Fitting mechanism between the driver and the bottom surface of the cartridge deck
The surgical stapling and cutting instrument with an articulating end effector and triple driver mechanism addresses alignment and articulation challenges, enhancing precision and efficiency in tissue stapling and cutting, especially in minimally invasive surgeries.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- CILAG GMBH INTERNATIONAL
- Filing Date
- 2022-03-21
- Publication Date
- 2026-04-27
AI Technical Summary
Existing surgical stapling and cutting instruments face challenges in efficiently stapling and cutting tissue with precise alignment and articulation, particularly in minimally invasive procedures, where the end effector's articulation and alignment with the shaft assembly can be cumbersome and inefficient.
The development of a surgical stapling and cutting instrument with an articulating end effector and a staple cartridge that includes a triple driver mechanism, allowing for improved alignment and articulation through a flexible firing drive system, enabling precise tissue stapling and cutting with enhanced flexibility and maneuverability.
The solution provides improved precision and efficiency in stapling and cutting operations, facilitating better maneuverability and alignment of the end effector with the shaft assembly, particularly in minimally invasive surgical procedures.
Smart Images

Figure 0007851954000001 
Figure 0007851954000002 
Figure 0007851954000003
Abstract
Description
Background Art
[0001] The present invention relates to surgical instruments, and in various configurations, to a surgical stapling and cutting instrument designed to staple and cut tissue, an end effector, and a staple cartridge for use therewith.
Brief Description of the Drawings
[0002] The various features of the embodiments described herein, together with their advantages, can be understood by 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 shaft assembly of the end effector and the surgical stapling instrument of FIG. 1, wherein the end effector is shown in a linear or non-articulating configuration according to at least one aspect of the present disclosure. [Figure 3] A perspective view of a portion of the shaft assembly of the end effector and the surgical stapling instrument of FIG. 1, wherein the end effector is shown in an articulating configuration according to at least one aspect of the present disclosure. [Figure 4] An exploded perspective view of a portion of the end effector and the 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 shaft assembly of the end effector and the surgical stapling instrument of FIG. 1, wherein the end effector is shown in an un-fired clamp configuration according to at least one aspect of the present disclosure. [Figure 6] A plan view of a portion of the end effector and the shaft assembly of the surgical stapling instrument of FIG. 1 according to at least one aspect of the present disclosure. [Figure 7]In at least one aspect of the present disclosure, the end effector is shown in an open configuration, and the image shows a cross-sectional elevation of the end effector and a portion of the shaft assembly of Figure 1 along the cutting line 6-6 in Figure 6. [Figure 8] This is a cross-sectional elevation view of a portion of the shaft assembly of Figure 1 along the cutting line 7-7 in Figure 6, showing the end effector in a clamp configuration, according to at least one aspect of the present disclosure. [Figure 9] A perspective view of a surgical staple fastening assembly comprising a shaft assembly and the end effector shown in Figure 1, wherein the end effector is attached to the shaft assembly via an articulated joint, according to at least one aspect of the present disclosure. [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, in which the end effector is shown in a non-firing clamp configuration. [Figure 12] A perspective view of a surgical staple fastening assembly comprising a shaft assembly and the end effector shown in Figure 1, wherein the end effector is attached to the shaft assembly via an articulated joint, according to at least one aspect of the present disclosure. [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 a non-firing clamp configuration. [Figure 15] A perspective view of a surgical staple fastening assembly comprising a shaft assembly and the end effector shown in Figure 1, wherein the end effector is attached to the shaft assembly via an articulated joint, according to at least one aspect of the present disclosure. [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 a non-firing 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, in which the surgical end effector assembly is shown in a non-firing clamp configuration according to at least one aspect of the present disclosure. [Figure 21] This is a perspective view of a robot controller according to at least one aspect of the present disclosure. [Figure 22] This is a perspective view of a robotic arm cart for a robotic surgical system, showing a manipulator on a robotic arm cart that operably supports a surgical tool, according to at least one aspect of the present disclosure. [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 staple cartridges according to various aspects of this disclosure. [Figure 25] Figure 24 is a perspective view of a portion of a staple cartridge, showing a triple driver in the firing configuration within the staple cartridge according to various aspects of this disclosure. [Figure 26] Figure 25 shows perspective views of the triple driver according to various aspects of this disclosure. [Figure 27] Figure 26 is a plan view of a triple driver according to various embodiments of this disclosure. [Figure 28]Figure 26 is a bottom perspective view of the triple driver according to various aspects of this disclosure. [Figure 29] This is an elevation cross-sectional view of a portion of an end effector showing a staple cartridge having a portion of the staple cartridge concealed internally for illustrative purposes, according to various aspects of the present disclosure. [Figure 30] Figure 29 is a detailed view of the end effector according to various aspects of this disclosure. [Figure 31] This is an elevation cross-sectional view of a portion of an end effector containing a staple cartridge internally, according to various aspects of the present disclosure. [Figure 32] This is a schematic diagram of a triple driver, showing the modified shape with dashed lines and the relative positioning of the rotary drive screws with dashed lines, according to various aspects of the present disclosure. [Figure 33] This is a bottom perspective view of a cartridge body, partially obscured for illustrative purposes, according to various aspects of this disclosure. [Figure 34] Figure 33 is a detailed view of a portion of the cartridge body showing a chamfered portion defined on the cartridge body around the inner staple cavity, according to various aspects of this disclosure. [Figure 35] Figure 33 shows an elevation cross-sectional view of the inner struts and a portion of the cartridge body of the driver, illustrating the inner struts in an unfired configuration relative to the inner staple cavity, according to various aspects of the present disclosure. [Figure 36] This is a perspective view of a portion of the driver support column according to various aspects of this disclosure. [Figure 37] Figure 36 is an elevation view of a portion of a support column, showing a portion of a staple supported on a support column according to various embodiments of this disclosure. [Figure 38] These are elevation views of staple cartridges according to various embodiments of this disclosure. [Figure 39] This is an elevation cross-sectional view of the staple cartridge shown in Figure 38, along the plane shown in Figure 38, according to various embodiments of the present disclosure. [Figure 40]A perspective cross-sectional view of a portion of the staple cartridge of FIG. 38 along the plane shown in FIG. 38, showing the driver in a fully fired position, according to various aspects of the present disclosure. [Figure 41] A perspective view of the driver of FIG. 40, according to various aspects of the present disclosure. [Figure 42] A perspective view of the driver, according to various aspects of the present disclosure. [Figure 43] A perspective cross-sectional view of a portion of the anvil, according to various aspects of the present disclosure. [Figure 44] A schematic diagram showing the deformation process of a 4D printed matrix for a staple cartridge, according to various aspects of the present disclosure. [Figure 45] A perspective view of a staple cartridge and a channel, showing the alignment and leveraging mechanism for installing the staple cartridge in the channel, and further showing the staple cartridge in a partially installed configuration aligned with the channel, according to various aspects of the present disclosure. [Figure 46] An elevation view of the proximal portion of the staple cartridge of FIG. 45 and the channel, showing the staple cartridge in a partially installed configuration aligned with the channel, according to various aspects of the present disclosure. [Figure 47] A perspective view of the distal portion of the staple cartridge of FIG. 45 and the channel, showing the staple cartridge in a partially installed configuration aligned with the channel, according to various aspects of the present disclosure. [Figure 48] A perspective view of the distal portion of the staple cartridge of FIG. 45 and the channel, showing the staple cartridge fully seated within the channel and further showing the anvil in a clamp configuration with respect to the staple cartridge, according to various aspects of the present disclosure. [Figure 49] A perspective view of the distal portion of the staple cartridge of FIG. 48, the channel, and the anvil, showing the staple cartridge fully seated within the channel and further showing the latch on the lower surface of the staple cartridge in a latched position with respect to the channel, according to various aspects of the present disclosure. [Figure 50]This is a perspective view of the distal portion of a staple cartridge, channel, and anvil, showing various embodiments of the present disclosure, in which the staple cartridge is installed in a channel, the anvil is clamped to the staple cartridge, and a flexible latch is located on the underside of the staple cartridge in a latched position relative to the channel. [Figure 51] This is a perspective view of a channel and a staple cartridge, illustrating alignment and levering mechanisms for installing a staple cartridge into a channel according to various aspects of the present disclosure, and further showing a partially installed staple cartridge aligned with the channel. [Figure 52] This is a perspective view of a staple cartridge and a portion of a channel, showing a lateral latch arm of the staple cartridge that engages with a lateral passage in the side wall of the channel, according to various aspects of the present disclosure. [Figure 53] Figure 52 is a plan view section of a staple cartridge and a channel, showing a lateral latch arm of the staple cartridge that engages with a lateral passage in the side wall of the channel, according to various aspects of the present disclosure. [Figure 54] This is a perspective view of a staple cartridge and a rotary drive screw according to various aspects of the present disclosure. [Figure 55] Figure 54 is a perspective view of the distal portion of the staple cartridge and rotary drive screw, showing the cartridge body and a driver having a driver in an unfired position within the cartridge body, according to various embodiments of the present disclosure. [Figure 56] Figure 55 is a perspective view of the distal portion of the staple cartridge and the rotary drive screw with the driver in the non-firing position, showing the internal mechanism obscured by dashed lines for illustrative purposes, according to various aspects of the present disclosure. [Figure 57] Another perspective view of the distal portion of the staple cartridge and rotary drive screw in Figure 55, with the driver in the non-firing position, showing the internal mechanism obscured by dashed lines for illustrative purposes, according to various aspects of the present disclosure. [Figure 58]Figure 54 is a perspective view of the distal portion of the staple cartridge in which the driver has moved to the firing position within the cartridge body, according to various aspects of this disclosure. [Figure 59] Figure 58 is a perspective view of the distal portion of a staple cartridge, in which the driver is in the firing position and the internal mechanism is obscured by dashed lines for illustrative purposes, according to various aspects of the present disclosure. [Figure 60] This is a perspective view of the proximal portion of a staple cartridge having a row of grooves according to various aspects of the present disclosure. [Figure 61] Figure 60 is a perspective cross-sectional view of a staple cartridge showing a recess in the cartridge body that engages with a lip on the side wall of the driver, according to various aspects of this disclosure. [Figure 62] This is an exploded perspective view of a part of a cartridge body and driver having an interference mechanism for engaging with the cartridge body, according to various aspects of the present disclosure. [Figure 63] These are perspective exploded views of staple cartridges according to various aspects of this disclosure. [Figure 64] This is a perspective view of an unformed cartridge frame and a portion of its arm according to various aspects of the present disclosure. [Figure 65] Figure 64 is a perspective view of a portion of the cartridge frame and an arm, showing an arm with a configuration formed according to various aspects of the present disclosure. [Figure 66] This is an elevation cross-sectional view showing a heat-sealing retaining mechanism between the cartridge body and the cartridge frame according to various aspects of the present disclosure. [Figure 67] These are elevation cross-sectional views of the cartridge body and cartridge frame during the heat crimping process according to various aspects of this disclosure. [Figure 68] Figure 67 shows perspective views of a cartridge frame and insert support for use in the thermal scrimping process according to various aspects of this disclosure. [Figure 69] This is a perspective view of a composite cartridge body including a metal pan and a plastic composite material, showing a metal pan obscured by dashed lines for illustrative purposes, according to various aspects of the present disclosure. [Figure 70] Figure 69 is an elevation view of a composite cartridge body showing a hidden metal pan with dashed lines for illustrative purposes, according to various aspects of the present disclosure. [Figure 71] This is a perspective view of a portion of a surgical end effector, including an internally positioned staple cartridge, according to various aspects of this disclosure. [Figure 72] Figure 71 shows elevation cross-sectional views of a portion of the surgical end effector and staple cartridge according to various embodiments of this disclosure. [Figure 73] This is a perspective view of a tamper-evident lid in various aspects of the present disclosure. [Figure 74] This is a perspective view of the body of a thread assembly according to various aspects of this disclosure. [Figure 75] Figure 74 shows an exploded perspective cross-sectional view of the thread assembly, including the body and knife, according to various embodiments of this disclosure. [Figure 76] Figure 74 shows a perspective cross-sectional view of the thread assembly according to various aspects of this disclosure. [Figure 77] Figure 74 shows a partial elevation section of an end effector, partially removed for illustrative purposes, illustrating the firing member, cartridge body, and thread assembly according to various embodiments of the present disclosure. [Figure 78] This is a perspective view of a thread assembly aligned with a driver column, according to various aspects of this disclosure. [Figure 79] Figure 78 is an exploded perspective view of the thread assembly according to various aspects of this disclosure. [Figure 80] Figure 78 is a partial perspective cross-sectional view of a thread assembly according to various aspects of this disclosure. [Figure 81] Figure 78 shows a perspective view of a threaded assembly engaged with a launching system, which includes a rotary drive screw and a launching member screwably connected to the rotary drive screw, according to various aspects of the present disclosure. [Figure 82] This is a perspective view of an end effector, including a lockout in a locked configuration, according to various aspects of this disclosure. [Figure 83]Figure 82 is a perspective view of a portion of the end effector with components removed for illustrative purposes, illustrating lockout in a lock configuration according to various aspects of this disclosure. [Figure 84] Figure 82 is an elevation cross-sectional view of a portion of the end effector, illustrating lockout in a lock configuration according to various aspects of this disclosure. [Figure 85] Figure 78 is a perspective view of a portion of an end effector with components removed for illustrative purposes, showing a staple cartridge including the thread assembly of Figure 82 installed within an end effector according to various aspects of the present disclosure, and further illustrating the lockout of the unlock configuration. [Figure 86] Figure 85 is an elevation view of a portion of the staple cartridge and thread assembly, showing a thread assembly in a non-firing position according to various aspects of this disclosure. [Figure 87] Figure 85 is a plan view of a portion of the bottom surface of a staple cartridge and thread assembly, showing a portion of a firing assembly with dashed lines for illustrative purposes, according to various embodiments of the present disclosure. [Figure 88] Figure 85 shows an elevation cross-sectional view of a staple cartridge according to various aspects of this disclosure. [Figure 89] This is an elevation cross-sectional view of a staple cartridge according to various aspects of the present disclosure. [Figure 90] This is a perspective view of a launch member and thread assembly showing a launch member in an unlaunched configuration according to various aspects of the present disclosure. [Figure 91] Figure 90 is an exploded view of the thread assembly according to various aspects of this disclosure. [Figure 92] Figure 90 is a perspective view of the launching member and thread assembly relative to the cartridge body, showing a launching assembly in a first forward configuration, indicated by dashed lines for illustrative purposes, in which the launching member is moved to engage with the thread assembly and to engage with a driver in the cartridge body, according to various aspects of the present disclosure. [Figure 93]Figure 90 is an elevation view of a launch member and thread assembly, illustrating a launch member in a first forward configuration according to various aspects of the present disclosure, with certain hidden features indicated by dashed lines for illustrative purposes. [Figure 94] Figure 90 shows an elevation cross-sectional view of the launch member and thread assembly of Figure 90, along the plane shown in Figure 90, illustrating a launch member in a first forward configuration according to various aspects of the present disclosure. [Figure 95] Figure 93 shows an elevation cross-sectional view of the launch member and thread assembly of Figure 90 along the plane shown, illustrating a launch member in a first forward configuration according to various aspects of this disclosure. [Figure 96A] Figure 90 is an elevation view of a launching member and thread assembly, showing a launching member in a first retracted configuration according to various aspects of the present disclosure, with certain hidden features indicated by dashed lines for illustrative purposes. [Figure 96B] Figure 90 is an elevation view of a launching member and thread assembly, showing a launching member in a second retracted configuration according to various aspects of the present disclosure, with certain hidden features indicated by dashed lines for illustrative purposes. [Figure 96C] Figure 90 is an elevation view of a launching member and thread assembly, showing a launching member in a third retracted configuration according to various aspects of the present disclosure, with certain hidden features indicated by dashed lines for illustrative purposes. [Figure 96D] Figure 90 is an elevation view of a launching member and thread assembly, showing a launching member in a fourth retracted configuration according to various aspects of the present disclosure, with certain hidden features indicated by dashed lines for illustrative purposes. [Figure 97] Figure 96D shows a launching member in a fourth retraction configuration according to various aspects of the present disclosure, and the cartridge body is shown by dashed lines for illustrative purposes, an elevation view of the launching member and thread assembly of Figure 90 relative to the cartridge body of Figure 92. [Figure 98] Figure 90 shows the launch member and thread assembly and Figure 92 shows a plan view of the cartridge body, illustrating the launch assembly in a fourth recoil configuration as shown in Figure 96D, according to various aspects of this disclosure. [Figure 99]This is a perspective view of a surgical end effector having a firing assembly including a rotary drive screw and a reusable firing member having an integrated two-rail thread, according to various aspects of the present disclosure. [Figure 100A] Figure 99 shows an exploded perspective view of a reusable launcher, as well as a single-use knife and a launch indicator for use with the reusable launcher, according to various aspects of the present disclosure. [Figure 100B] Figure 100A shows a single-use knife and firing indicator assembled to a reusable firing member, further illustrating a triple driver and staples positioned thereon by an integrated two-rail thread of the reusable firing member according to various aspects of the present disclosure. [Figure 101] Figure 100B shows elevation views of the triple driver, staples, and reusable launching member according to various embodiments of this disclosure. [Figure 102] This is a perspective view of one of the triple drivers in Figure 100B, according to various aspects of this disclosure. [Figure 103] This is a plan view of a portion of the cartridge body, which houses the triple driver shown in Figure 100B and further shows the firing member shown in Figure 100A, according to various embodiments of the present disclosure. [Figure 104] Figure 103 is a perspective view of the lower surface of a portion of the cartridge body according to various aspects of this disclosure. [Figure 105] Figure 103 shows an elevation cross-sectional view of an end effector including the cartridge body, firing member, and triple driver, according to various embodiments of this disclosure. [Figure 106] Figure 103 is a perspective cross-sectional view of the cartridge body according to various aspects of this disclosure. [Figure 107] This is a perspective view of the cartridge body in various aspects of this disclosure. [Figure 108] Figure 99 is a perspective view of a portion of an end effector, including the drive assembly, showing a lockout configuration in various aspects of the present disclosure, which includes a lock nut mounted on a rotary drive screw, with the lockout nut in the locked position. [Figure 109A]Figure 108 is an elevation view of an end effector showing a lock nut in the locked position, with certain components removed and other components obscured by dashed lines, according to various aspects of the present disclosure. [Figure 109B] Figure 108 is an elevation cross-sectional view of an end effector showing the lock nut in the unlocked position according to various aspects of the present disclosure, with certain components removed and other components obscured by dashed lines. [Figure 110] Figure 103 is a perspective view of a portion of the cartridge body, further illustrating a lockout key located proximal within the cartridge body according to various aspects of this disclosure. [Figure 111] Figure 108 is a perspective view of a portion of the end effector, in which the cartridge body of Figure 110 is installed in the end effector, and the lockout key is positioned in a proximal position such that it overcomes the lockout configuration by moving the lock nut to the unlocked position of Figure 109B, according to various aspects of the present disclosure. [Figure 112] Figure 110 is a perspective view of a portion of the underside of the cartridge body, showing the lockout key in the non-firing position, according to various aspects of this disclosure. [Figure 113] Figure 110 is a perspective section of a portion of the end effector, in which the cartridge body of Figure 108 is installed within the end effector, and which is partially cut out for illustrative purposes to expose the lockout key advanced to the distal position, according to various embodiments of the present disclosure. [Figure 114] Figure 113 is a perspective view of a portion of the end effector and cartridge body with the lockout key in the distal position, according to various aspects of this disclosure. [Figure 115] Figure 110 is a perspective section of a portion of the end effector, in which the cartridge body of Figure 108 is installed within the end effector, and the section is partially cut out for illustrative purposes to expose the lock nut in the locked position, according to various embodiments of the present disclosure. [Figure 116]This is a perspective view of a portion of an end effector, shown by dashed lines for illustrative purposes, illustrating a lockout configuration in a lock configuration according to various aspects of the present disclosure, with certain parts removed and other parts transparent. [Figure 117] Figure 116 is a perspective view of a portion of the end effector, showing a lockout configuration in a lock configuration according to various aspects of the present disclosure, with certain parts removed and other parts transparent for illustrative purposes. [Figure 118] This is a plan view of a staple cartridge showing the pattern of the staple cavity according to various aspects of the present disclosure. [Figure 119] This is a schematic diagram showing the staple cavity pattern of a staple cartridge according to various aspects of the present disclosure. [Figure 120] This is a schematic diagram showing the staple cavity pattern of a staple cartridge according to various aspects of the present disclosure. [Figure 121] This is a plan view of a staple cartridge showing the pattern of the staple cavity according to various aspects of the present disclosure. [Figure 122] This is a plan view of a staple cartridge schematically showing the tissue closure section according to various aspects of the present disclosure.
[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 titled "METHOD OF USING A POWERED STAPLING DEVICE," Agent Reference Number END9298USNP1 / 200859-1M, - U.S. Patent Application No. END9298USNP2 / 200859-2, entitled "SURGICAL STAPLING ASSEMBLY COMPRISING NONPLANAR STAPLES AND PLANAR STAPLES" - U.S. Patent Application Titled "SURGICAL STAPLE CARTRIDGE COMPRISING LONGITUDINAL SUPPORT BEAM," Agent Reference Number END9298USNP3 / 200859-3, - A U.S. patent application titled "ROTARY-DRIVEN SURGICAL STAPLING ASSEMBLY COMPRISING ECCENTRICALLY DRIVEN FIRING MEMBER," with agent reference number END9298USNP4 / 200859-4. - U.S. Patent Application titled "ROTARY-DRIVEN SURGICAL STAPLING ASSEMBLY COMPRISING A FLOATABLE COMPONENT," Agent Reference Number END9298USNP5 / 200859-5, - U.S. Patent Application No. END9298USNP6 / 200859-6, entitled "DRIVERS FOR FASTENER CARTRIDGE ASSEMBLIES HAVING ROTARY DRIVE SCREWS" - A U.S. patent application titled "LEVERAGING SURFACES FOR CARTRIDGE INSTALLATION," with agent reference number END9298USNP8 / 200859-8. - U.S. Patent Application No. END9298USNP9 / 200859-9, entitled "FASTENER CARTRIDGE WITH NON-REPEATING FASTENER ROWS" - U.S. Patent Application No. END9298USNP10 / 200859-10, entitled "FIRING MEMBERS HAVING FLEXIBLE PORTIONS FOR ADAPTING TO A LOAD DURING A SURGICAL FIRING STROKE" - U.S. Patent Application titled "STAPLING ASSEMBLY COMPONENTS HAVING METAL SUBSTRATES AND PLASTIC BODIES," Agent Reference Number END9298USNP11 / 200859-11, - A U.S. patent application titled "MULTI-AXIS PIVOT JOINTS FOR SURGICAL INSTRUMENTS AND METHODS OF MANUFACTURING SAME," with agent reference number END9298USNP12 / 200859-12. - A U.S. patent application titled "JOINT ARRANGEMENTS FOR MULTI-PLANAR ALIGNMENT AND SUPPORT OF OPERATIONAL DRIVE SHAFTS IN ARTICULATABLE SURGICAL INSTRUMENTS," with agent reference number END9298USNP13 / 200859-13, and, - A U.S. patent application titled "SURGICAL INSTRUMENT ARTICULATION JOINT ARRANGEMENTS COMPRISING MULTIPLE MOVING LINKAGE FEATURES," with 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, titled "METHOD FOR DETERMINING THE POSITION OF A ROTATABLE JAW OF A SURGICAL INSTRUMENT ATTACHMENT ASSEMBLY" - U.S. Patent No. 10,716,565, titled "SURGICAL INSTRUMENTS WITH DUAL ARTICULATION DRIVERS" - U.S. Patent No. 15 / 847,325 (currently U.S. Patent Application Publication No. 2019 / 0183491), titled "SURGICAL TOOLS CONFIGURED FOR INTERCHANGEABLE USE WITH DIFFERENT CONTROLLER INTERFACES". - U.S. Patent No. 10,729,509, entitled "SURGICAL INSTRUMENT COMPRISING CLOSURE AND FIRING LOCKING MECHANISM" - U.S. Patent No. 15 / 847,315 (currently U.S. Patent Application Publication No. 2019 / 0183594), entitled "ROBOTIC ATTACHMENT COMPRISING EXTERIOR DRIVE ACTUATOR", and, - U.S. Design Patent No. D910,847, titled "SURGICAL INSTRUMENT ASSEMBLY".
[0006] The applicant of this application owns the following U.S. patent applications and U.S. patents filed on June 28, 2017, which are incorporated herein by reference in their entirety. - U.S. Patent No. 15 / 635,693 (currently U.S. Patent Application Publication No. 2019 / 0000466), titled "SURGICAL INSTRUMENT COMPRISING AN OFFSET ARTICULATION JOINT" - U.S. Patent No. 15 / 635,729 (currently U.S. Patent Application Publication No. 2019 / 0000467), titled "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM RATIO" - U.S. Patent No. 15 / 635,785 (currently U.S. Patent Application Publication No. 2019 / 0000469), titled "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM RATIO" - U.S. Patent No. 15 / 635,808 (currently U.S. Patent Application Publication No. 2019 / 0000471), titled "SURGICAL INSTRUMENT COMPRISING FIRING MEMBER SUPPORTS" - U.S. Patent No. 15 / 635,837 (currently U.S. Patent Application Publication No. 2019 / 0000472), titled "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM LOCKABLE TO A FRAME" - U.S. Patent No. 10,779,824, entitled "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION SYSTEM LOCKABLE BY A CLOSURE SYSTEM" - U.S. Patent No. 15 / 636,029 (currently U.S. Patent Publication No. 2019 / 0000477), titled "SURGICAL INSTRUMENT COMPRISING A SHAFT INCLUDING A HOUSING ARRANGEMENT" - U.S. Patent No. 15 / 635,958 (currently U.S. Patent Application Publication No. 2019 / 0000474), entitled "SURGICAL INSTRUMENT COMPRISING SELECTIVELY ACTUATABLE ROTATABLE COUPLERS" - U.S. Patent No. 15 / 635,981 (currently U.S. Patent Application Publication No. 2019 / 0000475), titled "SURGICAL STAPLING INSTRUMENTS COMPRISING SHORTENED STAPLE CARTRIDGE NOSES" - U.S. Patent No. 15 / 636,009 (currently U.S. Patent Application Publication No. 2019 / 0000476), titled "SURGICAL INSTRUMENT COMPRISING A SHAFT INCLUDING A CLOSURE TUBE PROFILE" - U.S. Patent No. 10,765,427, entitled "METHOD FOR ARTICULATING A SURGICAL INSTRUMENT" - U.S. Patent No. 15 / 635,530 (currently U.S. Patent Application Publication No. 2019 / 0000457), titled "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTOR WITH AXIALLY SHORTENED ARTICULATION JOINT CONFIGURATIONS". - U.S. Patent No. 10,588,633, titled "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 (currently U.S. Patent Publication No. 2019 / 0000459), entitled "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". - U.S. Patent No. 10,786,253, titled "SURGICAL END EFFECTORS WITH IMPROVED JAW APERTURE ARRANGEMENTS" - U.S. Patent No. 15 / 635,594 (currently U.S. Patent Application Publication No. 2019 / 0000461), titled "SURGICAL CUTTING AND FASTENING DEVICES WITH PIVOTABLE ANVIL WITH A TISSUE LOCATING ARRANGEMENT IN CLOSE PROXIMITY TO AN ANVIL PIVOT AXIS" - U.S. Patent No. 15 / 635,612 (currently U.S. Patent Application Publication No. 2019 / 0000462), titled "JAW RETAINER ARRANGEMENT FOR RETAINING A PIVOTABLE SURGICAL INSTRUMENT JAW IN PIVOTABLE RETAINING ENGAGEMENT WITH A SECOND SURGICAL INSTRUMENT JAW", - U.S. Patent No. 10,758,232, titled "SURGICAL INSTRUMENT WITH POSITIVE JAW OPENING FEATURES" - U.S. Patent No. 10,639,037, entitled "SURGICAL INSTRUMENT WITH AXIALLY MOVABLE CLOSURE MEMBER" - U.S. Patent No. 10,695,057, titled "SURGICAL INSTRUMENT LOCKOUT ARRANGEMENT" - U.S. Design Patent No. D851,762, titled "ANVIL" - U.S. Design Patent No. D854,151, titled "SURGICAL INSTRUMENT SHAFT," and, - U.S. Design Patent No. D869,655, titled "SURGICAL FASTENER CARTRIDGE".
[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 No. 15 / 634,024 (currently U.S. Patent Application Publication No. 2018 / 0368839), titled "SURGICAL ANVIL MANUFACTURING METHODS" - U.S. Patent No. 10,772,629, titled "SURGICAL ANVIL ARRANGEMENTS" - U.S. Patent No. 15 / 634,046 (currently U.S. Patent Application Publication No. 2018 / 0368841), titled "SURGICAL ANVIL ARRANGEMENTS" - U.S. Patent No. 10,856,869, titled "SURGICAL ANVIL ARRANGEMENTS" - U.S. Patent No. 15 / 634,068 (currently U.S. Patent Application Publication No. 2018 / 0368843), titled "SURGICAL FIRING MEMBER ARRANGEMENTS" - U.S. Patent No. 15 / 634,076 (currently U.S. Patent Application Publication No. 2018 / 0368844), titled "STAPLE FORMING POCKET ARRANGEMENTS" - U.S. Patent No. 15 / 634,090 (currently U.S. Patent Application Publication No. 2018 / 0368845), titled "STAPLE FORMING POCKET ARRANGEMENTS" - U.S. Patent No. 15 / 634,099 (currently U.S. Patent Application Publication No. 2018 / 0368846), titled "SURGICAL END EFFECTORS AND ANVILS", and - U.S. Patent No. 10,631,859, titled "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, titled "STAPLE CARTRIDGE" - U.S. Design Patent Application No. 29 / 736,649, titled "STAPLE CARTRIDGE" - U.S. Design Patent Application No. 29 / 736,651, titled "STAPLE CARTRIDGE" - U.S. Design Patent Application No. 29 / 736,652, titled "STAPLE CARTRIDGE" - U.S. Design Patent Application No. 29 / 736,653, titled "STAPLE CARTRIDGE" - U.S. Design Patent Application No. 29 / 736,654, entitled "STAPLE CARTRIDGE", and, - U.S. Design Patent Application No. 29 / 736,655, titled "STAPLE CARTRIDGE".
[0009] The applicant of this application owns the following U.S. design patent applications and U.S. patents filed on November 14, 2016, which are incorporated herein by reference in their entirety. - U.S. Patent No. 15 / 350,621 (currently U.S. Patent Application Publication No. 2018 / 0132849), titled "STAPLE FORMING POCKET CONFIGURATIONS FOR CIRCULAR STAPLER ANVIL" - U.S. Patent No. 15 / 350,624 (currently U.S. Patent Application Publication No. 2018 / 0132854), titled "CIRCULAR SURGICAL STAPLER WITH ANGULARLY ASYMMETRIC DECK FEATURES" - U.S. Design Patent No. D833,608, entitled "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” are for convenience only 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. As the detailed description of the invention progresses, the reader will further understand that the various surgical devices disclosed herein can be inserted into the body in any way, such as through natural orifices, through incisions or puncture holes formed in tissue, etc. The working portion or end-effector portion of the surgical device can be inserted directly into the patient's body, or it can be inserted through an access device having a working channel that allows the end-effector and elongated shaft of the surgical device to 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. 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, i.e., unfired position and a second, i.e., fired position, 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 threads. The threads are movable between a proximal position adjacent to the proximal end of the cartridge body and a distal position adjacent to the distal end of the cartridge body. The threads include 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 its 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 in front of the knife that excises 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. For cutting and stapling 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 to advance a launching member 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 range 110 of the shaft assembly 100. Such articulation provides the user of the surgical staple fastener 10 with the ability to more precisely position and / or manipulate the end effector 200 near the target tissue.
[0023] The handle 20 comprises a housing 21 configured to house 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 a user and / or to be grasped and / or held by a user using the surgical stapling device 10. The handle 20 further comprises various actuators and / or triggers configured to be actuated by a 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 a 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 a 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 joint motion actuator 26 is configured to articulate the end effector 200 relative to the shaft assembly 100 by the joint motion area 110. The trigger and actuator of the surgical staple fastener 10 can activate various functions of the surgical staple fastener 10 by triggering one or more motors in the handle 20, and / or by manually driving various drive shafts and components.
[0024] The handle 20 further comprises a nozzle assembly 30 configured to support the shaft assembly 100 therein. The nozzle assembly 30 includes an operating wheel 31 configured to be rotated by 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 in which the surgical stapling device 10 is directly connected to a power source are conceivable. Embodiments in which the surgical stapling device 10 is, for example, entirely manual or non-electric are also conceivable. Embodiments in which the articulation of the end effector, clamping and unclamping of the jaws, firing of end effector staples and cut tissue, and rotation of the shaft and / or end effector are all electrically operated systems are also conceivable.
[0026] In at least one case, the shaft assembly 100 and the end effector 200 may be modular and detachable from the handle 20. In at least one case, the end effector 200 may be modular in that it can be detached from the shaft assembly 100 and replaced with a different end effector. In at least one case, the shaft assembly 100 and / or the end effector 200 can be used in a surgical robotic environment. Such embodiments provide power input from a 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 case, the shaft assembly 100 and the end effector 200 are configured for use with a surgical robot. In such a case, the shaft assembly 100 and the end effector 200 are configured to be coupled to a surgical robot having multiple output drivers. The multiple output drivers of the surgical robot are configured to mate with the drive systems of the shaft assembly 100 and the end effector 200. In such a case, the surgical robot can actuate various different functions of the end effector 200, for example, by articulating the end effector around multiple different articulated joints, by rotating the shaft assembly 100 and / or the end effector 200 around its longitudinal axis, by clamping the end effector 200 to clamp tissue between the jaws of the end effector 200, and / or by 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 articular motion, 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 or surgical robot interface within the handle 20 when the shaft assembly 100 is connected to the handle 20. In various embodiments, the staple fastener end effector may include two independently rotatable drive members, for example, one for grasping tissue and one for firing staples. The staple fastener end effector may further include an articular motion 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 a joint motion system, a gripping system, or a launching system.
[0029] Such a drive shaft may be actuated by a drive system or surgical robot interface within the handle 20 when the shaft assembly 100 is connected to the handle 20. Such a drive shaft may have linear actuation, rotary actuation, or a combination thereof. A combination of rotary and linear actuation may, for example, use a series of rack gears and / or drive screws.
[0030] In at least one case, 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 the 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 described in more detail below. The articulation region 110 allows the end effector 200 to articulate with respect to the outer shaft 101 in two different planes around two separate axes AA1, AA2.
[0032] The articular motion of the end effector 200 is described here, primarily with reference to Figure 4. The articular motion region 110 comprises two different articular joints and two articular actuators 150, 160. This allows the end effector 200 to articulate independently of each other in two different planes around two different axes AA1, AA2. The articular motion 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 pivotably 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 configuration provides articulation of the end effector 200 relative to the shaft assembly 100, with axes AA1 and AA2, independently of each other.
[0033] The proximal joint shaft component 120 comprises a proximal annular portion 121 fixedly fitted within the outer shaft 101. The proximal joint shaft component 120 also comprises an articular tab 123, which includes a hollow passage 122 through which various drive system components can pass and which comprises a pinhole 124 configured to receive an articular pin 125. The articular pin 125 pivotably connects the proximal joint shaft component 120 to the proximal articular tab 131 of the intermediate joint shaft component 130. To articulate the end effector 200 around axis AA1, the articular 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 articular actuator 150 is pivotably mounted on the articular crosslink 151. The joint motion crosslink 151 is pivotably mounted on the intermediate joint shaft component 130 out of axis relative to the joint motion pin 125. As a result, when the joint motion actuator 150 is activated, the joint motion crosslink 151 applies torque to the intermediate joint shaft component 130 out of axis relative to the joint motion pin 125, causing the intermediate joint shaft component 130, and therefore the end effector 200, to pivot around 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 articular pin 125 defining axis AA1. Specifically, the intermediate joint shaft component 130 includes a proximal articular tab 131 pivotably connected to the proximal joint shaft component 120 by the articular pin 125. The intermediate joint shaft component 130 further includes a hollow passage 132 configured to allow various drive system components to pass through it, and a distal articular tab 133. The distal articular tab 133 includes a pin hole 134 configured to receive another articular 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 is actuated by a key 135 to apply articulation torque to the proximal tab 141 of the distal joint shaft component 140. The articulation cable 160 is fixed to the key 135 such that when the cable 160 is rotated, the key 135 pivots relative to the intermediate joint shaft component 130. The key 135 is fitted into the keyhole 144 of the distal joint shaft component 140. Note that 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 provides an additional torque moment from the articulation cable 160 to the distal joint shaft component 140. The joint movement pin 136 is received in the pin hole 142 and pivotably connects the intermediate joint shaft component 130 and the distal joint shaft component 140.
[0036] In at least one case, the articular movement cable 160 can be pulled only in the proximal direction. In such a case, only one side of the articular movement cable 160 is pulled proximal to articularize the end effector 200 in the desired direction. In at least one case, the articular movement cable 160 is opposedly pushed and pulled. In other words, the cable 160 may include a rigid structure such that one side of the articular movement cable 160 is pushed distally and the other side is pulled proximal. Such a configuration can allow the articular movement force to be divided between the pushed half and the pulled half of the cable 160. In at least one case, the push-pull configuration allows a larger articular movement force to be transmitted to the corresponding articular joint. Such a force may be necessary in a configuration having two articular joints. For example, if the proximal joint is fully articulated, more force may be required from the articulation actuator to articulate the distal joint due to the extension and / or lengthening 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 it. 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 movement area 110.
[0038] As described above, the anvil jaw 201 is movable relative to the cartridge jaw 203 and clamps and unclams tissue with the end effector 200. The operation of this function of the end effector 200 is described below. 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 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 driver 250 is provided to open and close the anvil jaw 203 relative to the cartridge jaw 201.
[0040] The closing driver 250 is actuated by a flexible drive segment 175 consisting of a freely movable joint positioned or formed end-to-end. In various cases, the flexible drive segment 175 may include a serial 3D printed universal joint, all printed together as a single continuous system. As will be described in more detail below, the flexible drive segment 175 is driven by an input shaft traversing the shaft assembly 100. The flexible drive segment 175 transmits rotational operating motion via a double-jointed motion joint. The closing driver 250 comprises a closing screw 251 and a closing wedge 255 screwably coupled to the closing screw 251. The closing wedge 255 is configured to reliably cam the anvil jaw 203 to open and close. 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 a closing screw 251 that displaces the closing wedge 255. For example, the closing wedge 255 is screw-connected to the closing screw 251, and rotational movement of the closing wedge 255 relative to the staple cartridge 220 is restricted. The closing screw 251 drives the closing wedge 255 proximal or distal depending on the direction in which the closing screw 251 is rotated.
[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 to the clamped position (Figure 8).
[0043] To release or unclam the end effector 200 from the clamped position (Figure 8), 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 proximally. When the closing wedge 255 is moved distally, a pair of nubs 257 extending from the distal end of the closing wedge 255 contact a cam surface 234 near a tab 237 that extends downward from 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, causing it to rotate around the pin 233 to the open position (Figure 7).
[0044] In at least one case, 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 includes an inclined section similar to the inclined section of the upper inclined section of the cam surface 256.
[0045] As described above, the surgical stapling device 10 can be operated to advance a launching member through jaws 201, 203 to staple and cut tissue using the end effector 200. Next, the function of deploying staples 226 from the staple cartridge 220 and cutting tissue with a 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 arranged in a longitudinal row defined within the cartridge body 221, and a longitudinal slot 224 branching the cartridge body 221. 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 tissue support surface that is laterally contoured. In various embodiments, the contour of the deck surface 221 can form a peak along the central portion of the cartridge body 221. Such a peak can cover a longitudinally extending firing screw 261 that extends through the central portion of the cartridge body 221, which is further described herein. The increased height along the peak can, in various cases, be associated with smaller tissue gaps along the firing path of the knife 283. In certain embodiments of this disclosure, the driver height, formed staple height, staple pocket extension height, and / or staple overdrive distance can 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 is further described herein.
[0047] The staple driver 225 is configured such that when the thread 280 is pushed distally through the staple cartridge 220, the thread 280 is lifted, ejecting the staple 226, supported by the staple driver 225, into the staple cavity 223. The thread 280 includes an inclined portion 281 for contacting 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 deploy staples 226 and cut tissue with a knife 283, the end effector 200 comprises a launch driver 260. The launch driver 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 traverses the shaft assembly 100. The flexible drive shaft 176 transmits rotational actuation motion via a double-joint motion joint. The launch driver 260 comprises a launch screw 261 configured to be rotated by the flexible drive shaft 176. The launch screw 261 comprises a journal supported in a support member 259 and a bearing in the channel 210. In various cases, 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 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-connected to the launching screw 261 such that when the launching screw 261 rotates, the launching member 270 advances distally along the launching screw 261 or retracts proximally. Specifically, the launching member 270 comprises a body portion 271 having a hollow passage 272 defined inside. The launching screw 261 is configured to be received within the hollow passage 272 and to be screw-connected to a threaded component 273 of the launching member 270. Thus, when the launching screw 261 is rotated, 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 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 may, in various cases as further described herein, include lateral asymmetry to maximize the width of the thread rail and to house the firing screw 261 below the center of the cartridge 220.
[0050] At some point during the firing of the end effector 200, the user may retract the firing member 270 to allow the jaws 201 and 203 to unclam. In at least one case, the firing member 270 must be fully retracted to open the jaws 201 and 203, in which case upper and lower cam members are provided on the main body portion 271 such that they can be disengaged from the jaws 201 and 203 when the firing member 270 is fully retracted.
[0051] In various cases, the launching member 270 may be a hybrid structure of plastic and metal parts, as further described herein. In various cases, 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 cases. The launching member 270 may include a complex 3D printed shape that contains a grid pattern space inside. In various cases, 3D printing allows the launching member or a part thereof to function as a spring, allowing a part to bend more easily, thereby improving, for example, the distribution of force and / or tolerances during the launch stroke.
[0053] Figures 9 to 11 show a surgical stapling 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 described herein, however, the shaft assembly 310 comprises a single articulated joint and an articulated bar configured to articulate the end effector 200 around the single articulated joint. The surgical stapling assembly 300 is configured to cut and staple tissue. The surgical stapling assembly 300 may be attached to a surgical instrument handle and / or a surgical robot interface. The surgical instrument handle and / or surgical robot interface may be configured to actuate various functions of the surgical stapling 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 articulation pin 354. The first shaft coupling component 330 comprises a proximal tubular 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 articulation tab 333 having a pinhole 334 defined internally 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 articulation 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 articular pin 354. The articular pin 354 is also received in a pinhole 353 of the proximal extending articular tab 351 of the second shaft coupling component 350. The pinhole 353 is axially aligned with a pinhole 334. The articular pin 354 allows the second shaft coupling component 350 to articulate with respect to the first shaft coupling component 330 around the articular axis AA. The second shaft coupling component 350 further comprises a pin projection 352 extending from the proximal extending articular tab 351. As will be discussed in more detail below, the pin projection 352 is configured to be pivotably connected to the articular 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 articular movement bar 360 is provided to articulate the end effector 200 around the articular movement axis AA. The articular movement bar 360 may be actuated by any preferred means, such as a robot or electric input and / or a manual handle trigger. The articular movement bar 360 may be actuated, for example, in the proximal and distal directions. Embodiments have been conceived in which the articular movement system has rotational drive action in addition to, or instead of, linear action. The articular movement bar 360 extends through an outer shaft 311. The articular movement bar 360 has a distal end 361 pivotably connected to an articular movement coupling 362. The articular movement coupling 362 is pivotably connected from a proximal extending articular movement tab 351 to a pin projection 352 extending from a central articular movement tab relative to the articular movement axis AA. Such eccentric connection of the articular movement coupling 362 allows the articular movement bar 360 to apply force to the second shaft coupling component 350, thereby rotating the second shaft coupling component 350, and thus the end effector 200, relative to the first shaft coupling component 330. The articular movement bar 360 can advance distally to rotate the end effector 200 in a first direction about the articular movement axis AA, and retract proximal to rotate the end effector 200 in a second direction opposite to the first direction about the articular movement axis AA.
[0057] The shaft assembly 310 further comprises a joint motion component support structure 340 located within the joint motion joint 320. Such a support structure can provide support to various drive components configured to pass through the joint motion joint 320 and reach the end effector 200 when the end effector 200 is articulated. The support structure 340 may also serve to isolate the drive components from tissue residue during use.
[0058] Figures 12–14 show a surgical stapling 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 described herein, however, the shaft assembly 410 comprises a single articulated joint and an articulated cable configured to articulate the end effector 200 around the single articulated joint. The surgical stapling assembly 400 is configured to cut and staple tissue. The surgical stapling assembly 400 may be attached to a surgical instrument handle and / or a surgical robot interface. The surgical instrument handle and / or surgical robot interface may be configured to actuate various functions of the surgical stapling 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 around 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 articulation pin 454. The first shaft coupling component 430 comprises a proximal tubular 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 articulation tab 433 having a pinhole 434 defined inside. The distal portion 432 further defines 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, articulation actuators, closing actuators, and / or firing actuators.
[0060] The first shaft coupling component 430 is pivotably connected to the second shaft coupling component 450 by an articular pin 454. The articular pin 454 is also received in a pinhole 453 of the proximal extending articular tab 451 of the second shaft coupling component 450. The articular pin 454 allows the second shaft coupling component 450 to articulate with respect to the first shaft coupling component 430 around the articular axis AA. The second shaft coupling component 450 further comprises a drive ring structure 452. The drive ring structure 452 extends from the proximal extending articular 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 articular 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 articular motion cable 460 is provided to articulate the end effector 200 around the articular motion axis AA. The articular motion cable 460 may be actuated by any preferred means, such as a robotic input and / or manual trigger on the handle of a handheld surgical instrument. The articular motion cable 460 may have an antagonistic action form. In other words, when the first side of the articular motion cable 460 is pulled proximally, the second side of the articular motion cable 460 is made able to advance distally, like a pulley system. Similarly, when the second side is pulled proximally, the first side is made able to advance distally. The articular motion cable 460 extends through the outer shaft 411. The articular motion 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 articular motion cable 460 is actuated. When the articular motion cable 460 is activated, it is configured to apply rotational torque to the drive ring structure 452 of the second shaft coupling component 450, and therefore to the end effector 200. Such torque is configured to rotate or pivot the second shaft coupling component 450 relative to the first shaft coupling component 430, thereby causing the end effector 200 to articulate with respect to the outer shaft 411. The first side of the articular motion cable 460 can pull to rotate the end effector 200 in a first direction about the articular motion axis AA, and the second side of the articular motion cable 460 can pull to rotate the end effector 200 in a second direction opposite to the first direction about the articular motion axis AA.
[0062] The shaft assembly 410 further comprises a joint motion component support structure 440 located within the joint motion joint 420. Such a support structure 440 can provide support to various drive components configured to pass through the joint motion joint 420 and reach the end effector 200 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 articulated joint 420. The drive shaft segments 475 and 476 are configured to passively expand 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 to account for the respective longitudinal extension or contraction of the drive shaft length resulting from the articulation of the end effector 200 relative to the shaft assembly 410. During expansion and contraction of the drive shaft segments 475 and 476, they maintain rotational drive engagement with the corresponding input shaft and output shaft in the end effector 200, which extend through the outer shaft 411. In at least one case, the output shaft includes 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 effectors 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 described herein, however, the shaft assembly 510 comprises a single articulated joint and drive shaft segment configured to passively expand and contract. The surgical staple assembly 500 is configured to cut and staple tissue. The surgical staple assembly 500 may be attached to a surgical instrument handle and / or surgical robot interface. The surgical instrument handle and / or surgical robot interface 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 surgical robot interface. 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 case, 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 articular pin 543. The articular pin 543 is also received in a pinhole 542 of the proximal extending articular tab 541 of the second shaft coupling component 540. The articular pin 543 allows the second shaft coupling component 540 to articulate with respect to the first shaft coupling component 530 around the articular 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 case, the end effector 200 is articulated passively. In such an example, the end effector 200 may be pressed against tissue to, for example, apply a force to the end effector 200 to cause it to articulate around the articulation axis. In at least one case, the end effector 200 further comprises a spring configured to apply a neutral biasing force to the second shaft coupling segment 540 to, for example, bias the end effector 200 toward a non-articulation 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 articulated joint 520. The drive shaft segments 575, 576 are configured to passively expand and contract longitudinally when the end effector 200 is articulated. The articulation expands and contracts the drive shaft segments 575, 576, taking into account the longitudinal extension or contraction of the drive shaft length resulting from the articulation of the end effector 200. During the expansion and contraction of the drive shaft segments 575, 576, they maintain rotational drive engagement with the corresponding input and output shafts within the end effector 200. In at least one case, the output shaft includes 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, clamping tissue between the cartridge channel jaw 620 and the anvil jaw 660.
[0070] The cartridge channel jaw 620 includes a channel 630 including 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 placed 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 the launcher assembly is advanced through the end effector assembly 600.
[0071] The anvil 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 internally defined pinholes 662 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 pivotally mount the anvil jaw 660 to the channel 630. In at least one case, the channel 630 is mounted to the shaft portion 610 by a retaining ring or band that fits around the annular groove 632 of the channel 630 and the annular groove 615 of the shaft portion 610. The retaining ring or band is configured to hold the channel 630 to the shaft portion 610.
[0072] The end effector assembly 600 includes a closing driver 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 launch driver 680 configured to clamp, staple, and cut tissue by deploying a plurality of staples from a staple cartridge 640. The closing driver 670 includes a closing screw 671 located within the channel 630 and a closing wedge 675 screwably connected to the closing screw 671. As the closing screw 671 is rotated, the closing wedge 675 is advanced distally or retracted proximally to open or close the anvil jaw 660, respectively. The closing driver 670 may be actuated by any preferred means. For example, a rotary drive shaft may extend from the actuation interface through a shaft portion 610 to rotate the closing screw 671, for example. Other examples of suitable rotary drive shafts are described further herein.
[0073] The launch driver 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 the 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 so that the end effector assembly 600 can articulate 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 mounted to the lower launch member 682. The lower launch member 682 is configured to be reused with different staple cartridges.
[0074] The staple cartridge 640 includes a disposable upper launcher 683 configured to hook and engage or latch onto the lower launcher 682 so that the lower launcher 582 can push or drive the upper launcher 683 through the staple cartridge 640 and the support brace 650. In other words, the firing action includes a two-part launcher, consisting of a disposable upper launcher 683 incorporated into the cartridge 640 and a reusable lower launcher 682 incorporated into the firing driver 680, which can be coupled together when the cartridge 640 is seated in the elongated channel 630. The two-part launcher is described further herein.
[0075] The upper launching member 683 comprises an upper flange configured to engage with the anvil jaw 660, a knife edge configured to cut tissue, and a latch portion configured to hook and engage with the lower launching member 682. The staple cartridge 640 further comprises a thread 684 configured to engage with a staple driver located 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 into the end effector assembly 600.
[0076] The lower launch member 682 and the upper launch member 683 are configured to move via the support brace 650 so that vertical loads associated with the firing sequence are distributed via the support brace 650, the staple cartridge 640, the channel 630, and the anvil jaw 660. The support brace 650 may be made of, for example, a metallic material 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 case, 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, 653 are configured to distribute at least a portion of the force transmitted through the assembly 600 by the launch driver 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 pushed 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 driver 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. When the staple cartridge 640 is removed from the channel jaw 630, the upper firing member 683, thread 684, support brace 650, and staple cartridge 640 are removed. A replacement staple cartridge can be provided in an unused knife.
[0079] Various embodiments disclosed herein may be used in connection with a 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 depicted in Figure 22. The master controller 701 and the robotic arm slave cart 800, as well as their respective 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 known, the master controller 701 generally includes a controller (represented collectively as 703 in Figure 21) that is grasped by the surgeon and operated in space while the surgeon views the procedure via a stereo display 702. The controller 701 generally includes a manual input device that often further has an operable handle, trigger, or actuator that moves with multiple degrees of freedom and operates the tool (for example, to 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 referred to as 900. Various robotic surgical systems and methods utilizing the configuration of a master controller and robotic arm cart are disclosed in U.S. Patent No. 6,132,368, entitled "MULTI-COMPONENT TELEPRESENCE SYSTEM AND METHOD," the entirety of which is incorporated herein by reference.
[0081] In various embodiments, the robotic arm cart 800 includes a base 702 capable of supporting a surgical tool 900, as shown in the illustrated embodiment. In various embodiments, the surgical tool(s) 900 may be supported by a series of manually articulated linkages, commonly referred to as setup joints 804, and a robotic manipulator 806. In various embodiments, the linkages and joint devices can facilitate the rotation of the surgical tool about a point in space, as described more fully in U.S. Patent No. 5,817,084, entitled “REMOTE CENTER POSITIONING DEVICE WITH FLEXIBLE DRIVE,” whose entire disclosure is incorporated herein by reference. This parallelogram arrangement restricts the rotation to pivoting about an axis 812a, sometimes referred to as the pitch axis. Since the couplings supporting the parallelogram linkages are pivotably mounted on the setup joints 804 (Figure 22), the surgical tool can further rotate about 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 along the tool axis LT-LT relative to the manipulator 806 (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 a 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] Data communication between robotic components and the processor of the robotic surgical system is described herein primarily with reference to communication between surgical tools and the master controller 701, but it should be understood that similar communication may occur between manipulator circuits, setup junctions, endoscopes or other image capture devices, etc., and the processor of the robotic surgical system for purposes such as component compatibility verification, component type identification, component calibration (offset, etc.) communication, and confirmation of the connection of components to the robotic surgical system. In at least one aspect, the various surgical instruments disclosed herein may be used in connection 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 and 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 configurations that function to transmit drive 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 configurations must be capable of accommodating significant articular motion orientation of the end effector while effectively transmitting such drive motion across the articular 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 feature 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 installed 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 examples, the first and second rotary drive members can transmit rotational operating motion through the articulated joint(s) when in a non-flexible configuration and when in a flexible configuration. Exemplary rotary drive members are further described herein.
[0089] The motorized stapling assembly further comprises a closing driver having a first jaw, a second jaw, and a first rotary drive member extending through an articulated joint, and a firing driver 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 driver can be actuated, for example, by a closing trigger, and the actuation of the closing driver results in the rotation of the first rotary drive member, which transmits rotational motion to a closing screw via the articulated joint. The closing driver further comprises a closing wedge screwable to the closing screw, the closing wedge being configured to engage 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 driver 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. The actuation of the firing driver results in the rotation of the second rotary drive member, which transmits the rotational motion to the firing screw through an articulated joint. The firing driver further comprises a firing member screwably coupled to the firing screw, the firing member being 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 cases, at least one component within a motorized stapling device may be a 3D printed component. 3D printed components may be incorporated into articulated 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 specific cases. For example, 3D printing can enable printed components to exhibit metamaterial properties, resulting in greater structural strength and rigidity while enabling precision in the formation of small detail features and optimizing other properties of the component, such as selective flexibility and / or lubricity. Exemplary 3D printed components for motorized stapling devices, further described herein, include flexible, rotatable drive members(s), e.g., serially 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 composite plastic-metal 3D printed component. 3D printing of various components and considerations therefor are further described herein.
[0092] Methods of stapling using such surgical staple assemblies can also be conceived. These methods may include obtaining a surgical staple assembly and activating a closing driver 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 as a first rotary drive member rotates. The method may further include activating a firing driver by a firing trigger, wherein the firing member is configured to cam-engage with the first and second jaws and advance the cutting member and staple firing thread during a firing motion as a second rotary drive member rotates. Various applications of 3D printed components in such assemblies are further described herein.
[0093] In various cases, surgical end effectors and / or staple fastening assemblies for surgical devices may include rotary drive screws or rotary drive members, as further described herein. The rotary drive screw may extend through a channel and / or portion of the staple cartridge to a distal position within the end effector. The rotary drive screw may facilitate clamping and / or ejection of the staple cartridge, as further described herein. The rotary drive screw may extend along a longitudinal axis and may be aligned with the centerline of the staple cartridge, extending from the proximal end to the distal end of the staple cartridge.
[0094] The rotary drive screw passing through the end effector can occupy a significant portion of the limited area along the longitudinal center of the end effector and its staple cartridge. In various cases, the rotary drive screw may interfere with certain existing firing components, such as drivers and / or threads. The small footprint of the staple cartridge, as well as the considerable firing force applied to the various components within the end effector and staple cartridge, can present various challenges to structural deformation and / or repositioning of certain components.
[0095] For example, firing components(s) within a staple cartridge having a rotary drive screw through which it passes need to be modified to withstand the firing force during the firing stroke, balance the torque, avoid interference, and provide sufficient clearance around the rotary drive screw, in order to minimize damage to the components and / or misfiring of staples. In various cases, the rows of staples can be compressed (i.e., a higher density staple arrangement) and / or shifted laterally outward away from the rotary drive screw to increase the lateral space around the centerline of the staple cartridge. Rearranging and / or increasing the density of the staple rows may require various adaptations to firing components such as drivers and / or threads.
[0096] In various cases, the driver and / or threads may be modified to accommodate rearranged and / or compressed staple rows while minimizing jamming and / or misfiring. Modifications to the staple driver may include, for example, structural and geometric deformations of the staple posts and / or bridges between them. In particular cases, the upper portion of the driver (e.g., the width of the staple posts) may be asymmetrical with respect to the driver's centerline. Additionally or alternatively, the lower portion of the driver (e.g., the bridges and / or bases of the staple posts) may be asymmetrical with respect to the driver's centerline.
[0097] For example, in one aspect of the present disclosure, a staple cartridge may include a body extending along a longitudinal axis, rows of staples, and a triple driver configured to fire three staples simultaneously. The rows of staples may include an inner row on a first side of the longitudinal axis, the inner row containing inner staples. The rows of staples may also include an intermediate row on a first side of the longitudinal axis, the intermediate row containing intermediate staples. Furthermore, the rows of staples may include an outer row on a first side of the longitudinal axis, the outer row containing outer staples. The intermediate row may be spaced equidistant from the inner and outer rows. The triple driver may include an inner strut defining a first width, the inner strut configured to support the inner staples. The triple driver may also include an intermediate strut defining a second width, the intermediate strut configured to support the intermediate staples. Furthermore, the triple driver may include an outer strut defining a third width, the outer strut configured to support the outer staples. The first width can be smaller than the second width and smaller than the third width. In certain cases, the first width, the second width, and / or the third width can be different.
[0098] In various embodiments of this disclosure, the various widths of the staple posts of the multi-staple driver may be configured to provide more space for the thread rail while optimizing the area for the rotary drive screw along the central longitudinal portion of the staple cartridge. For example, various improvements to the staple cartridge, including the driver and cartridge body, and their advantages are further described herein.
[0099] Referring here to Figures 24 and 25, the staple cartridge 20100 includes a body 20102 extending along the longitudinal axis A. Staples are detachably disposed within the body 20102. Staples can be ejected from the body 20102 and fired into tissue, for example, during a firing stroke. Staples are arranged in longitudinal rows on either side of the longitudinal axis A. The cartridge body 20102 also includes a deck 20104, which may be called, for example, a tissue support surface. The deck 20104 is a transversely curved tissue support surface, defining a curved surface or contour from a first transverse side of the body 20102 to a second transverse side of the body 20102. The peak of the transversely curved tissue support deck 20104 is defined in the middle portion of the body 20102. The peak can be positioned, for example, between the longitudinal rows of staples and cover the longitudinal axis A. In various cases, for example, a rotary drive screw such as the launch screw 261 (Figures 4 and 5) extends through a portion of the staple cartridge 20100, as further described herein.
[0100] The staples are located within a cavity 20110 defined within the cartridge body 20102. The staples are arranged in longitudinal rows on both sides of the longitudinal axis A. For example, the cavity 20110 is located in cavity row 20112. The cavity row includes an inner row 20112a, an intermediate row 20112b, and an outer row 20112c on each side of the longitudinal axis A. The intermediate row 20112b is spaced equidistant from the inner row 20112a and the outer row 20112c. For example, the inner cavity row 20112a can be spaced laterally inward by a certain distance from the intermediate cavity row 20112b, and the outer cavity row 20112c can be spaced laterally outward by the same distance from the intermediate cavity row 20112b. The rotary drive screw can be aligned with the longitudinal axis A and can extend through the cartridge body 20102 adjacent to the inner cavity row 20112a. The rotary drive screw can be, for example, located between the inner cavity row 20112a and parallel to them.
[0101] The inner row 20112a holds the inner staples, the middle row 20112b holds the middle staples, and the outer row 20112c holds the outer staples. In various cases, the inner staples, middle staples, and outer staples may be identical. In other examples, the inner staples, middle staples, and / or outer staples may each differ, for example, with respect to staple type (e.g., wire or stamp), material, and / or size (e.g., different heights). The reader will understand that various staples, staple cavities, staple drivers, and staple cartridges are described herein. However, in certain examples, alternative fasteners may be available, such fasteners may be incorporated into a fastener cavity, driven by a fastener driver, and / or fired from a fastener cartridge which may be similar in many embodiments to the staple cavities, staple drivers, and / or staple cartridges described herein.
[0102] The staple cartridge 20100 may have different arrangements of staples. For example, the staple cartridge 20100 may have fewer than three rows of staples on each side of the longitudinal axis A, and in one embodiment, it may have only two rows of staples on each side of the longitudinal axis A. In yet another example, the staple cartridge 20100 may include four or more rows of staples on one or more sides of the longitudinal axis A. In various examples, the rows of staples may be asymmetrical with respect to the longitudinal axis A. For example, the first side of the staple cartridge 20100 may have a different number of rows of staples than the second side of the staple cartridge 20100.
[0103] Each staple cavity 20110 includes a proximal end, a distal end, and a lateral guide surface midway between the proximal and distal ends. The staple cavity 20110 is constructed and dimensional to guide the driver 20120 toward the deck 20104 through the staple cavity 20110. More specifically, the shape of the staple cavity 20110 can complement the shape of the driver 20120. For example, the lateral guide surface within each staple cavity 20110 is configured to guide the sidewall 20134 (e.g., the sidewall of the staple support) of the driver 20120 as it moves through the staple cavity 20110. Additionally or alternatively, the proximal and / or distal ends of each staple cavity 20110 may include an upright groove configured to slidably receive its end and / or tongue of the driver 20120. An alternative tongue-and-groove configuration can also be conceived, which may be configured to guide the driver 20120 through the staple cavity 20110 during the firing of staples from the staple cartridge 20100.
[0104] The driver 20120 is configured to support multiple staples during the firing stroke and to be driven from the cartridge body 20102. The driver 20120 can movably support staples that span two or more longitudinal rows of the staple cavity 20112. For example, the driver 20120 can movably support inner staples, intermediate staples, and outer staples on the same side of the staple cartridge 20100.
[0105] Here, referring mainly to Figures 26-28, the driver 20120 is shown. Multiple drivers, such as the driver 20120, are incorporated into, for example, the staple cartridge 20100. The driver 20120 is a triple driver configured to drive three staples simultaneously. The driver 20120 includes three struts: an inner strut 20122a configured to support the inner staples in the inner row of staples; an intermediate strut 20122b laterally outside the inner strut 20122a, configured to support the intermediate staples in the middle row of staples; and an outer strut 20122c laterally outside the intermediate strut 20122b, configured to support the outer staples in the outer row of staples. The struts 20122a, 20122b, and 20122c of each driver 20120 may be staggered longitudinally in various cases.
[0106] The driver 20120 also includes a bridge 20126 extending between adjacent struts 20122. For example, the first bridge 20126a extends between the inner strut 20122a and the intermediate strut 20122b, and the second bridge 20126b extends between the intermediate strut 20122b and the outer strut 20122c. Each bridge 20126a, 20126b includes an inclined lower surface 20128 configured to be driven and engaged by a thread during the firing stroke. In other words, each driver 20120 is configured to be engaged and lifted by two parallel thread rails along the inclined lower surface 20128 of the driver 20120. For example, the thread may be configured to move along the firing path during the firing stroke. The thread may comprise a central portion aligned with the longitudinal axis A, a first rail on the first side of the longitudinal axis A configured to drive-engage with the inclined lower surface 20128 of the first bridge 20126a, and a second rail on the second side of the longitudinal axis A configured to drive-engage with the inclined lower surface 20128 of the second bridge 20126b. The thread and its launching motion will be further described herein.
[0107] Each strut 20122 includes a proximal end 20130, a distal end 20132, and a pair of opposing side walls 20134 extending longitudinally between the proximal end 20130 and the distal end 20132. The side walls 20134 are configured to slidably engage with lateral guide surfaces within each staple cavity 20110 during the firing motion. Each strut 20122 includes a staple support cradle 20124. The base of the staples can be held within the staple support cradle 20124.
[0108] Each staple support cradle 20124 is aligned with one of the inner axis A1, intermediate axis A2, or outer axis A3, the inner axis A1, intermediate axis A2, or outer axis A3 corresponding to the axes defining the staples on one side of the staple cartridge 20100 and the longitudinal rows of the staple cavity 20110. A first lateral distance D1 is defined between the inner axis A1 and the intermediate axis A2, and a second lateral distance D2 is defined between the outer axis A3 and the intermediate axis A2. The axes are equidistant, and the first lateral distance D1 and the second lateral distance D2 are the same. The lateral distances D1 and D2 between the axes and adjacent rows of the staple cavity 20110 are the same, but the driver 20120 is asymmetrical with respect to the centerline of the driver 20120. For example, the center line of driver 20120 corresponds to the intermediate axis A2, and the inner and outer staples are positioned equidistant from the intermediate axis A2; however, driver 20120 is not symmetrical with respect to the intermediate axis A2.
[0109] Referring primarily to Figure 27, the inner support 20122a defines a first width Wa between its side walls 20134, the intermediate support 20122b defines a second width Wb between its side walls 20134, and the outer support 20122c defines a third width Wc between its side walls 20134. The first width Wa is different from the second width Wb and the third width Wc. For example, the first width Wa may be reduced or narrowed to less than the second width Wb and the third width Wc in order to accommodate a rotary drive screw passing through the central portion of the staple cartridge 20100. In certain cases, one or more narrower struts 20122 can maximize the width of the bridge 20126, and thus effectively narrow and reduce the footprint of the driver 20120 while maximizing the width of the thread rail that engages, for example, with the inclined lower surface 20128 of the bridge 20126 and delivers the firing force to the driver 20120. In various cases, increasing the width of the bridge 20126 and the thread rail can improve the rigidity of the thread rail and minimize deformation and / or damage to the thread during the firing stroke.
[0110] The widths Wa, Wb, and Wc are all different. For example, the width Wb of the intermediate support 20122b is wider than the width Wa of the inner support 20122a and the width Wc of the outer support 20122c. The width Wc is smaller than the width Wb of the intermediate support 20122b and wider than the width Wa of the inner support 20122a. The different widths Wa, Wb, and Wc are configured, for example, to optimize the width of the driver 20120 to accommodate the rotary drive screw along the longitudinal axis A while effectively transmitting firing force and minimizing torque and misfires.
[0111] As provided herein, in certain examples, the width of the staple struts on the driver can be modified to accommodate a rotary drive screw located within the staple cartridge. Additionally or alternatively, in certain embodiments of this disclosure, the lower portion of the driver can also be modified laterally, and the lower portion (e.g., the lower portion of the struts and / or bridge) may be asymmetrical with respect to a centerline passing through the intermediate struts. For example, the lower portion of the driver may be modified to increase the usable area at the longitudinal center of the staple cartridge. The asymmetrical shape of the lower portion of the driver can be chosen to improve the strength and rigidity of the triple driver while minimizing the height of the driver. In various cases, the thickness of the struts and / or the shape of the bridge can be modified laterally, but the struts can be spaced equally apart from the centroid of a substantially triangular triple driver. For example, the intermediate struts can be aligned longitudinally with the centroid, and the inner and outer struts can be offset longitudinally from the centroid. In various cases, the inclined surfaces can be spaced equally apart from the centroid of the triple driver.
[0112] Referring to Figures 29 and 30, an end effector 20240 is shown, which includes a staple cartridge 20200 and a triple driver 20220. The staple cartridge 20200 is similar in many embodiments to the staple cartridge 20100 (Figure 24), and the triple driver 20220 is similar in many embodiments to the triple driver 20120 (Figure 26). For example, the staple cartridge 20200 includes a cartridge body 20202 with three rows of staple cavities on each side of a rotary drive screw 20242, and the triple driver 20220 includes three parallel staple support cradles 20224 configured to support staples, and the triple driver 20220 is configured to fire staples from the inner row, middle row, and outer row.
[0113] The end effector 20240 includes a rotary drive screw 20242 and a launching member 20244, which are similar to the launching screw 261 (Figures 4 and 5) and the launching member 270 (Figures 4 and 5), respectively. The launching member 20244 is configured to move through the staple cartridge 20200 during the launch stroke to advance the thread and lift the driver 20220. The driver 20220 includes an inner column 20222a, an intermediate column 20222b, and an outer column 20222c. The columns 20222 include different widths, as further described herein. In various embodiments of this disclosure, one or more of the columns 20222 can also include different heights from the other columns. In various cases, the different heights are configured to form the staples at different heights, which may correspond, for example, to a laterally curved tissue support surface or deck contour of the cartridge body.
[0114] The lower portion of the driver 20220 includes a chamfered inner edge 20236. The chamfered inner edge 20236 is a notched or scalloped edge dimensioned to accommodate the lower portions of the drive screw 20242 and the launching member 20244. For example, the drive screw 20242 extends along the longitudinal axis A and is positioned between the driver 20220s on either side of the longitudinal axis A. In such a case, the drive screw 20242 may extend through the staple cartridge 20200 while minimizing the dimensions of the staple cartridge 20200 and the end effector 20240. The chamfered inner edge 20236 includes a notch into the base portion of the inner strut 20222a, which provides clearance for the launching component positioned along the longitudinal center portion of the end effector 20240. Furthermore, the chamfered inner edge 20236 is configured to provide a space closer to the vertical centerline of the end effector, i.e., equidistant between the upper and lower cams, which can improve and / or assist in balancing forces during the firing stroke.
[0115] Additionally or alternatively, the driver bridge may vary laterally and / or be asymmetrical with respect to a centerline passing through the driver's intermediate support. Referring here to Figure 31, an end effector 20340 is shown, including a staple cartridge 20300 and a triple driver 20320. In many embodiments, the staple cartridge 20300 is similar to the staple cartridge 20100 (see Figure 24), and the triple driver 20320 is similar in many embodiments to the triple driver 20120 (see Figure 26). For example, the staple cartridge 20300 includes a cartridge body 20302 and a deck 20304 with three rows of staple cavities positioned on each side of the rotary drive screw, and the triple driver 20320 includes three parallel staple support cradles 20324 configured to support staples, and the triple driver 20320 is configured to fire staples from the inner row, the middle row, and the outer row. Driver 20320 is shown in the launch configuration in Figure 31, with the upper portion of the staple support extending through deck 20304 (i.e., staple overdrive).
[0116] The end effector 20340 may include a rotary drive screw and a launching member. As further described herein, the launching member moves through the staple cartridge 20300 during the launch stroke to advance the thread 20350 having rail 20352 and lift the driver 20320. The driver 20320 includes an inner support 20322a, an intermediate support 20322b, and an outer support 20322c. The support 20322 includes different widths, as further described herein. In various embodiments of this disclosure, one or more of the support 20322 may also include different heights from the other support 20322, as further described herein.
[0117] The lower portion of the driver 20320 includes a chamfered inner edge 20336 that in many embodiments is similar to the chamfered edge 20236 (Figure 29). The lower portion of the driver 20320 also includes a bridge 20326 between adjacent staple posts 20322. The first bridge 20326a connects the inner post 20322a to the intermediate post 20322b, and the second bridge 20326b connects the intermediate post 20322b to the outer post 20322c. The shape of the first bridge 20326a is different from the shape of the second bridge 20326b. In other words, the bridge 20326a is asymmetrical with respect to the vertical plane P (Figure 31) passing through the driver 20320 and is aligned with the axis of the intermediate staple base / crown supported thereon.
[0118] The first bridge 20326a is higher than the second bridge 20326b. In various cases, as further described herein, the central longitudinal portion of the staple cartridge 20300 may be higher than the height along the sides of the staple cartridge 20300, defining a greater height at the peak of the laterally curved tissue support surface. As a result, the staple cartridge 20300 can accommodate the increased height / volume of additional material and / or driver 20320 between the inner struts 20322a and the intermediate struts 20322b than between the outer struts 20322c and the intermediate struts 20322b. The increased height of the first bridge 20326a from the base surface compared to the second bridge 20326b can compensate, for example, for stiffness loss resulting from the chamfered inner edge portion 20336. Additionally or alternatively, the height of the first bridge 20326a compared to the second bridge 20326b can minimize the dimensions of the staple cartridge 20300 and the end effector 20340, improving the rigidity and strength of the triple driver 20320 while maintaining a compact form factor.
[0119] In certain cases, the upper portion of the first bridge 20326a may be configured to guide the driver 20320 through the staple cavity during the initial part of the firing motion through the staple cavity. For example, when the inner strut 20322a is in the non-firing position, the inner strut 20322a may not be supported or guided by the lateral guide surface at least partially, because there is a notch in the central part of the cartridge body assembly 20300 to accommodate the rotary drive screw. If there is no particular lateral support surface around the inner strut 20322a, the driver 20320 may be prone to torque and / or misfire. However, the increased height of the first bridge 20326a may be configured to engage with an upright support surface in the cartridge body during the initial part of the firing motion to improve the guidance and support of the driver 20320.
[0120] Referring here to Figure 32, an alternative driver configuration for driver 20420 is shown. Driver 20420 is a triple driver and in many embodiments is similar to triple driver 20120 (Figure 26). For example, triple driver 20420 includes three parallel staple support cradles 20424 configured to support staples, and triple driver 20420 is configured to launch staples from inner, middle, and outer rows. Driver 20420 can be incorporated into various staple cartridges disclosed herein. For example, driver 20420 can be used with staple cartridges adapted to receive rotary drive screws extending along the longitudinal axis, and with a variable height deck.
[0121] The driver 20420 includes an inner support 20422a, an intermediate support 20422b, and an outer support 20422c. The support columns 20422 include different widths, as further described herein. In various embodiments of this disclosure, one or more of the support columns 20422 may also include different heights from the other support columns, as further described herein.
[0122] The lower portion of the driver 20420 includes a chamfered inner edge 20436 that in many embodiments is similar to the chamfered edge 20236 (Figure 29). The lower portion of the driver 20420 also includes bridges between adjacent staple posts 20422. A first bridge 20426a connects the inner post 20422a to the intermediate post 20422b, and a second bridge 20426b connects the intermediate post 20422b to the outer post 20422c. Variations of the shape of the lower portion of the driver 20420 are shown by dashed lines in the schematic diagram of Figure 32. For example, to provide adequate space and clearance along the central longitudinal portion of the staple cartridge for a rotary drive screw 20442, which in many embodiments is similar to the firing screw 261 (Figures 4 and 5), the driver 20420 includes a chamfered inner edge 20436 and an upper gusset 20438 between the first bridge 20426a and the inner support 20422a. In such a case, the driver 20420 can provide space and clearance for the rotary drive screw 20442 while maintaining sufficient structural integrity and rigidity to properly transmit the firing load.
[0123] In various cases, the highest height of the variable height deck and staple cartridge may be adjacent to the rotary drive screw 20442. In such cases, a narrower tissue gap can be defined along the firing bar and the cutting edge. The portion of the variable height deck covering the inner strut 20422a and / or the first bridge 20426a can define a maximum height, and therefore, in certain embodiments, the raised first bridge 20426a and / or gusset 20438 can be fitted between the first bridge 20426a and the inner strut 20422a.
[0124] In certain examples, one or more gusset plates may extend between the upper edge of the first bridge 20426a and the inner support 20424. In certain examples, the gusset 20438 may comprise longitudinal gusset ribs along at least a portion of the length of the inner support 20422a and the first bridge 20426a. The driver 20420 is asymmetrical with respect to a vertical plane P (Figure 32) passing through the intermediate support 20422b and is aligned with the longitudinal axis of the staple base supported therein. For example, the first bridge 20426a may have a different shape and a different cross-sectional outline from the second bridge 20426b by the gusset 20438 and / or the chamfered inner edge 20436.
[0125] In certain examples, a portion of the cartridge body may be cut out to accommodate a rotary drive screw along the central part of the staple cartridge. The cartridge body may include additional guide and support mechanisms configured to guide the driver through the staple cavity toward the deck of the cartridge body. The guides may be configured to engage with and support the driver even if a portion of the driver is not fully seated within the staple cavity.
[0126] Referring to Figures 33 and 34, the cartridge body 20502 is shown. In various cases, the cartridge body 20502 may be similar in many embodiments to the cartridge body 20102 (Figure 24), and may be incorporated into the staple cartridge 20100 and use the driver 20120 (Figure 26). Staples may be located in cavities 20510a, 20510b, and 20510c defined within the cartridge body 20502. Staples are arranged in longitudinal rows on both sides of the longitudinal axis A along the centerline of the cartridge body 20502. For example, cavities 20510a, 20510b, and 20510c are arranged in cavity rows. The cavity rows include an inner row 20512a, an intermediate row 20512b, and an outer row 20512c on each side of the longitudinal axis. The rotary drive screw (e.g., the firing screw 261 in Figures 4 and 5) can be aligned with the longitudinal axis A and can extend through the cartridge body 20502 adjacent to the inner cavity row 20512a. The rotary drive screw can be, for example, located between the inner cavity row 20512a and parallel to them.
[0127] Referring primarily to Figure 34, the cartridge body 20502 includes a guide surface 20514 extending around the inner cavity 20510a within the inner row 20512a. In various cases, the guide surface 20514 is configured to guide and pass the driver (e.g., the inner pillar 20122a of a triple driver 20120) into the inner cavity 20510a, even if the inner pillar 20122a is not fully seated within the inner cavity 20510a before firing. In various cases, the guide surface 20514 is a circumferential chamfer on the lower cartridge surface extending around the inner cavity 20510a. Such a circumferential chamfer is configured to prevent accidental snagging and hang-up when the inner pillar of the driver is advanced into the inner cavity 20510a. In other examples, the guide surface 20514 may include, for example, a fillet. The guide surface 20514 can extend around the entire circumference of the inner cavity 20510a. In other examples, the guide surface 20514 may be positioned around a portion of the periphery, for example, around the first lateral side, the proximal end, and / or the distal end.
[0128] See also Figure 35, which shows a portion of the inner cavity 20510a and driver 20120. The lower edge of the inner cavity 20510a includes a guide surface 20514 extending around the inner cavity 20510a. The upper edge of the inner strut 20122a also includes a guide surface 20125, which is configured to guide the inner strut 20122a to align with the inner cavity 20510a even when the inner strut 20122a is not fully seated within the inner cavity 20510a before the initial lift of the driver 20120 by the firing stroke and thread. In such examples, the guide surfaces 20514 and 20125 on the lower edge of the inner cavity 20510a and the upper edge of the inner strut 20122a are configured to interact with each other to ensure that the inner strut 20122a moves smoothly into the inner cavity 20510a during the firing stroke. As further described herein, the inner strut 20122a does not need to be fully seated in the inner cavity 20510a before the firing stroke to allow for space required by the rotary drive screw along the central longitudinal portion of the cartridge body 20502.
[0129] Referring here to Figures 36 and 37, a portion of the driver 20620 is shown. In various embodiments of this disclosure, the driver 20620 may be a triple driver and in many embodiments may be similar to the driver 20120 (Figure 26). In various embodiments of this disclosure, the driver 20620 may be incorporated into a staple cartridge 20100 (Figure 24). The driver 20620 includes a support column 20622 configured to support staples 20680 (Figure 37). The support column 20622 includes a proximal end 20630, a distal end 20632, and a pair of opposing side walls 20634 extending longitudinally between the proximal end 20630 and the distal end 20632. The side walls 20634 are configured to slidably engage with lateral guide surfaces in their respective staple cavities. The support column 20622 also includes a staple support cradle 20624, the base of which a staple 20860 may be held within the staple support cradle 20624.
[0130] The driver 20630 further includes proximal and distal upright mechanisms 20636, 20638 or extensions that extend away from the base of the driver 20630 and away from the staple support cradle 20624. The proximal upright mechanism 20636 is the nearest mechanism of the strut 20622 and extends from the proximal end 20630 of the strut 20622. The distal upright mechanism 20638 is the most distal mechanism of the strut 20622 and extends from the distal end 20636 of the strut 20622. In the driver's non-firing position, the proximal and distal upright mechanisms 20636, 20638 are below the deck of the staple cartridge and may extend toward the deck. The proximal and distal upright mechanisms 20636, 20638 may be configured, for example, to support the staple 20680 during formation and to guide the staple legs.
[0131] The proximal and distal upright mechanisms 20636, 20638 are the highest parts of the strut 20622. In certain cases, when the driver is moved to the firing position, the proximal and distal upright mechanisms 20636, 20638 extend over the deck, facilitating the gripping and / or holding of tissue adjacent to the staple 20860. For example, the proximal and distal upright mechanisms 20636, 20638 can grip tissue at the proximal and distal ends of the staple cavity. Furthermore, the proximal and distal upright mechanisms 20636, 20638 can function as guide surfaces for the driver 20630, and in certain examples, can guide the strut 20632 into the fastener cavity. For example, if the strut 20622 is not fully seated within the staple cavity before launch, the proximal and distal uprighting mechanisms 20636, 20638 are configured to guide the strut 20622 to align with the staple cavity during the launch motion, as further described herein.
[0132] In certain cases, the proximal and distal uprighting mechanisms 20636, 20638 may be incorporated into the inner struts (i.e., struts adjacent to the firing path and / or rotary drive screws). In such cases, the proximal and distal uprighting mechanisms 20636, 20638 can engage with the staple cavity during the firing stroke and are configured to guide the inner struts even if the inner struts are not fully seated in the staple cavity before firing, as further described herein. In other examples, the intermediate struts and / or outer struts may also include at least one of the proximal uprighting mechanism 20636 and / or the distal uprighting mechanism 20638.
[0133] In particular aspects of this disclosure, the proximal and distal upright mechanisms 20636, 20638 are configured to be received in recesses along the underside of the tissue support deck when the driver 20620 is in the fully advanced position. As further described herein, the underside of the tissue support deck may include an array of recesses that fit into pocket expansions on the anvil-facing side of the deck. The pocket expansions can surround, or at least partially surround, an opening in the tissue support deck, gripping tissue and / or guiding the staple legs during the firing stroke. Nesting the mechanism on the driver with the underside recesses in the tissue support deck is further described herein. By nesting the proximal and distal upright mechanisms within pocket expansions or ridges of the cartridge deck, desired tissue gaps and deck thickness can be maintained in a variety of cases.
[0134] In certain examples, a replaceable staple cartridge may be used in each firing stroke and then replaced with another replaceable staple cartridge for subsequent firing strokes. A replaceable staple cartridge may include a cartridge body, a driver, staples, and threads, as further described herein. A reusable multi-fire cutting edge may be incorporated into an end effector and, in certain examples, can be advanced relative to the replaceable staple cartridge. For example, the end effector may include a firing member such as an I-beam or E-beam having a distally oriented upright cutting edge along its leading edge. Exemplary firing members having a reusable cutting edge for use during multiple firing strokes are further described herein. In certain examples, the reusable knife and its cutting edge may be hardened parts that can be expensive to manufacture. In certain examples, placing a reusable knife within a surgical device may limit the number of times the surgical device can be reused. Furthermore, to resist blunting of the knife due to multiple firings, the reusable knife may, in certain cases, be less sharp than a single-use knife.
[0135] In other examples, the launching member, end effector, and / or surgical device may not include a multi-shot tissue resection knife. For example, instead of being incorporated into the surgical device itself, the knife may be incorporated, for example, into a replaceable staple cartridge. In such examples, an unused cutting edge can be used with each firing stroke.
[0136] Various interchangeable staple cartridge assemblies having a tissue resection knife are described herein. In one case, the launching member may include an integrated threaded component, and the knife may be releasably attached to or mounted on the launching member when inserting the staple cartridge into a surgical device having the launching member or into its end effector.
[0137] Referring here to Figure 99, an end effector 20840 is shown having a firing member 20841 with an integrated thread 20860 and a mounting mechanism (e.g., recess 20846) for connecting to a single-use knife 20830. In many embodiments, the end effector 20840 is similar to the end effector 200 (see Figures 4 and 5) and is configured to cut and staple patient tissue. For example, the end effector 20840 includes a cartridge jaw 20850 having opposing side walls 20852, and the end effector 20840 also includes an anvil jaw 20854. The cartridge jaw 20850 is configured to receive a staple cartridge, such as a replaceable staple cartridge 20800 shown in Figure 103. The end effector 20840 also includes a firing drive system 20839, which includes a rotary drive screw 20842 (Figure 105) and a firing member 20841, similar to the firing screw 261 (Figures 4 and 5) and the firing member 270 (Figures 4 and 5), respectively. The firing member 20841 is driven through the end effector 20840 as the rotary drive screw 20842 rotates during the firing stroke for firing staples from the staple cartridge 20800. The rotary drive screw 20842 extends along the longitudinal axis A through the fastener cartridge 20800.
[0138] Referring mainly to Figure 100A, the firing member 20841 includes an upright body portion 20843, upper cam members 20844 extending laterally from both sides of the upright body portion 20843, and lower cam members 20845 extending laterally from both sides of the upright body portion 20843. When the end effector 20840 is in a clamp configuration (Figure 105), the upper cam member 20844 is configured to cam-engage with the anvil jaw 20854 of the end effector 20840 during the firing stroke, and the lower cam member 20845 is configured to cam-engage with the cartridge jaw 20850 of the end effector 20840 during the firing stroke. The upper and lower cam members 20844 and 20845 are configured to clamp the jaws of the end effector 20840 and define the tissue gap during the firing stroke, as will be further described herein with respect to various firing members (e.g., I-beams and E-beams). A threaded opening 20847 passing through the upright body portion 20843 is configured to receive a rotary drive screw 20842 through it. In other examples, a threaded nut may be screw-connected to the rotary drive screw 20842 and mounted on the firing member 20841. Various threaded nuts and alternative firing members are further described herein.
[0139] Still referring to Figure 100A, the launching member 20841 further includes an integrated thread 20860. The thread 20860 has two rails 20866. One of the rails 20866 is configured to engage with a row of staple drivers on each side of the surgical end effector 20800. In other words, the thread 20860 includes a single rail 20866 for each side of the surgical end effector 20800, i.e., for each side of the staple cartridge 20800 (Figure 103). A single rail on each side can save lateral space within the surgical end effector 20840, which can provide additional space for accommodating a rotary drive screw 20842 along the central portion of the surgical end effector 20840. In such a case, the thread 20860 may be a reusable component provided together with the launching member 20841 and the surgical device, for example.
[0140] Referring primarily to Figure 103, the launching member 20841 is driven through a staple cartridge 20800, which includes a cartridge body 20802 and drivers 20820 and 20821 movably positioned therein. Driver 20820 is a triple driver, and driver 20821 is a double driver. In various cases, the nearest driver in the staple cartridge 20800 is the double driver 20821, and in other cases, one or more of the nearest drivers may be single drivers. The double driver 20821 includes a lateral flange with an inclined surface for drive engagement by a thread rail 20866, which is similarly aligned with an inclined recess 20818 (Figure 102) on the triple driver 20820. In other words, both the double driver 20821 and the triple driver 20820 are driven by a single thread rail 20866 on each side of the fastener cartridge 20800.
[0141] The parallel longitudinal slot 20803 (Figure 103) passing through the cartridge body 20802 is sized to accommodate the rail 20866 during the firing stroke. In other words, as the upright body portion 20843 of the firing member 20841 moves through the central longitudinal slot 20808 in the cartridge body 20802, the rail 20866 moves along the parallel slot 20803 along the underside of the cartridge body 20802. The parallel longitudinal slot 20803 is also parallel to the longitudinal slot 20808 from which the upright body portion 20843 of the firing member 20841 protrudes.
[0142] In other examples, the integrated thread of the launching member 20841 may have two or more rails on each side. For example, integrated threads having four rails and six rails can also be conceivable.
[0143] The launching member 20841 is adapted to be releasably connected to the knife 20830. The knife 20830 includes an opposing spring arm 20832 that extends proximal to the upright body portion 20843 of the launching member 20841 and elastically engages with the upright body portion 20843. The spring arm 20832 snaps around the upright body portion 20843 and extends into a cavity 20846 defined within the upright body portion 20843. The knife 20830 also includes a longitudinal body 20834, which is configured to sit and / or nest on a complementary surface on the launching member 20841, for example, above a threaded opening 20847 for a rotary drive screw 20842. The knife 20830 further includes an upright cutting edge 20836 configured to extend above the tissue support deck 20804 (Figure 105) for excising tissue during the firing stroke.
[0144] In various cases, the fastener cartridge 20800 and cartridge jaw 20850 may include alignment and / or levering mechanisms to facilitate the installation of the fastener cartridge 20800 into the cartridge jaw 20850. Various alignment and levering mechanisms are further described herein. These features can also be used to align the knife 20830 with the launching member 20841, and more specifically, to align the spring arm 20832 with the cavity 20846, ensuring that the knife 20830 is connected to the launching member 20841 when the staple cartridge 20800 is inserted into the cartridge jaw 20850.
[0145] In an unfired staple cartridge 20800, the knife 20830 is aligned with an indicator thread 20828, which is configured to be pushed distally by the knife 20830 during the firing stroke. As further described herein, the indicator thread 20828 provides a visual indication to the clinician and / or user when the firing stroke is complete by moving into a window 20806 (Figure 114) in the nose of the cartridge body 20802, as further described herein. Furthermore, the indicator thread 20808 is configured to selectively overcome lost and / or used cartridge lockouts in certain cases, as further described herein.
[0146] The indicator thread 20828 and knife 20830 are components of the staple cartridge 20800. When the staple cartridge 20800 is placed in the surgical end effector 20840, the knife 20830 is aligned with the firing member 20841 so that the spring arm 20832 elastically engages with the opening 20846. The insertion angle of the staple cartridge 20800 is configured to ensure proper alignment between the spring arm 20832 and the opening 20846. In such an example, an unused knife may be provided for each firing stroke along with each staple cartridge 20800.
[0147] Referring primarily to Figures 100B and 101, the integrated thread 20862 is configured to drive-engage with the triple driver 20820 during the firing stroke. The firing member 20841 and thread 20862 move along the longitudinal path within the staple cartridge 20800 during the firing stroke, lifting the driver 20820 along the transverse axis.
[0148] The triple driver 20820 is lifted by a single thread rail 20862 on each side of the staple cartridge 20800. Each triple driver 20820 includes an inclined recess 20818 (Figure 102) positioned and dimensioned to receive the thread rail 20862. In other words, the thread 20860 has a single rail 20862 on each side of the central portion, and the single rail 20872 is configured to lift and drive the triple driver 20820. In practice, the single rail 20862 is configured to fire all staples on one side of the staple cartridge 20800 and fire staples through the triple driver 20820 across three rows (e.g., inner row, middle row, outer row). Referring mainly to Figure 102, the triple driver 20820 includes an inclined recess 20818 (Figure 102) dimensioned to receive the thread rail 20862. The inclined recess 20818 extends along the central portion of the triple driver 20820 (e.g., beneath the intermediate / central support), as will be further described herein.
[0149] The triple driver 20820 may be similar to the triple driver 20120 (Figure 26) in many embodiments. For example, the triple driver 20820 supports three staples 20890 (Figures 100B and 101) and is configured to lift the three staples 20890 simultaneously. The triple driver 20820 also includes three struts, namely an inner strut 20822a configured to support the inner staples 20890 in the inner row of staples, an intermediate strut 20822b laterally outside the inner strut 20822a configured to support the intermediate staples 20890 in the middle row of staples, and an outer strut 20822b laterally outside the intermediate strut 20822b configured to support the outer staples 20890 in the outer row of staples.
[0150] The triple driver 20820 also includes bridges 20826 extending between adjacent struts 20822. For example, the first bridge 20826a extends between the inner strut 20822a and the intermediate strut 20822b, and the second bridge 20826b extends between the intermediate strut 20822b and the outer strut 20822c. The inclined recess 20818 is aligned with the drive rail 20866 and is located between the first bridge 20826a and the second bridge 20826b, proximal to the intermediate strut 20822b.
[0151] More specifically, the inclined recess 20818 is longitudinally aligned with the intermediate support 20822b. As a result, the intermediate support 20822b of the driver 28020 is located in a parallel longitudinal slot 20803 through the cartridge body 20802 and is not supported by the cartridge body 20802, or at least not supported along its lower portion, when in the unfired position within the cartridge body 20802. In such cases, the staples 20890 in the intermediate row of staples on each side of the cartridge body are supported by the intermediate support 20822b and are largely guided by the tissue support deck 20804 of the cartridge body 20802. In certain cases, pocket extensions and / or protrusions along the tissue support deck 20804 can further guide the staples 20890 during the firing stroke.
[0152] The triple driver 20820 may be symmetrical with respect to the longitudinal axis along the inclined recess 20818. In various cases, the triple driver 20820 may include wings 20824 extending laterally outward on both sides of the intermediate support 20822b. In certain examples, the wings 20824 are configured to prevent driver roll and reinforce the intermediate support 20822b. For example, the wings 20824 can help balance the intermediate support 20822b during the firing stroke when the intermediate support 20822b is not supported, or is not largely supported, by the cartridge body 20802.
[0153] Referring primarily to Figure 103, the wing 20824 extends into a complementary groove 20805 within the cartridge body 20802. During the firing stroke, the wing 20824 moves upward within the groove 20805 toward the tissue support deck 20804. Referring primarily to Figure 104, the groove 20805 is located on either side of the intermediate staple cavity and extends from the underside of the cartridge body 20802 toward the tissue support deck 20804. In certain cases, the tissue support deck 20804 can capture, prevent, and / or stop the further upward movement of the wing 20824, thereby retaining the driver 20820 within the cartridge body 20800 at the completion of the firing stroke.
[0154] Referring further to Figure 103, the distal portion of the intermediate support 20822b is further configured to nest within a portion of the adjacent triple driver 20820. More specifically, the triple driver 20820 includes a proximal groove 20817 (Figure 102), which is sized to receive the distal tip of an adjacent (e.g., immediately behind / proximal) triple driver 20820. The nested configuration of the end-to-end triple drivers 20820 has a nesting mechanism between them, which further facilitates the alignment and cooperative support of the triple drivers 20820 within the cartridge body 20802.
[0155] In short, the staple cartridge 20800 may include a triple driver 20820 configured to be lifted by a single thread rail 20866 that pushes the central portion of the triple driver 20820 and the inclined recess 20818 during the firing stroke. The triple driver 20820 may further include wings 20824 on both sides, which prevent the triple driver 20820 from rolling during the firing stroke. The wings 20824 can move within corresponding slots in the cartridge body 20802. In certain cases, the thread 20860 may be formed integrally with the firing member 20841 (e.g., I-beam or E-beam). In such cases, the thread 20860 may be a reusable component together with the firing member 20842, however, unused knives 20830 may be provided with each staple cartridge 20800. In other cases, the thread may be a separate component within the staple cartridge, and in certain cases, the firing member 20841 may include an integrated cutting edge.
[0156] In various cases, as described herein, a launcher having a triple driver and an integrated two-rail thread can allow the triple driver to be narrower, and therefore more space within the cartridge body for the rotary drive screw. For example, the rotary drive screw may be positioned higher within the end effector, closer to the upper cam of the launcher, rather than along the bottom of the end effector. A narrower driver can provide, for example, a narrower staple line, which can also improve hemostasis in certain cases. In addition, the inner row of staples can be moved laterally outward to accommodate the rotary drive screw, thereby reducing the possibility and / or incidence of staple tearing. Furthermore, the cartridge body can provide a robust design without narrower struts, towers, and / or thin sidewalls between the staple cavity and / or longitudinal slots for the launcher. The thread rail can also be wider in certain cases, and therefore less prone to bending under substantial firing loads. In certain cases, staple overdrive can be minimized when bending and deflection of the thread rail are limited.
[0157] Referring primarily to Figure 106, the staple cartridge 20800 includes a robust support wall to withstand the clamping load, and the tissue support deck 20804 defines a thickness t1 along the inner edge of the intermediate staple cavity and a thickness t2 along the outer edge of the intermediate staple cavity. Conversely, referring here to a staple cartridge 20900 having a cartridge body 20802 and a tissue support deck 20904, the support wall of the cartridge body 20902 can be narrower than the wall inside the cartridge body 20902. Furthermore, the tissue support deck 20904 has a thickness t3 that is smaller than the thicknesses t1 and t2 of the tissue support deck 20804. The cartridge body 20902 is adapted to receive, for example, four rail threads.
[0158] Performing a firing stroke when a staple cartridge is missing from the surgical end effector can result in the knife cutting the clamped tissue without any means of sealing the excision site. For example, without staples, a stapling device cannot staple and seal the cut tissue. Similarly, if an empty or used staple cartridge is loaded into the end effector, i.e., a staple cartridge without staples or without a complete set of staples, the tissue will also not be completely sealed along the excision site. A lost cartridge lockout can prevent a firing stroke when a staple cartridge is missing from the end effector, and a used cartridge lockout can prevent a firing stroke when a used staple cartridge is loaded into the end effector. In certain cases, a lockout can prevent a firing stroke when a staple cartridge is lost and used. If a rotary firing screw extends through the end effector, the lockout may be configured to limit and / or prevent the rotation of the rotary firing screw and thus prevent a firing stroke.
[0159] In one embodiment, the lock nut can be positioned on a rotary drive screw, and the lockout key can be incorporated into a movable mechanism within the staple cartridge. In the lock configuration, the lock nut rotates to disengage from the firing alignment and enters a lockout notch in the end effector. When an unfired staple cartridge is placed in the end effector, the lockout key engages with the lock nut, rotating it to the firing alignment and exiting the lockout notch. The lock nut moves distally along the rotary drive screw during the firing stroke, and the lockout key is also pushed distally during the firing stroke. The lockout key can remain in the distal position when the firing stroke and / or retraction of the firing member is complete, however the lock nut can return to its proximal position in the end effector. Since the staple cartridge has been fired (e.g., used), the lock nut rotates again to disengage from the firing alignment and enter the lockout notch, preventing subsequent firing strokes until a replacement unfired staple cartridge is placed in the end effector. In other cases, the lock on the rotary drive screw does not have to be screw-receptively engaged with the rotary drive screw, and a spring can be used to bias the lock into the lockout notch so as to selectively prevent the firing stroke.
[0160] Such lockout configurations can be configured to prevent firing strokes when a staple cartridge is missing and / or when a staple cartridge in the end effector has been used / fired. Furthermore, these configurations can occupy minimal space within the end effector. Moreover, the components can be simple and robust. In the example of a lock nut screwably connected to a rotary drive screw, only a single additional component in the end effector is required for the lockout configuration. In various cases, the lockout key can provide the clinician with a visual indication that a staple cartridge has already been fired.
[0161] Next, referring to Figures 108-115, the lockout configuration 21868 and its various components are shown. The lockout configuration 21868 is incorporated into the surgical end effector 21840, which in many embodiments is similar to the surgical end effector 20840 (see Figure 99). Furthermore, the end effector 21840 is adapted to receive a staple cartridge 20800 (see Figure 103). The end effector 21840 includes a cartridge jaw 21850 similar to the cartridge jaw 20850 (see Figure 99), however, the cartridge jaw 21850 further includes a lockout notch 21854 defined on the bottom side 21856.
[0162] More specifically, the cartridge jaw 21850 includes a bottom section 21856 and a side wall 21852 that form a channel sized and constructed to receive a staple cartridge 20800 internally. The lockout notch 21854 includes a lateral recess or opening in the proximal portion of the bottom section 21856. The lockout notch 21854 aligns with the lockout nut 21874, which is screw-connected to the rotary drive screw 20842, when the rotary drive screw 20842 and the lockout nut 21874 above it are in the non-firing or proximal position.
[0163] The lock nut 21870 includes a central threaded hole that penetrates the main body, an opposing flange 21874, and a lug 21872. The flange 21874 and lug 21872 extend radially outward from the main body. In the unlocked position (Figures 109B and 111), the flange 21874 extends laterally outward to the inner surface of the bottom 21856 of the cartridge channel 21850, positioned along and / or adjacent to the inner surface. Furthermore, in the unlocked position, the lug 21872 aligns with the upright main body portion 20843 of the launching member 20841. In the locked position (see Figures 108, 109A, and 115), the flange 21874 is rotated out of alignment with the inner surface of the bottom 21856 such that one of the flanges 21874 rotates into the lockout notch 21854. Furthermore, in the locked position, the lug 21872 rotates away from the firing position alignment with the upright main body portion 20843 of the firing member 20841.
[0164] The lock nut 21870 is screw-connected to the rotary drive screw 20842. The rotation of the rotary drive screw 20842 can rotate the lock nut 21870 together with it, unless the rotation of the lock nut 21870 is prevented or blocked. Initially, when the end effector 21840 does not have a staple cartridge inside (Figures 108 and 109A), the rotation of the rotary drive screw 20842 is configured to rotate the lock nut 21870 such that one of the flanges 21874 rotates into a lockout notch 21854 aligned with it. When an unused staple cartridge 20800 is installed in the surgical end effector 21840, the lockout nut 21854 is rotated to the unlocked position. The unlocked position of the lockout nut 21854 is shown in Figure 109B, however the staple cartridge is hidden for illustrative purposes.
[0165] Referring primarily to Figures 111 and 112, the lockout key 20828 includes a foot 20827 extending into the space within the cartridge body 20802 above the rotary drive screw 20842. When the unfired stapled cartridge 20800 is placed in the end effector 21840, the foot 20827 of the lockout key 20828 rotates the lockout nut 21870 to the unlocked position. More specifically, the foot 20827 includes an inclined surface configured to engage with and abut against the lug 21872, thereby biasing and rotating the lug 21872 to align with the upright body portion 20843. Referring primarily to Figure 112, the cartridge body 20802 includes a stopper 20809 extending toward the longitudinal slot 20808 within the cartridge body 20802. The retaining element 20809 is configured to hold the lockout key 20828 in place when the staple cartridge 20800 is inserted into the end effector 21840.
[0166] The lockout key 20828 also defines a contour outline 20829 corresponding to a contour outline track 20807 within the cartridge body 20802. The contour outline track 20807 is configured to resist rotation of the lockout key 20828 when it is pushed distally. In various cases, the foot 20827 forms a corner into which the lug 21872 is received. The foot 20827 rotates the lug 20872 to the unlocked position. Then, during the firing stroke, the lug 21872 can remain engaged with the corner within the lockout key 20828, allowing the lockout key 20828 to be pushed distally through the contour outline track 20807. The firing force may be sufficient to overcome the retaining arm 20809 that holds the foot 20827 in the proximal position of the cartridge body 20802.
[0167] Additionally or alternatively, the knife 20830 can push the lockout key 20828 distally through the cartridge body 20802. The knife 20830 also has a contoured outline, which is configured to move along the contoured outline track 20807 without rotating during the firing stroke and deviating from the firing alignment.
[0168] Referring here to Figures 113 and 114, upon completion of the firing stroke, the lockout key 20828 may be pushed to a distal position within the cartridge body 20802. In the distal position, the lockout key 20828 is visible through the window 20806 of the cartridge body 20802. For example, the distal nose of the cartridge body 20802 may include the window 20806, and the lockout key 20828 may be positioned near the window 20806 so that the lockout key 20828 is visible. The foot 20827 of the lockout key 20828 prevents the lockout key 20828 from falling out of the cartridge body 20802 through the window 20808.
[0169] The reverse rotational motion of the rotary drive screw 20842 is configured to retract the launching member 20841. As further described herein, the knife 20830 may, in various cases, retract together with the launching member 20841. However, the lockout key 21828 can be released from the knife 20830 and remain in a distal position within the cartridge body 20802. Referring mainly to Figure 115, when the launching member 20841 retracts back to its proximal position within the cartridge body 20802, the lockout nut 21870 also retracts proximal along the rotary drive screw 20842. Due to the direction of rotation of the rotary drive screw 20842 during the retraction motion, the lockout nut 21870 does not rotate within the lockout notch 21854. In other words, the lockout nut 21870 remains in the unlocked position and can move proximal beyond the lockout notch 21854 during the retraction motion. However, if another firing motion is initiated and the rotation direction of the rotary drive screw 20842 is reversed, moving distally within the end effector 21840, the lockout nut 21870 may disengage from its alignment with the firing member 20841 and rotate again, and the flange 21874 of the lockout nut 21870 may rotate into the lockout notch 21854.
[0170] In the locked position, the lockout nut 21870 cannot rotate relative to the rotary drive screw 20842 and cannot translate longitudinally through the end effector 21840. As a result, the rotational motion of the rotary drive screw 20842 is resisted, and the firing stroke is prevented until the lockout nut 21870 takes the unlocked position.
[0171] The lockout configuration 21868 described herein with respect to Figures 108 to 115 includes a threaded lockout nut 21870 connected to a rotary drive screw 20842. The displacement of the threaded lockout nut 21870 is a function of rotation of the rotary drive screw 20840. In other examples, the lockout configuration may include an unthreaded lock positioned around the rotary drive screw 20842. Referring here to Figures 116 and 117, the lockout mechanism 22868 and its various components are shown. The lockout configuration 22868 is incorporated into a surgical end effector 22840, which in many embodiments is similar to the surgical end effector 20840 (see Figure 99). The end effector 22840 is adapted to receive a staple cartridge 20800 (see Figure 103). The end effector 22840 includes a cartridge jaw 22850 similar to that of the cartridge jaw 20850 (see Figure 99), however, the cartridge jaw 22850 further includes a lockout notch 22854 defined on the bottom side 21856. Furthermore, the end effector 22840 includes a launching member 22841 similar to that of the launching member 20841 in many embodiments. However, the integrated thread 20860 of the launching member 22841 includes a thread rail 22868 having a hole 22868 therein, as will be further described herein.
[0172] The lockout configuration 22868 includes a lock 22870 which is similar in many embodiments to the lockout nut 21870, however, the lock 22870 is not screwably connected to the rotary drive screw 20842. The lock 22870 includes a body portion, an opposing flange 22874, and a central non-threaded hole through the lug 22872. The flange 22874 and the lug 22872 extend radially outward from the body portion.
[0173] In the unlocked position, flange 22874 extends laterally outward to the inner surface of the bottom side 22856 of the cartridge channel 22850, and is positioned to rest along and / or adjacent to the inner surface. Flange 22874 is received by hole 22868 in thread 22860. For example, hole 22868 is a through hole in thread rail 20866 that is sized and positioned to receive the opposing flange 22874 when the lock 22870 is in the unlocked position. As a result, the launching member 22841 and its thread rail 22868 are configured to pull the lock 22870 along the rotary drive screw 20842 during the firing stroke. Furthermore, in the unlocked position, lug 22872 is aligned with the upright body portion of the launching member 22841.
[0174] In the locked position (Figures 116 and 117), the flange 22874 is rotated away from alignment with the inner surface of the bottom 22856 so that one of the flanges 22874 rotates into the lockout notch 22854. Furthermore, in the locked position, the lug 22872 is rotated away from firing alignment with the upright body portion of the launching member 22841.
[0175] The lockout configuration 22868 also includes a spring 22870 configured to bias the lock 22870 into the lockout notch 22854. The lockout configuration 22868 can function similarly to the lockout configuration 21868, however, the spring 22870 can bias the lock 22870 into the lockout notch 22854 so that the lockout configuration 22868 is always locked unless an unfired staple cartridge 20800 is loaded into the end effector 22840 and its lockout key 21828 temporarily overcomes the lockout configuration 22868 until the completion of the firing stroke. As described above with respect to the lockout mechanism 21868, the lockout key 21828 is configured to move through a window 20806 in the cartridge body 20802 upon completion of the firing stroke to communicate the completion of the firing stroke and that the staple cartridge has been fired / used.
[0176] The height of the formed staple is a function of the space between the staple support surface and the staple forming surface. More specifically, the vertical space between (A) the staple support cradle on the driver in the firing position and (B) the staple forming pocket surface in the anvil in the clamping position controls the height of the formed staple. For example, different formed staple heights are selected for different surgical procedures and / or different tissue types. If the staple cartridge includes a rotary firing screw through it, the arrangement of the staples and the corresponding staple cavity and driver may be modified to accommodate the rotary firing screw. For example, the driver may include at least one asymmetry, as further described herein. In addition, or alternatively, the driver may be narrower and therefore require additional support and / or strength. Furthermore, in various cases, it is desirable to optimize the tissue gap while maintaining a desired formed staple height. For example, the tissue gap between the tissue support deck surface and the anvil may be maximized when the end effector is in a closed configuration, while maintaining a desired formed staple height.
[0177] In various examples, the underside of the tissue support deck may include a ruffled and / or rutted surface configured to receive one or more portions of the driver when the driver is fully launched and / or overdriven. Interlocks and / or nests between the underside of the tissue support deck and the tissue-facing sides of the driver can maximize the tissue gap while still maintaining the desired formed staple height. Furthermore, the interlock mechanism can improve the strength of the driver in various cases.
[0178] In one example, a staple cartridge may include a body containing a tissue support deck, the staple cavity defined through the tissue support deck within the body, and the tissue support deck including tissue-facing sides with uneven or raised surfaces. The tissue support deck further includes a lower surface opposite the tissue-facing sides, the lower surface including a grooved surface. Staples are detachably disposed within the staple cavity. A driver may be configured to movably support the staples and move through a portion of the staple cavity to a firing position to eject the staples from the staple cavity. Each driver may include a base housed within the staple cartridge, the base including a surface contour configured to engage with the grooved surface of the lower surface of the tissue support deck when moved to the firing position.
[0179] Referring here to Figures 38-40, a staple cartridge 22100 is shown. The staple cartridge 22100 is similar in many embodiments to the staple cartridge 20100 (Figure 24). For example, the staple cartridge 22100 includes a body 22102 extending along a longitudinal axis A. Staples are detachably arranged within the body 22102. Staples can be ejected from the body 22102 and fired into tissue, for example, during a firing stroke. Staples are arranged in longitudinal rows on both sides of the longitudinal axis A, and the longitudinal axis A is aligned with a rotary drive shaft 22242 (Figure 39) extending through it. The cartridge body 22102 also includes a deck 22104, which may be called, for example, a tissue support deck. The deck 22104 is a laterally curved tissue support deck that defines a curved tissue-facing surface from the first lateral side 22101 of the body 22102 to the second lateral side 22103 of the body 22102. The peak 22105 of the laterally curved tissue support deck 22104 is defined in the middle portion of the body 22102. The peak 22105 can be positioned, for example, between longitudinal rows of staples and cover the longitudinal axis A. In various cases, the rotary firing screw 22242 (Figure 39) extends through a portion of the staple cartridge 22100.
[0180] The cartridge body 22102 also includes an array of pocket extensions or raised portions 22114 extending from the tissue support deck 22104. The raised portions 22114 extend around the perimeter or opening formed within the tissue support deck 22104 for the staple cavity. The raised portions 22114 may be configured to grip and engage tissue positioned between the staple cartridge 22100 and the opposing anvil. In various cases, the raised portions 22114 can, for example, restrict and / or suppress tissue flow. Additionally or alternatively, the raised portions 22114 may be configured to guide the staple legs as they are directed to enter the tissue and engage with the respective formed pockets on the staple-forming surface of the anvil. The raised portions 22114 may extend, for example, around the proximal and distal ends of the staple cavity. The protruding or pocket extensions positioned proximal and distal can prevent the outwardly biased staple legs (for example, those of a V-shaped staple) from spreading outward and losing sight of the target position within the molded pocket aligned with them.
[0181] In certain embodiments, adjacent raised portions 22114 can be connected. For example, the raised portions 22114 can be interconnected to longitudinally offset staple cavities and / or laterally offset staple cavities.
[0182] In various cases, the array of laterally offset raised sections 22114 can define different heights. In various cases, the raised sections 22114 can define different laterally heights along the width of the cartridge body 22102. Different heights may correspond, for example, to the lateral curvature of the tissue support deck 22104 when the end effector is clamped, and / or different lengths for guiding the staples beyond the tissue support deck 22104, and / or different tissue gaps. With respect to the cartridge body 22102, the raised sections 22114 span three laterally spaced rows of staple cavities 22112a, 22112b, and 22112c, with the raised section 22114 aligned with the outer row 22112c being higher than the inner rows 22112a and 22112b, and therefore guiding the staple legs over a longer distance. However, the interstitial gaps are also larger across the outer row 22112c than across the inner row 22112a and 22112b, due to the lateral curvature of the tissue support deck 22104 and the non-stepped / contourless tissue clamp surface of the anvil.
[0183] The staples are located in cavities defined within the cartridge body 22102, similar to cavity 20110 (Figure 24). For example, the staples are located in longitudinal rows 22112 on either side of the longitudinal axis A. Cavity rows 22112 include inner rows 22112a, intermediate rows 22112b, and outer rows 22112c on each side of the longitudinal axis A. Intermediate rows 22112b may be equidistant from inner rows 22112a and outer rows 22112c. The rotary drive screws 22242 can be aligned with the longitudinal axis A and may extend through the cartridge body 22102 adjacent to the inner cavity rows 22112a. The rotary drive screws 22242 may be, for example, located between the inner cavity rows 22112a and parallel to the inner cavity rows 212a.
[0184] The inner row 22112a holds the inner staples, the middle row 22112b holds the middle staples, and the outer row 22112c holds the outer staples. In various cases, the inner staples, middle staples, and outer staples may be identical. In other examples, the inner staples, middle staples, and / or outer staples may differ, for example, with respect to staple type (e.g., wire or stamp), material, and / or size (e.g., different heights).
[0185] In other examples, the staple cartridge 22100 may have different arrangements of staples. For example, the staple cartridge 22100 may have fewer than three rows of staples on each side of the longitudinal axis A. In one embodiment of this disclosure, the staple cartridge 22100 may have only two rows of staples on each side of the longitudinal axis A. In yet another case, the staple cartridge 22100 may include four or more rows of staples on one or more sides of the longitudinal axis A. In various examples, the rows of staples may be asymmetrical with respect to the longitudinal axis A. For example, the first side of the staple cartridge 22100 may have a different number of rows of staples than the second side of the staple cartridge 22100.
[0186] Each staple cavity within the cartridge body 22102 may include a proximal end, a distal end, and a lateral guide surface midway between the proximal and distal ends. The staple cavity is constructed and sized to guide the driver 22120 through the staple cavity toward the deck 22104. The driver 22120 is shown primarily with reference to Figure 41. Furthermore, Figures 41 and 42 show one driver 22120 within a staple cartridge 22100. Although these figures show one driver 22120, the reader will understand that additional drivers, such as driver 22120, may be incorporated into the staple cartridge 22100 to fire staples from additional staple cavities during the firing stroke.
[0187] The shape of the staple cavity can complement the shape of the driver 22120. For example, lateral guide surfaces within each staple cavity are configured to guide the sidewalls 22134 of the driver 22120 as it moves through the staple cavity. Additionally or alternatively, the proximal and / or distal ends of each staple cavity may include upright grooves configured to slidably receive the ends and / or tongues of the driver 22120. An alternative tongue-and-groove configuration can also be conceivable, which may be configured to guide the driver 22120 through the staple cavity during the firing of staples from the staple cartridge 22100.
[0188] The driver 22120 is configured to support multiple staples during the firing stroke and to be driven from the cartridge body 22102. The driver 22120 can movably support staples spanning two or more longitudinal rows 22112. For example, the driver 22120 can movably support inner staples, intermediate staples, and outer staples on the same side of the staple cartridge 22100.
[0189] The driver 22120 is a triple driver configured to drive three staples simultaneously. The driver 22120 includes three struts: an inner strut 22122a configured to support the inner staples in the inner row of staples; an intermediate strut 22122b located laterally outside the inner strut 22122a and configured to support the intermediate staples in the middle row of staples; and an outer strut 22122c located laterally outside the intermediate strut 22122b and configured to support the outer staples in the outer row of staples.
[0190] The driver 22120 also includes bridges 22126 extending between adjacent struts 22122. For example, a first bridge 22126a extends between an inner strut 22122a and an intermediate strut 22122b, and a second bridge 22126b extends between an intermediate strut 22122b and an outer strut 22122c. Each of the bridges 22126a and 22126b includes an inclined lower surface 22128 configured to be driven and engaged by a thread during the firing stroke. For example, a thread 22150 (Figure 39) may be configured to move along the firing path during the firing stroke. The thread 22150 may comprise a central portion aligned with the longitudinal axis A, a first rail configured to drive-engage with the inclined lower surface 22128 of the first bridge 22126a, and a second rail configured to drive-engage with the inclined lower surface 22128 of the second bridge 22126b. The thread and its firing motion will be further described herein.
[0191] Referring primarily to Figures 38 and 39, the tissue support deck 22104 includes a tissue-facing side 22115 having an array of raised portions 22114, the raised portions forming a textured tissue gripping surface. The tissue support surface 22104 also includes a lower surface 22116 opposite to the tissue-facing side 22115. The lower surface 22116 includes a grooved surface having an array of grooves 22118 therein. The grooves 22118 can define a pattern of recesses and / or depressions on the lower surface 22116. The tissue support deck 22104 defines a deck height between the textured tissue-facing side 22115 and the grooved lower surface 22116. The deck height varies, however, a certain minimum height around the opening in the deck 22104 provides a minimum amount of guide length for the staple during the firing stroke. For example, if the deck is too thin around the staple cavity, the staples may not be properly supported during deployment into the tissue and towards the molded pocket.
[0192] Driver 22120 is configured to mate or nest with the grooved lower surface 22116 as the driver 22120 moves to its firing position. Referring again primarily to FIG. 41, the bridges 22126a, 22126b of the driver 22120 include protrusions 22130. The protrusions 22130 are surface contours and protrusions on the upper tissue-facing surfaces of the bridges 22126a, 22126b on the opposite side of the inclined lower surfaces 22128 of the bridges 22126a, 22126b. The protrusions 22130 are configured to be received within the grooves 22118 on the lower surface 22116 of the tissue support deck 22104 when the driver 22120 is moved to their firing positions. In the firing position, referring primarily to FIG. 40, the driver 22120 is overdriven relative to the deck 22104 such that a portion of the driver 22120 extends outside of the cartridge body 22102 beyond the tissue-facing side portion 22115.
[0193] The upper surfaces of the bridges 22126a and 22126b are symmetric with respect to the longitudinal centerlines of their respective bridges 22126a, 22126b. The centerlines of each of the bridges 22126a, 22126b can be equidistant between the longitudinal axes defined by the staple support cradles 22124 of the adjacent struts 22122. The protrusions 22130 are symmetric with respect to the longitudinal centerlines of their respective bridges 22126a, 22126b.
[0194] In other examples, the driver, its bridge, and / or its upper surface can be laterally asymmetric, as further described herein. Referring to driver 22220 of FIG. 42, driver 22200 is similar to driver 22120 (FIG. 41) in many aspects; however, driver 22200 defines lateral asymmetry with respect to interconnect bridges 22226a, 22226b and their respective upper surfaces 22230 thereabove. Driver 22220 includes three struts 22222a, 22222b, 22222c, each having a staple support cradle 22224. Bridges 22226a, 22226b connect adjacent struts 22222a, 22222b, 22222c. Bridges 22226a, 22226b include inclined lower surfaces 22228 that are driven by threads during the firing stroke, as further described herein. The upper surfaces 22230 of bridges 22226a, 22226b include diagonal surfaces and are asymmetric with respect to a centerline passing through bridges 22226a, 22226b and are aligned with the firing path of the thread rail during the firing stroke. The centerline of each of bridges 22226a, 22226b is equidistant between axes aligned with adjacent staple support cradles 22224 and staple bases / crowns therein.
[0195] The upper surfaces 22230 of each of bridges 22226a, 22226b include laterally inclined upper surfaces that are configured to complement a portion of the profiled lower surface of the tissue support deck, such as the grooved lower surface 22116 (FIGS. 39 and 40). Such a bridge configuration can provide improved inter-row support that can allow the overall bridges 22226a, 22226b to be thinner while adequately supporting staples across multiple rows.
[0196] An anvil 22370 for a surgical end effector is shown in Figure 43. The anvil 22370 includes a tissue compression surface 22374 and a pair of staple-forming pockets 22372 formed within the tissue compression surface 22374. Each pair of staple-forming pockets 22372 includes a proximal pocket 22372a and a distal pocket 22372b. The pockets may be aligned with the legs of a staple, for example, the wire legs of a staple. During the firing stroke, the tips of the staple legs are received within the staple-forming pockets 22372 and may form, for example, a B-shaped staple. In certain embodiments of this disclosure, the length of the staple-forming pockets 22372 may be configured to match the wire diameter of a staple aligned with it. For example, the proximal pocket 22372a and distal pocket 22372b in the first pair of staple-forming pockets 22372 within the anvil 22370 may have a first pocket length, while the proximal pocket 22372a and distal pocket 22372b in the second pair of staple-forming pockets 22372 within the anvil 22370 may have different pocket lengths. The first pocket length may correspond to a different staple wire diameter than the second pocket length. In various embodiments, staples with a larger wire diameter may correspond to a shorter pocket length.
[0197] The space d between the proximal pocket 22372a and the distal pocket 22372b in a pair of staple forming pockets 22372 can, in certain examples, be minimized to maximize the longitudinal forming length of the staple. Generally, staples are over-bent during the forming process to compensate for staple rebound. However, this over-bent staple can be reduced when the forming pocket is shorter and, in some cases, steeper. Shorter and steeper staple pockets that define a larger space or gap d between the proximal pocket 22372a and the distal pocket 22372b in a pair of staple forming pockets 22372 can reduce rebound. Shorter and steeper staple pockets can reduce rebound, for example, by curving the staple legs more and making the staples more plastically deformable. Furthermore, shorter and steeper staple pockets can, in certain cases, improve the bending of continuous staple legs. Referring to space d in Figure 43, the proximal pocket 22372a and distal pocket 22372b in a pair of staple-formed pockets 22372 can be shortened, while the pair as a whole can maintain the same length L so that a larger space d is defined between the proximal pocket 22372a and the distal pocket 22372b.
[0198] For example, in an end effector, the staples and / or drivers may differ from row to row. In certain examples, staples may be shorter, contain different wire diameters, and be lifted by drivers having different heights and / or different overdrive amounts. In certain examples, shorter staple forming pockets may be used with one row of staples in the same anvil, as described above, but not with adjacent rows of staples. For example, shorter staples may utilize shortened pockets to improve the bending of continuous staple legs (e.g., two continuous bends on each staple leg) to form a B-shape. In yet another example, staples along an inner row of staples, i.e., adjacent to the longitudinal knife path, may utilize shortened pockets to bend the staples more plastically, reduce rebound and form a narrower row. In these examples, the distance d in Figure 43 may differ from row to row.
[0199] Staple cartridges such as staple cartridge 20100 (Figure 24) and staple cartridge 22100 (Figure 39) include components with minimum size constraints to ensure, for example, adequate strength, rigidity, support, and / or manufacturing requirements are met. These minimum size constraints may make it difficult to optimize and / or increase tissue gaps, taking into account other constraints on the surgical end effector. For example, the minimum height of the tissue support deck is in some cases 0.01 inches due to molding constraints. For another example, the minimum height of the bridge between struts on the driver is in some cases 0.022 inches due to driver strength constraints. For yet another example, the minimum height of the driver (e.g., its struts) is in some cases 0.066 inches due to driver roll constraints. As another example, the minimum height of the staple legs is 0.166 inches in certain cases, 0.160 inches in other cases, 0.150 inches in other cases, 0.102 inches in other cases, and 0.085 inches in other cases, depending on the type of staple cartridge and target tissue. As yet another example, the minimum thickness of the anvil is 0.134 inches, and in certain cases, 0.154 inches due to constraints on the stiffness and strength of the anvil. Given such minimum size constraints, it may be advantageous in certain cases to reduce the minimum size limits and / or to double-count certain size limits or parts thereof in the stack-up of components.
[0200] For example, to reduce certain minimum size limitations, a portion of the driver may, in certain cases, be nested in a recess on the underside of the tissue support deck. In various cases, to ensure that the tissue support deck maintains an appropriate height, the recess may be aligned with local areas along the height-increased tissue support deck, such as below the pocket expansion / tissue gripping ridge. In other examples, one or more additional recesses on the underside of the tissue support deck may be configured to receive a portion of the driver and / or its bridge. An exemplary staggered arrangement of interlocking mechanisms between the inner surface of the staple cartridge and the driver is shown, for example, in Figure 39. Other driver mechanisms may similarly be received in corresponding recesses on the underside of the tissue support deck.
[0201] To reduce the vertical stacking dimensions of multiple components, the tissue support deck of a staple cartridge, such as staple cartridge 20100 (Figure 24) and staple cartridge 22100 (Figure 39), may have a predetermined clearance hole through which it passes, which may be separate and distinct from the staple cavity. The predetermined hole along the length and / or width of the staple cartridge can accommodate the driver mechanism (e.g., the bridge portion) at the fully fired position of the driver, and in various examples, at the overdriven position. In addition, or alternatively, the tissue support deck may include a weak point or "break point" configured to be physically broken by the driver when the driver moves to the fully fired position.
[0202] In addition, staple cartridges such as staple cartridge 20100 (Figure 24) and staple cartridge 22100 (Figure 39) may further include selectively compressible and expandable mechanisms, for example, to reduce the vertical stack-up dimensions. The driver and / or cartridge body may include such features.
[0203] For example, a vertically expandable driver may be configured to reduce the stationary or unfired height of the driver within the staple cartridge. The driver may be nested and its height can be defined as approximately 50% of its final height when in the unfired position. In such a case, the staple may be in a lower position within the cartridge body before firing. In some cases, a first portion of the thread rail can actuate the driver by overcoming a significant snapping mechanism with the driver body and extending it to its final height. The second portion of the thread rail can then complete the firing of the driver, ejecting the staple supported on it from the cartridge body. The first portion of the thread rail may be narrower than the second portion of the thread rail.
[0204] In addition, or alternatively, the tissue support deck may be equipped with a variable-height injection-molded deck that, when a predetermined tissue load is applied, can be compressed to increase the inter-tissue gaps. When the thread fires the driver and staples, the thread and / or driver can locally push the deck back into the tissue, temporarily increasing its height to temporarily reduce the inter-tissue gaps. The tissue support deck can then relax after the thread has passed, or otherwise return to a compressed state corresponding to the increased inter-tissue gaps.
[0205] For example, the cartridge body or its tissue support deck may include selectively positioned wall segments, which may be thin and configured to buckle under a predetermined tissue load, while still maintaining proper alignment between the staples and the staple-forming pockets within the anvil. In some cases, electrically actuated materials (e.g., electroactive polymers) may be incorporated into the tissue support deck. Components or features formed from such materials may become soft and / or more easily compressible when an electric current is applied to them, and stiff and / or more easily incompressible when no electric current is applied. In certain examples, a portion of the driver may be deformable to be received within the tissue support deck when the material is energized, and thus accommodate additional structures within it.
[0206] In certain cases, 4D printed material can facilitate the selective folding of the tissue support deck of a staple cartridge, such as staple cartridge 20100 (Figure 24) and staple cartridge 22100 (Figure 39). For example, the cartridge body may include 4D printed material printed on its upper or upper half. 4D printed material may be thermosensitive. In certain cases, the material may have a glass transition point between room temperature and human body temperature. For example, when the cartridge is clamped onto tissue, the material becomes flexible and deflectable, and thus can increase the inter-tissue gap. In such cases, increased heat from the patient can increase the heat of the 4D printed material, leading to a change in shape. Once the cartridge body is cooled (e.g., removed from heat transfer contact with tissue), the 4D printed material can return to its original shape and / or height. In its original recovered state, the tissue support deck may be higher than, for example, in the heated and folded state. The increased height in the original and restored state ensures, for example, that the staples stored within the staple cartridge remain protected and do not protrude from the cartridge body before being fired.
[0207] Referring here to Figure 44, the deformation and recovery process 22400 for a 4D printed matrix on the cartridge body is shown. During the shape programming phase 22490, the 4D printed matrix 22402 is heated and deformed from its original configuration to a deformed configuration 22402', and then cooled. During the shape recovery phase 22492, the 4D printed matrix 22402' is heated and returned to its original configuration 22402, and then cooled. Shape programming and recovery of 4D printed materials are further described in the paper "4D Printing Reconfigurable, Deployable and Mechanically Tunable Metamaterials" by Chen Yang et al. in Materials Horizon, Vol. 6, 2019.
[0208] In certain examples, the 4D printed matrix can be used in combination with a foldable or collapsible driver, for example, as further described herein. The 4D printed matrix on the staple cartridge may be configured, for example, to selectively fold the interference driver mechanism to integrate and / or compress the footprint and stack-up within the staple cartridge at a specific temperature. The interference mechanism can then be unfolded when withdrawn from the interference state, such as when the cartridge body recovers to its original undeformed state. In various embodiments, the driver can be fully extended when actively lifting and firing the staples. In certain examples, the driver may encounter an interference surface near its fully fired position, and the upper portion of the driver may be configured to fold inward. The 4D matrix may, in some cases, form an interference surface.
[0209] Users may desire to quickly and easily install staple cartridges into the channels of end effectors or disposable loading units during surgical procedures. A robust connection may also be desired. Some robust connections may require the clinician to overcome significant resistance and / or friction between interfering components. In addition, or alternatively, robust connections may have minimal clearance and require precise alignment of components by the clinician. While a robust connection between the staple cartridge and the channel may be desired, it may be useful to make the installation of the staple cartridge quicker and easier, and / or require less force and / or effort on the clinician's side.
[0210] In certain examples, a staple fastening assembly may include a lever mechanism that facilitates the placement of a staple cartridge into a channel. For example, the channel and staple cartridge may include complementary geometric alignment mechanisms. When the alignment mechanism of the staple cartridge is positioned relative to the alignment mechanism of the channel, the alignment mechanism of the channel can provide a fulcrum or contact surface, and the staple cartridge is leveraged around this fulcrum or contact surface to properly align the staple cartridge with the channel. When the staple cartridge is properly aligned by the contact relationship between the alignment mechanisms, additional alignment mechanisms (e.g., distal lugs and notches) can facilitate further connection between the staple cartridge and the channel.
[0211] In certain cases, the spring biases the staple cartridge distally along a longitudinal axis perpendicular to the insertion axis, allowing the staple cartridge to seat completely and securely within the channel. Additionally or alternatively, the distal firing force during the firing stroke can further shift the staple cartridge distally, interconnecting the inclined surfaces on the alignment mechanism (e.g., the distal lug and the distal edge of the notch). To further secure the staple cartridge in the channel upon proper positioning of the staple cartridge within the channel, alternative spring-loaded and / or elastic mechanisms may be conceived. In certain cases, a user-operated release mechanism may be configured to release one or more elastic mounting mechanisms between the staple cartridge and the channel. In other examples, the firing stroke may result in the release and / or destruction of one or more elastic mounting mechanisms.
[0212] In one example, a staple fastening assembly may include a staple cartridge, which includes a cartridge body defining a longitudinal axis, the cartridge body comprising a proximal cartridge alignment mechanism and a distal cartridge alignment mechanism. The staple fastening assembly may further include a channel dimensioned to receive the staple cartridge, the channel including a side wall comprising a proximal channel alignment mechanism and a distal channel alignment mechanism positioned to receive the distal cartridge alignment mechanism when the staple cartridge is moved along the insertion axis to a first position in the channel, with the proximal cartridge alignment mechanism abutting and engaging with the proximal channel alignment mechanism. The insertion axis may be perpendicular to the longitudinal axis. A spring may be configured to bias the staple cartridge distally within the channel along the longitudinal axis from the first position to a fully seated position. The proximal alignment mechanism may include a contoured abutment surface. The distal alignment mechanism may include a notch and a lug having complementary wedge-shaped distal ends.
[0213] In various cases, improved cartridge retention and release mechanisms can increase the engagement retention force while allowing the user to release the staple cartridge from the channel with substantially less force. For example, the user can quickly and easily remove the staple cartridge from the channel by sliding it proximal by overcoming a minimal spring force. In certain cases, the force required to remove a used or fired staple cartridge may be less than the force required to remove a new, unfired staple cartridge. For example, a firing stroke, or even a partial firing stroke, may be configured to disengage and / or release a particular elastic mounting mechanism that connects the staple cartridge to the channel.
[0214] Referring here to Figure 45, a staple fastening assembly 24000 is shown. The staple fastening assembly 24000 includes a channel 24050 and a staple cartridge 24100 that is removably disposed within the channel 24050. The staple cartridge 24100 is a disposable, single-use component configured to be removed from the channel 24050 after a firing stroke and any surgical procedure using it. The channel 24050 may be reusable and may be configured to receive a replacement staple cartridge assembly therein. In other examples, the staple cartridge 24100 may be removed from the channel 24050, loaded with additional staples, and reinstalled in the channel 24050. In certain examples, the channel 24050 may be a component of a disposable loading unit and / or a modular staple fastening assembly, including an anvil and / or shaft portion.
[0215] The staple cartridge 24100 may be similar to the staple cartridge 20100 (FIG. 24) in certain aspects. For example, the staple cartridge 24100 includes a cartridge body 24102 having a tissue support deck 24104, staples 24160 removably disposed within the cartridge body 24102, and a driver 24120 movably supporting the staples 24160. The staples 24160 include a base from end to end, and the base of the staples 24106 is oriented obliquely with respect to the longitudinal axis A along the length of the staple cartridge 24100. The staples 24160 can be configured to form a flexible staple line that allows for some twisting and / or elongation while minimizing damage to the tissue. In certain cases, the cartridge body 24102 can include staples in a plurality of longitudinal rows longitudinally aligned in longitudinal rows parallel to the longitudinal axis A, as further described herein.
[0216] The cartridge body 24102 includes at least one alignment tab 24162 having a proximal alignment surface 24164. In various cases, the alignment tab 24162 can project laterally from each side of the cartridge body 24102. The proximal alignment surface 24164 defines the curved proximal edge of the alignment tab 24162. In various cases, the alignment tabs 24162 on both sides of the cartridge body 24102 can be symmetric with respect to the longitudinal axis A.
[0217] The cartridge body 24102 further includes an alignment lug 24166 having a proximal end 24168 and a distal end 24170. One alignment lug 24166 is positioned on each side of the cartridge body 24102. The proximal end 24168 defines an upright or perpendicular plane to the tissue support deck 24104. The distal end 24170 of the alignment lug 24166 defines a wedge shape with an inclined distal surface. The inclined distal surface can form a narrower dimension along the deck 24104 and a wider dimension at the opposite end of the alignment lug 24166. In various cases, the alignment lug 24166 may be positioned on each side of the cartridge body 24102, and the alignment lug 24166 may be symmetrical with respect to the longitudinal axis A. The alignment lug 24166 is closer to the distal end of the cartridge body 24102 than the alignment nub 24162.
[0218] The channel 24050 includes lateral side walls 24052 that form a U-shaped channel. The staple cartridge 24100 can be releasably fixed within the U-shaped channel between the side walls 24052. The side walls 24052 and / or other parts of the channel 24050 may include an elastic snap-fit mechanism for engaging the staple cartridge 24100. Each side wall 24052 includes an alignment mechanism 24054 that includes a proximal alignment contour 24056. The proximal alignment contour 24056 has an edge configured to capture the proximal alignment surface 24164 of the alignment nub 24162. The proximal alignment contour 24056 resists longitudinal displacement of the alignment nub 24162 in the proximal direction beyond the proximal alignment contour 24056. As further described herein, the alignment mechanism 24054 may function as a fulcrum or support under which the staple cartridge 24100 is subjected to leverage during insertion and installation of the staple cartridge 24100 into the channel 24050.
[0219] The channel 24050 further includes an alignment notch 24058 having a proximal end 24060 and a distal end 24062. The alignment notch 24058 is positioned on each side of the channel 24050. The proximal end 24060 defines an upright or vertical plane within the side wall 24052, and the distal end 24062 defines another upright plane within the side wall 24052, which is not parallel to the vertical plane in the proximal end 24060. The upright plane defining the distal end 24062 of the alignment notch 24058 can define an inclined or inclined distal plane, which can form a wedge shape having a narrower dimension along the upper edge of the side wall 24052 and a wider dimension at the opposite end of the notch 24058. In various cases, the alignment notch 24058 may be positioned symmetrically about the longitudinal axis A. The alignment notch 24058 is closer to the distal end of the cartridge body 24102 than the alignment nub 24162. As further described herein, each alignment notch 24058 is positioned and dimensioned to receive one of the alignment lugs 24166 therein.
[0220] The alignment mechanism between channel 24050 and staple cartridge 24100 is configured to interact to facilitate the quick and easy placement of staple cartridge 24100 into channel 24050. For example, to quickly align alignment lug 24166 with alignment notch 24058, a clinician can pull alignment nub 24162 proximal to engage with the corresponding alignment mechanism 24054 on channel 24050. The proximal alignment contour 24056 on proximal alignment mechanism 24054 acts as a longitudinal stopper, preventing further proximal displacement of staple cartridge 24100 relative to channel 24050. The proximal edge 24164 of the contour outline of alignment nub 24162 can match or complement the contoured outline of proximal alignment contour 24056. When the complementary external shapes are fitted together, the alignment lugs 24166 are also aligned with their respective alignment notches 24058.
[0221] The spring 24172 is positioned between the upright surface of the alignment lug 24166 and the upright surface of the alignment notch 24060. More specifically, the spring 24172 is positioned between the proximal end 24168 of the alignment lug 24166 and the proximal end 24060 of the alignment notch 24060. When the staple cartridge 24100 is inserted into the channel 24050, the spring 24172 is configured to bias the inclined distal end 24170 of the alignment lug 24166 distally, causing it to engage and contact with the inclined distal end 24062 of the channel 24050. As the alignment nub 24162 engages with the proximal alignment contour 24056 and the staple cartridge 24100 and its alignment lug 24166 move into the channel 24050 in an installation direction 24101 parallel to the installation axis I, the spring 24172 can be compressed between the upright proximal end 24060 of the alignment notch 24060 and the upright proximal end 24168 of the lug 24166. The installation axis I is perpendicular to the longitudinal axis A.
[0222] During use, the cartridge body 24102 and its nub 24162 can engage with and act as a lever against the proximal alignment contour 24056 of the channel 24050 as the staple cartridge 24100 is moved into the channel along the installation axis I. The proximal levering position of the alignment contour 24056 can improve the mechanical advantages of installing the staple cartridge 24100 and its distal lug 24166 within the channel 24050. The nub 24164 can slide downward into the channel 24050 as the staple cartridge 24100 moves in the installation direction 24101 to a first position or insertion position. After the staple cartridge 24100 is moved to a first position in which the staple cartridge 24100 is inserted but not fully seated within the channel 24050, the spring 24172 is configured to shift the staple cartridge 24100 distally in a direction parallel to the longitudinal axis L to a second position in which the staple cartridge 24100 is fully seated within the channel 24050.
[0223] Referring primarily to Figure 47, spring 24172 is a leaf spring. Spring 24172 is a cantilever spring having a first end mounted on the alignment lug 24166, a second end opposite the first end, and a curved portion midway between the first and second ends. The curved portion can define an S-shaped curve, which aligns the proximal alignment contours 24056, 24164 and allows the staple cartridge 24100 to be compressed with minimal force and / or effort by a clinician when levered proximal to the alignment mechanism 24054. When the levering and compressive forces on spring 24172 are released, spring 24172 is configured to spring back, biasing the staple cartridge 24100 distally to the channel 24050 into a fully seated position (Figure 48).
[0224] In the fully seated position (Figure 48), the distal inclined ends 24062 and 24170 of the alignment lug 24166 and alignment notch 24058 are engaged, respectively. The undercut shape of the distal ends 24062 and 24170 is configured to secure the staple cartridge 24100 within the channel 24050 until the spring 24172 is compressed by a force applied by the user to pull the staple cartridge 24100 proximal along the longitudinal axis A, and then upward in a direction 24103 parallel to the installation axis I and opposite to the installation direction 24101, in order to remove the staple cartridge 24100 from the channel 24050.
[0225] In certain cases, the firing element is configured to apply a distal force to the staple cartridge 24100 during the firing stroke to further secure the staple cartridge 24100 within the channel 24050. For example, the inclined distal ends 24062, 24170 can form an interlock between the staple cartridge 24100 and the channel 24050 when the staple cartridge 24100 is pushed distally. In certain cases, the distal firing force and undercut shape of the inclined distal ends 24062, 24170 can secure the staple cartridge 24100 in the channel 24050 even without the distal biasing force of the spring 24172. For example, the staple retaining assembly 24000 does not have to include a spring configured to bias the staple cartridge 24100 against the channel 24050 in the direction of the firing stroke. The reader will understand that in a staple fastening assembly utilizing a distal-to-proximal firing stroke, for example, undercut interlocks between the staple cartridge 24100 and the channel 24050 may occur at the proximal ends 24168 and 24060 of the alignment lug 24166 and the alignment notch 24058, respectively.
[0226] Referring primarily to Figures 47-48, the staple fastening assembly 24000 is shown with the anvil 24090 clamped to the channel 24050, and the staple cartridge 24100 fully seated therein. The cartridge body 24102 includes a distal nose 24103 with a lock 24180. The lock 24180 includes a latch arm 24182 on the underside of the cartridge body 24102. The latch arm 24182 is configured to overlap a portion of the channel 24050 when the staple cartridge 24100 is fully seated within the channel 24050. For example, the channel 24050 includes a ledge or shelf 24082 on its underside facing the latch arm 24182. The lock 24180 is movable between a first position (Figure 49) in which the latch arm 24182 extends over the shelf 24082 to fix the distal nose 24103 of the cartridge body 24102 to the distal end of the channel 24050, and a second position in which the latch arm 24182 releases the shelf 24082 to facilitate the release of the staple cartridge 24100 from the channel 24050.
[0227] The lock 24180 also includes a release button 24184 facing the anvil on the opposite side of the latch arm 24182. The release button 24184 facing the anvil may be flush with or substantially flush with the upper surface of the distal nose 24103. The release button 24148 facing the anvil can be pressed by a clinician to drive the lock 24180 downward and / or distally, thereby releasing the latch 24182 from engagement with the shelf 24082. In certain cases, the lock 24180 may be made of an elastic and / or deformable material and may bend upon receiving user input to the release button 24184 facing the anvil, thereby moving the latch arm 24182 to a second position. In other examples, the lock 24180 may pivot relative to the cartridge body 24102, thereby moving the latch arm 24812 to a second position.
[0228] In other examples, the distal nose of the cartridge body may be deflectable to releasably engage with a retaining mechanism along the distal edge of an elongated channel. For example, referring here to Figure 50, the staple fastening assembly 24200 is shown with the anvil 24190 clamped to the channel 24050 and the staple cartridge 24300 fully seated therein. The staple cartridge 24300 is identical to the staple cartridge 24100, however, the distal nose 24301 is composed of a flexible material or a flexible portion forming a lock 24380 with a latch arm, the latch arm configured to bend to engage and disengage with a shelf 24082 on the underside of the channel 24050. In certain cases, the entire distal nose 24301 may be flexible to facilitate the bending of the latch arm 24382 to disengage from the ledge 24082. In other examples, only the lock 24380 and / or its latch arm 24382 have sufficient flexibility to disengage the ledge 24082.
[0229] In various cases, the cartridge body 24302 may be a composite cartridge body composed of different materials in different regions, such that the flexibility of a single composite cartridge body may differ from region to region. For example, the cartridge body 24302 may be 3D printed and include a flexible and / or elastic material for the lock 24380 and / or latch arm 24382 and a less flexible and / or less elastic material for adjacent regions within the cartridge body. Additionally or alternatively, in certain examples, the adjacent portions may be printed with a material having the same or similar relatively low durometer as the lock 24380 and / or latch arm 24382; however, metal embedded within the cartridge body, such as a metal frame and / or longitudinal support, can increase the overall strength and rigidity of the cartridge body.
[0230] Additional alignment and retention mechanisms between the staple cartridge and the channel can be conceived to improve the retention and release of the staple cartridge from the channel. Various features can improve the ease of aligning the components and the force required to remove the staple cartridge from the channel, while maintaining sufficient retention force between the staple cartridge and the channel. These additional alignment and retention mechanisms can be combined with the proximal alignment mechanisms between the staple cartridge and the channel, which are further described herein.
[0231] Figure 51 shows a surgical staple fastening assembly 25000. In many embodiments, the staple fastening assembly 25000 is similar to the staple fastening assembly 24000 and includes a staple cartridge 25100 and a channel 25050; however, the staple fastening assembly includes an alternative proximal alignment and retention mechanism between the staple cartridge 25100 and the channel 25050. In addition, the staple cartridge 25100 includes a longitudinal row of staple cavities within its cartridge body 25102 and longitudinally aligned staples positioned within the staple cavities. The staple cavities are oriented parallel to the longitudinal axis A extending along the longitudinal slots and the centerline of the cartridge body 25102.
[0232] The cartridge body 25102 includes alignment lugs 25166, which include a proximal end 25168 and a distal end 25170. The alignment lugs 25166 can be positioned on each side of the cartridge body 25102. The proximal end 25168 may define an upright or vertical plane, and the distal end 24170 may also have an upright or vertical plane. The upright planes defining the proximal end 25168 and the distal end 25170, respectively, may be parallel or substantially parallel. In various cases, the alignment lugs 25166 may be positioned on each side of the cartridge body 25102, and the alignment lugs 25166 may be symmetrical with respect to a centerline passing through the cartridge body 25102.
[0233] The staple cartridge 25100 also includes a lateral pin 25180 that protrudes outward from the cartridge body 25102. Another symmetrically positioned lateral pin 25180 may protrude laterally outward from the other side of the cartridge body 25102.
[0234] Channel 24050 includes lateral sidewalls 25052 that form a U-shaped channel. Staple cartridges 25100 can be removably fixed within the U-shaped channel between the sidewalls 25052. Channel 24050 further includes alignment notches 25058, which include a proximal end 25060 and a distal end 25062. The alignment notches 25058 can be positioned on each side of channel 24050 to receive corresponding alignment lugs 25166. The proximal end 24060 defines an upright or vertical plane within the sidewalls 24052, and the distal end 24062 defines another upright plane within the sidewalls 24052. The upright planes may be parallel or substantially parallel.
[0235] In other examples, the distal ends 25062 and 25170 of the alignment notches 25058 and 25166 are undercut, respectively, as further described herein, to further secure the staple cartridge 25100 to the channel 25050 when the staple cartridge 25100 is fully seated within the channel 25050.
[0236] Channel 25050 further includes a slot 25084 that defines an internal track for a lateral pin 25180. Slot 25080 includes a V-shaped or tapered entrance portion 25082 extending parallel to the insertion direction of the staple cartridge 25100 and an end portion 25084 extending parallel to the longitudinal axis of the cartridge body. The V-shaped entrance portion 25082 provides a wider entrance area 25083 for the lateral pin 25180 into slot 25084, which ensures that the clinician does not need to align the staple cartridge 25100 with channel 25050 with strict precision. Furthermore, the wider entry area 25083 to slot 25084 may define a larger range of longitudinal positions of the staple cartridge 25100 relative to channel 25050 than the allowable range of longitudinal positions for aligning the alignment lug 25166 with the entry area 25063 of the alignment notch 25058.
[0237] The alignment mechanism between channel 25050 and staple cartridge 25100 is configured to interact to facilitate the quick and easy placement of staple cartridge 25100 into channel 25050. For example, to quickly align the alignment lug 25166 with the alignment notch 25058, a clinician can position staple cartridge 25100 anywhere within a wider range of longitudinal positions for aligning the lateral pin 25180 within the entry portion 25083 of slot 25080. As the lateral pin 25180 moves along the narrowing track of the V-shaped portion 25082 of slot 25080, the lug 25166 may be funnel-shaped to align with the alignment notch 25058.
[0238] In various cases, the staple cartridge 25100 can fall into the channel 25050 with minimal interference or frictional resistance. For example, the staple cartridge 25100 does not need to be fixed in the channel 25050 by a robust frictional fitting mechanism between the staple cartridge 25100 and the channel 25050. Instead of, or in addition to, such a frictional fitting mechanism, the shape of the slot 25080 can fix the staple cartridge 25100 in the channel 25050. For example, the frictional force exerted on the staple cartridge 25100 during a proximal-to-distal firing stroke can move the lateral pin 25180 distally along the end portion 25084 of the slot 25080, thereby shifting the staple cartridge 25100 distally within the channel 25050. In such a case, the firing force can move the lugs(s) 25166 to their furthest positions, flush with the distal end 25062 of the alignment notch 25058.
[0239] In various cases, to remove the used staple cartridge 25100 from the channel 25050, the clinician can pull the staple cartridge 25100 proximal to detach the lateral pin 25180 from the end portion 25084 of the slot 25080. When the staple cartridge 25100 is shifted proximal by the clinician (which requires minimal force and effort), the clinician can quickly and easily lift the staple cartridge 25100 from the channel 25050.
[0240] An alternative latching mechanism between the staple cartridge 26100 and the channel 26050 for the staple fastening assembly 26000 is shown in Figures 52 and 53. In many embodiments, the staple cartridge 26100 is similar to the various staple cartridges described herein and may include a cartridge body 26102 having staples and a staple support driver movably disposed within the cartridge body 26102. The channel 26050 includes opposing side walls 26052 that form a U-shaped channel outline, and these side walls are configured to receive the staple cartridge 26100 between them or at least largely between them. For example, the staple cartridge 26100 includes a lateral latch arm 26180 configured to releasably engage with a lateral recess 26080 along the outer surface of the side wall 26052.
[0241] The latch arm 26180 extends along the lateral side of the staple cartridge 26000 and can be integrally formed (e.g., molded) with the cartridge body 26102. For example, the cartridge body 26102 and the latch arm 26180 can be a single, single-part component. In various examples, the latch arm 26180 can be deflected. The latch arm 26180 includes a user-activated button 26182 and a fastener 26184. The fastener 26184 is longitudinally offset from the user-activated button 26182. A lever arm extends between the user-activated button 26182 and the fastener 26184 such that the actuation of the button 26182 is configured to deflect the fastener 26184. For example, an actuation applied inward to the button 26182 is configured to deflect the fastener 26184 outward, disengaging it from the lateral recess 26080. In certain examples, the deflection of the fastener 26184 when the clinician activates button 26182 is configured to disengage the fastener 26184 from the recess 26080. In other examples, the fastener 26184 can move to a less engaged position and thus more easily overcome its position relative to the recess 26080. The clinician can apply a pinching motion to button 26182 to activate both buttons 26182 simultaneously, deflecting both fasteners 26184 and disengaging them from the recess 26080.
[0242] In various cases, to install the staple cartridge 26100 into the channel 26050, the staple cartridge 26100 may be moved perpendicular to the insertion direction until a portion of the cartridge body 26102 is stationary within the channel 26050. At this position, the latch arm 26180 may be aligned with a longitudinal guide along the outer surface of the side wall 26052. As the cartridge body 26102 slides proximal to a fully seated position within the channel 26050, the latch arm 26180 moves along the longitudinal guide, and the fastener 26184 snaps into the recess 26080, securing the staple cartridge 26100 in its fully seated position. When the staple cartridge 26100 is fully seated within the channel 26050 and the fastener 26184 is engaged or locked into the recess 26080, the width of the staple fastening assembly may still be within the limits of a conventional size trocar (e.g., 12 mm outer diameter). To release the staple cartridge 26100 from the channel 26050, the clinician grasps the button 26182 and biases the fastener 26184 outward from the recess 26080, thereby allowing the clinician to remove the staple cartridge 26100 by pulling it distally and / or perpendicularly along the longitudinal axis A from the channel 26050.
[0243] In certain examples, the cartridge body 26102 is made of plastic, and the latch arm 26180 is also made of plastic. For example, the cartridge body 26102 and the latch arm 26180 can be made of molded composite plastic components.
[0244] In other examples, the cartridge body may be a composite assembly of plastic and metal. For example, the latch arm may be a metal spring formed together with the cartridge body. The latch arm may also be an insert-molded metal arm. In certain examples, a metal latch arm can provide a higher spring constant and snap latch mechanism than a plastic arm.
[0245] In certain cases, a staple fastening assembly may include a fragile cartridge retention mechanism, which is configured to hold the staple cartridge in place within the channel until it is intentionally destroyed by the user. For example, a clinician may intentionally destroy the cartridge retention mechanism, and / or the mechanism may be destroyed during a firing stroke, for example, at or near the completion of the firing stroke. Destruction of the fragile cartridge retention mechanism can reduce the retaining force between the staple cartridge and the channel, resulting in the clinician being able to remove the staple cartridge with less force. In various cases, when the fragile mechanism is destroyed, it may remain attached to the staple cartridge body. For example, referring again to lock 24380 in Figure 50, the lock may include a fragile portion, which is configured to break but not detach when the user intentionally applies action to the staple cartridge to remove it from the channel.
[0246] In certain cases, the staple cartridge may include a retainer that engages with a channel and is released from the channel upon completion of the firing stroke. Referring here to Figures 54–59, a staple cartridge 26200 is shown, which in many embodiments is similar to the staple cartridge 20100 (Figure 24). For example, the staple cartridge 26200 includes a cartridge body 26202 containing a tissue support deck 26204 having a defined staple cavity inside, the staple cavity arranged in three longitudinal rows 26212a, 26212b, and 26212c on each side of a rotary drive screw 26242, which in many embodiments is similar to a firing screw 261 (see Figures 4 and 5). The staples in the staple cartridge 26200 are supported by a driver 26220, which in many embodiments is similar to a triple driver 20120 (Figure 26). For example, the driver 26220 includes three parallel staple support cradles configured to support staples so that the driver 26220 is configured to fire staples simultaneously from the inner row 26212a, the middle row 26212b, and the outer row 26212c.
[0247] The staple cartridge 26200 includes a retaining element 26280 that releasably engages with the channel. The retaining element 26280 is movable between a locked configuration (Figures 54-57) and an unlocked configuration (Figures 58 and 59). In certain examples, the inward-facing side of the channel sidewall, located adjacent to the cartridge body 26202, may include a recess of dimensions and structure that receives the retaining element 26280 in the locked configuration. For example, channel 20852 (Figure 99) includes a distal recess 20853. The recess is configured to hold the retaining element 26280, and thus the staple cartridge 26200, against the channel until the retaining element 26280 is moved to the unlocked configuration. In other examples, the outward bias of the retaining element 26280 against the channel sidewall is configured to frictionally engage with the channel without positioning the retaining element 26280 within the recess. Opposing retainers 26280 on both sides of the staple cartridge 26000 are configured to frictionally engage with the channel to hold the staple cartridge 26000 within the channel.
[0248] The retaining pin 26280 is housed in the distal staple cavity 26210 within the outer row 26212c. The through hole 26205 is defined within the outer wall 26203 of the cartridge body 26202, within the distal staple cavity 26210 within the outer row 26212c. The retaining pin 26280 is aligned with the through hole 26205 and protrudes from the cartridge body 26202 in the through hole 26205 when the retaining pin 26280 is in the locked configuration (Figures 54-57). The bar 26282 extends from the retaining pin 26280 and is operably engaged with the driver 26220 within the distal staple cavity 26210.
[0249] When the furthest driver 26220 is in the non-firing position (Figures 54-57), the furthest driver 26200 can bias the retainer 26280 to the locked position. Referring now to Figures 58 and 59, at the completion of the firing stroke, when the furthest driver 26200 is lifted by the thread through the staple cavity toward the tissue support deck 26204, the furthest driver 26220 moves away from the retainer 26280 and can engage with the bar 26282. As the furthest driver 26220 moves along the bar 26282, the driver 26220 is configured to bias the bar laterally outward, which pivots the retainer 26280 inward into and / or through the through hole 26205, disengaging it from the channel. In such an example, when the firing stroke is complete, the furthest driver 26220 releases the snap mechanism, i.e., the retainer 26280.
[0250] In certain examples, multiple driver-releaseable retainers may be arranged along the length of the cartridge body 26202. In certain examples, longitudinally staggered and / or longitudinally symmetrical retainers may be arranged along both sides of the cartridge body 26202. In addition to the driver-releaseable retainer 26280, threads may be configured to release a snap-fit or retaining mechanism in certain embodiments of the present disclosure. Furthermore, in certain examples, drivers may be configured to snap or break the retainer 26280 and / or its bar 26282 during the firing stroke to release the mounting mechanism.
[0251] In various cases, the staple cartridge assemblies herein may include a driver retention mechanism configured to prevent the driver from being released from the cartridge body. For example, certain staple cartridges include a metal pan that is heat-crimped or thermoformed onto the cartridge body after the driver is placed in the fastener cavity. The metal pan(s) may enclose the underside of the cartridge body and hold the driver inside. In certain examples, the driver may be held without a separate metal pan to create additional space within the small form factor of the cartridge assembly. For example, as further described herein, heat crimping between the cartridge body and the driver may hold the driver. Additionally or alternatively, the cartridge body may be overmolded with a metal pan. For example, the driver retention mechanism may include a thermoformed interference mechanism between the driver and the cartridge body, and / or an insert-molded component within the cartridge body.
[0252] Staple cartridge 26300 is shown in Figures 60 and 61. Staple cartridge 26300 is similar in many embodiments to staple cartridge 20100 (Figure 24). For example, staple cartridge 26300 includes a cartridge body 26302 containing a tissue support deck 26304 having a defined staple cavity inside, the staple cavity arranged in three longitudinal rows 26312a, 26312b, and 26312c on each side of the cartridge body 26302. Staples in staple cartridge 26300 are supported by a driver 26320 (Figure 61), which is similar in many embodiments to a triple driver 20120 (Figure 26). For example, the driver 26320 includes three parallel staple support cradles configured to support staples, such that the driver 26320 is configured to fire staples from the inner row 26312a, the middle row 26312b, and the outer row 26312c.
[0253] The cartridge body 26302 includes a row of indentations 26330 or dimples along the lower portion of the cartridge body 26302. The row of indentations 26330 can be arranged to engage with and hold the driver 26320 when it is in the non-firing position. In Figure 60, each indentation 26330 is configured to engage with the driver 26320. For example, each driver 26320 may be held in place by an adjacent indentation 26330 on the outer surface of an adjacent staple post. The indentations 26330 in the cartridge body 26302 can prevent the driver from falling out of the cartridge body 26302 when the driver 26320 is in its non-firing and lowest position.
[0254] A recess 26330 in the cartridge body 26302 is configured to engage with a recess 26321 on the outer surface of the driver 26320. The recess 26321 may include an upper lip or boundary that prevents vertical displacement of the driver 26320 relative to the cartridge body 26302. In various cases, the recess 26330 and the corresponding recess 26320 may be connected to a thermal riveting process by thermoforming, melting, or other means. Thermal riveting is described further herein.
[0255] Since driver 26320 is a triple driver, the heat-sealed connection between the outer wall of driver 26320 and the cartridge body 26302 can hold the entire driver 26320, including the intermediate and inner supports, in place within the cartridge body 26302. The interference connection between recess 26330 and recess 26321 can be overcome by the threads during the firing stroke to sequentially release and lift the driver 26320 as the threads move along the row of recesses 26330. In certain cases, a series of heat seals along the inner surface within the cartridge body 26302 can engage each driver 26320 during the firing motion. In such examples, driver 26320 can capture multiple vertical fasteners or dimples during the firing motion.
[0256] In certain examples, the driver and cartridge body may include interference mechanisms molded into the driver and / or cartridge body. Referring to Figure 62, the staple cartridge 26400 is similar in many embodiments to the staple cartridge 20100 (Figure 24). For example, the staple cartridge 26400 includes a cartridge body 26402 containing a tissue support deck 26404 having a defined staple cavity 26410 inside, the staple cavity 26410 arranged in three longitudinal rows on each side of the cartridge body 26402. The staples in the staple cartridge 26400 are supported by a driver 26420 (Figure 62), which is similar in many embodiments to a triple driver 20120 (Figure 26), except that the driver 26420 is a double driver. The retention mechanisms described herein with respect to the driver 26420 may be incorporated in other examples into a single driver and / or a triple driver.
[0257] The driver 26420 includes a integrally formed wedge 26421, which is narrower along the upper edge 26423 and thicker along the lower edge 26425. The wedge 26421 is positioned on the side wall of the staple post and configured to abut against the side wall of the staple cavity 26410. For example, the staple cavity 26410 includes a vertical groove 26405 that aligns with the wedge 26421. The wedge 26421 is configured to move along the vertical groove 26405 as the driver 26420 is lifted upward by the thread during the firing stroke. To accommodate the wedge 26421, the cartridge wall is configured to bend outward when the driver 26420 is inserted into the cartridge body 26402. During use, the firing force from the thread is sufficient to overcome the interference fit and lift the driver 26420. In other words, in the illustrated embodiment, the wedge 26421 is configured to move through the vertical groove 26405, however the depth of the groove 26405 is not sufficient for the wedge 26421 to pass through freely and clearly. The narrow upper edge 26423 can fit into the groove without interference, however between the narrow upper edge 26423 and the thicker lower edge 26425, the wedge 26421 may interfere with the cartridge body 26402 despite the vertical groove 26405. The interference connection between the wedge 26421 and the vertical groove 26405 is configured to hold the driver 26420 in place within the staple cavity 26410 during firing motion and resist downward movement, and the threads can overcome the interference during the firing stroke to sequentially release and lift the driver 26420 as the wedge 26421 traverses the cartridge body 26402 along the row of recesses 26330. The cartridge body 26402 can continue to flex as its driver 26420 and wedge 26421 move through the cavity 26410.
[0258] Referring next to Figure 63, a staple cartridge 26500 is shown. The staple cartridge 26500 includes a cartridge body 26502 containing a defined staple cavity, the staple cavity arranged in three longitudinal rows on each side of the cartridge body 26502. The staples 26580 within the staple cartridge 26500 are supported by a driver 26520, which in many embodiments is similar to a triple driver 20120 (Figure 26). The staple cartridge 26500 is similar in many embodiments to the staple cartridge 20100 (Figure 24), however, the staple cartridge 26500 also includes a metal frame 26503 that is insert-molded into the cartridge body 26502. The insert-molded metal frame 26503 is a two-part assembly including a first pan 26503a and a second pan 26503b that extend along the sides of the cartridge body 26502. Pans 26503a and 26503b can be insert-molded together with the cartridge body 26502 and can snap-fit to the cartridge body 26502 by friction fitting between a boss 26505 along the length of the cartridge body 26502 and the opening 26507 of pans 26503a and 26503b, and / or can be heat-crimped to the cartridge body 26502 by deforming the boss 26505 along the length of the cartridge body 26502 within the opening 26507 of pans 26503a and 26503b.
[0259] In one embodiment, a flat, uncurved pan can be insert-molded with the cartridge body 26502 (for example, pans 26503a, 26503b may initially define a linear shape instead of an L-shaped shape). The cartridge body 26502 may be formed, for example, from a metal sheet overmolded along its lateral sides. The exposed length of the overmolded metal sheet is then bent around a portion of the underside of the cartridge body 26502 to at least partially overlap some of the staple cavities, allowing the driver 26520 to be held within the cartridge body 26502 from its underside. In particular cases, the driver may be a triple driver spanning the outer staple cavity, the middle staple cavity, and the inner staple cavity. The bent portion of the metal sheet may overlap, or substantially overlap, the underside of the outer staple cavity in order to retain the driver within the cartridge body.
[0260] Alternatively, L-shaped pans, such as pans 26503a and 26503b, can be snapped into the lateral side of the cartridge body 26502 to hold the driver inside the cartridge body 26502 from the bottom surface of the cartridge body 26502, without insert molding the pans 26503a and 26503b into the cartridge body 26502.
[0261] In one embodiment, pans 26503a, 26503b may be insert-molded together with the cartridge body 26502 and may include exposed, bendable metal flanges or arms that are bent around the cartridge body 26502 after the driver 26520 is installed in the staple cavity. For example, referring here to Figures 64 and 65, a portion of a metal frame or pan 26603 for a cartridge body such as cartridge body 26502 (Figure 63) or cartridge body 20102 (Figure 24) is shown. Pan 26603 may be insert-molded together with the cartridge body. For example, pan 26603 includes a frame portion 26605 on which the cartridge body is molded. Pan 26603 also includes an arm 26609. Arm 26609 is deformed by a deformation force in direction F (Figure 65) from its initial configuration (Figure 64) to the bent arm 26609' configuration (Figure 65), allowing arm 26609 to wrap around the lower portion of the staple cavity and hold the driver inside.
[0262] In various embodiments of this disclosure, various techniques for forming a piece of metal on the outer staple cavity to hold a driver therein may be applied to the inner staple cavity in particular. For example, in various embodiments of this disclosure, the staple cartridge may include a support brace, such as a support brace 650 fitted within the staple cartridge 640 (see Figures 19 and 20). As further described herein, the staple cartridge 640 and the support brace 650 may be assembled together before the staple cartridge 640 is placed in the channel 630. In particular examples, such a support brace 650 or other insert-molded longitudinal frame member within the cartridge body may include a metal sheet, pan, or arm which may be bent around the underside of the cartridge body to hold a driver within the inner row staple cavity.
[0263] As described herein, the driver retention and / or interlock mechanism with the cartridge body may be thermally crimped to retain the driver within the cartridge body. In at least one aspect of this disclosure, each driver may include a thermal crimping mechanism corresponding to the cartridge body. It may be important to ensure that the depth of the thermal crimping is sufficient to prevent the driver from being disengaged, but without causing interference with drivers in their non-firing or down position. Thermal crimping and orbital forming techniques can be controlled to ensure sufficient engagement.
[0264] Referring here to Figure 67, a portion of the staple cartridge 26700 is shown, which includes a cartridge body 26702 having a driver 26720 inside. The staple cartridge 26700 is similar in many embodiments to the staple cartridge 20100 (Figure 24), but further includes a longitudinal support frame 26703 and a heat-sealing holding mechanism 26705 between the cartridge body 26702 and the longitudinal support frame 26703. In various cases, heat-sealing can be performed on a solid sheet of metal to fix the cartridge body 26702 to the longitudinal support frame 26703. The driver 26720 can then be installed in the staple cavity. For example, the driver 26720 and staples can be installed in the staple cavity 26710. After the driver 26720 is installed, the longitudinal support frame 26703 can be bent over the underside of the cartridge body 26702 to hold the driver 26720 therein. For example, a portion 26709 of the longitudinal support frame 26703 can cover the driver 26720 and the opening on the underside of the staple cartridge body 26702 associated with the outer staple support on the outer staple cavity 26710.
[0265] Insert supports can be used in certain thermal crimping operations to reduce the amount of pressure and improve consistency. For example, a removable insert support or backer can be placed behind each thermal crimp. Furthermore, the insert support can push the driver into an upward position during crimping to protect the driver from deformation or other effects of the thermal crimping operation.
[0266] Referring to Figure 67, the heat-sealing operation for the staple cartridge 26800 is shown, where the cartridge body 26802 is fixed to the longitudinal support frame 26803 by a heat-sealing clamp 26805. The staple cartridge 26800 is similar in many embodiments to the staple cartridge 20100 (Figure 24), but also includes the longitudinal support frame 26803 and the heat-sealing clamp 26805. The longitudinal support frame 26803 includes an upright sheet 26808 and a right-angle flange 26809 extending therefrom to form an L-shaped outline. The upright sheet 26808 includes an opening 26807 through which it passes, and the opening is aligned with the heat-sealing clamp 26805. The right-angle flange 26809 also includes an opening 26806 through which it is configured to receive the fingers 26892 of the insert support 26890.
[0267] During the thermal crimping operation, the L-shaped support frame 26803 is positioned along the length of the cartridge body 26802, and the insert support 26890 is positioned relative to the support frame 26803 and the cartridge body 26802 such that the fingers 26892 extend into the staple cavity 26810 through the opening 26806 in the orthogonal flange 26809. The fingers 26892 are configured to push the driver 26820 upward toward the tissue support deck 26804 of the cartridge body 26802. After the thermal crimping 26805 is formed between the cartridge body 26802 and the L-shaped support frame 26803, the insert support 26890 can be removed from the staple cartridge 26800, allowing the driver 26820 to move downward and take their unfired position in the staple cavity 26810. The right-angle flange 26809 is configured to cover a portion of the underside of the cartridge body 26802 and overlaps with multiple staple posts (e.g., outer posts and intermediate posts) and / or bridges between two adjacent staple posts, allowing the driver 26820, which spans multiple rows of the staple cavity 26810, to be held within the cartridge body 26802.
[0268] As further described herein, certain end-effector components may be constructed using 3D printing techniques to improve component capabilities. In certain examples, 3D printing can enable printed components to exhibit, for example, metamaterial properties. Metamaterials are synthetic composite materials that have structures that exhibit properties not typically found in natural materials. 3D printing is one technique used to create metamaterials by forming components that have two or more materials and / or structures within them. In other examples, insert molding and overmolding can produce composite components that may, in certain cases, have metamaterial properties.
[0269] Composite end-effector components can exhibit greater structural strength and rigidity while enabling precision in forming small detail features, and in certain cases, can provide improved frictional properties. For example, a metal-plastic composite cartridge body can exhibit certain metamaterial properties, such as being stronger and more rigid than a similar injection-molded, all-plastic, or composite cartridge body, while still allowing precision with respect to small detail features. In certain cases, a metal-plastic composite cartridge body can exhibit improved frictional properties for drivers movably positioned within each staple cavity. Certain composite metal-plastic components can be formed by insert molding or overmolding. In other examples, 3D printing can enable the creation of complex shapes and / or material combinations that would otherwise be too costly and time-consuming to manufacture with conventional molding techniques, or in certain cases, even impossible to manufacture without 3D printing technology.
[0270] Referring to Figure 69, for example, a composite metal-plastic cartridge body 30002 is shown. The composite metal-plastic cartridge body 30002 can provide metamaterial properties in certain cases. Additionally or alternatively, the composite metal-plastic body can enable improved integration of electronic components such as electronic sensors and flexible circuits.
[0271] In one embodiment, the cartridge body 30002 is formed from a punched metal frame 30001, or from two or more pans formed by punching and other methods into the skeletal shape of the cartridge body 30002. Next, a plastic material 30003 is molded onto the metal frame 30001. In such cases, the metal frame 30001 can be insert-molded into the plastic material 30003. The metal-plastic composite cartridge body 30002 can exhibit increased strength and folding rigidity compared to a completely plastic cartridge body, i.e., an injection-molded cartridge body without an internal metal frame. The plastic material 30003 on the metal or composite frame can provide a structural functional frame having a complex driver guide mechanism molded within the plastic material 30003.
[0272] The metal frame 30001 may include a thin metal framework, and the plastic material may, in certain examples, be injection molded together with the structural members. In one embodiment, the metal frame may constitute one or more integrated pans, which can save space within the cartridge body and / or increase the interstitial gaps, as further described herein. In addition, metal may be utilized for several components related to lockout, cartridge identification, and reset. The metal may be less prone to breakage or cracking in certain cases, and can withstand large forces, and the lockout components and / or mechanical keys (e.g., extended tabs or posts) may be useful in preventing the insertion of the staple cartridge into an unsuitable channel and / or device. Certain metal components may be elastic during firing stroke reset, i.e., when the thread is retracted during manufacturing to test the cartridge and ensure that all components are installed. Furthermore, composite metal-plastic cartridge bodies can facilitate smart cartridge technology, integrated wiring, and / or flexible circuits.
[0273] In certain examples, the metal frame 30001 may have flanges that interconnect or span multiple walls and / or columns within the cartridge body. For example, certain walls within the cartridge body may be thinner than others, and flanges may connect thinner walls to thicker walls to better distribute torque loads rather than twisting the support. In certain examples, the main upright support wall within the cartridge body may be connected by the metal frame to adjacent thicker support walls. For example, thinner internal cartridge walls may be connected to thicker external cartridge walls to improve clamping and / or force distribution during firing.
[0274] In another example, a composite plastic-metal cartridge body can be 3D printed. The orientation of the 3D construct forming the composite plastic-metal cartridge body can be optimized to ensure smooth driver movement during the firing stroke. For example, referring again to Figure 69, the cartridge body 30002 includes staple cavities 30010 arranged in multiple longitudinal rows 30012. The staple cavities 30010 are defined within the cartridge body 30002 through a tissue support deck 30004. A driver, such as driver 20120 (Figure 26) further described herein, can support staples within the cartridge body 30002.
[0275] The composite plastic-metal cartridge body 30002 can be printed in layers along the longitudinal axis A of the cartridge body 30002. In other words, the orientation of the 3D construction can be perpendicular to the longitudinal axis A and / or perpendicular to the tissue support deck 30004. When the directional 3D printing of the cartridge body 30002 is perpendicular to the longitudinal axis A (e.g., proximal to distal), the construction layers can be aligned with the direction of motion of the driver during the firing stroke. Referring again to Figure 69, each staple cavity 30010 extends along an axis D perpendicular to the longitudinal axis A. As the thread moves through the cartridge body 30002 along the longitudinal axis A, each driver is lifted upward toward the tissue support deck 30004 along its respective D axis. The construction direction is parallel to the D axis of the staple cavity, along which the driver moves during the firing stroke. By aligning the 3D construction layer with the driver's direction of motion, it may be possible to prevent the driver from becoming constrained and hanging up when it is lifted by the thread during the firing stroke.
[0276] In some cases, the 3D structure for the composite plastic-metal cartridge body is proximal to distal. In other cases, the 3D structure may be distal to proximal, for example. The support structure for a particular 3D structure may be minimized in certain cases when constructing the narrower body portion on top of the wider distal nose of the cartridge body.
[0277] In various cases, 3D printed composite cartridge bodies may contain different filler ratios and / or different materials to obtain metamaterial properties related to improving the strength of the cartridge body while minimizing frictional forces during the firing stroke. Furthermore, the support walls of such a cartridge body may define open spaces, voids, and / or cells between them. In various cases, the spaces between support walls (e.g., thin walls between staple cavities) may be configured to allow for improved bending resistance during clamping loads. For example, the spaces between the support walls of the cartridge body may include 3D printed internal fillets, chamfers, and / or supports, which are configured to improve the open-cell strength of the support walls.
[0278] Certain cartridge bodies described herein may include smaller cross-sectional shapes, less material, and / or thinner support walls due to the footprint of the central firing screw (e.g., firing screw 261 in Figures 4 and 5) passing through it, which occupies area in the compact form factor of the cartridge body. High loads on the cartridge body during firing strokes may exert deformable forces on the cartridge body, which may result in deformation of the cartridge body or a portion thereof. For example, thin walls separating the staple cavity may, in certain cases, tend to bend or buckle, which may orient the driver and the staples supported thereon out of alignment with the molded pockets in the anvil. In any case, connecting the lateral sides of the cartridge body with bridges can reinforce the cartridge body and help maintain alignment between the staples in the staple cavity and their associated molded pockets in the anvil, even under high loads.
[0279] Referring here to Figures 71 and 72, portions of the surgical end effector 30140 are shown. The surgical end effector 30140 is similar in many embodiments to the surgical end effector 20240 (Figure 29). For example, the end effector 30140 includes a staple cartridge 30100, which in many embodiments is similar to the staple cartridge 20100 (Figure 24), and includes a cartridge body 30102 and three rows of staple cavities on each side of a rotary drive screw 30142 (Figure 72), which in many embodiments is similar to, for example, a drive screw 261 (see Figures 4 and 5) and a rotary drive screw 20242 (Figure 29). The staple cartridge 30100 is installed in the channel 30150. The firing member 30144, having an upright cutting edge 30146, is configured to move along the rotary drive screw 30142 through the staple cartridge 30100 during the firing stroke, thereby advancing the thread and lifting the driver and staples on the thread into forming contact with the forming pocket in the anvil.
[0280] The cartridge body 30102 is similar in many embodiments to, for example, the cartridge body 20102 (Figure 24), however, the cartridge body 30102 further includes a bridge 30106 extending between the two lateral sides 30102a, 30102b of the cartridge body 30102. The bridge 30106 covers the longitudinal knife receiving slot 30108 defined within the cartridge body 30102, and a portion of the firing member 30144 moves along the longitudinal knife receiving slot during the firing stroke. The bridge 30106 forms a continuous tissue support deck 30104 between the two lateral sides 30102a, 30102b of the cartridge body 30102. In various cases, the bridge 30106 can improve the strength of the cartridge body 30102, for example, and can help maintain the alignment of the staples with the molded pocket on the anvil, for example, especially when firing under high load. In such cases, the bridge 30106 can, for example, mitigate lateral staple displacement resulting from high clamping loads.
[0281] The bridge 30106 is a vulnerable portion and is configured to be cut or traversed by the upright cut edge 30146 of the firing member 30144 during the firing stroke. In various cases, the shape of the bridge 30106 is configured to mitigate the risk of tearing. For example, the shape can allow for a predictable shape and orientation of the bridge 30106's failure. If the cartridge body 30102 is 3D printed, for example, the cartridge body 30102 may contain different materials, different filling densities, and / or different filling shapes along the bridge 30106 or the portion of the bridge 30106 compared to adjacent portions of the cartridge body 30102, which can further facilitate the cutting of the bridge 30106 during the firing stroke without damaging the firing member 30144 and / or without shattering the cartridge body 30102 from the firing load.
[0282] In certain cases, as further described herein, the staple cartridge 30100 may include, for example, a single-use knife capable of cutting off the bridge 30106 during a firing stroke. When a single-use knife is used, the knife is not at risk of blunting for subsequent firing strokes when cutting off the weak portion of the bridge 30106. The bridge 30106 may include, for example, plastic molded and / or 3D printed components, which can be easily cut off by the upright cutting edge 30146 without significant resistance. In other examples, the bridge 30106 can be cut using a reusable knife.
[0283] In certain cases, the bridge 30106 may include a row of perforations and / or break lines / tear lines along which the bridge 30106 is configured to separate from the cartridge body 30202. Referring to Figure 73, for example, the tamper-evident lid 30200 has a break tab 30202 and includes a fragile portion 30206 defined by a break line 30204 between the fragile portion and the rest of the lid 30200. The fragile portion 30206 can be removed or separated from the tamper-evident lid 30200 along the break line 30204. Similarly, the bridge 30106 can be removed from the cartridge body 30102 along a break line that facilitates the separation of the bridge 30106 from the cartridge body 30102. In certain cases, the bridge 30106 may be interrupted by a pocket along the side wall of the knife receiving slot 30108. The deflected and / or separated portions of the bridge 30106 may be configured to move into the pocket during the firing stroke, rather than being pushed out from the cartridge body 30102 and entering the tissue clamped between them.
[0284] In certain cases, as further described herein, the replaceable staple cartridge may include a single-use knife, which may provide an unused cutting edge for each firing stroke. However, in order to cut tissue clamped between the jaws of the end effector, the knife should, in various cases, extend beyond the tissue support deck of the staple cartridge. Such protruding knife and cutting edge pose a risk of unintentional and / or inadvertent contact outside the firing stroke, which may damage tissue and / or blunt the cutting edge. For example, the cutting edge may inadvertently come into contact with and / or cut the tissue of the patient and / or clinician before the firing stroke, such as when the staple cartridge is loaded into the end effector. In other examples, at the completion of the firing stroke, the cutting edge may remain in a distally protruding position, which may inadvertently come into contact with and / or cut the tissue of the patient and / or clinician as the end effector unclams the tissue and is withdrawn from the surgical site. Further scenarios of unintentional tissue contact can be conceivable.
[0285] In various cases, a tissue excision knife may be mounted on a thread within a staple cartridge. As the thread moves through the firing stroke, the knife may also move through the cartridge body. Furthermore, the thread may interact with a firing member (e.g., an I-beam or E-beam) within the end effector. For example, the thread and the knife on it may be releasably connected to the firing member so that the thread and knife advance distally during the firing stroke. In certain examples, the thread and knife may retract proximally with the firing member upon completion or termination of the firing stroke. In such cases, the knife may be reset and / or returned to its proximal position within the cartridge body before the firing member allows the jaws to open. In such cases, the protruding knife and its cutting edge may return to a predictable and / or at least partially shielded position at the proximal end of the cartridge body. In other examples, the thread may include multiple separable components (e.g., a two-part thread), where one part of the thread can be retracted proximally, while another part of the thread remains in the distal position. In certain embodiments, the retractable portion of the thread may include a knife. In further examples, the non-retractable portion of the thread may include a knife, which may be directed downward into the cartridge body as the retractable portion of the thread passes through the knife. In certain examples, a portion of the thread may interact with a lockout mechanism to prevent a firing stroke when the cartridge is lost and / or used.
[0286] In one aspect of this disclosure, the firing member may include a distally extending hook, and the thread may include a proximal cavity dimensioned to receive the distally extending hook. Furthermore, a knife may be pivotably connected to the thread and positioned to selectively engage and hold the distally extending hook within the thread. For example, the distally extending hook may hook around a portion of the knife. In various cases, the interconnection between the distally extending hook and the knife is configured to hold the knife in a protruding position relative to the cartridge body.
[0287] In such cases, the knife can be moved to a protruding position, in which the cutting edge is positioned to cut the tissue clamped between the jaws as the firing member advances and engages with the thread. Before the firing stroke, the knife can be pivoted to a shielded position, in which at least a portion of the cutting edge is shielded by the thread and / or the cartridge body. Furthermore, once the firing stroke is complete, the firing member can return to its proximal position within the cartridge body together with the thread and return to its shielded position. In various cases, the above configuration can avoid certain inadvertent tissue contact outside of the firing stroke.
[0288] Referring here to Figures 74-77, a thread assembly 30320 for the end effector 30340 (Figure 77) is shown. The end effector 30340 is similar in many embodiments to the end effector 200 (see Figures 4 and 5) and is configured to cut and staple patient tissue. The end effector 30340 may include, for example, a cartridge jaw and an anvil jaw, the cartridge jaw being configured to receive a staple cartridge 30300 having a tissue support deck 30304, which in many embodiments is similar to, for example, a staple cartridge 220 (see Figures 4 and 5). The end effector 30340 also includes a rotary drive screw and a launching member 30342, which are similar to the launching screw 261 (see Figures 4 and 5) and the launching member 270 (see Figures 4 and 5), respectively. The cartridge jaws are configured to receive a staple cartridge 30300 containing staples that can be ejected when the launching member 30342 is advanced within the staple cartridge 30300. For example, the launching member 30342 is driven through the end effector 30340 as the launching screw rotates during the firing stroke to advance the thread assembly 30320.
[0289] The firing member 30342 includes a main body portion 30343, upper cam members 30344 extending laterally from both sides of the main body portion 30343, and lower cam members 30345 extending laterally from both sides of the main body portion 30343. The upper cam members 30344 are configured to cam-engage with the upper jaw or anvil of the end effector 30340 during the firing stroke, and the lower cam members 30345 are configured to cam-engage with the lower jaw or elongated channel of the end effector 30340 during the firing stroke.
[0290] In addition to the above, a longitudinal opening extends through the main body portion 30343. The longitudinal opening is configured to receive the rotary drive screw described above. The main body portion 30343 further includes a notched region 30349 configured to receive a firing drive nut 30350. The firing drive nut 30350 is configured to engage screwably with the rotary drive screw to convert the rotational motion of the rotary drive screw into translation of the firing member 30342. The firing drive nut 30350 also includes lateral extending members 30351 extending from both sides of the firing drive nut 30350. The lateral extending members 30351 are aligned with the lower cam member 30345. Thus, the cam members 30345, 30351 cooperate during the firing stroke to engage in a cam action with the lower jaw of the end effector 30340.
[0291] The main body portion 30343 of the launching member 30342 also includes a distal nose portion 30346 that extends distally and forms a distal thread contact surface 30352. The distal extension 30347 extends substantially distally from the distal thread contact surface 30352 and is configured to selectively interlock with the thread assembly 30320. More specifically, the distal extension 30347 includes a transverse portion or fastener 30348 that extends in a direction transverse to the distal direction. The distal extension 30347 and the fastener 30347 form a hook shape that selectively engages with a portion of the thread assembly 30320, as further described herein.
[0292] The thread assembly 30320 includes a thread body 30321 and a knife 30338 having a rail 30322 positioned to engage with a driver, such as a driver 20120 (Figure 26). The rail 30322 is configured to lift the driver toward the tissue support deck 30304 of the staple cartridge 30300. The central portion 30333 of the thread body 30321 moves along the central longitudinal path within the staple cartridge 30300 during the firing stroke. In various embodiments, the central portion 30333 includes an upright hub 30334 with side walls 30335, the side walls being dimensional and constructed to move along the longitudinal slot within the staple cartridge 30300. The central portion 30333 also includes an arcuate lower profile 30334 dimensional and positioned to accommodate a rotary drive screw without interference.
[0293] The upright hub 30334 includes a recess or space 30328 between the side walls 30335 and a shaft or pin 30336 extending between the side walls 30335. A stopper 30337 also extends between the side walls 30334 and is further described herein. A knife 30338 of the threaded assembly 30320 is pivotably mounted on the pin 30336 in the hub 30339. In various embodiments, the hub 30339 can define a hub diameter that allows the knife 30338 to rotate around the pin 30336. Furthermore, the knife 30338 has a width narrower than the hub diameter and includes a mounting slot 30329 through which the pin 30336 passes in order to secure the hub 30339 to the pin 30336. In various embodiments, the knife 30338 can be snap-fitted or press-fitted onto the pin 30336, for example. Referring to the exploded view of the thread assembly 30320 in Figure 75, the knife 30338 can be moved along the assembly axis A in order to rotatably mount the knife 30338 onto the thread body 30321.
[0294] In various cases, the knife 30338 can pivot downward or to a recessed position relative to the thread body 30321. For example, the knife 30338 and its cutting edge can be directed, for example, generally downward and / or shielded by the side wall 30335 when the knife 30338 is in the recessed position. In a particular example, a biasing element is configured to bias the knife 30338 toward the recessed position.
[0295] Referring primarily to Figure 77, during the firing stroke, the firing member 30340 is advanced distally into the staple cartridge 30300, driving the distal extension 30347 and the fastener 30348 into the space 30328 between the side walls 30335 of the upright hub 30334. Once inserted into the space 30348, the fastener 30348 can hook around the end 30328 of the knife 30338. The end 30328 of the knife 30338 defines a flat contact surface 30327, and the spherical end 30327 extends together with the fastener 30348 to securely hold the fastener 30348 against the flat contact surface 30327. In this case, the fastener 30348 is held in the space 30328 at a position distal to the end 30328 of the knife 30338. Furthermore, the knife 30338 is rotated to a protruding position, in which case the cutting edge extends from the cartridge body 30302 and protrudes into the interstitial space defined between the tissue support surface 30304 and the anvil. In various cases, the distal extension 30347 and / or end 30328 are configured to bend under a predetermined load during distal firing to elastically connect the distal extension 30347 into the space 30328 of the thread assembly 30320.
[0296] Subsequently, the launching member 30340 can advance the thread assembly 30320 distally. As the thread assembly 30320 moves distally, the knife 30338 is pushed clockwise from the orientation shown in Figure 77. Resistance to the launching motion (e.g., tissue) may be configured to rotate the knife 30338 clockwise. The knife 30338 can rotate clockwise from the orientation in Figure 77 to engage with a stopper 30337 configured to prevent further clockwise rotation of the knife 30038. In such a case, the knife 30338 is maintained in an upright or protruding position relative to the tissue support deck 30304 during the distal movement of the launching stroke. For example, the contact surface 30327 may be flush or substantially flush with the inner surface of the fastener 30348.
[0297] Figure 77 shows the proximal retraction of the launch member 30320, with the launch member 30320 being pulled out in the proximal direction P. The retraction of the launch member 30320 in the proximal direction B is configured to pull the distal extension 30347 and the fastener 30348 proximal, thereby applying a force in the proximal direction to the end portion 30328 as well.
[0298] Next, this force on the end portion 30328 is configured to rotate the knife 30338 counterclockwise, while retracting the thread assembly 30320 together with the launching member 30320. In various cases, a slight clockwise rotation of the knife 30338 is configured to pivot, for example, the cutting edge of the knife 30338 downward in a direction that is less likely to contact and / or cut tissue.
[0299] In various cases, the interconnection between the launching member 30340 and the thread assembly 30320 is configured to ensure that the thread assembly 30320 and its knife 30338 are reset to their proximal position within the staple cartridge 30300 before the jaws are released from engagement by the cam members 30344, 30345, and 30351 of the launching member 30340 and can be opened. As the launching member 30340 retracts further and is withdrawn from the staple cartridge 30300, the distal extension 30347, the fastener 30348, and / or end 30328 may be configured to deflect the distal extension 30347 from the thread body 30321 and pivot the knife 30338 further counterclockwise from the orientation shown in Figure 77 to a shielded orientation.
[0300] In certain embodiments of this disclosure, the thread may be punched out from a metal sheet. In some cases, the thread may be a two-part thread formed from two punched sheets. In certain examples, the punched thread may have a substantially W-shaped outline. A knife may be integrated, for example, with one of the punched sheets. In certain examples, the two-part thread may include a first punched component that is retractable with the firing member and a second punched component that does not retract with the firing member. In a proximal non-firing position, the second punched component is configured to interact with and overcome a lost and spent cartridge lockout. In a distal firing position where the second punched component is not retracted by the firing member, the lost and spent cartridge lockout is configured to engage with the firing member and prevent the firing stroke.
[0301] A two-part thread and lockout configuration can prevent firing strokes when a staple cartridge is lost from the end effector and / or when a used or empty staple cartridge is placed inside the end effector. Furthermore, a thread formed from two punched metal sheets can provide a lower-cost thread and, in certain cases, has an integrated knife and cutting edge, a coupling mechanism for the firing member, and a lockout engagement mechanism. Such a punched metal thread can prevent bending or expansion of the thread rail under high staple forming loads and, in certain cases, can prevent thread breakage or cracking. Furthermore, a punched metal thread can define a thin rail that allows more plastic (or other materials) within the cartridge body, which can improve the strength of the cartridge body, including the strength of the support walls between the staple cavities. In certain examples, the thin profile of the punched metal thread can allow drivers to be positioned closer to each other and, in certain examples, better accommodate rotary drive screws.
[0302] Referring here to Figures 74-89, a thread assembly 30420 for the end effector 30440 (see Figure 82) is shown. The end effector 30440 is similar in many embodiments to the end effector 200 (see Figures 4 and 5) and is configured to cut and staple patient tissue. The end effector 30440 includes, for example, a cartridge jaw 30450 and an anvil jaw 30454, the cartridge jaw 30450 being configured to receive a staple cartridge 30400 having a cartridge body 30402 and a tissue support deck 30404, which is similar in many embodiments to, for example, a staple cartridge 220 (see Figures 4 and 5). The end effector 30440 also includes a firing drive system 30339, which includes a rotary drive screw 30442 and a firing member 30441, similar to the firing screw 261 (see Figures 4 and 5) and the firing member 270 (see Figures 4 and 5), respectively. The cartridge jaw 30450 defines a channel having opposing side walls 30452, configured to receive a staple cartridge 30400 containing staples that can be ejected as the firing member 30441 advances through the staple cartridge 30400. For example, the firing member 30341 is driven via the end effector 30340 as the rotary drive screw 30442 rotates during the firing stroke, advancing the thread assembly 30420.
[0303] Referring mainly to Figure 81, the firing member 30441 includes a main body portion 30443, upper cam members 30444 extending laterally from both sides of the main body portion 30443, and lower cam members 30445 extending laterally from both sides of the main body portion 30443. The upper cam member 30444 is configured to engage with the anvil jaw 30454 of the end effector 30400 by cam action during the firing stroke, and the lower cam member 30445 is configured to engage with the cartridge jaw 30450 of the end effector 30440 by cam action during the firing stroke.
[0304] In addition to the above, a longitudinal opening extends through the main body portion 30343. The longitudinal opening is configured to receive the rotary drive screw 30442 described above. In certain examples, the rotary drive screw 30442 can be screw-connected to the main body portion 30343, and in other examples, it can be screw-connected to a launch drive nut housed therein, as will be further described herein.
[0305] Referring primarily to Figures 78-81, the thread assembly 30420 includes two separate threads, namely a proximal thread 30422 and a distal thread 30424. Each thread 30422, 30424 is a distinct, separate punched component. For example, each thread 30422, 30424 can be formed by a separate punch. The threads 30422, 30424 are formed from a punched material sheet, such as a metal sheet. In at least one embodiment, the threads 30422, 30424 are formed from a steel plate; however, other materials may also be conceived. The proximal thread 30422 and the distal thread 30422 cooperate to engage with a driver 30416 housed within the cartridge body 30402. The driver 30416 can be a triple driver in various cases, and in many embodiments may be similar to, for example, driver 20120 (Figure 26).
[0306] The proximal thread 30422 and the distal thread 30424 can be connected by a push connection. In other words, while the proximal thread 30422 is applying a pushing force to the distal thread 30424, threads 30422 and 30424 may remain connected. Without a pushing force, threads 30422 and 30424 are separable components and can, in some cases, be selectively moved and rearranged.
[0307] Each thread 30422, 30424 includes a pair of punched wedges that form a rail. The proximal thread 30422 includes an outer rail 30423 for the thread assembly 30420, and the distal thread 30424 includes an inner rail 30425 for the thread assembly 30420. The outer rail 30423 and the inner rail 30425 may be configured to move along each side of the staple cartridge during the firing stroke and may be aligned with the row of drivers 30416. Between the rails 30423, 30425, the proximal and distal threads 30422, 30424 each include central upright portions 30426, 30428, respectively, the central upright portions 30426, 30428 defining lower arcuate outlines 30426a, 30428a to accommodate a rotary drive screw 30442 (Figure 81) through them. The central upright sections 30426 and 30428 also include keys 30426b and 30428b, respectively, which are configured to align and guide the threads 30422 and 30424 through the cartridge body 30402. The keys 30426b and 30428 are arc-shaped loops, but other geometric shapes can also be conceived. Right-angle flanges connect, for example, the central upright sections 30426 and 30428 to the respective rails 30423 and 30425. The right-angle flanges have the same thickness as the associated rails 30423 and 30425 due to their punching formation.
[0308] The thread assembly 30420 is shown inside the staple cartridge in Figure 88. The thickness of the metal sheet may correlate with the thickness of the rails 30423, 30425. In such an example, the inner rail 30423 necessarily has the same thickness, and the outer rail 30423 necessarily has the same thickness. In at least one embodiment, the inner rail 30423 and the outer rail 30423 may be punched separately but have the same thickness. In any case, since it is formed from a thin metal sheet, the thread assembly 30420 can have a reduced thickness while still being able to withstand high loads without bending and / or breaking. For example, the rails 30423, 30425 may be narrower than the cartridge wall between the staple cavities in adjacent longitudinal rows. For comparison, referring to staple cartridge 30500 in Figure 89, which has the same overall width and staple line shape, the inner rail 30523 and outer rail 30525 of the thread 30530 (e.g., molded plastic thread) within the cartridge body 30502 may be wider than the rails 30423 and 30425. In such an example, the cartridge body 30502 may have less space, and therefore less material and associated strength, for example, to support the inner row of the driver.
[0309] The proximal thread 30422 and distal thread 30424 can be aligned and assembled along assembly axis A (Figure 79). Once assembled, the central upright portions 30426 and 30428 can be staggered longitudinally, and the proximal portion of the inner rail 30425 can be rested on the orthogonal flange of the proximal thread 30422 (see Figure 80). Furthermore, the orthogonal flanges of both threads 30422 and 30424 are configured to slide along or otherwise move along a lower support surface, such as the inner surface of the cartridge jaw 30450 (see Figure 82).
[0310] Still referring to Figures 78-81, the proximal thread 30422 also includes an integrated knife 30430 having a distally facing cutting edge 30432. The knife 30430 may cut into a sheet of material, for example, when the proximal thread 30422 is punched out. The proximal thread 30422 also includes a proximal tail or extension 30434, which is configured to be releasably connected to the launching member 30441 (Figure 81) when the staple cartridge 30400 and its drive assembly 30420 are installed in the cartridge jaw 30450 (Figure 82). The proximal extension 30434 is T-shaped and includes a lateral bias configured to facilitate connection with a T-shaped recess 30448 (Figure 81) in the launching member 30441. For example, referring to Figure 87, the proximal extension 30434 can initially reside within a notch in the cartridge body 30402, which allows the proximal thread 30422 to be held in place relative to the cartridge body 30402. Then, as the launching member 30442 moves distally, the proximal extension 30434 bends into the T-shaped recess 30448, locking the proximal thread 30422 into the launching member 30442. Alternative complementary shapes can also be conceived to connect the proximal extension 30434 and the launching member 30441.
[0311] In various cases, once the staple cartridge 30400 is positioned within the cartridge jaw 30450, the launching member 30441 may be aligned with the drive assembly 30420 and, as shown in Figure 81, may be configured to move to engage with the drive assembly 30420 as the launching member 30441 moves distally over an initial distance during the firing stroke. Referring to Figure 87, for example, as the launching member 30441 begins to move proximal, deflection into the recess 30448 of the proximal extension 30434 is possible.
[0312] The proximal extension 30434 may be biased to retain engagement with a recess 30448 in the body 30443 of the launching member 30441, and may remain engaged with the recess 30448 during the proximal and distal displacement(s) of the launching member 30441 until the launching member 30441 is finally pulled proximal to the staple cartridge 30400, or nearly pulled out from the staple cartridge 30400, at the completion of the firing stroke. When the launching member 30441 is releasably attached to the proximal thread 30422, the upright body portion 30443 of the launching member 30441 is aligned with the knife 30430. As shown in Figure 81, the body portion 30443 can support the knife 30430 as it advances through the tissue. In various cases, additional support from the main body is configured to prevent the knife 30430 from deflecting away from the firing path and longitudinal axis of the end effector 30440.
[0313] The distal thread 30424 is pushed distally by the proximal thread 30422 during the firing stroke. The distal thread 30424 further includes a foot 30429 (Figure 86) extending downward from the rail 30245 and / or orthogonal flange. The foot 30429 may be configured to move through a slot in the cartridge jaw 30450 during the firing stroke when the firing member 30441 pushes the proximal thread 30422, and the proximal thread pushes the distal thread 30424 distally during the firing stroke. In various cases, the foot 30429 is configured to engage a lockout in the end effector 30440 when the distal thread 30424 is retained in the proximal unfired position. The distal thread 30424 and its lockout mechanism are further described herein.
[0314] Referring primarily to Figures 82-84, the end effector 30440 includes a lockout arm 30460 that is selectively engaged by a distal thread 30424. The lockout arm 30460 is movable between a locked position (Figures 82-84) in which firing stroke is prevented and an unlocked position (Figure 85) in which firing stroke is permitted. The lockout arm 30460 is flexibly positioned within a longitudinal recess 30453 in the channel portion of the cartridge jaw 30450 and, in certain examples, is configured to pivot around a central pivot portion 40646.
[0315] The lockout arm 30460 includes a proximal end 30466 that is biased into a lockout notch 30449 within the launch member 30341. For example, a spring 30470 located within the cartridge jaw 30450 is configured to push the proximal end 30466 into the lockout notch 30449 of the launch member 30341 when the launch member 30341 is in a proximal pre-launch stroke position. When the proximal end 30466 of the lockout arm 30460 is received into the lockout notch 30449, the lockout arm 30460 is configured to resist the translation of the launch member 30441 and thus prevent the launch stroke.
[0316] The thread assembly 30420 is configured to overcome the lockout arm 30460 by removing its proximal end 30466 from the lockout notch 30449. More specifically, when the distal thread 30424 is positioned in the proximal unfired position within the staple cartridge 30400, the foot 30429 of the distal thread 30424 is positioned to engage with the distal end 30462 of the lockout arm 30460 (see Figure 85). The pivot portion 30464 of the lockout arm 30400, located between the proximal end 30466 and the distal end 30462, is held within the arched support 30451 within the cartridge jaw 30450. The pivot portion 30464, and thus the entire lockout arm 20468, is configured, in a particular example, to pivot around the arched support 30451.
[0317] For example, the lockout arm 30460 pivots from the locked position to the unlocked position when the staple cartridge 30400 is installed in the end effector 30440 and the distal thread 30424 is in the proximal unfired position, indicating that the staple cartridge is not in use or is empty. The lockout arm 30460 pivots from the unlocked position to the locked position when the firing member 30441 pushes the proximal thread 30422 distally, which pushes the distal thread 30422 distally. When the lower upper foot 30429 of the distal thread 30422 disengages from the distal end 30462 of the lockout arm 30460, the lockout arm 30460 pivots due to the biasing force of the spring 30470. If the launching member later returns to its proximal position after the launch stroke and attempts to move the lockout notch 30449 beyond the lockout arm 30460, the spring 30470 pushes the proximal end 30466 of the lockout arm 30460 into the lockout notch 30449, preventing the launch stroke. The foot 30429 moves along the longitudinal recess 30453 in the channel 30450 during the launch stroke.
[0318] As described herein, the two-part thread assembly 30420 is configured to selectively overcome the lockout arm 30460 and enable the firing stroke. Furthermore, the thread assembly 30420 includes an integrated knife 30430, which is a single-use knife 30420 having a appropriately sharp cutting edge 30432 for excising tissue clamped by the end effector 30440. The single-use knife 30420 is retracted proximal together with the firing member 30441 upon completion of the firing stroke. Furthermore, since the firing beam 30441 includes opposing cams 30445, 30446, the firing member 30441 can ensure that the jaws 30450, 30542 remain closed until the knife 30420 is returned to its proximal position within the staple cartridge 30400.
[0319] As described herein, certain surgical devices may include a reusable knife incorporated into the surgical device, such as a distally oriented knife edge on a firing member. Once the firing stroke is complete, the reusable knife can be retracted from the staple cartridge and then re-fired with another staple cartridge. In such applications, the surgical device including the reusable knife may be cleaned and sterilized between surgical procedures.
[0320] In other examples, single-use knives can be used with surgical devices. For example, a staple cartridge may include a single-use knife used only with that particular staple cartridge. When the staple cartridge is removed from the surgical device, the single-use knife is also removed. When a replacement staple cartridge is installed in the surgical device, a new single-use knife is provided with the surgical device. In certain examples, the single-use knife may remain in the staple cartridge for the duration of the firing stroke, and even after the firing stroke, when the staple cartridge is removed from the surgical device. In certain cases, the cutting edge of the single-use knife may be at least partially shielded by the mechanism of the staple cartridge after the firing stroke and / or when the staple cartridge is removed from the surgical device. In certain cases, the knife or a part thereof may be folded or otherwise deformed and / or pushed downward into the staple cartridge from a protruding orientation.
[0321] For example, a staple cartridge may include a two-part thread assembly comprising a proximal thread and a distal thread. The proximal thread can be connected to a launching member when the two-part thread assembly is inserted into the surgical device. The distal thread may include an upright cutting edge. During the firing stroke, the launching member is configured to push the proximal thread distally, which in turn pushes the distal thread distally to excise tissue. Once the firing stroke is complete, the proximal thread can be retracted proximal by the launching member and separated from the distal thread. As the proximal thread is retracted proximal, the central ledge of the proximal thread is configured to move over the upright cutting edge, folding the cutting edge downward into the cartridge body. In various cases, the proximal thread may also include a support mechanism to support the upright cutting edge during the firing stroke.
[0322] In certain examples, a two-part thread assembly can be manufactured from a punched metal sheet, which can be a lower-cost alternative to other manufacturing techniques. A punched metal thread assembly may have thinner rails, but in certain examples, it is stronger than plastic thread for the same-sized staple cartridge. Furthermore, a punched metal thread assembly can form staples with less rebound and / or, in certain cases, allows staples to be positioned closer to each other in the staple line. In certain examples, the knife can be configured to sink and / or deform into the cartridge body at any point along the length of the firing stroke, allowing only the proximal stamped thread component to retract with the firing member. The folding and / or deformation of the knife during the proximal retraction of the firing member and the proximal stamped thread component can ensure that the knife is not reused during subsequent surgical procedures. In certain examples, the proximal stamped thread component and the firing member may be positioned to support the distal stamped thread component and its knife during the distal firing stroke.
[0323] Referring here to Figures 90-98, a two-part thread assembly 30620 is shown. The thread assembly 30620 includes two separate threads, namely a proximal thread 30622 and a distal thread 30624. Each thread 30622, 30624 is a distinct, separate punched component. For example, each thread 30622, 30624 can be formed by a separate punch. The threads 30622, 30624 are formed from a punched material sheet, such as a metal sheet. In at least one embodiment, the threads 30622, 30624 are formed from a steel sheet; however, other materials may also be conceived. The proximal thread 30622 and the distal thread 30622 cooperate to engage a driver 30616 (Figure 92) housed within a cartridge body 30602. Driver 30616 can be a triple driver in various cases, and may be similar to, for example, driver 20120 (Figure 26) in many embodiments.
[0324] The proximal thread 30622 and the distal thread 30624 can be connected by a push connection. In other words, while the proximal thread 30622 is applying a pushing force to the distal thread 30624, threads 30622 and 30624 may remain connected. When no pushing force is applied, threads 30622 and 30624 are separable components that can be selectively moved and rearranged in certain cases.
[0325] Each thread 30622, 30624 includes a pair of punched wedges that form a rail. The proximal thread 30622 includes an outer rail 30623 for the thread assembly 30620, and the distal thread 30624 includes an inner rail 30625 for the thread assembly 30620. The outer rails 30623 and inner rails 30625 may be configured to move along each side of the staple cartridge during the firing stroke and may be aligned with a row of drivers 30616. The proximal thread 30622 includes a central upright portion 30626 and a right-angle flange 30621 that connects the central upright portion 30426 to each outer rail 30623. The right-angle flange 30621 is configured to ride along the lower support surface (e.g., along the inner surface of the cartridge jaws) during the firing stroke and has the same thickness as the outer rail 30423 due to the punching formation of the proximal thread 30622. The central upright portion 20426 is dimensioned to fit around a portion of the distal thread 20624 and defines the ledge 30627.
[0326] The distal thread 30624 includes a central upright portion 30628 and a right-angle flange 30619 connecting the central upright portion 30626 to each inner rail 30625. The right-angle flange 30619 is configured to ride along the lower support surface (e.g., along the inner surface of the cartridge jaw) during the firing stroke and has the same thickness as the inner rail 30625 due to the punching formation of the distal thread 30624. The central upright portion 30628 defines a lower arcuate outer shape 30626a, which is dimensioned to accommodate a rotary drive screw 30642 (Figure 92) through it. In many embodiments, the rotary drive screw 30642 is similar to the firing screw 261 (see Figures 4 and 5). The central upright portion 30628 further includes an extending knife 30629 having a distally facing cutting edge 30630. The central upright portion 30626 of the proximal thread 30622 is configured to fit around the central upright portion 30626 of the distal thread 30622, except for the extending knife 30629 that extends beyond the ledge 30627 and the upper edge of the central upright portion 30628. The distal thread 30624 also includes a retraction prevention arm 30632, which is laterally biased and engages with the cartridge body 30602 to prevent the proximal retraction of the distal thread 30624 after the firing stroke. In certain cases, the retraction prevention arm 30632 may be positioned on each lateral side of the distal thread 30624.
[0327] Referring primarily to Figure 92, the thread assembly 30620 is a component of the staple cartridge 30600, which also includes a cartridge body 30602, a driver 30616, and staples detachably disposed within the cartridge body 30602. In various cases, the staple cartridge 30600, including its thread assembly 30620, may be removably installed in a surgical device or its end effector having a cartridge jaw, anvil jaw, and a launching member, as further described herein. Once the stapling motion is complete, the staple cartridge 30600, including the thread 30620, may be removed from the end e...
Claims
1. A fastening cartridge, A body comprising a tissue support deck, wherein a fastener cavity is defined through the tissue support deck within the body, the fastener cavity comprises a first cavity, and the tissue support deck is The opposing side of the tissue, A body comprising: a lower surface on the opposite side of the tissue-facing side, having a lower contour adjacent to the first cavity; A fastener removably disposed within the fastener cavity, A driver configured to movably support the fastener and move to a launch position through a portion of the fastener cavity to eject the fastener from the fastener cavity, wherein the driver comprises a first driver, and the first driver is A first support column equipped with a first fastening cradle, A driver comprising: a base extending laterally from the first support column, having an upper contour configured to engage with the lower contour when the first driver is in the firing position; The lower contour comprises a recess that does not penetrate, and the upper contour comprises a projection configured to nest within the recess when the first driver is in the firing position. A fastener cartridge comprising a first driver, a second support column offset laterally from the first support column, and a second support column having a second fastener cradle, wherein the base forms a bridge between the first support column and the second support column, and the upper part of the bridge has the upper contour.
2. The fastener cartridge according to claim 1, further comprising a thread having a thread rail configured to move along a firing path during a firing stroke for drive-engaging to the first driver, wherein the upper part of the bridge is asymmetrical with respect to the firing path.
3. The fastener cartridge according to claim 2, wherein the first driver is moved upward by the thread to the launch position such that the first fastener cradle extends from the fastener cartridge beyond the tissue support deck.
4. The bridge comprises a first bridge, the fastener cavity further comprises a second cavity, the lower surface further comprises a second lower contour adjacent to the first cavity, and the first driver is A third support column is offset laterally from the first and second support columns and is equipped with a third fastening cradle, The fastener cartridge according to claim 1, further comprising: a second bridge between the second support and the third support, the upper surface of the second bridge having a second upper contour configured to engage with the second lower contour when the first driver is in the firing position.
5. The thread further comprises, A first threaded rail configured to move along a first firing path during the firing stroke and to drive-engage with the first bridge, The fastener cartridge according to claim 4, comprising: a second thread rail configured to move along a second firing path during the firing stroke and drive-engage with the second bridge, wherein the upper part of the second bridge is asymmetrical with respect to the second firing path.
Citation Information
Patent Citations
Surgical cutting / stapling device with self-adjusting anvil
JP2010504807A
Staple driving assembly
JP2013176610A
Micro-surgical instrument and loading unit for use therewith
JP2017064399A
Surgical Staple and Driver Placement for Staple Cartridge
JP2017532123A
Fastener cartridge including a layer attached thereto
US20150297235A1