG. 76 during closure of the anvil of the surgical stapling device of FIG. 65; [Figure 78] FIG. 78 is a partial top view of the surgical stapling device of FIG. 77 with a portion of the anvil shown in cross section; [Figure 78A] FIG. 10 is a perspective view of another retainer embodiment attached to another staple cartridge embodiment; [Figure 78B] FIG. 10 is a perspective view of another staple cartridge embodiment; [Figure 78C]FIG. 78C is a top view of the staple cartridge embodiment of FIG. 78B; [Figure 79] FIG. 10 is a perspective view of another retainer embodiment. [Figure 80] FIG. 80 is a bottom perspective view of the retainer embodiment of FIG. 79. [Figure 81] 80 is another bottom perspective view of the retainer embodiment of FIG. 79, showing the frangible retention tab removed therefrom. [Figure 82] FIG. 10 is a perspective assembly view of another retainer embodiment and staple cartridge; [Figure 83] FIG. 83 is an exploded cross-sectional assembly view of the retainer and staple cartridge of FIG. 82; [Figure 84] FIG. 83 is a cross-sectional end view of the retainer and staple cartridge of FIG. 82 coupled together to form a cartridge assembly seated within a frame of a surgical stapling device; [Figure 85] 85 is a partial cross-sectional perspective view of the cartridge assembly of FIG. 84 seated in the frame of FIG. 84. FIG. [Figure 86] FIG. 10 is a partial perspective view of a nose portion of the staple cartridge; [Figure 87] FIG. 10 is a partial perspective view of a nose portion of another staple cartridge; [Figure 88] FIG. 10 is a partial perspective view of a nose portion of another staple cartridge; [Figure 89] FIG. 10 is a partial perspective view of a nose portion of another staple cartridge; [Figure 90] FIG. 10 is a partial perspective view of a nose portion of another staple cartridge; [Figure 91] FIG. 10 is a partial perspective view of a nose portion of another staple cartridge; [Figure 92] FIG. 10 is a partial perspective view of a nose portion of another staple cartridge; [Figure 93] FIG. 1 is a side view of a portion of a surgical stapling device showing a compatible staple cartridge and a compatible retainer seated within a frame of the surgical stapling device; [Figure 94] FIG. 94 is another side view of the surgical stapling device of FIG. 93, shown with a non-compatible staple cartridge and a non-compatible retainer seated within the frame of the device; [Figure 95] FIG. 10 is a perspective view of another retainer embodiment having a removable authentication key. [Figure 96] 96 is another perspective view of the retainer of FIG. 95, showing the removable authentication key removed from and tethered to the body portion of the retainer. [Figure 97] FIG. 10 is a bottom view of another retainer embodiment. [Figure 98] FIG. 98 is a cross-sectional view of a portion of the retainer of FIG. 97 prior to use. [Figure 99] FIG. 98 is another cross-sectional view of a portion of the retainer of FIG. 97 after the retainer has been used and removed from the staple cartridge; [Figure 100] FIG. 12 is a proximal perspective view of an embodiment of a retainer assembly. [Figure 101] FIG. 101 is an exploded view of the retainer assembly and staple cartridge of FIG. 100; [Figure 102] FIG. 101 is another proximal perspective view of the retainer assembly of FIG. 100. [Figure 103] FIG. 101 is a bottom view of the retainer assembly of FIG. 100. [Figure 104] 101 is a perspective view of the retainer assembly of FIG. 100 shown attached to a staple cartridge to form a cartridge assembly; [Figure 105] FIG. 10 is a perspective view of another retainer assembly embodiment shown attached to a staple cartridge to form a cartridge assembly; [Figure 106] FIG. 106 is an exploded perspective assembly view of the cartridge assembly of FIG. 105. [Figure 107] FIG. 106 is a partial perspective view of a portion of a surgical stapling device supporting the cartridge assembly of FIG. 105, showing the retainer cover removed from the cartridge assembly; [Figure 108] FIG. 10 is a side view of the cartridge assembly seated in the frame of the surgical stapling device, the cartridge assembly including an alternative retainer removably coupled to the staple cartridge; [Figure 109] FIG. 10 is a bottom view of the proximal end of another retainer embodiment. [Figure 110A] FIG. 10 is a top view of the proximal end of another retainer embodiment, showing its authentication key in a first position. [Figure 110B] FIG. 110B is another top view of the retainer of FIG. 110A showing the authentication key in a second position that renders the retainer non-reusable. [Figure 111] FIG. 10 is a bottom view of the proximal end of another retainer embodiment. [Figure 112] FIG. 10 is a bottom view of the proximal end of another retainer embodiment. [Figure 113] 113 is a cross-sectional view of the authentication key of the retainer of FIG. 112 taken along line 113-113 of FIG. [Figure 114] 10 is a schematic diagram of the composition of another retainer embodiment. [Figure 115] 115 is another view of the retainer embodiment of FIG. 114. [Figure 116] 115 is a schematic view of the embodiment of the retainer of FIG. 114 shown clamped between the jaws of a stapling device; [Figure 117] FIG. 10 is a top view of another retainer embodiment. [Figure 118] 118 is another top view of the retainer of FIG. 117, with some portions shown in cross section. [Figure 119] A partial perspective assembly view showing the initial installation of the retainer of Figure 117 on the staple cartridge. [Figure 120] 118 is another partial perspective view showing the retainer of FIG. 117 installed on the staple cartridge of FIG. 119; [Figure 121] FIG. 121 is a proximal end view of the retainer and staple cartridge assembly of FIG. 120; [Figure 122]FIG. 10 is a side view of another retainer embodiment installed on a staple cartridge, with a portion of the retainer shown in cross section and its authentication key in a retracted position; [Figure 123] FIG. 123 is another side view of the retainer and staple cartridge of FIG. 122, showing the retainer authentication key protruding proximally from the key housing on the retainer. [Figure 124] FIG. 124 is an enlarged view of a portion of the retainer and staple cartridge of FIG. 123; [Figure 125] FIG. 125 is an enlarged cross-sectional view of a portion of the retainer and staple cartridge of FIG. 124 with the plunger actuator in a depressed position removing the retainer from the staple cartridge; [Figure 126] FIG. 126 is an enlarged view of the plunger actuator of FIG. 125. [Figure 127] FIG. 10 is a perspective view of the proximal end of another retainer embodiment. [Figure 128] FIG. 128 is a perspective view showing the retainer of FIG. 127 coupled to an unfired staple cartridge. [Figure 129] FIG. 129 is an exploded assembly view of a portion of the retainer of FIG. 128 associated with the sled of the unfired staple cartridge of FIG. 128; [Figure 130] FIG. 10 is a top view of another retainer embodiment, showing its authentication key in an extended actuation position, with some of the retainer mechanisms removed for clarity. [Figure 131] 131 is a side view of the retainer of FIG. 130 with its authentication key in a retracted position. [Figure 132] FIG. 1 is an exploded view of the retainer system. [Figure 133] FIG. 133 is a partial cross-sectional view of the retainer of the retainer system of FIG. 132. [Figure 134] A cross-sectional assembly view of the retainer tool of the retainer system of Figure 132 supported on a staple cartridge. [Figure 135]FIG. 133 is another exploded view of the retainer system of FIG. 132 showing the retainer being initially installed onto the staple cartridge using a retainer tool; [Figure 136] FIG. 136 is another exploded view showing the retainer initially installed on the staple cartridge of FIG. 135 with the retainer tool being withdrawn from between the retainer and the staple cartridge; [Figure 137] FIG. 10 is an exploded view of another retainer system. [Figure 138] 138 is a bottom perspective assembly view showing the tool of the system of FIG. 137 inserted into the retainer of the system of FIG. 137 prior to installation on the staple cartridge. [Figure 139] 139 is a cross-sectional view of the tool of FIG. 138 inserted into the retainer of FIG. 138, showing the retainer seated on the staple cartridge; [Figure 140] FIG. 10 is a side view of a portion of another retainer embodiment. [Figure 141] FIG. 141 is a bottom view of a portion of the retainer embodiment of FIG. 140. [Figure 142] FIG. 10 is an exploded view of another retainer embodiment and surgical stapling device. [Figure 143] 144 is a perspective view showing the retainer of FIG. 142 attached to a staple cartridge seated in the frame of the stapling device of FIG. 143; [Figure 144] FIG. 144 is a side view of the retainer and stapling device of FIG. 143, with the movement of the release member of the retainer shown in phantom; [Figure 145] 145 is a partial side view showing the location of the authentication key of the retainer of FIG. 144 attached to the stapling device of FIG. 144; [Figure 146] FIG. 146 is a partial top view of the retainer and stapling device of FIG. 145 showing the staple cartridge / retainer assembly initially inserted into the stapling device; [Figure 147]FIG. 147 is another partial top view of the staple cartridge / retainer assembly of FIG. 146 seated in the stapling device of FIG. 146, showing the authentication key of the retainer disabling the lockout of the stapling device; [Figure 148] FIG. 10 is a side view of another retainer embodiment used to apply a prying motion to the nose of a used staple cartridge attached to the frame of the surgical stapling device. [Figure 149] 1 is a perspective view of an embodiment of a passivation tool. [Figure 150] FIG. 150 is a side view of the surgical stapling device with the deactivation tool of FIG. 149 placed thereon; [Figure 151] FIG. 151 is a partial top view of an authentication key of a deactivation tool initially contacting an actuator cam arm of the lockout of the surgical stapling device of FIG. 150; [Figure 152] FIG. 152 is a partial side view of the authentication key and actuator cam arm of FIG. 151. [Figure 153] 151 is another side view of the surgical stapling device of FIG. 150 with the deactivation tool biasing the lockout arms of the surgical stapling device into a jaw closed position; [Fig. 154] FIG. 154 is another side view of the surgical stapling device of FIG. 153 with the deactivation tool urging the lockout arms of the surgical stapling device into the jaw closed position and the staple cartridge installed within the frame of the surgical stapling device; [Figure 155] FIG. 154 is a partial top view of an authentication key of a deactivation tool that biases an actuator cam arm of the surgical stapling device of FIG. 153 into a jaw closed position; [Figure 156] FIG. 156 is a partial side view of the authentication key and actuator cam arm of FIG. 155. [Figure 157] FIG. 10 is a partial perspective view of a portion of a surgical stapling device having an embodiment of a deactivation insert that holds a first lockout arm of the surgical stapling device in a jaw closed position; [Figure 158] 158 is a partial cross-sectional top view of an embodiment of an installation tool supporting the deactivation insert of FIG. 157 thereon prior to installation into the surgical stapling device of FIG. 157; [Figure 159] 159 is another partial cross-sectional top view of the installation tool of FIG. 158 for installing the deactivation insert of FIG. 157 into the surgical stapling device of FIG. 158; [Figure 160] 159 after the inactivation insert has been installed therein and the installation tool has been withdrawn therefrom; FIG. [Figure 161] FIG. 10 is a partial perspective view of a portion of another surgical stapling device having another deactivation insert installed therein to retain a first lockout of the surgical stapling device in the jaw closed position; [Figure 162] FIG. 10 is a perspective view of another installation tool embodiment. [Figure 163] FIG. 163 is a side view of a surgical stapling device illustrating the use of the installation tool of FIG. 162 to bias a first lockout arm of the device into a jaw closed position. [Fig. 164] FIG. 10 is a top view of another installation tool embodiment for installing a deactivation insert within a channel of a surgical stapling device. [Figure 165] FIG. 164 is a side view of the surgical stapling device of FIG. 163 illustrating the use of an embodiment of a deactivator to hold the lockout arms of the surgical stapling device in the jaw closed position; [Figure 166] FIG. 164 is another side view of the surgical stapling device of FIG. 163 illustrating the use of another deactivator embodiment to hold the lockout arms of the surgical stapling device in the jaw closed position; [Figure 167]FIG. 10 is a partial top view of a portion of a surgical stapling device having an embodiment of a deactivation tool attached to hold the lockout arms of the surgical stapling device in a jaw closed or locked position until a staple cartridge is inserted into the frame of the device. [Figure 168] 14A-14C are partial perspective views of frames of various surgical stapling devices having channel ledges formed thereon for cartridge alignment purposes; [Figure 169] A partial perspective view of a portion of the anvil of various surgical stapling devices showing a relief area therein for accommodating the channel ledge of FIG. 168 when the anvil is moved to a closed position. [Figure 170] FIG. 10 is a top cross-sectional view of a portion of a surgical stapling device with a portion of a staple cartridge initially seated longitudinally therein; [Figure 171] FIG. 171 is another top cross-sectional view of the surgical stapling device and cartridge of FIG. 170, with the staple cartridge operably seated within the surgical stapling device; [Fig. 172] 172 is a partial perspective view of the staple cartridge of FIG. 171 and a first lockout arm of the surgical stapling device of FIG. 171; [Figure 173] FIG. 1 is a perspective view of an embodiment of a sled with an authentication key arrangement. [Fig. 174] FIG. 174 is a partial top view of the staple cartridge containing the sled of FIG. 173 in an unfired position and interacting with a first lockout arm of the surgical stapling device; [Figure 175] 12 is a perspective view of the proximal end of another staple cartridge having an authentication key formed within the cartridge pan of the cartridge; FIG. [Figure 176] FIG. 176 is another perspective view of the proximal end of the staple cartridge of FIG. 175; [Figure 177] 176 is a top view of a portion of the staple cartridge of FIG. 175 inserted within a portion of another surgical stapling device; [Figure 178] 178 is another top view of the staple cartridge of FIG. 175 fully inserted into the surgical stapling device of FIG. 177 with the first lockout in the unlocked or jaw closed position; [Figure 179] FIG. 10 is a perspective view of the proximal end of another staple cartridge embodiment, with the authentication key in a first state; [Figure 180] Another perspective view of the proximal end of the staple cartridge of FIG. 179, with the authentication key in a second state. [Figure 181] 179 during initial insertion into the surgical stapling device; [Figure 182] 182 is another partial top cross-sectional view of the staple cartridge and surgical stapling device of FIG. 181 with the staple cartridge operably seated within the device and the lockout arm of the device in the unlocked position; [Figure 183] 12 is a perspective view of the proximal end of another staple cartridge embodiment having an authentication key formed in the cartridge pan and in a first state; FIG. [Figure 184] Another perspective view of the proximal end of the staple cartridge of FIG. 183, with the authentication key in a second state. [Figure 185] 12 is a perspective view of the proximal end of another staple cartridge embodiment having an authentication key formed in the cartridge pan and in a first state; FIG. [Figure 186] FIG. 10 is a perspective view of another retainer embodiment having a movable authentication key arrangement attached to a staple cartridge. [Figure 187] FIG. 10 is a perspective view of another retainer embodiment having a movable authentication key arrangement attached to a staple cartridge. [Figure 188] FIG. 10 is a perspective view of another retainer embodiment having a movable authentication key arrangement attached to a staple cartridge. [Figure 189] FIG. 10 is a perspective view of another retainer embodiment having a movable authentication key arrangement attached to a staple cartridge. [Figure 190] FIG. 10 is a perspective view of another retainer embodiment having a movable authentication key arrangement attached to a staple cartridge. [Figure 191] 12 is a perspective view of another embodiment of a retainer attached to a staple cartridge having a movable authentication key arrangement formed in the cartridge pan of the staple cartridge; FIG. [Figure 192] FIG. 10 is a perspective view of another retainer embodiment having a collapsible authentication key arrangement attached to a staple cartridge; [Figure 193] FIG. 10 is a partial perspective view of a portion of a surgical stapling device with a cartridge assembly seated therein, the cartridge assembly including a retainer having a movable authentication key that is movable when contacted by a portion of the surgical stapling device; [Figure 194] 194 is a partial top view of the surgical stapling device of FIG. 193 with the cartridge assembly of FIG. 193 initially inserted within the stapling device; [Figure 195] Another partial top view of the surgical stapling device of FIG. 194, with the cartridge assembly seated in a final position where its movable authentication key has moved the first locking arm of the surgical stapling device into an unlocked position. [Figure 195A] Another partial top view of the surgical stapling device of Figure 194 having a cartridge assembly with an alternative retainer seated on a staple cartridge seated in a final position where a movable authentication key has moved the first lockout arm of the device into an unlocked position. [Figure 196] FIG. 10 is a partial perspective view of a portion of a surgical stapling device with another cartridge assembly seated therein, the cartridge assembly including another retainer having a movable authentication key that is movable when contacted by a portion of the surgical stapling device; [Figure 197] 197 is a partial top view of the surgical stapling device of FIG. 196 with the cartridge assembly of FIG. 196 initially inserted into the stapling device; [Figure 198]FIG. 197 is another partial top view of the surgical stapling device of FIG. 196 with the cartridge assembly seated in a final position with its movable authentication key moving the first locking arm of the device into an unlocked position; [Figure 199] FIG. 10 is a partial perspective view of a portion of a surgical stapling device with another cartridge assembly seated therein, the cartridge assembly including another retainer having a movable authentication key that is movable when contacted by a portion of the surgical stapling device; [Figure 200] 199 is a partial top view of the surgical stapling device of FIG. 199 with the cartridge assembly of FIG. 196 initially inserted into the surgical stapling device; [Figure 201] Another partial top view of the surgical stapling device of FIG. 196 with the cartridge assembly seated in a final position where its movable authentication key has moved the first locking arm of the surgical stapling device into an unlocked position. [Figure 202] 1 is a perspective view of an embodiment of a deactivation element. [Figure 203] FIG. 10 is a partial perspective view of a deactivation element installed on a cartridge assembly including a staple cartridge and a retainer. [Figure 204] FIG. 10 is a perspective view of a cartridge assembly and deactivator installed within a surgical stapling device; [Figure 205] 205 is another perspective view of the cartridge assembly and surgical stapling device of FIG. 204 with the retainer detached from the staple cartridge while the deactivation element remains within the surgical stapling device; [Figure 206] FIG. 10 is a bottom perspective view of the proximal end of an embodiment of a staple cartridge having an authentication key integrally formed thereon. [Figure 207] FIG. 207 is a bottom view of an embodiment of a sled of the staple cartridge of FIG. 206; [Figure 208] FIG. 207 is a top perspective view of the proximal end of the staple cartridge of FIG. 206; [Figure 209]207 is a partial top cross-sectional view of the staple cartridge of FIG. 206 aligned with the surgical stapling device prior to insertion therein; [Figure 210] Another partial top cross-sectional view of the staple cartridge and surgical stapling device of Figure 209 with the staple cartridge operably seated within the device and the lockout arm of the device in the unlocked position.
[0004] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate various embodiments of the invention in one form only, and such exemplifications should not be construed as limiting the scope of the invention in any manner. DETAILED DESCRIPTION OF THE INVENTION
[0005] The applicant of the present application owns the following US patent applications, filed on even date herewith, each of which is incorporated herein by reference in its entirety: -U.S. Patent Application, entitled "METHOD FOR PROVIDING AN AUTHENTICATION LOCKOUT IN A SURGICAL STAPLER WITH A REPLACEABLE CARTRIDGE," Attorney Docket No. END9170USNP1 / 190162-1M; -U.S. Patent Application, entitled "SURGICAL STAPLING ASSEMBLY WITH CARTRIDGE BASED RETAINER CONFIGURED TO UNLOCK A FIRING LOCKOUT," Attorney Docket No. END9170USNP2 / 190162-2; -U.S. Patent Application, entitled "SURGICAL STAPLING ASSEMBLY WITH CARTRIDGE BASED RETAINER CONFIGURED TO UNLOCK A CLOSURE LOCKOUT," Attorney Docket No. END9170USNP3 / 190162-3; -U.S. Patent Application, entitled "UNIVERSAL CARTRIDGE BASED KEY FEATURE THAT UNLOCKS MULTIPLE LOCKOUT ARRANGEMENTS IN DIFFERENT SURGICAL STAPLERS," Attorney Docket No. END9170USNP4 / 190162-4; -U.S. Patent Application, entitled "STABLE CARTRIDGE RETAINERS WITH FRANGIBLE RETENTION FEATURES AND METHODS OF USING SAME," Attorney Docket No. END9170USNP5 / 190162-5; -U.S. Patent Application, entitled "STAPLE CARTRIDGE RETAINER WITH FRANGIBLE AUTHENTICATION KEY," Attorney Docket No. END9170USNP6 / 190162-6; -U.S. Patent Application, entitled "STAPLE CARTRIDGE RETAINER WITH RETRACTABLE AUTHENTICATION KEY," Attorney Docket No. END9170USNP7 / 190162-7; -U.S. Patent Application, entitled "STAPLE CARTRIDGE RETAINER SYSTEM WITH AUTHENTICATION KEYS," Attorney Docket No. END9170USNP8 / 190162-8; -U.S. Patent Application, entitled "INSERTABLE DEACTIVATOR ELEMENT FOR SURGICAL STAPLER LOCKOUTS," Attorney Docket No. END9170USNP9 / 190162-9; -U.S. Patent Application, entitled "DUAL CAM CARTRIDGE BASED FEATURE FOR UNLOCKING A SURGICAL STAPLER LOCKOUT," Attorney Docket No. END9170USNP10 / 190162-10; -U.S. Patent Application, entitled "STAPLE CARTRIDGES WITH CAM SURFACES CONFIGURED TO ENGAGE PRIMARY AND SECONDARY PORTIONS OF A LOCKOUT OF A SURGICAL STAPLING DEVICE," Attorney Docket No. END9170USNP11 / 190162-11; -U.S. Patent Application, entitled "SURGICAL STAPLE CARTRIDGES WITH MOVABLE AUTHENTICATION KEY ARRANGEMENTS," Attorney Docket No. END9170USNP12 / 190162-12, and -U.S. Patent Application, entitled "DEACTIVATOR ELEMENT FOR DEFEATING SURGICAL STAPLING DEVICE LOCKOUTS," Attorney Docket No. END9170USNP13 / 190162-13.
[0006] The applicant of the present application owns the following U.S. design patent applications, filed on June 25, 2019, each of which is incorporated by reference in its entirety: - U.S. Design Patent Application No. 29 / 696,066, entitled "SURGICAL STAPLE CARTRIDGE RETAINER WITH FIRING SYSTEM AUTHENTICATION KEY"; -U.S. Design Patent Application No. 29 / 696,067, entitled "SURGICAL STAPLE CARTRIDGE RETAINER WITH CLOSURE SYSTEM AUTHENTICATION KEY"; and -U.S. Design Patent Application No. 29 / 696,072, entitled "SURGICAL STAPLE CARTRIDGE."
[0007] The applicant of this application owns the following U.S. patent applications, filed on February 21, 2019, each of which is incorporated by reference in its entirety: - U.S. Provisional Patent Application No. 16 / 281,658, entitled "METHODS FOR CONTROLLING A POWERED SURGICAL STAPLER THAT HAS SEPARATE ROTARY CLOSURE AND FIRING SYSTEMS"; -U.S. Patent Application No. 16 / 281,670, entitled "STAPLE CARTRIDGE COMPRISING A LOCKOUT KEY CONFIGURED TO LIFT A FIRING MEMBER"; -U.S. Patent Application No. 16 / 281,675, entitled "Surgical Staples with Arrangements for Maintaining a Firing Member Thereof in a Locked Configuration Unless a Compatible Cartridge Has Been Installed Therein"; -U.S. Patent Application No. 16 / 281,685, entitled "SURGICAL INSTRUMENT COMPRISING CO-OPERATING LOCKOUT FEATURES"; - U.S. Patent Application No. 16 / 281,693, entitled "SURGICAL STAPLING ASSEMBLY COMPRISING A LOCKOUT AND AN EXTERIOR ACCESS ORIFICE TO PERMIT ARTIFICIAL UNLOCKING OF THE LOCKOUT"; - U.S. Patent Application No. 16 / 281,704, entitled "SURGICAL STAPLING DEVICES WITH FEATURES FOR BLOCKING ADVANCEMENT OF A CAMMING ASSEMBLY OF AN INCOMPATIBLE CARTRIDGE INSTALLED THEREIN"; -U.S. Patent Application No. 16 / 281,707, entitled "SURGICAL INSTRUMENT COMPRISING A DEACTIVATABLE LOCKOUT"; -U.S. Patent Application No. 16 / 281,741, entitled "SURGICAL INSTRUMENT COMPRISING A JAW CLOSURE LOCKOUT"; -U.S. Patent Application No. 16 / 281,762, entitled "SURGICAL STAPLING DEVICES WITH CARTRIDGE COMPATIBLE CLOSURE AND FIRING LOCKOUT ARRANGEMENTS"; - U.S. Patent Application No. 16 / 281,660, entitled "SURGICAL STAPLE CARTRIDGE WITH FIRING MEMBER DRIVEN CAMMING ASSEMBLY THAT HAS AN ONBOARD TISSUE CUTTING FEATURE"; -U.S. Patent Application No. 16 / 281,666, entitled "SURGICAL STAPLING DEVICES WITH IMPROVED ROTARY DRIVEN CLOSURE SYSTEMS"; -U.S. Patent Application No. 16 / 281,660, entitled "SURGICAL STAPLING DEVICES WITH ASYMMETRIC CLOSURE FEATURES"; -U.S. Patent Application No. 16 / 281,678, entitled "ROTARY DRIVEN FIRING MEMBERS WITH DIFFERENT ANVIL AND FRAME ENGAGEMENT FEATURES"; and -U.S. Patent Application No. 16 / 281,682, entitled "SURGICAL STAPLING DEVICE WITH SEPARATE ROTARY DRIVEN CLOSURE AND FIRING SYSTEMS AND FIRING MEMBER THAT ENGAGES BOTH JAWS WHILE FIRING."
[0008] As described herein and illustrated in the accompanying drawings, numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments. Well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described herein. The reader will understand that the embodiments described and illustrated herein are non-limiting examples, and thus the specific structural and functional details disclosed herein may be representative and exemplary. Variations and modifications can be made thereto without departing from the scope of the claims.
[0009] The terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a surgical system, device, or instrument that "comprises," "has," "includes," or "contains" one or more elements has those one or more elements, but is not limited to having only those one or more elements. Similarly, a system, device, or apparatus element that "comprises," "has," "includes," or "contains" one or more features has those one or more features, but is not limited to having only those one or more features.
[0010] The terms "proximal" and "distal" are used herein with reference 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 located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "above," and "below" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0011] Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily understand that the various methods and devices disclosed herein can be used in many surgical procedures and applications, including, for example, those associated with open surgical procedures. As the reader progresses through the Detailed Description of the Invention section of this specification, the reader will further understand that the various instruments disclosed herein can be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture formed in tissue, etc. The working portions or end effector portions of these instruments can be inserted directly into the patient's body, or they can be inserted through an access device having a working frame through which the end effector and elongate shaft of the surgical instrument can be advanced.
[0012] The surgical stapling system can include a shaft and an end effector extending from the shaft. The end effector includes a first jaw and a second jaw. The first jaw includes a staple cartridge. The staple cartridge is insertable into and removable from the first jaw, although other embodiments are envisioned in which the staple cartridge is not removable from the first jaw, or at least not easily replaceable from the first jaw. The second jaw includes an anvil configured to deform staples ejected from the staple cartridge. Other embodiments are envisioned in which the second jaw is pivotable relative to the first jaw about a closure axis, while the first jaw is pivotable relative to the second jaw. The surgical stapling system further includes an articulation joint configured to rotate, or articulate, the end effector relative to the shaft. The end effector is rotatable about an articulation axis extending through the articulation joint. Other embodiments are also envisioned that do not include an articulation joint.
[0013] The staple cartridge includes a cartridge body. The cartridge body includes a proximal end, a distal end, and a deck extending between the proximal and distal ends. During use, the staple cartridge is positioned on a first side of tissue to be stapled, and the anvil is positioned on a second side of the tissue. The anvil is moved toward the staple cartridge to press and clamp the tissue against the deck. Staples removably stored within the cartridge body can then be deployed into the tissue. The cartridge body includes staple cavities defined therein, and the staples are removably stored within the staple cavities. The staple cavities are arranged in six longitudinal rows. Three rows of staple cavities are positioned on a first side of the longitudinal slot, and three rows of staple cavities are positioned on a second side of the longitudinal slot. Other arrangements of staple cavities and staples may be possible.
[0014] The staples are supported by staple drivers within the cartridge body. The drivers are movable between a first, unfired, position and a second, fired, position that ejects the staples from the staple cavities. The drivers are retained within the cartridge body by a retainer extending around the bottom of the cartridge body and include a resilient member configured to grip the cartridge body and hold the retainer against the cartridge body. The drivers are movable between their unfired and fired positions by a sled. The sled is movable between a proximal position adjacent the proximal end and a distal position adjacent the distal end. The sled includes a plurality of ramps configured to slide under the drivers and lift the drivers, on which the staples are supported, toward the anvil.
[0015] In addition to the above, the sled is moved distally by a firing member. The firing member is configured to contact the sled and push it toward the distal end. A longitudinal slot defined in the cartridge body is configured to receive the firing member. The anvil also includes a slot configured to receive the firing member. The firing member further includes a first cam engaging the first jaw and a second cam engaging the second jaw. When the firing member is advanced distally, the first cam and the second cam can control the distance between the deck portion of the staple cartridge and the anvil, i.e., the tissue gap. The firing member also includes a knife configured to cut tissue captured intermediate the staple cartridge and the anvil. It is desirable that the knife be positioned at least partially proximal to the beveled surface so that the staples are ejected forward of the knife.
[0016] FIG. 1 illustrates a surgical instrument 1010 including an interchangeable shaft assembly 1200 operably coupled to a housing 1012. FIG. 2 illustrates the interchangeable shaft assembly 1200 detached from the housing 1012 or handle 1014. As shown in FIG. 3, the handle 1014 may include a pair of interconnectable handle housing segments 1016 and 1018, which may be interconnected by screws, snap mechanisms, adhesives, or the like. In the illustrated arrangement, the handle housing segments 1016, 1018 cooperate to form a pistol grip portion 1019. FIGS. 1 and 3 illustrate a motorized surgical cutting and fastening instrument 1010, which may or may not be reusable. In the illustrated embodiment, the instrument 1010 includes the aforementioned housing 1012 with a handle 1014 configured to be grasped, manipulated, and actuated by a clinician. The housing 1012 is configured to operably attach to an interchangeable shaft assembly 1200, to which a surgical end effector 1300 configured to perform one or more surgical tasks or procedures is operably coupled. As the detailed description of the present invention progresses, it will be understood that the various forms of interchangeable shaft assemblies disclosed herein can also be effectively used in connection with robotically controlled surgical systems. Accordingly, the term "housing" may also encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system configured to generate and apply at least one control motion that can be used to actuate the interchangeable shaft assemblies disclosed herein and their respective equivalents. Additionally, various components may be "housed" or included within the housing, or various components may be "associated" with the housing. In such instances, components may not be contained within or directly supported by the housing. The term "frame" may refer to a portion of a handheld surgical instrument.Additionally, the term "frame" may refer to a portion of a robotically controlled surgical instrument and / or a portion of a robotic system that may be used to operatively control a surgical instrument. For example, the interchangeable shaft assemblies disclosed herein may be used with various robotic systems, instruments, components, and methods disclosed in U.S. Patent No. 9,072,535, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," which is incorporated herein by reference in its entirety.
[0017] The aforementioned housing 1012 shown in FIG. 1 is illustrated in connection with an interchangeable shaft assembly 1200 ( FIGS. 2 , 4 , and 5 ) including an end effector 1300 with a surgical cutting and fastening device configured to operably support a surgical staple cartridge 1350 therein. The housing 1012 may be configured for use in connection with interchangeable shaft assemblies having various shaft lengths, sizes, and types, including end effectors adapted to support various sizes and types of staple cartridges. In addition, the housing 1012 may also be effectively used in connection with a variety of other interchangeable shaft assemblies, including assemblies configured to apply, for example, motion and other forms of energy, such as radio frequency (RF) energy, ultrasonic energy, and / or motion, to end effector arrangements adapted for use in connection with various surgical applications and procedures. Furthermore, the end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system may utilize any suitable fastener that can be grasped and manipulated by a clinician. As described in more detail below, the handle 1014 operably supports a number of drive systems therein that are configured to generate and apply various controlled motions to corresponding portions of interchangeable shaft assemblies operably attached thereto.
[0018] 3, the handle 1014 may further include a frame 1020 that operably supports a plurality of drive systems. For example, the frame 1020 may operably support a "first" or closure drive system, generally designated 1030, that may be used to apply a closing or opening motion to an interchangeable shaft assembly 1200 operably attached or coupled thereto. In at least one form, the closure drive system 1030 may include an actuator in the form of a closure trigger 1032 pivotally supported by the frame 1020. More specifically, as shown in FIG. 3, the closure trigger 1032 is pivotally coupled to the housing 1014 by a pin 1033. Such an arrangement allows the closure trigger 1032 to be manipulated by a clinician. Specifically, when a clinician grasps the pistol grip portion 1019 of the handle 1014, the closure trigger 1032 can be easily pivoted from a starting or “unactuated” position to an “actuated” position, more specifically, a fully squeezed or fully actuated position. The closure trigger 1032 may be biased to the unactuated position by a spring or other biasing arrangement (not shown). In various forms, the closure drive system 1030 further includes a closure linkage assembly 1034 pivotally coupled to the closure trigger 1032. As shown in FIG. 3 , the closure linkage assembly 1034 may include a first closure link 1036 and a second closure link 1038 pivotally coupled to the closure trigger 1032 by a pin 1035. The second closure link 1038, also sometimes referred to herein as a “mounting member,” includes a lateral mounting pin 1037.
[0019] Continuing to refer to FIG. 3 , it can be seen that the first closure link 1036 can have a locking wall or end 1039 thereon that is configured to cooperate with a closure release assembly 1060 that is pivotally coupled to the frame 1020. In at least one form, the closure release assembly 1060 can include a release button assembly 1062 having a distally projecting locking pawl 1064 formed thereon. The release button assembly 1062 can be pivoted counterclockwise by a release spring (not shown). When the clinician depresses the closure trigger 1032 from its unactuated position toward the pistol grip portion 1019 of the handle 1014, the first closure link 1036 pivots upward to a point where the locking pawl 1064 drops into retaining engagement with the locking wall 1039 on the first closure link 1036, thereby preventing the closure trigger 1032 from returning to the unactuated position. The closure release assembly 1060 thus serves to lock the closure trigger 1032 in the fully actuated position. When a clinician wishes to unlock the closure trigger 1032 so that it can be biased to the unactuated position, the clinician simply pivots the release button assembly 1062, thereby moving the locking pawl 1064 out of engagement with the locking wall 1039 on the first closure link 1036. When the locking pawl 1064 has been moved out of engagement with the first closure link 1036, the closure trigger 1032 may pivot back to the unactuated configuration. Other closure trigger lock and release arrangements may be used.
[0020] An arm 1061 may extend from the release button assembly 1062. A magnetic element 1063, such as, for example, a permanent magnet, may be attached to the arm 1061. Rotating the release button assembly 1062 from its first position to its second position may cause the magnetic element 1063 to move toward the circuit board 1100. The circuit board 1100 may include at least one sensor configured to detect movement of the magnetic element 1063. In at least one embodiment, for example, a "Hall Effect" sensor (not shown) may be attached to a bottom surface of the circuit board 1100. The Hall Effect sensor may be configured to detect a change in a magnetic field surrounding the Hall Effect sensor caused by movement of the magnetic element 1063. The Hall effect sensor may, for example, be capable of signal communication with a microcontroller to determine whether the release button assembly 1062 is in its first position associated with the unactuated position of the closure trigger 1032 and the open configuration of the end effector, in its second position associated with the actuated position of the closure trigger 1032 and the closed configuration of the end effector, and / or in any position between the first and second positions.
[0021] In at least one form, the handle 1014 and frame 1020 can operably support another drive system, referred to herein as a firing drive system 1080, configured to apply a firing motion to a corresponding portion of an interchangeable shaft assembly attached thereto. The firing drive system 1080 can also be referred to herein as a “second drive system.” The firing drive system 1080 can employ an electric motor 1082 positioned within the pistol grip portion 1019 of the handle 1014. In various forms, the motor 1082 can be a brushed DC drive motor having a maximum rotational speed of, for example, approximately 25,000 RPM. In other arrangements, the motor can include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor 1082 can be powered by a power source 1090, which in one form can include a removable power pack 1092. For example, as can be seen in FIG. 3 , the power pack 1092 may include a proximal housing portion 1094 configured to attach to a distal housing portion 1096. The proximal housing portion 1094 and the distal housing portion 1096 are configured to operably support a plurality of batteries 1098 therein. The batteries 1098 may each include, for example, Lithium Ion ("LI") or other suitable batteries. The distal housing portion 1096 is configured to be removably and operably attached to a circuit board 1100 that is also operably coupled to the motor 1082. Several batteries 1098 may be connected in series and used as a power source for the surgical instrument 1010. Additionally, the power source 1090 may be replaceable and / or rechargeable.
[0022] As generally described above in connection with various other configurations, the electric motor 1082 can include a rotatable shaft (not shown) that operably interfaces with a gear reducer assembly 1084 mounted in meshing engagement with a set or rack of drive teeth 1122 on a longitudinally movable drive member 1120. In use, the voltage polarity provided by the power source 1090 causes the electric motor 1082 to operate in a clockwise direction, while the voltage polarity applied to the electric motor by the battery can be reversed to cause the electric motor 1082 to operate in a counterclockwise direction. When the electric motor 1082 is rotated in one direction, the drive member 1120 is driven axially in a distal direction "DD." When the motor 1082 is driven in the opposite rotational direction, the drive member 1120 is driven axially in a proximal direction "PD." The handle 1014 can include a switch that can be configured to reverse the polarity applied to the electric motor 1082 by the power source 1090. Similar to other configurations described herein, the handle 1014 may also include a sensor configured to detect the position of the drive member 1120 and / or the direction in which the drive member 1120 is being moved.
[0023] Actuation of the motor 1082 can be controlled by a firing trigger 1130 pivotally supported on the handle 1014. The firing trigger 1130 can pivot between an inactivated position and an activated position. The firing trigger 1130 can be biased to the inactivated position by a spring 1132 or other biasing arrangement, such that when the clinician releases the firing trigger 1130, it can be pivoted or otherwise returned to the inactivated position by the spring 1132 or other biasing arrangement. In at least one form, the firing trigger 1130 can be located “outside” of the closure trigger 1032, as described above. In at least one form, a firing trigger safety button 1134 can be pivotally attached to the closure trigger 1032 by a pin 1035. The safety button 1134 can have a pivot arm 1136 positioned between and projecting from the firing trigger 1130 and the closure trigger 1032. See FIG. 3 . When the closure trigger 1032 is in the unactuated position, the safety button 1134 is housed in the handle 1014. It is not easily accessible to the clinician and cannot be moved between a safety position that prevents actuation of the firing trigger 1130 and a firing position in which the firing trigger 1130 may be fired. When the clinician depresses the closure trigger 1032, the safety button 1134 and firing trigger 1130 pivot downward and can then be operated by the clinician.
[0024] As noted above, in at least one form, the longitudinally movable drive member 1120 has a rack of teeth 1122 formed thereon for meshing engagement with a corresponding drive gear 1086 of the gear reducer assembly 1084. At least one form also includes a manually actuated “emergency breakaway” assembly 1140 configured to allow a clinician to manually retract the longitudinally movable drive member 1120 if the motor 1082 is disabled. The emergency breakaway assembly 1140 may include a lever or emergency breakaway handle assembly 1142 configured to be manually pivoted to ratchet engagement with teeth 1122 also provided in the drive member 1120. Thus, a clinician can manually retract the drive member 1120 by using the emergency breakaway handle assembly 1142 to ratchet the drive member 1120 in the proximal direction “PD.” U.S. Patent No. 8,608,045, entitled "POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM," discloses an emergency detachment arrangement, as well as other components, arrangements, and systems that may also be used with the various instruments disclosed herein. U.S. Patent No. 8,608,045 is incorporated herein by reference in its entirety.
[0025] 2 and 5, the interchangeable shaft assembly 1200 includes a surgical end effector 1300 having an elongated frame 1310 configured to operably support a staple cartridge 1350 therein. The end effector 1300 may further include an anvil 2000 pivotally supported relative to the elongated frame 1310. The interchangeable shaft assembly 1200 may further include an articulation joint 3020 and an articulation lock 2140 that may be configured to releasably retain the end effector 1300 in a desired position relative to the shaft axis SA. Various features of embodiments of the end effector 1300, the articulation joint 3020, and at least one form of articulation lock are described in U.S. patent application Ser. No. 13 / 803,086, filed Mar. 14, 2013, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," now U.S. Patent Application Publication No. 2014 / 0263541. The entire disclosure of U.S. patent application Ser. No. 13 / 803,086, filed Mar. 14, 2013, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," now U.S. Patent Application Publication No. 2014 / 0263541, is incorporated herein by reference. As can be seen in FIG. 4, the interchangeable shaft assembly 1200 can further include a proximal housing or nozzle 1201 comprised of nozzle portions 1202 and 1203 .
[0026] The interchangeable shaft assembly 1200 can further include a closure system or closure member assembly 3000 that can be utilized to open and close the anvil 2000 of the end effector 1300. The shaft assembly 1200 includes a spine 1210 that can be configured to (1) slidably support a firing member therein and (2) slidably support the closure member assembly 3000 extending therearound. As shown in FIG. 5 , the distal end 1212 of the spine 1210 terminates in an upper lug attachment mechanism 1270 and a lower lug attachment mechanism 1280. The upper lug attachment mechanism 1270 defines a lug slot 1272 within which an upper mounting link 1274 can be fixedly supported. Similarly, the lower lug attachment mechanism 1280 defines a lug slot 1282 within which a lower mounting link 1284 can be fixedly supported. The upper mounting link 1274 includes a pivot socket 1276 therein that is adapted to rotatably receive a pivot pin 1292 formed on a frame cap or an anvil retainer 1290 mounted on the proximal end portion 1312 of the elongated frame 1310. The lower mounting link 1284 includes a lower pivot pin 1286 that is adapted to be received in a pivot hole 1314 formed in the proximal end portion 1312 of the elongated frame 1310. See FIG. 5. The lower pivot pin 1286 is vertically aligned with the pivot socket 1276 and defines an articulation axis AA about which the surgical end effector 1300 can articulate relative to the shaft axis SA. See FIG. 2.
[0027] In the illustrated embodiment, the surgical end effector 1300 is selectively articulatable about an articulation axis AA by an articulation system 2100. In one form, the articulation system 2100 includes a proximal articulation drive 2102 pivotally coupled to an articulation link 2120. As can be seen most particularly in FIG. 5 , an offset mounting lug 2114 is formed on the distal end 2110 of the proximal articulation drive 2102. A pivot hole 2116 is formed in the offset mounting lug 2114 and configured to pivotally receive a proximal link pin 2124 formed on the proximal end 2122 of the articulation link 2120. The distal end 2126 of the articulation link 2120 includes a pivot hole 2128 that is configured to pivotally receive a frame pin 1317 formed on the proximal end portion 1312 of the elongate frame 1310. Axial movement of the proximal articulation drive 2102, therefore, imparts an articulation motion to the elongate frame 1310, thereby articulating the surgical end effector 1300 about the articulation axis AA relative to the spine 1210. Further details regarding the construction and operation of the articulation system 2100 can be found in various references incorporated herein by reference, such as U.S. Patent Application No. 15 / 635,631, filed June 28, 2017, entitled "SURGICAL INSTRUMENT WITH AXIALLY MOVABLE CLOSURE MEMBER," now U.S. Patent Application Publication No. 2019 / 0000464, the entire disclosure of which is incorporated herein by reference. In various circumstances, when the proximal articulation drive 2102 is not moving proximally or distally, the proximal articulation drive 2102 can be held in place by a joint lock 2140. Further details regarding examples of joint locks 2140 can be found in U.S. Patent Application No. 15 / 635,631, now U.S. Patent Application Publication No. 2019 / 0000464, as well as other references incorporated by reference herein.
[0028] In various circumstances, the spine 1210 can include a proximal end 1211 that is rotatably supported within the chassis 1240. In one arrangement, for example, the proximal end 1211 of the spine 1210 is threaded 1214 for threaded attachment to a spine bearing 1216 configured to be supported within the chassis 1240. See FIG. 4. Such an arrangement facilitates rotatable attachment of the spine 1210 to the chassis 1240 such that the spine 1210 can be selectively rotated relative to the chassis 1240 about the shaft axis SA.
[0029] 4, the interchangeable shaft assembly 1200 includes a closure shuttle 1250 slidably supported therein for axial movement relative to the chassis 1240. The closure shuttle 1250 includes a pair of proximally projecting hooks 1252 configured for attachment to mounting pins 1037 (FIG. 3) attached to the second closure link 1038, as described in further detail below. In at least one example, the closure member assembly 3000 includes a proximal closure member segment 3010 having a proximal end 3012 coupled to the closure shuttle 1250 for rotation relative thereto. For example, a U-shaped connector 1263 is inserted into an annular slot 3014 in the proximal end 3012 of the proximal closure member segment 3010 and is retained within a vertical slot 1253 in the closure shuttle 1250. Such an arrangement allows the proximal closure member segment 3010 and the closure shuttle 1250 to rotate relative to the closure shuttle 1250 about the shaft axis SA while the proximal closure member segment 3010 is mounted for axial movement together. A closure spring 1268 is journaled on the proximal closure member 3010 and serves to bias the proximal closure member 3010 in the proximal direction "PD," thereby pivoting the closure trigger 1032 to an unactuated position when the shaft assembly is operably coupled to the handle 1014.
[0030] In at least one form, the interchangeable shaft assembly 1200 may further include an articulation joint 3020. However, other interchangeable shaft assemblies may not be articulatable. As shown in FIG. 5 , for example, a distal closure member or distal closure tube segment 3030 is coupled to the distal end of the proximal closure member segment 3010. The articulation joint 3020 includes a dual-pivoting closure sleeve assembly 3022. According to various forms, the dual-pivoting closure sleeve assembly 3022 includes an end effector closure tube 3050 having an upper proximally-extending tang 3052 and a lower proximally-extending tang 3054. The upper double pivot link 3056 includes upwardly projecting distal and proximal pivot pins that engage with the upper distal pin holes of the upper proximally projecting tangs 3052 and 3031, respectively, on the distal closure tube segment 3030. The lower double pivot link 3058 includes upwardly projecting distal and proximal pivot pins that engage with the lower distal and proximal pin holes of the lower proximally projecting tangs 3054 and 3034, respectively. See FIGS. 4 and 5. As described in more detail below, the closure member assembly 3000 is translated distally (direction DD) to close the anvil 2000, for example, in response to actuation of the closure trigger 1032. The anvil 2000 is opened by translating the closure member assembly 3000 proximally, which causes the end effector closure tube 3050 to interact with the anvil 2000 and pivot the anvil 2000 to the open position.
[0031] As also described above, the interchangeable shaft assembly 1200 further includes a firing member 1900 supported for axial movement within the shaft spine 1210. The firing member 1900 includes an intermediate firing shaft portion 1222 configured to attach to a distal cutting portion or knife bar 1910. The intermediate firing shaft portion 1222 may include a longitudinal slot 1223 at its distal end, which may be configured to receive a tab 1912 on the proximal end of the distal knife bar 1910. The longitudinal slot 1223 and the proximal end tab 1912 may be sized and configured to allow relative movement therebetween and may include a slip joint 1914. The slip joint 1914 may allow the intermediate firing shaft portion 1222 of the firing member 1900 to move and articulate the end effector 1300 without moving, or at least substantially without moving, the knife bar 1910. Once the end effector 1300 is properly oriented, the intermediate firing shaft portion 1222 may be advanced distally until the proximal sidewall of the longitudinal slot 1223 contacts the tab 1912 to advance the knife bar 1910 and fire a staple cartridge 1350 positioned within the frame 1310. The knife bar 1910 includes a knife portion 1920 that includes a blade or tissue-cutting edge 1922, and includes an upper anvil engagement tab 1924 and a lower frame engagement tab 1926. The configurations and operation of various firing members are disclosed in various other references, which are incorporated herein by reference.
[0032] As seen in FIG. 4 , the shaft assembly 1200 further includes a switch drum 1500 rotatably received on the proximal closure member segment 3010. The switch drum 1500 includes a hollow shaft segment 1502 having a shaft boss formed therein for receiving an outwardly protruding actuation pin. Under various circumstances, the actuation pin extends through a slot into a longitudinal slot provided in the locking sleeve to facilitate axial movement of the locking sleeve when engaged with the articulation driver. The rotational torsion spring 1420 is configured to engage the boss on the switch drum 1500 and a portion of the nozzle housing 1201 to apply a biasing force to the switch drum 1500. The switch drum 1500 can further include an at least partially circumferential opening 1506 defined therein, which can be configured to receive a circumferential mount extending from the nozzle portions 1202, 1203 and allow relative rotation but not translation between the switch drum 1500 and the nozzle 1201. The mount also extends through an opening 3011 in the proximal closure member segment 3010 and fits into a recess 1219 in the spine 1210. Rotation of the switch drum 1500 about the shaft axis SA ultimately rotates the actuation pin and locking sleeve between their engaged and disengaged positions. In one arrangement, rotation of the switch drum 1500 can be coupled to axial advancement of the closure tube or closure member. Thus, essentially, actuation of the closure system may operatively engage and disengage the firing drive system and the articulation drive system in a variety of ways as described in more detail in U.S. Patent Application No. 13 / 803,086, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," now U.S. Patent Application Publication No. 2014 / 0263541, and U.S. Patent No. 9,913,642, entitled "SURGICAL INSTRUMENT COMPRISING A SENSOR SYSTEM," the entire disclosures of each of which are incorporated herein by reference.For example, when the closure member segment 3010 is in its proximal-most position corresponding to the "jaws open" position, the closure member segment 3010 positions the switch drum 1500 to couple the articulation system with the firing drive system. When the closure tube is moved to its distal position corresponding to the "jaws closed" position, the closure tube rotates the switch drum 1500 to a position where the articulation system is decoupled from the firing drive system.
[0033] As also shown in FIG. 4 , the shaft assembly 1200 can include a slip ring assembly 1600 that can be configured, for example, to conduct power to and / or communicate signals with the end effector 1300. The slip ring assembly 1600 can include a proximal connector flange 1604 attached to a chassis flange 1242 extending from the chassis 1240 and a distal connector flange positioned in a slot defined in the shaft housing. The proximal connector flange 1604 can include a first surface, and the distal connector flange can include a second surface positioned adjacent to and movable relative to the first surface. The distal connector flange can rotate relative to the proximal connector flange 1604 about the shaft axis SA. The proximal connector flange 1604 can include a plurality of concentric, or at least substantially concentric, conductors defined in its first surface. The connector may be mounted proximally to the connector flange and may have multiple contacts, each corresponding to and in electrical contact with one of the conductors. Such an arrangement allows the proximal connector flange 1604 and the distal connector flange to rotate relative to each other while maintaining electrical contact therebetween. The proximal connector flange 1604 may include an electrical connector 1606, for example, that can place conductors in signal communication with a shaft circuit board 1610 mounted to the shaft chassis 1240. In at least one example, a wiring harness comprising multiple conductors can extend between the electrical connector 1606 and the shaft circuit board 1610. The electrical connector 1606 may extend proximally through a connector opening 1243 defined in the chassis flange 1242. See FIG. 4 .Further details regarding slip ring assembly 1600 can be found, for example, in U.S. patent application Ser. No. 13 / 803,086, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," now U.S. Patent Application Publication No. 2014 / 0263541, U.S. patent application Ser. No. 13 / 800,067, filed March 13, 2013, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," now U.S. Patent Application Publication No. 2014 / 0263552, and U.S. Patent No. 9,345,481, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM." U.S. Patent Application No. 13 / 803,086, now U.S. Patent Application Publication No. 2014 / 0263541, U.S. Patent Application No. 13 / 800,067, now U.S. Patent Application Publication No. 2014 / 0263552, and U.S. Patent No. 9,345,481 are each incorporated by reference herein in their entirety.
[0034] As described above, the shaft assembly 1200 may include a proximal portion fixably attached to the handle 1014 and a distal portion rotatable about a longitudinal axis. The rotatable distal shaft portion may be rotatable relative to the proximal portion about the slip ring assembly 1600, as described above. The distal connector flange of the slip ring assembly 1600 may be positioned within the rotatable distal shaft portion. Additionally to the above, the switch drum 1500 may also be positioned within the rotatable distal shaft portion. Rotation of the rotatable distal shaft portion may cause the distal connector flange and the switch drum 1500 to rotate synchronously with one another. Additionally, the switch drum 1500 may be rotated between a first position and a second position relative to the distal connector flange. When the switch drum 1500 is in its first position, the articulation drive system may be operably disengaged from the firing drive system, such that operation of the firing drive system may not articulate the end effector 1300 of the shaft assembly 1200. When the switch drum 1500 is in its second position, an articulation drive system may be operatively engaged with the firing drive system, such that operation of the firing drive system can articulate the end effector 1300 of the shaft assembly 1200. Moving the switch drum 1500 between its first position and its second position causes the switch drum 1500 to move relative to the distal connector flange. In various examples, the shaft assembly 1200 can include at least one sensor configured to detect the position of the switch drum 1500.
[0035] Referring again to FIG. 4, the chassis 1240 includes at least one, and preferably two, tapered mounting portions 1244 formed thereon that are adapted to be received within corresponding dovetail slots 1702 formed in the distal mounting flange portion 1700 of the frame 1020. See FIG. 3. Each dovetail slot 1702 may be tapered, or in other words, somewhat V-shaped, to seat and receive the mounting portion 1244 therein. As further shown in FIG. 4, a shaft mounting lug 1226 is formed on the proximal end of the intermediate firing shaft portion 1222. As will be described in more detail below, when the interchangeable shaft assembly 1200 is coupled to the handle 1014, the shaft mounting lug 1226 is received in a firing shaft mounting cradle 1126 formed on the distal end 1125 of the longitudinal drive member 1120. See FIG. 3.
[0036] Various shaft assembly embodiments use a latch system 1710 to removably couple the shaft assembly 1200 to the housing 1012, and more particularly, to the frame 1020. As can be seen in FIG. 4 , for example, in at least one form, the latch system 1710 includes a locking member or lock yoke 1712 that is movably coupled relative to the chassis 1240. In the illustrated embodiment, for example, the lock yoke 1712 has a U-shape with two spaced apart, downwardly extending legs 1714. Each of the legs 1714 has a pivot lug 1715 formed thereon that is adapted to be received in a corresponding hole 1245 formed in the chassis 1240. Such an arrangement facilitates pivotally mounting the lock yoke 1712 to the chassis 1240. The locking yoke 1712 may include two proximally protruding locking lugs 1716 configured to releasably engage corresponding locking detents or grooves 1704 in the distal mounting flange portion 1700 of the frame 1020. See FIG. 3 . In various forms, the locking yoke 1712 is proximally biased by a spring or biasing member (not shown). Actuation of the locking yoke 1712 may be accomplished by a latch button 1722 slidably mounted on a latch actuator assembly 1720 attached to the chassis 1240. The latch button 1722 may be biased proximally relative to the locking yoke 1712. As described in more detail below, distal biasing of the latch button may move the locking yoke 1712 to an unlocked position, which also pivots the locking yoke 1712 out of retaining engagement with the distal mounting flange 1700 of the frame 1020. When the locking yoke 1712 is in “retaining engagement” with the distal mounting flange 1700 of the frame 1020 , the locking lugs 1716 are retained within corresponding locking detents or grooves 1704 in the distal mounting flange 1700 .
[0037] When using interchangeable shaft assemblies, including end effectors of the type described herein adapted to cut and fasten tissue, as well as other types of end effectors, it may be desirable to prevent the interchangeable shaft assembly from being inadvertently separated from the housing during actuation of the end effector. For example, during use, a clinician may actuate the closure trigger 1032 to grasp and manipulate target tissue into a desired position. Once the target tissue is positioned in the end effector 1300 in a desired orientation, the clinician may then fully actuate the closure trigger 1032 to close the anvil 2000 and clamp the target tissue in place for cutting and stapling. In that case, the first drive system 1030 is fully actuated. After the target tissue is clamped in the end effector 1300, it may be desirable to prevent the shaft assembly 1200 from being inadvertently separated from the housing 1012. One form of the latch system 1710 is configured to prevent such inadvertent separation.
[0038] As seen most particularly in FIG. 4 , the locking yoke 1712 includes at least one, and preferably two, locking hooks 1718 that are adapted to contact corresponding locking lug portions 1256 formed on the closure shuttle 1250. When the closure shuttle 1250 is in the inactivated position (i.e., the first drive system 1030 is inactivated and the anvil 2000 is open), the locking yoke 1712 can pivot distally to unlock the interchangeable shaft assembly 1200 from the housing 1012. In that position, the locking hooks 1718 are not in contact with the locking protrusion portions 1256 of the closure shuttle 1250. However, when the closure shuttle 1250 is moved to the activated position (i.e., the first drive system 1030 is activated and the anvil 2000 is in the closed position), the locking yoke 1712 is prevented from pivoting to the unlocked position. In other words, if a clinician attempts to pivot the lock yoke 1712 to the unlocked position, or if the lock yoke 1712 is inadvertently pushed or contacted in a manner that causes it to pivot distally, for example, the lock hook 1718 of the lock yoke 1712 will contact the lock protrusion portion 1256 of the closure shuttle 1250, preventing the lock yoke 1712 from moving to the unlocked position.
[0039] The attachment of the interchangeable shaft assembly 1200 to the handle 1014 is described below. To begin the coupling process, the clinician may position the chassis 1240 of the interchangeable shaft assembly 1200 above or adjacent to the distal mounting flange portion 1700 of the frame 1020 so that the tapered mounting portion 1244 formed on the chassis 1240 is aligned with the dovetail slot 1702 of the frame 1020. The clinician may then move the shaft assembly 1200 along a mounting axis perpendicular to the shaft axis SA to seat the mounting portion 1244 in “operable engagement” with the corresponding dovetail receiving slot 1702. In doing so, the shaft mounting lugs 1226 on the intermediate firing shaft portion 1222 are also mounted within the cradle 1126 of the longitudinally movable drive member 1120, and portions of the pin 1037 on the second closure link 1038 are received within corresponding hooks 1252 of the closure shuttle 1250. As used herein, the term "operably engaged" in the context of two components means that the two components are sufficiently engaged with one another so that, upon application of an actuating motion thereto, the components can perform an intended action, function, and / or procedure.
[0040] At least five systems of the interchangeable shaft assembly 1200 can be operably coupled to at least five corresponding systems of the handle 1014. A first system can include a frame system that couples and / or aligns the frame or spine of the shaft assembly 1200 with the frame 1020 of the handle 1014. Another system can include a closure drive system 1030 that can operably connect the closure trigger 1032 of the handle 1014, and the closure tube 3050 and anvil 2000 of the shaft assembly 1200. As generally described above, the closure shuttle 1250 of the shaft assembly 1200 can engage the pin 1037 of the second closure link 1038. Another system can include a firing drive system 1080 that can operably connect the firing trigger 1130 of the handle 1014 with the intermediate firing shaft portion 1222 of the shaft assembly 1200. As outlined above, the shaft mounting lugs 1226 can be operatively connected to the cradle 1126 of the longitudinal drive member 1120. Another system can include an electrical system that can signal a controller in the handle 1014, such as, for example, a microcontroller, that a shaft assembly, such as, for example, shaft assembly 1200, is operatively engaged with the handle 1014, and / or secondarily conduct power and / or communication signals between the shaft assembly 1200 and the handle 1014. By way of example, the shaft assembly 1200 can include an electrical connector 1810 operatively mounted to the shaft circuit board 1610. The electrical connector 1810 is configured to matingly engage with a corresponding electrical connector 1800 on the control circuit board 1100. Further details regarding the circuitry and control systems can be found in U.S. Patent Application Serial No. 13 / 803,086, now U.S. Patent Application Publication No. 2014 / 0263541, and U.S. Patent Application Serial No. 14 / 226,142, now U.S. Patent No. 9,913,642, the entire disclosures of each of which have been previously incorporated by reference herein.A fifth system may comprise a latching system for releasably locking the shaft assembly 1200 to the handle 1014 .
[0041] The anvil 2000 in the illustrated example includes an anvil body 2002 terminating in an anvil mounting portion 2010. The anvil mounting portion 2010 is movably or pivotally supported on the elongated frame 1310 for selective pivotal movement relative to the elongated frame 1310 about a fixed anvil pivot axis PA that transverses the shaft axis SA. In the illustrated arrangement, pivot members or anvil trunnions 2012 extend laterally from each side of the anvil mounting portion 2010 and are received in corresponding trunnion cradles 1316 formed in an upstanding wall 1315 of the proximal end portion 1312 of the elongated frame 1310. The anvil trunnions 2012 are pivotally retained in their corresponding trunnion cradles 1316 by a frame cap or anvil retainer 1290. The frame cap or anvil retainer 1290 has a pair of mounting lugs configured to be retentively received within corresponding lug grooves or notches formed in the upstanding wall 1315 of the proximal end portion 1312 of the elongated frame 1310. See FIG.
[0042] 5 , in at least one arrangement, the distal closure member or end effector closure tube 3050 employs two axially offset proximal and distal positive jaw opening mechanisms 3060 and 3062. The positive jaw opening mechanisms 3060, 3062 are configured to interact with corresponding relief areas and stepped portions formed on the anvil mounting portion 2010, as described in further detail in U.S. Patent Application Serial No. 15 / 635,631, entitled "SURGICAL INSTRUMENT WITH AXIALLY MOVABLE CLOSURE MEMBER," now U.S. Patent Application Publication No. 2019 / 0000464, the disclosure of which is incorporated herein by reference in its entirety. Other jaw opening arrangements may also be used.
[0043] U.S. Patent Application No. 2004 / 0232200, filed May 20, 2003, entitled "SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT"; U.S. Patent Application No. 2004 / 0232199, filed May 20, 2003, entitled "SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL"; U.S. Patent Application No. 2004 / 0232197, filed May 20, 2003, entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM"; and U.S. Patent Application No. 2004 / 0232196, filed May 20, 2003, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND No. 2004 / 0232195, filed May 20, 2003, entitled "SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING," and U.S. Patent Application No. 2018 / 0085123, filed August 17, 2017, entitled "ARTICULATING SURGICAL STAPLING INSTRUMENT INCORPORATING A TWO-PIECE E-BEAM FIRING MECHANISM," the disclosures of which are incorporated herein by reference in their entireties.
[0044] Referring to FIG. 6 , an embodiment of a surgical stapling assembly 4000 is shown. The surgical stapling assembly 4000 may be used in conjunction with the surgical instrument 1010 described above or in conjunction with various other surgical instruments described in the various disclosures incorporated herein by reference. The surgical stapling assembly 4000 may be used in conjunction with, for example, the various forms of electrically controlled, battery-powered, manually, and / or robotically controlled surgical instruments disclosed in the aforementioned incorporated disclosures. As can be seen in FIG. 6 , the surgical stapling assembly 4000 comprises a surgical stapling device, generally designated 4002, having a first jaw, or frame 4010, configured to operably support a staple cartridge 4200 therein. The first jaw 4010 may be attached to the spine of a shaft assembly of a surgical instrument or robot in a variety of manners described herein and in the various disclosures incorporated herein by reference. In the illustrated embodiment, the first jaw 4010 is attached to a spine portion of a shaft assembly (not shown in FIG. 6 ) by a shaft mount flange 4030 that is pinned or otherwise attached to the proximal end 4014 of the first jaw 4010 by a pin 4032. In particular, the pin 4032 is configured to pass through aligned holes 4021 in the upright sidewalls 4020 of the first jaw 4010 and holes 4031 in the shaft mount flange 4030. The shaft mount flange 4030 is configured to interface with an articulation joint arrangement (not shown) configured to facilitate articulation of the first jaw 4010 relative to the shaft assembly in various known configurations. Other methods of attaching and operably interfacing the surgical device 4002 to the shaft of a surgical instrument may also be used. For example, the stapling device 4002 may be attached to the shaft assembly such that the stapling device (sometimes referred to as an “end effector”) cannot articulate relative to the shaft assembly.
[0045] 6, the surgical stapling device 4002 further includes a firing member assembly 4040 that includes a knife bar 4042 attached to a knife member or "firing member" 4050. The knife bar 4042 also interfaces with corresponding components within the surgical instrument and a firing system to receive a firing motion that can advance the knife bar 4042 and firing member 4050 distally through a staple firing stroke from a start position to an end position and retract the knife bar 4042 and firing member 4050 proximally to the start position. In the illustrated arrangement, the firing member 4050 includes a firing member body 4052 that supports a cutting edge or knife edge 4053. The firing member 4050 further includes feet 4054 formed at the bottom of the firing member body 4052 and extending laterally from each side of the firing member body 4052. The firing member 4050 further includes a pair of upper pins or tabs 4056 extending laterally from the firing member body 4052 which are adapted to engage ledges on the anvil, as discussed further herein. Additionally, the firing member 4050 includes a pair of central pins or tabs 4058 projecting laterally from each side of the firing member body 4052. In some of the disclosures incorporated by reference herein, the firing member 4050 may also be referred to as an "E-beam" firing member or cutting member.
[0046] Further to the above, the surgical stapling device 4002 includes a second jaw or anvil 4100 that is movable relative to the first jaw or frame 4010. The anvil 4100 includes an anvil body 4102 and an anvil mounting portion 4110. The anvil body 4102 includes a staple-forming lower surface or tissue-contacting surface 4104 having a series of staple-forming pockets (not shown) formed therein that are arranged to form corresponding staples when driven into forming contact therewith. The anvil mounting portion 4110 includes a pair of laterally extending anvil or trunnion pins 4112 that are configured to be received in corresponding trunnion slots 4022 in the upstanding sidewall 4020 of the first jaw 4010. In the illustrated arrangement, the trunnion slots 4022 are somewhat "kidney-shaped" to facilitate pivotal and axial movement of the corresponding trunnion pins 4112 therein. Such pivoting and axial movement of the anvil 4100 may be referred to as "translation" of the anvil during the anvil closure sequence.
[0047] As described above, and in several of the disclosures incorporated herein by reference, the anvil 4100 may be movable from an open position to a closed position at which a used or spent surgical staple cartridge may be removed from the first jaw or frame 4010 or an unfired surgical staple cartridge may be operably seated therein. The anvil 4100 may be movable between the open and closed positions by an axially movable closure member, which may include an end effector closure tube (not shown) that is part of a shaft assembly of a surgical instrument to which the surgical device 4002 is operably attached. For example, when the closure member is moved distally from a proximal position by actuating a closure control system within the surgical instrument, the closure member may operably engage a cam surface on the anvil mounting portion 4110. Such interaction between the closure member and the anvil mounting portion 4110 causes the anvil mounting portion 4110 and the anvil trunnion pin 4112 to pivot and translate the trunnion slots 4022 until the closure member moves the anvil 4100 to a fully closed position. When in the fully closed position, the staple forming pockets in the anvil 4100 are properly aligned with the staples in a corresponding compatible surgical staple cartridge that is operably seated in the first jaw or frame 4010. Thereafter, proximal movement of the axially movable closure member causes the closure member to interface with an upstanding tab 4114 on the anvil mounting portion 4110 to return the anvil 4100 to the open position.
[0048] One form of surgical staple cartridge 4200 that may be compatible with the surgical stapling device 4002 includes a cartridge body 4202 defining a cartridge deck surface or tissue contacting surface 4204. The cartridge body 4202 further includes a longitudinal slot 4206 that bisects the cartridge deck surface 4204 and is configured to accommodate the axial passage of a firing member 4050 therein between a start position and an end position of the firing member within the cartridge body 4202 during a staple firing stroke. The longitudinal slot 4206 lies along a central axis CA of the cartridge 4200. The surgical staple cartridge 4200 further includes a series of staple pockets 4208 formed within the cartridge body 4202. The staple pockets 4208 may be formed in offset “lines” located on each side of the longitudinal slot 4206. Each staple pocket 4208 may have a staple driver (not shown) associated therewith that supports a surgical staple or fastener (not shown) thereon. In at least one embodiment, the cartridge body 4202 is molded from a polymeric material having the staple pockets 4208 molded or machined therein. In one arrangement, the staple pockets 4208 also open through the bottom of the cartridge body 4202 to facilitate loading of the driver and fasteners into their respective staple pockets 4208. Once the driver and fasteners are inserted into their respective staple pockets 4208, a cartridge pan 4220 is attached to the cartridge body 4202. In one form, the cartridge pan 4220 is fabricated from a metal material and includes a bottom 4222 that extends across the bottom of the cartridge body 4202. The cartridge pan 4220 also includes two upstanding side walls 4224, one on each side of the cartridge body 4202. The cartridge pan 4220 may be removably attached to the cartridge body 4202 by hooks 4226 formed on the side walls 4224 and configured to hook-like engage corresponding portions of the cartridge body 4202.Additionally, the cartridge body 4202 can also have lugs or mounting formations protruding therefrom that are configured to retainingly engage corresponding portions of the cartridge pan 4220. When installed, the cartridge pan 4220 can, among other things, prevent drivers and fasteners from falling out the bottom of the cartridge body 4202 during handling and installation of the staple cartridge into the first jaw or frame 4010.
[0049] Some staple drivers operably support a single surgical staple thereon, while others support two or more surgical staples thereon, depending on the particular cartridge design. Each surgical staple includes a staple crown and two upstanding staple legs. The staple crown is typically supported on a cradle arrangement formed within the corresponding staple driver such that the legs are oriented perpendicularly toward the anvil when the cartridge is operably seated in the frame 4010. In some arrangements, the surgical staples have a somewhat V-shape, with the ends of the legs flaring outward slightly. This arrangement can serve to retain the staples within their corresponding staple pockets by frictional engagement between the legs and sides of the staple pockets if the cartridge is inadvertently inverted or turned upside down during use. Other surgical staples are generally U-shaped (with the ends of the legs not flaring outward) and may be prone to falling out of the staple pockets if the cartridge is inverted prior to use.
[0050] The surgical staple cartridge 4200 further includes a sled or cam member 4230 configured to advance axially through the cartridge body 4202 during a staple firing stroke. In a "new," "unused," or "unfired" surgical staple cartridge, the sled 4230 is in its proximal-most, "unfired" position. The sled 4230 includes a plurality of wedges or cam members 4232 configured to drivingly engage corresponding lines of staple drivers within the cartridge body. During the staple firing stroke, the firing member 4050 abuts the sled 4230 and urges it distally into camming contact with the staple drivers, thereby sequentially driving the staple drivers upward toward the anvil 4100 as the sled 4230 is driven from its unfired position to its distal-most, fully fired position within the cartridge body 4202. As the staple driver is driven upward, staples are driven through the tissue clamped between the deck surface 4204 of the staple cartridge 4200 and the anvil 4100 and make forming contact with the lower staple-forming surface 4104 of the anvil 4100. A tissue-cutting knife 4053 on the firing member 4050 severs the stapled tissue as the firing member 4050 is driven distally. After the staple firing stroke is completed and / or after a sufficient length of the staple firing stroke has been completed, the firing member 4050 is retracted proximally. However, the sled 4230 is not retracted proximally with the firing member 4050. Instead, the sled 4230 is left in the distal-most position where it was pushed by the firing member 4050.
[0051] After a staple cartridge is fired, or at least partially fired, it is removed from the frame and then replaced with another replaceable staple cartridge, if desired. At such a point, the stapling device can be reused to continue stapling and cutting patient tissue. However, in some cases, a previously fired staple cartridge may be accidentally loaded into the frame. If the firing member were to be advanced distally within such a previously fired staple cartridge, the stapling instrument would cut the patient tissue without stapling it. The stapling instrument would also cut the patient tissue without stapling it if the firing member was advanced distally through the staple firing stroke without any staple cartridge positioned in the cartridge jaws. Additionally, various surgical staple cartridges may have different arrays and / or orientations of staples / fasteners therein. The size of the staples or fasteners, as well as the number of fasteners, may vary from cartridge type to cartridge type depending on the particular surgical procedure or application. To ensure that staples are properly crimped or formed, a surgical staple cartridge must be used in conjunction with a corresponding compatible anvil having the appropriate array of staple-forming pockets therein, as well as the appropriate cutting and firing components. If an "incompatible" cartridge is loaded into a surgical stapling device having an anvil that is incompatible with the staple cartridge, the staples may not be properly formed during the firing process, which could have disastrous consequences. Therefore, the surgical stapling assembly 4000 includes one or more lockouts that prevent this from accidentally occurring, as discussed in more detail below.
[0052] Further to the above, the surgical stapling device 4002 includes a first lockout 4300 configured to prevent distal movement of the firing member 4050 from its proximal-most start position unless an approved or compatible staple cartridge is operably seated in the first jaw or frame 4010. The first lockout 4300 may also be referred to herein as an “authentication” lockout. In the illustrated arrangement, the first lockout 4300 includes a single, bidirectional first lockout spring 4310 supported on the proximal end 4014 of the frame 4010 and attached to the shaft mount flange 4030. For example, in one arrangement, the first lockout spring 4310 includes a first lockout arm 4312 located on one side of the cartridge axis CA and a second lockout arm 4314 located on the opposite side of the cartridge axis CA. The first lockout arm 4312 and the second lockout arm 4314 are attached to a central body portion 4316. See FIG. 7. The spring 4310 is supported on the first jaw or frame 4010 and secured to the shaft mount flange 4030 by a pin 4034 extending through a hole 4036 in the shaft mount flange 4030 and holes 4318 in the first lockout arm 4312 and second lockout arm 4314. The first lockout arm 4312 and the second lockout arm 4314 each further include a lockout window or opening 4320. The lockout windows 4320 are each adapted to receive a corresponding central pin 4058 protruding from an adjacent first or second side of the firing member 4050 when the firing member 4050 is in its proximal-most or start position. See FIGS. 8 and 9.
[0053] 8-10 illustrate the first lockout 4300 in a locked position in which the central pin 4058 is received within the lockout windows 4320 in the first lockout arm 4312 and the second lockout arm 4314. In some arrangements, a staple cartridge compatible with the surgical stapling device 4002, or stated another way, a staple cartridge having the appropriate number, size, and arrangement of staples, may have one or more unlocking or "approval" keys formed directly on the cartridge body and / or cartridge pan, which are configured to disable the first lockout when the compatible staple cartridge is operably seated in the first jaw or frame. Various staple cartridges having unlocking keys protruding therefrom are disclosed below, as well as in the various disclosures incorporated herein by reference. However, in certain embodiments, a clinician may desire to use a staple cartridge that is compatible with a surgical stapling device but otherwise lacks an unlocking key. In such cases, the clinician would not be able to otherwise use these compatible staple cartridges in the surgical stapling device. The surgical stapling device 4002 includes a mechanism designed to facilitate the use of such compatible staple cartridges that otherwise lack an unlocking key mechanism.
[0054] 6 and 10 , the stapling assembly 4000 further includes a retainer 4400 configured to be removably coupled to a staple cartridge 4200 that is otherwise compatible with the surgical stapling device 4002. In the illustrated arrangement, the retainer 4400 includes a top portion 4402 that is coextensive with and configured to be received on the deck surface 4204 of the cartridge body 4202. Thus, in at least one configuration, when the retainer 4400 is attached to the cartridge body 4202, the retainer 4400 covers all of the staple pockets 4208 within the cartridge body 4202. In this manner, when the retainer 4400 is attached to the staple cartridge 4200, the retainer 4400 can prevent the surgical staples contained within the staple pockets 4208 from falling out if the staple cartridge 4200 is inverted or upside down prior to use. The retainer 4400 also protects the deck surface from contamination during shipping and storage.
[0055] In one arrangement, the retainer 4400 may be molded from a polymeric material and includes a plurality of retainer lugs 4410 configured to latch onto an outwardly extending deck ledge portion 4205 formed on the cartridge body 4202. The retainer 4400 may further include an angled nose portion 4420 and a distal latch tab 4422 configured to latch onto a distal nose 4203 of the cartridge body 4202. The retainer 4400 may be removably coupled to the surgical staple cartridge 4200 by engaging the distal latch tab 4422 with an end of the distal nose 4203 and aligning the retainer 4400 so that the underside of the top 4402 faces the cartridge deck surface 4204 and the retainer lugs 4410 are located above the deck ledge portion 4205 on each side of the cartridge body 4202. The retainer 4400 can then be pressed toward the staple cartridge 4200, bending the retainer lugs 4410 laterally outward and snapping into latching engagement with the corresponding deck ledge portion 4205. Other retainer latch arrangements disclosed herein can also be used to removably secure the retainer 4400 to the staple cartridge 4200. The retainer 4400 can be removed from the staple cartridge 4200 by applying a prying motion to the distal latch tabs 4422 until the retainer lugs 4410 disengage the deck ledge portion 4205. In the illustrated embodiment, the word "LIFT" is molded, embossed, imprinted, or otherwise provided on the nose portion 4420 to provide removal instructions to the user.
[0056] 10-13, the retainer 4400 further comprises an authentication key 4430 configured to override, deactivate, or unlatch the first lockout 4300 when the retainer 4400 is attached to the staple cartridge 4200 to form a cartridge assembly 4500 and the cartridge assembly 4500 is operably seated in the first jaw or frame 4010. As can be seen in FIG. 11 , the authentication key 4430 protrudes proximally from the proximal end 4401 of the top 4402 of the retainer 4400 and comprises a right ramp mechanism 4440 and a left ramp mechanism 4450 separated by a space 4460 sized to receive a firing member body 4052 therebetween. In the illustrated embodiment, the right ramp mechanism 4440 is angled downwardly from the top 4402 of the retainer 4400 and comprises a proximal right tip 4442. The proximal right tip 4442 defines a first right cam surface 4444 that angles inwardly at its tip and extends distally to a second right cam surface 4446. The second right cam surface 4446 extends from the first right cam surface 4444 to the apex 4402. See FIG. 12 . Similarly, the left ramp mechanism 4450 angles downwardly from the apex 4402 of the retainer 4400 and includes a proximal left tip 4452. The proximal left tip 4452 angles inwardly at its tip and extends distally to a second left cam surface 4456. The second left cam surface 4456 extends from the first left cam surface 4454 to the apex 4402. The retainer 4400 further includes a retainer keel 4470 protruding from a bottom surface of the top portion 4402 and oriented to be received within the longitudinal slot 4206 of the surgical staple cartridge 4200. The retainer keel 4470 can serve to properly orient the retainer 4400 on the staple cartridge 4200 so that the right ramp mechanism 4440 and the left ramp mechanism 4450 extend on each side of the firing member 4050. Additionally, the retainer keel 4470 can be configured to engage the sled 4230 in the staple cartridge 4200 and hold the sled 4230 in an unfired position while the retainer 4400 is attached to the staple cartridge 4200.The retainer keel 4470 can be sized relative to the longitudinal slot 4206 to establish a friction fit therewith to retain the retainer 4400 on the staple cartridge 4200 .
[0057] 10, 14, and 15, after the retainer 4400 is attached to the staple cartridge 4200 to form the cartridge assembly 4500, the cartridge assembly 4500 can be inserted longitudinally into the first jaw or frame 4010 so that the right end 4442 of the right ramp mechanism 4440 of the authentication key 4430 contacts the upright unlocking tab 4322 on the first lockout arm 4312 and the left end 4452 of the left ramp 4450 contacts the upright unlocking tab 4324 on the second lockout arm 4314 of the first lockout spring 4310. During initial longitudinal insertion of the assembled cartridge arrangement 4500 proximally into the frame 4010, the first right cam surface 4444 biases the first lockout arm 4312 of the first lockout spring 4310 laterally outward (arrow RL in FIG. 14 ), and the first left cam surface 4454 biases the second lockout arm 4314 laterally outward (arrow LL) of the first lockout spring 4310. Further advancement of the cartridge assembly 4500 proximally into the first jaw or frame 4010 causes the first lockout arm 4312 to reach a first intermediate position where the first lockout arm 4312 disengages a corresponding central pin 4058 on the firing member 4050, and the second lockout arm 4314 to reach a second intermediate position where the second lockout arm 4314 disengages a corresponding central pin 4058 on the firing member 4050. Continued longitudinal insertion of the assembled cartridge arrangement 4500 proximally into the first jaw or frame 4010 causes the second right cam surface 4446 to further urge the first lockout arm 4312 laterally outward, and the second left cam surface 4456 to further urge the second lockout arm 4314 laterally outward, until the cartridge assembly 4500 is fully operably seated in the first jaw or frame 4010. See FIG. 15 . Once the cartridge assembly 4500 is operably seated in the first jaw or frame 4010, a distal first retention tab 4326 on the first lockout arm 4312 engages a corresponding side of the staple cartridge 4200 to retain the first lockout arm 4312 in its unlocked position.Similarly, a distal second retention tab 4328 formed on the second lockout arm 4314 engages another corresponding side of the staple cartridge 4200 to retain the second lockout arm 4314 in its unlocked position. When in that position, the first lockout 4300 is in the unlocked position, or otherwise "disabled." During the unlocking process, the right ramp 4440 and the left ramp 4450 can be reinforced by the firing member 4050 applying a high locking force generated from the first spring 4310.
[0058] The user can then remove the retainer 4400 from the staple cartridge 4200 by prying open the distal latch tabs 4422 and lifting the retainer 4400 upward until the retainer lugs 4410 disengage the deck ledge portion 4205 on the cartridge body 4202. With the first lockout 4300 disabled or unlocked, the firing member 4050 can be advanced distally from the start position and is in the "armed state." After the staple cartridge 4200 is fired, the firing member 4050 retracts back to the start position and the second jaw or anvil 4100 pivots back to the open position. The spent staple cartridge can then be removed from the first jaw or frame 4010. Once the spent staple cartridge 4200 is removed from the first jaw or frame 4010, the first lockout arm 4312 and the second lockout arm 4314 spring back to engage with the corresponding central pin 4058 on the firing member 4050, again holding the firing member 4050 in the starting position.
[0059] Other first lockout spring arrangements are contemplated. For example, the first lockout spring may include only one lateral lockout arm and engage only one side of the firing member. In such an arrangement, an authentication key with only one lamp may be required to unlock the lockout arm.
[0060] As described above, once the cartridge assembly 4500 is operably seated in the frame 4010, the first lockout 4300 is disabled or unlocked to allow the firing member 4050 to advance distally from its ready state during a staple firing stroke. When attached to the staple cartridge 4200, the retainer 4400 covers the cartridge deck surface 4204, preventing staples from falling out of the staple pockets 4208 and preventing any debris or contaminants from entering the longitudinal slots 4206 or the staple pockets 4208, which could damage the staple cartridge or prevent it from operating properly. Other variations of the retainer 4400 are contemplated, in which only a portion of the cartridge deck surface 4204 is covered by the retainer. Other configurations may not cover any of the staple pockets and / or any of the deck surface.
[0061] As described above, after a staple cartridge has been fired, or at least partially fired, it is removed from the first jaw or frame and then replaced with another compatible staple cartridge, if desired. At such point, the stapling device can be reused to continue stapling and cutting patient tissue. However, in some cases, a previously fired staple cartridge may be accidentally loaded into the frame. If the firing member is advanced distally within such a previously fired staple cartridge (sometimes referred to herein as a “used” cartridge), the stapling instrument will cut the patient tissue without stapling it. This could occur even if the retainer 4400 is inadvertently and accidentally attached to the used cartridge, causing the resulting cartridge assembly to seat and override the first lockout. If the firing member is advanced distally through the staple firing stroke without any staple cartridge positioned in the cartridge jaws, the surgical stapling device will similarly cut the patient tissue without stapling it. To prevent these events from occurring, the surgical stapling device 4002 further includes a second lockout 4600 configured to prevent the firing member 4050 from advancing distally through the staple firing stroke when a spent staple cartridge is seated in the first jaw or frame 4010.
[0062] 6 and 16-19, the knife bar 4042, which may comprise a solid or laminated structure, includes a spring tab 4044 configured to operably interface with a spring plate 4070 attached to or grounded to the bottom of the first jaw or frame 4010. The spring plate 4070 includes a hole 4072 configured to receive the spring tab 4044 therein when the firing member 4050 is in its proximal-most "start" position. When in that position, the spring tab 4044 extends into the hole 4072 and may serve to prevent any inadvertent distal movement of the firing member 4050 until desired by the operator. In the illustrated embodiment, the second lockout 4600 further includes a blocking mechanism or ledge 4602 formed on the bottom of the frame 4010. If a user attempts to advance the firing member 4050 distally before the cartridge is operably seated in the frame 4010, the spring tab 4044, in cooperation with the spring plate 4070, will cause the firing member 4050 to drop downward, causing the central pin 4058 on the firing member 4050 to contact the blocking mechanism 4602 in the frame, thereby preventing the firing member 4050 from advancing distally.
[0063] 16 and 17 illustrate operation of the second lockout 4600 when a spent staple cartridge 4200S is seated in the frame 4010. As used in this context, the term "spent" staple cartridge can refer to a staple cartridge that has previously been fully fired or partially fired. In either case, the sled 4230 has advanced distally from its proximal-most, unfired position. FIG. 16 illustrates the firing member 4050 in its proximal-most start position with a spent staple cartridge 4200S seated in the frame 4010. FIG. 17 illustrates the second lockout 4600 preventing the firing member 4050 from advancing distally into the spent cartridge 4200S. As can be seen in FIG. 17, the spring tabs 4044, in cooperation with the spring plate 4070, cause the firing member 4050 to drop downward, causing the central pin 4058 on the firing member 4050 to contact the blocking mechanism 4602 in the frame, thereby preventing the firing member 4050 from advancing distally.
[0064] 18 and 19 illustrate the operation of the second lockout 4600 when an unfired staple cartridge 4200 is seated in the first jaw or frame 4010. As can be seen in FIGS. 18 and 19, the sled 4230 is in its proximal-most, unfired position. The sled 4230 includes an unlocking ledge 4234 configured to be engaged by an unlocking mechanism 4055 formed on the firing member body 4052. FIG. 18 illustrates the firing member 4050 in its proximal-most, start position with an unfired staple cartridge 4200 seated in the first jaw or frame 4010. As the firing member 4050 advances distally, an unlocking mechanism 4055 on the firing member 4050 engages an unlocking ledge 4234 on the sled 4230, lifting the firing member 4050 upward, causing a central pin 4058 of the firing member 4050 to pass through a blocking mechanism 4060 in the first jaw or frame 4010. The firing member 4050 is now free to continue distal advancement into the staple cartridge 4200, completing a staple firing stroke. As the firing member 4050 advances distally, the foot 4054 can engage a corresponding surface on the bottom of the first jaw or frame 4010, and the top pin 4056 can engage a cam surface on the anvil 4100 of the surgical stapling device 4002, which cooperate to position the anvil 4100 and staple cartridge 4200 relative to one another. However, embodiments without either or both of the feet 4054 and the upper pin 4056 are envisioned.
[0065] As can be understood from the above, the first lockout 5300 is proximal to the second lockout 4600. The first lockout 5300 is positioned within the surgical stapling device 4002 such that the first lockout 5300 is proximal to the sled 4230 of an unfired staple cartridge 4200 seated in the first jaw or frame 4010. The first lockout 5300 is configured to move laterally between an engaged position, in which the first lock prevents distal advancement of the firing member 4050 from a start position, and a disengaged position, from which the firing member 4050 may advance distally (sometimes referred to herein as the "armed state"). For example, the first lockout arm 4312 and the second lockout arm 4314 are configured to move within a first horizontal plane FP between the engaged and disengaged positions. See FIG. 8. With respect to the second lockout 4600, the firing member 4050 moves vertically between the unlocked and locked positions along a second plane SP. See FIG. 9 . In the illustrated embodiment, the second plane SP is orthogonal to the first plane FP. When the firing member 4050 is in the armed state, application of a firing motion may cause the firing member 4050 to move distally. However, the firing member is prevented from advancing distally through a staple firing stroke unless a compatible staple cartridge having a thread positioned therein in an unfired position is seated in the frame to unlock the second lockout.
[0066] 20-23 illustrate another surgical stapling assembly 5000, which is similar in many respects to the surgical stapling assembly 4000 described above. The surgical stapling assembly 5000 includes a surgical stapling device 5002 that may be used in conjunction with the surgical instrument 1010 described above or in conjunction with various other surgical instruments described in the various disclosures incorporated herein by reference. As can be seen in FIG. 20 , the surgical end effector 5002 includes a first jaw or frame 5010 that is configured to operably support a compatible staple cartridge 4200 therein. The first jaw or frame 5010 may be attached to the spine of a shaft assembly of a surgical instrument or robot in a variety of manners described herein and / or as described in the various disclosures incorporated herein by reference. In the illustrated embodiment, the first jaw or frame 5010 is attached to the spine of a shaft assembly (not shown in FIG. 20 ) by a shaft mount flange 5030 that is pinned or otherwise attached to the proximal end 5014 of the first jaw 5010 by a pin 5032. In particular, the pin 5032 is configured to pass through aligned holes 5021 in the upright sidewalls 5020 of the first jaw or frame 5010 as well as a hole 5031 in the shaft mount flange 5030. The shaft mount flange 5030 is configured to interface with an articulation joint arrangement (not shown) configured to facilitate articulation of the first jaw 5010 relative to the shaft assembly in various known configurations. The surgical stapling device 5002 may also be used in association with shaft assemblies that do not facilitate articulation of the surgical stapling device 5002.
[0067] 20 , the surgical stapling device 5002 further includes a firing member assembly 5040 that includes a knife bar 5042 attached to a knife member or firing member 5050. The knife bar 5042 also interfaces with corresponding components and a firing system within a surgical instrument or robot to receive a firing motion that can advance the knife bar 5042 and firing member 5050 distally from a start position to an end position through a staple firing stroke and retract the knife bar 5042 and firing member 5050 proximally to the start position. In the illustrated arrangement, the firing member 5050 includes a firing member body 5052 that supports a cutting edge or knife edge 5053. The firing member 5050 further includes feet 5054 formed at the bottom of the firing member body 5052 and extending laterally from each side thereof. The firing member 5050 further includes a pair of top pins or tabs 5056 extending laterally from the firing member body 5052 which are adapted to engage ledges on a second jaw or anvil, as discussed further herein. In addition, the firing member 5050 includes a pair of central pins or tabs 5058 projecting laterally from each side of the firing member body 5052. In some of the disclosures incorporated by reference herein, the firing member 5050 may also be referred to as an "E-beam" firing member or cutting member.
[0068] In addition to the above, the surgical stapling device 5002 further includes a second jaw or anvil 5100 that is movable relative to the first jaw or frame 5010. The anvil 5100 includes an anvil body portion 5102 and an anvil mounting portion 5110. The anvil body 5102 includes a staple-forming lower surface or tissue-contacting surface 5104 having a series of staple-forming pockets (not shown) formed therein that are positioned to form corresponding staples when driven into forming contact with the corresponding staples. The anvil mounting portion 5110 includes a pair of laterally extending anvil or trunnion pins 5112 that are configured to be received in corresponding trunnion holes 5022 provided in an upstanding side wall 5020 of the first jaw or frame 5010. Unlike the anvil 4100 described above, the anvil 5100 is pivotally pinned to the frame 5010 for pivotal movement relative to the frame 5010 about a fixed pivot axis. Stated another way, unlike the anvil 4100, the anvil 5100 does not move or translate substantially axially during the anvil closure process. In various arrangements, the trunnion hole 5022 may be sized relative to the trunnion pin 5112 to facilitate attachment and free pivotal movement of the trunnion pin thereto, so that the trunnion pin may have some slight axial movement therein, but any such axial movement is much less than the axial translation of the anvil 4100.
[0069] As described above, and in several of the disclosures incorporated by reference herein, the anvil 5100 can be movable from an open position, in which a used or spent staple cartridge can be removed from the first jaw or frame 5010 or an unfired staple cartridge can be operably seated therein, to a closed position by an axially movable closure member or end effector closure tube (not shown). For example, as the closure member moves distally from the proximal position, the closure tube can operably engage a cam surface on the anvil mounting portion 5110. Such interaction between the closure member and the anvil mounting portion 5110 causes the closure member to pivot the anvil mounting portion 5110 and the anvil trunnion pin 5112 until it moves the anvil 5100 to the fully closed position. When in the fully closed position, the staple forming pockets in the anvil 5100 are properly aligned with the staples in a corresponding compatible surgical staple cartridge that is operably seated in the first jaw or frame 5010. Thereafter, when the axially movable closure member is moved proximally, it pivots the anvil 5100 back to the open position.
[0070] Further to the above, the surgical stapling device 5002 includes a first lockout 5300 configured to prevent distal movement of the firing member 5050 from its proximal-most start position when an approved or compatible staple cartridge is not operably seated in the frame 5010. The first lockout 5300 may also be referred to herein as an "authentication" lockout. In the illustrated arrangement, the first lockout 5300 is supported on the proximal end 5014 of the first jaw or frame 5010 and includes a single pivotable first spring assembly 5310 attached to the shaft mount flange 5030. For example, in one arrangement, the first spring assembly 5310 includes a first lockout arm 5312 and a second lockout arm 5314 attached to a central body portion 5316. The first spring assembly 5310 is attached to the shaft mount flange 5030 by a pin 5034 that extends through a hole 5036 in the shaft mount flange 5030 and through holes 5318 in the first lockout arm 5312 and the second lockout arm 5314. The first lockout arm 5312 and the second lockout arm 5314 each further include a lockout latch mechanism 5320. Each lockout latch mechanism 5320 is adapted to releasably capture a corresponding central pin 5058 on the firing member 5050 therein when the firing member 5050 is in its proximal-most or start position. See FIG. 21 . In addition, the first lockout spring assembly 5310 further includes one or more pivot springs 5330 that serve to bias or pivot the first spring assembly 5310 downward about the pin 5034 to latch or lock the latch mechanism 5320 into engagement with the corresponding central pin 5058.
[0071] The surgical stapling assembly 5000 may further include a retainer 5400 similar to the retainer 4400 described above. The retainer 5400 includes a top 5402 that is coextensive with and configured to be received on the deck surface 4204 of the staple cartridge 4200, such that when the retainer 5400 is attached to the cartridge body 4202, the retainer 5400 covers all of the staple pockets 4208 within the cartridge body 4202. Thus, when the retainer 5400 is attached to the staple cartridge 4200, the retainer 5400 can prevent the surgical staples contained within the staple pockets 4208 from falling out if the surgical staple cartridge 4200 is inverted or upside down prior to use. Other retainer configurations are contemplated in which the retainer top does not cover all or any of the staple pockets. In the illustrated arrangement, the retainer 5400 may be molded from a polymeric material and includes a plurality of retainer lugs 5410 configured to engage outwardly extending deck ledge portions 4205 on the staple cartridge body 4202. The retainer 5400 may further include an angled nose portion 5420 and a distal latch tab 5422 configured to latchingly engage the distal nose 4203 of the cartridge body 4202. The retainer 5400 may be removably coupled to the staple cartridge 4200 by engaging the distal latch tabs 5422 with an end of the staple cartridge distal nose 4203 and aligning the retainer 5400 so that an underside of the apex 5402 faces the cartridge deck surface 4204 and the retainer lugs 5410 are located above the deck ledge portions 4205 on each side of the staple cartridge body 4202. The retainer 5400 can then be pressed toward the staple cartridge 4200, causing the retainer lugs 5410 to bend laterally outward and snap into latching engagement with corresponding deck ledge portions 4205. Other retainer latch arrangements disclosed herein can also be used to releasably secure the retainer 5400 to the staple cartridge 4200.
[0072] The retainer 5400 further comprises an authentication key 5430 adapted to engage key pockets 5322 formed in the first lockout arm 5312 and the second lockout arm 5314. As can be seen in FIG. 20 , the authentication key 5430 comprises a right ramp mechanism 5440 and a left ramp mechanism 5450 that protrude proximally from the proximal end 5401 of the top 5402 of the retainer 5400 and are separated by a space sized to receive the firing member body 5052 therebetween. In the illustrated embodiment, the ramps 5440 and 5450 angle downwardly from the top 5402 of the retainer 5400 and are configured to enter the key pockets 5322 of the first lockout arm 5312 and the second lockout arm 5314.
[0073] During use, the retainer 5400 is removably attached to the staple cartridge 4200 to form the cartridge assembly 5500. The cartridge assembly is then initially inserted into the first jaw or frame 5010 to insert the ramps 5440 and 5450 of the authentication key 5430 into the key pockets 5322 in the first lockout arm 5312 and second lockout arm 5314. See FIG. 21 . Further longitudinal advancement proximally into the cartridge assembly 5500 into the first jaw or frame 5010 causes the ramps 5440 and 5450 to pivot the first spring 5310 upward to a disengaged or unlocked position where the latch mechanism 5320 disengages the corresponding central pin 5058. See FIG. 22 . When the cartridge assembly 5500 is operably seated in the first jaw or frame 5010, a distally facing detent 5326 formed on each of the first lockout arm 5312 and the second lockout arm 5314 retainingly engages the proximal end of the staple cartridge 4200, as shown in FIG. 22 . Such an arrangement serves to retain the first spring 5310 in a disengaged position. When in that position, the first lockout 5300 is in an unlocked position, or otherwise "overridden," unlocked, or unlatched. A user can then remove the retainer 5400 from the staple cartridge 4200 by prying open the distal latch tabs 5422 and lifting the retainer 5400 upward until the retainer lugs 5410 disengage the deck ledge portion 4205. In the illustrated embodiment, the word "LIFT" is molded, embossed, imprinted, or otherwise provided on the nose portion 5420 to provide removal instructions to the user. The surgical staple cartridge 5200 remaining within the frame 5010 is ready to be fired. See FIG. 23.
[0074] The surgical stapling device 5002 also includes a second lockout 5600 that is very similar to the second lockout 4600 described above. Referring now to FIGS. 20 and 21 , the knife bar 5042, which may comprise a solid or laminated structure, includes a spring tab 5044 configured to operatively interface with a spring plate 5070 attached to the bottom of the first jaw 5010. The spring plate 5070 serves to pivot the firing member 5050 downward so that the central pin 5038 on the firing member 5050 contacts a frame blocking or abutment mechanism (not shown) on the bottom of the frame 5010 unless the unlocking mechanism 5055 on the firing member 5050 engages the unlocking ledge 4234 on the sled 4230, causing the firing member 5050 to be lifted upward such that the central pin 5058 on the firing member 5050 passes through the blocking mechanism in the frame 5010 discussed above.
[0075] 24-26 show an alternative compatible surgical staple cartridge 4200' configured to activate the first lockout 5300 in the manner described above. However, in this arrangement, the authentication key 5030' is formed on the cartridge pan 4220'. As can be seen in FIG. 24, the authentication key 5030' includes a right ramp mechanism 5440' and a left ramp mechanism 5450' that are bent into the cartridge pan 4220' and protrude proximally therefrom. Reinforcing ribs 5441' may be embossed into each joint of the ramps 5440' and 5450' that may be formed to provide additional support and rigidity to each of the ramps 5440', 5450'. In the illustrated embodiment, the ramp 5440' has an angled proximal tip 5442', and the ramp 5450' includes an angled proximal tip 5452. The tips 5442', 5452' are each configured to enter the key pockets 5322 in the first lockout arm 5312 and the second lockout arm 5314, respectively, to pivot the first lockout 5300 in the manner described above. The first lockout 5300 operates otherwise in the manner described above.
[0076] Referring to FIG. 27, an embodiment of a surgical stapling assembly 6000 is shown. The surgical stapling assembly 6000 comprises a surgical stapling device 6002 that may be used in conjunction with the surgical instrument 1010 described above or in conjunction with various other surgical instruments or robots described in the various disclosures incorporated by reference herein. As can be seen in FIG. 27, the surgical end effector 6002 comprises a first jaw or frame 6010 configured to operably support a staple cartridge 4200 therein. The first jaw or frame 6010 is attached to the spine of a shaft assembly (not shown) by a shaft mounting flange 4030 ( FIG. 6 ) in various manners described herein. The surgical stapling device 6002 further comprises a firing member assembly comprising a knife bar attached to a knife member or firing member 4050 as described above.
[0077] Further to the above, the surgical stapling device 6002 includes a second jaw or anvil 6100 movable relative to the first jaw or frame 6010. The anvil 6100 is similar to the anvil 4100 described above and includes an anvil body 6102 and an anvil mounting portion 6110. The anvil body 6102 includes a staple-forming lower surface or tissue-contacting surface 6104 having a series of staple-forming pockets (not shown) formed therein that are positioned to form corresponding staples when driven into forming contact with the corresponding staples. The anvil mounting portion 6110 includes a pair of laterally extending anvil pin or trunnion assemblies 6112. Each trunnion assembly 6112 includes an outwardly and downwardly projecting locking lug portion 6120 having a trunnion pin 6122 extending therefrom. Each trunnion pin 6122 is configured to be received within a corresponding trunnion slot 6022 in the upstanding sidewall 6020 of the first jaw 6010. In the arrangement shown, the trunnion slot 6022 is somewhat "kidney-shaped" to facilitate pivotal and axial movement of the corresponding trunnion pin 6122 therein.
[0078] As described above, and in several of the disclosures incorporated by reference herein, the anvil 6100 can be operable by a closure member or end effector closure tube (not shown) that is axially movable from an open position to a closed position where a used or spent surgical staple cartridge can be removed from the frame 6010 or an unused, new staple cartridge can be operably seated therein. For example, as the closure member moves distally from a proximal position, the closure member can operably engage a cam surface on the anvil mounting portion 6110. Such interaction between the closure member and the anvil mounting portion 6110 causes the anvil mounting portion 6110 and the anvil trunnion pin 6122 to pivot and translate the trunnion slots 6022 until the closure member moves the anvil 6100 to the closed position. When in the fully closed position, the staple forming pockets in the anvil 6100 are properly aligned with the staples in a corresponding compatible staple cartridge that is operably seated in the frame 6010. Thereafter, as the axially movable closure member is moved proximally, it interfaces with the upstanding tabs 6114 on the anvil mounting portion 6110 to return the anvil 6100 to the open position.
[0079] Further to the above, the surgical stapling device 6002 includes a first lockout 6300 configured to prevent the second jaw or anvil 6100 from being movable from an open position to a closed position by the closure member. The first lockout 6300 may also be referred to herein as an “authentication” lockout. In the illustrated arrangement, the first lockout 6300 includes a first lockout arm 6310 pivotally supported within the frame 6010 by a lockout pin 6312 attached thereto. In one embodiment, the first lockout arm 6310 is fabricated from stainless steel or the like, and the lockout pin 6312 is welded or otherwise attached thereto. The lockout pin 6312 is pivotally seated within a pivot hole 6013 in the frame 6010 to facilitate pivotal movement of the first lockout arm 6310 between a locked position and an unlocked position. See FIG. 28 . In the illustrated embodiment, the lockout mechanism 6316 is formed on the proximal end 6314 of the first lockout arm 6310 and is configured to blockably engage the locking lug portion 6120 on the corresponding trunnion assembly 6112 when the first lockout arm 6310 is in the engaged position. When the lockout mechanism 6316 blocksably engages the locking lug portion 6120 on the trunnion assembly 6112, the lockout mechanism 6316 prevents the trunnion assembly 6112 from moving within the corresponding trunnion slot 6022 in the first jaw or frame 6010, thereby effectively preventing the second jaw or anvil 6100 from moving from the open position to the closed position when a closing motion is applied thereto. This position of the first lockout arm 6310 may be referred to herein as the "jaw-locked position." It will be appreciated that the lockout mechanism 6316, as well as the locking lug portion 6120, may be sufficiently robust to resist substantial closing motion applied to the anvil 6100 to prevent closure of the anvil 6100.
[0080] 28, the first lockout spring 6330 is supported on a corresponding side wall 6020 of the first jaw or frame 6010 to bias the first lockout arm 6310 in the locking direction LD to an engaged position, a locked position, or a "jaw lock position" in which the first lockout arm 6310 prevents the anvil 6100 from moving from the open position to the closed position. A travel limit plate or mounting plate 6070 is supported within the frame 6010 and attached to the shaft mounting assembly. The travel limit plate 6070 also provides lateral support to the first lockout arm 6310 when in the jaw lock position. See FIG. 29. As can be seen in FIGS. 28 and 29, the first lockout arm 6310 further includes an upstanding actuator cam arm 6322 formed on a distal end 6320 of the first lockout arm 6310. The actuator cam arm 6322 includes an actuator cam surface 6324. The first lockout arm 6310 further includes a retention tab 6326 configured to be received within a corresponding opening or tab window 6024 in the frame side wall 6020 .
[0081] 27 , the stapling assembly 6000 further includes a retainer 6400 configured to be removably coupled to the surgical staple cartridge 4200. In various embodiments, the retainer 6400 is substantially similar to the retainer 4400 described above, with the exception of the authentication key 6430. In the illustrated arrangement, the retainer 6400 includes a top portion 6402 coextensive with and configured to be received thereon, such that when the retainer 6400 is attached to the cartridge body 4202, the retainer 6400 covers all of the staple pockets 4208 in the cartridge body 4202. In alternative variations, the retainer top portion may cover only some, or none, of the staple pockets. The retainer 6400 may be molded from a polymeric material and may include a plurality of retainer lugs 6410 configured to engage an outwardly extending deck ledge portion 4205 formed on the staple cartridge body 4202. The retainer 6400 can further include an angled nose portion 6420 and a distal latch tab 6422 configured to engage the distal nose 4203 of the staple cartridge body 4202. The retainer 6400 can be removably coupled to the surgical staple cartridge 4200 by engaging the latch tab 6422 with the end of the distal nose 4203 and aligning the retainer 6400 so that an underside of the top 6402 of the retainer 6400 faces the cartridge deck surface 4204 and the retainer lugs 6410 are located above the deck ledge portions 4205 on each side of the cartridge body 4202. The retainer 6400 can then be pressed toward the staple cartridge 4200, bending the retainer lugs 6410 laterally outward and snapping them into latching engagement with the corresponding deck ledge portions 4205. Other retainer latch arrangements disclosed herein may also be used to removably secure the retainer 6400 to the staple cartridge 4200. The retainer 6400 can be removed from the staple cartridge 4200 by applying a prying motion to the distal latch tab 6422 and lifting upward until the retainer lug 6410 disengages the deck ledge portion 4205.In the illustrated embodiment, the word "LIFT" is molded or embossed into nose portion 6420 to provide removal instructions to the user.
[0082] 32-35 , the retainer 6400 further comprises an authentication key 6430 configured to disable, unlock, or unlatch the first lockout 6300 when the retainer 6400 is attached to the surgical staple cartridge 4200 and the surgical staple cartridge 4200 is operatively seated within the first jaw or frame 6010. As can be seen in FIG. 32 , the authentication key 6430 protrudes proximally from the proximal end 6401 of the top 6402 of the retainer 6400 and comprises an angled ramp mechanism 6440 positioned to one side of the cartridge axis CA when the retainer 6400 is attached to the staple cartridge 4200. In the illustrated embodiment, the ramp 6440 angles downward from the top 6402 of the retainer 6400 and includes a proximal tip 6442 that defines a first cam surface, or proximal cam surface 6444, that angles inward at the tip. A second cam surface, or distal cam surface 6446, is located below the first cam surface 6444. These dual continuous cam surfaces 6444, 6446 are configured to interface with an actuator cam surface 6324 on the actuator cam arm 6322 to move the first lockout arm 6310 from a locked or jaw-locked position to an unlocked or jaw-closed position. Such an arrangement provides little room for the authentication key 6430 to unlock and actuate the actuator cam arm 6322 when the staple cartridge supporting the retainer 6400 is operably seated within the first jaw or frame 6010. The dual cam surface arrangement facilitates pivoting of the first lockout arm 6310 the sufficient pivot distance required to place the first lockout arm 6310 in the disengaged or jaw closed position, which may be, for example, more than twice the width of the ramp 6440.
[0083] 29 illustrates the first lockout 6300 in a locked or jaw-locked position in which the first lockout arm 6310 is pivoted to a position where the lockout mechanism 6316 blocks and engages the locking lug portion 6120 on the trunnion assembly 6112 on the anvil 6100. Referring now to FIG. 36 , after the retainer 6400 is attached to the surgical staple cartridge 4200 to form a cartridge assembly 6500, the cartridge assembly 6500 can be inserted into the first jaw or frame 6010 such that the first cam surface 6444 engages the actuator cam surface 6324 on the actuator cam arm 6322 and begins to pivot the first lockout arm 6310 to an intermediate position out of the locked or jaw-locked position. Continued longitudinal insertion of the assembled cartridge arrangement 6500 proximally into the frame 6010 causes the first cam surface 6444 to disengage the actuator cam surface 6324 and the lower second cam surface 6446 to engage the actuator cam surface 6324, moving the first lockout arm 6310 from the intermediate position to the jaw-closed position. See FIG. 37 . When the first lockout arm 6310 is in the locked or jaw-locked position, the actuator cam arm 6322 is located distally of the firing member 6050. The lower second cam surface 6446 completes the pivotal movement of the first lockout arm 6310, thereby causing the actuator cam arm 6322 to unimpede operation of the firing member 6050 while allowing the anvil 6100 to move to the closed position. When the first lockout arm 6310 is in the unlocked or jaw closed position, the retention tab 6326 is received in the tab window 6024 in the frame side wall 6020 and is retained therein by the staple cartridge 4200. When in that position, the first lockout 6300 is in the jaw closed position, or otherwise "disabled," unlocked, or unlatched.The user may then remove the retainer 6400 from the surgical staple cartridge 4200 by prying open the distal latch tabs 6422 and lifting the retainer 6400 upward until the retainer lugs 6410 disengage the deck ledge portion 4205 .
[0084] As can be seen from the foregoing, the space required to interface with the first lockout 6300 is available when the anvil 6100 is open, but not when the anvil 6100 is closed. The retainer 6400 is present on the cartridge 4200 only when the anvil 6100 is open during the cartridge insertion process. The retainer 6400 is then removed from the staple cartridge 4200. The anvil 6100 cannot close when the retainer 6400 is in place. When closed, the anvil 6100 occupies the space previously occupied by the retainer 6400. This arrangement is very different from cartridge-based authentication key arrangements, which remain resident within the stapling device during closure and firing of the device. Dual sequential ramp / cam surfaces are used in this arrangement to laterally move the first lockout arm 6310 a distance at least approximately twice the width of the authentication key 6430. This may be an important aspect of this design.
[0085] The proximal, higher ramp or cam surface begins the unlocking movement and engages the staging actuator cam arm 6322 distal to the firing member 4050. It will be appreciated that a fixed locking mechanism that cannot be moved or removed cannot reach this area without affecting the ability to move the firing member 4050 through the staple firing stroke. The second, lower ramp / cam surface completes the unlocking movement of the first unlocking arm 6310, thereby preventing the anvil 6100 from closing altogether. The second ramp / cam surface is sequentially spaced rearward of the first ramp / cam surface such that it can engage the distal end of the first lockout arm 6310 only after the first ramp / cam surface has pivoted the first lockout arm 6310 to its intermediate position.
[0086] FIG. 38 shows the staple cartridge 4200 operably seated within the frame 6010 with the first lockout 6300 disabled and the retainer 6400 removed from the staple cartridge 4200. The anvil 6100 is now movable between an open position and a closed position, and the surgical staple cartridge 4200 can be otherwise fired. In at least one form, the surgical stapling device 6002 can also include a second lockout 4600 configured to prevent the firing member 4050 from advancing distally through a staple firing stroke when the spent staple cartridge is seated in the first jaw or frame 6010 in the various manners described above. After the staple cartridge 4200 is fired, the firing member 4050 retracts back to the start position, and the second jaw or anvil 6100 pivots back to the open position. The spent staple cartridge can then be removed from the first jaw or frame 6010. When the used staple cartridge 4200 is removed from the first jaw or frame 6010, the first lockout spring biases the first lockout arm 6310 back to a jaw lock position that prevents the second jaw or anvil 6100 from moving from the open position to the closed position.
[0087] 38A is another top view of the surgical stapling device 6002, showing a retainer 6400' attached to the staple cartridge 4200 with a cartridge assembly 6500' seated therein. The retainer 6400' is similar to the retainer 6400 described above, except that an authentication key 6430' and a lamp 6440' are incorporated into a side wall 6403' of the retainer 6400'. The retainer 6400' may otherwise operate in the same manner as the retainer 6400 described above.
[0088] FIG. 39 is a perspective view of the proximal end of a staple cartridge 4200'', which is identical to the staple cartridge 4200 described above, except that, as shown, the authentication key 4228'' is folded into a cartridge pan 4220'' attached to the cartridge body 4202''. As shown in FIGS. 40-42, the staple cartridge 4200'' is configured to be used in association with a surgical stapling assembly 6000' which includes a surgical stapling device 6002' which includes a first lockout 6300'. The surgical stapling device 6002' is substantially identical to the surgical stapling device 6002, except for the distal end 6311' of the first lockout arm 6310' which is pivotally supported on the frame 6010' by a lockout pin 6312' attached to the first lockout arm 6310'. The proximal end 6314' of the first lockout arm 6310' is identical to the proximal end 6314 of the first lockout arm 6310 and is configured for blocking engagement with a locking lug portion on a corresponding trunnion assembly 6112' of the anvil 6100' in the manner described in detail above. The lockout spring 6330' serves to pivot the first lockout arm 6310' to the locked position in the manner described above. FIG. 40 illustrates the insertion of the staple cartridge 4200'' into the frame 6010'. As can be seen in FIG. 40, the first lockout arm 6310' is in a locked or jaw-locked position in which the proximal end 6314' (FIG. 41) blocks engagement with a locking lug on the trunnion assembly 6112' to prevent closure of the anvil 6100'. 41 and 42 show the staple cartridge 4200 fully seated in the frame 6010'. As can be seen in FIGS. 41 and 42, the authentication key 4228'' pivots the first lockout arm 6310' to the jaw closed position and holds the first lockout arm 6310' in that position. When in the jaw closed position, the anvil 6100 is free to pivot closed, as shown in FIG. 41. In this arrangement, the authentication key 4228'' comprises a portion of the staple cartridge and is not attached to a removable retainer.The authentication key 4228'' holds the first lockout arm 6310' in the jaw closed position while the staple cartridge remains seated in the frame 6010' throughout the stapling procedure.
[0089] After the staple cartridge 4200′ is fired, the user returns the firing member of the surgical stapling device 6002′ to the start position, and the anvil 6100′ is pivoted to the open position, allowing the spent staple cartridge to be removed from the frame 6010′. Once the spent staple cartridge 4200′ is removed from the frame 6010′, the lockout spring 6330′ pivots the first lockout arm 6310′ back to the jaw-locked position. In some cases, spent staple cartridges may be “reprocessed” for reuse in another stapling procedure and / or another stapling device. It is important that these reprocessing businesses load the reprocessed staple cartridge with the appropriate surgical staples, as well as the appropriate number of surgical staples, which requires the cartridge to be compatible with the specific stapling device to ensure the desired results during use. Unfortunately, some reprocessing businesses may not be able to properly reprocess spent cartridges, but still provide the reprocessed spent cartridges as new cartridges manufactured by the original manufacturer. An end user may unknowingly obtain and use a defective cartridge in a surgical stapling device. To prevent such an occurrence, the authentication key 4228'' may be irretrievably flattened when the used cartridge is removed from the surgical stapling device 6002''. For example, as can be seen in FIG. 39 , the authentication key 4228'' is formed with a pair of lugs 4229'' that are slidably received in slots 4223'' provided in the cartridge pan 4220''. By applying a flattening force FF to the tip of the authentication key 4228'', the key may be flattened against the proximal end 4225'' of the cartridge pan 4220'', rendering the authentication key 4228 inoperable for future use.
[0090] FIG. 43 is a perspective view of the proximal end of a staple cartridge 4200''', which is identical to the staple cartridge 4200 described above, except that, as shown, the authentication key 4228''' is folded into the cartridge pan 4220''' attached to the cartridge body 4202'''. In this embodiment, the authentication key 4228''' protrudes from a top flap 4225''' of the cartridge pan 4220''' that is folded over a portion of the cartridge deck 4204''', which may serve to add strength to the authentication key 4228'''. The authentication key 4228''' may further comprise a folded reinforcement wall portion 4227''' and may have angled actuation or cam surfaces 4229A'' and latch surfaces 4229B'''. As shown in Figures 44-46, the staple cartridge 4200''' is configured to be used in association with a surgical stapling assembly 6000'' that includes a surgical stapling device 6002'' that includes a first lockout 6300''.
[0091] In many aspects, the surgical stapling device 6002'' is substantially identical to the surgical stapling device 6002 and includes a first lockout arm 6310'' pivotally supported on the frame 6010'' by a lockout pin 6312'' attached to the first lockout arm 6310''. The proximal end 6314'' of the first lockout arm 6310'' may be identical to the proximal end 6314 of the first lockout arm 6310 and is configured for blocking engagement with a locking lug portion on a corresponding trunnion assembly 6112'' of the anvil 6100'' in the manner described in detail above. The lockout spring 6330'' serves to pivot the first lockout arm 6310'' to a locked or jaw-locked position in the manner described above. The distal end of the first lockout arm 6310'' includes an upstanding actuator cam arm 6322'' configured to be engaged by an authentication key 4228'''' on the staple cartridge 4200'''.
[0092] FIG. 46 illustrates the insertion of the staple cartridge 4200'' into the frame 6010''. The first lockout arm 6310'' is in a jaw-lock position in which the proximal end 6314'' is in blocking engagement with a locking lug on the trunnion assembly 6112'' to prevent closure of the anvil 6100''. During initial insertion of the staple cartridge 4200'' into the frame 6010'', the angled actuation or cam surface 4229A'''' contacts the upright actuator cam arm 6322'' to begin pivoting the first lockout arm 6310'' out of the jaw-lock position. Continued insertion of the staple cartridge 4200''' into the frame 6010'' causes the authentication key 4228''' to pivot the first lockout arm 6310'' to an unlocked or jaw-closed position, and the actuator cam arm 6322'' disengages the angled cam surface 4229A'' and is retained in its unlocked or jaw-closed position by the latch surface 4229B''' on the authentication key 4228'''. See FIGS. 44 and 45. When in the unlocked or jaw-closed position, the anvil 6100'' is free to pivot closed. In this arrangement, the authentication key 4228''' comprises a portion of the staple cartridge and is not attached to a removable retainer. The authentication key 4228''' holds the first lockout arm 6310'' in the jaw-closed position while the staple cartridge 4200''' remains seated in the frame 6010'' throughout the stapling procedure.
[0093] 47 is a perspective view of the proximal end of a staple cartridge 4700, which is largely identical to the staple cartridge 4200 described above, except that, as shown, the authentication key 4728 is folded into a cartridge pan 4720 attached to the cartridge body 4702. In this embodiment, the authentication key 4728 protrudes from a top flap 4725 of the cartridge pan 4720, which is folded over a portion of the cartridge deck 4704, which may serve to add strength to the authentication key 4728. The authentication key 4728 includes an angled actuation or cam surface 4729A and a latch surface 4729B. The authentication key 4728 is folded to extend below the plane defined by the cartridge deck 4704 and may be used, for example, in the surgical stapling device 6002'' in the manner described above, or other surgical stapling devices having slightly shorter actuator cam arms.
[0094] 48-51 illustrate another surgical stapling assembly 7000, which is similar in many respects to the surgical stapling assembly 6000 described above. The surgical stapling assembly 7000 comprises a surgical stapling device 7002 that may be used in conjunction with the surgical instrument 1010 described above or in conjunction with various other surgical instruments or robots described in the various disclosures incorporated by reference herein. As can be seen in FIG. 48 , the surgical end effector 7002 includes a first jaw or frame 7010 configured to operably support a surgical staple cartridge 4200 therein. The first jaw or frame 7010 is attached to the spine of a shaft assembly in various manners described herein. In the illustrated embodiment, the first jaw or frame 7010 is attached to the spine of a shaft assembly (not shown in FIG. 48 ) by a shaft mount flange 7030 that is pinned or otherwise attached to the proximal end 7014 of the first jaw 7010 by a pin 7032. In particular, the pin 7032 is configured to pass through aligned holes 7021 in the upright sidewall 7020 of the first jaw or frame 7010 as well as holes 7031 in the shaft mount flange 7030. The shaft mount flange 7030 is configured to interface with an articulation joint arrangement (not shown) configured to facilitate articulation of the first jaw 7010 relative to the shaft assembly in various known configurations. The surgical stapling device 7002 may also be used in association with a shaft assembly that does not facilitate articulation of the surgical stapling device 7002.
[0095] 48 , the surgical stapling device 7002 further includes a firing member assembly 4040 that includes a knife bar 4042 attached to a knife member or firing member 4050. The operation of the firing member 4050 and the knife bar 4042 is described in detail above. In addition to the above, the surgical stapling device 7002 further includes a second jaw or anvil 7100 that is movable relative to the first jaw or frame 7010. The anvil 7100 includes an anvil body portion 7102 and an anvil mounting portion 7110. The anvil body 7102 includes a staple forming lower surface or tissue contacting surface 7104 having a series of staple forming pockets (not shown) formed therein that are positioned to form corresponding staples when actuated into forming contact with the corresponding staples. The anvil mounting portion 7110 includes a pair of laterally extending anvil or trunnion pins 7112 configured to be received in corresponding trunnion holes 7022 in the upright sidewall 7020 of the first jaw or frame 7010. Unlike the anvil 6100 described above, the anvil 7100 is pivotally pinned to the frame 7010 for pivotal movement relative to the frame 7010 about a fixed pivot axis. Stated differently, unlike the anvil 6100, the anvil 7100 does not move axially or translate substantially during the anvil closure process.
[0096] As discussed above, and in several disclosures incorporated herein by reference, the anvil 7100 can be movable from an open position, at which a current or spent staple cartridge can be removed from the first jaw or frame 7010 or an unfired staple cartridge can be operably seated therein, to a closed position by an axially movable closure member or end effector closure tube 7600. For example, as the closure tube 7600 moves distally from a proximal position, the closure tube 7600 can operably engage with a cam surface 7113 on the anvil mounting portion 7110. Such interaction between the closure tube 7600 and the anvil mounting portion 7110 causes the anvil mounting portion 7110 and the trunnion pin 7112 to pivot until the closure member moves the anvil 7100 to the fully closed position. When in the fully closed position, the staple forming pockets in the anvil 7100 are properly aligned with the staples in a corresponding compatible staple cartridge 4200 that is operably seated in the first jaw or frame 7010. Thereafter, as the axially movable closure tube 7600 is moved proximally, the tabs 7602 on the closure tube 7600 interact with the tabs 7114 on the anvil mounting portion 7110 to pivot the anvil 7100 back to the open position.
[0097] Further to the above, the surgical stapling device 7002 includes a first lockout 7300 configured to prevent the second jaw or anvil 7100 from being movable from an open position to a closed position by the closure member 7600. The first lockout 7300 may also be referred to herein as an “authentication” lockout. In the illustrated arrangement, the first lockout 7300 includes a first lockout arm 7310 pivotally supported within the first jaw or frame 7010 by a lockout pin 7312 attached thereto. In one embodiment, the first lockout arm 7310 is fabricated from stainless steel or the like, and the lockout pin 7312 may be machined into its proximal end. The lockout pin 7312 is pivotally seated within a pivot hole 7013 in the frame 7010 to facilitate pivotal movement of the first lockout arm 7310 in the locking direction LD between the jaw-locked position and the jaw-closed position. See FIG. 50 . In the illustrated embodiment, the first lockout arm 7310 is configured to blockably engage a locking lug portion 7120 that projects downwardly from the anvil mounting portion 7110 when the first lockout arm 7310 is in the jaw-locked position. When the first lockout arm 7310 is in its locked or engaged position, contact of the locking lug portion 7120 with the first lockout arm 7310 prevents pivotal movement of the anvil 7100. It will be appreciated that the first lockout arm 7310, as well as the locking lug portion 7120, are each sufficiently rigid to resist substantial closing motion applied to the anvil 7100 and prevent closure of the anvil 7100.
[0098] 50 , the first lockout spring 7330 is supported by a corresponding side wall 7020 of the first jaw or frame 7010 to bias the first lockout arm 7310 in the locking direction LD to a locked position, or a jaw-locked position, where the first lockout arm 7310 prevents the anvil 7100 from moving from the open position to the closed position. As can be seen in FIG. 50 , the first lockout arm 7310 further includes an upstanding actuator cam arm 7322 formed on a distal end 7320 of the first lockout arm 7310. The actuator cam arm 7322 includes an actuator cam surface 7324 thereon. The first lockout arm 7310 further includes a retention tab 7326 configured to be received in a corresponding opening or tab window 7024 in the frame side wall 7020.
[0099] 48 , the stapling assembly 7000 further includes a retainer 7400 configured to be removably coupled to the surgical staple cartridge 4200. In many aspects, the retainer 7400 is substantially similar to the retainer 4400 described above. In the illustrated arrangement, the retainer 7400 includes a top portion 7402 configured to be coextensive with and received on the deck surface 4204 of the staple cartridge body 4202. When the retainer 7400 is attached to the cartridge body 4202, the retainer 7400 covers all of the staple pockets 4208 within the cartridge body 4202. In other variations, only a portion, or none of the staple pockets are covered. The retainer 7400 may be molded from a polymeric material and includes a plurality of retainer lugs 7410 configured to engage the outwardly extending deck ledge portion 4205. The retainer 7400 may further comprise an angled nose portion 7420 and a distal latch tab 7422 configured to engage the distal nose 4203 of the cartridge body 4202 .
[0100] The retainer 7400 can be removably coupled to the surgical staple cartridge 4200 by aligning the retainer 7400 so that the distal latch tabs 7422 engage the ends of the distal nose 4203, the underside of the apex 7402 faces the cartridge deck surface 4204, and the retainer lugs 7410 are positioned above the deck ledge portions 4205 on each side of the cartridge body 4202. The retainer 7400 can then be pressed toward the staple cartridge 4200, causing the retainer lugs 7410 to bend laterally outward and snap into latching engagement with the corresponding deck ledge portions 4205. Other retainer latch arrangements disclosed herein can also be used to removably secure the retainer 7400 to the staple cartridge 4200. The retainer 7400 can be removed from the staple cartridge 4200 by applying a prying motion to the distal latch tab 7422 and lifting upward until the retainer lug 7410 disengages the deck ledge portion 4205. In the illustrated embodiment, the word "LIFT" is molded or embossed into the nose portion 7420 to provide removal instructions to the user.
[0101] 53-56 , the retainer 7400 further comprises an authentication key 7430 configured to disable the first lockout 7300 when the retainer 7400 is attached to the surgical staple cartridge 4200 and the surgical staple cartridge 4200 is operably seated in the first jaw or frame 7010. As can be seen in FIG. 53 , the authentication key 7430 comprises a right ramp mechanism 7440 and a left ramp mechanism 7450 that proximally project from the proximal end 7401 of the top 7402 of the retainer 7400 and are separated by a space 7460 sized to receive the firing member body 4052 therebetween. In the illustrated embodiment, the right ramp 7440 comprises a proximal right tip 7442 that angles downwardly from the top 7402 of the retainer 7400 and includes a first right or proximal right camming surface 7444 that angles inwardly at its tip. A second right cam surface, or distal right cam surface 7446, is located below the first right cam surface 7444. These dual continuous cam surfaces 7444, 7446 are configured to interface with the actuator cam surface 7324 on the actuator cam arm 7322 to move the first lockout arm 7310 from the jaw-locked position to the "jaw-closed position" in the various manners described above. Similarly, the left ramp 7450 includes a proximal left tip 7452 that angles downward from the top 7402 of the retainer 7400 and includes a first left cam surface, or proximal left cam surface 7454, that angles inward at the tip. The second left cam surface, or distal left cam surface 7456, is located below the first right cam surface 7444. These dual continuous cam surfaces 7454, 7456 are configured to interface with an actuator cam surface 7324 on an actuator cam arm 7322 of a first lockout arm 7310 that is mounted to the left or opposite side of the frame axis FA. The retainer 7400 further includes a retainer keel 7470 that protrudes from a bottom surface of the top portion 7402 and is oriented to be received within the longitudinal slot 4206 of the surgical staple cartridge 4200. The retainer keel 7470 may serve to properly orient the retainer 7400 on the surgical staple cartridge 4200 so that the right ramp 7440 and the left ramp 7450 extend on each side of the firing member 4050.The retainer keel 7470 can also be sized relative to the longitudinal slot 4206 to create a frictional retaining engagement with the staple cartridge 4200 when the retainer 7400 is attached thereto and can also be used to hold the sled 4230 in an unfired position with the staple cartridge 4200.
[0102] During use, the retainer 7400 is attached to the staple cartridge 4200 in various manners disclosed herein to form a cartridge assembly 7500. The cartridge assembly 7500 can then be inserted into the first jaw or frame 7010 so that the right ramp 7440 of the authentication key 7430 engages the actuator cam surface 7324 on the actuator cam arm 7322. During initial proximal insertion of the cartridge assembly 7500, the first right cam surface 7444 biases the actuator cam arm 7322 laterally outward to an intermediate position. Further proximal longitudinal advancement of the cartridge assembly 7500 into the first jaw or frame 7010 causes the first cam surface 7444 to disengage the actuator cam surface 7324 and the second right cam surface 7446 to engage the actuator cam surface 7324, moving the first lockout arm 7310 from the intermediate position to a fully disengaged or jaw closed position. When the first lockout arm 7310 is in the unlocked or jaw-closed position, the retention tab 7326 is received within the tab window 7024 of the frame side wall 7020 and is retained therein by the staple cartridge 4200. When in that position, the first lockout 7300 is in the unlocked or jaw-closed position, or otherwise "disabled," unlocked, or unlatched. A user can then remove the retainer 7400 from the surgical staple cartridge 4200 by prying open the distal latch tab 7422 and lifting the retainer 7400 upward until the retainer lug 7410 disengages the deck ledge portion 4205. The anvil 7100 is now movable between the open and closed positions, and the surgical staple cartridge 4200 can be otherwise fired. In at least one variation, the surgical stapling device 7002 can include a second lockout 4600 configured to prevent the firing member 4050 from advancing distally through the staple firing stroke when a used staple cartridge is seated in the first jaw or frame 7010 in the various manners described above.After the staple cartridge 4200 is fired, the firing member 4050 retracts back to the starting position and the second jaw or anvil 7100 pivots back to the open position. The spent staple cartridge can then be removed from the first jaw or frame 7010. Once the spent staple cartridge 4200 is removed from the first jaw or frame 7010, the first lockout spring biases the first lockout arm 7310 back to the engaged or jaw-locked position, which prevents the second jaw or anvil from moving from the open position to the closed position.
[0103] As can be seen in FIG. 52 , the surgical stapling device 7002 employs a first lockout 7300 positioned in a first jaw or frame 7010 on a first side 7005 of a frame axis FA that is coplanar with the cartridge axis CA when a staple cartridge is operably seated within the frame 7010. FIG. 56 shows a second surgical stapling device 7002′ that is identical to the surgical stapling device 7002 except that the first lockout 7300′ is positioned in the first jaw or frame 7010′ on a second or opposite side 7007 of the central frame axis FA. In such an example, the left ramp 7450 of the authentication key 7430 serves to move the first lockout arm 7310′ from an engaged or locked position to a disengaged or unlocked position when a cartridge assembly 7500′ is seated in the first jaw of the frame 7010′ of the surgical stapling device 7002′. A 45mm surgical stapler may have a first lockout on the right side of the cartridge axis, a 60mm surgical stapler may have a first lockout on the left side of the cartridge axis, or vice versa, or certain specialty stapling devices such as vascular staplers or thoracic staplers may have a lockout on a different side than a multipurpose stapler.
[0104] Referring to FIG. 57 , an example of a surgical stapling assembly 8000 is shown. The surgical stapling assembly 8000 may be used in conjunction with the surgical instrument 1010 described above or in conjunction with various other surgical instruments or robots described in the various disclosures incorporated by reference herein. The surgical stapling assembly 8000 may be used in conjunction with the various forms of electrically controlled, battery-powered, manually driven, and / or robotically controlled surgical instruments disclosed in the aforementioned incorporated disclosures. As can be seen in FIG. 57 , the surgical stapling assembly 8000 comprises a surgical stapling device, generally designated 8002, including a first jaw or frame 8010 configured to operably support a staple cartridge 4200 therein. The first jaw 8010 is attached to a spine of a shaft assembly of the surgical instrument or robot in various manners described herein. In the illustrated embodiment, the first jaw 8010 is attached to a spine portion of a shaft assembly (not shown in FIG. 57 ) by a shaft mount flange 8030 that is pinned or otherwise attached to the proximal end 8014 of the first jaw 8010. Other methods of attaching and operably interfacing the surgical device 8002 to the shaft of the surgical instrument may also be used. For example, the stapling device 8002 may be attached to the shaft assembly such that the stapling device (sometimes referred to as an "end effector") cannot articulate relative to the shaft assembly.
[0105] 57 , the surgical stapling assembly 8000 further includes a firing member assembly 5040 including a knife bar 5042 attached to the knife member 5050 or "firing member." The knife bar 5042 also interfaces with corresponding components and a firing system within a surgical instrument or robot to receive a firing motion that can advance the knife bar 5042 and firing member 5050 distally through a staple firing stroke from a start position to an end position and also retract the knife bar 5042 and firing member 5050 proximally, returning the firing member 5050 to the start position. In the illustrated arrangement, the firing member 5050 includes a firing member body 5052 that supports a cutting edge or knife edge 5053. The firing member 5050 further includes feet 5054 formed at the bottom of the firing member body 5052 and extending laterally from each side thereof. The firing member 5050 further includes a pair of upper pins or tabs 5056 extending laterally from the firing member body 5052, which are adapted to engage ledges on the anvil, as discussed further herein. In addition, the firing member 5050 includes a pair of central pins or tabs 5058 projecting laterally from each side of the firing member body 5052. In some of the disclosures incorporated by reference herein, the firing member 5050 may also be referred to as an "E-beam" firing member or cutting member.
[0106] In addition to the above, the surgical stapling device 8002 further includes a second jaw or anvil 8100 that is movable relative to the first jaw or frame 8010. The anvil 8100 includes an anvil body portion 8102 and an anvil mounting portion 8110. The anvil body 8102 includes a staple-forming lower surface or tissue-contacting surface 8104 having a series of staple-forming pockets (not shown) formed therein that are positioned to form corresponding staples when driven into forming contact therewith. The anvil mounting portion 8110 includes a pair of laterally extending anvil or trunnion pins 8112 that are configured to be received in corresponding trunnion holes 8022 in the upstanding side walls 8020 of the first jaw or frame 8010. Unlike the anvil 4100 described above, the anvil 8100 is pivotally pinned to the frame 8010 for pivotal movement relative to the frame 8010 about a fixed pivot axis. Stated another way, unlike anvil 4100, anvil 8100 does not move or translate substantially axially during the anvil closure process.
[0107] As described above, and in several of the disclosures incorporated by reference herein, the anvil 8100 can be movable from an open position, in which a used or spent staple cartridge can be removed from the first jaw or frame 8010 or an unfired staple cartridge can be operably seated therein, to a closed position by an axially movable closure member or end effector closure tube (not shown). For example, as the closure member moves distally from the proximal position, the closure tube can operably engage a cam surface on the anvil mounting portion 8110. Such interaction between the closure member and the anvil mounting portion 8110 causes the anvil mounting portion 8110 and the trunnion pin 8112 to pivot until the closure member moves the anvil 8100 to the fully closed position. When in the fully closed position, staple forming pockets in the anvil 8100 are properly aligned with staples in a corresponding compatible surgical staple cartridge operably seated in the first jaw or frame 8010. Thereafter, when the axially movable closure member is moved proximally, it pivots the anvil 8100 back to the open position.
[0108] In addition to the above, the surgical stapling assembly 8000 further comprises a first lockout 8300 configured to prevent distal movement of the firing member 5050 from its proximal-most start position when an approved or compatible staple cartridge is not operably seated in the first jaw or frame 8010. The first lockout 8300 may also be referred to herein as an “authentication” lockout. In the illustrated arrangement, the first lockout 8300 comprises a single bidirectional first spring 8310 supported on the proximal end 8014 of the frame 8010 and attached to the shaft mount flange 8030. For example, in one arrangement, the first spring 8310 comprises a first lockout arm 8312 located on one side of the cartridge axis CA and a second lockout arm 8314 located on an opposite side of the cartridge axis CA from the first lockout arm 8312. The first lockout arm 8312 and the second lockout arm 8314 are attached to a central body portion 8316. See FIG. 58. The spring 8310 is attached to the first jaw or frame 8010 and is attached to the shaft mount flange 8030 by a pin 8034 extending through a hole 8036 in the shaft mount flange 8030 and holes 8318 in the first lockout arm 8312 and the second lockout arm 8314. The first lockout arm 8312 and the second lockout arm 8314 each further include a lockout window or opening 8320 adapted to receive therein a corresponding central pin 5058 protruding from a first side and a second side of the firing member 5050 when the firing member 5050 is in its proximal-most or start position. See FIGS. 59 and 61.
[0109] 59-61 illustrate the first lockout 8300 in a locked position, with the central pin 5058 received within the lockout windows 8320 in the first lockout arm 8312 and the second lockout arm 8314. In some arrangements, a staple cartridge compatible with the surgical stapling device 8002, or stated another way, a staple cartridge having an appropriate number, size, and arrangement of staples, can have one or more unlocking keys formed directly on the cartridge body and / or cartridge pan, which are configured to disable the first lockout when the compatible cartridge is operably seated in the first jaw or frame. Various cartridge unlocking keys protruding therefrom are disclosed in various disclosures incorporated herein by reference. However, in other instances, a clinician may desire to use a staple cartridge that is otherwise compatible with the surgical stapling assembly, but that otherwise lacks an unlocking key. In such cases, the clinician would not be able to otherwise use these compatible staple cartridges in a surgical stapling device. Surgical stapling assembly 8000 includes a mechanism designed to facilitate the use of such compatible staple cartridges that otherwise lack an unlocking key mechanism.
[0110] 51 and 55 , the stapling assembly 8000 further includes a retainer 4400 configured to be removably coupled to the staple cartridge 4200. Specific details regarding the retainer 4400 are described above and will not be repeated here. As noted above, the retainer 4400 further includes an authentication key 4430 configured to disable the first lockout 4300 when the retainer 4400 is attached to the staple cartridge 4200 and the staple cartridge 4200 is operably seated in the first jaw or frame 8010. As can be seen in FIG. 11 , the authentication key 4430 includes a right ramp mechanism 4440 and a left ramp mechanism 4450 that protrude proximally from a proximal end 4401 of the top 4402 of the retainer 4400 and are separated by a space 4460 sized to receive a firing member body 4052 therebetween. In the illustrated embodiment, the right ramp 4440 is angled downward from the top 4402 of the retainer 4400 and includes a proximal right tip 4442. The proximal right tip 4442 defines a first right camming surface 4444 that is angled inward at its tip and extends distally to a second right camming surface 4446. The second right camming surface 4446 extends from the first right camming surface 4444 to the top 4402. See FIG. 12 . Similarly, the left ramp 4450 is angled downward from the top 4402 of the retainer 4400 and includes a proximal left tip 4452. The proximal left tip 4452 is angled inward at its tip and extends distally to a second left camming surface 4456. The second left camming surface extends from the first left camming surface 4454 to the top 4402.
[0111] 61 and 62 , during use, the retainer 4400 is removably attached to the staple cartridge 4200 to form a cartridge assembly 4500. The cartridge assembly 4500 is then inserted into the first jaw or frame 8010 so that the right tip 4442 of the authentication key contacts the upstanding unlocking tab 8322 on the first lockout arm 8312 and the left tip 4452 contacts the upstanding unlocking tab 8324 on the second lockout arm 8314. During initial proximal insertion of the cartridge assembly 4500, the first right cam surface 4444 biases the first lockout arm 8312 laterally outward (arrow RL in FIG. 62 ) and the first left cam surface 4454 biases the second lockout arm 8314 laterally outward (arrow LL). Further longitudinal advancement of the cartridge assembly 4500 proximally within the first jaw or frame 8010 causes the first lockout arm 8312 to reach a first intermediate position where the first lockout arm 8312 disengages the corresponding central pin 5058 on the firing member 5050, and the second lockout arm 8314 to reach a second intermediate position where the second lockout arm 8314 disengages the corresponding central pin 5058 of the firing member 5050. Continued longitudinal insertion of the cartridge assembly 4500 proximally into the first jaw or frame 8010 causes the second right cam surface 4446 to further bias the first lockout arm 8312 laterally outward and the second left cam surface 4456 to further bias the second lockout arm 8314 laterally outward until the cartridge assembly 4500 is fully operably seated in the first jaw or frame 8010. See FIG. 63 .
[0112] When the cartridge assembly 4500 is operably seated in the first jaw or frame 5010, a distal first retention tab 8326 on the first lockout arm 8312 engages a corresponding side of the staple cartridge 4200 to retain the first lockout arm 8312 in its unlocked position. As can be seen in FIG. 62 , a clearance pocket 8021R is provided in the side wall 8020 to accommodate the first retention tab 8326. Similarly, a distal second retention tab 8328 formed on the second lockout arm 8314 engages another corresponding side of the staple cartridge 4200 to retain the second lockout arm 8314 in its unlocked position. A clearance pocket 8021L is provided in the side wall 8020 to accommodate the second retention tab 8328. When in that position, the first lockout 8300 is in an unlocked position, or otherwise "disabled." The user can then remove the retainer 4400 from the staple cartridge 4200 in the manner described above. With the first lockout 8300 disabled or unlocked, the firing member 5050 can be advanced distally from the start position and is in the "armed state."
[0113] After the staple cartridge 4200 is fired, the firing member 5050 is retracted back to the start position and the second jaw or anvil 8100 pivots back to the open position. The spent staple cartridge can then be removed from the first jaw or frame 8010. Once the spent staple cartridge 4200 is removed from the first jaw or frame 8010, the first lockout arm 8312 and the second lockout arm 8314 spring back to engage corresponding central pins 5058 on the firing member 5050, again holding the firing member 5050 in the start position. Also, in at least one variation, the surgical stapling device 8002 includes a second lockout 5600 configured to prevent the firing member 5050 from advancing distally through the staple firing stroke once the spent staple cartridge is seated in the first jaw or frame 8010. Details regarding the operation of the second lockout are provided above and will not be repeated here.
[0114] In addition to the above, at least one form of the retainer 4400 can be attached to a variety of staple cartridges adapted (compatible) for use with different forms of surgical stapling devices. Stated another way, the retainer 4400 can be used on a staple cartridge that can seat in different stapling devices to override various lockout mechanisms of those stapling devices. The staple cartridge 8200 can likewise be used with different stapling devices having different forms of lockout. For example, FIG. 64 shows a surgical stapling system, generally designated 8600, including a first stapling device 4002 and at least a second stapling device 8002. The retainer 4400 can be coupled to the surgical staple cartridge 4200 to form a cartridge assembly 4500 that is compatible with both of the surgical stapling devices 4002, 8002. When the retainer 4400 is attached to a compatible staple cartridge 4200 to form an assembled cartridge arrangement 4500, the assembled cartridge arrangement can be used in either of the devices 4002, 8002. Similarly, the staple cartridge 4200 can also be used in either of the stapling devices 4002, 8002. The surgical stapling device 4002 uses a translating anvil 4100. The stapling device 8002 uses a pivoting anvil 8100. These devices have very different amounts of space for the authentication key arrangement to operate due to the different amounts of space required for the anvil of each device to move between the open and closed positions. Therefore, in various applications, the authentication ramp mechanism may need to use a rather narrow, gradual, vertically displacing cam surface to activate the lockout configuration of both types of stapling devices.
[0115] In connection with another general aspect, the various authentication keys and authentication lights disclosed herein can be coordinated and aligned with the retainer body configurations disclosed herein, such that a single retainer / authentication key / lamp configuration can be used with staple cartridges that can be used in multiple stapling devices disclosed herein. Such a retainer / authentication key / lamp configuration can be used to override multiple lockout systems within these various stapling devices. Stated another way, a single retainer / authentication key / authentication light configuration can be used to unlock several jaw block lockouts and / or firing member lockouts of the stapling devices disclosed herein.
[0116] As discussed herein, authentication key arrangements may be provided on a removable retainer, cartridge pan, cartridge body, sled, or another auxiliary mounting component. These authentication keys may be tailored to defeat the various first lockout systems of those surgical stapling devices disclosed herein that employ a translating jaw arrangement, as well as those surgical stapling devices that employ a jaw arrangement that pivots about a fixed pivot. The design of such a “universal” authentication key may be limited and determined by the amount of space available within such devices when the movable jaw or anvil is in the closed position (for keys designed to reside in the device throughout the stapling firing motion) as well as in the open position.
[0117] When designing an authentication key configuration that can be used to defeat lockouts in surgical stapling devices that use translating jaws, as well as in surgical stapling devices that use movable jaws that pivot about a fixed axis, the amount of available space available in each surgical stapling device necessarily dictates the particular shape of the "universal" authentication key. In these types of surgical stapling devices, the jaw shapes and paths of travel differ, resulting in different amounts of available space for the authentication key when the jaws open and close.
[0118] 64A-64C show an example of the amount of space available to accommodate the authentication key 4228A of the staple cartridge 4200A when the authentication key feature 4228A is formed in the bottom of the cartridge pan 4220A and the staple cartridge 4200A is seated within a surgical stapling device 4002 having the translating anvil 4100 in, for example, a closed position. As can be seen in these figures, the "closed" space envelope 4800 has vertical legs 4800V and horizontal legs 4800H, where, when used in connection with one surgical stapling device, for example, a is approximately 0.16 inches, b is approximately 0.14 inches, c is approximately 0.047 inches, d is approximately 0.025 inches, e is approximately 0.04 inches, f is approximately 0.035 inches, and g is approximately 0.05 inches. Figures 64D-64G show the "open" space envelope 4802 of staple cartridge 4200A when the jaws of the surgical stapling device are open, where, for example, h is approximately 0.14 inches, i is approximately 0.26 inches, j is approximately 0.17 inches, k is approximately 0.04 inches, L is approximately 0.07 inches, and M is approximately 0.03 inches.
[0119] 64H-64J show an example of the amount of space available to accommodate an authentication key 4228B of another staple cartridge 4200B when the authentication key feature 4228B is formed in the bottom of the cartridge pan 4220B and the staple cartridge 4200B is seated in a surgical stapling device 4002 having a translating anvil 4100 in, for example, a closed position. As can be seen in these figures, the "closed" space envelope 4804 has vertical legs 4804V and horizontal legs 4804H, and when used in connection with a surgical stapling device, for example, n is about 0.16 inches, o is about 0.16 inches, p is about 0.14 inches, q is about 0.025 inches, r is about 0.04 inches, s is about 0.095 inches, and t is about 0.05 inches.
[0120] 64K-64M show examples of the amount of space available to accommodate an authentication key 4228C of a staple cartridge 4200C when the authentication key feature 4228C is formed in the bottom of the cartridge pan 4220C and the staple cartridge 4200C is seated in a surgical stapling device 4002 having a translating anvil 4100 in, for example, a closed position. As can be seen in these figures, the "closed" space envelope 4806 has vertical legs 4806V and horizontal legs 4806H, and when used in connection with one surgical stapling device, for example, u is approximately 0.16 inches, v is approximately 0.15 inches, w is approximately 0.037 inches, x is approximately 0.025 inches, y is approximately 0.04 inches, z is approximately 0.095 inches, and aa is approximately 0.06 inches. Figures 64N-64Q show the "open" space envelope 4808 of the staple cartridge 4200C when the jaws of the surgical stapling device are open, where, for example, bb is approximately 0.26 inches, cc is approximately 0.23 inches, dd is approximately 0.12 inches, ee is approximately 0.12 inches, ff is approximately 0.08 inches, and gg is approximately 0.04 inches.
[0121] 64R-64T show an example of the amount of space available to accommodate an authentication key 4228D of a staple cartridge 4200D when the authentication key feature 4228D is formed in the bottom of the cartridge pan 4220D and the staple cartridge 4200D is seated in a surgical stapling device 8002 having, for example, an anvil 8100 that is movable between open and closed positions about a fixed pivot. As can be seen in these figures, the "closed" space envelope 4810 has vertical legs 4810V and horizontal legs 4810H, where, when used in connection with one surgical stapling device, for example, hh is approximately 0.16 inches, ii is approximately 0.20 inches, jj is approximately 0.047 inches, kk is approximately 0.025 inches, ll is approximately 0.05 inches, mm is approximately 0.025 inches, and nn is approximately 0.09 inches. Figures 64U-64X show the "open" space envelope 4812 of staple cartridge 4200D when the jaws of the surgical stapling device are open, where, for example, oo is approximately 0.09 inches, pp is approximately 0.08 inches, qq is approximately 0.05 inches, rr is approximately 0.06 inches, ss is approximately 0.10 inches, tt is approximately 0.03 inches, and uu is approximately 0.09 inches.
[0122] 64Y-64ZZ show examples of the amount of space available to accommodate an authentication key 4228E of a staple cartridge 4200E, where the authentication key mechanism 4228E is formed in the bottom portion of a cartridge pan 4220E and is seated when the staple cartridge 4200E is seated in a surgical stapling device 8002 having, for example, an anvil 8100 that is movable between open and closed positions about a fixed pivot. As can be seen in these figures, the "closed" space envelope 4814 has vertical legs 4814V and horizontal legs 4814H, where, when used in connection with one surgical stapling device, for example, vv is approximately 0.16 inches, ww is approximately 0.20 inches, xx is approximately 0.047 inches, yy is approximately 0.025 inches, zz is approximately 0.05 inches, aaa is approximately 0.085 inches, and bbb is approximately 0.09 inches.
[0123] 65-71 illustrate another surgical stapling assembly 9000, which is similar in many respects to the surgical stapling assembly 7000 described above. The surgical stapling assembly 9000 comprises a surgical stapling device 9002 that may be used in conjunction with the surgical instrument 1010 described above or in conjunction with various other surgical instruments and robots described in the various disclosures incorporated by reference herein. As can be seen in FIG. 65 , the surgical end effector 9002 includes a first jaw or frame 9010 configured to operably support a surgical staple cartridge 9200 therein. The first jaw or frame 9010 is attached to the spine of a shaft assembly in various manners described herein. In the illustrated embodiment, the first jaw or frame 9010 is attached to the spine of the shaft assembly (not shown in FIG. 65 ) by a shaft mount flange 9030. The surgical stapling device 9002 can also be used in association with a shaft assembly that does not facilitate articulation of the surgical stapling device 9002 .
[0124] 65 , the surgical stapling device 9002 further includes a firing member assembly 4040 that includes a knife bar (not shown) attached to a knife member 4050 or "firing member." The operation of the firing member 4050 and the knife bar has been described in detail above and will not be repeated here. The surgical stapling device 9002 further includes a second jaw or anvil 9100 that is movable relative to the first jaw or frame 9010. The anvil 9100 includes an anvil body portion 9102 and an anvil mounting portion 9110. The anvil body 9102 includes a staple forming lower surface or tissue contacting surface 9104 having a series of staple forming pockets (not shown) formed therein that are positioned to form corresponding staples when driven into forming contact with the corresponding staples. The anvil mounting portion 9110 includes a pair of laterally extending anvil or trunnion pins 9112 configured to be received in corresponding trunnion holes 9022 in the upright sidewall 9020 of the first jaw or frame 9010. Unlike the anvil 6100 described above, the anvil 9100 is pivotally pinned to the frame 9010 for pivotal movement relative to the frame 9010 about a fixed pivot axis. Stated differently, unlike the anvil 6100, the anvil 9100 does not move axially or translate substantially during the anvil closure process.
[0125] As discussed above, and in several disclosures incorporated herein by reference, the anvil 9100 can be movable from an open position, at which a current or spent staple cartridge can be removed from the first jaw or frame 9010 or an unfired staple cartridge can be operably seated therein, to a closed position by an axially movable closure member or end effector closure tube 9600 ( FIG. 69 ). For example, as the closure tube 9600 moves distally from a proximal position, the closure tube 9600 can operably engage with a cam surface 9113 on the anvil mounting portion 9110. Such interaction between the closure tube 9600 and the anvil mounting portion 9110 causes the anvil mounting portion 9110 and the anvil trunnion pin 9112 to pivot until the closure member moves the anvil 9100 to a fully closed position. When in the fully closed position, the staple forming pockets in the anvil 9100 are properly aligned with the staples in a corresponding compatible staple cartridge 9200 that is operably seated in the first jaw or frame 9010. Thereafter, as the axially movable closure tube 9600 is moved proximally, a mechanism on the closure tube 9600 interfaces with the anvil mounting portion 9110 to pivot the anvil 9100 back to the open position.
[0126] Further to the above, the surgical stapling device 9002 includes a first lockout 9300 configured to prevent the second jaw or anvil 9100 from being movable from an open position to a closed position by the closure tube 9600. The first lockout 9300 may also be referred to herein as an “authentication” lockout. In the illustrated arrangement, the first lockout 9300 includes a first lockout arm 9310 pivotally supported within the first jaw or frame 9010 by a lockout pin 9312 attached thereto. See FIG. 66 . In one embodiment, the first lockout arm 9310 is fabricated from stainless steel or the like, and the lockout pin 9312 may be machined into its proximal end. The lockout pin 9312 is pivotally seated within a pivot hole 9013 in the frame 9010 to facilitate pivotal movement of the first lockout arm 9310 between the jaw-locked position and the jaw-closed position. See FIG. 68 . In the illustrated embodiment, the first lockout arm 9310 is configured to blockably engage a locking lug portion 9120 that projects downwardly from the anvil mounting portion 9110 when the first lockout arm 9310 is in the locked or jaw-locked position. See FIG. 69 . When the first lockout arm 9310 is in its locked or engaged position, contact of the locking lug portion 9120 with the first lockout arm 9310 prevents pivotal movement of the anvil 9100. It will be appreciated that the first lockout arm 9310, as well as the locking lug portion 9120, are each sufficiently rigid to resist substantial closing motion applied to the anvil 9100 and prevent closure of the anvil 9100.
[0127] 66, the first lockout spring 9330 is supported by a corresponding side wall 9020 of the first jaw or frame 9010 and applies a lateral biasing force to the first lockout arm 9310, biasing the first lockout arm 9310 in the locking direction LD to a locked or jaw-locked position (FIG. 68) in which the first lockout arm 9310 prevents the anvil 9100 from moving from the open position to the closed position. As can be seen in FIG. 66, the first lockout arm 9310 further includes an upstanding cam actuator tab 9322 formed on a distal end 9320 of the first lockout arm 9310. As can be seen in FIG. 71, the cam actuator tab 9322 includes an upper actuator cam surface 9324. Additionally, a lower actuator cam member 9326 is formed on the distal end 9320 of the first lockout arm 9310.
[0128] In at least one embodiment, the stapling assembly 9000 includes a staple cartridge 9200 that is identical to the staple cartridge 4200 described above, except that an authentication key 9430 is formed on the cartridge pan 9220. See FIG. 72 . The authentication key 9430 is configured to override, unlock, or unlatch the first lockout 9300 when the staple cartridge 9200 is operably seated in the frame 9010. As can be seen in FIG. 72 , the authentication key 9430 protrudes proximally from the proximal end 9221 of the cartridge pan 9220 and includes an upper ramp mechanism 9440 and a lower ramp mechanism 9450 that is vertically displaced from the upper ramp mechanism 9440. The authentication key 9430 is bent at approximately a right angle from a portion 9223 of the cartridge pan 9220 that extends across a portion of the distal end of the cartridge body 9202. The upper ramp mechanism 9440 includes an upper ramp tab 9441 that is bent into the authentication key 9430, and the lower ramp mechanism 9450 includes a lower ramp tab 9451 that is bent into the authentication key 9430. As can be seen in FIG. 72 , both the upper ramp mechanism 9440 and the lower ramp mechanism 9450 are located on the same side of the cartridge axis CA defined by the cartridge body 9202. The upper ramp mechanism 9440 is also formed proximal to the lower ramp mechanism 9450. As described above, the upper ramp mechanism 9440 and the lower ramp mechanism 9450 are bent out of the cartridge pan 9220. Stated another way, the upper ramp mechanism 9440 and the lower ramp mechanism 9450 are integrally formed with the cartridge pan 9220. In the illustrated embodiment, the upper ramp mechanism 9440 includes a first upper cam surface 9442 and a second upper cam surface 9444. The first upper cam surface 9442 is proximal to and angled relative to the second upper cam surface 9444. The lower ramp mechanism 9450 includes a first lower cam surface 9452 and a second lower cam surface 9454. The first lower cam surface 9452 is proximal to and angled relative to the second lower cam surface 9454.
[0129] 73-77 illustrate the interaction between the upper ramp mechanism 9440 and lower ramp mechanism 9450 of the authentication key 9430 and the cam actuator tab 9322 and the upper actuator cam surface 9324 on the lower actuator cam member 9326. FIG. 73 illustrates the position of the authentication key 9430 relative to the cam actuator tab 9322 during initial longitudinal insertion (direction PD) of the staple cartridge 9200 into the frame 9010. As can be seen in FIG. 73 , the first upper cam surface 9442 of the upper ramp mechanism 9440 cams into engagement with the upper actuator cam surface 9324 on the cam actuator tab 9322 and begins to bias the cam actuator tab 9322, as well as the first lockout arm 9310, in a lateral direction. As can be further seen in FIG. 73, a lockout pocket 9021 is provided in an adjacent upright side wall 9020 of the frame 9010 to accommodate the cam actuator tab 9322 when the first lockout arm 9310 moves from the locked or jaw-locked position to the unlocked or jaw-closed position.
[0130] 74 illustrates continued longitudinal insertion of the staple cartridge 9200 proximally into the frame 9010. As can be seen in FIG. 74 , the staple cartridge 9200 is inserted to a point where the first upper cam surface 9442 advances past the upper actuator cam surface 9324, allowing the tip 9325 of the cam actuator tab 9322 to engage a second upper cam surface 9444 on the upper ramp mechanism 9440 of the authentication key 9430. This continued interaction continues to move the cam actuator tab 9322 and first lockout arm 9310 laterally to an intermediate position between the locked or jaw-locked position and the unlocked or jaw-closed position.
[0131] FIG. 75 illustrates the position of the staple cartridge 9200 as it continues to be inserted longitudinally within the frame 9010 in the proximal direction PD. As can be seen in FIG. 75, the tip 9325 of the cam actuator tab 9322 remains engaged with the second upper cam surface 9444 on the upper ramp mechanism 9440, and the lower actuator cam member 9326 now engages the first lower cam surface 9452 on the lower ramp mechanism 9450. This continued interaction continues to move the cam actuator tab 9322, as well as the first lockout arm 9310, laterally.
[0132] FIG. 76 illustrates the position of the actuator tab 9322 after the staple cartridge 9200 is operatively (fully) seated in the frame 9010. As can be seen in FIG. 76 , the lower actuator cam member 9326 remains engaged with the second lower cam surface 9454 on the lower ramp mechanism 9450, causing the cam actuator tab 9322 to move laterally to seat in the lockout pocket 9021 in the upright side wall 9020 of the frame 9010. When the first lockout arm 9310 is in the unlocked or jaw-closed position shown in FIG. 76 , the anvil 9100 can be pivoted from the open position to the closed position without being blocked by the first lockout arm 9310. When the first lockout arm 9310 is in the locked or jaw-locked position, the lower actuator cam member 9326 is located in front of the firing member body 4052, such that a jaw-unlocking procedure cannot be initiated by distally advancing the firing member. The lower actuator cam member 9326 is positioned over the central pin 4058 of the firing member 4050 to provide sufficient clearance therebetween during the unlocking procedure. Figures 77 and 78 show the position of the first lockout arm 6310 relative to a portion of the anvil 9100 after the anvil 9100 has been pivoted to the closed position.
[0133] The surgical stapling device 9002 may further include a second lockout similar to second lockout 4600 for preventing the firing member 4050 from advancing through the firing stroke once a spent staple cartridge is seated in the first jaw of the frame 9010. The second lockout 4600 is described in detail above and will not be repeated here.
[0134] FIG. 78A illustrates an alternative cartridge assembly 9500 that may be used in connection with the surgical stapling device 9002 in the manner described above. In the illustrated embodiment, the cartridge assembly 9500 includes a staple cartridge 9200′ having a retainer 6400″ attached thereto. The retainer 6400″ is similar to the retainer 6400 described above, except for the shape and configuration of the authentication key 6430″ and the lamp 6440″. The retainer 6400″ may, in many aspects, be identical to the retainer 6400 described above.
[0135] 78A , cartridge assembly 9500 includes a staple cartridge 9200′ similar to staple cartridge 4200 described above, except that a second authentication ramp 9450′ is formed on a cartridge pan 9220′ that is attached to the cartridge body 9202′. As shown, when retainer 6400″ is attached to the staple cartridge 9200′, ramp 6440″ includes a “first” ramp that includes a first upper cam surface 6442″ and a second upper cam surface 6444″. First upper cam surface 6442″ is proximal to and angled relative to second upper cam surface 6444″. Second authentication ramp 9450′ located on cartridge pan 9220′ includes a first lower cam surface 9452′ and a second lower cam surface 9454′. The second ramp 9450' is positioned below the first ramp 6440" on the retainer 6400" and positioned distally of the first upper cam surface 6442". When the cartridge assembly 9500 is operably seated in the frame 9010 of the surgical stapling device 9002, the combination of the first ramp 6440" on the retainer 6400" and the second ramp 9450" on the cartridge pan 9220' operate in the same manner as the upper ramp mechanism 9440 and second ramp mechanism 9450 on the cartridge 9200 to sequentially disable, unlock, or unlatch the first lockout arm 9300 in the manner described in detail above. When the first lockout arm 9310 is moved to the unlocked or "jaw closed position," the second ramp 9450' holds the first lockout arm 9310 in that position. The user can then remove the retainer 6400'' from the staple cartridge 9200' and the anvil 9100 can pivot from the open position to the closed position.
[0136] 78B-78C illustrate an alternative staple cartridge 9200″ that is similar to the staple cartridge 9200 described above, except that a first authentication key 9430″ is formed or molded into the cartridge body 9202″. The first authentication key 9430″ includes a first ramp 9440″ having a first upper cam surface 9442″ and a second upper cam surface 9444″ formed thereon. The first upper cam surface 9442″ is proximal to and angled relative to the second upper cam surface 9444″. A second authentication ramp 9450″, which comprises a portion of the cartridge pan 9220″, includes a first lower cam surface 9452″ and a second lower cam surface 9454″. The second authentication ramp 9450'' is located below the first ramp 9440'' and is positioned distally of the first upper cam surface 9442''. When the cartridge assembly 9200'' is operably seated in the frame 9010 of the surgical stapling device 9002, the combination of the first ramp 9440'' and the second ramp 9450 operates in the same manner as the upper ramp mechanism 9440 and the lower ramp mechanism 9450 on the cartridge 9200 to override the first lockout 9300 in the manner described in detail above.
[0137] 79-81 illustrate one form of a retainer 10400 configured to be removably coupled to a staple cartridge 4200, for example, of the type shown in FIG. 6. In various embodiments, the retainer 10400 includes an upper portion 10402 configured to be coextensive with and received on the deck surface 4204 of the staple cartridge 4200 such that, when the retainer 10400 is attached to the cartridge body 4202, the retainer 10400 covers all of the staple pockets 4208 within the cartridge body 4202. The retainer 10400 may be molded from a polymeric material and may include a plurality of lateral retention features projecting downwardly from each side of the retainer 10400. In the illustrated embodiment, two lateral retainer lug assemblies 10410 are associated with a generally central portion of the retainer 10400. Each lateral retention lug assembly 10410 is molded into a corresponding side portion of the retainer 10400 such that a retention arm 10412 extends downwardly below the bottom surface 10403 of the retainer 10400. In the illustrated embodiment, each retention arm 10412 extends from a corresponding side boss portion 10414 that extends above the top surface 10402. Such an arrangement serves to provide sufficient strength to the retainer lug assembly 10410 while allowing each of the retention arms 10412 the ability to flex slightly outward during installation and removal of the retainer 10400 from the staple cartridge 4200. Each retention arm 10412 includes a catch feature 10416 molded into its end that corresponds to a notch 10405 in the bottom surface 10403 of the retainer. The catch mechanism 10416 is configured to latch onto a corresponding portion of a deck ledge portion 4205 formed on the cartridge body 4202 or other portion of the staple cartridge 4200 .
[0138] 79-81 , the retainer 10400 may include additional lateral retention features in the form of lateral retainer arms 10480 and 10484 extending downwardly from each side of the retainer 10400 and distal to the lateral retainer lug assembly 10410. Each lateral retainer arm 10480 includes a catch feature 10482 formed at an end thereof. Each lateral retainer arm 10484 includes a tab including an angled end portion 10486 configured to engage a corresponding side of the staple cartridge 4200. The retainer 10400 further includes an angled nose portion 10420 and a distal latch tab 10422. The distal latch tab 10422 includes an inwardly extending lip 10424 configured to latchably engage the distal nose 4203 of the cartridge body 4202.
[0139] 80 and 81 , the retainer 10400 further includes a proximal keel feature 10470, a central keel feature 10472, and a distal keel feature 10474 that are axially aligned with one another and protrude from the bottom surface 10403 of the retainer body. The proximal keel feature 10470, the central keel feature 10472, and the distal keel feature 10474 are configured to be inserted into longitudinal slots 4206 in the staple cartridge 4200. The proximal keel feature 10470, the central keel feature 10472, and the distal keel feature 10474 ensure that the retainer is properly aligned on the staple cartridge 4200 to facilitate installation and removal of the retainer and further serve to ensure that the retainer authentication key 10430 is properly positioned for engagement with an unlocking mechanism of a stapling device in which the cartridge and retainer assembly is seated. The proximal keel feature 10470, the central keel feature 10472, and the distal keel feature 10474 can be sized relative to and create a friction fit with the longitudinal slot 4206 of the cartridge body 42020. Additionally, the proximal keel feature 10472 can serve to retain the sled within the staple cartridge in an unfired position.
[0140] Also, in at least one arrangement, a series of frangible retainer tabs are molded on the bottom surface of the retainer 10400 between the proximal keel 10470 and the central keel 10472 and between the central keel 10472 and the distal keel 10474. More specifically, with reference to FIG. 80 , four frangible retention tabs are used between the proximal keel 10470 and the central keel 10472, and four frangible retention tabs are used between the central keel 10472 and the distal keel 10474. However, other numbers of frangible retention tabs may be used. In the illustrated embodiment, each series of frangible retention tabs comprises two right retention tabs 10490R and two left retention tabs 10490L. Each right retention tab 10490R and each left retention tab 10490L is attached to the bottom surface 10403 of the retainer 10400 by a corresponding frangible joint 10492 that facilitates selective removal of the retention tabs 10490R, 10490L from the retainer 10400. Each right retention tab 10490R is oriented for insertion into the longitudinal slot 4206 of the staple cartridge 4200 and has a leftward angled bias to frictionally engage the left side wall of the longitudinal slot 4206. Each left retention tab 10490L is oriented for insertion into the longitudinal slot 4206 of the staple cartridge 4200 and has a rightward angled bias to frictionally engage the right side wall of the longitudinal slot 4206. Thus, the right retention tab 10490R and the left retention tab 10490L are angled downward in opposite directions. When the right and left retention tabs 10490R, 10490L are inserted into the longitudinal slot 4206, they frictionally engage opposite side walls of the slot 4206 to further retainingly secure the retainer 10400 to the staple cartridge 4200.
[0141] As used in this context, the term "frangible joint" refers to a joint configured to facilitate removal of the tab from the body of the retainer. Such a joint may include an area of reduced cross-section compared to the cross-section of the remainder of the tab / body portion to which it is attached. In other arrangements, the frangible joint may be fabricated from a material having properties different from those of the retainer body material. Such properties may result in a joint that is easily broken by a user. In all such cases, once the frangible joint is broken and the tab is removed from the retainer body, the tab cannot be reattached to the body for reuse by the user. Such frangible joint / attachment mechanism arrangements are distinguishable from other retainer arrangements that use removable clips or other mechanisms that can be reattached to the retainer to facilitate its reuse.
[0142] The retainer 10400 can be removably coupled to the surgical staple cartridge 4200 by engaging the inwardly extending lip 10424 on the distal latch tab 10422 with the end of the distal nose 4203 and aligning the retainer 10400 so that the underside of the retainer top 10402 faces the cartridge deck surface 4204 and the proximal keel feature 10470, central keel feature 10472, distal keel feature 10474, and frangible retention tabs 10490R, 10490L are aligned with the longitudinal slots 4206 in the staple cartridge 4200. The retainer 10400 can then be pressed toward the staple cartridge 4200, bending the retainer arms 10412, 10480, 10484 laterally outward and snapping into latching engagement with corresponding portions of the staple cartridge body 4202. When the retainer 10400 is pressed downward, the angled frangible retention tabs 10490R, 10490L frictionally engage the side walls of the longitudinal slot 4206. The retention tabs 10490R, 10490L, along with the retainer arms 10412, 10480, 10484, secure the retainer 10400 to the staple cartridge 4200.
[0143] The retainer 10400 can be removed from the staple cartridge 4200 by applying a prying motion to the distal latch tab 10422 and lifting the retainer 10400 upward until the retention tabs 10490R, 10490L and the retainer arms 10412, 10480, 10484 disengage from the cartridge 4200. In the illustrated embodiment, the word "LIFT" is molded or embossed into the nose portion 10420 to provide removal instructions to the user. In various examples, the retainer 10400 may be reused on another staple cartridge after being cleaned and resterilized using conventional cleaning and sterilization methods compatible with the retainer material. Attaching and removing and resterilizing the retainer can tend to degrade the retainer over time to the point that it may become unreliable. At that point, the retainer 10400 can be discarded for a new retainer. Consistent with such a process, the user may remove one or more of the frangible retention tabs 10490R, 10490L after each use until all of the frangible retention tabs 10490R, 10490L have been removed at which point the retainer 10400 should be discarded. See FIG. 81.
[0144] In the illustrated embodiment, the retainer 10400 includes an authentication key 10430 similar in structure and operation to the authentication key 6430. The structure and operation of the authentication key 6430 have been described in detail above and will not be repeated here. However, in alternative configurations, the retainer 10400 may be formed with any one of the various authentication key / authentication lamp arrangements disclosed herein.
[0145] In certain situations, some retainers are designed to be easily installed and removed from a compatible staple cartridge. Many retainers are typically installed by the cartridge manufacturer, who can ensure that the retainer matches a particular staple cartridge that is compatible for use with a particular stapling device. Once the retainer is removed from the staple cartridge and the staple cartridge is used, the retainer and the used staple cartridge can be discarded. However, in some instances, the staple cartridge and retainer can be "reprocessed" for reuse in another stapling procedure and / or another stapling device. It is important that these reprocessors install the appropriate surgical staples and the appropriate number of surgical staples into the reprocessed staple cartridge and match the reprocessed staple cartridge with the particular stapling device to ensure the desired results during use. Furthermore, when using a reprocessed retainer, it is important that the retainer be attached to a staple cartridge that is compatible or matches the particular stapling device. For example, if a reprocessed retainer is inadvertently attached to a staple cartridge that is incompatible with a particular stapling device and the cartridge assembly is seated in the device, defeating various lockouts therein, a user may unintentionally fire the device with an improper cartridge installed. Accordingly, some of the retainers disclosed herein are designed to be used once or a limited number of times to reduce the chance of their reuse with an incompatible or improper staple cartridge.
[0146] 82-85 illustrate one form of a retainer 11400 configured to be removably coupled to a staple cartridge 4200, for example, of the type shown in FIG. 6. In various embodiments, the retainer 11400 includes an upper portion 11402 configured to be coextensive with and received on the deck surface 4204 of the staple cartridge 4200, such that when the retainer 11400 is attached to the cartridge body 4202, the retainer 11400 covers all of the staple pockets 4208 within the cartridge body 4202. The retainer 11400 may be molded from a polymeric material and may include a plurality of lateral retention features projecting downwardly from each side of the retainer 11400. In the illustrated embodiment, three lateral retainer lug assemblies 11410 are associated with a central portion of the retainer 11400. Each lateral retention lug assembly 11410 is molded into a corresponding side portion of the retainer 11400, such that a retention arm 11412 extends downwardly below the bottom surface 11403 of the retainer 11400. In the illustrated embodiment, each retention arm 11412 extends from a corresponding side boss portion 11414. This arrangement serves to provide sufficient strength to the retainer lug assembly 11410 while allowing each of the retention arms 11412 the ability to flex slightly outward during installation and removal of the retainer 11400 from the staple cartridge 4200. Each retention arm 11412 corresponds to a notch in the bottom surface 11403 and has a catch mechanism 11416 molded into its end. The catch mechanism 11416 is configured to latch into a corresponding portion of a ledge 4205 formed on the cartridge body 4202. The cartridge body 4202 may be formed with an angled surface 4011, as shown in FIG. 84, to facilitate latching of the catch mechanism under the ledge 4205. The catch mechanism 11416 may also be configured to engage other portions of the cartridge body 4202.
[0147] 82 , the retainer 11400 further includes a proximal keel feature 11470 and a distal keel feature 11474 that are axially aligned with one another and protrude from the bottom surface 11403 of the retainer body. The proximal keel feature 11470 and the distal keel feature 11474 are configured to be inserted into longitudinal slots 4206 in the staple cartridge 4200. The proximal keel feature 11470 and the distal keel feature 11474 serve to ensure that the retainer 11400 is properly aligned on the staple cartridge 4200 to facilitate installation and removal of the retainer 11400, as well as ensure that the retainer authentication key 11430 is properly positioned for engagement with an unlocking mechanism of a stapling device in which the cartridge assembly is seated. The proximal keel feature 11470 and the distal keel feature 11474 can be sized to establish a friction fit with the cartridge slot 4206. The proximal keel feature 11470 can also be configured to hold the sled within the staple cartridge in an unfired position while the retainer 11400 is coupled to the staple cartridge 4200.
[0148] Also, in at least one arrangement, a series of releasable retention members are molded on the bottom surface between the proximal keel 11470 and the distal keel 11474. In the arrangement shown, two pairs of right and left releasable retention members are positioned between the proximal keel 11470 and the distal keel 11474. Each pair includes a right releasable retention member 11480R and a left releasable retention member 11480L. Each right releasable retention member 11480R is molded with a leftward angular bias (as viewed from the distal end of the retainer), and each left releasable retention member 11480L is molded with a rightward angular bias. See FIG. 83. Each right releasable retaining member 11480R is molded with a right bottom latch mechanism 11481R having a "rightward" angled surface 11482R terminating in a relatively blunt, pointed right end 11483R. A right central lug 11484R is molded to each right bottom latch mechanism 11481R, defining a space 11485R therebetween that is sized to receive a portion of the cartridge pan 4220 therebetween. Similarly, each left releasable retaining member 11480L is molded with a left bottom latch mechanism 11481L having a "leftward" angled surface 11482L that terminates in a relatively blunt, pointed left end 11483L. A left central lug 11484L is molded to each left bottom latch mechanism 11481L, defining a space 11485L therebetween that is sized to receive a portion of the cartridge pan 4220 therebetween.
[0149] As can also be seen in FIG. 82 , the retainer 11400 further includes two pairs of retention tabs oriented between the pair of right and left releasable retention members. Each pair includes a right retention tab 11490R and a left retention tab 11490L. Each right retention tab 11490R is oriented for insertion into a longitudinal slot 4206 of the staple cartridge 4200 and has a leftward angular bias to allow the right retention tab 11490R to frictionally engage a left side wall of the longitudinal slot 4206. Each left retention tab 11490L is oriented for insertion into a longitudinal slot 4206 of the staple cartridge 4200 and has a rightward angular bias to allow the left retention tab 11490L to frictionally engage a right side wall of the longitudinal slot 4206. Thus, the right and left retention tabs 11490R, 11490L are angled downwardly in opposite directions, as are the right and left releasable retention members. When the right and left retention tabs 11490R, 11490L are inserted into the longitudinal slot 4206, they frictionally engage opposite side walls of the cartridge slot 4206 to further retentively secure the retainer 11400 to the staple cartridge 4200.
[0150] 82-84 , the retainer 11400 can be removably coupled to the staple cartridge 4200 by engaging an inwardly extending lip (not shown) associated with the distal latch tab 11422 with the end of the distal nose 4203 and aligning the retainer 11400 so that the underside of the top 11402 faces the cartridge deck surface 4204 and the pointed ends 11483R, 11483L of the right and left releasable retaining members 11480R, 11480L are inserted into the longitudinal slots 4206 of the staple cartridge 4200. An installation force "IF" is then applied to the retainer 11400 to urge the retainer downwardly onto the staple cartridge 4200. The right and left releasable retaining members 11480R, 11480L and the right and left retaining tabs 11490R, 11490L slidably engage opposing walls 4207L, 4207R of the slot 4206 when the retainer 11400 is advanced downwardly onto the cartridge 4200. As shown in FIG. 83 , each of the catch mechanisms 11416 includes an angled surface 11417 configured to contact a ledge 4205 on the cartridge 4200 and pivot the catch mechanism 11416 laterally outward to snap into engagement with the ledge 4205. Continued downward advancement of the retainer 11400 causes the pointed ends 11483R, 11483L of the right and left releasable retaining members 11480R, 11480L, respectively, to enter and snap into engagement with the slots 4221 in the cartridge pan 4220, thereby receiving the cartridge pan 4220 in the spaces 11485R, 11485L. When the retainer 11400 is attached to the staple cartridge 4200, the assembly comprises a “cartridge assembly” 11500.
[0151] 84 and 85 illustrate installation of cartridge assembly 11500 within the first jaw or frame 4010 of the stapling device 4002. As can be seen in FIGS. 83 and 85, when cartridge assembly 11500 is inserted into frame 4010 and pushed downwardly therein (arrow IF), angled surface 11417 on catch mechanism 11416 slidably contacts angled surface 11417 on frame 4010, biasing catch mechanism 11416 laterally outward (arrow L in FIG. 84) to disengage catch mechanism 11416 from ledge 4205 on staple cartridge 4200. Additionally, the angled surfaces 11482R, 11482L on the right and left releasable retaining members 11480R, 11480L, respectively, contact the edges of the channel slot 4209 in the bottom of the frame 4010, causing the right and left releasable retaining members 11480R, 11480L to disengage the cartridge pan 4220. A user can then apply a prying force to the distal latch tabs 11422 on the distal end of the retainer 11400 to pry the retainer 11400 off the cartridge 4200 that is now seated in the channel 4010. The distal latch tabs 11422 extend distally from the angled nose portion 11420 of the retainer 11400. In various arrangements, the right releasable retaining member 11480R and the left releasable retaining member 11480L are shaped with a relatively strong angular bias that makes it difficult to reinstall the retainer 11400 onto another staple cartridge. In the illustrated embodiment, the retainer 11400 includes an authentication key 11430 configured to override the lockout of the surgical stapling device 4002. The retainer 11400 may also be configured for use on other staple cartridges that are compatible with any of the surgical staple cartridges disclosed herein. In such cases, the retainer 11400 would include an authentication key 11430 that is compatible with the lockout of the particular surgical stapling device with which it is to be used.
[0152] In various instances, it is desirable for a user to ensure that the staple cartridge being used in a particular surgical stapling device is authentic or compatible with the surgical stapling device. For example, in many cases, cartridges manufactured by the same manufacturer of the surgical stapling device are generally compatible with those stapling devices. For example, to provide and display to the user the identification of the manufacturer of the staple cartridge 4200, a manufacturer's logo 4260 or supplier identification markings may be provided, for example, on the nose 4203 or other portion of the cartridge 4200. Such supplier identification markings may be applied to each of the components of the surgical stapling device and each of the staple cartridge and retainer components. In the embodiment shown in FIG. 86 , the logo 4260 is embossed on the nose 4203. In the embodiment shown in FIG. 87 , the logo 4260 is notched into a portion of the distal nose 4203. 88 and 89 show alternative logo or supplier indicia markings 4262 provided on a distal portion of the cartridge deck 4204. In the embodiment shown in FIG. 88, the logo 4262 is embossed on the deck 4204. In the embodiment shown in FIG. 89, the logo 4262 is notched into the deck 4204. FIG. 90 shows the nose 4203 of the staple cartridge 4200 without supplier indicia markings thereon. FIG. 91 shows the nose 4203′ of the staple cartridge 4200 that is provided with a unique shape (which may be associated with the manufacturer or a particular type of cartridge) and has a logo / supplier indicia 4264 provided on the cartridge deck 4204. FIG. 92 shows an alternative nose configuration 4203″ for the staple cartridge 4200 that provides a unique shape to provide an indication to the user regarding the supplier of the cartridge.
[0153] In various instances, it may also be desirable to ensure that a retainer used in connection with a staple cartridge is authentic or compatible with that cartridge and surgical stapling device. In the embodiment of FIGS. 91 and 92, the underside of the nose portion of a compatible retainer may be formed with features that mate with or match nose configurations 4203′, 4203″, such that when the retainer is attached to those cartridges, a user is provided with an indication as to whether the retainer is compatible with, or otherwise compatible with, those staple cartridges. Another embodiment is shown in FIG. 93, in which the frame 11010 of the surgical stapling device 11002 has a bottom 11262 of a logo or supplier marking 11260 printed or embossed thereon. A compatible staple cartridge 11200 has a middle portion 11264 of the logo 11260 printed on one side of a deck ledge 11205 of the cartridge 11200. The compatible retainer 11400′ has the top 11266 of the logo 11260 printed or formed thereon. Thus, as shown in FIG. 93 , when assembled together, the marking 11262 on the frame 11010, the marking 11264 on the staple cartridge 11200, and the marking 11266 on the retainer 11400′ cooperate to form the complete logo 11260 “ETHICON” or other name or logo, providing a user with confirmation that all three components are from the same supplier and are compatible with one another. FIG. 94 illustrates the use of a staple cartridge 11200′ and a retainer 11400″, which may be incompatible with one another and with the stapling device 11202. As can be seen in FIG. 94 , the retainer 11400″ and staple cartridge 11200′ form the complete logo 11260 without having any markings thereon. The various markings mentioned above can be molded into the (plastic) component, pad printed, laser etched, chemically marked, or mechanically machined into the component / part. The markings can be recessed into the surface on which they are located, or they can protrude from the surface.Such markings may be used, for example, to increment distances or indicate lengths.
[0154] 95 and 96 show a retainer 12400 that is, in many aspects, identical to the retainer 4400 described above. The retainer 12400 includes an authentication key assembly 12430 removably coupled to a retainer body 12402. The authentication key assembly 12430 includes a key body portion 12432 and a key ramp 12440 projecting proximally from the key body portion 12432. The authentication key assembly 12430 may include any of the authentication key / lamp arrangements disclosed herein. In at least one arrangement, the authentication key assembly 12430 is attached to the retainer body 12402 by a frangible joint 12435 that allows a user to remove the authentication key assembly 12430 from the retainer body 12402 after use. Thus, when the retainer 12400 is used in the various methods disclosed herein, the retainer 12400 is removed from the staple cartridge and the user then removes the authentication key assembly 12430 from the retainer body, thus making the retainer 12400 a "disposable" retainer. In at least one arrangement, a tether 12437 attaches the detached authentication key assembly 12430 to the retainer body 12402 to prevent the detached authentication key assembly 12430 from being lost. See FIG. 87 . Any of the various retainer body configurations disclosed herein may include an authentication key assembly removably coupled thereto by a frangible or otherwise detachable joint, making the retainer a "disposable" retainer. Such retainer arrangements may or may not employ frangible retaining members / tabs / arms configured to attach the retainer to the staple cartridge and then be detached therefrom after use.
[0155] FIG. 97 illustrates another disposable retainer 13400 that, in many aspects, is very similar to the retainer 10400 described above. At one or more locations along a central cross-section of the retainer body 13402, one or more slits 13405 are provided in the bottom surface 13403 of the retainer body 13402. FIG. 98 illustrates a cross-sectional view of a portion of the retainer 13400 (with the retention mechanism omitted) at the location shown in FIG. 97 , illustrating, for example, the slits 13405. The slits 13405 only extend partially upwardly into the retainer body 13402, such that, during installation of the retainer on a staple cartridge to form a cartridge assembly in the manner disclosed herein, the retainer body 13402 maintains a cross-sectional configuration that is sufficiently rigid to ensure that the authentication key 13430 is properly oriented to defeat the lockout of the stapling device in which the cartridge assembly is seated. However, during removal of the retainer 13400 in the various manners disclosed herein, the slits 13405 can sufficiently weaken the retainer body 13402 such that the retainer body 13402 assumes the non-planar configuration shown in FIG. 99 or a similar unusable configuration that prevents reuse of the retainer 13400 on another staple cartridge. Any of the various retainer body configurations disclosed herein can include at least one slit in the manner described above, making the retainer a disposable retainer. Additionally, any of the authentication key arrangements disclosed herein can be used on the retainer 13400.
[0156] 100-104 illustrate another retainer assembly 14400 that may be used in connection with the surgical staple cartridge 4200 or other suitable staple cartridge arrangement. As can be seen in FIG. 101 , the retainer assembly 14400 includes a retainer base 14500 configured to be removably mounted within a retainer cover 14600. The retainer base 14500 includes an inner body 14502 including two side walls 14504 projecting from a retainer nose mechanism 14503 configured to be inserted onto the nose 4203 of the staple cartridge 4200. The side walls 14504 are connected by a proximal bridge 14506 configured to seat on a proximal portion of the cartridge deck 4204. Additionally, an authentication key 14530 extends proximally from the end of the proximal bridge 14506. The authentication key 14530 may comprise any of the authentication key arrangements disclosed herein, depending on the particular surgical stapling device with which it is to be used.
[0157] The retainer cover 14600 includes a cover top 14602 and two cover side walls 14604 having a series of cover attachment features or attachment lugs 14606 formed therein for releasably engaging the side walls 14504 of the retainer base 14500. Distal latch tabs 14608 are formed on the distal end of the retainer cover 14600 to aid in removal of the retainer cover 14600. In use, the retainer cover 14600 can be snapped onto the retainer base 14500 such that the attachment lugs 14606 latch onto the underside of the side walls 14504, as shown in FIG. 100 . When the retainer cover 14600 and the retainer base 14500 are coupled together, the assembly can be referred to as a “retainer assembly” 14700. The retainer assembly 14700 is installed onto the staple cartridge 4200 by inserting the retainer noose mechanism 14503 onto the nose 4203 of the staple cartridge 4200. As can be seen in FIG. 100 , a keel 14610 is formed on the underside of the cover top 14602. The keel 14610 is oriented and sized to be received within the longitudinal slot 4206 of the staple cartridge 4200 when assembled. The keel 14610 can be sized relative to the longitudinal slot 4206 to create frictional engagement therewith. Additionally, the keel 14610 can serve to retain the sled in an unfired position when the retainer assembly 14700 is attached to the staple cartridge 4200.
[0158] When assembled, the retainer cover 14600 completely covers the staple cartridge 4200 to form a cartridge assembly 14702. See FIG. 104 . In some cases, the cartridge body 4202 of the staple cartridge 4200 is molded in a particular color to indicate the type or size of the cartridge. In at least one arrangement, one or more windows 14505 are provided in the retainer base 14500. The windows 14505 are configured to mate with cooperating windows 14612 in the retainer cover 14600 and allow a user to view the staple cartridge body 4202 when the retainer assembly 14700 is attached to the staple cartridge 4200 or other compatible staple cartridge.
[0159] Once the retainer assembly 14700 is inserted into the staple cartridge 4200 to form the cartridge assembly 14702, the cartridge assembly 14702 can then be inserted into a channel of a surgical stapling device such that contact between the side walls of the channel and the attachment lugs 14606 in the cover side walls 14604 causes the cover attachment mechanism or attachment lugs 14606 to disengage from the retainer base 14500. Alternatively, the retainer cover 14600 can be removed from the retainer assembly 14700 prior to installing the cartridge assembly 14702 into the channel of the surgical stapling device by applying a prying motion to the distal latch tabs 14608. In either case, after the retainer cover 14600 is removed, the cartridge assembly 14702, excluding the retainer cover 14600, continues to be inserted into the channel in the various manners described herein until the authentication key mechanism 14530 overrides, unlocks, or unlatches the lockout of the surgical stapling device and the cartridge assembly 14702 is seated within the channel. As can be seen in FIG. 101 , the side walls 14504 of the retainer base 14500 do not extend to the bottom of the staple cartridge 4200, exposing a portion of the staple cartridge side and engaging a portion of the lockout arm of the lockout when the cartridge assembly 14702 is seated within the channel. The user can then pull the retainer base 14500 distally to remove it from the staple cartridge 4200, leaving the staple cartridge 4200 operably seated within the frame and, in either case, holding the lockout in the unlocked or jaw closed position.
[0160] 105-107 illustrate another retainer assembly 15400 that may be used in connection with the surgical staple cartridge 4200 or other staple cartridge configurations. As can be seen in FIG. 106 , the retainer assembly 15400 includes a retainer base 15410 including two bottom sidewalls 15412 projecting from a retainer noose feature 15414. The retainer noose feature 15414 is configured to be inserted onto the nose 4203 of the staple cartridge 4200. The bottom sidewalls 15412 are connected by a proximal bridge 15416 configured to seat on a proximal portion of the staple cartridge deck 4204. Additionally, an authentication key 15530 extends proximally from the end of the proximal bridge 15416. The authentication key 15530 may include any of the authentication key arrangements disclosed herein. The retainer base 15410 is configured to be inserted onto the nose 4203 of the staple cartridge 4200. In at least one arrangement, one or more latch lugs 15413 can be formed on each side wall 15412 to engage a ledge 4205 on the cartridge body 4202.
[0161] The retainer assembly 15400 further includes a retainer cover 15600 that is removably coupled to the retainer base 15410 by a series of frangible attachment joints 15604. In the illustrated arrangement, the retainer cover 15600 includes a distal latch tab 15602 and a window 15606. The window 15606 is configured to allow a user to view the cartridge body 4202 when the retainer assembly 15400 is attached. When the retainer assembly 15400 is attached to the staple cartridge 4200, the retainer assembly 15400 completely covers the staple cartridge 4200 to form the cartridge assembly 15700. The cartridge assembly 15700 may then be inserted into the frame of the surgical stapling device such that contact between the proximal end portion 15608 or other portion of the retainer cover 15600 and a side wall or other portion of the channel causes the frangible attachment joint 15604 to rupture, allowing the retainer cover 15600 to be removed from the retainer base 15410. Alternatively, once the cartridge assembly 15700 is seated within the channel of the surgical stapling device, a user may apply a prying motion to the distal latch tab 15602 to rupture the frangible attachment joint 15604, allowing the retainer cover 15600 to be removed from the retainer base 15410. See FIG. 107 . In either case, after the retainer cover 15600 is removed, the cartridge / retainer base assembly continues to be inserted into the channel in various manners described herein, for example, until the authentication key mechanism 15530 overrides the lockout of the surgical stapling device 4002 (or other surgical stapling device) and the cartridge assembly 15700 is seated in the frame 4010. A user can then pull the retainer base 15410 away from the staple cartridge 4200, in either case, by pulling the retainer base 15410 distally while leaving the staple cartridge 4200 operably seated within the frame 4010, thereby holding the lockout in a locked out or jaw closed position.Such a retainer assembly 15400 may be referred to as a "disposable" retainer.
[0162] FIG. 108 illustrates another cartridge assembly 16500 that includes a retainer 16400 attached to a staple cartridge 4200. As can be seen in FIG. 108 , the retainer 16400 includes a retainer body 16402 configured to extend over and cover the cartridge deck 4204. An authentication key 16530 is formed on a proximal end of the retainer body 16402. The authentication key 16530 can include any of the authentication key arrangements disclosed herein, depending on the particular surgical stapling device to be used. As can be further seen in FIG. 108 , a release member 16406 is formed on a distal end 16404 of the retainer body. The distal end 16404 includes a nose attachment portion 16408 that engages the nose 4203 of the staple cartridge 4200.
[0163] In at least one arrangement, after staples are loaded into the staple cartridge 4200 by the manufacturer, the retainer 16400 is inserted onto the staple cartridge 4200 in the manner shown in FIG. 108 and the lower attachment mechanism 16410 on the nose attachment portion 16408 is temporarily attached to the cartridge nose 4203 to form the cartridge assembly 16500. For example, the lower attachment mechanism 16410 can be "heat staked" or plastic welded to the cartridge nose 4203. In another arrangement, the attachment mechanism 16410 can be temporarily attached to the cartridge nose or cartridge body 4202 by a suitable adhesive that allows for removal of the retainer 16400 as desired. In use, after the cartridge assembly 16500 is seated in the frame 4010 of the surgical stapling device 4002 and the authentication key 16530 has disabled its lockout, the user can grasp the removal member 16406 and pull the retainer 16400 in the longitudinal distal direction DD, thereby deflecting or otherwise breaking the joint between the attachment mechanism 16410 and the nose 4203 and allowing the retainer 16400 to be removed from the staple cartridge 4200.
[0164] In various instances where it may be desirable to prevent any of the various retainers disclosed herein from being reprocessed / reused, the various authentication keys disclosed herein can also be attached to their respective retainer bodies in a joint arrangement that allows the authentication key to be irreparably destroyed, deformed, or repositioned to a position that disables the authentication key from the first activated position or the proper activated position and defeats the lockout within the surgical stapling device without completely removing the authentication key from the remainder of the retainer. For example, FIG. 109 illustrates a retainer 17400 including a retainer body portion 17402 and an authentication key 17430 attached to a proximal end 17401 of the retainer body portion 17402 by a reconfigurable hinge or joint arrangement 17480. The retainer body 17402 can be identical to any of the various retainer body portions disclosed herein and can be removably attachable to the staple cartridge 4200 by any of the various arrangements disclosed herein. The authentication key 17430 may comprise any of the authentication key arrangements disclosed herein, depending on the particular surgical stapling device to be used.
[0165] 110A-110B illustrate a reconfigurable joint or hinge arrangement 17480 that includes a slit 17482 cut into the bottom of the authentication key 17430. The slit 17482 is of sufficient depth to weaken the joint arrangement 17480 to allow the authentication key 17430 to be reconfigured to an unusable position after the retainer 17400 is removed from the staple cartridge 4200 without being completely removed from the retainer body 17402.
[0166] FIG. 111 illustrates another reconfigurable joint arrangement comprising a reconfigurable hinge or joint 17480′ fabricated from a rapidly degrading polymeric material, which allows the authentication key 17430 to be reconfigured after a period of time into an unusable configuration after initial use. In such an arrangement, the retainer body 17402 may be fabricated from a first polymeric material. The reconfigurable joint 17480′ may be fabricated from a second polymeric material, such as a hydrolytically degradable material such as polyglycolic acid, that degrades at the fastener rate from the first polymeric material. In another arrangement, the second material may include a carboxyphenoxy-based polyanhydride, which upon exposure to moisture during package opening and use begins to rapidly degrade, sufficiently weakening the authentication key joint to prevent reuse. Material properties can be “tuned” based on desired initial strength and degradation rate. Furthermore, if a reprocessor or other user of the authentication key intends to reuse it, the geometry and amount of degradable polymer material can be altered to increase the degradability of the authentication key (e.g., increased areas of degradable polymer that allow for breakage but not complete rupture). In an alternative arrangement, the entire retainer can be fabricated from such a second polymer material. Such material compositions can also be used in connection with the various frangible joint arrangements described in connection with the other frangible joint arrangements disclosed herein.
[0167] Fig. 112 illustrates an authentication key 17430' in which a portion 17430A of the key 17430' is fabricated from a highly degradable polymer material. Fig. 113 illustrates a cross section of an authentication key 17430'' fabricated from a degradable polymer material and including hollow truss elements 17431'' that help weaken the authentication key 17430'' during decomposition.
[0168] 114 and 115 illustrate, in schematic form, an alternative retainer 15400 and authentication key arrangement 15430 that can be reconfigured to an unusable state after initial use. As can be seen in FIG. 114 , the retainer body 15402 and authentication key 15430 comprise a composite structure including a soft central ridge 15403 supported on either side by stronger, thicker pieces 15405. The central ridge 15403 is configured with a serpentine path that allows thin webs 15407 of stronger material to connect during manufacturing and provide structural integrity to the retainer 15400. These webs 15407 are of low strength and may hold the retainer 15400 onto the staple cartridge during initial use, but are connected to a mechanism that may rupture during removal of the retainer 15400. In such cases, for example, closure of the stapling device jaws JA, JB may be used to assist in removal of the retainer 15400. See FIG. 116 . The closing jaws may apply sufficient load / force to the retainer 15400 to break or deform it. The retainer 15400 may further include an embedded wire 15409 that serves to attach the authentication key 15430 to the retainer body 15402, such that even if the authentication key 15430 breaks from the retainer body 15402, it remains attached to it by the wire 15409. See FIG. 115.
[0169] In yet other arrangements, any of the retainer arrangements disclosed herein can be temporarily secured to an unfired staple cartridge by a suitable adhesive, for example, that secures the retainer to the cartridge body but breaks, allowing the retainer to be removed from the cartridge body by a user.
[0170] 117-121 , a retainer 18400 is shown. The retainer 18400 is configured to be removably coupled to the staple cartridge 18200 or other staple cartridge and is compatible with certain surgical stapling devices that include various types of lockouts disclosed herein that prevent the stapling device from operating unless overridden, unlocked, or unlatched by an authentication key on the retainer or staple cartridge. In one arrangement, for example, the retainer 18400 can be used with a staple cartridge 18200 that is compatible with the surgical stapling device 6002. The staple cartridge 18200 includes a cartridge body 18204 that includes a longitudinal slot 18206 configured to accommodate a firing member of the surgical stapling device. The staple cartridge 18200 further includes a series of staple pockets 18208 formed within the cartridge body 18202. The staple pockets 18208 may be formed with offset "lines" located on each side of the longitudinal slot 18206. Each staple pocket 18208 may have an associated staple driver (not shown) that supports a surgical staple or fastener (not shown) thereon. In at least one embodiment, the cartridge body 18202 is molded from a polymeric material having the staple pockets 18208 molded or machined therein. In one arrangement, the staple pockets 18208 also open through the bottom of the cartridge body 18202 to facilitate installation of the driver and fastener into their respective staple pockets 18208. Once the driver and fastener are inserted into their respective staple pockets 18208, the cartridge pan 18220 is attached to the cartridge body 18202. In one form, the cartridge pan 18220 is fabricated from a metal material and includes a bottom 18222 that extends across the bottom of the cartridge body 18202. The cartridge pan 18220 also includes two upstanding side walls 18224 corresponding to each side of the cartridge body 18202 .The cartridge pan 18220 can be removably attached to the cartridge body 18202 by hooks 18226 formed on the sidewalls 18224 and configured for hook-engagement with corresponding portions of the cartridge body 18202 .
[0171] The retainer 18400 is coextensive with and includes an upper portion 18403 configured to be received on the deck surface 18204 of the cartridge body 18202. Thus, in at least one configuration, when the retainer 18400 is attached to the cartridge body 18202, the retainer 18400 covers all of the staple pockets 18208 in the cartridge body 4202. In this manner, when the retainer 18400 is attached to the staple cartridge 18200, the retainer 18400 can prevent the surgical staples stored in the staple pockets 18208 from falling out if the staple cartridge 18200 is inverted or turned upside down prior to use. The retainer body 18402 can include any of the retainer body arrangements disclosed herein whereby the retainer 18400 is removably attachable to the staple cartridge 18200. In one arrangement, the retainer 18400 may be molded from a polymeric material and may include a plurality of retainer lugs 18410 configured to latch onto an outwardly extending deck ledge portion 18205 formed on the cartridge body 4202. See FIG. 121 . The retainer 18400 further includes a retainer keel 18470 protruding from a bottom surface of the retainer body portion 18402 and oriented to be received within the longitudinal slot 18206 of the surgical staple cartridge 18200. The retainer keel 18470 may be sized to establish a friction fit with the longitudinal slot 18206. The retainer keel 18470 may also be configured to hold the sled in an unfired position while the retainer 18400 is attached to the cartridge 18200.
[0172] The illustrated embodiment includes an authentication key 18430 movably supported on the retainer body 18402, such that the retainer 18400 is movable between a first, activated position and a retracted position. The authentication key 18430 is L-shaped and has one leg 18440 pivotally pinned to the retainer body 18402 and another leg 18442 that includes a ramp mechanism 18446. The authentication key 18430 is supported within a key housing 18450 that is molded or otherwise attached to the proximal end 18405 of the retainer body 18402. When the authentication key 18430 is in the activated position, the leg 18442 protrudes proximally from the key housing 18450, and when the authentication key 18430 is in the retracted position, the authentication key 18430 is fully contained within the key housing 18450. In another arrangement, when the authentication key 18430 is in the retracted position, at least the legs 18442 are inoperably received within the key housing 18450. As can be seen in FIGS. 117 and 118 , a torsion spring or other biasing member 18452 is mounted within the key housing 18450 to bias the authentication key 18430 toward the retracted position.
[0173] FIG. 119 illustrates the initial installation of the retainer 18400 on the staple cartridge 18200 by the original manufacturer. During installation, the authentication key 18430 is held in an activated position while the retainer is removably attached to the staple cartridge 18200. An activation hole 18448 is provided through the leg 18442 of the activation key 18430 and is adapted to receive a retainer peg 18209 therein, which projects upwardly from the deck surface 18204. When a new, unused retainer 18400 is seated on an unfired cartridge 18200 by the manufacturer, the retainer peg 18209 is received in the hole 18448 in the leg 18442 to hold the authentication key 18430 in the activated position. See FIG. 120 . Once the new retainer 18400 is attached to the unfired staple cartridge 18400, the resulting cartridge assembly 18500 can be seated in the frame 6010 of the surgical stapling device 6002 in various manners disclosed herein, causing the legs 18442 of the authentication key 18430 to override, unlock, and unlatch the lockout of the surgical stapling device 6002. Once the cartridge assembly 18500 is seated in the frame 6010 of the surgical stapling device 6002 and its lockout has been overridden, unlocked, and unlatched, the user can remove the retainer 18400 from the staple cartridge 18200 in various manners disclosed herein. Such an action disengages the legs 18442 from the retention pegs 18209. When the legs 18442 are removed from the retention peg 18209, the torsion spring 18452 springs the authentication key 18430 into the key housing 18450 to a retracted position where the authentication key 18430 cannot be reactivated to an activated position. Thus, the retainer 18400 is a disposable retainer and cannot be reused on another staple cartridge.
[0174] 122-126 illustrate another retainer 19400 configured to be removably coupled to the staple cartridge 4200 or other staple cartridges compatible with certain surgical stapling devices including various types of lockouts disclosed herein. The retainer 19400 includes an upper portion 19403 configured to be coextensive with and received on the deck surface 4204 of the cartridge body 4202. Thus, in at least one configuration, when the retainer 19400 is attached to the cartridge body 4202, the retainer 19400 covers all of the staple pockets within the cartridge body 4202. Thus, when the retainer 19400 is attached to the staple cartridge 4200, the retainer 19400 can prevent the surgical staples stored in the staple pockets from falling out if the staple cartridge 4200 is inverted or turned upside down prior to use. The retainer body 19402 can include any of the retainer body arrangements disclosed herein whereby the retainer 19400 is removably attachable to the staple cartridge 4200. In one arrangement, the retainer 19400 includes a retention tab or retention feature 19480 configured to removably engage the staple cartridge 4200.
[0175] In the illustrated embodiment, the retainer 19400 includes an authentication key 19430 movably supported on the retainer body 19402, such that the retainer 19400 is movable between a first activated position and a retracted position. The authentication key 19430 is supported for axial movement within a key housing 19450 molded or otherwise attached to the proximal end 19405 of the retainer body 19402. The authentication key 19400 slidably extends through a housing wall 19452 and has a flange 19431 formed thereon. A retraction spring 19454 is journaled on the authentication key 19430 between the housing wall 19452 and the flange 19431 to bias the authentication key 19430 distally (direction DD) to the retracted position. When the authentication key 19400 is in the activated position, a proximal end 19440, which may have an operating cam surface 19442 thereon, protrudes from the key housing 19450.
[0176] As can be seen in FIGS. 125 and 126 , the retainer 19400 further includes a plunger actuator 19500 configured to interface with the authentication key 19430. In the illustrated arrangement, the plunger actuator 19500 includes an actuator rod 19502 that extends laterally through the key housing 19450 and is axially movable between an installed position and a removed position. A plunger pad 19504 is attached to a bottom end of the actuator rod 19502 that is configured to engage the deck surface 4204 of the staple cartridge 4200. A plunger button 19506 is attached to a top end of the actuator rod 19502 as shown. The actuator rod 19502 further includes a vertical notch 19508 that corresponds to the distal end 19435 of the authentication key 19430. The vertical notch 19508 intersects with a throughbore 19510 that extends through the actuator rod 19502.
[0177] During use, the retainer 19400 is installed on the staple cartridge 4200 to form a cartridge assembly 19600 that can be seated in various types of surgical stapling devices disclosed herein. As can be seen in FIGS. 123 and 124 , the distal end 19435 of the authentication key 19430 is received in the vertical notch 19508 and the proximal end 19440 protrudes proximally from the key housing 19450. When the authentication key 19430 is in its activated position, the proximal end portion 19440 is positioned to interact with a lockout arm of a lockout of the surgical stapling device in which the cartridge assembly 19600 is seated. Once the cartridge assembly 19600 is seated in the frame of the surgical stapling device and the authentication key 19430 has disabled, unlocked, or unlatched the lockout, the user depresses the plunger actuator 19500 toward the staple cartridge 4200. By depressing the plunger actuator 19500, the plunger actuator removes the retainer 19400 from the staple cartridge 4200 and causes the distal end 19435 of the authentication key to ride up the vertical slot 19508 until it enters the throughbore 19510 in the actuator rod 19502, thereby allowing the authentication key 19430 to move distally to a retracted position. See FIG. 125 . When in the retracted position, the authentication key 14430, and more specifically, the proximal end 19440 of the authentication key 19430, cannot defeat the lockout of the surgical stapling device. In at least one arrangement, the amount of force required to remove the retainer 19400 from the staple cartridge 4200 is great enough to cause permanent deformation of the actuator rod, which may prevent reuse of the retainer 19400.
[0178] 127-129 illustrate another retainer 20400 that is configured to be removably coupled to the staple cartridge 4200 or other staple cartridges that are compatible with certain surgical stapling devices that include various types of lockouts disclosed herein. The retainer 20400 comprises a retainer body 20402 that is coextensive with and includes an upper portion 20403 that is configured to be received on the deck surface 4204 of the cartridge body 4202. Thus, in at least one configuration, when the retainer 20400 is attached to the cartridge body 4202, the retainer 20400 covers all of the staple pockets within the cartridge body 4202. Thus, when the retainer 20400 is attached to the staple cartridge 4200, the retainer 20400 can prevent the surgical staples stored in the staple pockets from falling out if the staple cartridge 4200 is inverted or turned upside down prior to use. The retainer body 20402 is removably attachable to the staple cartridge 4200. In one arrangement, the retainer 20400 includes retention tabs or retention features 20480 configured to removably engage the staple cartridge 4200 in various manners described herein.
[0179] As described above, the surgical staple cartridge 4200 includes a sled or cam member 4230 configured to advance axially through the cartridge body 4202 during a staple firing stroke. In a "new," "unused," or "unfired" surgical staple cartridge, the sled 4230 is in its proximal-most, "unfired" position. The sled 4230 includes a central body portion 4231 that mates with a longitudinal slot 4206 in the cartridge body 4202. The sled 4230 further includes a plurality of wedges or cam members 4232 configured to drivingly engage corresponding lines of staple drivers within the cartridge body 4202. During the staple firing stroke, the firing member of the surgical stapling device abuts the central body portion 4231 of the sled 4230 and pushes the sled 4230 distally into cam contact with the staple driver, thereby continuously driving the staple driver upwardly toward the anvil as the sled 4230 is driven within the cartridge body 4202 from its unfired position to its distal-most fully fired position.
[0180] As can be seen in FIGS. 127-129 , the retainer 20400 includes an authentication key assembly 20430 including a first authentication key portion 20440 and a second authentication key portion 20450 that are axially movable relative to one another. The first authentication key portion 20440 and the second authentication key portion 20450 are slidably supported within a longitudinal pocket 20405 formed in the retainer body 20402. The first authentication key portion 20440 includes a first authentication ramp portion 20444 on its proximal end 20442. Similarly, the second authentication key portion 20450 includes a second authentication ramp portion 20454 formed on its proximal end 20452.
[0181] When the first authentication key portion 20440 and the second authentication key portion 20450 are axially aligned in the activated position, the first authentication ramp portion 20444 and the second authentication ramp portion 20454 cooperate to form an authentication key ramp assembly 20700 configured to disable a lockout of an associated surgical stapling device in various manners described herein. In at least one arrangement, the first authentication key portion 20440 further comprises a first thread engagement mechanism 20446 configured to engage the central body portion 4231 of the sled 4230 when the retainer 20400 is attached to the staple cartridge 4200 and the sled 4230 is in the unfired position. Similarly, the second authentication key portion 20450 further comprises a second thread engagement mechanism 20456 configured to engage the central body portion 4231 of the sled 4230 when the retainer 20400 is attached to the staple cartridge 4200 and the sled 4230 is in the unfired position. In one arrangement, one or more biasing members (not shown) are supported within the retainer body 20402 to bias the first and second authentication key portions 20440, 20450 out of their activated positions unless the first and second thread-engaging features 20446, 20456 engage the central body portion 4231 of an unfired sled 4230 in the staple cartridge 4200 to which the retainer 20400 is attached. Stated another way, the first and second authentication key portions 20440, 20450 are axially misaligned such that the first and second ramp portions 20444, 20454 are not misaligned to form the authentication key ramp assembly 20700. See FIG. 127 . Other arrangements do not use biasing members. 127 and 128, authentication key portion 20440 includes a movement limiter 20448 that is received within a cavity 20409 in the top portion 20403 of retainer 20400. Similarly, authentication key portion 20450 includes a movement limiter 20458 that is also received within cavity 20409. This arrangement serves to restrict authentication key portions 20440, 20450 to a limited amount of axial movement.
[0182] During use, the retainer 20400 is aligned over the unfired staple cartridge 4200 such that the first thread engagement feature 20446 and the second thread engagement feature 20456 are aligned with the longitudinal slots 4206 in the staple cartridge 4200. The retainer 20400 is then pressed onto the staple cartridge 4200 in a manner described herein to form the cartridge assembly 20800. When the retainer 20400 is attached to the staple cartridge 4200, the first thread engagement feature 20446 and the second thread engagement feature 20456 engage the central body portion 4231 of the unfired sled 4230 and move the first authentication key portion 20440 and the second authentication key portion 20450 to the activated position. When the cartridge assembly 20800 is seated within the frame of a surgical staple cartridge with which the retainer 20400 is associated, the authentication key ramp assembly 20700 overrides the lockout of the surgical stapling device in various manners disclosed herein. When the retainer 20400 is removed from the staple cartridge 4200, the first sled engagement mechanism 20446 and the second sled engagement mechanism 20456 disengage the central body portion 4231 of the sled 4230 and the first authentication key portion 20440 and the second authentication key portion 20450 move to a misaligned position.
[0183] 130 and 131 show another retainer 21400 comprising a retainer body 21402 configured to be removably coupled to a staple cartridge 4200 or other staple cartridge compatible with certain surgical stapling devices comprising various types of lockouts disclosed herein. The retainer body 21402 comprises a top portion 21403 that is coextensive with and configured to be received on the deck surface 4204 of the cartridge body 4202 of the staple cartridge 4200. Thus, in at least one configuration, when the retainer 21400 is attached to the cartridge body 4202, the retainer 21400 covers all of the staple pockets within the cartridge body 4202. Thus, when the retainer 21400 is attached to the staple cartridge 4200, the retainer 21400 can prevent the surgical staples stored in the staple pockets from falling out if the staple cartridge 4200 is inverted or turned upside down prior to use. The retainer body 21402 is removably attachable to the staple cartridge 4200 to form a cartridge assembly configured to seat in a frame of a surgical stapling device. In one arrangement, the retainer 21400 includes retention tabs or mechanisms (not shown) configured to removably engage the staple cartridge 4200 in various manners described herein.
[0184] As can be seen in FIGS. 130-131 , the retainer 21400 includes an authentication key assembly 21430 movably supported within the retainer body 21402, such that it is movable between an activated position and a non-activated or retracted position. In the illustrated arrangement, the authentication key assembly 21430 includes a key body 21432 slidably supported within the retainer body 21402. A proximal end 21440 projects proximally from the retainer body 21402. The proximal end 21440 can include a cam surface 21442 configured to interface with an upstanding cam actuator arm or actuation tab on a lockout arm of a lockout of the surgical stapling device in which the cartridge assembly is seated. As can be seen in FIG. 130 , the key body 21432 further includes a series of locking teeth 21434 configured to lockingly interface with engaged teeth 21405 formed within the retainer body 21402. The release mechanism 21436 is formed on the distal end of the key body 21432 as shown.
[0185] Prior to installation on the staple cartridge 4200, the authentication key assembly 21430 is moved axially to an activated position such that the proximal end portion 21440 is positioned to override, unlock, or unlatch the lockout of the surgical stapling device in which the cartridge assembly is seated. This can be done by a manufacturer who installs the retainer assembly 21400 on the staple cartridge. The retainer assembly 21400 is then pressed onto the staple cartridge or otherwise removably attached in various manners disclosed herein. The end user then seats the cartridge assembly into the frame of the surgical stapling device, which causes the proximal end 21440 of the authentication key assembly 21430 to override, unlock, or unlatch the lockout of the surgical stapling device in various manners disclosed herein. A user can then remove the retainer assembly 21400 from the staple cartridge by pulling the release mechanism 21436 and axially pulling the retainer assembly 21400 in a distal direction. In addition to removing the retainer assembly 21400 from the staple cartridge 4200, such an operation retracts the authentication key assembly 21430 to a retracted position in which the authentication key assembly 21430 cannot override the lockout if the retainer 21400 is reattached to another staple cartridge and reseat within the stapling device.
[0186] In at least one arrangement, the release mechanism includes a hole 21438 through which an adjustable wire tie, sometimes referred to as a “zipper tie,” can be inserted and then pulled. Additionally, or in an alternative arrangement, a zipper tie can be threaded between one of the retention tabs and the cartridge body, allowing a pulling force to be applied thereto. Also, in at least one embodiment, the manufacturer of the retainer assembly 21400 initially sets the authentication key assembly 21430 in an activated position. The set of locking teeth 21434 and engaged teeth 21405 are “one-way” teeth that only allow the authentication key assembly 21430 to be retracted distally to the retracted position. The teeth 21434, 21405 do not allow the authentication key assembly 21430 to move proximally from the retracted position to the activated position. The set of teeth can also be referred to as a “one-way latch.” When the authentication key assembly 21430 is in the retracted position, it cannot be used to defeat the lockout of the surgical stapling device. Thus, the retainer assembly 21400 is configured for single use only.
[0187] 132-136 illustrate a staple cartridge retainer system generally designated 22000. In one form, the system 22000 includes a retainer 22400 similar in design to the various other retainers disclosed herein. In one embodiment, the retainer 22400 includes a retainer body 22402 having a top portion 22403 coextensive with and configured to be received on the deck surface 4204 of the staple cartridge 4200 such that, when the retainer 22400 is attached to the cartridge body 4202, the retainer 22400 covers all of the staple pockets 4208 within the cartridge body 4202. The retainer 22400 may be molded from a polymeric material and may include a plurality of lateral retention members projecting downwardly from each side of the retainer 22400. In the illustrated embodiment, two lateral retainer lug assemblies 22410 are associated with a generally central portion of the retainer 22400. Each lateral retention lug assembly 22410 is molded into a corresponding side portion of the retainer 22400 such that the retention member 22412 extends downwardly below the bottom surface 22405 of the retainer 22400. In the illustrated embodiment, each retention member 22412 extends from a corresponding side boss portion 22414. This arrangement serves to provide sufficient strength to the retainer lug assembly 22410 while allowing each of the retention arms 22412 the ability to flex slightly outward during attachment and detachment of the retainer 22400 to and from the staple cartridge 4200. Each retention member 22412 includes a catch mechanism 22416 molded onto an end thereof. The catch mechanisms 22416 each include an angled surface 22417 and are configured to latch onto a corresponding portion of a ledge 4205 formed on the cartridge body 4202 of the staple cartridge 4200.
[0188] The retainer 22400 may include additional lateral retention features in the form of lateral retention members 22480 and 22484 extending downwardly from each side of the retainer 22400 and distal to the lateral retainer lug assembly 22410. Each lateral retention member 22480 includes a latch end 22482 configured to engage a corresponding portion of the staple cartridge 4200. Each lateral retention member 22484 includes an angled end portion 22486 configured to engage a corresponding side of the staple cartridge 4200. The retainer 22400 further includes an angled nose portion 22420 and a distal latch tab 22422.
[0189] As can be seen in FIG. 135 , the retainer 22400 additionally includes a proximal keel feature 22470 and a distal keel feature 22474. Also, in at least one arrangement, a series of central retention tabs are molded on the bottom surface 22405 of the retainer 22400 between the proximal keel 22740 and the distal keel 22474. The central retention tabs include alternating right and left retention tabs 22490R and 22490L. Each right retention tab 22490R is attached to the staple cartridge 4200 and includes a pair of catch mechanisms 22492R configured to extend into and snap into engagement with a slot 4221 in the cartridge pan 4220. See FIG. 134 . Prior to installation, the right retention tabs 22490R are in a “first state” with a leftward angular bias that prevents the right retention tab 22490R from being insertable into the longitudinal slot 4206. Each right retention tab 22490R must be straight in its "second state" to be insertable into the longitudinal slot 4206. Each left retention tab 22490L includes a pair of catch mechanisms 22492L configured to extend through and snap into engagement with a slot 4221 in the cartridge pan 4220. Prior to installation, each left retention tab 22490L is oriented in a first state with a rightward angled bias that prevents the left retention tab 22490L from being inserted into the longitudinal slot 4206 of the staple cartridge 4200. Thus, the right retention tab 22490R and the left retention tab 22490L angle downward in opposite directions when in their respective first states.
[0190] In the illustrated embodiment, the right and left retention tabs 22490R, 22490L are shaped with a significantly stronger angular bias in the first state that prevents their insertion into the longitudinal slot 4206 of the staple cartridge 4200 unless they are sufficiently straightened to the second state during the assembly process. In at least one example, the retainer system 22000 includes a retainer tool 22800 that is configured to be used to straighten the right and left retention tabs 22490R, 22490L (or move the right and left retention tabs 22490R, 22490L from the first state to the second state) during attachment of the retainer 22400 to the staple cartridge 4200. In one form, the retainer tool 22800 includes an elongate body 22802 including a top 22810 and two downwardly depending sidewalls 22820. The sidewalls 22820 are spaced apart from one another to receive the staple cartridge deck 4204 therebetween. See FIG. 134 . The top 22810 includes a raised central portion 22812 having a tool slot 22814. The raised central portion 22812 is coincident with the bottom surface 22405 of the retainer body 22402. The tool slot 22814 includes a wider top portion 22816 sized to receive the ends of the right and left retention tabs 22490R and 22490L therein, and a narrow bottom portion 22818 having a width similar to or slightly less than the width of the longitudinal slot 4206 in the staple cartridge 4200. When the retainer tool 22800 is removably supported on the staple cartridge deck 4204, the tool slot 22814 aligns with the longitudinal slot 4206 of the staple cartridge 4200. In one arrangement, a small ledge feature 22820 is formed on one side of the top 22816 of the slot 22814 to accommodate initial positioning of the right and left retention tabs 22490R, 22490L during the installation process. See FIG. 134 .
[0191] 132 , the retainer 22400 is installed on the staple cartridge 4200 by first placing the retainer tool 22800 on the deck 4204 of the staple cartridge 4200, as shown, so that the tool slot 22814 is aligned with the longitudinal slot 4206 in the staple cartridge 4200. The retainer 22400 is then placed on the retainer tool 22800 so that the bottom surface 22405 is oriented over the raised central portion 22812 and the ends of the right and left retention tabs 22490R and 22490L are received within the wide portion 22816 of the tool slot 22814 (while in their respective first positions). The retainer 22400 is then pressed downwardly onto the tool 22800. As the retainer 22400 is pressed downward, the angled surface 22417 on each retention member 22412 engages a corresponding tool sidewall 22820 and is bent outward, causing the catch mechanism 22416 to pass over the ledge 4205 on the cartridge body 4202. Each of the right and left retention tabs 22490R, 22490L is bent inward to enter the bottom portion 22818 of the tool slot 22814 and ultimately enter the longitudinal slot 4206 of the staple cartridge 4200 (assuming their respective second condition). When the retainer 22400 is in its intermediate installation position, the retainer tool 22800 can be slid longitudinally out from between the retainer 22400 and the staple cartridge 4200 by grasping the proximal end of the retainer tool 22800 and pulling the tool in the proximal longitudinal direction PD. See FIG. 136. The retainer 22400 can then continue to be pressed downwardly to a fully seated position on the cartridge. When in the fully seated position, the catch mechanisms 22492R, 22492L extend into and snap into engagement with slots 4221 in the cartridge pan 4220. Each retaining member 22412 engages a ledge 4205 on the cartridge body 4202, and each of the lateral retainer arms 22480 and 22484 is in retaining engagement with a corresponding portion of the staple cartridge 4200.
[0192] Once the retainer 22400 is attached to the staple cartridge 4200 to form the cartridge assembly 22500, the cartridge assembly 22500 can be inserted into the frame of a surgical stapling device in various manners as disclosed herein. The retainer 22400 further comprises an authentication key 22430 configured to override a lockout within the surgical stapling device in which the cartridge assembly 22500 is seated. When the cartridge assembly 22500 is seated within the frame, the angled surfaces 22417 on the catch mechanisms 22416 of the retention arms 22412, as well as the angled surfaces 22483 on the side walls of each lateral retention member 22482 of the frame, serve to bias the catch mechanisms 22416, 22482 laterally outwardly out of engagement with the ledge 4205 on the cartridge body 4202. Similarly, when the catch mechanisms 22492R, 22492L on the right and left retention tabs 22490R, 22490L contact the corresponding side walls of the slot in the frame of the surgical stapling device, the catch mechanisms 22492R, 22492L are biased out of engagement with the cartridge pan 4220. The retainer 22400 can then be removed by applying a prying motion to the distal latch tabs 22422 and pulling the retainer 22400 upwardly from the staple cartridge 4200. In at least some arrangements, the left and right retention tabs 22490R, 22490L, as well as the retention arms 22412, are sufficiently rigid that it can be very difficult, if not impossible, to install the retainer 22400 onto the staple cartridge 4200 without the use of the retainer tool 22800 unless the retainer 22400 is attached to the cartridge. In such cases, the retainer may actually comprise a disposable retainer.
[0193] 137-139 illustrate another staple cartridge retainer system, designated 22000', generally similar to system 22000, except for retainer tool 22800'. In this arrangement, retainer tool 22800' includes a tool body 22802' having downwardly extending straightening arms corresponding to each of left and right retention tabs 22490R, 22490L. In the illustrated arrangement, retainer 22400 includes three right retention tabs 22490R and two left retention tabs 22490L. Thus, retainer tool 22800' includes three right straightening arms 22810R' and two left straightening arms 22810L'. Each of the straightening arms 22810R', 22810L' corresponds to a hole 22407 in top portion 22403 of retainer 22400. See FIG. 138.
[0194] To install the retainer 22400 onto the staple cartridge 4200, the corrective arms 22810R', 22810L' are inserted into corresponding holes 22407 in the top 22403 of the retainer 22400 and engage the corresponding left and right retention tabs 22490R, 22490L. The corrective arms 22810R' engage the corresponding right retention tabs 22490R and bias them into a relatively straight insertion position that allows them to be inserted into the slots 4206 of the staple cartridge 4200. Similarly, the corrective arms 22810L' engage the corresponding left retention tabs 22490L and bias them into a relatively straight insertion position that allows them to be inserted into the slots 4206 of the staple cartridge 4200. Once the retainer tool 22800' is inserted into the retainer 22400, the retainer can be pressed onto the staple cartridge 4200. The tool 22800' can then be removed from the retainer 22400 by pulling it upwardly from the retainer, thereby allowing the catch mechanisms of the left and right retention tabs 22490L, 22490R to engage the edges of the slot 4221 in the cartridge pan 4220.
[0195] 140 and 141 illustrate a portion of another retainer 23400, which may be the same as or similar to any of the retainers disclosed herein, except for the following differences. In particular, the retainer 23400 includes a retainer body 23402 having an apex portion 23403. A central keel assembly 23470 extends from an underside 23405 of the apex portion and is configured to be received within a longitudinal slot in a cartridge body of a staple cartridge. In the illustrated arrangement, the keel assembly 23470 includes two axially aligned primary keel portions 23472, 23474 and two movable retention flaps 23476, 23478 that are biased out of planar or axial alignment with the primary keel portions 23472, 23474. The primary keel portions 23472, 23474 are axially aligned on a retainer axis RA. The movable retention flaps 23476, 23478 are biased to a first state in which they are on opposite sides of the retainer axis RA. See FIG. 141 . To install the retainer 23400 onto the staple cartridge 4200, the keel assembly 23470 is aligned with a slot in the staple cartridge and the two movable retention flaps 23476, 23478 are biased to a flat surface (second state) when the keel assembly 23470 is pressed into the slot 4206 of the staple cartridge 4200. The retainer 23400 also includes an authentication key assembly 23430, which may include any of the various authentication key arrangements disclosed herein.
[0196] 142-147 illustrate another disposable retainer 24400 that may be used in connection with a staple cartridge 4200 that is compatible for use with the surgical stapling device 6002. The surgical stapling device 6002 is described in detail above. In the illustrated embodiment, the retainer 24400 comprises a retainer body 24402 having a planar top 24410. A nose pocket 24414 is formed on a distal end 24412 of the top 24410. The nose pocket 24414 is configured to hook onto the distal nose 4203 of the staple cartridge 4200. The top portion 24410 is sized relative to the staple cartridge 4200 such that the top portion 24410 is coextensive with and configured to be received on the deck surface 4204 of the staple cartridge 4200, or other suitable staple cartridge, such that when the retainer 24400 is attached to the cartridge body 4202, the retainer 24400 covers all of the staple pockets 4208 in the cartridge body 4202. The retainer 24400 may be molded from a polymeric material and includes lateral retention features 24420 that project downwardly from each side of the retainer top portion 24410. Each lateral retention feature 24420 is configured to retainingly engage a ledge portion 4205 of the staple cartridge body 4202. See FIG. 144 .
[0197] In the illustrated arrangement, the retainer 24400 further includes a retainer removal member 24430 attached to the proximal end 22416 of the top 24410 by a living hinge 24432. An authentication key 24440 is formed on the retainer removal member 24430 and configured to release the lockout 6300 of the surgical stapling device 6002 or other lockouts of other surgical stapling devices disclosed herein. The retainer removal member 24430 further includes at least one ejector post or one-way tab mechanism 24434 protruding from a bottom surface of the retainer actuator 24430. In at least one arrangement, an ejector post or one-way tab mechanism 24434 is formed adjacent each side of the retainer actuator 24430. Each ejector post or one-way tab mechanism 24434 corresponds to a hole 24418 in the retainer top 24410.
[0198] The retainer 22400 can be installed on the staple cartridge 4200 with the retainer removal member 24430 in the first, inactivated position. The retainer 24400 is installed by hooking the nose pocket 24414 onto the nose 4203 of the staple cartridge 4200 and pressing the top portion 24410 downward onto the deck surface 4204 of the staple cartridge 4200 until the lateral retention feature 24420 retainingly engages the ledge 4205 of the cartridge body 4202. The retainer 24400 and the staple cartridge 4200 now form a cartridge assembly 24500. The cartridge assembly 24500 can then be inserted into the frame 6010 of the surgical stapling device 6002, causing the authentication key 24440 of the retainer to engage the actuator cam arm 6322 of the first lockout arm 6310 in the surgical stapling device 6002, disabling the lockout 6300 while the retainer removal member 24430 is in the first, inactivated position. FIG. 145 illustrates the retainer removal member 24430 (solid lines) in the first, inactivated position. As can be seen in FIG. 145, the authentication key 24440 engages the actuator cam arm 6322. FIG. 146 also illustrates the authentication key 24440 engaging the actuator cam arm 6322 during initial insertion of the cartridge assembly 24500 into the frame 6010. FIG. 147 illustrates the cartridge assembly 24500 operably seated within the frame 6010, where the authentication key 24440 pivots the first lockout arm 6310 to the jaw closed position, thereby disabling the lockout 6300 of the stapling device 6002. The user can then press the retainer removal member 24430 toward the retainer top 24410 to a second actuated position where the one-way tab mechanisms 24434 pass through the holes 24418 in the retainer top 24410. As the one-way tab mechanisms 24434 pass through the holes 24418, they engage the deck surface 4204 of the staple cartridge 4200, disengaging the lateral retention mechanism 24420 from the deck ledge portion 4205.When the retainer removal member 24430 is pivoted to the second or activated position, the authentication key 24440 disengages from the actuator cam arm 6322 of the first lockout arm 6310 of the surgical stapling device 6002, while the staple cartridge 4200 retains the lockout 6300 in the disabled or unlocked position. The retainer 24400 can now be removed from the staple cartridge 4200 seated within the frame 6010. In the illustrated arrangement, when the one-way tab mechanisms 24434 are pressed through corresponding holes 24418 in the top portion 24410, they cannot return through the holes 24418, thereby retaining the retainer removal member 24430 in the second or activated position. Because the authentication key 24440 cannot override the lockout of the surgical stapling device when the retainer removal member 24430 is in the second or activated position (shown in dashed lines in FIG. 145 ), and because the retainer removal member 24430 is held in the second or activated position by the one-way tab mechanism 24434, the retainer 24400 cannot be used again on another staple cartridge. To further render the retainer 24400 non-reusable, a user may cut the living hinge 24432 after the first use of the retainer 24400.
[0199] FIG. 148 illustrates another retainer 25400 that can be used with the staple cartridge 4200. The retainer 24500 can be similar to any of the various retainers disclosed herein and includes a cartridge removal mechanism 25600 at its distal end. Stated another way, any of the various retainer arrangements disclosed herein can be additionally formed with a cartridge removal mechanism 25600. In one embodiment, the cartridge removal mechanism 25600 includes a prybar portion 25602 integrally formed on the distal end of the top 25403 of the retainer 25400. The prybar portion 25602 extends distally beyond the angled nose portion 25420 of the retainer to form a nose pocket 25610 therebetween. A downwardly extending prybar arm 25604 is formed on the distal end of the prybar portion 25602.
[0200] The retainer 25400 is attached to the staple cartridge 4200 in various manners disclosed herein to form a cartridge assembly. The cartridge assembly is then seated within the frame of the surgical stapling device, whereby the authentication key 25430 of the retainer 25400 overrides its lockout in any of the various manners disclosed herein. The retainer 25400 is then removed from the staple cartridge 4200, and the stapling device is used to fire the staples in the staple cartridge 4200. Once the staple cartridge has been fired, a user can remove the spent staple cartridge 4200S from the frame 25010 of the stapling device using the cartridge removal mechanism 25600. As can be seen in FIG. 148 , the nose 4203 of the spent staple cartridge 4200S protrudes distally from the frame 25010. A user manipul...
Claims
1. 1. A staple cartridge configured for use with a surgical stapling device comprising a lockout to prevent operation of the surgical stapling device, the staple cartridge comprising: a cartridge body, the cartridge body comprising: a proximal end portion and a distal end portion; a centrally located longitudinal slot extending from the proximal end to the distal end portion, the longitudinal slot defining a cartridge axis; a plurality of longitudinal cam slots, each of said plurality of longitudinal cam slots extending from said proximal end to said distal end portion, said staple cartridge comprising: a sled movably supported within the cartridge body, the sled being movable between an unfired position and a fired position within the cartridge body, the sled including a plurality of cam members, each cam member being slidably received in one of the plurality of longitudinal cam slots; a tapered authentication ramp extending from the proximal end of the cartridge body, the tapered authentication ramp comprising a ramp tip and a ramp face extending from a location corresponding to one of the plurality of longitudinal cam slots along a ramp axis that forms an acute angle with the cartridge axis to the ramp tip, the ramp face comprising a first cam surface configured to contact the lockout of the surgical stapling device away from the cartridge axis when the staple cartridge is initially seated within the surgical stapling device; A staple cartridge, wherein the tapered authentication ramp prevents the sled from falling off a rear of the cartridge body, and the ramp surface is disposed along the ramp axis.
2. A staple cartridge configured for use with a surgical stapling device comprising a lockout for preventing operation of the surgical stapling device, the staple cartridge comprising: a cartridge body, the cartridge body comprising: a proximal end portion and a distal end portion; a centrally located longitudinal slot extending from the proximal end to the distal end portion, the longitudinal slot defining a cartridge axis; a plurality of longitudinal cam slots, each of said plurality of longitudinal cam slots extending from said proximal end to said distal end portion, said staple cartridge comprising: a sled movably supported within the cartridge body, the sled being movable between an unfired position and a fired position within the cartridge body, the sled including a plurality of cam members, each cam member being slidably received in one of the plurality of longitudinal cam slots; a tapered authentication ramp extending from the proximal end of the cartridge body, the tapered authentication ramp comprising a ramp tip and a ramp face extending from a location corresponding to one of the plurality of longitudinal cam slots along a ramp axis that forms an acute angle with the cartridge axis to the ramp tip, the ramp face comprising a first cam surface configured to contact the lockout of the surgical stapling device away from the cartridge axis when the staple cartridge is initially seated within the surgical stapling device; the cartridge body includes a cartridge width, the tapered authentication ramp extends a ramp distance from the proximal end of the cartridge body, the ramp distance being greater than 30 percent of the cartridge width and less than 50 percent of the cartridge width; A staple cartridge, wherein the tapered authentication ramp has a portion that extends parallel to a boundary of one slot and an angled portion that prevents further proximal movement of the thread so that the thread does not fall.
3. 3. The staple cartridge of claim 1 or 2, wherein the ramp surface includes a second cam surface configured to move the lockout of the surgical stapling device into an unlocked position upon contact therewith when the staple cartridge is fully seated within the surgical stapling device.
4. 2. The staple cartridge of claim 1, wherein the cartridge body includes a cartridge width, the tapered authentication ramp extends a ramp distance from the proximal end of the cartridge body, the ramp distance being greater than 30 percent of the cartridge width and less than 50 percent of the cartridge width.
5. The staple cartridge of claim 1 or 2, wherein the thread is located within the cartridge body through a thread opening at a bottom of the cartridge body.
6. The staple cartridge of claim 5 , further comprising a cartridge pan attached to said cartridge body, said cartridge pan spanning a portion of said thread opening.
7. The staple cartridge of claim 1 or 2, wherein each cam slot extends from a corresponding cam slot opening in the proximal end of the cartridge body.
8. The staple cartridge of claim 7, wherein said proximal end of said cartridge body defines a cartridge plane, and wherein each said cam member extends from said cartridge plane when said sled is positioned in said unfired position.
9. The staple cartridge of claim 1 or 2, wherein said cartridge body defines a deck surface, and said tapered authentication ramp has an upper portion that is flush with said deck surface.
10. The staple cartridge of claim 9, wherein said tapered authentication ramp is cantilevered from said proximal end of said cartridge body.
Citation Information
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