Surgical staple fastening assembly with non-planar staples and planar staples
The surgical stapling instruments with non-planar and planar staples and improved articulation systems address the challenges of stapling and cutting tissue in various configurations, enhancing surgical precision and efficiency.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- CILAG GMBH INTERNATIONAL
- Filing Date
- 2022-03-21
- Publication Date
- 2026-06-02
AI Technical Summary
Existing surgical stapling and cutting instruments face challenges in efficiently and effectively stapling and cutting tissue, particularly in articulating configurations, due to limitations in articulation joints and end effector designs.
The development of surgical stapling instruments with non-planar and planar staples, along with improved articulation systems and end effector mechanisms, enhances the ability to staple and cut tissue efficiently in various configurations, including articulated positions.
The solution provides enhanced tissue stapling and cutting capabilities, ensuring consistent performance across different instrument orientations, thereby improving surgical precision and efficiency.
Smart Images

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Abstract
Description
Background Art
[0001] The present invention relates to surgical instruments and, in various devices, to surgical stapling and cutting instruments, end effectors, and staple cartridges for use therewith, which are designed to staple and cut tissue.
Brief Description of the Drawings
[0002] The various features of the embodiments described herein, together with their advantages, can be understood by carrying out the following invention in conjunction with the following accompanying drawings. [Figure 1] A perspective view of a surgical stapling instrument comprising a handle, a shaft assembly, and an end effector, according to at least one aspect of the present disclosure. [Figure 2] A perspective view of a portion of the end effector and shaft assembly of the surgical stapling instrument of FIG. 1, according to at least one aspect of the present disclosure, wherein the end effector is shown in a straight configuration, i.e., a non-articulated configuration. [Figure 3] A perspective view of a portion of the end effector and shaft assembly of the surgical stapling instrument of FIG. 1, according to at least one aspect of the present disclosure, wherein the end effector is shown in an articulated configuration. [Figure 4] An exploded perspective view of a portion of the end effector and shaft assembly of the surgical stapling instrument of FIG. 1, according to at least one aspect of the present disclosure. [Figure 5] A cross-sectional elevation view of a portion of the end effector and shaft assembly of the surgical stapling instrument of FIG. 1, according to at least one aspect of the present disclosure, wherein the end effector is shown in an un-fired clamp configuration. [Figure 6] A plan view of a portion of the end effector and shaft assembly of the surgical stapling instrument of FIG. 1, according to at least one aspect of the present disclosure. [Figure 7]A section elevation view of a portion of the end effector and shaft assembly of Figure 1 along the cutting line 6-6 of Figure 6, according to at least one aspect of the present disclosure, the end effector is shown in an open configuration. [Figure 8] A section elevation view of a portion of the end effector and shaft assembly of Figure 1 along the cutting line 7-7 of Figure 6, according to at least one aspect of the present disclosure, where the end effector is shown in a clamp configuration. [Figure 9] Figure 1 is a perspective view of a surgical staple fastening assembly comprising the shaft assembly and end effector shown in Figure 1, according to at least one aspect of the present disclosure, wherein the end effector is attached to the shaft assembly by an articulated joint. [Figure 10] Figure 9 is an exploded perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 11] Figure 9 is a cross-sectional elevation view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, with the end effector shown in an unfired clamp configuration. [Figure 12] Figure 1 is a perspective view of a surgical staple fastening assembly comprising the shaft assembly and end effector shown in Figure 1, according to at least one aspect of the present disclosure, wherein the end effector is attached to the shaft assembly by an articulated joint. [Figure 13] Figure 12 is an exploded perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 14] Figure 12 is a cross-sectional elevation view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, in which the end effector is shown in an unfired clamp configuration. [Figure 15] Figure 1 is a perspective view of a surgical staple fastening assembly comprising the shaft assembly and end effector shown in Figure 1, according to at least one aspect of the present disclosure, wherein the end effector is attached to the shaft assembly by an articulated joint. [Figure 16]Figure 15 is an exploded perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 17] Figure 15 is a cross-sectional elevation view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, in which the end effector is shown in an unfired clamp configuration. [Figure 18] Figure 1 is a perspective view of a surgical end-effector assembly comprising the end-effector and flexible firing drive system according to at least one aspect of the present disclosure. [Figure 19] Figure 18 is an exploded perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 20] Figure 18 is a cross-sectional elevation view of a surgical end effector assembly according to at least one aspect of the present disclosure, the surgical end effector assembly is shown in an unfired clamp configuration. [Figure 21] This is a perspective view of a robot controller according to at least one aspect of the present disclosure. [Figure 22] A perspective view of a robotic arm cart for a robotic surgical system according to at least one aspect of the present disclosure, showing a manipulator on the robotic arm cart that operably supports a surgical tool. [Figure 23] Figure 22 is a side view of the manipulator and surgical gripping tool of the surgical arm cart according to at least one aspect of the present disclosure. [Figure 24] This is a perspective view of an end effector assembly comprising an anvil, a channel, and a staple cartridge according to at least one aspect of the present disclosure. [Figure 25] Figure 24 is a cross-sectional perspective view of an end effector assembly according to at least one aspect of the present disclosure. [Figure 26]Figure 24 is a partial cross-sectional perspective view of an end effector assembly according to at least one aspect of the present disclosure, the end effector assembly comprising a firing drive unit configured to position staples from a staple cartridge, and a closing drive unit configured to open and close an anvil relative to a channel. [Figure 27] Figure 24 is a cross-sectional elevation view of an end effector assembly according to at least one aspect of the present disclosure. [Figure 28] Figure 24 is a partial cross-sectional perspective view of an end effector assembly according to at least one aspect of the present disclosure, the end effector assembly comprising a launch assembly having an upper launch member and a lower launch member, the upper launch member being shown disengaged from the lower launch member. [Figure 29] Figure 24 shows an exploded perspective view of the staple cartridge and support beam of the end effector assembly according to at least one aspect of the present disclosure. [Figure 30] Figure 24 is a cross-sectional perspective view of the staple cartridge and support beam according to at least one aspect of the present disclosure. [Figure 31] Figure 24 is a cross-sectional perspective view of an end effector assembly according to at least one aspect of the present disclosure. [Figure 32] Figure 24 is a cross-sectional perspective view of the proximal end of the end effector assembly according to at least one aspect of the present disclosure, with various components not shown for clarity. [Figure 33] Figure 24 is a cross-sectional perspective view of the distal end of an end effector assembly according to at least one aspect of the present disclosure. [Figure 34] This is a perspective view of a support beam used with a stapled assembly according to at least one aspect of the present disclosure. [Figure 35] Figure 34 is a cross-sectional elevation view of a support beam and a thread pinned to the support beam, according to at least one aspect of the present disclosure. [Figure 36]Exploded perspective view of a portion of a stapling assembly including a support beam, a firing member assembly, and a thread, according to at least one aspect of the present disclosure. [Figure 37] Exploded perspective view of a portion of the stapling assembly of FIG. 33, according to at least one aspect of the present disclosure, where the distal end of the support beam is shown in hidden lines to illustrate the outer profile of the longitudinal channel of the support beam. [Figure 38] Elevation view of a support beam used with a stapling assembly, according to at least one aspect of the present disclosure. [Figure 39] Elevation view of a support beam used with a stapling assembly, according to at least one aspect of the present disclosure. [Figure 40] Cross-sectional elevation view of a stapling assembly including a staple cartridge, a thread, a cartridge support, and an I-beam, according to at least one aspect of the present disclosure. [Figure 41] Elevation view of the cartridge support of FIG. 40, according to at least one aspect of the present disclosure. [Figure 42] Elevation view of a cartridge support used with a surgical stapling assembly, according to at least one aspect of the present disclosure. [Figure 43] Cross-sectional elevation view of a portion of a stapling assembly including a thread and a cartridge support, according to at least one aspect of the present disclosure. [Figure 44] Elevation view of a guide slot of a staple cartridge or a thread configured to fit within a cartridge support of a stapling assembly, according to at least one aspect of the present disclosure. [Figure 45] Cross-sectional perspective view of a portion of a cartridge support configured to receive a thread internally, according to at least one aspect of the present disclosure. [Figure 46] Schematic view of a portion of a stapling assembly including an anvil, a firing member, a cartridge joe, and a thread pinned to the firing member, according to at least one aspect of the present disclosure. [Figure 47] This is a cross-sectional view of a staple fastening assembly comprising a cartridge channel and an anvil according to at least one aspect of the present disclosure. [Figure 48] This is a perspective view of a launch member assembly comprising a main body portion and a drive nut according to at least one aspect of the present disclosure. [Figure 49] Figure 48 is an exploded perspective view of the launch member assembly according to at least one aspect of the present disclosure. [Figure 50] This is a perspective view of a launch member assembly comprising the main body portion and drive nut of the launch member assembly shown in Figure 48, according to at least one aspect of the present disclosure. [Figure 51] Figure 50 is an exploded perspective view of the launch member assembly according to at least one aspect of the present disclosure. [Figure 52] Figure 50 is a perspective view of the launch member assembly according to at least one aspect of the present disclosure, in which the drive nut is welded to the main body portion. [Figure 53] This is a partially exploded cross-sectional perspective view of a staple fastening assembly comprising a channel jaw, a drive screw, and a launching member assembly according to at least one aspect of the present disclosure. [Figure 54] This is an elevation view of the launch member assembly of Figure 53 according to at least one aspect of the present disclosure. [Figure 55] This is an exploded elevation view of the launch member assembly of Figure 53 according to at least one aspect of the present disclosure. [Figure 56] This is a partial cross-sectional elevation view of the launch member assembly of Figure 53, according to at least one aspect of the present disclosure. [Figure 57] This is a perspective view of a launch member assembly comprising a main body portion and a drive nut according to at least one aspect of the present disclosure. [Figure 58] Figure 57 is an elevation view of the launch member assembly according to at least one aspect of the present disclosure. [Figure 59] This is a perspective view of the main body portion of the launch member assembly shown in Figure 57, according to at least one aspect of the present disclosure. [Figure 60]This is a cross-sectional elevation view of the launch member assembly of Figure 57 according to at least one aspect of the present disclosure. [Figure 61] This is another cross-sectional elevation view of the launch member assembly of Figure 57, obtained from the distal opening of the main body portion, according to at least one aspect of the present disclosure. [Figure 62] This is a perspective view of a launching member assembly comprising a main body portion, and a drive nut assembly comprising an internal drive nut and an external drive unit, according to at least one aspect of the present disclosure. [Figure 63] Figure 62 is a perspective view of the launch member assembly according to at least one aspect of the present disclosure, in which a portion of the external drive portion of the drive nut has been cut away for illustrative purposes to expose the internal drive nut. [Figure 64] This is a perspective view of the main body portion and internal drive nut of the launch member assembly shown in Figure 62, according to at least one aspect of the present disclosure. [Figure 65] This is an elevation view of the main body portion and internal drive nut of the launch member assembly shown in Figure 62, according to at least one aspect of the present disclosure. [Figure 66] This is a perspective view of the launch member assembly of Figure 62 according to at least one aspect of the present disclosure. [Figure 67] An elevation view of a launch member assembly comprising a main body portion and a drive nut according to at least one aspect of the present disclosure, wherein the main body portion comprises a proximal tail extension portion. [Figure 68] A perspective view of a firing member assembly screw-coupled to a firing drive screw according to at least one aspect of the present disclosure, the firing member assembly comprising a main body portion and a drive nut. [Figure 69] Figure 68 is a partial cross-sectional elevation view of the launch member assembly according to at least one aspect of the present disclosure, where the drive nut is in cross-section through a vertical plane. [Figure 70] This is a perspective view of the drive nut of the launch member assembly shown in Figure 68, according to at least one aspect of the present disclosure. [Figure 71] Figure 68 is a perspective cross-sectional view of the launch member assembly according to at least one aspect of the present disclosure. [Figure 72] This is an elevation view of the launch member assembly of Figure 68 according to at least one aspect of the present disclosure. [Figure 73] This is an elevation view of a launch member assembly comprising a main body portion and a drive nut, according to at least one aspect of the present disclosure. [Figure 74] This is a cross-sectional perspective view of an end effector assembly comprising a cartridge channel, a staple cartridge, an anvil, and a firing assembly, according to at least one aspect of the present disclosure. [Figure 75] Figure 74 is a cross-sectional elevation view of the end effector assembly as seen from the proximal end of the end effector assembly, according to at least one aspect of the present disclosure. [Figure 76] Figure 74 is a partial cross-sectional perspective view of an end effector assembly according to at least one aspect of the present disclosure, the launch member assembly comprising a launch drive screw and a launch member assembly. [Figure 77] Figure 74 is a partial cross-sectional perspective view of the channel and launch assembly according to at least one aspect of the present disclosure, where certain hidden features are indicated by dashed lines for illustrative purposes. [Figure 78] This is a partial cross-sectional elevation view of the end effector assembly of Figure 74, according to at least one aspect of the present disclosure. [Figure 79] This is a cross-sectional elevation view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, comprising a channel, a staple cartridge, an anvil, and a drive screw, a launching member assembly, and a launching assembly comprising a thread. [Figure 80] Figure 79 is an elevation view of the launch member assembly according to at least one aspect of the present disclosure. [Figure 81] A cross-sectional elevation view of a jaw assembly for use with a surgical staple fastening assembly according to at least one aspect of the present disclosure, the jaw assembly comprising a channel and a firing drive screw. [Figure 82]Figure 82 is a perspective view of a surgical staple fastening assembly comprising a staple cartridge, a cartridge channel, and a firing drive assembly, according to at least one aspect of the present disclosure, with the staple cartridge obscured. [Figure 83] Figure 82 is a partial cross-sectional perspective view of a surgical staple assembly according to at least one aspect of the present disclosure. [Figure 84] Figure 82 is an elevation view of a portion of the cartridge channel and firing member assembly according to at least one aspect of the present disclosure, with the distal support head and a pair of bushings obscured in Figure 84. [Figure 85] A perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, comprising a cartridge channel and a launching member assembly supported by a support flange of the cartridge channel. [Figure 86] This is an elevation view of a portion of a surgical staple fastening assembly comprising a firing drive screw and a channel support, according to at least one aspect of the present disclosure, wherein the proximal end of the firing drive screw is pivotably mounted to a cartridge support. [Figure 87] Figure 86 is an elevation view of a portion of a surgical staple fastening assembly according to at least one aspect of the present disclosure, in which the firing drive screw is shown in a loading configuration. [Figure 88] This is an elevation view of a launch member assembly comprising a main body portion and a drive nut floating within the main body portion, according to at least one aspect of the present disclosure. [Figure 89] Figure 88 is an elevation view of a pre-assembled launch member assembly according to at least one aspect of the present disclosure. [Figure 90] Figure 88 is an elevation view of the mid-assembly of the launch member assembly according to at least one aspect of the present disclosure. [Figure 91] This is an elevation view of the partially assembled launch member assembly of Figure 88, according to at least one aspect of the present disclosure. [Figure 92]This is an elevation view of a flexible firing drive screw comprising a flexible core member and an outer helical member, according to at least one aspect of the present disclosure. [Figure 93] This is a schematic cross-sectional view of the flexible firing drive screw of Figure 92 according to at least one aspect of the present disclosure. [Figure 94] This is a schematic diagram of a launch assembly comprising a flexible launch drive screw according to at least one aspect of the present disclosure. [Figure 95] This is an elevation view of a portion of a firing drive screw used with a surgical staple fastening assembly, according to at least one aspect of the present disclosure. [Figure 96] An elevation view of a portion of a firing drive screw for use with a surgical staple fastening assembly, according to at least one aspect of the present disclosure, the firing drive screw comprising an overmolded portion of the threads. [Figure 97] Figure 96 is an elevation view of a portion of the firing drive screw according to at least one aspect of the present disclosure, with the overmolded portion of the screw threads removed for clarity. [Figure 98] This is a perspective view of a shaft coupling used with a drive system for a surgical staple fastening assembly, according to at least one aspect of the present disclosure. [Figure 99] This is a perspective view of a shaft coupling used with a drive system for a surgical staple fastening assembly, according to at least one aspect of the present disclosure. [Figure 100] This is a perspective view of a shaft coupling used with a drive system for a surgical staple fastening assembly, according to at least one aspect of the present disclosure. [Figure 101] This is a perspective view of a closing drive assembly comprising a closing drive screw and a closing wedge configured to open and close the jaws of an end effector assembly, according to at least one aspect of the present disclosure. [Figure 102] Figure 101 is an elevation view of the closing drive assembly and anvil according to at least one aspect of the present disclosure. [Figure 103]This is a cross-sectional elevation view of the closing drive assembly of Figure 101 according to at least one aspect of the present disclosure. [Figure 104] This is a cross-sectional elevation view of a closing drive unit comprising a drive screw and a restraint collar according to at least one aspect of the present disclosure, wherein the restraint collar is not mounted on the drive screw. [Figure 105] Figure 104 is a cross-sectional elevation view of the closing drive unit according to at least one aspect of the present disclosure, in which the restraint collar is mounted on the drive screw. [Figure 106] Figure 106 is a cross-sectional elevation view of a drive assembly mounted on a channel flange using a locking member according to at least one aspect of the present disclosure, and shows a pre-assembled drive assembly. [Figure 107] Figure 106 is a cross-sectional elevation view of the drive assembly and channel flange according to at least one aspect of the present disclosure, and Figure 107 shows the drive assembly in an assembled configuration. [Figure 108] A perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, comprising a channel jaw, a closing drive, a firing drive, and a support component positioned within the channel jaw, a portion of which is obscured for illustrative purposes. [Figure 109] Figure 108 is a perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, with various components obscured for clarity. [Figure 110] Figure 108 is a perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure, with various components obscured for clarity. [Figure 111] This is a perspective view of a closing drive assembly comprising a closing drive unit and a support element according to at least one aspect of the present disclosure. [Figure 112] A perspective view of the drive screw shaft of the closing drive assembly shown in Figure 111, according to at least one aspect of the present disclosure. [Figure 113] A perspective view of the retaining clip of the closing drive assembly shown in Figure 111, according to at least one aspect of the present disclosure. [Figure 114] This is a perspective view of a closing drive unit comprising a drive screw shaft and a closing drive nut according to at least one aspect of the present disclosure. [Figure 115] This is a perspective view of the drive screw shaft of Figure 114 according to at least one aspect of the present disclosure. [Figure 116] Figure 114 is a cross-sectional elevation view of the closing drive unit according to at least one aspect of the present disclosure, in which the distal end of the drive screw shaft is shown in a pre-formed configuration. [Figure 117] Figure 114 is a cross-sectional elevation view of the closing drive unit according to at least one aspect of the present disclosure, where the distal end of the drive screw shaft is shown as a formed configuration. [Figure 118] This is a perspective view of a launch drive assembly according to at least one aspect of the present disclosure, comprising a rotating launch shaft, a launch member screw-coupled to the rotating launch shaft, and a bailout section configured to release the screw-out between the rotating launch shaft and the launch member. [Figure 119] This is a perspective view of the launching member of Figure 118 according to at least one aspect of the present disclosure. [Figure 120] Figure 118 is a cross-sectional elevation view of the launch drive assembly according to at least one aspect of the present disclosure, with the bailout section shown in a non-operational configuration. [Figure 121] Figure 118 is a cross-sectional elevation view of the launch drive assembly obtained from a housing component of the bailout section according to at least one aspect of the present disclosure, where the bailout section is shown in a non-operational configuration. [Figure 122] Figure 118 is a cross-sectional elevation view of the launch drive assembly according to at least one aspect of the present disclosure, where the bailout section is shown in the operating configuration. [Figure 123] Figure 118 is a cross-sectional elevation view of the launch drive assembly obtained from the housing component of the bailout section according to at least one aspect of the present disclosure, where the bailout section is shown in an operational configuration. [Figure 124] This is a perspective view of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 125]Figure 124 is a plan view of the anvil surface of the anvil of the surgical staple assembly according to at least one aspect of the present disclosure. [Figure 126] Figure 124 is a plan view of the formed rows of staples in a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 127] An end view and a side view of a planar forming staple according to at least one aspect of the present disclosure. [Figure 128] An end view and a side view of a non-planar forming staple according to at least one aspect of the present disclosure. [Figure 129] This is a cross-sectional elevation view of an anvil having a plurality of staple-forming pocket rows according to at least one aspect of the present disclosure. [Figure 130] This is an elevation view of a thread used with a staple cartridge, according to at least one aspect of the present disclosure. [Figure 131] This is an elevation view of a first staple and a second staple for use with a surgical staple fastening assembly, according to at least one aspect of the present disclosure. [Figure 132] An end view and a side view of a planar forming staple according to at least one aspect of the present disclosure. [Figure 133] An end view and a side view of a non-planar forming staple according to at least one aspect of the present disclosure. [Figure 134] This is a cross-sectional elevation view of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 135] Figure 134 is a partial cross-sectional elevation view of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 136] Figure 134 is a cross-sectional elevation view of a staple cartridge and staple driver of a surgical staple fastening assembly according to at least one aspect of the present disclosure. [Figure 137] This is a perspective view of a surgical stapling assembly comprising a replaceable staple cartridge and a replaceable anvil plate, according to at least one aspect of the present disclosure. [Figure 138] Figure 137 is a perspective view of a surgical staple assembly shown in a clamp-release configuration according to at least one aspect of the present disclosure, where the anvil plate is not attached to the anvil jaw of the surgical staple assembly. [Figure 139] Figure 137 is a perspective view of a surgical stapling assembly according to at least one aspect of the present disclosure, in which the anvil plate is partially attached to the anvil jaw.
[0003] Throughout the drawings, corresponding reference numerals indicate corresponding parts. The examples described herein illustrate various embodiments of the invention in one form and should not be construed as limiting the scope of the invention in any way. [Modes for carrying out the invention]
[0004] The applicant of this application also owns the following U.S. patent applications filed on the same day as this application, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application entitled "METHOD OF USING A POWERED STAPLING DEVICE", Agent Reference Number END9298USNP1 / 200859-1M, - U.S. Patent Application entitled "SURGICAL STAPLE CARTRIDGE COMPRISING LONGITUDINAL SUPPORT BEAM", Agent Reference Number END9298USNP3 / 200859-3, - U.S. Patent Application entitled "ROTARY-DRIVEN SURGICAL STAPLING ASSEMBLY COMPRISING ECCENTRICALLY DRIVEN FIRING MEMBER", Agent Reference Number END9298USNP4 / 200859-4, - U.S. Patent Application entitled "ROTARY-DRIVEN SURGICAL STAPLING ASSEMBLY COMPRISING A FLOATABLE COMPONENT", Agent Reference Number END9298USNP5 / 200859-5, - U.S. Patent Application entitled "DRIVERS FOR FASTENER CARTRIDGE ASSEMBLIES HAVING ROTARY DRIVE SCREWS", Agent Reference Number END9298USNP6 / 200859-6, - U.S. Patent Application entitled "MATING FEATURES BETWEEN DRIVERS AND UNDERSIDE OF A CARTRIDGE DECK", Agent Reference Number END9298USNP7 / 200859-7, - U.S. Patent Application entitled "LEVERAGING SURFACES FOR CARTRIDGE INSTALLATION", Agent Reference Number END9298USNP8 / 200859-8, - U.S. Patent Application entitled "FASTENER CARTRIDGE WITH NON-REPEATING FASTENER ROWS", Agent Reference Number END9298USNP9 / 200859-9 - U.S. Patent Application entitled "FIRING MEMBERS HAVING FLEXIBLE PORTIONS FOR ADAPTING TO A LOAD DURING A SURGICAL FIRING STROKE", Agent Reference Number END9298USNP10 / 200859-10, - U.S. Patent Application entitled "STAPLING ASSEMBLY COMPONENTS HAVING METAL SUBSTRATES AND PLASTIC BODIES", Agent Reference Number END9298USNP11 / 200859-11, - U.S. Patent Application entitled "MULTI-AXIS PIVOT JOINTS FOR SURGICAL INSTRUMENTS AND METHODS OF MANUFACTURING SAME", Agent Reference Number END9298USNP12 / 200859-12, - U.S. Patent Application entitled "JOINT ARRANGEMENTS FOR MULTI-PLANAR ALIGNMENT AND SUPPORT OF OPERATIONAL DRIVE SHAFTS IN ARTICULATABLE SURGICAL INSTRUMENTS", Agent Reference Number END9298USNP13 / 200859-13, and - U.S. Patent Application entitled "SURGICAL INSTRUMENT ARTICULATION JOINT ARRANGEMENTS COMPRISING MULTIPLE MOVING LINKAGE FEATURES", Agent Reference Number END9298USNP14 / 200859-14.
[0005] The applicant of this application owns the following U.S. patent applications and U.S. patents filed on December 19, 2017, which are incorporated herein by reference in their entirety. - U.S. Patent No. 10,835,330, Title of Invention: "Method for Determining the Position of a Rotatable Jaw of a Surgical Instrument Attachment Assembled" - U.S. Patent No. 10,716,565, Title of Invention: "SURGICAL INSTRUMENTS WITH DUAL ARTICULATION DRIVERS", - U.S. Patent Application No. 15 / 847,325, Title of Invention: "SURGICAL TOOLS CONFIGURED FOR INTERCHANGEABLE USE WITH DIFFERENT CONTROLLER INTERFACES" (currently U.S. Patent Application Publication No. 2019 / 0183491), - U.S. Patent No. 10,729,509, Title of Invention: "SURGICAL INSTRUMENT COMPRISING CLOSURE AND FIRING LOCKING MECHANISM", - U.S. Patent Application No. 15 / 847,315, Title of Invention "ROBOTIC ATTACHMENT COMPRISING EXTERIOR DRIVE ACTUATOR" (currently U.S. Patent Application Publication No. 2019 / 0183594), and - U.S. Design Patent No. D910,847, Title of Invention: "SURGICAL INSTRUMENT ASSEMBLY".
[0006] The applicant of this application owns the following U.S. patent applications and U.S. patents filed on 28 June 2017, which are incorporated herein by reference in their entirety. - U.S. Patent Application No. 15 / 635,693, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN OFFSET ARTICULATION JOINT" (currently U.S. Patent Application Publication No. 2019 / 0000466), - U.S. Patent Application No. 15 / 635,729, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM RATIO" (currently U.S. Patent Application Publication No. 2019 / 0000467), - U.S. Patent Application No. 15 / 635,785, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM RATIO" (currently U.S. Patent Application Publication No. 2019 / 0000469), - U.S. Patent Application No. 15 / 635,808, Title of Invention: "SURGICAL INSTRUMENT COMPRISING FIRING MEMBER SUPPORTS" (currently U.S. Patent Publication No. 2019 / 0000471), - U.S. Patent Application No. 15 / 635,837, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM LOCKABLE TO A FRAME" (currently U.S. Patent Application Publication No. 2019 / 0000472), - U.S. Patent Application No. 10,779,824, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM LOCKABLE BY A CLOSURE SYSTEM", - U.S. Patent Application No. 15 / 636,029, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A SHAFT INCLUDING A HOUSING ARRANGEMENT" (currently U.S. Patent Publication No. 2019 / 0000477), - U.S. Patent Application No. 15 / 635,958, Title of Invention: "SURGICAL INSTRUMENT COMPRISING SELECTIVELY ACTUATABLE ROTATABLE COUPLERS" (currently U.S. Patent Application Publication No. 2019 / 0000474), - U.S. Patent Application No. 15 / 635,981, Title of Invention: "SURGICAL STAPLING INSTRUMENTS COMPRISING SHORTENED STAPLE CARTRIDGE NOSES" (currently U.S. Patent Application Publication No. 2019 / 0000475), - U.S. Patent Application No. 15 / 636,009, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A SHAFT INCLUDING A CLOSURE TUBE PROFILE" (currently U.S. Patent Application Publication No. 2019 / 0000476), - U.S. Patent No. 10,765,427, Title of Invention: "METHOD FOR ARTICULATING A SURGICAL INSTRUMENT", - U.S. Patent Application No. 15 / 635,530, Title of Invention: "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTOR WITH AXIALLY SHORTENED ARTICULATION JOINT CONFIGURATIONS" (currently U.S. Patent Application Publication No. 2019 / 0000457), - U.S. Patent No. 10,588,633, Title of Invention: "SURGICAL INSTRUMENTS WITH OPEN AND CLOSABLE JAWS AND AXIALLY MOVABLE FIRING MEMBER THAT IS INITIALLY PARKED IN CLOSE PROXIMITY TO THE JAWS PRIOR TO FIRING", - U.S. Patent Application No. 15 / 635,559, Title of Invention: "SURGICAL INSTRUMENTS WITH JAWS CONSTRAINED TO PIVOT ABOUT AN AXIS UPON CONTACT WITH A CLOSURE MEMBER THAT IS PARKED IN CLOSE PROXIMITY TO THE PIVOT AXIS" (currently U.S. Patent Application Publication No. 2019 / 0000459), - U.S. Patent No. 10,786,253, Title of Invention: "SURGICAL END EFFECTORS WITH IMPROVED JAW APERTURE ARRANGEMENTS", - U.S. Patent Application No. 15 / 635,594, Title of Invention: "SURGICAL CUTTING AND FASTENING DEVICES WITH PIVOTABLE ANVIL WITH A TISSUE LOCATING ARRANGEMENT IN CLOSE PROXIMITY TO AN ANVIL PIVOT AXIS" (currently U.S. Patent Application Publication No. 2019 / 0000461), - U.S. Patent Application No. 15 / 635,612, Title of Invention: "JAW RETAINER ARRANGEMENT FOR RETAINING A PIVOTABLE SURGICAL INSTRUMENT JAW IN PIVOTABLE RETAINING ENGAGEMENT WITH A SECOND SURGICAL INSTRUMENT JAW" (currently U.S. Patent Application Publication No. 2019 / 0000462), - U.S. Patent No. 10,758,232, Title of Invention: "SURGICAL INSTRUMENT WITH POSITIVE JAW OPENING FEATURES", - U.S. Patent No. 10,639,037, Title of Invention: "SURGICAL INSTRUMENT WITH AXIALLY MOVABLE CLOSURE MEMBER", - U.S. Patent No. 10,695,057, Title of Invention: "SURGICAL INSTRUMENT LOCKOUT ARRANGEMENT", - U.S. Design Patent No. D851,762, Title of Invention "ANVIL", - U.S. Design Patent No. D854,151, Title of Invention "SURGICAL INSTRUMENT SHAFT", and - U.S. Design Patent No. D869,655, Title of Invention: "SURGICAL FASTENER CARTRIDG".
[0007] The applicant of this application owns the following U.S. patent applications and U.S. patents filed on June 27, 2017, which are incorporated herein by reference in their entirety. - U.S. Patent Application No. 15 / 634,024, Title of Invention "SURGICAL ANVIL MANUFACTURING METHODS" (currently U.S. Patent Publication No. 2018 / 0368839), - U.S. Patent No. 10,772,629, Title of Invention: "SURGICAL ANVIL ARRANGEMENTS", - U.S. Patent Application No. 15 / 634,046, Title of Invention "SURGICAL ANVIL ARRANGEMENTS" (currently U.S. Patent Publication No. 2018 / 0368841), - U.S. Patent No. 10,856,869, Title of Invention: "SURGICAL ANVIL ARRANGEMENTS", - U.S. Patent Application No. 15 / 634,068, Title of Invention "SURGICAL FIRING MEMBER ARRANGEMENTS" (currently U.S. Patent Application Publication No. 2018 / 0368843), - U.S. Patent Application No. 15 / 634,076, Title of Invention: "STAPLE FORMING POCKET ARRANGEMENTS" (currently U.S. Patent Publication No. 2018 / 0368844), - U.S. Patent Application No. 15 / 634,090, Title of Invention: "STAPLE FORMING POCKET ARRANGEMENTS" (currently U.S. Patent Publication No. 2018 / 0368845), - U.S. Patent Application No. 15 / 634,099, Title of Invention "SURGICAL END EFFECTORS AND ANVILS" (currently U.S. Patent Application Publication No. 2018 / 0368846), and - U.S. Patent No. 10,631,859, Title of Invention: "ARTICULATION SYSTEMS FOR SURGICAL INSTRUMENTS".
[0008] The applicant of this application owns the following U.S. patent applications filed on June 2, 2020, which are incorporated herein by reference in their entirety. - U.S. Design Patent Application No. 29 / 736,648, Title of Invention: "STAPLE CARTRIDGE", - U.S. Design Patent Application No. 29 / 736,649, Title of Invention: "STAPLE CARTRIDGE", - U.S. Design Patent Application No. 29 / 736,651, Title of Invention: "STAPLE CARTRIDGE", - U.S. Design Patent Application No. 29 / 736,652, Title of Invention: "STAPLE CARTRIDGE", - U.S. Design Patent Application No. 29 / 736,653, Title of Invention: "STAPLE CARTRIDGE", - U.S. Design Patent Application No. 29 / 736,654, Title of Invention "STAPLE CARTRIDGE", and - U.S. Design Patent Application No. 29 / 736,655, Title of Invention: "STAPLE CARTRIDGE".
[0009] The applicant of this application owns the following U.S. patent applications and U.S. patents filed on November 14, 2016, which are incorporated herein by reference in their entirety. - U.S. Patent Application No. 15 / 350,621 (currently U.S. Patent Publication No. 2018 / 0132849), Title of Invention: "STAPLE FORMING POCKET CONFIGURATIONS FOR CIRCULAR STAPLER ANVIL", - U.S. Patent Application No. 15 / 350,624 (currently U.S. Patent Publication No. 2018 / 0132854), Title of Invention: "CIRCULAR SURGICAL STAPLER WITH ANGULARLY ASYMMETRIC DECK FEATURES", - U.S. Design Patent No. D833,608, title "STAPLING HEAD FEATURE FOR SURGICAL STAPLER", and - U.S. Design Patent No. D830,550, titled "SURGICAL STAPLER".
[0010] Numerous specific details are described in order to provide a complete understanding of the overall structure, function, manufacture, and use of the embodiments, as described in the specification and shown in the accompanying drawings. Well-known operations, components, and elements are not 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 therefore certain structural and functional details disclosed herein may be representative and illustrative. Modifications and changes thereto may be made without departing from the claims.
[0011] 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 “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 may have, but is not limited to, one or more of those elements. Similarly, an element of a system, device, or instrument that “comprises,” “has,” “includes,” or “contains” one or more features may have, but is not limited to, one or more of those features.
[0012] The terms “proximal” and “distal” are used herein in reference to the clinician operating the handle portion of the surgical device. “Proximal” refers to the portion closest to the clinician, and “distal” refers to the portion further away from the clinician. For convenience and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein in reference to the drawings. However, surgical devices are used in many orientations and positions, and these terms are not intended to be restrictive and / or absolute. In the following descriptions, terms such as “first,” “second,” “upper,” “lower,” “up,” and “down” should be understood as terms used for convenience and should not be interpreted as restrictive.
[0013] References to singular items should be understood to include plural items unless explicitly stated otherwise or evident from the text, and vice versa. Grammatical conjunctions, unless otherwise stated or evident from the context, are intended to express any and all disjunctive and conjunctive combinations of joined clauses, sentences, words, etc. Therefore, the term "or" should generally be understood to mean "and / or," etc.
[0014] The descriptions of value ranges in this invention are intended to refer individually, rather than limiting, to any and all values within that range, unless otherwise specified herein, and each distinct value within such range is incorporated into the specification as if it were individually enumerated herein. Words such as “about” and “approximately,” when accompanied by numerical values, should be interpreted as indicating a deviation that would be understood by a person skilled in the art to function satisfactorily for the intended purpose. Similarly, approximate words such as “approximately” or “substantially,” when used in reference to physical properties, should be interpreted as inducing a range of deviations that would be recognized by a person skilled in the art to function satisfactorily for the corresponding use, function, purpose, etc.
[0015] Any and all examples provided herein, i.e., the use of illustrative language ("for example," "etc.," or otherwise) is intended solely to better illustrate each embodiment and not to limit the scope of the embodiments. Nothing in the specification should be construed as indicating that any unclaimed element is essential to the practice of the embodiments.
[0016] Various exemplary apparatuses and methods for performing laparoscopic and minimally invasive surgical procedures are provided. However, it will be readily apparent to the reader that the various methods and apparatuses disclosed herein can be used in many surgical procedures and applications, including, for example, those related to incisional surgical procedures. By continuing to read the “Modes for Carrying Out the Invention” section herein, the reader will further understand that the various surgical devices disclosed herein can be inserted into the body in any way, for example, through a pre-existing opening, through an incision or puncture hole formed in the tissue, etc. The working portion, or end-effector, of these surgical devices can be inserted directly into the patient’s body, or through an access device having a working passage through which the end-effector and elongated shaft of the surgical device can be advanced.
[0017] A surgical stapling system may comprise a shaft and an end effector extending from the shaft. The end effector comprises a first jaw and a second jaw. The first jaw comprises a staple cartridge. The staple cartridge is insertable into and removable from the first jaw, although other embodiments can be conceived 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 comprises an anvil configured to deform staples ejected from the staple cartridge. The second jaw is pivotable relative to the first jaw about a closing axis, although other embodiments can be conceived in which the first jaw is pivotable relative to the second jaw. The surgical stapling system further comprises an articulating joint configured to rotate, i.e., articulate, the end effector relative to the shaft. The end effector is rotatable about an articulating axis extending through the articulating joint. Other embodiments can also be conceived in which the articulating joint is not included.
[0018] A staple cartridge comprises a cartridge body. The cartridge body includes a proximal end, a distal end, and a deck extending between the proximal and distal ends. During use, the staple cartridge is positioned on the first side of the tissue to be stapled, and the anvil is positioned on the second side of the tissue to be stapled. The anvil is moved toward the staple cartridge to press and clamp the tissue against the deck. Staples, which are detachably stored within the cartridge body, can then be deployed into the tissue. The cartridge body includes a defined staple cavity, and staples are detachably stored within the staple cavity. The staple cavity is arranged in six longitudinal rows. Three rows of staple cavities are positioned on the first side of the longitudinal slots, and three rows of staple cavities are positioned on the second side of the longitudinal slots. Other devices for staple cavities and staples can also be conceived.
[0019] The staples are supported by a staple driver within the cartridge body. The driver is movable between a first position, i.e., an unfired position, and a second position, i.e., a fired position, in order to eject the staples from the staple cavity. The driver is held within the cartridge body by a retainer extending around the lower perimeter of the cartridge body and includes an elastic member configured to grip the cartridge body and hold the retainer relative to the cartridge body. The drivers are movable between their unfired and fired positions by a thread. The thread is movable between a proximal position close to the proximal end of the cartridge body and a distal position close to the distal end of the cartridge body. The thread includes a plurality of inclined surfaces configured to slide beneath the driver and lift the driver, on which the staples are supported and directed toward the anvil.
[0020] In addition to the above, the thread is moved distally by the launching member. The launching member is configured to contact the thread and push it toward the distal end. A longitudinal slot defined within the cartridge body is configured to receive the launching member. The anvil also includes a slot configured to receive the launching member. The launching member further comprises a first cam that engages with a first jaw and a second cam that engages with a second jaw. When advancing the launching member distally, the first and second cams can control the distance between the deck of the staple cartridge and the anvil, i.e., the tissue gap. The launching member also comprises a knife configured to excise tissue trapped between the staple cartridge and the anvil. It is desirable that the knife be positioned at least partially proximal to the inclined surface so that the staple is ejected into the tissue ahead of the knife that cuts the tissue.
[0021] Figures 1 to 8 show a surgical stapling device 10 configured to clamp, staple, and cut patient tissue. The surgical stapling device 10 comprises a handle 20, a shaft assembly 100 attached to the handle 20, and an end effector 200. To cut and staple patient tissue, the end effector 200 comprises a cartridge jaw 201 and an anvil jaw 203. The anvil jaw 203 is pivotable relative to the cartridge jaw 203 to clamp tissue between the anvil jaw 203 and the cartridge jaw 203. Once tissue is clamped between the jaws 201 and 203, the surgical stapling device 10 can be actuated so that a launching member advances through the jaws 201 and 203 to staple and cut the tissue using the end effector 200, as will be discussed in more detail below.
[0022] As will be discussed in more detail below, the end effector 200 is articulated by the articulation region 110 of the shaft assembly 100. Such articulation gives the user of the surgical staple fastener 10 the ability to position and / or manipulate the end effector 200 more precisely near the target tissue.
[0023] The handle 20 comprises a housing 21 configured to accommodate various mechanical and electrical components, and a handle portion 22 extending from the housing 21. The handle portion 22 is configured to fit in the palm of the user's hand and / or to be grasped and / or held by the user using the surgical stapling device 10. The handle 20 further comprises various actuators and / or triggers configured to be actuated by the user to operate one or more functions of the surgical stapling device 10. The handle 20 comprises a closing trigger 24, a firing trigger 25, and at least one articulated actuator 26. When actuated by the user, the closing trigger 24 is configured to clamp tissue at the end effector 200 by moving the anvil jaw 203 toward the cartridge jaw 201. When actuated by the user, the firing trigger 25 is configured to cut and staple tissue at the end effector 200 by advancing a firing member to eject a staple and cutting the tissue with a knife. When activated by the user, the articulation actuator 26 is configured to articulate the end effector 200 to the shaft assembly 100 by the articulation region 110. The trigger and actuator of the surgical stapler 10 can trigger one or more motors in the handle 20 to activate various functions of the surgical stapler 10, and / or manually drive various drive shafts and components to activate various functions of the surgical stapler 10.
[0024] The handle 20 further comprises a nozzle assembly 30 configured to internally support the shaft assembly 100. The nozzle assembly 30 includes an operating wheel 31 configured to allow the user to rotate the shaft assembly 100 and the end effector 200 around a longitudinal axis LA relative to the handle 20. Such a mechanism allows the user of the surgical staple fastener 10 to rotate only the shaft assembly 100 and / or the end effector 200 without having to rotate the entire handle 20.
[0025] The handle 20 further comprises a battery 23 configured to power various electronic components, sensors, and / or motors of the surgical stapling device 10. Embodiments have been conceived in which the surgical stapling device 10 is directly connected to a power source. Embodiments have also been conceived in which the surgical stapling device 10 is, for example, entirely manual or non-powered. Embodiments have been conceived in which the articulation of the end effector, clamping and unclamping of the jaws, firing of the end effector staples and cutting of tissue, and rotation of the shaft and / or end effector are all powered systems.
[0026] In at least one example, the shaft assembly 100 and the end effector 200 may be modular and detachable from the handle 20. In at least one example, the end effector 200 may be modular in that it can be removed from the shaft assembly 100 and replaced with another end effector. In at least one example, the shaft assembly 100 and / or the end effector 200 can be used in a surgical robotic environment. Such embodiments provide power input from the surgical robot interface to operate each function of the end effector 200. Examples of such surgical robots and surgical tools are further described in U.S. Patent Application Publication No. 2020 / 0138534, entitled “ROBOTIC SURGICAL SYSTEM,” published on May 7, 2020, which is incorporated herein by reference in its entirety.
[0027] In at least one example, the shaft assembly 100 and the end effector 200 are configured for use with a surgical robot. In such an example, the shaft assembly 100 and the end effector 200 are configured to be coupled to a surgical robot having multiple power drive units. The multiple power drive units of the surgical robot are configured to mate with the drive systems of the shaft assembly 100 and the end effector 200. In such an example, the surgical robot can actuate various different functions of the end effector 200, for example, articulating the end effector around multiple different joints, rotating the shaft assembly 100 and / or the end effector 200 around its longitudinal axis, clamping the end effector 200 to clamp tissue between the jaws of the end effector 200, and / or firing the end effector 200 to cut and / or staple tissue.
[0028] The shaft assembly 100 is configured to house various drive system components and / or electronic components of the surgical staple fastener 10 so that the end effector 200 and the shaft assembly 100 can be inserted through a trocar for laparoscopic surgery. The various drive system components are configured to be actuated by various triggers and actuators of the handle 20. Such components may include a drive shaft for articulation, a drive shaft for clamping and unclamping the end effector 200, and / or a drive shaft for firing the end effector 200. Such drive shafts may be rotated by a drive system in the handle 20 or by a surgical robot interface in an example to which the shaft assembly 100 is connected. In various embodiments, the staple fastener end effector may include two independently rotatable drive members (e.g., one for gripping tissue and the other for firing staples). The staple fastener end effector may further include an articulation joint, through which rotational motion may be transmitted. In various embodiments, the stapled end effector may include one or more 3D printed assemblies that can be incorporated into an articulated joint system, a gripping system, or a launching system.
[0029] Such a drive shaft may be actuated by the drive system or surgical robot interface in the handle 20, in an example where the shaft assembly 100 is connected to the drive system or surgical robot interface in the handle 20. Such a drive shaft may have linear action, rotational action, or a combination thereof. A combination of rotational and linear action may be achieved, for example, by using a series of rack gears and / or drive screws.
[0030] In at least one example, the shaft assembly 100 is also configured to accommodate, for example, wires for various sensors and / or motors, which are located within the shaft assembly 100 and / or end effector 200.
[0031] The shaft assembly 100 includes an outer shaft 101 extending from the nozzle assembly 30 to an articulation region 110, which has a double articulated joint, as will be discussed in more detail below. The articulation region 110 allows the end effector 200 to articulate with the outer shaft 101 in two separate planes around two separate axes AA1 and AA2.
[0032] The articulation of the end effector 200 will now be described, primarily with reference to Figure 4. The articulation region 110 comprises two separate articulation joints and two articulation actuators 150 and 160. This allows the end effector 200 to articulate independently of each other in two different planes around two different axes AA1 and AA2. The articulation region 110 comprises a proximal joint shaft component 120, an intermediate joint shaft component 130, and a distal joint shaft component 140. The proximal joint shaft component 120 is attached to the distal end of the shaft assembly 100, the intermediate joint shaft component 130 is pivotally connected to the proximal joint shaft component 120 and the distal joint shaft component 140, and the distal joint shaft component 140 is fixedly attached to the end effector 200 by a retaining ring 146. As will be discussed in more detail below, this device provides articulated joints of the end effector 200 to the shaft assembly 100, which is centered on axes AA1 and AA2 independently of each other.
[0033] The proximal joint shaft component 120 comprises a proximal annular portion 121 fitted and fixed within the outer shaft 101. The proximal joint shaft component 120 also comprises an articulation tab 123 which includes a hollow passage 122, allowing various drive system components to pass through, and a pinhole 124 configured to receive an articulation pin 125. The articulation pin 125 pivotably connects the proximal joint shaft component 120 to the proximal articulation tab 131 of the intermediate joint shaft component 130. To articulate the end effector 200 around axis AA1, the articulation actuator 150 is actuated linearly in either the distal or proximal direction. Such an actuator may comprise a bar or rod made of any suitable material, such as metal and / or plastic. The articulation actuator 150 is pivotably mounted on the articulation crosslink 151. The articulated cross link 151 is pivotably mounted to the intermediate joint shaft component 130 out of axis relative to the articulated pin 125. As a result, when the articulated actuator 150 is operated, the articulated cross link 151 applies torque to the intermediate joint shaft component 130 out of axis relative to the articulated pin 125, causing the intermediate joint shaft component 130, and therefore the end effector 200, to pivot about axis AA1 relative to the proximal joint shaft component 120.
[0034] The intermediate joint shaft component 130 is pivotably connected to the proximal joint shaft component 120 by an articulation pin 125 defining axis AA1. Specifically, the intermediate joint shaft component 130 includes a proximal articulation tab 131 that is pivotally connected to the proximal joint shaft component 120 by the articulation pin 125. The intermediate joint shaft component 130 further includes a hollow passage 132 configured to allow various drive system components to pass through, and a distal articulation tab 133. The distal articulation tab 133 includes a pin hole 134 configured to receive another articulation pin 136 defining axis AA2, and a key 135 projecting distally.
[0035] To articulate the end effector 200 around axis AA2, the articulation cable 160 acts to apply articulation torque to the proximal tab 141 of the distal joint shaft component 140 via a key 135. The articulation cable 160 is fixed to the key 135 such that the key 135 pivots relative to the intermediate joint shaft component 130 as the cable 160 rotates. The key 135 is fitted into the keyhole 144 of the distal joint shaft component 140. In particular, the key 135 is not fixed to the intermediate joint shaft component 130, but is rotatable relative to the intermediate joint shaft component 130. The articulation cable 160 also contacts the proximal tab 141 around a pinhole 142. This brings an additional torque moment from the articulation cable 160 to the distal joint shaft component 140. The joint pin 136 is received in the pin hole 142, pivotably connecting the intermediate joint shaft component 130 and the distal joint shaft component 140.
[0036] In at least one example, the articulating cable 160 can be pulled only in the proximal direction. In such an example, only one side of the articulating cable 160 is pulled in the proximal direction to articulate the end effector 200 in the desired direction. In at least one example, the articulating cable 160 is pushed and pulled antagonistically. In other words, the cable 160 may have a rigid structure such that one side of the articulating cable 160 is pushed distally and the other side of the articulating cable 160 is pulled proximal. Such a device may allow the articulating force to be divided between the pushed half and the pulled half of the cable 160. In at least one example, a push-pull device allows a larger articulating force to be transmitted to the corresponding articulating joint. Such a force may be required in a device having two articulating joints. For example, if the proximal joint is fully articulated, more force may be required in the articulation actuator intended to articulate the distal joint due to the extended and / or lengthened distance that the articulation actuator for the distal joint must travel.
[0037] The distal joint shaft component 140 further includes a notch 143 that allows various drive components to pass through. The retaining ring 146 secures the channel 210 of the cartridge jaw 201 to the distal joint shaft component 140, thereby securing the end effector assembly 200 to the distal end of the joint region 110.
[0038] As described above, the anvil jaw 201 is movable relative to the cartridge jaw 203 to clamp and release tissue with the end effector 200. The operation of this function of the end effector 200 is described here. The cartridge jaw 201 comprises a channel 210 and a staple cartridge 220 configured to be received in a cavity 214 of the channel 210. The channel 210 further comprises an annular groove 211 configured to receive a retaining ring 146 and a pair of pivot holes 213 configured to receive a jaw connecting pin 233. The jaw connecting pin 233 allows the anvil jaw 203 to pivot relative to the cartridge jaw 201.
[0039] The anvil jaw 203 comprises an anvil body 230 and a pair of pivot holes 231. The pivot holes 231 located in the proximal portion of the anvil jaw 203 are configured to receive jaw connecting pins 233, thereby pivotally connecting the anvil jaw 203 to the cartridge jaw 201. A closing drive unit 250 is provided to open and close the anvil jaw 203 relative to the cartridge jaw 201.
[0040] The closing drive unit 250 is actuated by a flexible drive segment 175 consisting of a movable joint whose ends are arranged or formed to touch. In various examples, the flexible drive segment 175 may include a serial 3D printed universal joint, which is printed together as a single continuous system. As will be discussed in more detail below, the flexible drive segment 175 is driven by an input shaft that passes through the shaft assembly 100. The flexible drive segment 175 transmits rotational operating motion via a double-jointed joint. The closing drive unit 250 comprises a closing screw 251 and a closing wedge 255 screw-coupled to the closing screw 251. The closing wedge 255 is configured to reliably cam-operate and open the anvil jaw 203. The closing screw 251 is supported by a first support 258 and a second support 259 fixed within the channel 210.
[0041] To move the anvil jaw 203 between the clamped position (Figure 8) and the unclamped position (Figure 7), the closing drive shaft is actuated to actuate the flexible drive segment 175. The flexible drive segment 175 is configured to rotate the closing screw 251, which moves the closing wedge 255. For example, the closing wedge 255 is screw-coupled to the closing screw 251, and rotational movement of the closing wedge 255 relative to the staple cartridge 220 is suppressed. Depending on the direction of rotation of the closing screw 251, the closing wedge 255 is driven in the proximal or distal direction.
[0042] To clamp the end effector 200 from the unclamped position (Figure 7), the closing wedge 255 is moved proximal. As the closing wedge 255 moves proximal, the proximal cam surface 256 of the closing wedge 255 contacts the corresponding cam surface 234 defined on the proximal end 235 of the anvil body 230. When the cam surface 256 contacts the cam surface 234, a force is applied to the proximal end 235 of the anvil body 230, rotating the anvil body 230 around the pin 233 into the clamped position (Figure 8).
[0043] To open the end effector 200 from the clamped position (Figure 8), i.e., to release it, the closing wedge 255 is moved distally by rotating the closing screw 251 in the opposite direction to the direction in which the closing wedge 255 is moved proximal. As the closing wedge 255 moves distally, a pair of nubs 257 extending from the distal end of the closing wedge 255 contact the cam surface 234 near the tab 237 that extends downward on the anvil body 230. When the nubs 257 contact the cam surface 234 near the tab 237, a force is applied to the anvil body 230, rotating the anvil body 230 around the pin 233 into the open position (Figure 7).
[0044] In at least one example, the shape of the cam surface 234 corresponds to the shape of the cam surface 256. For example, the cam surfaces 234 and 256 may coincide so that the maximum cam force is applied to the anvil body 230 to cause a desired rotation of the anvil body 230. As shown in Figure 8, for example, the cam surface 234 defined by the proximal end 235 of the anvil body 230 has an inclined portion similar to the inclined portion of the upper inclined portion of the cam surface 256.
[0045] As described above, the surgical stapling device 10 can be operated so that a launching member advances through the jaws 201, 203 to staple and cut tissue using the end effector 200. Now, the function of positioning staples 226 from the staple cartridge 220 and cutting tissue with the knife 283 will be described. The staple cartridge 220 comprises a cartridge body 221, a plurality of staple drivers 225, and a plurality of staples 226 detachably stored within the cartridge body 221. The cartridge body 221 comprises a deck surface 222, a plurality of staple cavities 223 defined within the cartridge body 221 and arranged in a longitudinal row, and a longitudinal slot 224 dividing the cartridge body 221 in two. The knife 283 is driven through the longitudinal slot 224 and configured to cut tissue clamped between the anvil body 230 and the deck surface 221.
[0046] The deck surface 221 has a laterally undulating tissue support surface. In various embodiments, the undulations of the deck surface 221 may form vertices along the central portion of the cartridge body 221. Such vertices may overlap longitudinally extending firing screws 261 that extend through the central portion of the cartridge body 221, which will be further described herein. The increased height along the vertices may, in various examples, correspond to smaller tissue gaps along the firing path of the knife 283. In certain embodiments of this disclosure, the driver height, the height of the formed staples, the height of the staple pocket extensions, and / or the staple overdrive distance may also vary laterally along the deck surface 221. Laterally variable stapling (e.g., a combination of 2D and 3D stapling) has also been conceived and will be further described herein.
[0047] The staple driver 225 is configured to be lifted by the thread 280 when the thread 280 is pushed distally through the staple cartridge 220, thereby ejecting the staple 226 supported within the staple cavity 223 by the staple driver 225. The thread 280 has an inclined surface 281 for contact with the staple driver 225. The thread 280 also includes a knife 283. The thread 280 is configured to be pushed by the launching member 270.
[0048] To position the staples 226 and cut the tissue with the knife 283, the end effector 200 comprises a launch drive unit 260. The launch drive unit 260 is actuated by a flexible drive shaft 176. As will be described in more detail below, the flexible drive shaft 176 is driven by an input shaft that passes through the shaft assembly 100. The flexible drive shaft 176 transmits rotational operating motion via a double-jointed joint. The launch drive unit 260 comprises a launch screw 261 configured to be rotated by the flexible drive shaft 176. The launch screw 261 comprises a support member 259 and a journal supported in a bearing within the channel 210. In various examples, the launch screw 261 may float relative to the channel 210, as will be further described herein. The launch screw 261 comprises a proximal end 262 supported within the support member 259 and the channel 210, a distal end 263 supported within the channel 210, and threads 265 extending along a portion of the length of the launch screw 261.
[0049] The launching member 270 is screw-coupled to the launching screw 261 such that when the launching screw 261 rotates, the launching member 270 advances distally or retracts proximally along the launching screw 261. Specifically, the launching member 270 comprises a body portion 271 having a defined hollow passage 272 inside. The launching screw 261 is configured to be received within the hollow passage 272 and to be screw-coupled to a threaded component 273 of the launching member 270. Thus, when the launching screw 261 rotates, the threaded component 273 applies a linear force to the body portion 271, causing the launching member 270 to advance distally or retract proximally. When the launching member 270 advances distally, it pushes the thread assembly 280. As further described herein, the distal movement of the thread 280 causes the ejection of staples 223 by engaging a plurality of staple drivers 225. The driver 225 is a triple driver configured to fire multiple staples 223 simultaneously. The driver 225, with lateral asymmetry as further described herein, can maximize the width of the thread rail and house the firing screw 261 below the center of the cartridge 220 in various examples.
[0050] At some point during the firing of the end effector 200, the user may retract the firing member 270 to release the jaws 201 and 203. In at least one example, the firing member 270 must be fully retracted to open the jaws 201 and 203, and when the firing member 270 is fully retracted, upper and lower cam members are provided on the main body portion 271 that can be released from the jaws 201 and 203.
[0051] In various examples, the launching member 270 may be a hybrid structure of plastic and metal parts, as further described herein. In various examples, the threaded component 273 may be a metal component incorporated into the launching member body 271, for example, by insert molding or overmolding.
[0052] The launching member 270 may also be referred to as an I-beam in certain examples. The launching member 270 may include a complex 3D-printed geometric shape containing a grid-like space inside. In various examples, 3D printing allows the launching member or a portion thereof to function as a spring, allowing a portion to bend more easily, thereby improving, for example, the distribution and / or tolerance of forces during the launch stroke.
[0053] Figures 9 to 11 show a surgical staple assembly 300 comprising a shaft assembly 310 and the end effectors 200 shown in Figures 1 to 8, attached to the shaft assembly 310. The shaft assembly 310 may be similar in many respects to various other shaft assemblies discussed herein. However, the shaft assembly 310 comprises a single articulated joint and an articulated bar configured to articulate the end effectors 200 around the single articulated joint. The surgical staple assembly 300 is configured to cut and staple tissue. The surgical staple assembly 300 may be attached to the handle of a surgical instrument and / or the interface of a surgical robot. The handle of a surgical instrument and / or the interface of a surgical robot may be configured to actuate various functions of the surgical staple assembly 300. The shaft assembly 310 comprises an articulated joint 320. As will be discussed in more detail below, the end effector 200 is configured to articulate with respect to the outer shaft 311 of the shaft assembly 310 around axis AA.
[0054] The shaft assembly 310 comprises an outer shaft 311, a first shaft coupling component 330, and a second shaft coupling component 350 pivotably connected to the first shaft coupling component 330 by an articulating pin 354. The first shaft coupling component 330 comprises a proximal tube portion 331 configured to fit into the inner diameter of the outer shaft 311. Such fitting may include, for example, press-fitting. However, any preferred mounting means may be used. The first shaft coupling component 330 also includes a distal portion 332. The distal portion 332 comprises an articulating tab 333 having a pinhole 334 defined inside, and a hollow passage 335 through which various drive components of the surgical staple fastening assembly 300 can pass. Such drive components may include, for example, an articulating actuator, a closing actuator, and / or a firing actuator.
[0055] The first shaft coupling component 330 is pivotably connected to the second shaft coupling component 350 by an articulation pin 354. The articulation pin 354 is also received in a pinhole 353 of an articulation tab 351 extending proximal to the second shaft coupling component 350. The pinhole 353 is axially aligned with a pinhole 334. The articulation pin 354 allows the second shaft coupling component 350 to articulate with respect to the first shaft coupling component 330 about articulation axis AA. The second shaft coupling component 350 further comprises a pin projection 352 extending from the proximal articulation tab 351. As will be discussed in more detail below, the pin projection 352 is configured to be pivotably connected to an articulation drive system. The second shaft coupling component 350 further comprises a distal portion 355 having an annular groove 356 configured to receive a retaining ring 358. The distal portion 355 also includes a hollow passage 357 through which various drive components of the surgical staple fastening assembly 300 can pass. The retaining ring 358 is configured to hold the first jaw 201 to the second shaft coupling component 350 by fitting into the annular groove 211 of the cartridge channel 210 and the annular groove 356 of the second shaft coupling component 350.
[0056] An articulation bar 360 is provided to articulate the end effector 200 around the articulation axis AA. The articulation bar 360 can be actuated by any suitable means, such as a robot or electric input and / or a manual handle trigger. The articulation bar 360 can be actuated, for example, in the proximal and distal directions. Embodiments have been conceived in which the articulation system includes rotational drive action in addition to, or instead of, linear action. The articulation bar 360 extends through an outer shaft 311. The articulation bar 360 has a distal end 361 pivotably connected to an articulation link 362. The articulation link 362 is pivotably connected from an articulation tab 351 extending in the proximal direction to a pin projection 352 extending off-center with respect to the articulation axis AA. Such off-center connection of the articulation link 362 allows the articulation bar 360 to apply force to the second joint shaft component 350, thereby rotating the second shaft articulation component 350, and thus the end effector 200, relative to the first joint shaft component 330. The articulation bar 360 can advance distally to rotate the end effector 200 in a first direction around the articulation axis AA, and retract proximal to rotate the end effector 200 in a second direction opposite to the first direction around the articulation axis AA.
[0057] The shaft assembly 310 further comprises a joint component support structure 340 positioned within the joint 320. Such a support structure can support various drive components configured to reach the end effector 200 through the joint 320 when the end effector 200 articulates. The support structure 340 may also serve to isolate the drive components from tissue residue during use.
[0058] Figures 12–14 show a surgical staple assembly 400 comprising a shaft assembly 410 and the end effectors 200 shown in Figures 1–8, attached to the shaft assembly 410. The shaft assembly 410 may be similar in many respects to various other shaft assemblies discussed herein. However, the shaft assembly 410 comprises a single articulated joint and an articulated cable configured to articulate the end effectors 200 around the single articulated joint. The surgical staple assembly 400 is configured to cut and staple tissue. The surgical staple assembly 400 may be attached to the handle of a surgical instrument and / or the interface of a surgical robot. The handle of a surgical instrument and / or the interface of a surgical robot may be configured to actuate various functions of the surgical staple assembly 400. The shaft assembly 410 comprises an articulated joint 420. As will be discussed in more detail below, the end effector 200 is configured to articulate with respect to the outer shaft 411 of the shaft assembly 310, with respect to axis AA.
[0059] The shaft assembly 410 comprises an outer shaft 411, a first shaft coupling component 430, and a second shaft coupling component 450 pivotably connected to the first shaft coupling component 430 by an articulating pin 454. The first shaft coupling component 430 comprises a proximal tube portion 431 configured to fit into the inner diameter of the outer shaft 411. Such fitting may include, for example, press-fitting. However, any preferred mounting means may be used. The first shaft coupling component 430 also includes a distal portion 432, which comprises an articulating tab 433 having a pinhole 434 defined inside. The distal portion 432 further includes a hollow passage 435 through which various drive components of the surgical staple fastening assembly 400 can pass. Such drive components may include, for example, an articulating actuator, a closing actuator, and / or a firing actuator.
[0060] The first shaft coupling component 430 is pivotably connected to the second shaft coupling component 450 by an articulation pin 454. The articulation pin 454 is also received in a pinhole 453 of an articulation tab 451 extending proximal to the second shaft coupling component 450. The articulation pin 454 enables the second shaft coupling component 450 to articulate with respect to the first shaft coupling component 430 about articulation axis AA. The second shaft coupling component 450 further comprises a drive ring structure 452. The drive ring structure 452 extends from the proximal articulation tab 451 and further defines a portion of the pinhole 453. As will be discussed in more detail below, the drive ring structure 452 is configured to be engaged by an articulation drive system. The second shaft coupling component 450 further comprises a distal portion 455 having an annular groove 456 configured to receive a retaining ring 458. A hollow passage 457 passing through the distal portion 455 is configured to receive various drive components of the surgical staple fastening assembly 400 through it. A retaining ring 458 is configured to hold the first jaw 201 to the second shaft coupling component 450 by fitting into the annular groove 211 of the cartridge channel 210 and the annular groove 456 of the second shaft coupling component 450.
[0061] An articulation cable 460 is provided to articulate the end effector 200 around the articulation axis AA. The articulation cable 460 can be actuated by any preferred means, such as a robot input and / or a manual trigger on a handheld surgical instrument. The articulation cable 460 may have an antagonistic acting shape. In other words, when the first side of the articulation cable 460 is pulled proximally, the second side of the articulation cable 460 can advance distally, like a pulley system. Similarly, when the second side is pulled proximally, the first side can advance distally. The articulation cable 460 extends through the outer shaft 411. The articulation cable 460 is positioned around a drive ring structure 452 and held thereon by friction, allowing the rotation of the second shaft coupling component 450 when the articulation cable 460 is actuated. When the articulation cable 460 is actuated, it is configured to apply rotational torque to the drive ring structure 452 of the second joint shaft component 450, and thus to the end effector 200. Such torque is configured to rotate, i.e., pivot the second joint shaft component 450 relative to the first joint shaft component 430, thereby articulating the end effector 200 with respect to the outer shaft 411. The first side of the articulation cable 460 can be pulled to rotate the end effector 200 in a first direction about the articulation axis AA, and the second side of the articulation cable 460 can be pulled to rotate the end effector 200 in a second direction opposite to the first direction about the articulation axis AA.
[0062] The shaft assembly 410 further comprises a joint component support structure 440 positioned within the joint 420. Such a support structure 440 can support various drive components configured to reach the end effector 200 through the joint 420 when the end effector 200 is articulated. The support structure 440 may also serve to isolate the drive components from tissue residue during use.
[0063] The surgical staple fastening assembly 400 further comprises a closing drive shaft segment 475 and a launch drive shaft segment 476, each configured to transmit rotational motion to the end effector 200 via an articulation joint 420. The drive shaft segments 475 and 476 are configured to passively extend and contract longitudinally when the end effector 200 is articulated. For example, articulation can cause expansion and contraction of the drive shaft segments 475 and 476, resulting in longitudinal expansion and contraction of the respective drive shafts due to the articulation of the end effector 200 with respect to the shaft assembly 410. During the extension and contraction of the drive shaft segments 475 and 476, they maintain rotational drive engagement with the corresponding input and output shafts within the end effector 200, which extend through the outer shaft 411. In at least one example, the output shaft comprises a closing screw 251 configured to result in gripping, closing, or tissue manipulation by the jaws 201, 203, and a launching screw 261 configured to result in clamping of the jaws 201, 203 and launching of the launching member 270.
[0064] Figures 15–17 show a surgical staple assembly 500 comprising a shaft assembly 510 and the end effector 200 shown in Figures 1–8, attached to the shaft assembly 510. The shaft assembly 510 may be similar in many respects to various other shaft assemblies discussed herein. However, the shaft assembly 510 comprises a single articulated joint and a drive shaft segment configured to retract passively. The surgical staple assembly 500 is configured to cut and staple tissue. The surgical staple assembly 500 may be attached to the handle of a surgical instrument and / or the interface of a surgical robot. The handle of a surgical instrument and / or the interface of a surgical robot may be configured to actuate various functions of the surgical staple assembly 500. The shaft assembly 510 comprises an articulated joint 520. As will be discussed in more detail below, the end effector 200 is configured to articulate around axis AA.
[0065] The shaft assembly 510 comprises a first shaft coupling component 530 and a second shaft coupling component 540 pivotably connected to the first shaft coupling component 530 by an articulation pin 543. The first shaft coupling component 530 is configured to be attached to the shaft of a surgical instrument assembly and / or to the interface of a surgical robot. The first shaft coupling component 530 comprises a proximal portion 531 and an articulation tab 533 having a pinhole 534 defined inside. In at least one example, the first shaft coupling component 530 includes a hollow passage through which various drive components of the surgical staple fastening assembly 400 can pass. Such drive components may include, for example, an articulation actuator, a closing actuator, and / or a firing actuator.
[0066] The first shaft coupling component 530 is pivotably connected to the second shaft coupling component 540 by an articulation pin 543. The articulation pin 543 is also received in a pinhole 542 of an articulation tab 541 extending proximal to the second shaft coupling component 540. The articulation pin 543 allows the second shaft coupling component 540 to articulate with respect to the first shaft coupling component 530 about articulation axis AA. The second shaft coupling component 540 further comprises a distal portion 545 having an annular groove 547 configured to receive a retaining ring 548 and a hollow passage 546 through which various drive components of the surgical staple fastening assembly 500 can pass. The retaining ring 548 is configured to retain the first jaw 201 on the second shaft coupling component 540 by fitting into the annular groove 211 of the cartridge channel 210 and the annular groove 547 of the second shaft coupling component 540.
[0067] The end effector 200 can be articulated around axis AA using any suitable articulation drive system. In at least one example, the end effector 200 is passively articulated. In such an example, the end effector 200 may be pressed against tissue to apply force to the end effector 200, for example, to articulate the end effector 200 around the articulation axis. In at least one example, the end effector 200 further comprises a spring configured to apply a neutral biasing force to the second shaft coupling segment 540, for example, to bias the end effector 200 toward a non-articulated configuration.
[0068] The surgical staple fastening assembly 500 further comprises a closing drive shaft segment 575 and a launch drive shaft segment 576, each configured to transmit rotational motion to the end effector 200 via an articulation joint 520. The drive shaft segments 575 and 576 are configured to passively extend and retract longitudinally when the end effector 200 is articulated. The articulation causes the drive shaft segments 575 and 576 to extend and retract, resulting in longitudinal extension and retraction of the drive shafts due to the articulation of the end effector 200. During the extension and retraction of the drive shaft segments 575 and 576, they maintain rotational drive engagement with the corresponding input and output shafts within the end effector 200. In at least one example, the output shaft comprises a closing screw 251 and a launch screw 261, which are further described herein.
[0069] Figures 18–20 show a surgical staple-fastening end-effector assembly 600 comprising a shaft portion 610 and an end-effector 600. The end-effector assembly 600 is similar in many respects to various other end-effector assemblies disclosed herein. However, the end-effector assembly 600 comprises a multi-component launching member driven by a flexible launching shaft. The end-effector assembly 600 is configured to cut and staple tissue. The end-effector assembly 600 can be attached to a surgical instrument handle and / or surgical robot interface by a proximal tab 611 of the shaft portion 610. The surgical instrument handle and / or surgical robot interface may be configured to actuate various functions of the end-effector assembly 600. The end effector assembly 600 comprises a cartridge channel jaw 620 and an anvil jaw 660 pivotably mounted on the cartridge channel jaw 620, and clamps tissue between the cartridge channel jaw 620 and the anvil jaw 660.
[0070] The cartridge channel jaw 620 comprises a channel 630 having a proximal end 631, a staple cartridge 640 configured to house a plurality of staples and to be received within the channel 630, and a support brace 650 fitted into the staple cartridge 640. The staple cartridge 640 and the support brace 650 are configured to be assembled together before the staple cartridge 640 is installed within the channel 630. As will be discussed in more detail below, the support brace 650 is configured to further support the launcher assembly as it advances through the end effector assembly 600.
[0071] The second jaw 660 is configured to form staples ejected from the staple cartridge 640. The anvil jaw 660 has a proximal end 661 having a pair of pinholes 662 defined inside, and is configured to receive a connecting pin 663. The anvil jaw 660 is pivotable around the connecting pin 663 between an unclamped position and a fully clamped position. The connecting pin 663 is also received in a pair of pinholes 633 defined in the proximal end 631 of the channel 630. The connecting pin 663 serves to pivotably mount the anvil jaw 660 to the channel 630. In at least one example, the channel 630 is attached to the shaft portion 610 by a retaining ring, i.e., a band, which fits around the annular groove 632 of the channel 630 and the annular groove 615 of the shaft portion 610. The retaining ring, i.e., a band, is configured to hold the channel 630 to the shaft portion 610.
[0072] The end effector assembly 600 includes a closing drive unit 670 configured to grip tissue between the anvil jaw 660 and the cartridge channel jaw 620 by pivoting the anvil jaw 660 relative to the channel 630. The end effector assembly 600 also includes a firing drive unit 680 configured to clamp, staple, and cut tissue by positioning a plurality of staples from a staple cartridge 640. The closing drive unit 670 includes a closing screw 671 positioned within the channel 630 and a closing wedge 675 screw-coupled to the closing screw 671. As the closing screw 671 rotates, the closing wedge 675 advances distally or retracts proximal to open and close the anvil jaw 660, respectively. The closing drive unit 670 may be actuated by any preferred means. For example, a rotary drive shaft may extend from the operating interface, for example, through a shaft portion 610, to rotate the closing screw 671. Other suitable examples of rotary drive shafts are further described herein.
[0073] The launch drive unit 680 includes a flexible drive shaft 681 configured to move linearly through the end effector assembly 600. The flexible drive shaft 681 may be actuated, for example, by a manually actuated drive shaft of a robot input and / or handle assembly. The flexible drive shaft 681 is configured to extend through a hollow passage 614 of the distal end 613 of the shaft portion 610, and is flexible; therefore, the end effector assembly 600 may be articulated with respect to the shaft from which the end effector 600 extends. The flexible drive shaft 681 extends through a clearance slot 676 defined within a closing wedge 675 and is fixedly attached to the lower launch member 682. The lower launch member 682 is configured to be reused with another staple cartridge.
[0074] The staple cartridge 640 includes a disposable upper launch member 683 configured to hook into, or latch into, the lower launch member 682, so that the lower launch member 582 can push, or drive, the upper launch member 683 via the staple cartridge 640 and the support brace 650. In other words, the firing action includes a two-part launch member consisting of a disposable upper launch member 683 incorporated into the cartridge 640 and a reusable lower launch member 682 incorporated into the firing drive unit 680, which can be coupled together when the cartridge 640 is installed in the elongated channel 630. The two-part launch member will be described further herein.
[0075] The upper launching member 683 comprises an upper flange configured to engage with and position the anvil jaw 660, a knife edge configured to cut tissue, and a latch portion configured to hook-engage with the lower launching member 682. The staple cartridge 640 further comprises a thread 684 configured to engage with a staple driver positioned within the staple cartridge 640 to eject staples from the staple cartridge 640. Since the knife and cutting edge are incorporated into the disposable upper launching member 683 of the staple cartridge 640, new and / or unused cutting edges can be supplied with each staple cartridge loaded in the end effector assembly 600.
[0076] The lower launch member 682 and the upper launch member 683 are configured to move through a support brace 650, so that the vertical load associated with the firing sequence is distributed through the support brace 650, the staple cartridge 640, the channel 630, and the anvil jaw 660. The support brace 650 is made of, for example, a metal material and may be inserted into the staple cartridge 640. The support brace 650 includes a key rail 655 configured to fit into a corresponding key slot defined within the longitudinal slot of the staple cartridge 640. The support brace 650 further includes a longitudinal slot 653 configured to receive the knife of the upper launch member 683, and a cylindrical passage 657 configured to receive a portion of the upper launch member 683, a portion of the lower launch member 682, and a flexible drive shaft 681. The support brace 650 further includes a vertical key extension 656 configured to be received within a corresponding key hole in the cartridge deck. Such extensions are visible through the cartridge deck when the support brace 650 is installed inside the staple cartridge 640. In at least one example, the support brace 650 is configured to be inserted into the staple cartridge 640 from the bottom of the staple cartridge 640 facing the channel 630.
[0077] The support brace 650 further comprises a proximal tab 651 and a distal tab 653, both configured to engage with the channel 630. The tabs 651 and 653 are configured to distribute at least a portion of the force transmitted through the assembly 600 by the launch drive unit 680 and its corresponding components. The distal tab 651 may function to prevent the upper launch member 683 and the lower launch member 682 from being pressed through the distal end of the support brace 650 by sharing and / or redistributing the load applied to the support brace 650 by the launch drive unit 680 with the channel 630.
[0078] When the staple cartridge 640 is replaced so that the end effector assembly 600 can be reused, the staple cartridge 640 is removed from the channel jaw 630. Removing the staple cartridge 640 from the channel jaw 630 removes the upper firing member 683, thread 684, support brace 650, and staple cartridge 640. New knives may come equipped with a replacement staple cartridge.
[0079] Various embodiments disclosed herein may be used in connection with the robotic system 700. An exemplary robotic system is shown, for example, in Figures 21 to 23. Figure 21 shows a master controller 701 which may be used in connection with a surgical robot, such as the robotic arm slave cart 800 shown in Figure 22. The master controller 701 and the robotic arm slave cart 800, as well as their individual components and control systems, are collectively referred to herein as the robotic system 700. Examples of such systems and devices are disclosed in U.S. Patent No. 7,524,320, titled "MECHANICAL ACTUATOR INTERFACE SYSTEM FOR ROBOTIC SURGICAL TOOLS," and U.S. Patent No. 9,072,535, titled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS" (each incorporated herein in its entirety by reference). As is well known, the master controller 701 generally includes a controller (generally represented as 703 in Figure 21) that the surgeon grasps and manipulates in space while viewing the surgery via a stereo display 702. The controller 701 generally includes a manual input device, which often further has an operable handle, trigger, or actuator that moves preferably with multiple degrees of freedom and operates the tool (e.g., close gripping jaws, apply potential to electrodes, etc.).
[0080] As shown in Figure 22, in one embodiment, the robotic arm cart 800 may be configured to actuate one or more surgical tools, generally indicated as 900. Various robotic surgical systems and methods using a master controller and robotic arm cart device are disclosed in U.S. Patent No. 6,132,368, titled "MULTI-COMPONENT TELEPRESENCE SYSTEM AND METHOD," the entire disclosure of which is incorporated herein by reference.
[0081] In various embodiments, the robotic arm cart 800 has a base 702, from which a surgical tool 900 may be supported in the illustrated embodiment. In various embodiments, the surgical tool 900 may be supported by a series of manually articulated linkage mechanisms and a robotic manipulator 806, commonly referred to as a setup joint 804. In various embodiments, the linkage mechanisms and joint devices may facilitate the rotation of the surgical tool around a point in space, as further fully described in U.S. Patent No. 5,817,084, title of the invention, “REMOTE CENTER POSITIONING DEVICE WITH FLEXIBLE DRIVE,” the entire disclosure of which is incorporated herein by reference. This parallelogram arrangement limits the rotation to pivoting around an axis 812a, sometimes referred to as the pitch axis. The couplings supporting the parallelogram linkage mechanisms are pivotably mounted on the setup joint 804 (Figure 22), so that the surgical tool can further rotate around an axis 812b, also referred to as the yaw axis. The pitch axis 812a and the yaw axis 812b intersect at a remote center 814 aligned along the elongated shaft of the surgical tool 900. The surgical tool 900 may have further driven degrees of freedom supported by the manipulator 806, including sliding motion of the surgical tool 900 along the longitudinal axis "LT-LT". When the surgical tool 900 slides against the manipulator 806 along the tool axis LT-LT (arrow 812c), the remote center 814 remains fixed relative to the base 816 of the manipulator 806. Thus, the entire manipulator is generally moved to reposition the remote center 814. The linkage mechanism 808 of the manipulator 806 may be driven by a series of motors 820. These motors actively move the linkage mechanism 808 in response to commands from the processor of the control system. The motors 820 may also be used to operate the surgical tool 900. Alternative joint structures and setup configurations can also be conceived.Examples of other joints and setup devices are disclosed, for example, in U.S. Patent Application No. 5,878,193, titled "AUTOMATED ENDOSCOPE SYSTEM FOR OPTIMAL POSITIONING," the entire disclosure of which is incorporated herein by reference.
[0082] While this specification primarily describes data communication between robotic components and the processor of a robotic surgical system in relation to communication between surgical tools and the master controller 701, it should be understood that similar communication may also occur between circuits such as manipulators, setup fittings, endoscopes, or other imaging devices and the processor of the robotic surgical system for purposes such as component suitability assessment, component type identification, component calibration (offset, etc.), and confirmation of the component's connection to the robotic surgical system. In at least one embodiment, the various surgical instruments disclosed herein may be used in conjunction with other robotic control or automated surgical systems and are not necessarily limited to use with the specific robotic system components shown in Figures 21-23, as described in the aforementioned references.
[0083] During various laparoscopic surgical procedures, it is a common technique to access the surgical site located within the patient's abdomen by inserting the surgical end-effector portion of a surgical instrument through a trocar placed in the patient's abdominal wall. In its simplest form, a trocar is a pen-shaped instrument with a sharp triangular tip at one end, typically used in a hollow tube known as a cannula or sleeve, through which a surgical end-effector can be introduced. Such an instrument forms an access port in the body cavity into which a surgical end-effector can be inserted. The inner diameter of the trocar's cannula inevitably limits the size of the end-effector and drive support shaft of the surgical instrument that can be inserted through the trocar.
[0084] Regardless of the specific type of surgical procedure being performed, once a surgical end-effector is inserted into the patient through a trocar cannula, it is often necessary to move the surgical end-effector relative to the shaft assembly positioned within the trocar cannula in order to properly position it relative to the tissue or organ being treated. This movement or positioning of the surgical end-effector relative to the portion of the shaft that remains within the trocar cannula is often referred to as "articular movement" of the surgical end-effector. To facilitate such articular movement of the surgical end-effector, various articular joints have been developed for attaching the surgical end-effector to the associated shaft. As is expected in many surgical procedures, it is desirable to use a surgical end-effector with the largest possible range of articular movement.
[0085] Due to the size constraints imposed by the size of the trocar cannula, the components of the articular joint must be sized to be freely insertable through the trocar cannula. These size constraints also limit the size and configuration of various drive members and components that operably interact with motors and / or other control systems supported within a housing, which may be handheld or part of a larger automated system. Often, these drive members must operably pass through the articular joint so as to be operably coupled to or operably interacted with the surgical end effector. For example, one such drive member is commonly used to imparticular control movement to a surgical end effector. During use, the articular movement drive member may be non-actuated to position the surgical end effector in a non-articular movement position to facilitate insertion of the surgical end effector through the trocar, and then actuated to articularize the surgical end effector to the desired position when the surgical end effector enters the patient.
[0086] Therefore, the aforementioned size constraints present many challenges in developing articular motion systems that can achieve the desired range of joint movement and accommodate the various different drive systems necessary to operate the various features of the surgical end effector. Furthermore, once the surgical end effector is positioned in the desired articular motion position, the articular motion system and joint must be able to hold the surgical end effector in that position during operation of the end effector and during the performance of surgical procedures. Such a joint device must also be able to withstand the external forces that the end effector experiences during use.
[0087] Various surgical instruments utilize different drive shaft devices that function to transmit driving motion from a corresponding drive motion source supported by the handle of the surgical instrument or other parts of an automatic or robotic control system. These drive shaft devices must be able to adapt to significant articulated orientations of the end effector while effectively transmitting such driving motion beyond the articulation joints of the surgical instrument. In addition, due to the aforementioned size constraints required by the size of the trocar into which the instrument shaft must be inserted, these drive shaft components must occupy the smallest possible space within the shaft. To meet such requirements, many drive shaft devices have several movable elements connected in series with one another. The small size (e.g., 4 mm in diameter) and number of components result in difficult and redundant assembly procedures that increase the cost and complexity of the device.
[0088] As further described herein, an electric stapling device may include two independently rotatable drive members: a first rotary drive member configured to bring the jaws of an end effector to close, and a second rotary drive member configured to bring a staple cartridge mounted within the end effector to fire. The first and second rotary drive members are flexible and configured to extend through at least one articulated joint. In such an example, the first and second rotary drive members can transmit rotational operating motion through the articulated joint when in an unflexed configuration and when in a flexed configuration. Exemplary rotary drive members are further described herein.
[0089] The motorized staple fastening assembly further comprises a closing drive unit having a first jaw, a second jaw, and a first rotary drive member extending through an articulated joint, and a firing drive unit having a second rotary drive member extending through an articulated joint. The second rotary drive member may be rotatable independently of the first rotary drive member. The closing drive unit can be actuated, for example, by a closing trigger, and the actuation of the closing drive unit results in the rotation of the first rotary drive member, which transmits rotational motion to a closing screw via the articulated joint. The closing drive unit further comprises a closing wedge screw-coupled to the closing screw, the closing wedge engaging with the first jaw to move the first jaw from an open position to a closed position when the first rotary drive member rotates.
[0090] The firing drive unit may be actuated, for example, by a firing trigger separate from the closing trigger. The rotation of the second rotary drive member is separate from the rotation of the first rotary drive member, and the closing motion is separate from the firing motion and is distinctly different. Activation of the firing drive unit results in the rotation of the second rotary drive member, which transmits rotational motion to the firing screw via an articulated joint. The firing drive unit further comprises a firing member screw-coupled to the firing screw, the firing member cam-engaged with the first and second jaws and configured to move the cutting member and / or staple firing thread when the second rotary drive member rotates.
[0091] In various examples, at least one component within a motorized stapling device may be a 3D printed component. 3D printed components may be incorporated into articulated joint systems, closing / gripping systems, and / or firing systems, as further described herein. 3D printing technology can be used to improve the capabilities of components in certain examples. For example, 3D printing can enable printed components to exhibit metamaterial properties, resulting in increased structural strength and rigidity while enabling precision in forming small, fine features and optimizing other properties of the component, such as selective flexibility and / or lubricity. Exemplary 3D printed components for motorized stapling devices are further described herein, including, for example, flexible, rotatable drive members, such as serial 3D printed universal joints, firing members, or I-beams, and / or staple cartridges and / or their subcomponents. In one example, a staple cartridge may be a plastic-metal composite 3D printed component. 3D printing of various components and considerations therefor are further described herein.
[0092] A method of stapling using such a surgical staple assembly has also been conceived. This method may include obtaining the surgical staple assembly and activating a closing drive by a closing trigger, wherein the closing wedge is configured to engage with a first jaw to move the first jaw from an open position to a closed position when a first rotary drive member rotates. This method may further include activating a firing drive by a firing trigger, wherein the firing member is configured to cam-engage with the first and second jaws to advance the cutting member and / or staple firing thread during the firing motion when a second rotary drive member rotates. Various applications of 3D printed components in such assemblies are described further herein.
[0093] Figures 24 to 33 show an end effector assembly 1000 for stapling tissue. The end effector assembly 1000 is similar to the end effector assembly 600. However, the end effector assembly 1000 and the accompanying description include more detail than the end effector assembly 600. The end effector assembly 1000 comprises a shaft portion 1010 and an end effector having a first jaw 1011 and a second jaw 1013 movable relative to the first jaw 1011. The end effector assembly 1000 is configured to cut and staple tissue captured between the jaws 1011, 1013. The end effector assembly 1000 can be attached by the shaft portion 1010 to the handle of a surgical instrument and / or to the interface of a surgical robot. The handle of a surgical instrument and / or the interface of a surgical robot may be configured to operate various functions of the end effector assembly 1000. The first jaw 1011 is equipped with a cartridge channel 1020, and the second jaw 1013 is pivotably mounted to the cartridge channel 1020 by a pin 1084 and is equipped with an anvil 1080 that clamps tissue between the jaws 1011 and 1013.
[0094] The end effector assembly 1000 further comprises a replaceable staple cartridge 1050 configured to be mounted within a cartridge channel 1020, and a support beam 1100 positioned within the staple cartridge 1050. As will be discussed in more detail below, the support beam 1100 is configured to provide additional internal support to the end effector assembly 1100 within the staple cartridge 1050. The staple cartridge 1050 comprises a cartridge body 1055 having a proximal end 1051, a distal end 1053, and a cartridge deck 1056. The cartridge body 1055 further comprises a plurality of staple cavities 1057 defined within the deck 1056 and arranged in a longitudinal row, and a longitudinal slot 1059 defined within the deck 1056 and configured to receive a portion of the launcher assembly, as will be discussed in more detail below.
[0095] The replaceable staple cartridge 1050 is configured to detachably house multiple staples within a staple cavity 1057. The staples are ejected from the staple cartridge and contact the anvil surface 1083 of the anvil 1080 to form a staple, thereby stapling any trapped tissue between the deck 1056 and the anvil surface 1083. To eject the staples, the thread 1070 is pushed by the launching member assembly from the proximal end 1051 of the staple cartridge 1050 toward the distal end 1053. As the thread 1070 translates longitudinally within the staple cartridge 1050, it is configured to contact and lift multiple staple drivers supporting the staples within the staple cartridge 1050, and then contact the anvil surface 1083 to form a staple.
[0096] A closing drive 1210 is provided to open and close the anvil 1080 relative to the cartridge channel 1020 and the staple cartridge 1050. Referring to Figures 25 to 27, the closing drive 1210 includes a rotary closing drive 1211 configured to be actuated, for example, by a rotary output shaft of a surgical instrument handle and / or a robot interface. The rotary closing drive 1211 is supported within the proximal end 1021 of the channel 1020 and includes a thread 1212. The closing drive 1210 further includes a closing wedge 1220 having a thread 1223 screw-coupled to the thread 1212 of the rotary closing drive 1211. Thus, as the rotary closing drive 1211 rotates, the closing wedge 1220 is configured to translate longitudinally within the anvil cavity 1085 defined within the proximal end 1081 of the anvil 1080. The rotary closing drive unit 1211 may be called a closing screw in various examples.
[0097] The closure wedge 1220 comprises an opening cam surface 1222 and a closure cam numb 1223. To close the anvil 1080, the closure wedge 1220 is moved proximal by the rotary closure drive 1221 so that the opening cam surface 1222 defined thereon engages with the proximal end 1081 of the anvil 1080, thereby pivoting the anvil 1080 toward the closed position around the pin 1084. To open the anvil 1080, the closure wedge 1220 is moved distally by the rotary closure drive 1221 so that the closure cam numbs 1223 engage with the proximal end 1081 of the anvil 1080, thereby pivoting the anvil 1080 toward the open position around the pin 1084. The closing wedge 1220 further comprises a U-shaped slot 1221 configured to allow passage of the linear-actuated launch drive unit, which will be discussed in more detail below.
[0098] A launch drive 1250 is provided to launch the end effector assembly 1000. The launch drive 1250 comprises a flexible launch shaft 1251 configured to be actuated by a linear output shaft of a surgical instrument handle and / or a robotic interface. The flexible launch shaft 1251 passes through a U-shaped slot 1221 of a closing wedge 1220 toward the launch assembly comprising a lower launch member 1260 and an upper launch member 1270. The launch shaft 1251 comprises a distal end 1252 fixed in a drive slot 1263 defined in a guide portion 1265 of the lower launch member 1260. In at least one example, the launch shaft 1251 is rotatably supported (e.g., pivotally supported) within the drive slot 1263 so that the launch shaft 1251 can rotate within the drive slot 1263 while pushing and pulling the lower launch member 1260. Such a configuration allows rotation of the flexible launch shaft 1251 relative to the lower launch member 1260 while maintaining a linearly operable engagement. The anvil 1080 further comprises an upper anvil cap 1090 configured to be attached to the anvil 1080. The anvil cap 1090 may, for example, be welded to the anvil 1080 and serve to reinforce the anvil 1080. The channel 1020 may also comprise a channel cap 1030.
[0099] The lower launch member 1260 comprises a lower cam flange 1261 extending laterally from the lower launch member 1260, an upper cam flange 1262 extending laterally from the lower launch member 1260, and a guide portion 1265 configured to be received within the support beam 1100, which will be described in more detail below. The lower cam flange 1261 is configured to engage with the channel 1020 during the launch stroke to maintain the defined clamp structure gap between the staple cartridge 1050 and the anvil 1080. The upper cam flange 1262 is configured to engage with the support beam 1100 during the launch stroke. As will be discussed in more detail below, providing multiple cam flanges within the launch assembly can help distribute the clamping force within the end effector assembly 1000. When discussing the cam flanges, it should be understood that, as seen in the drawings, the flanges extend laterally outward from both sides of the main body portion of the launch member.
[0100] An upper launch member 1270 is also provided. The upper launch member 1270 is configured to be advanced through the launch stroke by the lower launch member 1260. A guide portion 1265 is configured to press against a guide portion 1274 of the upper launch member 1270. The upper launch member 1270 comprises an upper cam flange 1272 extending laterally from the upper launch member 1270, a lower cam flange 1273 extending laterally from the upper launch member 1270, and a guide portion 1274 configured to be received within the support beam 1100 and described in more detail below. The upper cam flange 1272 is configured to engage with the anvil 1080 during the launch stroke. Specifically, the upper cam flange 1272 is configured to apply a clamping force to the anvil 1080 in the slot 1086. At the start of the firing stroke, the upper cam flange 1272 is configured to engage with the proximal inclined portion 1087 of the slot 1086, thereby initiating the application of a clamping force within the end effector assembly 1000.
[0101] The lower cam flange 1273 of the upper launch member 1270 is configured to engage with the support beam 1100 during the launch stroke. Such a lower cam flange 1273 can provide an additional cam flange within the launch member assembly to help distribute the clamping force within the end effector assembly 1000. The upper launch member 1270 further comprises a cutting edge, i.e., a knife 1271, configured to cut the tissue clamped between the staple cartridge 1050 and the anvil 1280. The upper launch member 1270 further comprises a drive surface 1276 defined on the front of the upper launch member 1270. The drive surface 1276 is configured to press the drive flange 1071 of the thread 1070. As the thread 1070 advances through the end effector assembly 1000 by the upper launch member 1270, the thread rail 1072 of the thread 1070 is configured to engage with the staple driver, lift the staple driver, and eject the staple to staple the tissue.
[0102] In at least one example, the upper launcher 1270 is disposable, and the lower launcher 1260 is reusable. In such an example, when the upper launcher 1270 is replaced, the staple cartridge 1050 is positioned in a ready-to-mount or ready-to-fire position. In other words, each time a new staple cartridge is mounted, the user receives a new upper launcher. Such a configuration can provide a new staple cartridge with each new knife.
[0103] The lower launch member 1260 is provided with a hook receiving slot 1264, and the upper launch member 1270 is provided with a hook portion 1275 configured to be received within the hook receiving slot 1264. The staple cartridge 1050, including the thread 1070 and the upper launch member 1270, may be mounted at an angle similar to the angle of the anvil 1080 when it is positioned in its open position. Such an angle allows the user to latch, or hook, the upper launch member 1270 into the lower launch member 1260 when mounting the staple cartridge 1050 into the channel 1020. In at least one example, the lower launch member 1260 is configured to push and pull the upper launch member 1270 within the end effector assembly 1000 by pushing the guide portion 1274 with the guide portion 1265 and pulling the hook portion 1275 with the hook portion 1264. In a particular example, the alignment and / or levering features between the staple cartridge 1050 and the channel 1020 are configured to interact to ensure proper alignment and insertion of the staple cartridge 1050.
[0104] Since a new disposable knife may be provided each time a staple cartridge is installed, the staple cartridge 1050 further comprises a knife guard tab 1060 extending upward from the deck 1056. The knife guard tab 1060 may protect the user from being cut by the knife edge 1271 when handling the staple cartridge 1050. The knife guard tab 1060 may also prevent the tissue from being accidentally cut when the tissue is clamped by the end effector assembly 1000 and before the cutting motion. If tissue leaks toward the knife guard tab 1060 before firing, the knife guard tab 1060 protects the unstapled tissue before firing.
[0105] As described above, various types of firing and clamping forces are present within the end effector assembly 1000. The support beam 1100 is configured to increase the force distribution within the end effector assembly, thereby distributing the clamping force within the end effector assembly to various components and helping to reduce the likelihood of failure in any of the components. In end effectors without a support beam, the clamping force may be applied mainly to the channel and anvil. The end effector assembly 1000 allows for greater distribution of the clamping force within the end effector assembly 1000.
[0106] Referring primarily to Figures 28 to 33, the internal support beam 1100 is positioned within the internal longitudinal channel 1060 of the staple cartridge 1050. The internal support beam 1100 may be made of a material with higher strength than the cartridge body 1055. In at least one example, the support beam 1100 is made of a metallic material, and the cartridge body 1055 is made of a polymer. In such an example, the support beam 1100 can help distribute the clamping force within the end effector assembly 1100 by being made of a material with higher strength than the material of the cartridge body 1055.
[0107] The support beam 1100 has an upper surface 1110, the upper surface 1110 having a plurality of projections 1111 that protrude therefrom and are configured to be received in corresponding slots 1058 defined in the deck 1056 of the staple cartridge 1050. The projections 1111 may provide additional lateral and longitudinal support within the staple cartridge 1050. In other words, the projections 1111 can prevent the support beam 1100 from sliding laterally or longitudinally relative to the cartridge body 1055. The projections 1111 may also help align the support beam 1100 with the cartridge body 1055 when assembling the support beam 1100 with the cartridge body 1055. In at least one example, the support beam 1100 is mounted inside the staple cartridge 1050 before packaging. In such an example, the replaceable staple cartridge 1050 already has the support beam 1100. Therefore, when the staple cartridge 1050 is replaced, a new support beam is installed.
[0108] The support beam 1100 can slide vertically from the bottom of the staple cartridge 1050 on the opposite side of the deck 1056 into the internal longitudinal channel 1060 of the cartridge body 1055. The cartridge body 1055 further comprises a lateral rail, or ledge 1062, defined on the channel wall 1061 of the internal longitudinal channel 1060. The rail 1062 is configured to fit into a corresponding slot 1109 defined on the side of the support beam 1100. The rail 1062 is configured to hold the support beam 1100 within the cartridge body 1055 and prevent the support beam 1100 from falling from the bottom of the cartridge body 1055. The internal longitudinal channel 1060 further comprises an upper surface 1063 defined below the thickness of the deck 1056. The upper surface 1110 of the support beam 1100 is configured to abut against the upper surface 1063.
[0109] In at least one example, the cartridge body 1055 is overmolded onto the support beam 1100. Such a configuration can provide a variety of internal features that would otherwise be difficult to provide if the parts were manufactured separately and required assembly after their manufacture. In at least one example, the cartridge body 1055 is overmolded and / or insert-molded onto the support beam 1100 and the upper launching member 1270. In such an example, the staples, staple driver, and threads may be incorporated into the staple cartridge 1050 and the support beam 1100 after the completion of the overmolding process. In at least one example, the support beam 1100 is insert-molded into the staple cartridge 1050.
[0110] The support beam 1100 further comprises a longitudinal cavity 1120 having a lower cam slot 1121, an upper cam slot 1123, and a cylindrical slot 1122. The lower cam slot 1121 is configured to receive the upper cam flange 1262 of the lower launch member 1260. The upper cam slot 1123 is configured to receive the lower cam flange 1273 of the upper launch member 1270. The cylindrical slot 1122 is configured to receive the guide portion 1274, the guide portion 1265, and the flexible launch shaft 1251 as the upper launch member 1270 and the lower launch member 1260 advance through the end effector assembly 1000. The longitudinal cavity 1120 is also configured to receive the drive flange 1071 of the thread 1070 when the thread 1070 is pushed by the upper launch member 1270. In at least one example, the flexible launch shaft 1251 is configured to be closely received within a cylindrical slot 1122 such that their respective cross-sectional outlines substantially coincide. In such an example, the cylindrical slot 1122 can function to help prevent buckling of the flexible launch shaft 1251 as it advances through the cylindrical slot 1122. When the flexible launch shaft 1251 is subjected to compressive forces, the cylindrical slot 1122 can support the length of the flexible launch shaft 1251 positioned within it, thus helping to prevent buckling of the flexible launch shaft 1251.
[0111] As described above, the support beam 1100 is configured to help distribute the clamping force applied to the end effector assembly 1100 by the flanges 1272, 1273, 1262, and 1261. Guide portions 1274 and 1265 may also apply vertical clamping forces by the flanges 1272, 1273, 1262, and 1261 and may also help distribute the clamping force through the support beam 1100. As the upper launch member 1270 and the lower launch member 1260 advance through the end effector assembly 1000, the flanges 1272, 1273, 1262, and 1261 can apply vertical clamping forces to the anvil 1080, the channel 1020, and the support beam 1100. These forces can be distributed primarily between the anvil 1080, the channel 1020, and the support beam 1100, and these components are stronger than the staple cartridge 1050, which can be made primarily of metal. By distributing the clamp load through these components, the vertical crushing force applied to the cartridge body 1055 itself can be reduced. Such a device can also reduce the possibility of any of the flanges 1272, 1273, 1262, and 1261 being sheared from their respective launch member bodies, as they can share the vertical clamping force along the vertical length of the end effector assembly 1000. The support beam 1100 can also have an additional support between the channel 1020 and the anvil 1080, rather than relying solely on the channel 1020 and the anvil 1080 to cope with all the clamping forces applied by the channel flange and anvil flange alone.
[0112] In at least one example, the upper launch member 1270 and the lower launch member 1260 are referred to as a double I-beam. This configuration may allow for a central longitudinal cavity, such as a cylindrical slot 1122 defined within a support beam 1100 positioned between the upper flange 1262 of the lower launch member 1260 and the lower flange 1273 of the upper launch member 1270.
[0113] Guide sections 1265 and 1274 can also help reinforce the launch members 1260 and 1270 by providing rounded sections that engage with the support beam 1100. The rounded sections can also provide a source of strength to the launch members 1260 and 1270 because they can withstand significant vertical forces. Failure is more likely to require shear-type failure rather than bending-type failure, and in certain examples the strength of the rounded sections is greater than that of the lateral flanges. Having launch members with both lateral flanges and rounded sections can increase the overall strength of the launch assembly because it is related to the vertical clamping forces it receives within the end effector assembly 1000. All of the vertical clamping forces can function to maintain a predetermined structural gap between the staple cartridge 1050 and the anvil 1080.
[0114] The end effector assembly 1000 is also subjected to longitudinal loads. For example, the launcher assembly may be subjected to longitudinal loads applied by the tissue on the knife 1271. The launcher assembly may also be subjected to longitudinal loads generated by the clamping forces applied to the channel 1020 and the anvil 1080. The launcher assembly may also be subjected to longitudinal loads when it contacts its components at its nearest position. The launcher assembly and / or thread may also be subjected to longitudinal loads when it contacts the distal end of the end effector assembly 1000. In such an example, the thread and / or launcher assembly components may be pushed distally towards the nose, anvil, and / or support beam of the staple cartridge. The end effector assembly 1000 also includes features that help distribute these longitudinal loads within the end effector assembly 1000.
[0115] The support beam 1100 includes a proximal hook 1102 (Figure 29) and a distal hook 1104 (Figure 30) extending downward from the support beam 1100. The proximal hook 1102 is configured to be received in a corresponding channel opening 1023 defined at the proximal end 1021 of the channel 1020. The proximal hook 1102 can be latched into the opening 1023 when the staple cartridge 1050 and the support beam 1100 are installed in the channel 1020. The hook 1102 may be installed with a click, for example, to inform the user that the installation was successful. The hook 1102 is also visible from below the channel 1020 so that the user can see whether the hook 1102 is properly engaged with the channel 1020. The distal hook 1104 is configured to be received in a corresponding channel opening 1024 defined at the distal end 1022 of the channel 1020. The distal hook 1104 may be snapped into the opening 1024 by the inclined surface 1104' after the proximal hook 1102 has been properly mounted within the proximal end 1021 of the channel 1022. The hooks 1102 and 1104 may function to distribute the longitudinal load received within the end effector assembly 1000. The distal hook 1104 may allow the launching members 1260 and 1270 to apply force primarily to the channel 1020 instead of the distal end, i.e., the nose 1053, of the staple cartridge 1050 at the end of the launch stroke. Such a configuration may protect the integrity of the nose 1053 of the staple cartridge 1050, which is typically made of a material that is more fragile than the channel 1020. The channel 1020 may function to support the force applied distally by the launching members 1260 and 1270 instead of the cartridge nose 1053. The distal end 1103 of the support beam 1100 also has a mating shape configured to fit into the nose 1053 of the staple cartridge 1053.
[0116] As described above, the upper launch member 1270 is disposable and can be removed together with the staple cartridge 1050 so that a new upper launch member can be installed in a new staple cartridge. In such an example, the upper launch member 70 may move to its nearest position after the completion of the firing stroke. When the upper launch member 1270 is retracted to its nearest position, the anvil 1080 may be pivoted open by the closing drive unit 1210. As the anvil 1080 pivots open, the engagement surface 1087 may tilt the upper launch member proximal to the lower launch member 1260, thereby releasing the hook 1275. At that point, the staple cartridge 1050 and the upper launch member 1270 can be pulled away from the channel 1020 and / or their snap fasteners can be released, so that a new staple cartridge, support beam, and upper launch member can be installed in the channel 1020 and the end effector assembly 1000 can be reused.
[0117] Figures 34 and 35 show a portion of a staple fastening assembly 1200, comprising a support beam 1210, a launching member such as a thread 1220, and a connecting member 1201 for connecting the launching member 1220 to the support beam 1210. The staple fastening assembly 1200 may be used in any suitable staple cartridge, such as the staple cartridge disclosed herein. The support beam 1210 comprises a central drive cavity 1211 configured to receive at least a portion of the launching beam and / or launching member assembly (e.g., the upper and lower launching members described above), an upper slot 1214 configured to receive at least a portion of the launching member assembly, and a pair of horizontal slots 1213 configured to receive the connecting member 1201. The upper slot 1214 may be aligned with a longitudinal slot defined in the deck of the staple cartridge. The connecting member 1201 may consist of, for example, a pin.
[0118] The launching member 1220 is configured to eject staples from the staple cartridge as the launching member advances through the staple cartridge and the support beam 1210. The support beam 1210 further comprises at least a partially curved wall, i.e., a flange 1212, that partially surrounds the central drive cavity 1211. The launching member 1220 includes a drive inclined surface 1222 configured to push staples and / or a staple driver out of the staple cartridge.
[0119] In at least one example, the launcher assembly is configured to push only the launcher 1220, causing it to advance through the staple cartridge and support beam 1210. Such a configuration may allow the majority of the launch force to be applied directly to the launcher 1220. In at least one example, the launcher assembly is configured to push both the connecting member 1201 and the launcher 1220, causing the launcher 1220 to advance through the staple cartridge and support beam 1210. Such a configuration may allow the application of the launch force to be shared and distributed across the entire connecting member 1201 and launcher 1220.
[0120] In at least one example, the launch member assembly is configured to push only the connecting member 1201 to advance the launch member 1220 through the staple cartridge and support beam 1210. Such a configuration can, in certain examples, allow for a more concentrated firing force to be applied to the metallic components rather than the polymer components. For example, the launch member 1220 may be made of polymer, while the connecting member 1201 may be made of metal. In at least one example, the launch member 1220 and the connecting member 1201 are made of the same material.
[0121] For example, by applying a firing force to a connecting member such as the connecting member 1201, the applied firing force can be spread laterally along the longitudinal movement path of the firing member 1220. This lateral dispersion can help distribute the firing force across the entire support beam 1210. The firing member 1220 is configured to surround the bottom of the support beam 1210. Such a configuration can allow the use of threads of different sizes within the cartridge channel.
[0122] Figures 36 and 37 show a staple-holding cartridge 1300 configured for use with any suitable staple cartridge disclosed herein. The staple-holding assembly 1300 comprises a launch assembly 1310 configured to be actuated by a launch shaft, a support beam 1340 configured to be positioned with the staple cartridge, and a thread, i.e., a launching member 1350, configured to eject staples from the staple cartridge. The launch assembly 1310 comprises a lower launching member 1320 and an upper launching member 1330 configured to be actuated by the lower launching member 1320. The lower launching member 1320 comprises a drive unit 1323 configured to drive the upper launching member 1330, a shaft connection cavity 1321 configured to receive the launch shaft inside, and a bottom 1322. The upper launching member 1330 comprises, for example, an upper flange 1331 configured to engage with an anvil, and a lower flange 1332 configured to engage with a portion of the support beam 1340.
[0123] The support beam 1340 comprises a longitudinal channel 1343 configured to receive the launch member assembly 1310 therein, and a flared ledge 1341 configured to support the launch member 1350. The lower flange 1332 is configured to apply a cam force to the support beam 1340 within the longitudinal channel 1343. Collectively, the upper flange 1331 and the lower flange 1332 are configured to maintain a predetermined tissue gap between the staple cartridge and the anvil.
[0124] The thread 1350 comprises a guide arm 1351 configured to be supported by a flared ledge 1341 of a support beam 1340, and a drive inclined surface 1352 configured to eject staples from a staple cartridge. The thread 1350 can be pivoted for assembly and mounted on one end of the support beam 1340. The thread 1350 is suspended from the flared ledge 1341. Such a configuration may allow the use of different sized threads and the same support beam 1340 for different cartridges. The launch assembly 1310 is configured to push the thread 1350 through the staple launch stroke. The flared ledge 1341 may further function to transmit the vertical cam force applied by the launch member assembly 1310 to the staple cartridge. In at least one example, the vertical cam force applied by the launch member assembly 1310 is isolated from the staple cartridge. In such an example, the support beam 1340 is configured to receive, if not all, of the vertical clamping force, in addition to, for example, the anvil and / or channel. Such a configuration allows the vertical clamping force to be concentrated on a higher-strength component, such as a metal component.
[0125] Alternative support beam geometric shapes can also be conceived. For example, Figure 38 shows a support beam 1410 configured to be positioned within a staple cartridge, such as the staple cartridge disclosed herein. The support beam 1410 is configured to help distribute vertical clamping forces across the end effector assembly. The support beam 1410 includes a substantially circular, elliptical, or radial outer circumference 1411, and therefore a cross-sectional shape. The support beam 1410 further comprises an upper channel 1413 and a lower channel 1415. The channels 1413, 1415 are configured to receive one or more components of a launch member assembly, such as those disclosed herein. Channel 1413 includes a cylindrical cavity portion 1414, which can receive, for example, a guide portion of an upper launch member. Channel 1415 includes a cylindrical cavity portion 1416, which can receive, for example, a guide portion of a lower launch member. The substantially radial cross-sectional shape of the support beam can serve to reinforce the support beam 1410. In such a configuration, the support beam 1410 is less likely to be damaged by the bending load applied by the vertical clamping force. A rounded cam flange can also be used with the support beam 1410. The rounded cam flange can provide a reinforced flange system within the end effector assembly, as will be further described herein.
[0126] Figure 39 shows a support beam 1420 configured to be positioned within a staple cartridge, such as a staple cartridge disclosed herein. The support beam 1420 is configured to help distribute vertical clamping forces across the end effector assembly. The support beam 1420 includes a substantially circular or radial outer circumference 1421, and therefore a cross-sectional shape. The support beam 1410 further comprises a substantially circular or radial lower flange 1424 extending from the outer circumference 1421. In at least one example, the lower flange 1424 is configured to engage with, for example, the bottom of the staple cartridge and may comprise one of the flanges in a multi-flange system. In such an example, the launching member of the launching member assembly may have a flange receiving cavity rather than a laterally extending flange.
[0127] The support beam 1420 further comprises an upper channel 1422. The channel 1422 is configured to receive one or more components of a launch member assembly as disclosed herein. The channel 1422 comprises a cylindrical cavity portion 1423 which can receive, for example, a guide portion of the upper launch member.
[0128] Figures 40 and 41 show a staple fastening assembly 1500 configured to cut and staple a patient's tissue. The staple fastening assembly 1500 comprises a staple cartridge 1510 configured to removably house a plurality of staples inside, a thread 1520 having a drive inclined surface 1521 configured to eject staples housed in the staple cartridge 1510, and an I-beam 1570 configured to push the thread 1520 through the staple cartridge 1510. The staple fastening assembly 1500 further comprises a cartridge support 1530 positioned within a longitudinal channel 1511 of the staple cartridge 1510, defined by an inner wall 1512 and a ledge 1513. The cartridge support 1530 comprises an upper cam channel 1533 configured to receive a lower cam flange 1572 of the I-beam 1570, and a lower cam channel 1531 configured to receive a cam flange 1523 of the thread 1520.
[0129] The cam flange 1523 comprises a support portion 1524 extending upward into the cam channel 1531 and a flange 1525. The flange 1525 extends from the support portion 1524 to form a T-shape. However, other geometric shapes can also be conceived. As the thread 1520 advances through the staple cartridge 1510 and the cartridge support 1530, the flange 1525 moves through the cam channel 1531. The cartridge support 1530 is configured to support the vertical clamping force applied to the staple fastening assembly 1500 by the I-beam 1570 and the thread 1520.
[0130] The staple fastening assembly 1500 further comprises a deck plate 1560 positioned on the deck surface 1514 of the staple cartridge 1510. The deck plate 1560 may help distribute the clamping force within the staple fastening assembly 1500. The deck plate 1560 may be made of, for example, a metal material. The deck plate 1560 comprises a plurality of openings 1561 configured to align with staple cavities defined within the staple cartridge 1510. The deck plate 1560 further comprises longitudinal slots 1562 aligned with longitudinal channels 1511. The cartridge support 1530 further comprises a central cylindrical support cavity 1535 configured to receive at least a portion of the launcher assembly. For example, the central cylindrical support cavity 1535 is configured to receive, for example, a linear actuator, a guide portion of a launcher component, and / or a guide portion of a thread.
[0131] Referring primarily to Figure 41, the cartridge support 1530 includes a longitudinal slot 1536 configured to receive the ledge 1513 of the staple cartridge 1510. The width 1541 and height 1542 can be adjusted, for example, to accommodate cartridges, staples, and / or staple drivers of different sizes. The width 1541 and height 1542 of the cartridge support 1530 can also be adjusted for different tissue gap distances between the staple cartridge 1510 and the anvil. In at least one example, the width 1541 and height 1542 can be adjusted to adjust the distribution of clamping load for different scenarios. For example, in staple fasteners with lower clamping forces, a cartridge support with a narrower width than the cartridge support 1530 may be useful.
[0132] Figure 42 shows a cartridge support 1600 configured to be positioned within a staple cartridge, such as a staple cartridge disclosed herein. The cartridge support 1600 comprises a cylindrical central portion 1606 defining a central longitudinal guide cavity 1605, an upper cam channel 1603, and lower cam channels 1601 and 1601, respectively, configured to receive cam flanges. The central longitudinal guide cavity 1605 may be configured to receive guide portions of one or more components of a launch assembly, such as a thread, an upper launch member, or a lower launch member. The central longitudinal guide cavity 1605 may also be configured to receive a launch shaft internally. The cam channels 1601, 1603 include radial cross-sections. Such a device can reduce the possibility of breakage of the internally received flanges due to bending loads.
[0133] Figure 43 shows a staple fastening assembly 1700 comprising a cartridge support 1710 and a thread 1720. The cartridge support 1710 comprises a longitudinal slot 1711 configured to receive at least a portion of the thread 1720 through its interior during the firing stroke. The thread 1720 comprises a base 1721 configured to be screw-coupled, for example, to a firing drive screw, and a first arm 1722 extending upward from the base 1721 around a first side of the cartridge support 1710. The thread 1720 further comprises a second arm 1723 extending upward from the base 1721 around a second side of the cartridge support 1710. The arms 1722 and 1723 each comprise guide teeth 1724 and 1725, respectively, which are received in corresponding slots 1712 and 1713 of the cartridge support 1710, respectively. The engaging features for securing the thread 1720 within the cartridge support 1710 are asymmetrical with respect to the vertical centerline plane. More specifically, the arms 1722, 1723 have different geometric shapes, e.g., different heights, and the guide teeth 1724, 1724 also have different geometric shapes, e.g., different lengths and / or shapes. The slots 1712, 1713 have similar external shapes to the teeth they are configured to receive. Such a configuration can provide means to ensure that the thread 1720 is mounted in the correct orientation. Such a configuration can also allow for fine adjustment of the load applied to the thread 1720 via the differently sized arms 1722, 1723.
[0134] Figure 44 shows a thread 1730 configured for use with any suitable staple cartridge and / or staple cartridge support discussed herein. Unlike thread 1720, thread 1730 comprises an arm 1732 having the same height and shape. The arm 1732 comprises teeth 1733 extending from a base 1731 and extending outward relative to thread 1731. Such a thread may be configured to be guided by the cartridge support and / or staple cartridge within an internal guide slot defined within the cartridge support and / or staple cartridge, thanks to the outwardly extending teeth 1733.
[0135] Figure 45 shows a cartridge support 1740 having a central cavity 1741 configured to receive, for example, a thread 1730 (Figure 45) internally. The central cavity 1741 has laterally opposed slots 1742, each having a vertical mounting portion 1743 configured to receive, for example, a tooth 1733. The firing member assembly may be configured to push the thread 1730 through the cartridge support 1740 during the firing stroke.
[0136] Figure 46 shows a staple fastening assembly 1800 comprising a cartridge jaw 1810, an anvil 1820, a launching member 1840, and a thread 1830 configured to be pushed by the launching member 1840 and pass through the cartridge jaw 1810. The thread 1830 is pinned to the launching member 1840 by a pin 1812. For example, when the launching member 1840 is advanced by the launching shaft, the thread 1830 is pushed by the pin 1812. The launching member 1840 comprises a bottom flange 1842 configured to be received in a slot 1811 of the cartridge jaw 1810, and an upper flange 1841 configured to be received in a slot 1821 defined in the anvil 1820.
[0137] Figure 47 shows a surgical staple fastening assembly 1900 comprising a cartridge channel 1910 and an anvil 1920. The surgical staple fastening assembly 1900 further comprises a support beam 1940 and a staple cartridge 1970. The surgical staple fastening assembly 1900 further comprises a launching member 1950 comprising an upper flange 1952 configured to engage with the anvil 1920 and a lower flange 1951 configured to engage with the support beam 1940. The surgical staple fastening assembly further comprises a thread 1930 pinned to the staple cartridge 1970 and the support beam 1940 by a pin 1960.
[0138] In various examples, a launcher assembly configured to be driven by a launch drive screw located within an end effector may become stuck during the firing stroke. This sticking may occur in the threaded engagement between the launcher assembly and the launch drive screw. In certain examples, such sticking may be due to the location of the force transmission from the drive screw to the launcher assembly. In various examples, the force transmission location occurs directly adjacent to the threads of the launch drive screw and the receiving threads of the launcher assembly. Since the launch drive screw is generally located within the cartridge channel jaws, the force transmission location is situated at a distance from the center of mass and / or the drive center of the launcher assembly. Applying this force can create a torque load on the launcher assembly that can cause a threaded engagement between the launch drive screw and the launcher assembly, resulting in sticking.
[0139] Various launch member assemblies are disclosed herein, which can reduce the occurrence of seizing by shifting the location of the transmitted force closer to the center of mass and / or drive center of the launch member assembly. More specifically, these configurations can reduce the possibility of screw seizing between the launch member assembly and the launch drive screw. Such configurations can also result in more efficient force transmission from the launch drive screw to the launch member assembly and to the thread and / or cutting member. By applying force directly to the thread and / or cutting member by the launch member assembly, the overdrive force required for the launch drive screw can be reduced. Such direct force applied near the center of the launch member assembly can also reduce the driving force required to maintain a given structural gap using the upper and lower cam flanges of the launch member assembly. This can be achieved by concentrating the force application to the launch member assembly at or near the vertical center of the cam action flange.
[0140] Figures 48 and 49 show a launcher assembly 2000 configured for use in a surgical staple assembly, such as a surgical staple assembly disclosed herein. The launcher assembly 2000 is actuated by a launcher drive screw and configured to cut and staple tissue. Specifically, the launcher assembly 2000 is configured to push a thread to position staples from a staple cartridge. In at least one example, the thread includes a cutting member configured to cut tissue when the launcher assembly 2000 is actuated via an end effector. In another example, the cutting member is part of the launcher assembly. The launcher assembly 2000 is further configured to maintain a predetermined tissue gap by providing cam flanges that engage with the upper and lower jaws of an end effector.
[0141] The launch member assembly 2000 comprises a main body portion, i.e., a distal head 2010, and a drive nut 2030 configured to fit into a drive cavity, i.e., a receptacle 2023, of the main body portion 2010. The main body portion 2010 comprises an upper portion 2011 having a jaw engagement flange 2012. The upper portion 2011 further comprises a distal nose 2013, which can be used to clamp the jaws from an unclamped position. The main body portion 2010 comprises a drive surface 2014 configured, for example, to press a thread and / or cutting member. The main body portion 2010 further comprises a lower portion 2015 having a proximal portion 2016 and a distal portion 2019 defining a drive cavity 2023. The proximal portion 2016 comprises a proximal lower flange 2018 extending laterally therefrom, and a drive thread duct 2017. The distal portion 2019 comprises a distal lower flange 2021 and a drive screw duct 2020. The drive screw ducts 2017 and 2020 are aligned with each other and configured to receive a launch drive screw passing through them. However, the drive screw ducts 2017 and 2020 are not screw-coupled to the drive screw. Rather, the drive screw ducts 2017 and 2020 may include support channels configured to support a launch drive screw (e.g., the launch screw 261 in Figures 4 and 5) that is screw-coupled to, for example, the launch member assembly 2000.
[0142] The drive nut 2030 is configured to be screw-coupled to the firing drive screw and to apply actuation force to the main body portion 2010. The drive nut 2030 is configured to fit into the drive cavity 2023. The drive nut 2030 includes a lower threaded portion 2035 comprising a cam flange 2031 configured to engage with the jaws of the end effector, a threaded channel 2037 configured to be screw-coupled to the firing drive screw, and a proximal projection 2036 configured to fit into the drive cavity 2023. The drive nut 2030 further comprises an upper drive portion 2040 extending upward from the threaded portion 2035. The drive portion 2040 comprises a proximal drive surface 2041 and a distal drive surface 2043. The proximal drive surface 2041 is configured to press the proximal drive surface 2025 of the drive cavity 2023 when the launch member assembly 2000 moves in the proximal direction, and the distal drive surface 2043 is configured to press the distal drive surface 2024 of the drive cavity 2023 when the launch member assembly 2000 moves in the distal direction.
[0143] As shown in Figure 49, the drive nut 2030 is configured to apply a drive force DF to the main body portion 2010, off-center with respect to the longitudinal screw axis SA. The longitudinal screw axis SA is defined by a longitudinal centerline passing through the drive screw configured to actuate the launch member assembly 2000. The longitudinal screw axis SA may also be synonymous with a longitudinal centerline defined through the ducts 2017 and 2020.
[0144] In at least one example, the drive nut 2030 has a cross-sectional shape substantially similar to that of the main body portion 2010. The drive unit 2040 is configured to apply an axial drive force to the main body portion 2010 away from and / or off-axis from the firing drive screw and thread 2037.
[0145] Figures 50 and 51 show a launcher assembly 2000 comprising a main body portion 2010 of the launcher assembly 2100 and a drive nut 2130. The launcher assembly 2100 is similar to the launcher assembly 2000 except for the drive nut 2100. The drive nut 2100 is configured to fit into a drive cavity 2023 of the main body portion 2010. Unlike the drive nut 2030, the drive nut 2130 does not include a proximal projection. The drive nut 2130 comprises a lower threaded portion 2135 having a cam flange 2131 configured to engage with the jaws of the end effector and a threaded channel 2137 configured to screw-couple to a launch drive screw. The drive nut 2130 further comprises an upper drive portion 2140 extending upward from the threaded portion 2135. The drive unit 2140 comprises a proximal drive surface 2141 and a distal drive surface 2143. The proximal drive surface 2141 is configured to press the proximal drive surface 2025 of the drive cavity 2023 when the launch member assembly moves in the proximal direction, and the distal drive surface 2043 is configured to press the distal drive surface 2024 of the drive cavity 2023 when the launch member assembly moves in the distal direction. The drive unit 2140 also comprises an upper surface 2145. The upper surface 2145 does not abut the main body portion 2010 within the drive cavity 2023. Embodiments have been conceived in which the upper surface 2145 abuts the main body portion 2010 within the drive cavity 2023. In at least one example, the flange 2131 is configured so that the drive nut 2130 does not rotate with the launch drive screw during operation.
[0146] Figure 52 shows a launcher assembly 2000 comprising a main body portion 2010 of the launcher assembly 2200 and a drive nut 2130. The launcher assembly 2100 is similar to the launcher assembly 2100, except for welds 2251, 2253, and 2255. Unlike the launcher assembly 2100, welds 2251, 2253, and 2255 provide a secure mounting mechanism within the drive cavity 2023 to attach the drive nut 2130 to the main body portion 2010. In other words, the drive nut 2130 is welded to the main body portion 2010. The welding may be performed after the drive nut 2130 is positioned within the drive cavity 2023 and screwed onto the launch drive screw. The threaded portion 2135 of the drive nut 2130 is welded to the proximal portion 2016 and the distal portion 2019 of the main body portion 2010. The upper surface 2045 of the drive unit 2140 is also welded to the main body portion 2010. These welds can provide strength to the launch member assembly 2200.
[0147] Figures 53 to 56 show a stapled assembly 2300 comprising a channel jaw 2310, a firing drive screw having threads 2321, i.e., a rotary drive member 2320, and a firing member assembly 2330. The firing member assembly 2330 is similar to the firing member assembly described above. However, the firing member assembly 2330 comprises a different drive nut and mounting means for attaching the drive nut to the main body portion. As seen in Figure 53, the firing member assembly 2330 is screw-coupled to the threads 2321 of the firing drive screw 2320. The firing drive screw 2320 is configured to be supported within the channel jaw 2310. The firing member assembly 2330 is configured to actuate proximal and distally through the firing stroke relative to the channel jaw 2310.
[0148] The launch member assembly 2330 comprises a main body portion 2331 and a drive nut 2360 configured to fit into the drive cavity of the main body portion 2331, i.e., the receptacle 2343. The main body portion 2331 comprises an upper portion 2332 having an anvil engagement flange 2333. The upper portion 2332 further comprises a distal nose 2334, which can be used to clamp the anvil jaw from the unclamped position. The main body portion 2331 comprises a drive surface 2335 configured, for example, to press a thread and / or cutting member. The main body portion 2331 further comprises a lower portion 2336 having a proximal portion 2337 and a distal portion 2339 defining the drive cavity 2343. The proximal portion 2337 comprises a proximal lower flange 2338 extending laterally therefrom and a drive thread duct. The distal portion 2339 comprises a distal lower flange 2341 and a drive screw duct 2340. The flanges 2338 and 2341 are configured to engage with the channel jaw 2310 to ensure a consistent tissue gap between the anvil jaw and the channel jaw 2310. The drive screw ducts 2337 and 2340 of the proximal portion 2337 are aligned with each other and configured to receive the firing drive screw 2320 through them in a non-screwed manner.
[0149] The drive nut 2360 comprises a threaded portion 2365 configured to screw-connect to the firing drive screw 2320 by threads 2366, and a drive unit 2070. The drive nut 2360 further comprises a lower cam flange 2361 also configured to cam-engage with the channel jaw 2310 during the firing stroke. The drive unit 2370 comprises laterally opposed tabs 2371 extending upward from the threaded portion 2365. The drive tabs 2371 are configured to support or straddle a corresponding drive tab 2350 extending downward from the main body portion 2331 into the drive cavity 2343. The drive unit 2370 further comprises an internal transverse member, i.e., a brace 2372, which connects the tabs 2350 to each other and fixes or mounts the drive unit 2370 to the drive tabs 2371 and thus to the main body portion 2331. The crossbar 2372 is configured to be received in a drive slot 2351 defined within the drive tab 2350. When the drive nut 2360 is actuated, a force can be applied from the crossbar 2372 to the drive tab 2350 within the slot 2351 to the main body portion 2331. Such a configuration can provide a driving force to the main body portion 2331, which is off-center with respect to the drive screw 2320 and closer to the center of the launch member assembly 2330. In other words, the drive nut 2360 can apply a driving force to the main body portion 2331 eccentrically with respect to the longitudinal axis of the drive screw 2320. This can be seen, for example, in Figure 53. The drive nut 2360 can apply a driving force DF to the main body portion 2310 off-center with respect to the longitudinal screw axis SA.
[0150] The drive tab 2350 further comprises a pair of drive teeth 2353 extending downward from an internal channel 2367 defined within the drive nut 2360. The drive teeth 2353 are configured to directly engage with the threads 2321 of the drive screw 2320. The teeth 2353 can reinforce the overall threading between the launch drive screw 2320 and the launch member assembly 2330.
[0151] In at least one example, the drive nut 2360 is formed above the drive screw 2320. This allows for a complex shape of the drive nut and finely tuned engagement features between the drive nut 2360 and the main body portion 2331. Such engagement features include, for example, a crossbar 2372. When formed above the drive screw 2320 and through the slot 2351, the drive nut 2360 remains permanently fixed to the main body portion 2331 even if the drive nut 2360 is broken and removed from the main body portion 2331.
[0152] In at least one example, the drive nut 2360 is snapped onto the drive tab 2350. For example, the drive nut 2360 may be made of the material corresponding to the internal channel 2367 and have some degree of flexibility and manufacturing cracks or fractures, allowing the drive nut 2360 to be spread out around the drive tab 2350 and snapped onto it. In at least one example, the drive nut 2360 is separated between the drive tab 2350 and one side of the crossbar 2372, thereby allowing the drive tab 2359 to be pried open and the crossbar 2372 to be positioned in the slot 2351.
[0153] In at least one example, the crossbar 2372 is configured to separate from the drive nut 2360 when the firing force between the drive screw 2320 and the drive nut 2360 exceeds a predetermined threshold. Such a configuration can provide a safety feature to prevent the launch member assembly from being overdriven through the launch stroke when the launch member assembly is subjected to a higher-than-normal load.
[0154] Figures 57 to 61 show the launch member assembly 2400. The launch member assembly 2400 is similar to the launch member assembly described above. However, the launch member assembly 2400 includes a different drive nut and mounting means for attaching the drive nut to the main body portion. The launch member assembly 2400 also includes alignment features for use with a forming tool. The launch member assembly 2400 is configured to be screw-coupled to a launch drive screw and is configured to be actuated by the launch drive screw in the proximal and distal directions throughout the launch stroke.
[0155] The launch member assembly 2400 comprises a main body portion, i.e., a distal head 2410, and a drive nut 2450 configured to fit into a drive cavity, i.e., a receptacle 2430, of the main body portion 2410. The main body portion 2410 comprises an upper portion 2411 having a jaw engagement flange 2412. The upper portion 2411 further comprises a distal nose 2413, the distal nose which can be used to clamp the anvil jaw from the unclamped position. The main body portion 2410 further comprises a drive surface 2414 configured, for example, to press thread and / or cutting members. The main body portion 2410 further comprises a lower portion 2415 having a proximal portion 2416 and a distal portion 2420 defining the drive cavity 2430. The proximal portion 2416 comprises a proximal lower flange 2417 extending laterally therefrom and a drive screw duct 2418. The distal portion 2420 comprises a distal lower flange 2421 and a drive screw duct 2422. The flanges 2417 and 2421 are configured to engage with the jaws of the end effector to ensure a consistent tissue gap is maintained between one jaw and another jaw of the end effector. The drive screw ducts 2418 and 2422 are aligned with each other and configured to receive a non-screwed firing drive screw through their interiors. As will be discussed in more detail below, the proximal portion 2416 and the distal portion 2420 each comprise an alignment opening 2423 configured for use during the overmolding and / or insert molding process.
[0156] The drive nut 2450 comprises a threaded portion, i.e., a driven portion 2451, configured to screw-couple to a firing drive screw by threads 2453, and a drive portion, i.e., a driving portion 2460. The drive nut 2450 further comprises a lower cam flange 2452 configured to cam-engage with the end effector jaw during the firing stroke. The drive nut 2450 has a substantially trapezoidal shape. As will be discussed in more detail below, the firing member assembly 2400 comprises a proximal clearance void, i.e., a longitudinal space 2431, defined between the proximal portion 2416 and the proximal driving surface 2454 of the threaded portion 2451, and a distal clearance void, i.e., a longitudinal space 2455, defined between the distal portion 2420 and the distal driving surface 2455 of the threaded portion 2451.
[0157] The drive unit 2460 comprises laterally opposed tabs 2461 extending upward from the threaded portion 2451. It should be understood that the main body portion 2410 and the drive nut 2450 are symmetrical with respect to the vertical plane defined by the main body portion 2410, except for the threads 2453. The drive tab 2461 is configured to support or straddle the corresponding drive tab 2440, which extends downward from the main body portion 2410 into the upper portion 2433 of the drive cavity 2430. The drive unit 2060 further comprises a plurality of internal transverse members, i.e., ribs 2463, extending between the tabs 2461. The ribs 2463 fix or attach the drive unit 2460 to the drive tab 2440 and therefore to the main body portion 2410. The ribs 2463 are configured to be received within a plurality of corresponding openings 2441 defined within the drive tab 2440. When the drive nut 2450 is actuated, a force can be applied to the main body portion 2410 from the rib 2463 to the drive tab 2440 within the slot 2441. Such a configuration can provide the driving force to the main body portion 2331, which is off-center with respect to the drive screw located within the threaded channel 2453 and closer to the center of the launch member assembly 2400. As shown in Figures 57 and 60, the drive nut 2450 may be configured to apply the driving force DF to the main body portion 2410 off-center with respect to the longitudinal thread axis SA.
[0158] The tab 2461 of the drive nut 2450 is further configured to apply force to the proximal drive surface 2443 and distal drive surface 2445 on the main body portion 2410 within the upper portion 2433 of the drive cavity 2430. These additional drive surfaces can further concentrate the drive force on the main body portion 2410, which is closer to the center of the launch member assembly 2400.
[0159] As described above, the launch member assembly 2400 includes clearance voids 2431 and 2432 positioned between the threaded portion 2451 of the drive nut 2450 and the proximal portion 2416 and distal portion 2420 of the main body portion 2410. The clearance voids are configured to further concentrate the driving force within the launch member assembly 2400 from the drive nut 2450 to the main body portion 2410. The clearance voids 2431 and 2432 prevent the threaded portion 2451 from contacting the proximal portion 2416 and distal portion 2420 of the main body portion 2410, thereby preventing the driving force from being applied immediately adjacent to the drive screw configured to drive the launch member assembly 2400.
[0160] Clearance voids 2431 and 2432 may also be configured to control the overall deflection of the drive nut 2450. In various examples, the launch drive screw may deflect relative to the end effector being positioned. This may be due, among other things, to the clamping force applied to the jaws of the end effector during the launch stroke. Notably, when the drive screw deflects, the drive nut 2450 is biased to deflect or rotate relative to the main body portion 2410 together with the drive screw, due to the threading between the drive nut 2450 and the launch drive screw. The trapezoidal shape and clearance voids 2431 and 2432 provide a certain degree of flexibility, or tolerance, for the drive nut 2450 to deflect and rotate together with the launch drive screw. Allowing this tolerance within the launch member assembly 2400 may help prevent the threading between the drive nut 2450 and the launch screw from becoming stuck. A rigid launch assembly and drive nut combination may provide little or no flexibility, for example, further increasing the possibility of screw seizure. In certain cases, other components of the launch member assembly (e.g., the cam flange and / or drive cross member described above) may be elastically deformed due to bending and / or shear forces within the end effector assembly. In at least one example, the drive cavity 2430 includes a trapezoidal shape in addition to, or instead of, the drive nut 2450.
[0161] In at least one example, the drive nut 2450 is insert-formed above the drive screw. This allows for a complex shape of the drive nut and finely tuned engagement features between the drive nut 2450 and the main body portion 2410. Such engagement mechanisms include, for example, a rib 2463. In at least one example, the drive nut 2450 is overmolded onto the main body portion 2410.
[0162] As described above, the proximal portion 2416 and the distal portion 2420 each have alignment openings 2419 and 2423 configured for use during the overmolding and / or insert molding process. The alignment openings 2419 and 2423 are configured to hold the main body portion 2410 within the molding tool and are aligned at the equator, i.e., center, of the ducts 2418 and 2020. This positioning can help align the mold used for the drive nut 2450 and the ducts 2418 and 2020 for manufacturing so that the drive nut 2450, specifically the threaded portion 2451, is aligned with the ducts 2418 and 2020. This alignment ensures that the firing drive screw is aligned within the ducts 2018 and 2020 and the threaded portion 2451 during assembly. In at least one example, both the firing drive screw and the main body portion 2410 are presented before the molding of the drive nut 2450. In such an example, the drive nut 2450 may be molded around a pre-positioned main body portion 2410 and a firing drive screw. In at least one example, only the main body portion 2410 is presented before the drive nut 2450 is molded.
[0163] Figures 62 to 66 show the launch member assembly 2500. The launch member assembly 2500 is similar to the launch member assembly described above. However, the launch member assembly 2500 includes a drive nut assembly comprising an external drive unit 2550 and an internal drive nut 2560 positioned within the external drive unit 2550. The launch member assembly 2500 is configured to be screw-coupled to a launch drive screw and is actuated by the launch drive screw in the proximal and distal directions throughout the launch stroke within the end effector assembly.
[0164] The launch member assembly 2500 comprises a main body portion 2510 and a drive nut assembly configured to fit into the drive cavity of the main body portion 25510, i.e., the receptacle 2530. The main body portion 2510 comprises an upper portion 2511 having an anvil engagement flange 2512. The upper portion 2511 further comprises a distal nose 2513, which can be used to clamp the anvil jaw from the unclamped position. The main body portion 2510 further comprises a drive surface 2514 configured, for example, to press thread and / or cutting members. The main body portion 2510 further comprises a lower portion 2515 having a proximal portion 2516 and a distal portion 2520 defining the drive cavity 2530. The proximal portion 2516 comprises a proximal lower flange 2517 extending laterally therefrom and a drive thread duct 2518. The distal portion 2520 comprises a distal lower flange 2521 and a drive screw duct 2522. The flanges 2517 and 2521 are configured to engage with the jaws of the end effector to ensure a consistent tissue gap is maintained between one jaw and another jaw of the end effector. The drive screw ducts 2518 and 2522 are aligned with each other and configured to receive a non-screwed firing drive screw through their interiors.
[0165] As described above, the drive nut assembly comprises an external drive unit 2550 and an internal drive nut 2560 positioned within the external drive unit 2550. In at least one example, the internal drive nut 2560 includes a stock drive nut made of, for example, a metallic material. In at least one example, the external drive unit 2550 is made of, for example, a polymer and is overmolded and / or insert-molded within the launch member assembly 2500. In such an example, the drive nut assembly comprises a hybrid multi-material drive nut assembly, which in certain examples may have metamaterial properties. In at least one example, the external drive unit 2560 is insert-molded into the internal drive nut 2550, and the drive nut assembly is then positioned within the drive cavity 2530 for assembly into the launch drive screw and main body portion 2510. In any case, the drive nut assembly comprises a multi-piece device.
[0166] The external drive unit 2550 comprises a lower portion 2551 having a flange 2552. The lower portion 2551 surrounds the internal drive nut 2560 and is configured to be fixed within the drive nut assembly. The external drive unit 2550 further comprises a drive tab 2553 located within the upper portion of the drive cavity 2530. The drive cavity 2530 further comprises a clearance slot 2531 located between the drive tab 2553 and the main body portion 2510. Such a clearance slot 2531 can allow the drive nut assembly to float relative to the main body portion 2510 together with the firing drive screw. In such an example, the main body portion 2510 may be constrained by various elements of the end effector assembly, such as anvil jaws and channel jaws.
[0167] As described above, the external drive unit 2550 is configured to fix the internal drive nut 2560 internally and to coincide with the screw axis SA. The screw axis SA is defined as the center of the ducts 2518, 2522 and the main cylindrical portion 2561 of the internal drive nut 2560. The threads 2562 are defined within the main cylindrical portion 2561 of the internal drive nut 2560. The threads 2562 are configured to screw, i.e., be screw-coupled, with the threads of the firing drive screw. The internal drive nut 2560 further comprises a row 2563 of gripping features 2564 configured to prevent the internal drive nut 2560 from rotating relative to the external drive unit 2550 during rotation of the drive screw. The external drive unit 2550 can surround the internal drive nut 2560 during the molding process. The internal drive nut 2560 further comprises a flared proximal end 2565. The flared proximal end 2565 can assist in the assembly of the launch member assembly 2500 and the launch drive screw. For example, the launch drive screw can be inserted through the duct 2518 and guided by the flared proximal end 2565 into the threads 2562 of the internal drive nut 2560.
[0168] In at least one example, the gripping feature 2564 can assist in the manufacturing process of the drive nut assembly. For example, the gripping feature 2564 may be fitted into a corresponding slot in a mold configured to hold the drive nut 2560 during the molding of the external drive unit 2550.
[0169] Figure 67 shows the launch member assembly 2600. The launch member assembly 2600 is similar to the launch member assembly described above. However, the launch member assembly 2600 includes a proximal tail extension configured to further support the launch member assembly 2600 throughout the launch stroke. The launch member assembly 2600 is configured to be screw-coupled to a launch drive screw and is actuated by the launch drive screw in the proximal and distal directions throughout the launch stroke within the end effector assembly.
[0170] The launch member assembly 2600 comprises a main body portion 2610 and a drive nut 2630. The main body portion 2610 comprises an upper portion 2611 and a lower portion 2615. The upper portion 2611 comprises an anvil cam flange 2612. The upper portion 2611 further comprises a distal nose 2613 configured to close the jaws of the end effector from an open position to a closed position. The main body portion 2610 further comprises a drive surface 2614 configured to push, for example, a thread and / or cutting member. The lower portion 2615 comprises a proximal portion 2616 comprising a proximal lower flange 2617 and a proximal tail extension 2618. The lower portion 2615 further comprises a distal portion 2620 comprising a distal lower flange 2621. Flanges 2617, 2621, and 2612 may be configured to maintain a predetermined structural gap between the staple cartridge and the anvil throughout the entire firing stroke of the launch member assembly 2600.
[0171] The proximal tail extension 2618 is an extension of the threaded duct of the proximal portion 2616, as described above. Such a proximal tail extension can further support the launch member assembly 2500 throughout the launch stroke. Such a proximal tail extension can also resist deflection or rotation of the main body portion 2610, which can be fixed by creating a threaded engagement between the drive nut 2630 and the launch drive screw.
[0172] Figures 68 to 72 show a launch member assembly 2700 screw-coupled to a launch drive screw 2701. The launch assembly 2700 is similar to the launch member assembly described above. However, the launch member assembly 2700 comprises a main body portion 2710 and a drive nut 2750 that can be snapped to the main body portion 2710. The launch member assembly 2700 is configured to be actuated proximal and distal through the launch stroke by the launch drive screw 2701 within the end effector assembly.
[0173] The main body portion 2710 comprises an upper portion 2711 and a lower portion 2715 defining a drive cavity 2730. A drive nut 2750 is configured to be positioned within the drive cavity 2730. The upper portion 2711 comprises a jaw cam flange 2712. The upper portion 2711 further comprises a distal nose 2713 configured to close the jaws of the end effector from an open position to a closed position. The main body portion 2710 further comprises a drive surface 2714 configured, for example, to push a thread. The lower portion 2715 further comprises a proximal portion 2716 comprising a proximal lower flange 2717. The lower portion 2715 further comprises a distal portion 27720 comprising a distal lower flange 2721 and an internally defined drive screw duct 2722 configured to receive a firing drive screw 2701 in a non-screwed manner. Flanges 2617, 2721, and 2712 may be configured to maintain a predetermined structural gap between the staple cartridge and the anvil throughout the entire firing stroke of the launch member assembly 2700.
[0174] In at least one example, the outer shape or circumference of the drive screw duct 2722 and / or the proximal portion of the drive screw duct may be, for example, elliptical and / or oblong, or non-circular. Such a configuration can reduce the possibility of friction or interference within the screw duct by a deflected drive screw, which may cause stack-up losses when the drive screw is deflected. Stack-up losses may refer to various problematic engagements between the drive screw and other components in the system that would result in various interferences in scenarios where the drive screw is significantly deflected. For example, when the drive screw is significantly deflected, the deflected drive screw may rub against the drive screw duct as described above, the deflected drive screw may lock the threads of the drive nut, and / or the deflected drive screw may lock near its connection to the firing output shaft, for example. By providing features that minimize such stack-up losses, it is possible to prevent, for example, premature failure of components and / or reduce the firing force required to drive the firing member assembly.
[0175] In at least one example, the drive screw duct 2722 and / or the proximal portion of the drive screw duct includes a filleted edge or a chamfered edge. Such a configuration can further reduce the possibility of the duct coming into contact with and becoming stuck to the firing drive screw.
[0176] In at least one example, the screw duct of the main body portion can provide lateral and / or vertical support to the drive screw, thereby preventing the drive screw from bending at least near the threaded drive nut if a load sufficient to cause the drive screw to bend is applied to the drive screw. Such a configuration may help prevent sticking between the threads of the drive screw and the threaded drive nut.
[0177] In at least one example, the thread of the staple cartridge may have a distally extending cradle support feature that extends from the distal end of the thread. The cradle support feature may also support the firing drive screw and help prevent the firing drive screw from bending at least near the cradle support feature. In at least one example, the thread prevents the drive screw from bending in only one direction. In at least one example, the thread has a proximal cradle support feature in addition to, or instead of, the distal cradle support feature.
[0178] The drive nut 2750 comprises a jaw engagement flange 2751, a threaded portion 2755 configured to screw-connect to the launch drive screw 2701 by threads 2756, and a laterally opposed drive tab 2760 extending upward from the threaded portion 2755. The drive nut 2750 has a substantially trapezoidal shape, such as a drive nut having a trapezoidal shape as discussed herein.
[0179] The drive tabs 2760 are configured to support or straddle the corresponding drive tabs 2740, which extend downward from the main body portion 2710. The drive tabs 2760 define slots 2761 between them, each comprising a snap nub 2762 projecting inward from there. Each snap nub 2762 comprises an inclined top surface 2763 and a latching surface 2764. As shown in Figure 71, the drive tabs 2760 are configured to snap onto the drive tabs 2740 of the main body portion 2710. Specifically, the drive tab 2740 has a horizontally extending slot 2741 defined inside, and the snap nub 2762 is configured to sufficiently spread the drive tab 2740 during the attachment of the drive nut 2750 to the main body portion 2710 so that the latching surface 2764 can pass through the drive tab 2760 and bias inward into the slot 2741. In at least one example, the snap nub 2762 is not configured to transmit any longitudinal driving force from the launch drive screw 2701 to the main body portion 2710. Instead, the drive tab 2760 is configured to fit into the drive cavity 2730 such that the drive tab 2760 directly pushes and pulls the main body portion 2710 relative to the launch drive screw, as is the case with the various launch member assemblies discussed herein. Such a configuration can transmit the launch force from the launch drive screw 2701 to the main body portion 2710 by reducing the reliance of the drive nut 2750 on the internal crossbar. This may be advantageous in that the drive nut 2750 may remain attached to the main body portion 2710 via the drive nub 2762 over higher loads than usual. As is the case with the various drive tabs discussed herein, the drive tab 2760 of the drive nut 2750 is further configured to apply force to the main body portion 2710 closer to the center of the main body portion 2710. As shown in Figure 69, the drive nut 2750 is configured to apply a driving force DF to the main body portion 2710 off-axis with respect to the longitudinal screw axis SA.
[0180] In at least one example, the drive nut 2750 is injection molded before being snap-fitted onto the main body portion 2710. In at least one example, the drive nut 2750 is insert-molded onto the main body portion 2710 and the firing drive screw 2701. In such examples, the drive nut 2750 may be replaced, for example, if the drive nut 2750 wears out over time, by releasing the snap-fit.
[0181] Figure 73 shows a launch member assembly 2800 comprising a main body portion 2810 and a drive nut 2850 configured to be screw-coupled to a launch drive screw. The launch member assembly 2800 is similar to the various launch member assemblies described above. However, the launch member assembly 2800 further comprises a drive cavity 2830 configured to allow the main body portion 2810 to bend during the launch drive stroke, as will be discussed in more detail below.
[0182] The main body portion 2810 comprises an upper portion 2811 having a laterally extending flange 2812 and a distal nose 2813 configured to close the jaws from an open position during a closing stroke. The main body portion 2810 further comprises a drive surface 2814 configured to push, for example, a thread and / or cutting member through a staple firing stroke. Other embodiments can be conceivable in which various other surfaces on the front side of the main body portion 2810 are configured to drive various components, for example, a thread and / or cutting member. The main body portion 2810 further comprises a lower portion 2815 comprising a proximal portion 2816 having a proximal lower flange 2817 and a distal portion 2820 having a distal lower flange 2821. Collectively, the flanges 2812, 2817, and 2821 are configured to ensure that opposing jaws are separated during a firing stroke and to maintain a consistent tissue gap between the opposing jaws.
[0183] The drive nut 2850 is positioned within the drive cavity 2830 and configured to be screw-coupled to the launch drive screw. The drive nut 2850 is configured to apply an axial driving force to the main body portion 2810 when the launch drive screw is actuated to move the launch member assembly 2810 in the proximal and distal directions within the end effector. The drive cavity 2830 comprises a lower portion 2833 in which the drive nut 2850 is initially positioned and configured to float within it, and an upper triangular portion 2831. The upper triangular portion 2831 is configured to allow the main body portion 2810 to bend during the launch stroke. For example, under a clamping load, the triangular portion 2831 is configured to allow the proximal portion 2816 to bend longitudinally away from the distal portion 2820. Such bending can provide tolerance within the launch member assembly 2800, for example, to prevent seizing. In addition to the bending of the main body portion 2810, the drive nut 2850 is configured to float within the drive cavity 2850. Collectively, such a device can reduce the locking engagement between screw connections and / or between the flange and the jaw.
[0184] The various drive nuts disclosed herein include a laterally extending flange that is aligned with proximal and distal lower flanges of a lower portion of the main body portion. Such a flange can prevent the drive nut from rotating with the launch drive screw. Such a flange may have a rounded bottom to reduce fixed engagement with a corresponding jaw. For example, the proximal and distal lower flanges may be configured to handle most of the clamping load, and the drive nut flange provides support to the drive nut but does not necessarily need to handle high clamping loads. Rounding the flange can reduce overall contact with the corresponding jaw, thus reducing the likelihood that the flange contacts and adheres to the corresponding jaw. In such an example, the flange of the drive nut, i.e., the side fin, is configured to be loose within a corresponding jaw such as a channel jaw. This loose engagement between the flange and the corresponding jaw allows for a rotation prevention feature without the flange needing to handle high clamping loads. In at least one example, the side fin is generally thinner and has an upper edge positioned below the upper edge of the corresponding proximal and distal lower flanges of the main body portion.
[0185] In at least one example, the main body portion is machined from a metallic material and the drive nut is injection molded, insert molded, or overmolded from a polymer and / or plastic material. Such a configuration can reduce manufacturing costs and machining complexity because the various molding processes can enable more complex geometries and shapes. The various molding processes can also enable the assembly and manufacture of components in various orders. As described above, insert molding allows a multi-material launch member assembly to include various materials and complex integrated geometries between different materials. Further, insert molding allows, for example, the launch drive screw to be positioned within the launch member assembly prior to molding of the drive nut.
[0186] Figures 74-78 illustrate an end effector assembly 3000 configured to cut and staple a patient's tissue. The end effector assembly 3000 includes a first jaw 3010 and a second jaw 3020 movable relative to the first jaw 3010. Embodiments where the first jaw 3010 is movable relative to the second jaw 3020 are contemplated. The first jaw 3010 includes a cartridge channel 3100 and a replaceable staple cartridge 3300 configured to be removably positioned within the cartridge channel 3100. The second jaw 3020 includes an anvil 3200 configured to deform staples removably stored within the staple cartridge 3300 during a staple firing stroke. The second jaw 3020 is movable, i.e., pivotable, relative to the first jaw 3010 and clamps tissue between the anvil 3200 and the staple cartridge 3300. When the tissue is clamped between the anvil 3200 and the staple cartridge 3300, the end effector assembly 3000 is fired, ejecting staples by a firing assembly 3400 of the end effector assembly 3000 and cutting the tissue.
[0187] As discussed in more detail below, the firing assembly 3400 includes a firing drive screw 3401 supported within the cartridge channel 3100. The firing assembly 3400 further includes a firing member assembly 3409 threadedly coupled to the firing drive screw 3401 and configured to push a thread during a firing stroke to position staples from the staple cartridge 3300, push a cutting member during the firing stroke to cut the tissue, and maintain a consistent tissue gap between the staple cartridge 3300 and the anvil 3200 during the firing stroke.
[0188] The cartridge channel 3100 comprises a longitudinal channel cavity 3111 into which a staple cartridge 3300 is removably positioned. The cartridge channel 3100 further comprises a side wall 3113 configured to support the staple cartridge 3300. In at least one example, the staple cartridge comprises a ledge configured to rest on the side wall 3113. The cartridge channel 3100 further comprises a base 3120. The base 3120 comprises an inner bottom 3121 and a cam ledge 3123. A longitudinal slot 3125 is defined between the cam ledges 3123 and is configured to receive at least a portion of the launch assembly 3400 through its interior.
[0189] The anvil 3200 comprises a body portion 3210 and an anvil cap 3220 configured to be attached to the body portion 3210 within a longitudinal channel 3212. The body portion 3210 comprises an anvil surface 3211. The anvil surface 3211 comprises a plurality of staple-forming pockets aligned with a staple cavity 3312 defined within the deck 3311 of the staple cartridge body 3310. The body portion 3210 also comprises a cam ledge 3213 extending laterally inward into the longitudinal channel 3212, defining a longitudinal slot 3225 between them. As will be discussed in more detail below, the cam ledges 3123, 3213 are configured to cooperately engage with the corresponding flanges of the launcher assembly 3409 to ensure that the jaws 3010, 3020 are separated from each other. In at least one example, during the firing stroke, the engagement of the flange of the firing member assembly 3409 with the cam ledges 3213, 3123 defines a predetermined structural gap between the cartridge deck 3311 and the anvil surface 3211.
[0190] The staple cartridge 3300 further comprises deck projections, i.e., pocket extensions 3314, configured to increase the effective height of each staple cavity 3312. The deck projections 3314 may be configured to assist in gripping tissue clamped between jaws 3010 and 3020. The staple cartridge 3300 may further comprise longitudinal slots 3315 configured to receive at least a portion of the launching member assembly 3409 through the interior. As described above, the thread and / or cutting members are configured to advance through jaws 3010, 3020 to cut tissue in the launching assembly 4400 during the staple firing stroke and fire the staples.
[0191] The launch assembly 3400 comprises a launch drive screw 3401 and a launch member assembly 3409 screw-coupled to the launch drive screw 3401. The launch member assembly 3409 comprises a main body portion 3410, a drive nut 3450 configured to screw-couple to the launch drive screw 3401, and a rear support brace 3430. The main body portion 3410 comprises an upper portion 3411 having an anvil engagement flange 3412 and a distal nose portion 3413. The anvil engagement flange 3412 is configured to move within a longitudinal channel 3212, more specifically, to apply clamping pressure to the upper surface 3214 of the cam ledge 3213. In at least one example, an anvil cap 3220 is configured to provide an upper boundary to the anvil cam flange 3412. Nevertheless, the anvil cam flange 3412 is configured to move within the longitudinal channel 3212 during the firing stroke, applying a cam force thereto, thereby ensuring a consistent tissue gap distance between the cartridge deck 3311 and the anvil surface 3211.
[0192] The main body portion 3410 further comprises a lower portion 3415 having a proximal portion 3416 with a channel cam flange 3417 and a threaded duct 3418 configured to receive a firing drive screw 3401 through the interior in a non-threaded manner. The lower portion 3415 further comprises a distal portion 3420 having a channel cam flange 3421 and a threaded duct 3422 configured to receive a firing drive screw 3401 in a non-threaded manner. The drive nut 3450 is configured to fit between the proximal portion 3416 and the distal portion 3420. The drive nut 3450 has a threaded portion 3451 having a channel cam flange 3452 and is configured to be screw-coupled to the firing drive screw 3401. In at least one example, the channel cam flange 3452 has a thickness less than the thickness of the channel cam flanges 3417 and 3421. The drive nut 3450 also includes a drive tab 3460 extending upward toward the main body portion 3410. The drive nut 3450 is configured to apply axial driving force in the proximal and distal directions relative to the main body portion 3410, thereby moving the launch member assembly 3409 through the jaws 3010, 3020. The channel cam flanges 3417, 3452, and 3421 are configured to apply cam force to the cam ledge 3123. Collectively, the cam flange 3412 and flanges 3417, 3452, and 3421 are configured to maintain a consistent tissue gap distance between the cartridge deck 3311 and the anvil surface 3211.
[0193] The launch member assembly may be subjected to loads that cause off-center moment loads. For example, an anvil ledge engaged with the upper cam flange 3412 can apply an off-center moment load to the launch member 3400 in certain cases, such as when a thick and / or rigid structure is clamped between the jaws. It may be advantageous to provide means to counteract such off-center moment loads. The launch member assembly 3409 includes a rear support brace 3430 extending at an angle proximal to the upper portion 3411 of the main body portion 3410. The rear support brace 3430 includes a support member 3431 and an arched brace portion 3433 extending from the support member 3431. The arched brace portion 3433 includes a laterally extending flange 3435 configured to support the rear support brace 3430 and counteract moment loads on the main body portion 3410. The flange 3435 is configured to rest in contact with the inner bottom surface 3121. In particular, the flange 3435 rests on the cam ledge 3123 such that the flange 3432 of the rear support brace 3430 and the channel cam flange 3421 are in contact with both sides of the base 3120 of the channel 3100.
[0194] In at least one example, if the main body portion 3410 is subjected to a load causing rotation in the opposite direction, the flange 3435 may provide flexibility to lift from the inner bottom 3121 and resist torque application to the anvil cam flange 3412 that would attempt to disengage from substantially parallel alignment with the longitudinal channel 3214. The rear support brace 3430 may be configured to provide some flexibility to allow some bending of the main body portion 3410 under load, while preventing the excessive bending that would cause seizing in the case of screw engagement between the drive nut 3450 and the launch drive screw 3401. In certain examples, the rear support brace 3430 may function as a spring feature for balancing the load.
[0195] Embodiments are conceivable in which flange 3435 is positioned below ledge 3123. Embodiments are also conceivable in which two sets of flanges are provided. One set of flanges can be positioned above ledge 3123, and the other set of flanges can be positioned below ledge 3123.
[0196] In various examples, the rear support brace 3430 acts as a spring member of the launch member assembly 3409 to balance the various loads on the launch member assembly 3409. Furthermore, a clearance is provided between the arched brace portion 3433 and the launch drive screw 3401. Such a configuration can prevent, for example, rotation of the I-beam and balance the I-beam or the launch member assembly throughout the entire staple firing stroke. Embodiments have been conceived in which the arched brace portion 3433 is also threaded and screw-coupled to the launch drive screw 3401.
[0197] In various examples, the geometric shapes of various launch component parts can be optimized. For example, referring to Figure 78, the length of the central part of the main body portion 3410 is referred to as the body length BL, and the lengths of the lower flanges 3417 and 3421 are collectively referred to as the pin length PL. Generally, the pin length PL is about twice the length of the body length BL. This also applies to the upper flange 3412. However, in certain examples, for example, the upper flange 3412 may have a pin length shorter than twice the body length BL, since at least the rear support brace 3430 can help prevent rotation and / or deflection of the upper flange 3412 under load. In various examples, the longer the pin length, the more likely the corresponding flange is to become stuck in its slot. In such examples, the clearance slot in which the flange is positioned must be smaller to reduce sticking between the flange and the clearance slot.
[0198] Figures 79 and 80 show a surgical staple assembly 3700 similar to the surgical staple assembly described above. However, the surgical staple assembly 3700 combines a triangular drive cavity cutout with various other features described herein. The surgical staple assembly 3700 comprises a channel jaw 3710, a staple cartridge 3730 configured to be received within the channel jaw 3710, and a firing drive screw 3711 supported within the channel jaw 3710. The surgical staple assembly 3700 further comprises an anvil jaw 3720 configured to deform staples ejected from the staple cartridge 3730. The surgical staple assembly further comprises a firing member assembly 3740 configured to be actuated by the firing drive screw 3711 through the jaws 3710, 3720. The launching member assembly 3740 comprises a main body portion 3741, a rear support brace 3745, and a drive nut 3743 screw-coupled to a launching drive screw 3711. The main body portion 3741 includes a triangular drive cavity cutout 3745 configured to provide an additional spring feature within the launching member assembly 3740, configured to balance the various loads subjected to the launching member assembly 3740. The surgical staple fastening assembly 3700 further comprises a knife 3750 configured to cut tissue during the firing stroke and a thread 3760 configured to position staples from a staple cartridge 3730. The knife 3750 and the thread 3760 can each receive and transmit loads to the launching member assembly 3740.
[0199] The knife 3750 is a component of the thread 3760 and is mounted on the thread 3760 at its pivot axis. During distal firing, the knife 3750 can be in an upright configuration as shown in Figure 79, with the knife 3750 protruding from the cartridge body and its cutting edge configured to cut tissue. During proximal firing, the knife 3750 can be in a shielded configuration in which at least a portion of the cutting edge of the knife 3750 is shielded by the fastener cartridge. The knife 3750 can pivot between the upright and shielded configurations depending on the firing direction within the staple cartridge and / or various mechanical lockout and / or biasing mechanisms.
[0200] Figure 81 shows a jaw assembly 3800 configured to support a launch drive screw 3801 internally. Under high loads, the launch drive screw may be prone to buckling. The jaw assembly 3800 is configured to prevent buckling of the launch drive screw 3801. The jaw assembly comprises a channel jaw 3810 having a base 3811 and a channel wall 3813 extending from the base 3811. The base 3811 comprises a drive cavity 3815 configured to receive the launch drive screw 3801 and one or more flanges, such as a cam flange as discussed herein. The base 3811 further comprises a lower support 3816 and a lateral support 3818 extending from a cam ledge 3817. The lower support 3816 and the lateral support 3818 are configured to suppress buckling of the launch drive screw 3801 under high loads. In at least one example, the supports 3816, 3818 are positioned, for example, only near the midpoint between the firing stroke and the channel jaw. Such a device may be sufficient due to the fact that, under high load, the firing drive screw 3801 may tend to buckle near the center of its effective length. In at least one example, the supports 3816, 3818 may be longitudinal ribs extending along most of the length of the firing drive screw 3801 and the channel jaw 3810. Support 3818 may have a metal arm and act as a hard stop for the firing drive screw 3801.
[0201] In at least one example, the support 3818 comprises, for example, a plastic arm. In such an example, the support 3818 can be pulled out by the launch member assembly so as not to obstruct the launch member assembly as the launch member assembly passes through the support 3818 during the launch stroke. Such a configuration may be advantageous because, at the very least, once the launch member assembly reaches the position of the support 3818 during the launch stroke, the launch member assembly itself can support the launch drive screw 3801 and prevent its buckling.
[0202] In various examples, balancing the I-beam, i.e., the launch member assembly, may be advantageous to optimize the load on the launch member assembly between the anvil cam flange and the channel cam flange, for example. Various forces are applied to the launch member assembly. These forces are applied by the threads configured to position the launch drive screw and / or drive nut, anvil cam flange, channel cam flange, structure, and / or staples. It may be advantageous to balance these forces so that the driving force provided by the drive screw drives the launch member assembly in an optimal position. Applying less than the optimal driving force may result in unwanted rolling, rotation, and / or oscillating of the launch member assembly relative to and / or the longitudinal axis defined by the launch screw. Torsional loads can cause such rolling, rotation, and / or oscillating, for example. Applying the driving force in a position that optimally reacts to the predictable torsional loads applied to the launch member assembly may help prevent rolling, rotation, and / or oscillating of the launch member assembly.
[0203] In various examples, channel / anvil cam flanges or pins have widths and lengths configured to adjust to the corresponding slots into which they are received. In at least one example, the longer the flange length along the longitudinal axis, the smaller the clearance required within its corresponding cam slot. In other words, the corresponding cam slot may have a geometry that receives the flange more tightly. Conversely, the longer the flange length along the longitudinal axis, the larger the clearance required within its corresponding cam slot. In other words, the corresponding cam slot may have a geometry that receives the flange more loosely. In at least one example, the ideal length of one or more flanges may be approximately twice the width of the main body portion of the launcher assembly. In particular, the thickness of the main body portion refers to the portion of the main body portion configured to move through the longitudinal staple cartridge slots.
[0204] In various examples, the drive nuts disclosed herein are configured to float vertically, vertically and horizontally, and / or horizontally relative to the main body portion of the launcher assembly. The floating of the drive nut can reduce the possibility of the drive screw becoming stuck to various other components. As described above, in certain examples, the drive nut may be firmly welded to the main body portion.
[0205] In various examples, the various components of the surgical staple assembly disclosed herein may be assembled in a specific order to prevent accidental disassembly. For example, various components may be introduced during assembly after the introduction of the launcher assembly; otherwise, without a retaining force within the assembly, such as provided by the flange of the launcher assembly, they would be prone to accidental detachment or disassembly. Components and subassemblies added to or other than the launcher assembly may also provide assembly retaining forces, for example. For example, a drive screw may be pre-loaded, as discussed herein, to provide an internal assembly retaining force during assembly. A drive screw may be installed in the surgical staple assembly before various other components. In certain examples, the aforementioned assembly retaining forces may actually facilitate the accidental disassembly of one or more components. In such examples, such components may be installed after certain components, and therefore, once such components are installed, ensure that the entire assembly at that point can maintain an assembled state, reducing the likelihood of accidental disassembly.
[0206] In at least one example, a plastic and / or metal injection-molded (MIM) drive nut of a launcher assembly may first be fitted to the main body portion of the launcher assembly. Once the drive nut is in place, a drive screw may be screwed into the drive nut through a corresponding duct in the main body portion. By assembling in this manner, the drive screw connects the drive nut to the main body portion of the launcher assembly, preventing accidental disassembly of the drive nut and the main body portion.
[0207] In addition to the above, the drive screw ends can then be connected to their corresponding supports using their corresponding attachment means. For example, all the bearings and / or springs used can be assembled at this point, for example. This prevents the firing member assembly from disengaging from the proximal or distal end of the drive screw. Additionally, for example, if the firing member assembly is overdriven, the thrust bearing already exists and the firing member assembly will not unduly load, for example, only the thrust bearing and / or the distal head portion of the drive screw, but will, for example, predictably deflect the channel via the thrust bearing and / or the channel support flange. If the firing member assembly advances into the thrust bearing and / or the distal head portion of the drive screw, the firing member assembly will exert an unexpected load on the thrust bearing and / or the distal head portion of the drive screw and, in some cases, may cause premature failure of, for example, the thrust bearing and / or the distal head portion. This can be due to, for example, the drive screw ends not being assembled to the corresponding channel support flange, which is designed such that the drive screw ends interact and cooperate to apply load. For example, without the channel flange and channel, the distal head portion of the drive screw can be shaved if it is prematurely loaded, for example, before mounting the drive screw within the channel support flange.
[0208] In at least one example, the launcher assembly advances beyond its distal position during the actual operation of the surgical staple fastening assembly on the drive screw so that the flanges of the launcher assembly can be inserted, for example, into corresponding slots in the anvil, channel, and / or staple cartridge. Once the flanges are aligned with their corresponding slots, the drive screw can be rotated to move the launcher assembly proximal, thereby moving the flanges into their corresponding slots. At such a point, the drive screw can be set, for example, within its support flanges. In at least one example, by using such a sequential assembly method, it is possible to prevent, for example, the flanges from coming out of their respective slots during assembly.
[0209] In at least one example, various supports positioned within the proximal end of the end-effector assembly are configured, for example, to support the proximal end of a firing drive screw and to support a closing drive screw that works in conjunction with a cartridge channel. In such an example, an anvil may be introduced into the end-effector assembly and pinned to the cartridge channel using pivot pins after the various supports have been positioned within the cartridge channel. The pivot pins themselves can prevent vertical separation loads from separating the various components of the end-effector assembly. In such an example, the lateral channel walls, together with lateral tissue anchors (anvil lateral walls configured to straddle the lateral channel walls when clamping tissue), can prevent lateral separation loads from separating the various components of the end-effector assembly. In various examples, the end-effector assembly is configured such that each component and subassembly can be assembled and disassembled in one unique sequential manner. This ensures that the system can be assembled in only one way, providing supports and preventing accidental disassembly during assembly.
[0210] In various examples, one or more components of the surgical staple fastening assemblies described herein can be 3D printed. More specifically, such components can be fabricated using a graphite-based selective laser sintering process, which may be an additive manufacturing process that enables the complex geometric shapes of parts while eliminating the need for expensive machine tool equipment. Specifically, thrust bearings and / or drive nuts of a launching member assembly can be manufactured using this process. In various examples, drive nuts can be 3D printed from, for example, graphite and steel. In at least one example, about 1% to about 5% of the component consists of graphite, and the remainder of the component consists of iron. In such examples, for example, the exposed graphite of the drive nut can provide some lubrication within the threaded connection.
[0211] In various examples, the launch member assembly is configured to be driven by a launch drive screw located within the end effector. The launch member assembly and / or launch drive screw may be subjected to various loads during the launch stroke. For example, the launch member assembly may be subjected to loads applied by the tissue as the launch member assembly advances through the launch stroke. The launch member assembly may be subjected to various loads applied by the launch drive screw itself. The launch member assembly may also be subjected to loads resulting from the engagement of the cam flange of the launch member assembly with the cartridge channel jaws and / or anvil jaws. The launch drive screw may also be subjected to various loads during the various stages of use of the end effector assembly in which the screw is located. For example, the launch drive screw may be subjected to bending loads resulting from cam forces and / or clamping forces applied within the end effector assembly when the jaws close and clamp the tissue, and / or when the tissue is further clamped by the flange of the launch member assembly during the staple launch stroke. Various devices configured to manage the various loads subjected to the launch member assembly and the launch drive screw are discussed herein. Such devices can, for example, reduce sticking between the launch drive screw and various components. Such devices can also be used in conjunction with a closing drive system. For example, in various examples, an end effector assembly may include a separate closing drive screw configured to open and close one jaw relative to another. In such examples, the closing drive screw may also be subjected to various loads that may cause, for example, bending and / or locking with various drive components.
[0212] Figures 82 to 84 show a surgical staple fastening assembly 5000 comprising a cartridge channel 5010, a staple cartridge 5050 mounted within the cartridge channel 5010, and a rotary drive assembly 5030 supported within the channel 5010. The cartridge channel 5010 comprises a distal portion 5011, a base 5020, and a side wall 5012 extending vertically from the base 5020. The base 5020 comprises a distal end 5021, an annular cradle slot 5022 defined within the distal end 5021 of the base, and a pair of arched flanges 5023 extending upward from the base 5020. The arched flanges 5023 are configured to provide floating support for the rotary drive assembly 5030. Various features of the distal end 5021 include, for example, a distal mounting portion for a drive screw 5031.
[0213] The rotary drive assembly 5030 comprises a threaded portion 5031 and a distal end 5033 supported by the distal portion 5011 of the cartridge channel 5010. The distal end 5033 of the rotary drive assembly 5030 comprises, for example, two thrust bearings, i.e., bushings 5034, configured to contact the arched flange 5023. The distal end 5033 further comprises a distal support head 5035 configured to contact the arched flange 5023 and support the thrust bearings 5034. The distal support head 5035 may be formed, for example, on the distal end of the launch drive screw using a raceway forming process. This forming process may be performed, for example, after one or more bushings and / or bearings have been positioned on the distal end of the launch drive screw.
[0214] The arched flanges 5023 define a floating cavity 5025 between them within the distal portion 5011 of the cartridge channel 5010. A portion 5032 of the rotary drive assembly 5030 is configured to be supported within the floating cavity 5025, thereby allowing the distal end 5033 of the rotary drive assembly 5030 to float within the floating cavity 5025, for example, when the cartridge channel 5010 is deflected. In an example where the distal portion 5011 of the cartridge channel 5011 is deflected downward, the distal end 5033 of the rotary drive assembly 5030 may remain relatively unloaded by floating within the floating cavity 5025. As shown in Figure 84, the floating cavity 5025 includes a vertical slot portion 5026 configured to allow a predetermined floating distance, i.e., vertical limiting of floating, for the drive assembly 5030 and / or portion 5032 of the rotary drive assembly 5030. The portion 5032 may be limited in its ability to float vertically within the floating cavity 5025, for example, by a flange 5023.
[0215] Embodiments can be conceived in which there is no vertical limiting feature defined by the bottom 5020 of the cartridge channel 5010. In at least one example, the annular cradle slot 5022 is configured to support the bushing 5034 and / or the distal support head 5035. In at least one example, the annular cradle slot 5022 defines a lower vertical limiting feature, i.e., a stop, configured so that the distal end 5033 of the rotary drive assembly 5030 does not float below a certain threshold defined by contact between, for example, the bushing 5034 and / or 5035 and the annular cradle slot 5022. In at least one example, the vertical slot portion 5026 and the flange 5023 define an upper vertical limiting feature, i.e., a stop, configured so that the distal end 5033 of the rotary drive assembly 5030 does not float above a certain threshold defined by contact between the distal end 5033 and the flange 5023.
[0216] As shown in Figure 83, the staple cartridge 5050 includes a distal nose 5051 that defines a nose cavity 5053 inside. The nose cavity 5053 may provide space for the distal portion 5033 of the rotary drive assembly to float inside it.
[0217] In at least one example, the proximal end of the rotary drive assembly 5030 is fixed in place. In at least one example, the proximal end of the rotary drive assembly 5030 is also configured to float relative to the cartridge channel 5010.
[0218] In at least one example, a spring is provided, for example, at the proximal and / or distal mounting positions of the firing drive screw in the cartridge channel. The spring is configured to bias the firing drive screw into a neutral configuration. In at least one example, the spring is configured to resist bending loads applied to the firing drive screw. In at least one example, one or more magnets are provided within the mounting position, and screw magnets of opposite polarity are provided on the firing drive screw at the mounting position. Such a configuration can bias the firing drive screw towards a neutral configuration and can resist bending loads applied to the firing drive screw. Such a spring may, for example, include a bushing that is deformable in the vertical direction. In at least one example, a coil spring is used within the mounting position.
[0219] In various examples, the flexible floating mounts described herein are configured to allow a limited vertical floating range of the rotary drive assembly relative to the cartridge channel. For example, a vertical floating range of 0.0002 to 0.0003 inches may be permitted by the distal mounts described herein. In other examples, a vertical floating range of 0.001 inches may be permitted, and in specific examples, a vertical floating range of up to 0.0015 inches may be permitted by the flexible floating mounts. The size of the vertical floating range may be configured to avoid applying lateral loads to the rotary drive assembly that are suitable for tensile loads but could cause bending under lateral loads. Instead, the rotary drive assembly can float within the limited vertical floating range to ensure that the rotary drive assembly is not subjected to lateral loads. Even when thick and / or rigid tissue is clamped between the jaws and the anvil bends in the clamp configuration, the vertical floating range allows for movement of the rotary drive assembly and avoids lateral loads on the rotary drive assembly.
[0220] In at least one example, the flanges of the launch member assembly are configured to define a limited vertical floating range of the launch drive screw through a threaded connection between the launch member assembly and the launch drive screw. For example, an anvil engagement flange may contact the upper portion of the anvil slot, and / or a channel engagement flange may contact the upper portion of the channel slot, providing an upper stop for the launch drive screw. In addition to the above, an anvil engagement flange may contact the lower portion of the anvil slot, and / or a channel engagement flange may contact the lower portion of the channel slot, providing a lower stop for the launch drive screw. In at least one example, a drive nut notch, drive cavity, and / or receptacle configured to receive a drive nut are configured to further define the vertical floating range of the launch drive screw.
[0221] Figure 85 shows a surgical staple fastening assembly 5000, which includes a cartridge channel 5010 for the surgical staple fastening assembly 5100. The surgical staple fastening assembly 5100 includes a rotary drive assembly 5130 which includes a threaded portion 5131 and a distal end 5133. The distal end 5133 includes one or more bearings 5134 configured to support the distal end 5133 in contact with a flange 5023. The distal end 5133 further includes a distal support head 5135 which includes a swaged threaded end 5136. The swaged threaded end 5136 may be externally swaged and / or internally swaged. The swaged threaded end 5136 is configured to provide a distal bearing surface for one or more bearings 5134. The rotary drive assembly 5130 is configured to float within the cartridge channel 5010, similar to the rotary drive assembly 5030.
[0222] Any suitable bushing and / or bearing may be used with any of the various rotary drive assemblies and / or launch drive screws disclosed herein. In at least one example, a compression bushing may be used at the proximal or distal end of a launch drive screw within a cartridge channel. When such a compression bushing is installed within a cartridge channel, it can, for example, impose a compressive preload on the launch drive screw. Such a compressive preload can prevent the launch drive screw from disengaging from any support element supporting it within the cartridge channel. For example, a compression bushing may be used at one or more ends of a launch drive screw to prevent the proximal and / or distal ends of the launch drive screw from disengaging from the corresponding support, such as an arched flange extending from the cartridge channel.
[0223] Compressive preloads can be caused, for example, by springs, longitudinal threads, and / or rivets on a compression bushing. In such examples, the compression bushing tends to expand radially under compressive preload. Such radial expansion can fill annular cradle supports and / or floating cavities, such as those described herein. For example, this tendency of the compression bushing to fill such slots and / or cavities can help prevent the launch drive screw from disengaging longitudinally, laterally, and / or vertically from the support element, such as the arched flange discussed herein.
[0224] In at least one example, a bushing and / or bearing configured to support a rotary drive assembly disclosed herein includes a flange extending radially outward from there. This flange is configured to be positioned on the channel support flange side opposite to the distal support head of the launch drive screw. The radial flange may then be biased by a spring to move away from the channel support flange and, consequently, the distal support head. In such an example, the spring would, for example, press the channel support flange and the radial flange of the bushing. In such an example, the radial flange and spring may be configured to retract the distal support head into the channel support flange. In at least one example, this tensile force applied to the distal support head may be configured to seat the distal support head so that it cannot be lifted directly from the channel support flange without first pulling the launch drive screw distally and overcoming the force applied by the spring. Only after overcoming the force can the distal support head be disengaged from the channel support flange, and only then can the launch drive screw be lifted out from the channel support flange.
[0225] In addition to the above, the spring may be compressed, for example, by a distal tightening screw configured to pull the distal support head proximal toward the channel support flange relative to a bushing having a radial flange. Another embodiment has been conceived in which the bearing is positioned distal to the channel support flange, and then a nut is screwed onto a drive screw. The nut can then be rotated to press the bearing against the channel support flange.
[0226] Figures 86 and 87 show a surgical staple fastening assembly 5200 comprising a support channel 5210 and a launch drive screw 5220 configured to actuate a launch member assembly, such as a launch member assembly disclosed herein. The launch drive screw 5220 defines a screw axis SA. As described above, the launch drive screw used in a surgical end effector assembly can be subjected to bending loads. As seen in Figure 87, arrow 5230 indicates a bending load applied to the distal end 5223 of the launch drive screw 5220. The launch drive screw 5220 comprises a proximal ball joint 25221 mounted in a ball joint socket of the channel support 5211, i.e., in the mounting portion 5211. Such a configuration allows the launch drive screw 5220 to pivot relative to the channel support 5211 when subjected to a bending load. In at least one example, the ball joint 5221 and socket 5211 allow the firing drive screw 5220 to pivot without significantly bending it. Bending can cause, for example, seizing of the threaded portion 5225 with the firing member assembly. The ball joint can be finely tuned to allow a predetermined amount of pivoting so as not to allow the firing drive screw 5220 to pivot beyond a predetermined allowable amount and, in some cases, to avoid causing other problems within the end effector assembly. In at least one example, the proximal mounting position of the firing drive screw 5220 has a radial and / or spherical shape to allow slight rotation of the firing drive screw 5220 relative to the screw axis SA. Such a configuration can also prevent seizing and / or gouging of the firing drive screw 5220 within the proximal mounting position.
[0227] In at least one example, the proximal and / or distal ends of the drive screw are supported within the channel and / or anvil by, for example, two or more support flanges extending from the channel and / or anvil. For example, the two or more support flanges may comprise a plurality of flanges arranged in series with respect to each other. One or more corresponding thrust bearings of the drive screw may be configured to be supported in contact with two or more support flanges. Such a configuration may be useful for supporting the drive screw, for example, when the drive screw is to be moved in the proximal and distal directions. In at least one example, for example, a separate thrust bearing is provided on the drive screw for each support flange extending from the channel and / or anvil. In at least one example, each thrust bearing is configured to engage only with its corresponding support flange. In other examples, one thrust bearing is provided between two flanges, and this one thrust bearing is configured to engage with both flanges in the proximal and distal directions. In such examples, one or more additional thrust bearings may be provided proximal and / or distal to both support flanges. Such a device may provide multiple thrust surfaces to the drive screw, as opposed to a single thrust surface.
[0228] In at least one example, the thrust surface of the support flange comprises, for example, a concave inner donut hole. In such an example, the thrust bearing of the drive screw may be configured to be received within the concave inner donut hole. In at least one example, the deformable thrust bearing is press-fitted into the concave hole. In at least one example, the deformable thrust bearing has a diameter larger than the outer diameter of the concave hole. Such a configuration can provide additional support to the drive screw. In at least one example, the deformable thrust bearing comprises a soft, low-density polyethylene washer. In at least one example, the thrust bearing is compressed using a raceway forming process. In at least one example, the thrust bearing may comprise, for example, a threaded washer.
[0229] In various examples, springs and / or magnets may be integrated into various components of an end-effector assembly to allow the various components of the end-effector assembly to float and / or move relative to one another under load. For example, springs and / or magnets may be integrated, for example, at proximal and / or distal mounting positions where the firing drive screw is supported by the cartridge channel. Another example involves incorporating springs and / or magnets into a firing member assembly to allow the drive nut of the firing member assembly to float relative to the main body portion.
[0230] Figures 88 to 91 show a launch member assembly 5300 configured to push thread and / or cutting members through a staple firing stroke within an end effector assembly. The launch member assembly 5300 comprises a main body portion 5010 and a threaded drive nut 5350 configured to screw-couple to a launch drive screw. The drive nut 5350 is configured to apply an axial driving force to the main body portion 5010, pushing and pulling the main body portion 5010 through the end effector assembly. The main body portion 5010 comprises an upper portion 5311 configured to engage with a first jaw of the end effector assembler and a lower portion 5315 configured to engage with a second jaw of the end effector. The lower portion 5315 comprises a proximal portion 5316 and a distal portion 5320, each configured to receive the launch drive screw through it in a non-threaded manner. The drive nut cavity 5330 is defined between the proximal portion 5316 and the distal portion 5320 and is configured to receive the drive nut 5350 inside. The launch member assembly 5300 further comprises a magnetic element 5360 configured to connect the drive nut 5350 to the main body portion 5310.
[0231] The magnetic elements 5360 may comprise, for example, a cylindrical rod, i.e., a pin, and / or a rectangular rod, i.e., a pin. Nevertheless, one of the magnetic elements 5360 is attached to a spring 5361 in a proximal channel 5363 defined within the proximal portion 5316, thereby being subjected to a spring load. Another of the magnetic elements 5360 is attached to a spring 5361 in a distal channel 5365 defined within the distal portion 5320, thereby being subjected to a spring load. In order to mount the drive nut 5350 to the main body portion 5310, the magnetic elements 5360 are retracted into their respective channels 5363, 5365 by an externally located magnet 5370 (Figure 90), which is configured to overcome the spring force applied to the magnetic elements by the spring 5361. Only then can the drive nut 5350 be inserted into the drive nut cavity 5330. When the drive nut 5350 is positioned, the externally located magnet 5370 moves away from the magnetic element 5360, which may allow the spring 5361 to bias the magnetic element 5360 inward toward the drive nut 5350.
[0232] Specifically, the magnetic element 5360 is configured to reside within a corresponding proximal channel 5351 defined within the drive nut 5350 and a corresponding distal channel 5355 defined within the drive nut 5350. The channels 5351, 5355 have a width and / or diameter greater than the width and / or diameter of the magnetic element 5360. This size difference allows the drive nut 5350 to float relative to the main body portion 5310. The amount of float of the drive nut 5350 relative to the main body portion 5310 may be determined and limited, at least in part, by the size difference 5371 between the magnetic element 5360 and the channels 5351, 5355. In at least one example, one of the width and / or height is substantially the same as the width and / or height of the magnetic element 5360. Such a configuration allows the drive nut to float in only one plane. For example, if the vertical heights of the magnetic element 5360 and the drive nut channels 5351 and 5355 are substantially the same, and the widths of the drive nut channels 5351 and 5355 are greater than the width of the magnetic element 5360, the drive nut 5350 can float horizontally, i.e., only laterally, relative to the main body portion 5310. On the other hand, if the widths are substantially the same but the vertical heights are different, the drive nut 5350 can float only vertically relative to the main body portion 5310. Either type of floating can ultimately be limited by the size of the drive screw ducts of the proximal portion 5316 and the distal portion 5320, as will be discussed in more detail above.
[0233] In at least one example, the channels, i.e., pockets 5363, 5365, may be machined into the metal main body portion. In at least one example, the channels, i.e., pockets 5351, 5355, may be part of the injection molding die during the manufacture of the drive nut 5350. In at least one example, the magnetic element 5360 may comprise, for example, a steel pin. In at least one example, the device described above can reduce the need to precisely align the female threaded channel defined within the drive nut, which is connected to the firing drive screw, with the corresponding drive screw duct of the main body portion. In such an example, if the female threaded channel is molded slightly off-center with respect to the corresponding drive screw duct of the main body portion, the magnetic element device described above can allow the drive nut 5350 to float and align with the main body portion 5310. The floating of the drive nut 5350 can also help, for example, prevent the drive nut 5350 from becoming stuck to the firing drive screw. In at least one example, a third degree of motion may be controlled and defined by the proximal portion 5316 and the distal portion 5320, which can define the amount of floating, if any, that is permitted along the longitudinal axis relative to the main body portion 5310.
[0234] In various applications, a launch drive screw may be configured to provide an adaptable drive screw that can adapt to various loads subjected to the launch drive screw, for example, and reduce the possibility of the drive screw seizing. Such an adaptable drive screw can, for example, automatically adapt and / or conform under different load conditions. Such adaptability can be achieved by changing the shape of the drive screw itself, as will be discussed in more detail below.
[0235] Figures 92 and 93 show a launch drive screw 5400 configured to automatically conform under load. The launch drive screw 5400 comprises a cable, i.e., a main core member 5410, having a proximal end 5401 and a distal end 5403. The distal end 5403 may, for example, include a flange portion extending directly therefrom and / or a press-fit thrust bearing. The launch drive screw 5400 also comprises a spring, i.e., a helical member 5420, defining individual threaded portions 5421, configured, for example, to provide a threaded interface to a threaded launch member assembly. The main core member 5410 includes a flexible material so that the main core member 5410 can bend under load and conform to its shape. Together with the main core member 5410, the helical member 5420 also includes a flexible material so that the helical member 5420 can bend together with the main core member 5410 under load. This flexibility of the core member 5410 and the helical member 5420 allows the individual threaded portions 5421 to move relative to one another. The individual threaded portions 5421 can move relative to one another. However, the threaded portions 5421 may be configured to move semi-independently. Such a configuration allows for slight movement of each member 5421. However, since all the threaded portions 5421 are part of a single helical member 5420, movement of one threaded portion 5421 may cause some movement of one or more adjacent helical members, and so on. This may also be referred to as the expansion of the threaded portions 5421 when the firing drive screw 5420 is under load. The firing drive screw 5420 can reduce the possibility of the drive screw seizing under load. In various examples, the main core member 5410 and the helical member may include different materials. The schematic cross-sectional view in Figure 93 shows the space, or gap, between the inner diameter of the helical member 5420 and the outer diameter of the main core member 5410, but in other examples, the inner diameter of the helical member 5420 is in contact with and / or abuts against the outer diameter of the main core member 5410.
[0236] Figure 94 is a schematic diagram of a launch assembly 5500 comprising a flexible launch drive screw 5550. The launch drive screw 5550 may have many similarities with, for example, the launch drive screw 5400, among the launch drive screws disclosed herein. The launch assembly 5500 comprises a launch drive screw 5550 mounted on a channel frame 5510. The proximal drive member of the launch drive screw 5550, i.e., a solid bushing 5551, comprises a flange 5552 configured to be supported by the proximal end 5511 of the channel frame 5510. The distal portion 5556 of the launch drive screw 5550 is configured to be supported by a distal support flange 5513 extending from the channel frame 5512. The launch drive screw 5550 further comprises a flexible core member 5556 and a helical member 5554 that surrounds the flexible core member 5556 and defines a threaded portion, i.e., region 5555. The helical member 5554 is attached to the proximal drive member 5551, and the sleeve / plug 5557 is fixedly attached to the distal portion 5556 of the firing drive screw 5550. For example, the proximal drive member 5551 may be swaged onto the flexible core member 5556 of the firing drive screw 5556. The distal portion 5556 comprises a threaded portion 5558, a bushing 5559, and a distal nut 5560 screw-coupled to the threaded portion 5558. A pair of bushings 5559 are positioned proximal to the distal nut 5560 in the socket and may be sandwiched between the distal nut 560 and the distal support flange 551 (see, for example, bearing 5034 in Figure 82).
[0237] In at least one example, the inner diameter of the helical member 5554 is configured to surround and contact the outer diameter of the flexible core member 5553. The helical member 5554 may comprise, for example, some kind of coil spring. The flexible core member 5553 may comprise, for example, a flexible cable. In at least one example, the helical member 5554 is manufactured with an inner diameter smaller than the outer diameter of the flexible core member 5553. In such an example, the helical member 5554 can be reversed to increase its inner diameter in order to assemble it onto the flexible core member 5553. Once the helical member 5554 is positioned on the flexible core member 5553, it can be released. When the helical member 5554 is released, it will be biased to return to its neutral, unloaded configuration, and will align itself tightly with, i.e., clamp onto, the flexible core member 5553. In at least one example, the helical member 5554 is welded to the flexible core member 5553 at various positions along the length of the flexible core member 5553.
[0238] In at least one example, the nut 5560 is configured to be tightened and / or loosened to provide a desired configuration of the helical member 5554. Tightening and / or loosening the nut 5560 may also allow adjustment of the tension of the flexible core member 5553. Adjusting the tension of the flexible core member 5553 may directly correlate to the amount of deflection allowed along the length of the flexible core member 5553 under load. A more taut cable may allow for smaller bends than, for example, a looser cable. This can be adjusted to a desired tension, for example, during manufacturing. Embodiments can be conceived that are differently adjusted for cartridges of different sizes and / or surgical stapling systems that require different firing forces.
[0239] In various examples, launch drive screws are provided that are configured to minimize their plastic deformation under various loads. Such launch drive screws may include variations in their cross-sectional shape along their longitudinal length. Such variations may result in a portion of the launch drive screw that is more flexible than adjacent portions. The more flexible portion of the launch drive screw may, for example, withstand greater bending loads than the less flexible portion. Variations of the launch drive screw may be located in the proximal, intermediate, distal portions, or any combination thereof. The location of the variation may depend, for example, on the application and region of the launch drive screw that will experience the highest load.
[0240] Figure 95 shows a launch drive screw 5600 configured for use with a surgical staple assembly, such as a surgical staple assembly discussed herein. The launch drive screw 5600 includes a proximal driven end 5601 configured to be attached to a rotary drive shaft. The launch drive screw 5600 also includes a proximal flange 5602 configured to be supported, for example, within a frame component of an end effector assembly. The launch drive screw 5600 includes a screw shaft 5610 having a main threaded portion 5613 and a proximal neck-down portion 5611. The proximal neck-down portion 5611 has a smaller cross-sectional diameter than the main threaded portion 5613. Such a change in cross-sectional diameter allows for slight bending of the neck-down portion 5611, reducing the excessive bending effect on the main threaded portion 5613. If the launch member assembly is configured to be driven so as to be screwable in the proximal and distal directions to the main threaded portion 5613, the possibility of the drive screw seizing in the portion of the launch drive screw 5600 engaged with the launch member assembly can be reduced by reducing the bending effect on the main threaded portion. In at least one example, the launch member assembly is also configured to move so as to be screwable through the neck-down portion 5611. However, in at least one example, a high driving force may not be required throughout the stroke length of the neck-down portion 5611.
[0241] Figures 96 and 97 show a launch drive screw 5700 comprising a proximal driven end 5701 and a mounting flange 5702. The launch drive screw 5700 further comprises, for example, a proximal portion 5720 of threads 5721 that are overmolded and / or insert-molded onto the proximal portion 5711 of the spindle 5710 of the launch drive screw 5700. The launch drive screw 5700 comprises a main threaded portion 5712 having a cross-sectional diameter larger than the diameter of the proximal portion 5711. As described above, the change in cross-sectional diameter allows for bending of the spindle 5710, and in particular, the bending can be localized to the proximal portion 5711 so as to reduce the possibility of the drive screw becoming stuck with the drive nut of the launch member assembly. For example, the threads 5721 may be made of a polymer material and the spindle 5710 may be made of a metallic material. Thread 5721 may help maintain a consistent thread pattern along the moving stroke of the launch member assembly, which is screw-coupled to the launch drive screw 5700.
[0242] In at least one example, various portions along the length of the firing drive screw include, for example, overmolded plastic thread portions. In at least one example, the various overmolded portions may accommodate differences in manufacturing tolerances between the drive nut of the firing assembly and the thread profile of the firing drive screw, and in certain examples, may provide, for example, a smoother thread engagement surface. In at least one example, the central portion of the firing drive screw midway through the firing stroke has various cross-sectional shapes.
[0243] Figures 98 to 100 show various types of shaft couplings 5810, 5820, and 5830 that can be used with a launch drive screw, such as the launch drive screw disclosed herein. The shaft couplings 5810, 5820, and 5830 can be positioned at any location along the length of the launch drive screw to provide locations intended to localize the bending of the launch drive screw. The shaft couplings 5810, 5820, and 5830 are configured to convert rotational axial motion from one axis to another. The shaft coupling 5810 can introduce virtually no or no backlash into the launch drive screw used with it. The shaft couplings 5810, 5820, and 5830 can tolerate some angular displacement of the shaft, for example, due to bending forces applied to the launch drive screw in the end effector, parallel displacement of the shaft, and / or axial movement of the shaft.
[0244] The shaft coupling 5810 may be, for example, a beam coupling. The coupling 5810 comprises a proximal hub 5811 configured to be attached to the distal end of one portion of the firing drive screw, a distal hub 5813 configured to be attached to the proximal end of another portion of the firing drive screw, and a helical notch 5815 configured to bend during a shaft misalignment scenario.
[0245] The shaft coupling 5820 may be, for example, a bellows coupling. The coupling 5820 comprises a proximal hub 5821 configured to be attached to the distal end of one portion of the firing drive screw, a distal hub 5823 configured to be attached to the proximal end of another portion of the firing drive screw, and a flexible corrugated portion 5825 configured to bend during shaft shearing scenarios.
[0246] The shaft coupling 5830 may be, for example, a curved jaw coupling. The coupling 5830 comprises a proximal hub 5831 configured to be attached to the distal end of one portion of the firing drive screw, a distal hub 5833 configured to be attached to the proximal end of another portion of the firing drive screw, and a toothed spider gear 5835. The spider gear may be made of a softer material and configured to bend between the hubs 5831 and 5833 while maintaining a drive engagement between the spider gear, the proximal hub 5831, and the distal hub 5833.
[0247] In end effector assemblies, such couplings 5810, 5820, and 5830 allow for bending of the firing drive screw within the coupling itself, reducing bending within the screw shaft itself. As discussed herein, bending of the screw shaft can cause seizing of the firing drive screw and firing member assembly, which are screw-coupled to each other.
[0248] Figures 101 to 103 show a closing drive assembly 6000 comprising a closing drive unit 6010 and a closing nut, i.e., a wedge 6020, screw-coupled to the closing drive unit 6010. The closing nut 6010 is configured to open and close the jaws 6040 of the closing drive assembly 6000 relative to opposing jaws having a cam nub 6023 and a cam surface 6021, respectively. The closing drive assembly 6000 includes a support element 6030 configured to support the closing drive unit 6010. The support element 6030 may be fixed, for example, to a channel retainer. The support element 6030 includes shaft seating flanges 6031, 6032 configured to internally support the closing drive screw 6013 of the closing drive unit 6010. The closing drive unit 6010 further comprises a proximal driven portion 6010 configured to be driven by a rotary closing drive shaft, a thrust bearing 6012 configured to abut against the flange 6031, and a distal thrust bearing portion 6016 configured to abut against the flange 6032.
[0249] The closing drive screw 6013 comprises a threaded portion 6014 and a distal non-threaded portion 6015. The closing nut 6020 further comprises a female threaded portion 6025 configured to screw-engage with the threaded portion 6014, so that the closing nut can advance along the threaded portion in the proximal and distal directions to open and close the jaw 6003. In at least one example, the closing nut 6020 is configured to be 3D printed on a pre-fabricated closing drive 6010. The closing nut 6020 may be made of, for example, a metallic material and / or a polymer material. The closing nut 6020 is configured to be printed around the distal non-threaded portion 6015. Such a device may allow the female threaded portion 6025 of the closing nut 6020 to be printed with a slightly smaller effective diameter than if the closing nut were printed directly around the threaded portion 6015. When printed on the closing drive screw 6013, the closing nut 6020 is effectively trapped between the bearing 6012 and the bearing portion 6016, preventing accidental disassembly after manufacturing. In at least one example, the bearing 6012 and the bearing portion 6016 are printed on the drive screw 6013 before the closing nut 6020 is printed.
[0250] In at least one example, one or more parts of the closing drive unit 6010 are also 3D printed. In such an example, the closing drive unit 6010 may be 3D printed to a size slightly larger than the desired size. For example, the closing drive unit 6010 may be 0.5% larger than the desired size. In such an example, various details of the closing drive unit 6010 that require precise dimensions may be machined after printing the closing drive unit 6010. Such a manufacturing process can reduce machining waste and shorten the time required to manufacture one or more parts in certain examples. For example, a closing drive unit having a shaft with a non-threaded portion and a threaded portion, where the non-threaded portion has a diameter less than or equal to the smaller diameter of the threaded portion, requires the removal of at least a ring of material having the width of the thread depth in the non-threaded portion. By 3D printing such a closing drive unit, it becomes possible to print the non-threaded portion, which is slightly larger for the reasons mentioned above, but much closer to the smaller diameter of the threads.
[0251] Figures 104 and 105 show a closing drive unit 6100 comprising a drive screw 6110 and a restraint collar 6120 configured to be fixed to the drive screw 6110. The restraint collar 6120 may be analogous to the distal thrust bearing portion 6016 of the closing drive unit 6010. The restraint collar 6120 may be configured, for example, to contact a support flange to support the closing drive unit 6110. The restraint collar 6120 may be referred to, for example, a washer, a nut, and / or a flange. The drive screw 6110 comprises a main threaded portion 6111 having threads 6112. The main threaded portion 6111 may be configured, for example, to drive a closing nut thereon in the proximal and distal directions to open and close the jaws of the end effector.
[0252] The drive screw 6110 further comprises a distal end 6113 having an annular slot 6114 and threads 6115. The annular slot 6114 is configured to support a restraint collar 6120 internally. The threads 6115 are configured to allow the mounting of the restraint collar 6120 and to prevent the removal of the restraint collar 6120 from the drive screw 6110. The restraint collar 6120 has a proximal inclined surface 6122 defined internally. The proximal inclined surface 6122 is configured to allow the restraint collar 6120 to screw into the threads 6115 of the drive screw 6110, thereby allowing the restraint collar 6120 to pass through the threads 6115 and its internal support surface 6121 to fit into the annular slot 6114. When mounted on the drive screw 6110, the threads 6115 are distal to the distal vertical wall 6123 defined within the restraint collar 6120. The distal wall 6123 is configured to prevent the restraint collar 6120 from being pulled out from the distal end 6113 of the drive screw 6110.
[0253] In at least one example, the drive screw 6110 is machined and / or 3D printed from a metallic material. In at least one example, the restraint collar 6120 is molded and / or 3D printed from a polymer. In at least one example, the restraint collar 6120 is made of a material that allows for some degree of flexibility so that the restraint collar 6120 can bend around the threads 6115 and pass through the threads. A large force may be required to attach the restraint collar 6120 onto the drive screw 6110. In at least one example, a greater force may be required to remove the restraint collar 6120 from the drive screw 6110, at least for the distal wall 6123.
[0254] In at least one example, such a restraining collar may be used in conjunction with a launch drive screw configured to drive the launch member assembly in a screwable manner. In various examples, such a restraining collar may be used at the proximal end of the drive screw, the distal end of the drive screw, or at both ends of the drive screw.
[0255] In at least one example, the restraint collar is mounted on the drive screw using a retaining washer. In such an example, the threads and / or multiple threads configured to mount the restraint collar upward may be configured to further tighten the locking engagement between the retaining washer and the restraint collar, for example, when the drive screw is under load. For example, each end of the restraint collar may have threads with opposite thread directions. For example, the proximal end of the restraint collar may have left-handed threads, the distal end of the restraint collar may have right-handed threads, or vice versa. Once mounted, the restraint collar can be introduced into the opposite thread pattern, thereby causing the restraint collar to move away from the distal end of the drive screw, and the opposite thread pattern may function to further tighten the locking engagement between the retaining washer and the restraint collar.
[0256] In at least one example, the launch drive screw and / or closing drive screw can be 3D printed. In such an example, various features can be printed directly onto the drive screw. For example, support flanges, bearings, restraint collars, etc., can be printed directly onto the drive screw. In at least one example, one or more of these various features may contain a different material than the drive screw itself. In such an example, features containing a different material than the drive screw can be printed directly onto a drive screw, for example, made of metal. In at least one example, the various features contain the same material as the drive screw. In such an example, various metallic features can be printed onto a metal drive screw, for example, using a process called directed energy deposition. In at least one example, the various features may contain different materials that can be welded to the drive screw after printing onto it.
[0257] In various applications, for example, using feature parts made of different materials on a drive screw, such as flanges, can provide a lower coefficient of friction between the flange and the support structure compared to, for example, a support structure and flange that both contain metal materials. Manufacturing feature parts after machining the main part of the drive screw can also reduce the manufacturing time and cost of the entire closing drive unit, for example.
[0258] Figures 106 and 107 show a drive assembly 6200 mounted on a channel flange 6210. The drive assembly 6200 comprises a drive screw shaft 6220 having a threaded portion configured to screw-couple to a launching member of a surgical staple fastening assembly. The drive screw shaft 6220 further comprises a flanged end 6224 and a distal end 6223 having an annular slot 6225. A locking assembly 6230 is provided for securing the drive screw shaft 6220 to the channel flange 6210. The locking assembly 6230 comprises a distal nut 6240 and a locking member 6250. The locking member 6250 is configured to lock within the annular slot 6225 and provide a contact surface to which the distal end 6223 of the drive screw shaft 6220 contacts and is secured. The distal nut 6240 can be screwed onto the distal end 6223 after the locking member 6250 has contacted the channel flange 6210 and is positioned on the drive screw shaft 6220. When the distal nut 6240 is tightened or moves proximal toward the channel flange 6210, the locking member 6250 may include a flexible material so that it is biased into the annular slot 6225 by the inclined surface 6241 of the distal nut 6240. In at least one example, the locking member 6250 is configured to take on a mushroom shape and / or balloon shape when pressure is applied by the distal nut 6240. In at least one example, the distal nut 6240 includes a metallic material. In at least one example, the locking member 6250 includes a deformable restraint for the drive screw shaft 6200. For example, when a load is applied to the drive screw shaft in direction 6260, the drive screw shaft 6220 is prevented from being pulled proximal to the channel flange 6210 in order to expand the locking member 6250. The flanged end 6224 can transmit the load to the locking member 6250, which transmits the load to the channel flange 6210.
[0259] In at least one example, a drive screw shaft, such as the drive screw shaft discussed herein, can be manufactured using a subtractive manufacturing method, such as the Swiss screw manufacturing method. Such a manufacturing method can reduce, for example, material waste and manufacturing time of the drive screw. Such a manufacturing method can also enable high-precision machining of such relatively small drive screws, and the diameter along the length of such a drive screw shaft may vary and include relatively small differences in size.
[0260] In various examples, the locking members, such as locking member 6250, include, for example, rubber material and / or low-density polyethylene and / or polypropylene. The material of the locking member may be selected based on its ability to shear under load so that, under a predetermined threshold load, the locking member can shear and prevent failure of other components in the system. Such locking members can also automatically center the drive screw shaft when mounted by being uniformly constrained around its periphery.
[0261] In various examples, an end effector assembly, such as the end effector assembly disclosed herein, may comprise stackable supports configured to support one or more drive units of the end effector assembly. For example, one or more stackable supports may be configured to support non-concentric closing and firing drive units. One or more stackable supports may be configured to support one or more drive units in contact with a common frame element, such as a channel jaw.
[0262] Figures 108–110 show a surgical staple assembly 6300. The surgical staple assembly 6300 comprises a joint component 6310 and a channel jaw 6320. The channel jaw 6320 is attached to the joint component 6310 by a fixing band, i.e., a ring, configured to be received in an annular slot 6315 of the joint component 6310. The channel jaw 6320 comprises a base 6321 and vertical slots 6322 on both sides of the channel jaw 6320, configured to receive tabs 6314 on both sides of the articulation component 6310. The joint component 6310 defines an articulation pin slot 6311 internally. The channel jaw 6310 can be articulated around an axis defined by the articulation pin slot 6311. The joint component 6310 is configured to receive one or more drive shafts through it to drive the closing drive unit 6340 and the firing drive unit 6350 of the surgical staple fastening assembly 6300.
[0263] The closing drive unit 6340 comprises a drive screw 6341 and a closing wedge 6342 screw-coupled to the drive screw 6341. The closing wedge 6342 is actuated by the drive screw 6341 in the proximal and distal directions to open and close a jaw, such as an anvil jaw, that faces the channel jaw 6320. The firing drive unit 6350 comprises a drive screw 6351 with a proximal end 6352 and a firing member assembly 6353 configured to screw-engage with the drive screw 6351. The firing drive unit 6350 is configured to eject staples from a staple cartridge and cut patient tissue during a staple firing stroke as the firing member assembly 6350 is actuated along the drive screw 6351.
[0264] The closing drive unit 6340 and the firing drive unit 6350 are supported within the channel jaw 6320 by a lower support element, i.e., a mounting portion 6380, and an upper support element, i.e., a mounting portion 6370. The support elements 6370, 6380 may be stackable and may support one or more elements of the closing drive unit 6340 and the firing drive unit 6350. The lower support element 6380 comprises a lower portion 6381 and an upper portion 6383. The lower portion 6381 comprises a key 6382 configured to be received in a corresponding slot defined within the channel jaw 6320. Such a key and slot configuration can prevent the lower support element 6380 from moving relative to the channel jaw 6320. The upper portion 6383 comprises a shaft support 6384 comprising a lower arched support portion 6385 and an upper arched support portion 6386. The lower arched support portion 6385 is configured to receive the input shaft 6355 of the firing drive unit 6350, which is connected to the proximal end 6352 of the drive screw 6351 and is driven by it. The upper arched support portion 6386 is configured to receive and support the drive screw 6341 of the closing drive unit 6340.
[0265] The upper support element 6370 may be received on the lower support element 6380 in a track-like manner. For example, a corresponding cavity defined within the upper support element 6370 may be configured to receive the upper portion 6383 of the lower support element 6370, thereby allowing the upper support element 6370 to fit and surround the upper portion 6383 during installation. The upper support element 6370 further comprises a key 6371 configured to be received in a corresponding slot defined within the channel jaw 6320. The upper support element 6370 further comprises a top surface 6373 and a distal support tab 6372 configured to receive and support a portion of the drive screw 6341 internally. The top surface 6373 is configured to support the bottom surface 6343 of the closing wedge 6342 on it. In at least one example, a closing wedge track is defined on the upper surface 6373, and a closing wedge 6342 can engage with and move along the closing wedge track during proximal and distal movement. The upper support element 6370 further comprises a window 6374 configured to receive an upper portion 6383. Both the upper support element 6370 and the lower support element 6380 may be supported by the bottom 6321 of the channel jaw 6320.
[0266] In at least one example, the upper support element 6370 and / or the lower support element 6380 may be supported within corresponding tracks defined within the channel jaw 6320, thereby allowing some longitudinal movement while the upper support element 6370 and the lower support element 6380 are still supported by the channel jaw 6320. This may be useful during clamping, unclamping, and / or articulation of the end effector assembly, where extension and retraction of various drive shaft components are required due to the clamping, unclamping, and / or articulation movements of the end effector assembly, as well as the associated forces of the end effector assembly.
[0267] In at least one example, the upper support element 6370 and / or the lower support element 6380 are manufactured from a single material into a single component. Such a configuration can be achieved, for example, by using a metal machining process. In at least one example, the upper support element 6370 and / or the lower support element 6380 are manufactured separately. In such an example, one of the upper support element 6370 and the lower support element 6380 comprises a machined component, while the other of the upper support element 6370 and the lower support element 6380 comprises, for example, a punched component. In at least one example, both the upper support element 6370 and the lower support element 6380 are punched.
[0268] Various types of closing wedges and / or nuts are disclosed herein. A closing wedge may comprise a cam surface configured to close a jaw and one or more cam surfaces configured to open a jaw. In various examples, the angles of the corresponding cam surfaces may include angles that are sharper with respect to the engagement surfaces of the jaws with which they cam-engage. The cam surfaces may be adjusted so as to minimize the driving force required from the corresponding closing drive screw while maintaining a sufficient closing drive cam force.
[0269] Figures 111 to 113 show a closing drive assembly 6400 configured to open and close the jaws of an end effector assembly. The closing drive assembly 6400 comprises a jaw support element 6410 and a closing drive unit 6420 supported by support flanges 6411, 6413 of the jaw support element 6410. The closing drive unit 6420 comprises a drive screw shaft 6430 having a proximal end 6431 configured to be rotated by a rotary drive shaft, a proximal bearing portion 6432 configured so that the drive screw shaft 6430 does not move distally relative to the flange 6413, and a threaded portion 6433 configured to be screw-coupled to a closing wedge 6450. The drive screw shaft 6430 further comprises a distal end 6434 supported in a flange support slot 6412 of the flange 6411 and fixed to the flange 6411 by a clip 6440. The clip 6440 is configured to be received in a clip slot 6435 defined within the distal end 6435 of the drive screw shaft 6430. The clip 6440 is configured to prevent the drive screw shaft 6430 from moving proximal to the flange 6411. The clip 6440 may include, for example, an e-clip. However, any suitable clip, retaining clip, and / or retaining ring may be used. In at least one example, the closing wedge 6450 may be screwed onto the drive screw shaft 6430 from the distal end 6434.
[0270] Figures 114 to 117 show a closing drive unit 6500 comprising a drive screw shaft 6510 and a closing drive nut, i.e., a wedge 6540, configured to open and close the jaws of an end effector assembly. The drive screw shaft 6510 comprises a proximal end 6511 and a distal end 6515. The proximal end 6511 comprises a driven portion 6512 configured to be rotated by a rotary drive shaft, a proximal bearing portion 6513, and a threaded portion 6514 configured to be screw-coupled to the closing wedge 6540. The distal end 6515 comprises a mounting portion 6516 having a diameter smaller than the diameter of the drive screw shaft 6510 immediately proximal to the mounting portion 6516. The mounting portion 6516 is configured to receive a locking member, i.e., a radial washer 6520, on it.
[0271] Next, with reference to Figures 116 and 117, the mounting of the locking member 6520 will be described here. The distal end 6515 can be swaged, for example, to radially expand the mounting portion 6516. This radial expansion can result in a frictional retaining engagement between the locking member 6520 and the mounting portion 6516. A central slot 6517 is provided. The slot 6517 is used to insert a swaging tool into it, thereby expanding the mounting portion 6516 and locking the locking member 6520 into place. In at least one example, the locking member 6520 is deformable, for example, the swaging of the mounting portion 6516 is configured to deform the locking member 6520 into a mounting configuration.
[0272] In at least one example, the locking member 6520 is pinned to the mounting portion 6516 in addition to, or instead of, the swaging process described above. In at least one example, the locking member 6520 further comprises an annular groove, and the mounting portion 6516 further comprises a corresponding annular slot defined on its outside, configured to receive the annular groove of the locking member 6520. In at least one example, a hole is machined within the drive screw, and an alignment pin is configured to be inserted into the hole to hold the closing wedge on the drive screw.
[0273] In at least one example, a high-density polyethylene washer is positioned proximal to the locking member 6520. The high-density polyethylene washer may also be provided with a deformable support flange such that the washer deforms when, for example, the locking member 6520 is assembled to the drive screw shaft 6510.
[0274] In at least one example, the deformable washer used herein comprises a grooved surface and / or a knurled surface. Such grooved and / or knurled surfaces may be used to compensate for cumulative tolerances of various components within a drive system. For example, such grooved and / or knurled surfaces may be slightly worn after a first operating stage after assembly to compensate for cumulative tolerances.
[0275] Figures 118 to 123 show a launch drive assembly 7000 comprising a rotary drive shaft 7010, a launch member 7020 screw-coupled to the rotary drive shaft 7010, and a bail-out assembly 7030 configured to screw-couple the launch member 7020 to the rotary drive shaft 7010 and to allow bail-out and / or disengagement of the screw engagement between the rotary drive shaft 7010 and the launch member 7020. The rotary drive shaft 7010 comprises a distal end 7011 and a threaded, i.e., grooved portion 7013. The launch member 7020 comprises an upper flange, a proximal edge portion 7022, and a distal edge portion 7023. The launch member 7020 further comprises a lower portion 7024 having a drive shaft duct 7026 configured to receive the rotary drive shaft 7010 through the drive shaft duct 7026. The lower portion 7024 further comprises a lower flange 7025.
[0276] The bailout assembly 7030 comprises a bailout actuator, i.e., a cable 7031, and a housing 7032 defining a housing cavity 7033. The bailout assembly 7030 further comprises a biasing plate 7040 and an actuator plate 7050. The actuator plate 7050 comprises a main plate portion 7051 and a tip portion, i.e., a pin 7052, which extends inward and is received and driven by the threaded portion 7013 of the rotary drive shaft 7013. The pin 7052 is received in a pin slot 7028 defined in the lower portion 7024 and is configured to drive-engage with the threaded, i.e., grooved portion 7013. The actuator plate 7050 is spring-biased relative to the lower portion 7024 by a spring 7060 located in a spring slot 7027 defined in the lower portion 7024. The spring 7060 is configured to bias the actuator plate 7050 and disengage it from its screw engagement with the rotary drive shaft 7010.
[0277] To hold the actuator plate 7050 in a threaded engagement with the rotary drive shaft 7010, the biasing plate 7040 is positioned or pressed between the housing 7032 and the main plate portion 7051 within the housing cavity 7033. This wedge engagement overcomes the spring force applied to the actuator plate 7050 by the spring 7060, keeping the pin 7052 engaged with the threaded portion 7013 of the rotary drive shaft 7010. In various examples, the launch drive assembly 7000 may become immobile or jammed within the end effector assembly due to various circumstances. The bailout assembly 7030 allows the launch member 7020 to be disengaged from the rotary drive shaft 7010 and pulled proximal independently of the rotary drive shaft 7010 to overcome the immobile or jammed scenario.
[0278] To bail out the launch drive assembly 7000, the pin 7052 is moved from its innermost position (Figures 120, 121) to its outermost position (Figures 122, 123), disengaging the pin 7052, and therefore the launch member 7020, from the rotary drive shaft 7010. To achieve this action, the biasing plate 7040 is pulled proximally by the actuator 7031, moving the biasing plate 7040 out of the path of the actuator plate 7050, thereby allowing the spring 7060 to push the main plate portion 7051, and therefore the pin 7052, disengaging it from the screw engagement with the screw portion 7013 of the rotary drive shaft 7010. At that point, the actuator 7031 can continue to be pulled proximally, applying a tensile force to the launch member 7020 via the biasing plate 7040. The housing cavity 7033 includes a proximal limiting wall configured to transmit tensile force from the biasing plate 7040 to the launch member 7050. When the launch member 7020 is retracted to its proximal position, the end effector assembly can be opened and removed from the surgical site, for example.
[0279] In at least one example, the launch drive assembly 7000 and the end effector assembly using the launch drive assembly 7000 may not be reusable due to the nature of the bailout assembly 7030. For example, the bailout assembly 7030 may not be able to be reattached and returned to screw engagement with the rotary drive shaft 7010. In at least one example, the bailout assembly 7030 may be reattached and reusable. In at least one example, another pin 7052 and a corresponding structure are provided on the other side of the launch member 7020. In such an example, the same or separate cables may be provided to actuate the other pin.
[0280] In at least one example, the actuator, i.e., the cable, may be controlled using a geared pulley system. In at least one example, the cable may be motor-driven. In at least one example, the cable may be manually actuated. In at least one example, the cable may be both manually actuated and motor-driven. For example, a manual actuation method can be used during a power outage when the motor-driven system is temporarily stopped. In at least one example, the cable may lengthen during the operation of the launcher to prevent premature activation of the bailout assembly. The cable may move passively or actively to adapt to the movement of the launcher.
[0281] In various examples, surgical stapling devices are provided that are configured to form staples, such as conventional wire staples, differently within a single staple cartridge. More specifically, the staple cartridge may contain staples having, for example, the same unformed height, size, and shape. In such examples, different features are provided to form the same unformed staples into different final formed configurations. In at least one example, the various formations of the staples change gradually along the width of the staple cartridge. More specifically, the staples in the inner row may be formed into a planar, i.e., 2D formed configuration, while the staples in the middle row and / or the outer row may be formed into a non-planar, i.e., 3D formed configuration. Such a device can compress various stapled tissues along the width of the staple cartridge.
[0282] In addition to the above, such surgical stapling devices may include tissue-grasping features, i.e., staple cavity extensions, defined on the deck of the staple cartridge. Such tissue-grasping features may vary in shape and / or size, for example, along the lateral direction of the staple cartridge. The deck of the staple cartridge may have a curved surface, the apex of such a curved deck defined in the longitudinal slots of the staple cartridge. The deck of the staple cartridge may also have one or more flat surfaces, either a single flat surface defining all of the staple rows, or a stepped deck device having one or more corresponding staple rows with various stepped portions of the deck defined inside.
[0283] The tissue gripping features may also be interconnected along the width of the staple cartridge. The staple cartridge may, for example, have three rows of staple cavities on both sides of the longitudinal slot of the staple cartridge, and therefore three rows of staples detachably housed inside. The tissue gripping features, i.e., deck projections, may be positioned around each cavity in each row. However, the tissue gripping features may be interconnected between one or more of the staple cavity rows, for example, while still varying in shape and / or size. Such tissue gripping features can result in varying tissue compressions along the width of the staple cartridge. Tissue gripping features of varying sizes may be advantageous when forming staples in a particular row into a non-planar 3D configuration and staples in a particular row into a planar 2D configuration. Such features may be specifically tailored for the corresponding staple configuration of staples formed through the tissue gripped by the features. For example, a gripping feature configured to grip tissue to be stapled between an anvil and a row of staple cavities comprising staples configured to form a non-planar configuration may have a first shape, and a gripping feature configured to grip tissue to be stapled between an anvil and a row of staple cavities comprising staples configured to form a planar configuration may have a second shape, the first shape being different from the second. In certain examples, a gripping feature aligned with a row of 3D staples may have notches in areas where curved, formed legs would interfere. For example, a row aligned with 2D staples may have a full gripping feature surrounding the staple cavity, and a row aligned with 3D staples may include a gripping feature having notches around it to accommodate the staple legs during 3D forming.
[0284] In various cases, staples formed in a planar configuration and staples formed in a non-planar configuration may result in different formation compression heights. This can be due to the distance required for the legs of each staple to travel to the corresponding staple-forming pocket defined within the anvil. For example, the legs of staples formed in a non-planar configuration may have to travel diagonally to the corresponding staple-forming pocket. This distance may be greater than the distance required for the legs of staples formed in a planar configuration to travel to the corresponding staple-forming pocket, without altering any other features of the staple fastening assembly.
[0285] In various examples, the distance each leg must travel to form its corresponding configuration (non-planar or planar) can be adjusted by modifying one or more features of the surgical staple fastening assembly. In at least one example, the depth of a staple-forming pocket defined within the anvil is adjusted to correspond to the staple-forming configuration formed thereon. In at least one example, the unformed length of a staple is configured to be adjusted to correspond to the staple-forming configuration formed thereon. In at least one example, the corresponding driver height is adjusted to correspond to the staple-forming configuration formed thereon. In at least one example, one or more of these adjustments are combined to accommodate 2D-forming staples and 3D-forming staples.
[0286] Figures 124–128 show a surgical stapling assembly 8000. The surgical stapling assembly 8000 comprises a cartridge jaw 8001 having a cartridge channel 8010 and a staple cartridge 8020. The surgical stapling assembly 8000 also comprises an anvil jaw 8003 having an anvil 8050. The staple cartridge 8020 comprises a plurality of staple cavities 8030 and a longitudinal slot 8022 defined within a cartridge deck 8021. The staple cartridge 8020 also comprises a plurality of tissue gripping features, i.e., cavity extensions 8040, defined on the deck 8021. The staple cavities 8030 are aligned in longitudinal rows offset from one another. In this example, the staple cartridge 8020 has three rows of staple cavities on either side of the longitudinal slot. However, any preferred number of rows of staple cavities may be used. The staple cavity 8030 is configured to removably house staples that are configured to be injected into staple-forming pockets defined within the anvil surface 8051 of the anvil 8050.
[0287] Referring to Figures 125 and 126, the anvil 8050 comprises an anvil slot 8052 defined within the anvil surface 8051. The anvil 8050 further comprises a pair of inner staple-forming pocket rows 8061, a pair of intermediate staple-forming pocket rows 8063, and a pair of outer staple-forming pocket rows 8065. Rows 8061, 8063, and 8065 are aligned with corresponding rows of staple cavity 8030. The inner staple row 8081 comprises staples 8070 configured to be formed by staple-forming pocket row 8061, the intermediate staple row 8082 comprises staples 8070 configured to be formed by staple-forming pocket row 8063, and the outer staple row 8083 comprises staples 8075 configured to be formed by staple-forming pocket row 8065. The position of the staple tip entry point of the pockets within the staple-fastening pocket row 8065 is aligned with, or substantially aligned with, the staple tips within the outer staple row 8065. However, the position of the staple tip exit point of these pockets may be laterally offset from the staples positioned within the outer staple row 8065. Staples 8070 and 8075 include conventional wire staples. Staples 8070 and 8075 have the same unformed height. Staple 8070 is formed in a planar configuration, and staple 8075 is formed in a non-planar configuration.
[0288] Each pair of forming pockets in row 8061 comprises a proximal forming pocket 8061A and a distal forming pocket 8061B. Each pair of forming pockets in row 8063 comprises a proximal forming pocket 8063A and a distal forming pocket 8063B. Each pair of forming pockets in row 8065 comprises a proximal forming pocket 8065A and a distal forming pocket 8065B. Forming pockets 8061A and 8061B have a central axis, i.e., a longitudinal pocket axis, that is aligned with each other along row 8061. Similarly, forming pockets 8063A and 8063B have a central axis, i.e., a longitudinal pocket axis, that is aligned with each other along row 8063. Forming pockets 8065A and 8065B have a central axis, i.e., a transverse pocket axis, that is transverse to the central axes of pockets 8061A and 8061B and the central axes of pockets 8063A and 8063B. The central axes of pockets 8065A and 8065B may be substantially parallel to each other. In addition to the above, one proximal leg of staple 8070 is configured to enter the proximal forming pocket 8065A, and the distal leg of the staple is configured to enter the distal forming pocket 8065B. The forming pockets 8065A and 8065B are configured to orient the legs of staple 8075 laterally away from the crown of the staple, i.e., laterally away from each other (see Figure 126). This variation of 2D-formed and 3D-formed staples along the transverse direction of the width of the staple fastening assembly 8000, with respect to the longitudinal axis thereby defined, can provide a variety of tissue compressions to the stapled tissue. For example, an outer 3D staple may provide less tissue compression compared to an inner 2D-formed staple near the tissue cutting line.
[0289] As shown in Figure 125, longitudinal gaps are defined between each pair of forming pockets 8061A and 8061B, longitudinal gaps are defined between each pair of forming pockets 8063A and 8063B, and gaps are defined between each pair of forming pockets 8065A and 8065B. The gap defined between forming pockets 8061A and 8061B may be substantially the same as and / or similar to the gap defined between forming pockets 8063A and 8063B. The gap defined between forming pockets 8065A and 8065B is larger than the gaps defined between forming pockets 8061A and 8061B and between forming pockets 8063A and 8063B. The gap defined between forming pockets 8065A and 8065B may be defined as an intermediate space between forming pockets 8065A and 8065B.
[0290] As shown in Figures 127 and 128, staple 8070 is formed in a planar configuration, and staple 8075 is formed in a non-planar configuration. Staple 8070 comprises a crown portion 8071 and a staple leg portion 8072 extending from the crown portion 8071. The leg portion 8072 further comprises a staple tip portion 8073 configured to penetrate the tissue and enter the corresponding forming pocket. Staple 8070 defines a forming compression height "X1", which is the effective height of tissue compression captured by staple 8070. Staple 8075 comprises a crown portion 8076 and a leg portion 8077 extending from the crown portion 8076. The leg portion 8077 further comprises a staple tip portion 8078 configured to penetrate the tissue and enter the corresponding forming pocket. Staple 8075 defines a formed compression height "X2", which is the effective height of tissue compression captured by staple 8075. Due to the non-planar forming configuration of staple 8075, the formed compression height X2 is higher than the formed compression height X1. In at least one example, this is desirable, as the compression can gradually decrease as the row of staples moves laterally away from the cutting line. For example, a more densely formed compression height near the cutting line may provide sufficient tissue sealing pressure, while a more loosely formed compression height further away from the cutting line gradually reduces the pressure on the tissue as the row of staples moves laterally outward relative to the cutting line.
[0291] In at least one example, the legs 8077 are formed at different angles away from the crown 8076 relative to each other. For example, the proximal legs may be formed away from the crown at a first angle, and the distal legs may be formed away from the crown in the opposite direction at a second angle. The first angle is different from the second angle. This allows for a smaller footprint for the corresponding staple-forming pockets. Furthermore, when stamping these pocket shapes onto an anvil, the different angles and / or smaller footprint ensure that the walls between adjacent rows of formed pockets are sufficiently maintained, thereby preventing features in one row from flowing out or being pushed into features in an adjacent row during the stamping process.
[0292] 3D staples can be interspersed within and / or across longitudinal rows, thereby maximizing the use of the anvil surface, further nesting of pockets, and enabling a smaller footprint. In certain examples, the interspersed 3D staple pockets can improve tissue pressure distribution along the anvil. In at least one example, 3D staple pockets can be positioned along the pockets of the outermost row to further alleviate and / or taper the tissue pressure along the edge of the staple row furthest from the cutting line.
[0293] In various cases, the gripping feature 8040 and the curved deck 8021 can provide laterally varying tissue gaps. More specifically, the gaps for tissue captured between the staple cavities and staple-forming pockets of each corresponding row vary between rows. The outermost row has the highest gripping feature compared to the inner and intermediate rows. This can provide additional tissue compression in the row configured to form 3D staples. This can provide greater stability during staple formation due to the additional cavity extension length of the outer staple cavities. A higher gripping mechanism can maintain a similar compression shape between the gripping feature and the corresponding forming pocket. However, due to the lateral curvature of the deck, the portion of the deck surface 8021 where the staple cavities of the outer row are defined is further away from the anvil than the portion of the deck surface 8021 where the staple cavities of the inner and intermediate rows are defined. Collectively, the higher gripping features and lower deck surface can, in certain examples, provide a stable platform for 3D-formed staples.
[0294] In various examples, flat-formed, i.e., punched staples can be used in addition to, or instead of, wire staples. In various examples, two of the three rows of staples on each side of the cartridge are configured to form a non-planar configuration, and the other of the three rows on that side of the cartridge is configured to form a planar configuration. In at least one example, staples in the same longitudinal row include both planar-forming staples and non-planar-forming staples. In at least one example, the unformed heights of staples within the same row vary. In at least one example, the unformed heights of staples in different rows vary. In at least one example, planar and non-planar staples vary along the axis traversing the longitudinal slots of the staple cartridge, spreading the staple pressure. In at least one example, the staple legs of non-planar-forming staples are formed laterally on one side of the crown rather than in opposite directions away from each other relative to the crown. In such examples, the gaps between each row may be substantially similar, since at least the legs may be formed away from the crown during injection but return towards the crown to fasten the row of staples. Such a configuration may help maintain a consistent lateral gap between the staple-forming pockets of each row.
[0295] As described above, one or more adjustments can be made to change the final forming height and / or compression height of the staples, for example, laterally, i.e., in different shapes from row to row. Figure 129 shows an anvil 8100 configured to deform a staple cartridge or ejected staples. The anvil 8100 comprises an anvil body 8110 having an anvil surface 8111 and a launching member slot 8112 defined within the anvil body 8110. The anvil surface 8111 has multiple rows of staple forming pockets, comprising an inner row 8121, an intermediate row 8123, and an outer row 8125. The inner row 8121 and the intermediate row 8123 are configured to form staples in a planar configuration, while the outer row 8125 is configured to form staples in a non-planar configuration. As shown in Figure 129, the inner row 8121 and the intermediate row 8123 define a pocket depth 8131, while the outer row defines a pocket depth 8135 that is shallower than the pocket depth 8131. This shallower pocket depth may correspond to compression due to the oblique formation path of non-planar staples, i.e., loss of final formation height. In at least one example, the pocket depth is adjusted so that the final compression height is the same between non-planar staples and planar staples. In another example, the pocket depth is adjusted so that the final compression height is different between non-planar staples and planar staples.
[0296] Figure 130 shows a thread 8200 comprising an inner inclined surface 8220 and an outer inclined surface 8230. The inner inclined surface is configured to lift the staple by a height of 8221, and the outer inclined surface 8230 is configured to lift the staple by a height of 8231. The inclined surface 8220 is configured to lift staples formed in a planar configuration, and the inclined surface 8230 is configured to lift staples formed in a non-planar configuration. The height 8231 may correspond to compression due to the oblique formation path of non-planar staples, i.e., loss of final formation height.
[0297] Figure 131 shows a staple 8300 used with a surgical staple fastening assembly. The staple 8300 includes a first staple 8310 having a first unformed height 8311 and a second staple 8320 having a second unformed height 8321. The first unformed height 8311 is smaller than the second unformed height 8321. The different unformed heights may correspond to compression due to the oblique formation path of the non-planar staple, i.e., loss of final formed height. The second staple 8320 may be configured to form a non-planar configuration, and the first staple 8310 may be configured to form a planar configuration.
[0298] Figures 132 and 133 show staples 8410 and 8420. Staple 8410, formed in a planar configuration, defines a final compression height 8411, and staple 8420, formed in a non-planar configuration, defines a final compression height 8421. The final compression height 8421 is smaller than the compression height 8411. However, staple 8420 defines a distance 8422 defined between the vertices of each formed leg and the crown. The distance 8422 may be substantially equal to the final compression height 8411. The distance 8422 may be the effective compression height of staple 8420.
[0299] In various examples, surgical stapling assemblies are provided that are configured to overdrive staples from a staple cartridge. The amount of staple overdrive may vary from row to row. In various examples, staple drivers may include varying amounts of support from the corresponding staple cartridge support wall. More specifically, an inner staple driver may have less support from the staple cartridge support wall than an outer staple driver due to the geometry of the cartridge body and firing assembly, and / or the internal drive screw. In various examples, inter-tissue gaps may vary from row to row while maintaining similar or identical drive distances between rows.
[0300] Figures 134 to 136 show a surgical staple fastening assembly 8500. The surgical instrument 8500 comprises a lower jaw 8501 and an upper jaw 8502. The lower jaw 8501 comprises a cartridge channel 8510 and a staple cartridge 8520 configured to be received within the cartridge channel 8510. The upper jaw 8502 comprises an anvil 8530, which includes an anvil body 8531. The anvil body 8531 comprises an anvil surface 8532 and a plurality of forming pockets defined within the anvil surface 8532. The anvil surface 8532 comprises an inner forming pocket 8533, an intermediate forming pocket 8534, and an outer forming pocket 8535. The staple cartridge comprises a plurality of staple cavities 8522, each having an inner staple cavity 8522A aligned with an inner forming pocket 8533, an intermediate staple cavity 8522B aligned with an intermediate forming pocket 8534, and an outer cavity 8522C aligned with an outer forming pocket 8534. The staple cavities 8522 are configured to house the corresponding drivers and staples that are injected into the aligned forming pockets.
[0301] The staple cartridge 8520 comprises a curved cartridge deck 8529 having a plurality of defined staple cavities 8522 inside, and a plurality of tissue gripping features, namely cavity extensions 8523, 8524, and 8525, extending from the cartridge deck 8529. The staple cartridge 8520 also comprises a thread 8550 having inclined surfaces 8551 and 8552. The staple cartridge 8520 comprises a plurality of drivers 8540 that are sequentially aligned and eject multiple rows of staples from the staple cavities when lifted by the inclined surfaces 8551 and 8552. Each driver 8540 comprises an inner row support, i.e., an inner column 8541, which is housed in an inner staple cavity 8522A and configured to support and drive staples ejected from there; an intermediate row support, i.e., an intermediate column 8542, which is housed in an intermediate staple cavity 8522B and configured to support and drive staples ejected from there; and an outer row support, i.e., an outer column 8543, which is housed in an outer staple cavity 8522C and configured to support and drive staples ejected from there.
[0302] As shown in Figure 135, the staple cartridge 8520 comprises an inner support wall 8526A configured to support the inner row support 8541 when the driver 8540 is lifted by the thread 8550, an intermediate support wall, i.e., an intermediate support column 8526B configured to support the intermediate row support 8542 when the driver 8540 is lifted by the thread 8550, and an outer support wall 8526c configured to support the outer row support 8543 when the driver 8540 is lifted by the thread 8550. As shown in Figure 135, the level of support contact between each support 8541, 8542, 8543 and its corresponding support wall 8526A, 8526B, 8526C differs for each row. In the non-firing position, the outer support 8541 has the greatest support contact, the intermediate support 8542 has less support contact than the outer support 8541, and the inner support 8541 has the least amount of support contact. As can be seen in Figure 135, supports 8541, 8542, and 8543 are overdriven to the same limit, resulting in the same drive formation distance for each staple supported by supports 8541, 8542, and 8543. However, the amount of overdrive for their corresponding gripping features 8523, 8524, and 8525 differs from row to row. The outer rows are overdriven to the maximum extent beyond their gripping features, while the inner rows are overdriven to the minimum extent beyond their gripping features.
[0303] As discussed herein, staple cartridges can be replaced within a surgical staple assembly. In various examples, anvil plates are provided, which can also be replaced. In such examples, the anvil plate may be supplied together with the corresponding staple cartridge, and as a result, the new staple cartridge and anvil plate are packaged together and replaced together within the surgical staple assembly. In such examples, various features of the anvil plate and the corresponding staple cartridge may be specially tailored to each other. For example, different anvil plates may include, among other things, staple-forming pockets with different patterns, staple-forming pockets with different formation depths, and / or different staple-forming pocket types in each row.
[0304] A universal fitting outline can be used for various anvil plates so that the staple fastening assembly can accommodate several different anvil plates. Replacing the anvil plate can also provide a new staple-forming pocket. The anvil plate and staple cartridge can be paired based on the length of the staple legs, the type of staples stored in the staple cartridge, and / or the desired stapling height of the staples. In such examples, the anvil jaw configured to receive the anvil plate may be manufactured with or without a stapling pocket defined directly on it. This can reduce manufacturing costs because the anvil jaw can be reused in different scenarios rather than introducing entirely different surgical staple fastening devices with different types of stapling pockets.
[0305] Figures 137–139 show a surgical staple fastening assembly 8600, comprising a first jaw 8601 and a second jaw 8603 movable relative to the first jaw 8601, for clamping tissue between them. The surgical staple fastening assembly 8600 is configured to cut and staple the tissue trapped between the jaws 8601 and 8603. The first jaw 8601 comprises a replaceable staple cartridge 8620, configured to detachably house multiple staples in multiple staple cavities 8622 defined within the deck surface 8621 of the staple cartridge 8620. The first jaw 8601 further comprises a cartridge channel 8610 configured to receive the replaceable staple cartridge 8620 internally. As described above, various different types of staple cartridges can be mounted in the cartridge channel 8610. Various differences between interchangeable staple cartridges may include, for example, different heights and / or orientations of unformed staple legs, different cartridge lengths, and / or different staple diameters.
[0306] The second jaw 8603 comprises a replaceable anvil plate 8640 having an anvil surface 8641 and a plurality of forming pockets 8642 defined in the anvil surface 8641. The second jaw 8603 further comprises an upper anvil jaw portion 8630 configured to receive the replaceable anvil plate 8640 internally. In at least one example, the replaceable anvil plate 8640 slides into the distal end of the anvil jaw portion 8630. In at least one exampl...
Claims
1. A surgical staple fastening assembly, It is an anvil, Anvil surface, The anvil surface is defined by the first row of forming pockets, An anvil comprising a second row of forming pockets defined on the anvil surface, It is a staple cartridge, The deck side and, A longitudinal slot defining the side of the first cartridge and the side of the second cartridge of the staple cartridge, A first row of staple cavities defined on the deck surface on the side of the first cartridge, the first row of staple cavities being positioned at a first lateral distance from the longitudinal slot, A tissue gripping feature portion of the first row extending from the deck surface, wherein the tissue gripping feature portion of the first row is aligned with the staple cavity of the first row and the forming pocket of the first row, and the tissue gripping feature portion of the first row has a first outer shape, A second row of staple cavities defined on the deck surface on the side of the first cartridge, wherein the second row of staple cavities is located at a second lateral distance from the longitudinal slot, and the second lateral distance is greater than the first lateral distance, A tissue gripping feature portion of a second row extending from the deck surface, wherein the tissue gripping feature portion of the second row is aligned with the staple cavity and the forming pocket of the second row, and the tissue gripping feature portion of the second row has a second outer shape, and the second outer shape and the first outer shape have different geometric shapes, A staple cartridge comprising: a plurality of staples, each detachably stored in the staple cavity of the first row and the staple cavity of the second row, wherein the staples detachably stored in the staple cavity of the first row are configured to be formed into a planar staple configuration by the forming pockets of the first row, and the staples detachably stored in the staple cavity of the second row are configured to be formed into a non-planar staple configuration by the forming pockets of the second row; A surgical staple assembly wherein the first distance between the tissue gripping feature portion of the first row and the anvil surface is smaller than the second distance between the tissue gripping feature portion of the second row and the anvil surface.
2. The surgical staple assembly according to claim 1, wherein each of the forming pockets in the first row defines a first central axis aligned with the arrangement direction of the forming pockets in the first row.
3. The surgical staple assembly according to claim 2, wherein each of the forming pockets in the second row defines a second central axis that intersects the first central axis.
4. The surgical stapling assembly according to claim 1, wherein the anvil further comprises a third row of forming pockets defined on the anvil surface, and the staple cartridge further comprises a third row of staple cavities defined on the deck surface on the side of the first cartridge, the third row of staple cavities being positioned at a third lateral distance from the longitudinal slot, the third lateral distance being smaller than the first lateral distance and the second lateral distance.
5. The surgical staple assembly according to claim 1, wherein at least one of the anvil and the staple cartridge is movable to reposition the surgical staple assembly in a clamp configuration, a first interstitial space distance is defined in the clamp configuration between the staple cavity of the first row and the forming pocket of the first row, a second interstitial space distance is defined in the clamp configuration between the staple cavity of the second row and the forming pocket of the second row, and the first interstitial space distance and the second interstitial space distance are different distances.
6. The surgical staple fastening assembly according to claim 1, wherein the plurality of staples include wire staples.
7. Each of the plurality of staples comprises a crown portion and a leg portion extending from the crown portion, The surgical staple fastening assembly according to claim 6, wherein the plurality of staples are such that the distance from the crown portion to the tip of the leg portion is the same when the plurality of staples are housed in the staple cavity of the first row and the staple cavity of the second row.
8. The surgical stapling assembly according to claim 1, wherein at least one of the anvil and the staple cartridge is movable to reposition the surgical stapling assembly in a clamp configuration, and the staple cartridge further comprises a plurality of first staple drivers positioned in the staple cavity of the first row and a plurality of second staple drivers positioned in the staple cavity of the second row, wherein a first distance is defined between the forming pocket of the first row and the first staple drivers in the clamp configuration, and a second distance is defined between the forming pocket of the second row and the second staple drivers in the clamp configuration, and the first distance and the second distance are different distances.
9. The surgical staple fastening assembly according to claim 1, wherein the deck surface has a laterally curved outer shape.
10. A surgical staple fastening assembly, It is an anvil, Anvil surface, The anvil surface is defined by the first row of forming pockets, An anvil comprising a second row of forming pockets defined on the anvil surface, It is a staple cartridge, On the deck side, The deck protrusions of the first row, A deck surface comprising a second row of deck protrusions, A longitudinal slot defining the side of the first cartridge and the side of the second cartridge, A first row of staple cavities defined on the deck surface on the side of the first cartridge, positioned at a first lateral distance from the longitudinal slot, wherein the first row of deck projections is aligned with the first row of staple cavities, A second row of staple cavities defined on the deck surface, positioned at a second lateral distance from the longitudinal slot, wherein the second lateral distance is greater than the first lateral distance, and the deck projections of the second row are aligned with the staple cavities of the second row. A staple cartridge comprising: a plurality of staples detachably stored in the staple cavities of a first row and the staple cavities of a second row, wherein the forming pockets of the first row are configured to form the staples detachably stored in the staple cavities of the first row into a planar staple configuration, and the forming pockets of the second row are configured to form the staples detachably stored in the staple cavities of the second row into a non-planar staple configuration; A surgical staple fastening assembly wherein the first distance between the deck projections of the first row and the anvil surface is smaller than the second distance between the deck projections of the second row and the anvil surface.
11. The surgical staple assembly according to claim 10, wherein the deck projections of the first row have a first shape, the deck projections of the second row have a second shape, the first shape has a first height, the second shape has a second height, and the first height and the second height are different heights.
12. Each of the plurality of staples is The crown part, A proximal leg extending from the crown portion, It comprises a distal leg portion extending from the crown portion, The surgical staple assembly according to claim 10, wherein the proximal leg and the distal leg define a leg plane that is on the same plane as the crown.
13. The surgical staple assembly according to claim 12, wherein in the non-planar staple configuration, the proximal leg defines a proximal leg plane, the distal leg defines a distal leg plane, and the proximal leg plane traverses the distal leg plane.
14. Each of the plurality of staples comprises a crown portion and a leg portion extending from the crown portion, The surgical staple fastening assembly according to claim 10, wherein the plurality of staples are such that the distance from the crown portion to the tip of the leg portion is the same when the plurality of staples are housed in the staple cavity of the first row and the staple cavity of the second row.
15. The surgical staple fastening assembly according to claim 10, wherein the deck surface has a laterally curved outer shape.
16. The surgical staple fastening assembly according to claim 10, wherein the plurality of staples include wire staples.
17. The surgical staple assembly according to claim 10, wherein each of the forming pockets in the first row defines a first central axis aligned with the arrangement direction of the forming pockets in the first row, and each of the forming pockets in the second row defines a second central axis that intersects the first central axis.
18. A surgical staple fastening assembly, The shaft and An end effector attached to the shaft, wherein the end effector is It is an anvil, Anvil surface, The anvil surface is defined by the first row of forming pockets, An anvil comprising a second row of forming pockets defined on the anvil surface, It is a staple cartridge, The deck side and, A longitudinal slot defining the side of the first cartridge and the side of the second cartridge, A first row of staple cavities defined on the deck surface on the side of the first cartridge, located at a first lateral distance from the longitudinal slot, wherein the deck surface comprises a plurality of first tissue-grasping features aligned with the first row of staple cavities, A second row of staple cavities defined on the deck surface on the side of the second cartridge, positioned at a second lateral distance from the longitudinal slot, wherein the second lateral distance is greater than the first lateral distance, and each of the staple cavities in the second row of staple cavities comprises a plurality of second tissue gripping features aligned with the second row of staple cavities, the first tissue gripping features and the second tissue gripping features defining different geometric shapes, A plurality of first staples, detachably stored within the staple cavity of the first row, wherein the forming pocket of the first row is configured to form the first staples into a planar staple configuration having a forming height, An end effector comprising a staple cartridge comprising: a plurality of second staples, which are detachably stored in the staple cavity of the second row, wherein the forming pockets of the second row are configured to form the second staples into a non-planar staple configuration having the forming height; A surgical staple assembly wherein the first distance between the tissue gripping feature portion of the first row and the anvil surface is smaller than the second distance between the tissue gripping feature portion of the second row and the anvil surface.
19. The surgical staple assembly according to claim 18, wherein each of the forming pockets in the first row has a first pocket depth, and each of the forming pockets in the second row has a second pocket depth, the second pocket depth being smaller than the first pocket depth.
20. The surgical staple assembly according to claim 19, wherein the first distance is defined by the forming pockets of the first row of forming pockets, and the second distance is defined by the forming pockets of the second row of forming pockets, and the first distance and the second distance are different distances.
21. The aforementioned staple cartridge is A plurality of first staple driver bodies configured to support the first staple, wherein a first distance is defined between the first staple driver body and the forming pocket of the first row of forming pockets, The surgical stapling assembly according to claim 18, further comprising a plurality of second staple driver bodies configured to support the second staple, wherein a second distance is defined between the second staple driver body and the forming pocket of the second row of forming pockets.
22. The surgical staple fastening assembly according to claim 21, wherein the first distance and the second distance are different distances.
23. The aforementioned staple cartridge is It is a thread, A first inclined surface configured to eject the first staple, wherein the first inclined surface is configured to lift the first staple by a first height, A surgical staple fastening assembly according to claim 18, further comprising: a second inclined surface configured to eject the second staple, the second inclined surface configured to raise the second staple by a second height, the first height defining a first distance of the first staple, and the second height defining a second distance of the second staple.
24. The surgical staple fastening assembly according to claim 23, wherein the first distance and the second distance are different distances.