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WO2024218633A1 - Surgical stapling device with floating knife - Google Patents

Surgical stapling device with floating knife Download PDF

Info

Publication number
WO2024218633A1
WO2024218633A1 PCT/IB2024/053667 IB2024053667W WO2024218633A1 WO 2024218633 A1 WO2024218633 A1 WO 2024218633A1 IB 2024053667 W IB2024053667 W IB 2024053667W WO 2024218633 A1 WO2024218633 A1 WO 2024218633A1
Authority
WO
WIPO (PCT)
Prior art keywords
knife
cartridge
assembly
latch
working member
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/053667
Other languages
French (fr)
Inventor
Logamurugaraj Shanmugavel
Suresh Kumar Prema Mohanasundaram
Satish Gundala
Shaik Ahmed Sajid HUSSAIN
Sanket Anil NAWATE
Kenneth H. Whitfield
Roanit A. Fernandes
Vincent LAFRAGOLA JR.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Covidien LP
Original Assignee
Covidien LP
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Covidien LP filed Critical Covidien LP
Priority to CN202480025760.XA priority Critical patent/CN120957671A/en
Publication of WO2024218633A1 publication Critical patent/WO2024218633A1/en
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07278Stapler heads characterised by its sled or its staple holder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0801Prevention of accidental cutting or pricking
    • A61B2090/08021Prevention of accidental cutting or pricking of the patient or his organs

Definitions

  • This disclosure is directed to surgical stapling devices and, more particularly, to surgical stapling devices that have a tool assembly including a staple cartridge having a knife.
  • Surgical stapling devices for ejecting staples to join tissue or tissue segments in a fast and efficient manner in a variety of surgical procedures, e.g., anastomoses procedures, are well known.
  • a surgical stapling device includes a tool assembly having first and second jaws that support a cartridge assembly and an anvil, respectively.
  • the cartridge assembly includes a staple cartridge that supports a plurality of staples.
  • the first and second jaws are mounted together to allow movement of the tool assembly between open and clamped positions. In the clamped position, the staple cartridge of the cartridge assembly and the anvil are supported in juxtaposed alignment and include tissue contact surfaces that define a predetermined tissue gap.
  • the tissue gap and the size of the staples within the staple cartridge are dimensioned to receive and suture tissue having a thickness within a predetermined range to properly effect hemostasis. If the tissue positioned between the jaws is outside the predetermined range, i.e., either too thick or too thin, the stapling device may not provide effective hemostasis. In addition, if the tissue thickness is misidentified by the clinician or if the tissue thickness falls near the outer edges of the range for a given staple size, the likelihood of ineffective hemostasis is increased.
  • This disclosure is directed to a surgical stapling device having a tool assembly including an anvil, a cartridge assembly, and a drive assembly.
  • the cartridge assembly includes a channel that defines a cavity and a staple cartridge that is supported within the cavity for movement between a raised position and a lowered position.
  • the drive assembly includes a working member having an I-beam configuration.
  • the staple cartridge includes an actuation sled that can move in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions.
  • the knife is coupled to the working member and is movable in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions.
  • the actuation sled supports the knife and can pivot from a knife raised position to a knife lowered position when the actuation sled moves from a sled retracted position to a sled advanced position.
  • One aspect of the disclosure is directed to a tool assembly including an anvil, a cartridge assembly, and a drive assembly.
  • the cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between an unclamped position and a clamped position.
  • the cartridge assembly includes a channel, a compliant member, and a staple cartridge.
  • the channel includes side walls and a bottom wall that define a cavity, and the staple cartridge is received within the cavity of the channel.
  • the staple cartridge includes a cartridge body, staples, an actuation sled, a knife, and a latch having a width.
  • the cartridge body defines a knife slot and staple receiving pockets, and the staples are received within the staple receiving pockets.
  • the actuation sled is movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body, and the knife is movable with the actuation sled from a knife retracted position to a knife advanced position.
  • the compliant member is positioned on the channel to support the staple cartridge within the cavity of the channel for movement between a cartridge raised position and a cartridge lowered position.
  • the drive assembly includes a flexible drive beam and a working member.
  • the flexible drive beam has a distal portion secured to the working member, and the working member has an I-shaped configuration and includes a first beam, a second beam, and a vertical strut.
  • the vertical strut has a distal end and a proximal end and defines a recess having a height that extends across the vertical strut from the distal end to the proximal end.
  • the drive assembly is movable between a drive retracted position and a drive advanced position to move the actuation sled from the sled retracted position to the sled advanced position and to move the knife between the knife retracted position and the knife advanced position.
  • the latch extends through the recess and is configured to couple the knife to the vertical strut of the working member.
  • the latch is movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member as the staple cartridge moves between the cartridge raised position and the cartridge lowered position.
  • a stapling device including a handle assembly, an adapter assembly, and a tool assembly.
  • the adapter assembly has a proximal portion and a distal portion, and the proximal portion of the adapter assembly is coupled to the handle assembly.
  • the tool assembly is coupled to the distal portion of the adapter assembly and includes an anvil, a cartridge assembly, and a drive assembly.
  • the cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between an unclamped position and a clamped position.
  • the cartridge assembly includes a channel, a compliant member, and a staple cartridge.
  • the channel includes side walls and a bottom wall that define a cavity, and the staple cartridge is received within the cavity of the channel.
  • the staple cartridge includes a cartridge body, staples, an actuation sled, a knife, and a latch having a width.
  • the cartridge body defines a knife slot and staple receiving pockets, and the staples are received within the staple receiving pockets.
  • the actuation sled is movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body, and the knife is movable with the actuation sled from a knife retracted position to a knife advanced position.
  • the compliant member is positioned on the channel to support the staple cartridge within the cavity of the channel for movement between a cartridge raised position and a cartridge lowered position.
  • the drive assembly includes a flexible drive beam and a working member.
  • the flexible drive beam has a distal portion secured to the working member, and the working member has an I-shaped configuration and includes a first beam, a second beam, and a vertical strut.
  • the vertical strut has a distal end and a proximal end and defines a recess having a height that extends across the vertical strut from the distal end to the proximal end.
  • the drive assembly is movable between a drive retracted position and a drive advanced position to move the actuation sled from the sled retracted position to the sled advanced position and to move the knife between the knife retracted position and the knife advanced position.
  • the latch extends through the recess and is configured to couple the knife to the vertical strut of the working member.
  • the latch is movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member as the staple cartridge moves between the cartridge raised position and the cartridge lowered position.
  • the recess is defined by a guide surface that extends from the distal end of the vertical strut towards the proximal end of the vertical strut and upwardly towards the first beam in a proximal direction.
  • the compliant member includes a wave spring that is positioned on the bottom wall of the channel.
  • the bottom wall of the channel defines a knife slot that is longitudinally aligned with the knife slot of the cartridge body, and the wave spring is positioned on the bottom wall of the channel on opposite sides of the knife slot.
  • the knife is positioned between the actuation sled and the working member of the drive assembly and is movable with the working member between a knife retracted position and a knife advanced position.
  • the knife includes a cutting edge and is movable through the knife slot of the cartridge body between the knife retracted position and the knife advanced position.
  • the latch is movable from a non-deformed state spaced from the vertical strut of the working member of the drive assembly to a deformed state engaged with the vertical strut of the working member.
  • the latch is movable from the non-deformed state to the deformed state in response to movement of the latch into the knife slot of the cartridge body.
  • the cartridge body includes a tissue engaging surface and knife guards that extend upwardly from the tissue engaging surface towards the anvil, and the cutting edge of the knife is positioned between the knife guards when the knife is in the knife retracted position.
  • the knife includes a distal surface in abutting relation to the actuation sled.
  • a tool assembly including an actuation sled, a knife, and a drive assembly.
  • the actuation sled includes a central portion and cam members positioned on opposite sides of the central portion.
  • the knife includes a cutting edge and supports a latch having a width.
  • the drive assembly includes a flexible drive beam and a working member, and the flexible drive beam has a distal portion that is secured to the working member.
  • the working member has an I-shaped configuration and includes a first beam, a second beam, and a vertical strut.
  • the vertical strut has a distal end and a proximal end and defines a recess having a height that extends across the vertical strut from the distal end to the proximal end.
  • the latch extends through the recess and is configured to couple the knife to the vertical strut of the working member.
  • the latch is movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member.
  • a tool assembly including an anvil and a cartridge assembly.
  • the cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between open and clamped positions and includes a channel member and a staple cartridge.
  • the channel member includes side walls and a bottom wall that define a cavity.
  • the staple cartridge is received within the cavity of the channel member and includes a cartridge body, staples, an actuation sled, and a staple guard.
  • the cartridge body includes an upper tissue engaging surface and defines a knife slot and staple receiving pockets that are positioned on each side of the knife slot. The staples are received within the staple receiving pockets.
  • the actuation sled supports a knife and is movable within the cartridge body from a sled retracted position to a sled advanced position to eject the staples from the staple receiving pockets.
  • the staple guard is secured to a lower portion of the cartridge body to retain the staples within the cartridge body.
  • the cartridge body includes a first structure, and the actuation sled includes a second structure. The first structure engages the second structure when the actuation sled moves to the sled advanced position to retain the actuation sled in the sled advanced position and allow the actuation sled to move from a first position in which the knife is exposed to a second position in which the knife is shielded.
  • the first structure includes protrusions
  • the second structure includes concavities
  • the actuation sled pivots from the first position to the second position.
  • the first structure includes ribs
  • the second structure includes elongated concavities
  • the actuation sled moves along a linear path from the first position to the second position.
  • the tool assembly includes a biasing member that is supported on the cartridge body and is positioned to engage the actuation sled when the actuation sled is in the sled advanced position to urge the actuation sled towards the second position.
  • a surgical stapling device including a drive assembly, a knife holder, and an actuation sled.
  • the drive assembly includes a working member having an I-shaped configuration and including a first beam, a second beam, and a vertical strut.
  • the vertical strut defines a vertical axis and supports a knife having a distally facing cutting edge.
  • the knife includes cam members that are positioned distally of the vertical strut.
  • the knife holder includes a base portion, a central portion, and guide members positioned outwardly of the central portion.
  • the central portion of the knife holder includes a resilient arm and inner surfaces that define a cavity.
  • the inner surfaces of the central portion of the knife holder define cam slots that receive the cam members of the knife to facilitate movement of the knife holder in relation to the working member and the knife in a direction parallel to the vertical axis of the vertical strut.
  • the resilient arm extends from the central portion of the knife holder in a direction away from the working member.
  • the actuation sled includes a central portion and cam members positioned on opposite sides of the central portion of the actuation sled.
  • the resilient arm of the knife holder is releasably engaged with the central portion of the actuation sled, and the knife holder and the actuation sled are movable in relation to the working member and the knife between raised and lowered positions.
  • the central portion of the actuation sled includes a detent
  • the resilient arm of the knife holder defines a concavity
  • the detent is received within the concavity to couple the knife holder to the actuation sled.
  • the vertical strut defines an elongate slot that receives a proximal portion of the knife.
  • the knife includes first and second protrusions and the vertical strut of the working member defines first and second transverse slots that communicate with the elongate slot.
  • first and second protrusions are received within the first and second transverse slots to secure the knife to the working member.
  • FIG. 1 is a side perspective view of a stapling device including aspects of the disclosure with a tool assembly of the stapling device in an open position;
  • FIG. 2 is an exploded, side perspective view of the cartridge assembly and a distal portion of a drive assembly of the stapling device shown in FIG. 1 ;
  • FIG. 2A is an exploded view of the staple cartridge of the cartridge assembly shown in FIG. 2;
  • FIG. 3 is a side perspective view of a working member of the drive assembly and a knife bar of a staple cartridge of the cartridge assembly of the stapling device shown in FIG. 1 ;
  • FIG. 4 is a side view of tool assembly of the stapling device shown in FIG. 1 clamped about thin tissue as the stapling device is fired with the knife bar of the staple cartridge coupled to the working member of the drive assembly and the remaining components of the tool assembly shown in phantom;
  • FIG. 5 is an enlarged view of the indicated area of detail shown in FIG. 4;
  • FIG. 6 is an enlarged view of the indicated area of detail shown in FIG. 4;
  • FIG. 7 is a side perspective view of the working member of the drive assembly and the knife bar of the staple cartridge of the cartridge assembly as shown in 4;
  • FIG. 8 is a side view of tool assembly of the stapling device shown in FIG. 1 clamped about thick tissue as the stapling device is fired with the knife bar of the staple cartridge coupled to the working member of the drive assembly and the remaining components of the tool assembly shown in phantom;
  • FIG. 9 is an enlarged view of the indicated area of detail shown in FIG. 8;
  • FIG. 10 is an enlarged view of the indicated area of detail shown in FIG. 8;
  • FIG. 11 is a side perspective view of the working member of the drive assembly and the knife bar of the staple cartridge of the cartridge assembly as shown in 8;
  • FIG. 12 is a side perspective view of an alternate version of the tool assembly of the stapling device shown in FIG. 1 with the staple cartridge separated from the channel of the cartridge assembly;
  • FIG. 13 is a side view of the staple cartridge and the channel of the cartridge assembly of the tool assembly shown in FIG. 12 with the staple cartridge positioned above the channel prior to insertion of the staple cartridge within the channel;
  • FIG. 14 is a side view of the cartridge assembly of the tool assembly shown in FIG. 12 with the staple cartridge inserted within the channel;
  • FIG. 15 is an exploded perspective view of the staple cartridge of the cartridge assembly shown in FIG. 12;
  • FIG. 16 is an enlarged perspective view of the indicated area of detail shown in FIG. 15 illustrating the actuation sled assembly of the staple cartridge with a latch of the actuation sled of the actuation sled assembly separated from the actuation sled;
  • FIG. 17 is a perspective view of the actuation sled assembly shown in FIG. 16 with the latch of the actuation sled assembly coupled to the actuation sled;
  • FIG. 18 is a side perspective view of an alternate version of the distal portion of the drive assembly of the stapling device shown in FIG. 1 ;
  • FIG. 19 is a bottom perspective cutaway view of the distal portion of the cartridge body of the staple cartridge shown in FIG. 15;
  • FIG. 20 is a perspective cutaway view of a proximal portion of the staple cartridge shown in FIG. 15;
  • FIG. 21 is a cross-sectional view taken along section line 21-21 of FIG. 20;
  • FIG. 22 is a side perspective view of the tool assembly shown in FIG. 12 in the clamped position with all the components of the tool assembly except the actuation sled assembly and the drive assembly shown in phantom;
  • FIG. 23 is an enlarged view of the indicated area of detail shown in FIG. 22 illustrating the actuation sled assembly and the drive assembly of the stapling device with the actuation sled assembly and drive assembly in the clamped position;
  • FIG. 24 is a cross-sectional view taken along section line 24-24 of FIG. 23;
  • FIG. 25 is a side perspective view of the actuation sled assembly and the drive assembly shown in FIG. 23 with the actuation sled assembly and drive assembly in an engaged position during the firing of the stapling device;
  • FIG. 26 is a cross-sectional view taken along section line 26-26 of FIG. 25;
  • FIG. 27 is a side perspective view of the distal portion of the tool assembly shown in FIG. 12 during firing of the stapling device with the actuation sled assembly and the drive assembly in advanced positions and all the components of the tool assembly except the actuation sled assembly and the drive assembly shown in phantom;
  • FIG. 28 is a cross-sectional view taken along section line 28-28 of FIG. 27;
  • FIG. 29 is a side perspective view of the distal portion of the tool assembly shown in FIG. 27 during firing of the stapling device as the actuation sled assembly and the drive assembly are retracted from their advanced positions with all the components of the tool assembly except the actuation sled assembly and the drive assembly shown in phantom;
  • FIG. 30 is a perspective view from above of the distal portion of the tool assembly shown in FIG. 27 during firing of the stapling device as the actuation sled assembly and the drive assembly are retracted from their advanced positions with the anvil shown in phantom;
  • FIG. 31 is an exploded side perspective view of an alternate version of the staple cartridge and drive assembly of the stapling device shown in FIG. 1 ;
  • FIG. 32 is an enlarged view of the indicated area of detail shown in FIG. 31 illustrating a side perspective view of the actuation sled;
  • FIG. 33 is a perspective cutaway bottom view of a distal portion of a cartridge body and biasing member of the staple cartridge shown in FIG. 31 ;
  • FIG. 34 is a side perspective view of the distal portion of a tool assembly including the staple cartridge shown in FIG. 31 during firing of the stapling device with the actuation sled assembly and the drive assembly in advanced positions and all the components of the tool assembly except the actuation sled assembly, the drive assembly, and the biasing member of the staple cartridge shown in phantom;
  • FIG. 35 is a bottom perspective, cutaway view of the distal portion of the staple cartridge shown in FIG. 31 with the actuation sled in an advanced position;
  • FIG. 36 is a side perspective view of the distal portion of the tool assembly shown in FIG. 34 during firing of the stapling device as the actuation sled assembly and the drive assembly are retracted from their advanced positions with all the components of the tool assembly except the actuation sled assembly, the drive assembly, and the biasing member shown in phantom;
  • FIG. 37 is a side perspective view of an alternate version of the drive assembly and the actuation sled assembly of the stapling device shown in FIG. 1 ;
  • FIG. 38 is an exploded side perspective view of the actuation sled assembly and drive assembly shown in FIG. 37;
  • FIG. 39 is a cross-sectional view taken along section line 39-39 of FIG. 38;
  • FIG. 40 is a cross-sectional view taken along section line 40-40 of FIG. 37;
  • FIG. 41 is a side view of the actuation sled assembly and drive assembly shown in
  • FIG. 37 with the actuation sled assembly in a raised position; and [0071] FIG. 42 is a side view of the actuation sled assembly and drive assembly shown in FIG. 37 with the actuation sled assembly in a lowered position.
  • proximal is used generally to refer to that portion of the device that is closer to a clinician when the device is used in its customary manner
  • distal is used generally to refer to that portion of the device that is farther from the clinician when the device is used in its customary manner.
  • clinical is used generally to refer to medical personnel including doctors, nurses, and support personnel.
  • directional terms such as front, rear, upper, lower, top, bottom, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.
  • the disclosure is directed to a surgical stapling device having a tool assembly including an anvil, a cartridge assembly, and a drive assembly.
  • the cartridge assembly includes a channel that defines a cavity and a staple cartridge that is supported within the cavity for movement between a raised position and a lowered position.
  • the drive assembly includes a working member having an I-beam configuration.
  • the staple cartridge includes an actuation sled that can move in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions.
  • the knife is coupled to the working member and is movable in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions.
  • FIG. 1 illustrates a surgical stapling device shown generally as stapling device 10 that includes a handle assembly 12, an adapter assembly 14, and a tool assembly 16.
  • the handle assembly 12 is powered and includes a stationary handgrip 18 and an actuation button or buttons 19.
  • the actuation buttons 19 are operable to actuate various functions of the tool assembly 16 via the adapter assembly 14, i.e., approximation of the tool assembly 16, and stapling and cutting of tissue.
  • the handle assembly 12 supports batteries (not shown) that provide power to the handle assembly 12 to operate the stapling device 10.
  • the stapling device 10 is illustrated as a powered stapling device, it is envisioned that the advantages of this disclosure are suitable for use with manually powered surgical stapling devices as well as robotically controlled stapling devices.
  • U.S. Patent No. 5,865,361 describes a stapling device that includes exemplary aspects of a manually powered stapling device.
  • the adapter assembly 14 defines a longitudinal axis “X” and includes a proximal portion 14a and a distal portion 14b.
  • the proximal portion 14a of the adapter assembly 14 is coupled to the handle assembly 12, and the distal portion 14b of the adapter assembly 14 supports the tool assembly 16.
  • the tool assembly 16 is pivotably coupled to the distal portion 14b of the adapter assembly 14 to facilitate articulation of the tool assembly 16 in relation to the adapter assembly 14 about an articulation axis “Y”.
  • the tool assembly 16 includes an anvil 20 and a cartridge assembly 22.
  • the anvil 20 has a tissue engaging surface 20a (FIG. 5).
  • the cartridge assembly 22 is coupled to the anvil 20 to pivot towards the anvil 20 and facilitate movement of the tool assembly 16 between an unclamped position (FIG. 1) and a clamped position.
  • the anvil 20 can be mounted to pivot towards the cartridge assembly 22.
  • FIG. 2 illustrates the cartridge assembly 22 which includes a channel member 34, a compliant member 36, and a staple cartridge 38.
  • the channel member 34 includes side walls 40 and a bottom wall 42 that define a cavity 34a that receives the staple cartridge 38.
  • Each of the side walls 40 of the channel member 34 defines a cutout 40a.
  • the staple cartridge 38 can be removably received within the cavity 34a of the channel member 34 to allow for replacement of the staple cartridge 38 after each firing of the stapling device 10 to facilitate reuse of the stapling device 10 (FIG. 1).
  • the bottom wall 42 of the channel member 34 defines a knife slot 42a.
  • the compliant member 36 which can be in the from of a wave spring, is secured to the bottom wall 42 of the channel member 34 and supports the staple cartridge 38 within the cavity 34a of the channel member 34.
  • the compliant member 36 is compressible to facilitate movement of the staple cartridge 38 within the cavity 34a of the channel member 34 in relation to the anvil 20 between a raised position and a lowered position when tissue is clamped within the tool assembly 16 (FIG. 1).
  • the compliant member 36 can be formed from a variety of different compliant materials and functions to allow a tissue gap, e.g. tissue gap “Gl” (FIG.
  • the compliant member 36 is positioned along opposite sides of the knife slot 42a. Although shown as a wave spring, the compliant member 36 can be formed from compressible pads or the like and can be positioned at any location of the channel member 34 to support the staple cartridge 38.
  • FIG. 2A illustrates an exploded view of the staple cartridge 38 which includes a cartridge body 43, staples 44, pushers 46, an actuation sled 48, a knife bar 50, and a staple guard 52.
  • the cartridge body 43 of the staple cartridge 38 is received within the cavity 34a defined by the channel member 34 and includes a tissue engaging surface 54, knife guards 54a, and protrusions 55 that extend outwardly from side walls of the cartridge body 43 towards the channel member 34.
  • the protrusions 55 are received within the cutouts 40a in the side walls 40 of the channel member 34 to properly locate the staple cartridge 38 within the cavity 34a of the channel member 34.
  • the protrusions 55 move vertically (as viewed in FIGS.
  • the cartridge body 43 defines a knife slot 56 and a plurality of staple receiving pockets 58 that are arranged in rows on each side of the knife slot 56.
  • the knife slot 56 of the cartridge body 43 is longitudinally aligned with the knife slot 42a of the channel member 34.
  • the knife guards 54a are positioned adjacent a proximal portion of the knife slot 56.
  • Each of the staple receiving pockets 58 receives a staple 44 and at least a portion of one of the pushers 46.
  • the staple guard 52 is secured to a bottom of the cartridge body 43 opposite to the tissue engaging surface 54 to retain the staples 44 and pushers 46 within the cartridge body 43 during shipping and handling of the staple cartridge 38.
  • the actuation sled 48 includes a central portion 48a and cam members 48b that are positioned on opposite sides of the central portion 48a.
  • the central portion 48a is received within the knife slot 56 (FIG. 2) of the cartridge body 43 (FIG. 2).
  • the cam members 48b define ramps 404a that are positioned to engage pushers 46 (FIG. 3) supported within the cartridge body 43 (FIG. 2) as the actuation sled 48 moves from a sled retracted position towards a sled advanced position to sequentially eject the staples 44 from the cartridge body 43 (FIG. 3).
  • the knife bar 50 is positioned proximal to the actuation sled 48 and is movable within the knife slot 56 of the cartridge body 43 between a knife retracted position and a knife advanced position.
  • the knife bar 50 includes a cutting edge 50a that is positioned within a gap, e.g., tissue gap “Gl” (FIG. 5), defined between the tissue engaging surface 54 of the cartridge body 43 and the anvil 20 when the tool assembly 16 (FIG. 1) is in the clamped position to cut tissue clamped between staple cartridge 38 and the anvil 20.
  • the knife bar 50 also includes a flange 51 that is positioned on a lower end of the knife bar 50 opposite to the cutting edge 50a.
  • the flange 51 of the knife bar 50 is positioned to move along an inner surface of a bottom wall of the staple guard 52 when the knife bar 50 is moved from the knife retracted position to the knife advanced position.
  • the actuation sled 48 is positioned distally of the knife bar 50 and is engaged by the knife bar 50 when the knife bar 50 is moved from the knife retracted position to the knife advanced position within the cartridge body 43 to move the actuation sled 48 from the sled retracted position to the sled advanced position within the cartridge body 43 into sequential engagement with the pushers 46 to urge the pushers 46 upwardly and eject the staples 44 from the staple receiving pockets 58 of the cartridge body 43.
  • FIGS. 2 and 3 illustrate a distal portion of the drive assembly 60 of the stapling device 10 (FIG. 1) which includes a flexible drive beam 62 and a working member 64.
  • the flexible drive beam 62 has a distal portion that is secured to a proximal portion of the working member 64.
  • the working member 64 has an I-shaped configuration and includes a first beam 66, a second beam 68, and a vertical strut 70.
  • the first beam 66 is received within a channel defined in the anvil 20, and the second beam 68 is engaged with the channel 34 of the cartridge assembly 22.
  • the vertical strut 70 defines a vertical axis “Z” (FIG.
  • the recess 71a is partially defined by a guide surface 71b that is angled upwardly towards the first beam 66 in a proximal direction.
  • the drive assembly 60 is movable between a drive retracted position and a drive advanced position via a drive clamped position.
  • the first beam 66 engages the anvil 20 and the second beam 68 engages the channel 34 to move the tool assembly 16 (FIG. 1) from the unclamped position to the clamped position.
  • the knife bar 50 supports a latch 72 that is secured to the vertical strut 70 and includes proximal end having a hook portion 74.
  • the latch 72 is formed of a resilient material, e.g., spring steel, and is movable from a non-deformed state to a deformed state. In the nondeformed state, the proximal portion of the latch 72 bends outwardly of the knife slot 56 of the cartridge body 43 such that the hook portion 74 of the latch 72 is spaced outwardly of the vertical strut 70 of the drive assembly 60.
  • the proximal portion of the latch 72 is positioned within the recess 71a of the vertical strut 70 of the working member 64 of the drive assembly 60 to couple the knife bar 50 to the working member 64 of the drive assembly 60.
  • the width “A” (FIG. 3) of the latch 72 is smaller than the height “B” (FIG. 3) of the recess 71a in the vertical strut 70 of the working member 64 of the drive assembly 60 to allow the latch 72 to slide within the recess 71a of the working member 64. This allows the knife bar 50 to float or move in relation to the working member 64 in a direction parallel to the vertical axis “Z” (FIG. 3) of the vertical strut 70.
  • the latch 72 moves into the knife slot 56 of the cartridge body 43 to move the latch 72 from the non-deformed state to the deformed state.
  • the angled surface 71b defining a distal portion of the recess 71a of the vertical strut 70 can act as a guide surface to direct the latch 72 into the recess 71a.
  • the knife 50 is coupled to the working member 50 such that movement of the drive assembly 60 between the drive retracted position and the drive advanced position moves the knife 50 between the knife retracted position and the knife advanced position.
  • FIGS 4-7 illustrate the tool assembly 16 of the stapling device 10 (FIG. 1) in the clamped position about thin tissue “Tl”.
  • the compliant material 36 remains substantially undeformed to maintain the staple cartridge 38 in its uppermost position within the cavity 34a.
  • the tissue gap “Gl” (FIG. 5) defined between the tissue engaging surface 20a of the anvil 20 and the tissue engaging surface 54 of the staple cartridge 38 of the cartridge assembly 22 is at its smallest such that the tissue “Tl” is clamped between the anvil 20 and the staple cartridge 38.
  • the knife bar 50 is supported on the staple guard 52 of the staple cartridge 38.
  • the knife member 50 When the staple cartridge 38 is in the uppermost position within the cavity 34a of the channel 34 of the cartridge assembly 22, the knife member 50 is positioned in its uppermost position in relation to the vertical strut 70 of the working member 64 of the drive assembly 60. In the uppermost position of the knife bar 50, the flange 51 of the knife bar 50 is positioned above the second beam 68 of the working member 64 and the latch 72 is positioned in an upper end of the recess 71a of the vertical strut 70 of the working member 64 of the drive assembly 66.
  • FIGS. 8-11 illustrate the tool assembly 16 of the stapling device 10 (FIG. 1) clamped about thick tissue “T2”.
  • the compliant material 36 is deformed or compressed to allow the staple cartridge 38 to move downwardly within the cavity 34a of the channel 34 to its lowermost position.
  • the tissue gap “G2” (FIG. 9) defined between the tissue engaging surface 20a of the anvil 20 and the tissue engaging surface 54 of the staple cartridge 38 of the cartridge assembly 22 is at its largest to accommodate the thick tissue “T2”.
  • the knife bar 50 is supported on the staple guard 52 of the staple cartridge 38.
  • the knife member 50 moves downwardly in relation to the vertical strut 70 of the working member 64 of the drive assembly 60 such that the flange 51 of the knife bar 50 moves downwardly towards the second beam 68 of the working member 64 and the latch 72 moves downwardly within the recess 71a of the vertical strut 70 of the working member 64 of the drive assembly 66 to its lowermost position.
  • FIGS. 12-30 illustrate an alternate version the tool assembly 16 (FIG. 1) of the stapling device 10 shown generally as tool assembly 116.
  • FIG. 12 illustrates the tool assembly 116 which includes an anvil 120 and a cartridge assembly 122.
  • the anvil 120 has a tissue engaging surface 120a (FIG. 5).
  • the cartridge assembly 122 is coupled to the anvil 120 to pivot towards the anvil 120 and facilitate movement of the tool assembly 116 between an unclamped position (FIG. 1) and a clamped position.
  • the anvil 120 can be coupled to the cartridge assembly 122 to pivot towards the cartridge assembly 122.
  • FIGS. 13-15 illustrate cartridge assembly 122 which includes a channel member 134, and a staple cartridge 138.
  • the channel member 134 includes side walls 140 and a bottom wall 142 that define a cavity 134a that receives the staple cartridge 138.
  • the staple cartridge 138 can be removably received within the cavity 134a of the channel member 134 to allow for replacement of the staple cartridge 138 after each firing of the stapling device 10 (FIG. 1) to facilitate reuse of the stapling device 10 (FIG. 1).
  • the bottom wall 142 of the channel member 134 defines a knife slot 142a.
  • the cartridge assembly 122 can include a compliant member to allow the staple cartridge 138 to float within the cavity 134a of the channel 134.
  • the staple cartridge 138 includes a cartridge body 143, staples 144, pushers 146, an actuation sled 148, a distal staple guard 150, a proximal staple guard 152, and a biasing member 154.
  • the cartridge body 143 of the staple cartridge 138 is received within the cavity 134a defined by the channel member 134 and includes an upper tissue engaging surface 138a.
  • the cartridge body 143 defines a knife slot 156 and a plurality of staple receiving pockets 158 that are arranged in rows on each side of the knife slot 156. Although two rows are shown, each side of the knife slot 156 can include one or more rows of staple receiving pockets 158.
  • Each of the staple receiving pockets 158 receives a staple 144 and at least a portion of one of the pushers 146.
  • the cartridge body 143 includes a knife guard 157 positioned on each side of a proximal end of the knife slot 156.
  • the knife guards 157 extend upwardly from the tissue engaging surface 138a of the cartridge body 143 of the staple cartridge 138.
  • the distal staple guard 150 is secured to a distal portion of the cartridge body 143 opposite to the tissue engaging surface 138a and the proximal staple guard 152 is secured to a proximal portion of the cartridge body 143 opposite to the tissue engaging surface 138a.
  • the proximal and distal staple guards 150, 152 cover the bottom of the cartridge body 143 to retain the staples 44 and pushers 46 within the cartridge body 143 during shipping and handling of the staple cartridge 38.
  • the proximal and distal staple guards 150, 152 define side openings 160 that receive tabs 162 formed on the cartridge body 143 to secure the proximal and distal staple guards 150, 152 to the cartridge body 143 in snap-fit fashion.
  • the distal staple guard 150 has a bottom wall 166 and the proximal staple guard 152 has a bottom wall 168 (FIG. 13).
  • the bottom walls 166 and 168 define knife slots 166a, 168a that are longitudinally aligned with the knife slot 156 in the cartridge body 143.
  • the bottom wall 166 of the distal staple guard 150 is spaced further from the bottom of the cartridge body 143 than the bottom wall 168 of the proximal staple guard 152 (FIG. 14) to allow the actuation sled 148 to pivot downwardly when the actuation sled 148 is positioned in the sled advanced position as described below.
  • a proximal surface of the distal staple guard 150 is in abutting relation to a distal surface of the channel 134 (FIG. 15) when the staple cartridge 138 is received within the channel member 134.
  • FIGS. 16 and 17 illustrate the actuation sled 148 which includes a body 170 that has a central portion 172 and cam members 174 positioned on opposite sides of the central portion 172 of the body 170.
  • the central portion 172 is received within the knife slot 156 (FIG. 13) of the cartridge body 143.
  • the cam members 174 define ramps 174a that are positioned to engage the pushers 146 as the actuation sled 148 moves from a sled retracted position towards a sled advanced position to sequentially eject the staples 144 from the cartridge body 143 (FIG. 13).
  • the central portion 172 of the body 170 of the actuation sled 148 includes a vertical portion 176 that extends upwardly from a proximal portion of the central portion 172 of the actuation sled 148 through the central knife slot 156 in the cartridge body 143 (FIG. 6).
  • the vertical portion 176 of the actuation sled 148 includes a knife 178 having a cutting edge 178a that faces distally.
  • the knife 178 is formed of metal and is over molded to the vertical portion 176 of the actuation sled 148. Alternately, the knife 178 can be machined into the vertical portion 176 of the actuation sled 148.
  • Each of the cam members 174 includes a side wall that includes a first structure configured to engage a second structure on the cartridge body 143 to retain the actuation sled 148 in the sled advanced position while allowing the actuation sled 148 to move to a position to shield the cutting edge 178a of the knife 178.
  • the cam members 174 of the actuation sled 148 define a concavities 180 that are longitudinally aligned with each other on a distal portion of the actuation sled 148
  • the second structure includes protrusions 182 that are longitudinally aligned with other on the distal portion of the cartridge body 143.
  • the concavities 180 receive the protrusions 182 (FIG. 19) when the actuation sled 148 is in the sled advanced position to pivotally secure the actuation sled 148 to the cartridge body 143 in the sled advanced position.
  • the central portion 172 of the actuation sled 148 defines a recess 184 that receives and supports a resilient latch 186.
  • the recess 184 extends through a proximal portion of the central portion 172 of the actuation sled 148 and has a height that is greater than a width of the latch 186 to allow the latch 186 to move within the recess 184.
  • the latch 186 has a proximal portion that includes a hook 186a.
  • FIG. 18 illustrates an alternate version of the drive assembly 60 (FIG. 2) of the stapling device 10 (FIG. 1) shown generally as drive assembly 190.
  • the drive assembly 190 includes a flexible drive beam 192 and a working member 194.
  • the flexible drive beam 192 has a distal portion that is secured to a proximal portion of the working member 194 and a proximal portion (not shown) that is adapted to engage a drive member positioned within the adapter assembly 14 of the stapling device 10 (FIG. 1).
  • the working member 194 has an I-shaped configuration and includes a first beam 196, a second beam 198, and a vertical strut 200.
  • the first beam 196 is received within a channel defined in the anvil 120, and the second beam 198 is engaged with the channel 134 of the cartridge assembly 122.
  • the vertical strut 200 defines a vertical axis “Z” (FIG. 3) and has a first end secured to the first beam 196, a second end secured to the second beam 198, and a side wall 202 that defines a recess 204.
  • the recess 204 receives the proximal end of the latch 186 and includes a proximal portion that defines a pocket 206 that receives the hook 186a of the latch 186 to couple the actuation sled 148 to the working member 194 of the drive assembly 190.
  • the drive assembly 190 is movable between a drive retracted position and a drive advanced position via a drive clamped position.
  • the first beam 196 of the working member 194 engages the anvil 120 and the second beam 198 engages the channel 134 to move the tool assembly 116 (FIG. 12) from the unclamped position to the clamped position.
  • FIG. 19 illustrates the biasing member 154 secured to a distal portion of the cartridge body 143.
  • the biasing member 154 which can be in the form of a leaf spring, is secured to the distal portion of the cartridge body 143 of the staple cartridge 138 and extends into a distal portion of the knife slot 156 at a position to engage the central portion 172 of the actuation sled 148 when the actuation sled 148 is in the sled advanced position.
  • the biasing member 154 is secured to the cartridge body 143 in cantilevered fashion and has a distal portion and a proximal portion.
  • the distal portion of the biasing member 154 is secured to the cartridge body 143 and the proximal portion of the biasing member 154 extends proximally and upwardly to a position adjacent a distal portion of the knife slot 156 of the cartridge body 143.
  • the biasing member 154 curves upwardly from its distal end towards its proximal end.
  • FIGS. 20 and 21 illustrate a proximal portion of the staple cartridge 138 with the actuation sled 148 in the sled retracted position before the staple cartridge 138 is inserted into the cavity 134a of the channel 134.
  • the latch 186 projects from the proximal portion of the knife slot 156 and is confined within the recess 184 in the central portion 172 of the actuation sled 148 by inner walls of the cartridge body 143. It is noted that the latch 186 is not fixedly attached to the actuation sled 148 within the recess 184 and can float within the recess 184.
  • the knife 178 including the cutting edge 178a is shielded between the knife guards 157 of the cartridge body 143.
  • FIGS. 22-24 illustrate the tool assembly 116 of the stapling device 10 (FIG. 1) as the drive assembly 190 is moved in the direction of arrow “A” in FIG. 22 to the drive clamped position to move the tool assembly 116 to the clamped position.
  • the proximal portion of the latch 186 is partially received within the recess 204 in the side wall 202 of the vertical strut 200 of the working member 194 of the drive assembly 190.
  • the working member 194 of the drive assembly 190 is spaced proximally of the actuation sled 148 such that the hook 186a of the latch 186 is positioned distally of the pocket 206 in the vertical strut 200 of the working member 194. As such, the actuation sled 148 is not coupled to the working member 194 of the drive assembly 190.
  • FIGS. 25 and 26 illustrate the tool assembly 116 as the drive assembly 190 of the stapling device 10 (FIG. 1) moves from the drive clamped position towards the drive advanced position in the direction of arrow “B” during a firing stroke of the stapling device 10 (FIG. 1).
  • the latch 186 moves further into the recess 204 in the vertical strut 200 until the hook 186a on the proximal portion of the latch 186 aligns with the pocket 206 in the vertical strut 200 of the working member 194.
  • the latch 186 snaps inwardly in the direction indicated by arrow “C” in FIG.
  • the actuation sled 148 moves from the sled retracted position to the sled advanced position to eject the staples 144 (FIG. 13) from the cartridge body 143 and cut tissue clamped between the tissue engaging surfaces 120a, 138a (FIG. 12) of the anvil 120 and the staple cartridge 138.
  • the cartridge assembly can include a compliant material 36 (FIG. 2) that allows the staple cartridge 138 to float within the channel 134 to compensate for tissues of different thicknesses.
  • the height of the recess 184 in the actuation sled 148 is greater than the width of the latch 186 to allow actuation sled 148 to move vertically with the staple cartridge 138 in relation to the latch 186 in a direction parallel to the vertical axis “Z” of the vertical strut 200 of the working member 194 of the drive assembly 190 as the staple cartridge 138 moves within the channel 134 between the raised and lowered positions.
  • FIGS. 27 and 28 illustrate a distal portion of the tool assembly 116 as the actuation sled 148 moves in the direction of arrow “D” to the sled advanced position.
  • the protrusions 182 on the inner surface of the cartridge body 143 are received within the concavities 180 of the actuation sled 148 (FIG. 28) to pivotably secure the actuation sled 148 in the sled advanced position.
  • the central portion 172 of the actuation sled 148 moves beneath the biasing member 154 and deforms the biasing member upwardly in the direction of arrow “E” in FIG. 27.
  • the biasing member 154 is urged upwardly, the biasing member 154 applies a downward force onto the central portion 172 of the actuation sled 148.
  • the latch 186 remains engaged with the working member 194 of the drive assembly 190.
  • FIGS. 29 and 30 illustrate the tool assembly as the drive assembly 190 is moved in the direction of arrow “F” from the drive advanced position to the drive retracted position.
  • the latch 186 is withdrawn from the recess 184 in the central portion 172 of the actuation sled 148.
  • the distal portion of the latch 186 which is angled downwardly towards the bottom of the cartridge body 143 engages an upwardly angled surface 184a defining the recess 184 to pivot the actuation sled 148 in the direction of arrow “F” in FIG.
  • the biasing member 154 also biases the actuation sled 148 in the direction of arrow “F” towards the lowered position even after the latch 186 disengages from the actuation sled 148.
  • the cutting edge 178a of the knife 178 of the actuation sled 148 is recessed or substantially recessed within the cartridge body 143 below the tissue engaging surface 138a to shield the cutting edge 178a of the knife 178.
  • FIGS. 31-36 illustrate an alternate version of the staple cartridge 138 of the stapling device 10 (FIG. 1) shown generally as staple cartridge 238
  • the staple cartridge 238 includes a cartridge body 243, staples and pushers (not shown), an actuation sled 248, distal and proximal staple guards (not shown), and a biasing member 254.
  • the cartridge body 243 of the staple cartridge 238 is received within the cavity 134a defined by the channel member 134 (FIG. 12) and includes an upper tissue engaging surface 238a.
  • the cartridge body 243 defines a knife slot 256 and a plurality of staple receiving pockets 258 that are arranged in rows on each side of the knife slot 256.
  • FIG. 32 illustrates the actuation sled 248 which is like actuation sled 148 and includes a body 270 that has a central portion 272 and cam members 274 that are positioned on opposite sides of the central portion 272 of the body 270. The central portion 272 is received within the knife slot 256 (FIG. 31) of the cartridge body 243.
  • the cam members 274 define ramps 274a that are positioned to engage the pushers (not shown) as the actuation sled 248 moves from a sled retracted position towards a sled advanced position to sequentially eject the staples (not shown) from the cartridge body 243 (FIG. 31).
  • the central portion 272 of the body 270 of the actuation sled 248 includes a vertical portion 276 that extends upwardly from a proximal portion of the central portion 272 of the actuation sled 248 towards the anvil 220 (FIG. 34) through the central knife slot 256 in the cartridge body 243 (FIG. 31).
  • the vertical portion 276 of the actuation sled 248 includes a knife 278 having a cutting edge 278a that faces distally.
  • the knife 278 is formed of metal and is over molded to the vertical portion 276 of the actuation sled 248.
  • Each of the cam members 274 includes a side wall that defines a first structure configured to engage a second structure on the cartridge body 243 to retain the actuation sled 248 in the sled advanced position while allowing the actuation sled 248 to move to a position to shield the cutting edge 278a of the knife 278.
  • the cam members 274 of the actuation sled 148 define elongated concavities 280 that are longitudinally aligned with each other on a distal portion of the actuation sled 248, and the second structure includes ribs 282 that are longitudinally aligned with other on the distal portion of the cartridge body 243.
  • the concavities 280 receive the ribs 282 (FIG. 33) when the actuation sled 248 is in the sled advanced position to secure the actuation sled 248 in the sled advanced position.
  • the ribs 282 are received within the concavities 280 to facilitate movement of the actuation sled 228 along a linear path from a raised position to a lowered position when the actuation sled 248 is in the sled advanced position.
  • the actuation sled 248 In the lowered position, the actuation sled 248 is positioned above the distal staple guard 150 (FIG. 14) which provides additional space beneath the cartridge body 243 to allow the actuation sled 228 to move downwardly towards the distal staple guard 150 (FIG. 14).
  • the actuation sled 248 includes a knife guard 284 that extends from the vertical portion 276 of the actuation sled distally in a direction parallel to the longitudinal axis “X” of the elongate body 14 (FIG. 1) of the stapling device 10.
  • the knife guard 284 is positioned above the central portion 272 of the actuation sled 248 to shield the cutting edge 278a of the knife 278 of the actuation sled 248.
  • FIG. 33 illustrates a distal portion of the cartridge body 243 and the biasing member 254.
  • the biasing member 254 which can be in the form of a leaf spring, is secured to the distal portion of the cartridge body 243 of the staple cartridge 238 and is aligned with a distal portion of the knife slot 256 at a position to engage the central portion 272 of the actuation sled 248 when the actuation sled 248 is in the sled advanced position.
  • the biasing member 254 is secured to the cartridge body 243 in cantilevered fashion and has a distal portion 254a and a proximal portion 254b.
  • the distal portion of the biasing member 254 has a stepped configuration and is secured to the cartridge body 243 and the proximal portion of the biasing member 254 extends to a position aligned with the distal portion of the knife slot 256 of the cartridge body 243.
  • FIGS. 34 and 35 illustrate the actuation sled 248 when the actuation sled 248 is moved by the drive assembly 190 in the direction of arrow “K” in FIG. 34 from the sled retracted position to the sled advanced position.
  • the protrusions 282 are received within the elongate concavities 280 to retain the actuation sled 248 in the sled advanced position.
  • the biasing member 254 is deformed upwardly towards the anvil 220 in the direction of arrow “F” in FIG. 35.
  • the biasing member 254 applies a downward force onto the central portion 272 of the actuation sled 248. Engagement of the drive assembly 190 with the actuation sled 248 retains the actuation sled 248 in the raised position.
  • FIG. 36 illustrates the drive assembly 190 as the drive assembly 190 moves from the drive advanced position back to the drive retracted position in the direction indicated by arrow “G” after the stapling device 10 (FIG. 1) has been fired.
  • the drive assembly 190 moves back towards the drive retracted position, the drive assembly 190 disengages from the actuation sled 248 and the biasing member 254 urges the actuation sled 248 downwardly along a linear path (vertically) towards the distal staple guard 150 in the direction of arrow “H” to the lowered position.
  • the cutting edge 278a of the knife 278 is shielded within the cartridge body 243.
  • FIG. 37-40 illustrate an alternate version of the actuation sled, knife, and working member of the drive assembly of the stapling device 10 shown in FIG. 1 shown generally as actuation sled 348, knife assembly 350, and working member 352.
  • the working member 352 is coupled to a flexible beam (not shown) that is secured to a proximal surface of the working member 352.
  • the working member 352 has an I-shaped configuration and includes a first beam 354, a second beam 356, and a vertical strut 358 that connects the first beam 354 to the second beam 356.
  • the vertical strut 358 defines an elongate slot 360 having a first transverse slot portion 362 and a second transverse slot portion 364.
  • the first and second transverse slot portions 362, 364 are spaced from each other along a length of the elongate slot 360.
  • the working member 352 is engaged with the anvil 20 and the cartridge assembly 22 (FIG. 1) and functions like the working member 64 (FIG. 11) described above. As such, the working member 352 will not be described in further detail herein.
  • the knife assembly 350 includes a knife 366 and a knife holder 368.
  • the knife 366 includes an elongate body 370 and a distally facing, elongate cutting edge 372.
  • the elongate body 370 of the knife 366 includes first protrusions 374, second protrusions 376, and cam members 378 that extend from opposite sides of the elongate body 370 of the knife 366.
  • the elongate body 370 of the knife 366 is received within the elongate slot 360 of the vertical strut 358 of the working member 352 to fixedly secure the knife 366 to the working member 352.
  • first protrusions 374 are received within the first transverse slot portion 362 and the second protrusions 376 are received within the second transverse slot portion 364.
  • first protrusions 374 have a rectangular configuration and the second protrusions 376 have a circular configuration. Other protrusion configurations are envisioned.
  • the knife holder 368 includes a base portion 380, a central portion 382, and guide members 384 that are positioned in spaced relation to each other on opposite sides of the central portion 382.
  • the central portion 382 of the knife holder 368 includes inner surfaces 386 that define a cavity 388.
  • Each of the inner surfaces 386 of the central portion 382 of the knife holder 368 define a cam slot 390 (FIG. 39) that receives one of the cam members 378 of the knife 366.
  • the cam slots 390 have a stepped configuration and define a horizontal portion 392 that defines an axis that is transverse to a longitudinal axis of the vertical strut 358 of the working member 352.
  • the central portion 382 also supports a resilient arm 394 that extends over the actuation sled 348 and defines a concavity 396 (FIG. 39) that faces the actuation sled 348.
  • the concavity 396 is defined in part by a curved or angled distal wall 396a.
  • the actuation sled 348 includes a body 400 that has a central portion 402 and cam members 404 that are positioned on opposite sides of the central portion 402 of the body 400.
  • the central portion 402 is received within the knife slot 56 (FIG. 2) of the cartridge body 43 (FIG. 2).
  • the cam members 404 define ramps 404a that are positioned to engage pushers 46 (FIG. 2A) supported within the cartridge body 43 (FIG. 2) as the actuation sled 348 moves from a sled retracted position towards a sled advanced position to sequentially eject staples 44 (FIG. 2A) from the cartridge body 43 (FIG. 2).
  • the central portion 402 of the actuation sled 348 includes a detent 408 that is received within the concavity 396 of the resilient arm 394 of the knife holder 368 of the knife assembly 350.
  • the detent 408 includes an angled distal surface 408a that is engaged with the angled distal wall 396a defining the concavity 396 in the resilient arm 394 of the knife holder 368.
  • FIG. 41 illustrates the knife assembly 350 when the staple cartridge 38 is in the raised position.
  • the staple cartridge 38 is in the raised position, such as when thin tissue is clamped between the anvil 20 and the staple cartridge 38 (FIG. 1)
  • the cam member 378 of the knife 366 of the knife assembly 350 is supported on the horizontal portion 392 of the cam slot 390 of the knife holder 368 such that the base portion 380 of the knife holder 368 is positioned above the second beam 356 of the working member 352.
  • FIG. 42 illustrates the knife assembly 350 when thicker tissue is clamped between the anvil 20 and the staple cartridge 38 of the tool assembly 16 (FIG. 1).
  • the knife holder 368 and the actuation sled 348 move downwardly with the staple cartridge 38 in relation to the vertical strut 358 and the knife 366 towards the second beam 356 of the working member 352 such that the cam member 378 moves downwardly within the cam slot 390.
  • the knife holder 368 and actuation sled 348 can be positioned at any position from the raised position (FIG. 41 and the lowered position (FIG. 42).
  • the actuation sled 348 is moved to the actuation sled advanced position and the working member 352 is returned to the retracted position, the knife 366 (which is fixedly secured to the working member 352) and the knife holder 368 (which is coupled to the knife 372 via receipt of the cam member 378 in the cam slot 390 of the knife holder 368) are moved to their retracted positions with the working member 352.
  • the angled surfaces 396a and 408a of the resilient arm 394 and detent 408, respectively, cause the resilient arm 394 to disengage from the actuation sled 348 such that the actuation sled 348 remains in the sled advanced position.

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Abstract

A surgical stapling device has a tool assembly including an anvil, a cartridge assembly, and a drive assembly. The cartridge assembly includes a channel that defines a cavity and a staple cartridge that is supported within the cavity for movement between a raised position and a lowered position. The drive assembly includes a working member having an I-beam configuration. The staple cartridge includes an actuation sled that can move in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions.

Description

SURGICAL STAPLING DEVICE WITH FLOATING KNIFE
[0001] This Application claims priority from U.S. Provisional Patent Application 63/459,753, filed 17 April 2023, the entire content of which is incorporated herein by reference.
FIELD
[0002] This disclosure is directed to surgical stapling devices and, more particularly, to surgical stapling devices that have a tool assembly including a staple cartridge having a knife.
BACKGROUND
[0003] Surgical stapling devices for ejecting staples to join tissue or tissue segments in a fast and efficient manner in a variety of surgical procedures, e.g., anastomoses procedures, are well known. Typically, a surgical stapling device includes a tool assembly having first and second jaws that support a cartridge assembly and an anvil, respectively. The cartridge assembly includes a staple cartridge that supports a plurality of staples. The first and second jaws are mounted together to allow movement of the tool assembly between open and clamped positions. In the clamped position, the staple cartridge of the cartridge assembly and the anvil are supported in juxtaposed alignment and include tissue contact surfaces that define a predetermined tissue gap. The tissue gap and the size of the staples within the staple cartridge are dimensioned to receive and suture tissue having a thickness within a predetermined range to properly effect hemostasis. If the tissue positioned between the jaws is outside the predetermined range, i.e., either too thick or too thin, the stapling device may not provide effective hemostasis. In addition, if the tissue thickness is misidentified by the clinician or if the tissue thickness falls near the outer edges of the range for a given staple size, the likelihood of ineffective hemostasis is increased.
[0004] Accordingly, a continuing need exists in the suturing arts for a surgical stapling device that can provide effective hemostasis for a greater range of tissue thicknesses.
SUMMARY
[0005] This disclosure is directed to a surgical stapling device having a tool assembly including an anvil, a cartridge assembly, and a drive assembly. The cartridge assembly includes a channel that defines a cavity and a staple cartridge that is supported within the cavity for movement between a raised position and a lowered position. The drive assembly includes a working member having an I-beam configuration. The staple cartridge includes an actuation sled that can move in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions. In aspects of the disclosure, the knife is coupled to the working member and is movable in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions. In other aspects of the disclosure, the actuation sled supports the knife and can pivot from a knife raised position to a knife lowered position when the actuation sled moves from a sled retracted position to a sled advanced position.
[0006] One aspect of the disclosure is directed to a tool assembly including an anvil, a cartridge assembly, and a drive assembly. The cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between an unclamped position and a clamped position. The cartridge assembly includes a channel, a compliant member, and a staple cartridge. The channel includes side walls and a bottom wall that define a cavity, and the staple cartridge is received within the cavity of the channel. The staple cartridge includes a cartridge body, staples, an actuation sled, a knife, and a latch having a width. The cartridge body defines a knife slot and staple receiving pockets, and the staples are received within the staple receiving pockets. The actuation sled is movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body, and the knife is movable with the actuation sled from a knife retracted position to a knife advanced position. The compliant member is positioned on the channel to support the staple cartridge within the cavity of the channel for movement between a cartridge raised position and a cartridge lowered position. The drive assembly includes a flexible drive beam and a working member. The flexible drive beam has a distal portion secured to the working member, and the working member has an I-shaped configuration and includes a first beam, a second beam, and a vertical strut. The vertical strut has a distal end and a proximal end and defines a recess having a height that extends across the vertical strut from the distal end to the proximal end. The drive assembly is movable between a drive retracted position and a drive advanced position to move the actuation sled from the sled retracted position to the sled advanced position and to move the knife between the knife retracted position and the knife advanced position. The latch extends through the recess and is configured to couple the knife to the vertical strut of the working member. The latch is movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member as the staple cartridge moves between the cartridge raised position and the cartridge lowered position. [0007] Other aspects of the disclosure are directed to a stapling device including a handle assembly, an adapter assembly, and a tool assembly. The adapter assembly has a proximal portion and a distal portion, and the proximal portion of the adapter assembly is coupled to the handle assembly. The tool assembly is coupled to the distal portion of the adapter assembly and includes an anvil, a cartridge assembly, and a drive assembly. The cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between an unclamped position and a clamped position. The cartridge assembly includes a channel, a compliant member, and a staple cartridge. The channel includes side walls and a bottom wall that define a cavity, and the staple cartridge is received within the cavity of the channel. The staple cartridge includes a cartridge body, staples, an actuation sled, a knife, and a latch having a width. The cartridge body defines a knife slot and staple receiving pockets, and the staples are received within the staple receiving pockets. The actuation sled is movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body, and the knife is movable with the actuation sled from a knife retracted position to a knife advanced position. The compliant member is positioned on the channel to support the staple cartridge within the cavity of the channel for movement between a cartridge raised position and a cartridge lowered position. The drive assembly includes a flexible drive beam and a working member. The flexible drive beam has a distal portion secured to the working member, and the working member has an I-shaped configuration and includes a first beam, a second beam, and a vertical strut. The vertical strut has a distal end and a proximal end and defines a recess having a height that extends across the vertical strut from the distal end to the proximal end. The drive assembly is movable between a drive retracted position and a drive advanced position to move the actuation sled from the sled retracted position to the sled advanced position and to move the knife between the knife retracted position and the knife advanced position. The latch extends through the recess and is configured to couple the knife to the vertical strut of the working member. The latch is movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member as the staple cartridge moves between the cartridge raised position and the cartridge lowered position.
[0008] In aspects of the disclosure, the recess is defined by a guide surface that extends from the distal end of the vertical strut towards the proximal end of the vertical strut and upwardly towards the first beam in a proximal direction. [0009] In some aspects of the disclosure, the compliant member includes a wave spring that is positioned on the bottom wall of the channel.
[0010] In certain aspects of the disclosure, the bottom wall of the channel defines a knife slot that is longitudinally aligned with the knife slot of the cartridge body, and the wave spring is positioned on the bottom wall of the channel on opposite sides of the knife slot.
[0011] In aspects of the disclosure, the knife is positioned between the actuation sled and the working member of the drive assembly and is movable with the working member between a knife retracted position and a knife advanced position.
[0012] In some aspects of the disclosure, the knife includes a cutting edge and is movable through the knife slot of the cartridge body between the knife retracted position and the knife advanced position.
[0013] In certain aspects of the disclosure, the latch is movable from a non-deformed state spaced from the vertical strut of the working member of the drive assembly to a deformed state engaged with the vertical strut of the working member.
[0014] In aspects of the disclosure, the latch is movable from the non-deformed state to the deformed state in response to movement of the latch into the knife slot of the cartridge body.
[0015] In some aspects of the disclosure, the cartridge body includes a tissue engaging surface and knife guards that extend upwardly from the tissue engaging surface towards the anvil, and the cutting edge of the knife is positioned between the knife guards when the knife is in the knife retracted position.
[0016] In certain aspects of the disclosure, the knife includes a distal surface in abutting relation to the actuation sled.
[0017] Still other aspects of the disclosure are directed to a tool assembly including an actuation sled, a knife, and a drive assembly. The actuation sled includes a central portion and cam members positioned on opposite sides of the central portion. The knife includes a cutting edge and supports a latch having a width. The drive assembly includes a flexible drive beam and a working member, and the flexible drive beam has a distal portion that is secured to the working member. The working member has an I-shaped configuration and includes a first beam, a second beam, and a vertical strut. The vertical strut has a distal end and a proximal end and defines a recess having a height that extends across the vertical strut from the distal end to the proximal end. The latch extends through the recess and is configured to couple the knife to the vertical strut of the working member. The latch is movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member.
[0018] Other aspects of the disclosure are directed to a tool assembly including an anvil and a cartridge assembly. The cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between open and clamped positions and includes a channel member and a staple cartridge. The channel member includes side walls and a bottom wall that define a cavity. The staple cartridge is received within the cavity of the channel member and includes a cartridge body, staples, an actuation sled, and a staple guard. The cartridge body includes an upper tissue engaging surface and defines a knife slot and staple receiving pockets that are positioned on each side of the knife slot. The staples are received within the staple receiving pockets. The actuation sled supports a knife and is movable within the cartridge body from a sled retracted position to a sled advanced position to eject the staples from the staple receiving pockets. The staple guard is secured to a lower portion of the cartridge body to retain the staples within the cartridge body. The cartridge body includes a first structure, and the actuation sled includes a second structure. The first structure engages the second structure when the actuation sled moves to the sled advanced position to retain the actuation sled in the sled advanced position and allow the actuation sled to move from a first position in which the knife is exposed to a second position in which the knife is shielded.
[0019] In aspects of the disclosure, the first structure includes protrusions, and the second structure includes concavities, and the actuation sled pivots from the first position to the second position.
[0020] In some aspects of the disclosure, the first structure includes ribs, and the second structure includes elongated concavities, and the actuation sled moves along a linear path from the first position to the second position.
[0021] In certain aspects of the disclosure, the tool assembly includes a biasing member that is supported on the cartridge body and is positioned to engage the actuation sled when the actuation sled is in the sled advanced position to urge the actuation sled towards the second position.
[0022] Other aspects of the disclosure are directed to a surgical stapling device including a drive assembly, a knife holder, and an actuation sled. The drive assembly includes a working member having an I-shaped configuration and including a first beam, a second beam, and a vertical strut. The vertical strut defines a vertical axis and supports a knife having a distally facing cutting edge. The knife includes cam members that are positioned distally of the vertical strut. The knife holder includes a base portion, a central portion, and guide members positioned outwardly of the central portion. The central portion of the knife holder includes a resilient arm and inner surfaces that define a cavity. The inner surfaces of the central portion of the knife holder define cam slots that receive the cam members of the knife to facilitate movement of the knife holder in relation to the working member and the knife in a direction parallel to the vertical axis of the vertical strut. The resilient arm extends from the central portion of the knife holder in a direction away from the working member. The actuation sled includes a central portion and cam members positioned on opposite sides of the central portion of the actuation sled. The resilient arm of the knife holder is releasably engaged with the central portion of the actuation sled, and the knife holder and the actuation sled are movable in relation to the working member and the knife between raised and lowered positions.
[0023] In aspects of the disclosure, the central portion of the actuation sled includes a detent, and the resilient arm of the knife holder defines a concavity, and the detent is received within the concavity to couple the knife holder to the actuation sled.
[0024] In some aspects of the disclosure, the vertical strut defines an elongate slot that receives a proximal portion of the knife.
[0025] In certain aspects of the disclosure, the knife includes first and second protrusions and the vertical strut of the working member defines first and second transverse slots that communicate with the elongate slot.
[0026] In aspects of the disclosure, the first and second protrusions are received within the first and second transverse slots to secure the knife to the working member.
[0027] Other aspects of the disclosure will be appreciated from the following description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Various aspects of the disclosed stapling device are described herein below with reference to the drawings, wherein:
[0029] FIG. 1 is a side perspective view of a stapling device including aspects of the disclosure with a tool assembly of the stapling device in an open position;
[0030] FIG. 2 is an exploded, side perspective view of the cartridge assembly and a distal portion of a drive assembly of the stapling device shown in FIG. 1 ; [0031] FIG. 2A is an exploded view of the staple cartridge of the cartridge assembly shown in FIG. 2;
[0032] FIG. 3 is a side perspective view of a working member of the drive assembly and a knife bar of a staple cartridge of the cartridge assembly of the stapling device shown in FIG. 1 ;
[0033] FIG. 4 is a side view of tool assembly of the stapling device shown in FIG. 1 clamped about thin tissue as the stapling device is fired with the knife bar of the staple cartridge coupled to the working member of the drive assembly and the remaining components of the tool assembly shown in phantom;
[0034] FIG. 5 is an enlarged view of the indicated area of detail shown in FIG. 4;
[0035] FIG. 6 is an enlarged view of the indicated area of detail shown in FIG. 4;
[0036] FIG. 7 is a side perspective view of the working member of the drive assembly and the knife bar of the staple cartridge of the cartridge assembly as shown in 4;
[0037] FIG. 8 is a side view of tool assembly of the stapling device shown in FIG. 1 clamped about thick tissue as the stapling device is fired with the knife bar of the staple cartridge coupled to the working member of the drive assembly and the remaining components of the tool assembly shown in phantom;
[0038] FIG. 9 is an enlarged view of the indicated area of detail shown in FIG. 8;
[0039] FIG. 10 is an enlarged view of the indicated area of detail shown in FIG. 8;
[0040] FIG. 11 is a side perspective view of the working member of the drive assembly and the knife bar of the staple cartridge of the cartridge assembly as shown in 8;
[0041] FIG. 12 is a side perspective view of an alternate version of the tool assembly of the stapling device shown in FIG. 1 with the staple cartridge separated from the channel of the cartridge assembly;
[0042] FIG. 13 is a side view of the staple cartridge and the channel of the cartridge assembly of the tool assembly shown in FIG. 12 with the staple cartridge positioned above the channel prior to insertion of the staple cartridge within the channel;
[0043] FIG. 14 is a side view of the cartridge assembly of the tool assembly shown in FIG. 12 with the staple cartridge inserted within the channel;
[0044] FIG. 15 is an exploded perspective view of the staple cartridge of the cartridge assembly shown in FIG. 12; [0045] FIG. 16 is an enlarged perspective view of the indicated area of detail shown in FIG. 15 illustrating the actuation sled assembly of the staple cartridge with a latch of the actuation sled of the actuation sled assembly separated from the actuation sled;
[0046] FIG. 17 is a perspective view of the actuation sled assembly shown in FIG. 16 with the latch of the actuation sled assembly coupled to the actuation sled;
[0047] FIG. 18 is a side perspective view of an alternate version of the distal portion of the drive assembly of the stapling device shown in FIG. 1 ;
[0048] FIG. 19 is a bottom perspective cutaway view of the distal portion of the cartridge body of the staple cartridge shown in FIG. 15;
[0049] FIG. 20 is a perspective cutaway view of a proximal portion of the staple cartridge shown in FIG. 15;
[0050] FIG. 21 is a cross-sectional view taken along section line 21-21 of FIG. 20;
[0051] FIG. 22 is a side perspective view of the tool assembly shown in FIG. 12 in the clamped position with all the components of the tool assembly except the actuation sled assembly and the drive assembly shown in phantom;
[0052] FIG. 23 is an enlarged view of the indicated area of detail shown in FIG. 22 illustrating the actuation sled assembly and the drive assembly of the stapling device with the actuation sled assembly and drive assembly in the clamped position;
[0053] FIG. 24 is a cross-sectional view taken along section line 24-24 of FIG. 23;
[0054] FIG. 25 is a side perspective view of the actuation sled assembly and the drive assembly shown in FIG. 23 with the actuation sled assembly and drive assembly in an engaged position during the firing of the stapling device;
[0055] FIG. 26 is a cross-sectional view taken along section line 26-26 of FIG. 25;
[0056] FIG. 27 is a side perspective view of the distal portion of the tool assembly shown in FIG. 12 during firing of the stapling device with the actuation sled assembly and the drive assembly in advanced positions and all the components of the tool assembly except the actuation sled assembly and the drive assembly shown in phantom;
[0057] FIG. 28 is a cross-sectional view taken along section line 28-28 of FIG. 27;
[0058] FIG. 29 is a side perspective view of the distal portion of the tool assembly shown in FIG. 27 during firing of the stapling device as the actuation sled assembly and the drive assembly are retracted from their advanced positions with all the components of the tool assembly except the actuation sled assembly and the drive assembly shown in phantom;
[0059] FIG. 30 is a perspective view from above of the distal portion of the tool assembly shown in FIG. 27 during firing of the stapling device as the actuation sled assembly and the drive assembly are retracted from their advanced positions with the anvil shown in phantom;
[0060] FIG. 31 is an exploded side perspective view of an alternate version of the staple cartridge and drive assembly of the stapling device shown in FIG. 1 ;
[0061] FIG. 32 is an enlarged view of the indicated area of detail shown in FIG. 31 illustrating a side perspective view of the actuation sled;
[0062] FIG. 33 is a perspective cutaway bottom view of a distal portion of a cartridge body and biasing member of the staple cartridge shown in FIG. 31 ;
[0063] FIG. 34 is a side perspective view of the distal portion of a tool assembly including the staple cartridge shown in FIG. 31 during firing of the stapling device with the actuation sled assembly and the drive assembly in advanced positions and all the components of the tool assembly except the actuation sled assembly, the drive assembly, and the biasing member of the staple cartridge shown in phantom;
[0064] FIG. 35 is a bottom perspective, cutaway view of the distal portion of the staple cartridge shown in FIG. 31 with the actuation sled in an advanced position;
[0065] FIG. 36 is a side perspective view of the distal portion of the tool assembly shown in FIG. 34 during firing of the stapling device as the actuation sled assembly and the drive assembly are retracted from their advanced positions with all the components of the tool assembly except the actuation sled assembly, the drive assembly, and the biasing member shown in phantom;
[0066] FIG. 37 is a side perspective view of an alternate version of the drive assembly and the actuation sled assembly of the stapling device shown in FIG. 1 ;
[0067] FIG. 38 is an exploded side perspective view of the actuation sled assembly and drive assembly shown in FIG. 37;
[0068] FIG. 39 is a cross-sectional view taken along section line 39-39 of FIG. 38;
[0069] FIG. 40 is a cross-sectional view taken along section line 40-40 of FIG. 37;
[0070] FIG. 41 is a side view of the actuation sled assembly and drive assembly shown in
FIG. 37 with the actuation sled assembly in a raised position; and [0071] FIG. 42 is a side view of the actuation sled assembly and drive assembly shown in FIG. 37 with the actuation sled assembly in a lowered position.
DETAILED DESCRIPTION
[0072] The disclosed surgical stapling device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the disclosed aspects are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure.
[0073] In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician when the device is used in its customary manner, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician when the device is used in its customary manner. Further, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel. Moreover, directional terms such as front, rear, upper, lower, top, bottom, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.
[0074] The disclosure is directed to a surgical stapling device having a tool assembly including an anvil, a cartridge assembly, and a drive assembly. The cartridge assembly includes a channel that defines a cavity and a staple cartridge that is supported within the cavity for movement between a raised position and a lowered position. The drive assembly includes a working member having an I-beam configuration. The staple cartridge includes an actuation sled that can move in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions. In aspects of the disclosure, the knife is coupled to the working member and is movable in relation to the working member as the staple cartridge moves within the channel of the cartridge assembly between the raised and lowered positions. In other aspects of the disclosure, the actuation sled supports the knife and can pivot from a knife raised position to a knife lowered position when the actuation sled moves from a sled retracted position to a sled advanced position. [0075] FIG. 1 illustrates a surgical stapling device shown generally as stapling device 10 that includes a handle assembly 12, an adapter assembly 14, and a tool assembly 16. The handle assembly 12 is powered and includes a stationary handgrip 18 and an actuation button or buttons 19. The actuation buttons 19 are operable to actuate various functions of the tool assembly 16 via the adapter assembly 14, i.e., approximation of the tool assembly 16, and stapling and cutting of tissue. In certain aspects of the disclosure, the handle assembly 12 supports batteries (not shown) that provide power to the handle assembly 12 to operate the stapling device 10. Although the stapling device 10 is illustrated as a powered stapling device, it is envisioned that the advantages of this disclosure are suitable for use with manually powered surgical stapling devices as well as robotically controlled stapling devices. U.S. Patent No. 5,865,361 describes a stapling device that includes exemplary aspects of a manually powered stapling device.
[0076] The adapter assembly 14 defines a longitudinal axis “X” and includes a proximal portion 14a and a distal portion 14b. The proximal portion 14a of the adapter assembly 14 is coupled to the handle assembly 12, and the distal portion 14b of the adapter assembly 14 supports the tool assembly 16. In aspects of the disclosure, the tool assembly 16 is pivotably coupled to the distal portion 14b of the adapter assembly 14 to facilitate articulation of the tool assembly 16 in relation to the adapter assembly 14 about an articulation axis “Y”. The tool assembly 16 includes an anvil 20 and a cartridge assembly 22. The anvil 20 has a tissue engaging surface 20a (FIG. 5). In aspects of the disclosure, the cartridge assembly 22 is coupled to the anvil 20 to pivot towards the anvil 20 and facilitate movement of the tool assembly 16 between an unclamped position (FIG. 1) and a clamped position. Alternately, it is envisioned that the anvil 20 can be mounted to pivot towards the cartridge assembly 22.
[0077] FIG. 2 illustrates the cartridge assembly 22 which includes a channel member 34, a compliant member 36, and a staple cartridge 38. The channel member 34 includes side walls 40 and a bottom wall 42 that define a cavity 34a that receives the staple cartridge 38. Each of the side walls 40 of the channel member 34 defines a cutout 40a. In aspects of the disclosure, the staple cartridge 38 can be removably received within the cavity 34a of the channel member 34 to allow for replacement of the staple cartridge 38 after each firing of the stapling device 10 to facilitate reuse of the stapling device 10 (FIG. 1). The bottom wall 42 of the channel member 34 defines a knife slot 42a. [0078] The compliant member 36, which can be in the from of a wave spring, is secured to the bottom wall 42 of the channel member 34 and supports the staple cartridge 38 within the cavity 34a of the channel member 34. The compliant member 36 is compressible to facilitate movement of the staple cartridge 38 within the cavity 34a of the channel member 34 in relation to the anvil 20 between a raised position and a lowered position when tissue is clamped within the tool assembly 16 (FIG. 1). The compliant member 36 can be formed from a variety of different compliant materials and functions to allow a tissue gap, e.g. tissue gap “Gl” (FIG. 5), defined between the tissue engaging surface 20a of the anvil 20 and the tissue engaging surface 54 of the staple cartridge 38 of the cartridge assembly 22 to change when the tool assembly 16 is in the clamped position and/or fired to accommodate different tissue thicknesses. In some aspects of the disclosure, the compliant member 36 is positioned along opposite sides of the knife slot 42a. Although shown as a wave spring, the compliant member 36 can be formed from compressible pads or the like and can be positioned at any location of the channel member 34 to support the staple cartridge 38.
[0079] FIG. 2A illustrates an exploded view of the staple cartridge 38 which includes a cartridge body 43, staples 44, pushers 46, an actuation sled 48, a knife bar 50, and a staple guard 52. The cartridge body 43 of the staple cartridge 38 is received within the cavity 34a defined by the channel member 34 and includes a tissue engaging surface 54, knife guards 54a, and protrusions 55 that extend outwardly from side walls of the cartridge body 43 towards the channel member 34. The protrusions 55 are received within the cutouts 40a in the side walls 40 of the channel member 34 to properly locate the staple cartridge 38 within the cavity 34a of the channel member 34. The protrusions 55 move vertically (as viewed in FIGS. 5 and 9) within the cutouts 40a as the staple cartridge 38 moves within the cavity 34a of the channel member 34 between the raised and lowered positions. The cartridge body 43 defines a knife slot 56 and a plurality of staple receiving pockets 58 that are arranged in rows on each side of the knife slot 56. The knife slot 56 of the cartridge body 43 is longitudinally aligned with the knife slot 42a of the channel member 34. The knife guards 54a are positioned adjacent a proximal portion of the knife slot 56. Each of the staple receiving pockets 58 receives a staple 44 and at least a portion of one of the pushers 46. The staple guard 52 is secured to a bottom of the cartridge body 43 opposite to the tissue engaging surface 54 to retain the staples 44 and pushers 46 within the cartridge body 43 during shipping and handling of the staple cartridge 38. [0080] The actuation sled 48 includes a central portion 48a and cam members 48b that are positioned on opposite sides of the central portion 48a. The central portion 48a is received within the knife slot 56 (FIG. 2) of the cartridge body 43 (FIG. 2). The cam members 48b define ramps 404a that are positioned to engage pushers 46 (FIG. 3) supported within the cartridge body 43 (FIG. 2) as the actuation sled 48 moves from a sled retracted position towards a sled advanced position to sequentially eject the staples 44 from the cartridge body 43 (FIG. 3).
[0081] The knife bar 50 is positioned proximal to the actuation sled 48 and is movable within the knife slot 56 of the cartridge body 43 between a knife retracted position and a knife advanced position. The knife bar 50 includes a cutting edge 50a that is positioned within a gap, e.g., tissue gap “Gl” (FIG. 5), defined between the tissue engaging surface 54 of the cartridge body 43 and the anvil 20 when the tool assembly 16 (FIG. 1) is in the clamped position to cut tissue clamped between staple cartridge 38 and the anvil 20. The knife bar 50 also includes a flange 51 that is positioned on a lower end of the knife bar 50 opposite to the cutting edge 50a. The flange 51 of the knife bar 50 is positioned to move along an inner surface of a bottom wall of the staple guard 52 when the knife bar 50 is moved from the knife retracted position to the knife advanced position. The actuation sled 48 is positioned distally of the knife bar 50 and is engaged by the knife bar 50 when the knife bar 50 is moved from the knife retracted position to the knife advanced position within the cartridge body 43 to move the actuation sled 48 from the sled retracted position to the sled advanced position within the cartridge body 43 into sequential engagement with the pushers 46 to urge the pushers 46 upwardly and eject the staples 44 from the staple receiving pockets 58 of the cartridge body 43.
[0082] FIGS. 2 and 3 illustrate a distal portion of the drive assembly 60 of the stapling device 10 (FIG. 1) which includes a flexible drive beam 62 and a working member 64. The flexible drive beam 62 has a distal portion that is secured to a proximal portion of the working member 64. The working member 64 has an I-shaped configuration and includes a first beam 66, a second beam 68, and a vertical strut 70. The first beam 66 is received within a channel defined in the anvil 20, and the second beam 68 is engaged with the channel 34 of the cartridge assembly 22. The vertical strut 70 defines a vertical axis “Z” (FIG. 3) and has a first end secured to the first beam 66, a second end secured to the second beam 68, and a side wall 71 that defines a recess 71a that extends from a distal end of the vertical strut 70 to a proximal end of the vertical strut 70. In aspects of the disclosure, the recess 71a is partially defined by a guide surface 71b that is angled upwardly towards the first beam 66 in a proximal direction.
[0083] The drive assembly 60 is movable between a drive retracted position and a drive advanced position via a drive clamped position. When the drive assembly 60 is moved from the drive retracted position to the drive clamped position, the first beam 66 engages the anvil 20 and the second beam 68 engages the channel 34 to move the tool assembly 16 (FIG. 1) from the unclamped position to the clamped position. When the drive assembly 60 moves from the drive clamped position to the drive advanced position, a distal portion of the vertical strut 70 of the working member 64 of the drive assembly 60 abuts the knife bar 50 to advance the knife bar 50 into engagement with the actuation sled 48 and advance the knife bar 50 and the actuation sled 48 from their retracted positions to their advanced positions to eject the staples 44 from the cartridge body 43 and cut tissue clamped between the anvil 20 and the cartridge assembly 22. When the stapling device 10 is fired and the drive assembly 60 is moved from the drive advanced position to the drive retracted position, the actuation sled 48 remains in the sled advanced position.
[0084] The knife bar 50 supports a latch 72 that is secured to the vertical strut 70 and includes proximal end having a hook portion 74. The latch 72 is formed of a resilient material, e.g., spring steel, and is movable from a non-deformed state to a deformed state. In the nondeformed state, the proximal portion of the latch 72 bends outwardly of the knife slot 56 of the cartridge body 43 such that the hook portion 74 of the latch 72 is spaced outwardly of the vertical strut 70 of the drive assembly 60. In the deformed state, the proximal portion of the latch 72 is positioned within the recess 71a of the vertical strut 70 of the working member 64 of the drive assembly 60 to couple the knife bar 50 to the working member 64 of the drive assembly 60. The width “A” (FIG. 3) of the latch 72 is smaller than the height “B” (FIG. 3) of the recess 71a in the vertical strut 70 of the working member 64 of the drive assembly 60 to allow the latch 72 to slide within the recess 71a of the working member 64. This allows the knife bar 50 to float or move in relation to the working member 64 in a direction parallel to the vertical axis “Z” (FIG. 3) of the vertical strut 70.
[0085] In aspects of the disclosure, as the knife bar 50 moves from the knife retracted position towards the knife advanced position, the latch 72 moves into the knife slot 56 of the cartridge body 43 to move the latch 72 from the non-deformed state to the deformed state. The angled surface 71b defining a distal portion of the recess 71a of the vertical strut 70 can act as a guide surface to direct the latch 72 into the recess 71a. In the deformed state, the knife 50 is coupled to the working member 50 such that movement of the drive assembly 60 between the drive retracted position and the drive advanced position moves the knife 50 between the knife retracted position and the knife advanced position.
[0086] FIGS 4-7 illustrate the tool assembly 16 of the stapling device 10 (FIG. 1) in the clamped position about thin tissue “Tl”. When the tool assembly 16 is clamped about thin tissue “Tl”, the compliant material 36 remains substantially undeformed to maintain the staple cartridge 38 in its uppermost position within the cavity 34a. In the uppermost position of the staple cartridge 38, the tissue gap “Gl” (FIG. 5) defined between the tissue engaging surface 20a of the anvil 20 and the tissue engaging surface 54 of the staple cartridge 38 of the cartridge assembly 22 is at its smallest such that the tissue “Tl” is clamped between the anvil 20 and the staple cartridge 38. As described above, the knife bar 50 is supported on the staple guard 52 of the staple cartridge 38. When the staple cartridge 38 is in the uppermost position within the cavity 34a of the channel 34 of the cartridge assembly 22, the knife member 50 is positioned in its uppermost position in relation to the vertical strut 70 of the working member 64 of the drive assembly 60. In the uppermost position of the knife bar 50, the flange 51 of the knife bar 50 is positioned above the second beam 68 of the working member 64 and the latch 72 is positioned in an upper end of the recess 71a of the vertical strut 70 of the working member 64 of the drive assembly 66.
[0087] FIGS. 8-11 illustrate the tool assembly 16 of the stapling device 10 (FIG. 1) clamped about thick tissue “T2”. When the tool assembly 16 is clamped about thick tissue “T2”, the compliant material 36 is deformed or compressed to allow the staple cartridge 38 to move downwardly within the cavity 34a of the channel 34 to its lowermost position. In the lowermost position of the staple cartridge 38, the tissue gap “G2” (FIG. 9) defined between the tissue engaging surface 20a of the anvil 20 and the tissue engaging surface 54 of the staple cartridge 38 of the cartridge assembly 22 is at its largest to accommodate the thick tissue “T2”. As described above, the knife bar 50 is supported on the staple guard 52 of the staple cartridge 38. When the staple cartridge 38 moves downwardly within the cavity 34a of the channel 34 of the cartridge assembly 22, the knife member 50 moves downwardly in relation to the vertical strut 70 of the working member 64 of the drive assembly 60 such that the flange 51 of the knife bar 50 moves downwardly towards the second beam 68 of the working member 64 and the latch 72 moves downwardly within the recess 71a of the vertical strut 70 of the working member 64 of the drive assembly 66 to its lowermost position.
[0088] FIGS. 12-30 illustrate an alternate version the tool assembly 16 (FIG. 1) of the stapling device 10 shown generally as tool assembly 116. FIG. 12 illustrates the tool assembly 116 which includes an anvil 120 and a cartridge assembly 122. The anvil 120 has a tissue engaging surface 120a (FIG. 5). In aspects of the disclosure, the cartridge assembly 122 is coupled to the anvil 120 to pivot towards the anvil 120 and facilitate movement of the tool assembly 116 between an unclamped position (FIG. 1) and a clamped position. Alternately, it is envisioned that the anvil 120 can be coupled to the cartridge assembly 122 to pivot towards the cartridge assembly 122.
[0089] FIGS. 13-15 illustrate cartridge assembly 122 which includes a channel member 134, and a staple cartridge 138. The channel member 134 includes side walls 140 and a bottom wall 142 that define a cavity 134a that receives the staple cartridge 138. In aspects of the disclosure, the staple cartridge 138 can be removably received within the cavity 134a of the channel member 134 to allow for replacement of the staple cartridge 138 after each firing of the stapling device 10 (FIG. 1) to facilitate reuse of the stapling device 10 (FIG. 1). The bottom wall 142 of the channel member 134 defines a knife slot 142a. Although not shown, the cartridge assembly 122 can include a compliant member to allow the staple cartridge 138 to float within the cavity 134a of the channel 134.
[0090] The staple cartridge 138 includes a cartridge body 143, staples 144, pushers 146, an actuation sled 148, a distal staple guard 150, a proximal staple guard 152, and a biasing member 154. The cartridge body 143 of the staple cartridge 138 is received within the cavity 134a defined by the channel member 134 and includes an upper tissue engaging surface 138a. The cartridge body 143 defines a knife slot 156 and a plurality of staple receiving pockets 158 that are arranged in rows on each side of the knife slot 156. Although two rows are shown, each side of the knife slot 156 can include one or more rows of staple receiving pockets 158. Each of the staple receiving pockets 158 receives a staple 144 and at least a portion of one of the pushers 146. The cartridge body 143 includes a knife guard 157 positioned on each side of a proximal end of the knife slot 156. The knife guards 157 extend upwardly from the tissue engaging surface 138a of the cartridge body 143 of the staple cartridge 138. [0091] The distal staple guard 150 is secured to a distal portion of the cartridge body 143 opposite to the tissue engaging surface 138a and the proximal staple guard 152 is secured to a proximal portion of the cartridge body 143 opposite to the tissue engaging surface 138a. The proximal and distal staple guards 150, 152 cover the bottom of the cartridge body 143 to retain the staples 44 and pushers 46 within the cartridge body 143 during shipping and handling of the staple cartridge 38. In aspects of the disclosure, the proximal and distal staple guards 150, 152 define side openings 160 that receive tabs 162 formed on the cartridge body 143 to secure the proximal and distal staple guards 150, 152 to the cartridge body 143 in snap-fit fashion. In some aspects of the disclosure, the distal staple guard 150 has a bottom wall 166 and the proximal staple guard 152 has a bottom wall 168 (FIG. 13). The bottom walls 166 and 168 define knife slots 166a, 168a that are longitudinally aligned with the knife slot 156 in the cartridge body 143. In certain aspects of the disclosure, the bottom wall 166 of the distal staple guard 150 is spaced further from the bottom of the cartridge body 143 than the bottom wall 168 of the proximal staple guard 152 (FIG. 14) to allow the actuation sled 148 to pivot downwardly when the actuation sled 148 is positioned in the sled advanced position as described below. In some aspects of the disclosure, a proximal surface of the distal staple guard 150 is in abutting relation to a distal surface of the channel 134 (FIG. 15) when the staple cartridge 138 is received within the channel member 134.
[0092] FIGS. 16 and 17 illustrate the actuation sled 148 which includes a body 170 that has a central portion 172 and cam members 174 positioned on opposite sides of the central portion 172 of the body 170. The central portion 172 is received within the knife slot 156 (FIG. 13) of the cartridge body 143. The cam members 174 define ramps 174a that are positioned to engage the pushers 146 as the actuation sled 148 moves from a sled retracted position towards a sled advanced position to sequentially eject the staples 144 from the cartridge body 143 (FIG. 13). The central portion 172 of the body 170 of the actuation sled 148 includes a vertical portion 176 that extends upwardly from a proximal portion of the central portion 172 of the actuation sled 148 through the central knife slot 156 in the cartridge body 143 (FIG. 6). The vertical portion 176 of the actuation sled 148 includes a knife 178 having a cutting edge 178a that faces distally. In aspects of the disclosure, the knife 178 is formed of metal and is over molded to the vertical portion 176 of the actuation sled 148. Alternately, the knife 178 can be machined into the vertical portion 176 of the actuation sled 148. Each of the cam members 174 includes a side wall that includes a first structure configured to engage a second structure on the cartridge body 143 to retain the actuation sled 148 in the sled advanced position while allowing the actuation sled 148 to move to a position to shield the cutting edge 178a of the knife 178. In aspects of the disclosure, the cam members 174 of the actuation sled 148 define a concavities 180 that are longitudinally aligned with each other on a distal portion of the actuation sled 148, and the second structure includes protrusions 182 that are longitudinally aligned with other on the distal portion of the cartridge body 143. The concavities 180 receive the protrusions 182 (FIG. 19) when the actuation sled 148 is in the sled advanced position to pivotally secure the actuation sled 148 to the cartridge body 143 in the sled advanced position.
[0093] The central portion 172 of the actuation sled 148 defines a recess 184 that receives and supports a resilient latch 186. The recess 184 extends through a proximal portion of the central portion 172 of the actuation sled 148 and has a height that is greater than a width of the latch 186 to allow the latch 186 to move within the recess 184. The latch 186 has a proximal portion that includes a hook 186a.
[0094] FIG. 18 illustrates an alternate version of the drive assembly 60 (FIG. 2) of the stapling device 10 (FIG. 1) shown generally as drive assembly 190. The drive assembly 190 includes a flexible drive beam 192 and a working member 194. The flexible drive beam 192 has a distal portion that is secured to a proximal portion of the working member 194 and a proximal portion (not shown) that is adapted to engage a drive member positioned within the adapter assembly 14 of the stapling device 10 (FIG. 1). The working member 194 has an I-shaped configuration and includes a first beam 196, a second beam 198, and a vertical strut 200. The first beam 196 is received within a channel defined in the anvil 120, and the second beam 198 is engaged with the channel 134 of the cartridge assembly 122. The vertical strut 200 defines a vertical axis “Z” (FIG. 3) and has a first end secured to the first beam 196, a second end secured to the second beam 198, and a side wall 202 that defines a recess 204. The recess 204 receives the proximal end of the latch 186 and includes a proximal portion that defines a pocket 206 that receives the hook 186a of the latch 186 to couple the actuation sled 148 to the working member 194 of the drive assembly 190.
[0095] The drive assembly 190 is movable between a drive retracted position and a drive advanced position via a drive clamped position. When the drive assembly 190 is moved from the drive retracted position to the drive clamped position, the first beam 196 of the working member 194 engages the anvil 120 and the second beam 198 engages the channel 134 to move the tool assembly 116 (FIG. 12) from the unclamped position to the clamped position. When the drive assembly 190 moves from the drive clamped position to the drive advanced position, a distal portion of the vertical strut 200 of the working member 194 of the drive assembly 190 abuts the actuation sled 148 and advances the actuation sled 148 from the sled retracted position to the sled advanced position to eject the staples 144 from the cartridge body 143 and cut tissue clamped between the anvil 120 and the cartridge assembly 122. When the drive assembly 190 engages the actuation sled 148, the hook 186a of the latch 186 snaps into the pocket 206 of the vertical strut 200 to couple the actuation sled 148 to the drive assembly 190.
[0096] FIG. 19 illustrates the biasing member 154 secured to a distal portion of the cartridge body 143. The biasing member 154, which can be in the form of a leaf spring, is secured to the distal portion of the cartridge body 143 of the staple cartridge 138 and extends into a distal portion of the knife slot 156 at a position to engage the central portion 172 of the actuation sled 148 when the actuation sled 148 is in the sled advanced position. In aspects of the disclosure, the biasing member 154 is secured to the cartridge body 143 in cantilevered fashion and has a distal portion and a proximal portion. The distal portion of the biasing member 154 is secured to the cartridge body 143 and the proximal portion of the biasing member 154 extends proximally and upwardly to a position adjacent a distal portion of the knife slot 156 of the cartridge body 143. In some aspects of the disclosure, the biasing member 154 curves upwardly from its distal end towards its proximal end.
[0097] FIGS. 20 and 21 illustrate a proximal portion of the staple cartridge 138 with the actuation sled 148 in the sled retracted position before the staple cartridge 138 is inserted into the cavity 134a of the channel 134. As illustrated, the latch 186 projects from the proximal portion of the knife slot 156 and is confined within the recess 184 in the central portion 172 of the actuation sled 148 by inner walls of the cartridge body 143. It is noted that the latch 186 is not fixedly attached to the actuation sled 148 within the recess 184 and can float within the recess 184. When the actuation sled 148 is in the sled retracted position, the knife 178 including the cutting edge 178a is shielded between the knife guards 157 of the cartridge body 143.
[0098] FIGS. 22-24 illustrate the tool assembly 116 of the stapling device 10 (FIG. 1) as the drive assembly 190 is moved in the direction of arrow “A” in FIG. 22 to the drive clamped position to move the tool assembly 116 to the clamped position. In the clamped position of the tool assembly 116, the proximal portion of the latch 186 is partially received within the recess 204 in the side wall 202 of the vertical strut 200 of the working member 194 of the drive assembly 190. As illustrated, the working member 194 of the drive assembly 190 is spaced proximally of the actuation sled 148 such that the hook 186a of the latch 186 is positioned distally of the pocket 206 in the vertical strut 200 of the working member 194. As such, the actuation sled 148 is not coupled to the working member 194 of the drive assembly 190.
[0099] FIGS. 25 and 26 illustrate the tool assembly 116 as the drive assembly 190 of the stapling device 10 (FIG. 1) moves from the drive clamped position towards the drive advanced position in the direction of arrow “B” during a firing stroke of the stapling device 10 (FIG. 1). As the drive assembly 190 moves in the direction of arrow “B”, the latch 186 moves further into the recess 204 in the vertical strut 200 until the hook 186a on the proximal portion of the latch 186 aligns with the pocket 206 in the vertical strut 200 of the working member 194. When the hook 186a of the latch 186 aligns with the pocket 206, the latch 186 snaps inwardly in the direction indicated by arrow “C” in FIG. 26 to couple the actuation sled 148 to the working member 194 of the drive assembly 190. As the drive assembly 190 continues to move toward the drive advanced position in the direction of arrow “B”, the actuation sled 148 moves from the sled retracted position to the sled advanced position to eject the staples 144 (FIG. 13) from the cartridge body 143 and cut tissue clamped between the tissue engaging surfaces 120a, 138a (FIG. 12) of the anvil 120 and the staple cartridge 138.
[00100] As described above regarding the tool assembly 16 (FIG. 1), the cartridge assembly can include a compliant material 36 (FIG. 2) that allows the staple cartridge 138 to float within the channel 134 to compensate for tissues of different thicknesses. The height of the recess 184 in the actuation sled 148 is greater than the width of the latch 186 to allow actuation sled 148 to move vertically with the staple cartridge 138 in relation to the latch 186 in a direction parallel to the vertical axis “Z” of the vertical strut 200 of the working member 194 of the drive assembly 190 as the staple cartridge 138 moves within the channel 134 between the raised and lowered positions.
[00101] FIGS. 27 and 28 illustrate a distal portion of the tool assembly 116 as the actuation sled 148 moves in the direction of arrow “D” to the sled advanced position. When the actuation sled 148 reaches the sled advanced position, the protrusions 182 on the inner surface of the cartridge body 143 are received within the concavities 180 of the actuation sled 148 (FIG. 28) to pivotably secure the actuation sled 148 in the sled advanced position. As the actuation sled 148 reaches the sled advanced position, the central portion 172 of the actuation sled 148 moves beneath the biasing member 154 and deforms the biasing member upwardly in the direction of arrow “E” in FIG. 27. As the biasing member 154 is urged upwardly, the biasing member 154 applies a downward force onto the central portion 172 of the actuation sled 148. In sled advanced position, the latch 186 remains engaged with the working member 194 of the drive assembly 190.
[00102] FIGS. 29 and 30 illustrate the tool assembly as the drive assembly 190 is moved in the direction of arrow “F” from the drive advanced position to the drive retracted position. As the drive assembly 190 moves from the drive advanced position towards the drive retracted position, the latch 186 is withdrawn from the recess 184 in the central portion 172 of the actuation sled 148. As illustrated, the distal portion of the latch 186 which is angled downwardly towards the bottom of the cartridge body 143 engages an upwardly angled surface 184a defining the recess 184 to pivot the actuation sled 148 in the direction of arrow “F” in FIG. 29 about a transverse axis defined by the protrusions 182 from a raised position to a lowered position to move the knife from an exposed position to a shielded position. The biasing member 154 also biases the actuation sled 148 in the direction of arrow “F” towards the lowered position even after the latch 186 disengages from the actuation sled 148. In the lowered position, the cutting edge 178a of the knife 178 of the actuation sled 148 is recessed or substantially recessed within the cartridge body 143 below the tissue engaging surface 138a to shield the cutting edge 178a of the knife 178.
[00103] FIGS. 31-36 illustrate an alternate version of the staple cartridge 138 of the stapling device 10 (FIG. 1) shown generally as staple cartridge 238 The staple cartridge 238 includes a cartridge body 243, staples and pushers (not shown), an actuation sled 248, distal and proximal staple guards (not shown), and a biasing member 254. The cartridge body 243 of the staple cartridge 238 is received within the cavity 134a defined by the channel member 134 (FIG. 12) and includes an upper tissue engaging surface 238a. The cartridge body 243 defines a knife slot 256 and a plurality of staple receiving pockets 258 that are arranged in rows on each side of the knife slot 256. The staples, pushers, and distal and proximal staple guards are identical to the staples 144, pushers 146, and distal and proximal staple guards 150, 152 described above (FIG. 13) regarding staple cartridge 138 and will not be described in further detail herein. [00104] FIG. 32 illustrates the actuation sled 248 which is like actuation sled 148 and includes a body 270 that has a central portion 272 and cam members 274 that are positioned on opposite sides of the central portion 272 of the body 270. The central portion 272 is received within the knife slot 256 (FIG. 31) of the cartridge body 243. The cam members 274 define ramps 274a that are positioned to engage the pushers (not shown) as the actuation sled 248 moves from a sled retracted position towards a sled advanced position to sequentially eject the staples (not shown) from the cartridge body 243 (FIG. 31). The central portion 272 of the body 270 of the actuation sled 248 includes a vertical portion 276 that extends upwardly from a proximal portion of the central portion 272 of the actuation sled 248 towards the anvil 220 (FIG. 34) through the central knife slot 256 in the cartridge body 243 (FIG. 31). The vertical portion 276 of the actuation sled 248 includes a knife 278 having a cutting edge 278a that faces distally. In aspects of the disclosure, the knife 278 is formed of metal and is over molded to the vertical portion 276 of the actuation sled 248. Each of the cam members 274 includes a side wall that defines a first structure configured to engage a second structure on the cartridge body 243 to retain the actuation sled 248 in the sled advanced position while allowing the actuation sled 248 to move to a position to shield the cutting edge 278a of the knife 278. In aspects of the disclosure, the cam members 274 of the actuation sled 148 define elongated concavities 280 that are longitudinally aligned with each other on a distal portion of the actuation sled 248, and the second structure includes ribs 282 that are longitudinally aligned with other on the distal portion of the cartridge body 243. The concavities 280 receive the ribs 282 (FIG. 33) when the actuation sled 248 is in the sled advanced position to secure the actuation sled 248 in the sled advanced position. The ribs 282 are received within the concavities 280 to facilitate movement of the actuation sled 228 along a linear path from a raised position to a lowered position when the actuation sled 248 is in the sled advanced position. In the lowered position, the actuation sled 248 is positioned above the distal staple guard 150 (FIG. 14) which provides additional space beneath the cartridge body 243 to allow the actuation sled 228 to move downwardly towards the distal staple guard 150 (FIG. 14).
[00105] In aspects of the disclosure, the actuation sled 248 includes a knife guard 284 that extends from the vertical portion 276 of the actuation sled distally in a direction parallel to the longitudinal axis “X” of the elongate body 14 (FIG. 1) of the stapling device 10. The knife guard 284 is positioned above the central portion 272 of the actuation sled 248 to shield the cutting edge 278a of the knife 278 of the actuation sled 248.
[00106] FIG. 33 illustrates a distal portion of the cartridge body 243 and the biasing member 254. The biasing member 254, which can be in the form of a leaf spring, is secured to the distal portion of the cartridge body 243 of the staple cartridge 238 and is aligned with a distal portion of the knife slot 256 at a position to engage the central portion 272 of the actuation sled 248 when the actuation sled 248 is in the sled advanced position. In aspects of the disclosure, the biasing member 254 is secured to the cartridge body 243 in cantilevered fashion and has a distal portion 254a and a proximal portion 254b. The distal portion of the biasing member 254 has a stepped configuration and is secured to the cartridge body 243 and the proximal portion of the biasing member 254 extends to a position aligned with the distal portion of the knife slot 256 of the cartridge body 243.
[00107] FIGS. 34 and 35 illustrate the actuation sled 248 when the actuation sled 248 is moved by the drive assembly 190 in the direction of arrow “K” in FIG. 34 from the sled retracted position to the sled advanced position. When the actuation sled 248 is moved to the sled advanced position, the protrusions 282 are received within the elongate concavities 280 to retain the actuation sled 248 in the sled advanced position. When the central portion 272 of the actuation sled 248 moves beneath the biasing member 254, the biasing member 254 is deformed upwardly towards the anvil 220 in the direction of arrow “F” in FIG. 35. As the biasing member 254 is urged upwardly, the biasing member 254 applies a downward force onto the central portion 272 of the actuation sled 248. Engagement of the drive assembly 190 with the actuation sled 248 retains the actuation sled 248 in the raised position.
[00108] FIG. 36 illustrates the drive assembly 190 as the drive assembly 190 moves from the drive advanced position back to the drive retracted position in the direction indicated by arrow “G” after the stapling device 10 (FIG. 1) has been fired. When the drive assembly 190 moves back towards the drive retracted position, the drive assembly 190 disengages from the actuation sled 248 and the biasing member 254 urges the actuation sled 248 downwardly along a linear path (vertically) towards the distal staple guard 150 in the direction of arrow “H” to the lowered position. In the lowered position, the cutting edge 278a of the knife 278 is shielded within the cartridge body 243. [00109] FIGS. 37-40 illustrate an alternate version of the actuation sled, knife, and working member of the drive assembly of the stapling device 10 shown in FIG. 1 shown generally as actuation sled 348, knife assembly 350, and working member 352. Although not shown, the working member 352 is coupled to a flexible beam (not shown) that is secured to a proximal surface of the working member 352.
[00110] The working member 352 has an I-shaped configuration and includes a first beam 354, a second beam 356, and a vertical strut 358 that connects the first beam 354 to the second beam 356. The vertical strut 358 defines an elongate slot 360 having a first transverse slot portion 362 and a second transverse slot portion 364. The first and second transverse slot portions 362, 364 are spaced from each other along a length of the elongate slot 360. The working member 352 is engaged with the anvil 20 and the cartridge assembly 22 (FIG. 1) and functions like the working member 64 (FIG. 11) described above. As such, the working member 352 will not be described in further detail herein.
[00111] The knife assembly 350 includes a knife 366 and a knife holder 368. The knife 366 includes an elongate body 370 and a distally facing, elongate cutting edge 372. The elongate body 370 of the knife 366 includes first protrusions 374, second protrusions 376, and cam members 378 that extend from opposite sides of the elongate body 370 of the knife 366. The elongate body 370 of the knife 366 is received within the elongate slot 360 of the vertical strut 358 of the working member 352 to fixedly secure the knife 366 to the working member 352. In that respect, the first protrusions 374 are received within the first transverse slot portion 362 and the second protrusions 376 are received within the second transverse slot portion 364. In aspects of the disclosure, the first protrusions 374 have a rectangular configuration and the second protrusions 376 have a circular configuration. Other protrusion configurations are envisioned.
[00112] The knife holder 368 includes a base portion 380, a central portion 382, and guide members 384 that are positioned in spaced relation to each other on opposite sides of the central portion 382. The central portion 382 of the knife holder 368 includes inner surfaces 386 that define a cavity 388. Each of the inner surfaces 386 of the central portion 382 of the knife holder 368 define a cam slot 390 (FIG. 39) that receives one of the cam members 378 of the knife 366. In aspects of the disclosure, the cam slots 390 have a stepped configuration and define a horizontal portion 392 that defines an axis that is transverse to a longitudinal axis of the vertical strut 358 of the working member 352. The central portion 382 also supports a resilient arm 394 that extends over the actuation sled 348 and defines a concavity 396 (FIG. 39) that faces the actuation sled 348. The concavity 396 is defined in part by a curved or angled distal wall 396a.
[00113] The actuation sled 348 includes a body 400 that has a central portion 402 and cam members 404 that are positioned on opposite sides of the central portion 402 of the body 400. The central portion 402 is received within the knife slot 56 (FIG. 2) of the cartridge body 43 (FIG. 2). The cam members 404 define ramps 404a that are positioned to engage pushers 46 (FIG. 2A) supported within the cartridge body 43 (FIG. 2) as the actuation sled 348 moves from a sled retracted position towards a sled advanced position to sequentially eject staples 44 (FIG. 2A) from the cartridge body 43 (FIG. 2). The central portion 402 of the actuation sled 348 includes a detent 408 that is received within the concavity 396 of the resilient arm 394 of the knife holder 368 of the knife assembly 350. The detent 408 includes an angled distal surface 408a that is engaged with the angled distal wall 396a defining the concavity 396 in the resilient arm 394 of the knife holder 368.
[00114] As described above regarding the cartridge assembly 22 shown in FIG. 2, the staple cartridge 38 is movable within the concavity 34a of the channel 34 between raised and lowered positions to compensate for tissues of different thicknesses. FIG. 41 illustrates the knife assembly 350 when the staple cartridge 38 is in the raised position. When the staple cartridge 38 is in the raised position, such as when thin tissue is clamped between the anvil 20 and the staple cartridge 38 (FIG. 1), the cam member 378 of the knife 366 of the knife assembly 350 is supported on the horizontal portion 392 of the cam slot 390 of the knife holder 368 such that the base portion 380 of the knife holder 368 is positioned above the second beam 356 of the working member 352.
[00115] FIG. 42 illustrates the knife assembly 350 when thicker tissue is clamped between the anvil 20 and the staple cartridge 38 of the tool assembly 16 (FIG. 1). When thicker tissue is clamped between anvil 20 and the staple cartridge 38 of the cartridge assembly 22 (FIG. 1), the knife holder 368 and the actuation sled 348 move downwardly with the staple cartridge 38 in relation to the vertical strut 358 and the knife 366 towards the second beam 356 of the working member 352 such that the cam member 378 moves downwardly within the cam slot 390. It is noted that depending on the thickness of the tissue clamped between the anvil 20 and the staple cartridge 38, the knife holder 368 and actuation sled 348 can be positioned at any position from the raised position (FIG. 41 and the lowered position (FIG. 42). [00116] Although not shown, when the actuation sled 348 is moved to the actuation sled advanced position and the working member 352 is returned to the retracted position, the knife 366 (which is fixedly secured to the working member 352) and the knife holder 368 (which is coupled to the knife 372 via receipt of the cam member 378 in the cam slot 390 of the knife holder 368) are moved to their retracted positions with the working member 352. When the knife holder 368 returns to its retracted position, the angled surfaces 396a and 408a of the resilient arm 394 and detent 408, respectively, cause the resilient arm 394 to disengage from the actuation sled 348 such that the actuation sled 348 remains in the sled advanced position.
[00117] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects of the disclosure. It is envisioned that the elements and features illustrated or described in connection with one exemplary aspects of the disclosure may be combined with the elements and features of another without departing from the scope of the disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the abovedescribed aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A tool assembly comprising: an anvil; a cartridge assembly coupled to the anvil to facilitate movement of the tool assembly between an unclamped position and a clamped position, the cartridge assembly including a channel, a compliant member, and a staple cartridge, the channel including side walls and a bottom wall that define a cavity, the staple cartridge received within the cavity of the channel and including a cartridge body, staples, an actuation sled, a knife, and a latch, the cartridge body defining a knife slot and staple receiving pockets, the staples received within the staple receiving pockets, the actuation sled movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body, the knife movable with the actuation sled from a knife retracted position to a knife advanced position, the compliant member positioned on the channel to support the staple cartridge within the cavity of the channel for movement between a cartridge raised position and a cartridge lowered position, the latch having a width; and a drive assembly including a flexible drive beam and a working member, the flexible drive beam having a distal portion secured to the working member, the working member having an I-shaped configuration and including a first beam, a second beam, and a vertical strut, the vertical strut having a distal end and a proximal end and defining a recess that extends across the vertical strut from the distal end to the proximal end, the recess having a height that is greater than the width of the latch to facilitate movement of the latch within the recess, the drive assembly movable between a drive retracted position and a drive advanced position to move the actuation sled from the sled retracted position to the sled advanced position and to move the knife between the knife retracted position and the knife advanced position, wherein the latch extends through the recess and is configured to couple the knife to the vertical strut of the working member, the latch movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member as the staple cartridge moves between the cartridge raised position and the cartridge lowered position.
2. The tool assembly of claim 1, wherein the recess is defined by a guide surface that extends from the distal end of the vertical strut towards the proximal end of the vertical strut, the guide surface extending upwardly towards the first beam in a proximal direction.
3. The tool assembly of claim 1, wherein the compliant member includes a wave spring positioned on the bottom wall of the channel.
4. The tool assembly of claim 3, wherein the bottom wall of the channel defines a knife slot that is longitudinally aligned with the knife slot of the cartridge body, and the wave spring is positioned on the bottom wall of the channel on opposite sides of the knife slot.
5. The tool assembly of claim 1, wherein the knife is positioned between the actuation sled and the working member of the drive assembly and is movable with the working member between a knife retracted position and a knife advanced position.
6. The tool assembly of claim 1, wherein the knife includes a cutting edge and is movable through the knife slot of the cartridge body between the knife retracted position and the knife advanced position.
7. The tool assembly of claim 1, wherein the latch is movable from a non-deformed state spaced from the vertical strut of the working member of the drive assembly to a deformed state engaged with the vertical strut of the working member.
8. The tool assembly of claim 7, wherein the latch is movable through the knife slot of the cartridge body, the latch movable from the non-deformed state to the deformed state in response to movement of the latch into the knife slot of the cartridge body.
9. The tool assembly of claim 6, wherein the cartridge body includes a tissue engaging surface and knife guards that extend upwardly from the tissue engaging surface towards the anvil, the cutting edge of the knife positioned between the knife guards when the knife is in the knife retracted position.
10. The tool assembly of claim 1, wherein the knife includes a distal surface in abutting relation to the actuation sled.
11. A stapling device comprising: a handle assembly; an adapter assembly having a proximal portion and a distal portion, the proximal portion of the adapter assembly coupled to the handle assembly; and a tool assembly coupled to the distal portion of the adapter assembly, the tool assembly including: an anvil; a cartridge assembly coupled to the anvil to facilitate movement of the tool assembly between an unclamped position and a clamped position, the cartridge assembly including a channel, a compliant member, and a staple cartridge, the channel including side walls and a bottom wall that define a cavity, the staple cartridge received within the cavity of the channel and including a cartridge body, staples, an actuation sled, a knife, and a latch, the cartridge body defining a knife slot and staple receiving pockets, the staples received within the staple receiving pockets, the actuation sled including cam members and movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body, the knife movable with the actuation sled from a knife retracted position to a knife advanced position, the compliant member positioned on the channel to support the staple cartridge within the cavity of the channel for movement between a cartridge raised position and a cartridge lowered position, the latch having a width; and a drive assembly including a flexible drive beam and a working member, the flexible drive beam having a distal portion secured to the working member, the working member having an I-shaped configuration and including a first beam, a second beam, and a vertical strut, the vertical strut having a distal end and a proximal end and defining a recess that extends across the vertical strut from the distal end to the proximal end, the recess having a height that is greater than the width of the latch to facilitate movement of the latch within the recess, the drive assembly movable between a drive retracted position and a drive advanced position to move the actuation sled from the sled retracted position to the sled advanced position and to move the knife between the knife retracted position and the knife advanced position, wherein the latch extends through the recess and is configured to couple the knife to the vertical strut of the working member, the latch movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member as the staple cartridge moves between the cartridge raised position and the cartridge lowered position.
12. The stapling device of claim 11, wherein the recess is defined by a guide surface that extends from the distal end of the vertical strut towards the proximal end of the vertical strut, the guide surface extending upwardly towards the first beam in a proximal direction.
13. The stapling device of claim 11, wherein the compliant member includes a wave spring positioned on the bottom wall of the channel.
14. The stapling device of claim 13, wherein the bottom wall of the channel defines a knife slot that is longitudinally aligned with the knife slot of the cartridge body, and the wave spring is positioned on the bottom wall of the channel on opposite sides of the knife slot.
15. The stapling device of claim 11 , wherein the knife is positioned between the actuation sled and the working member of the drive assembly and is movable with the working member between a knife retracted position and a knife advanced position.
16. The stapling device of claim 11, wherein the knife includes a cutting edge and is movable through the knife slot of the cartridge body between the knife retracted position and the knife advanced position.
17. The stapling device of claim 11, wherein the latch is movable from a non-deformed state spaced from the vertical strut of the working member of the drive assembly to a deformed state engaged with the vertical strut of the working member.
18. The stapling device of claim 17, wherein the latch is movable through the knife slot of the cartridge body, the latch movable from the non-deformed state to the deformed state in response to movement of the latch into the knife slot of the cartridge body.
19. The stapling device of claim 16, wherein the cartridge body includes a tissue engaging surface and knife guards that extend upwardly from the tissue engaging surface towards the anvil, the cutting edge of the knife positioned between the knife guards when the knife is in the knife retracted position.
20. A tool assembly comprising: an actuation sled including a central portion and cam members positioned on opposite sides of the central portion; a knife including a cutting edge and supporting a latch, the latch having a width; and a drive assembly including a flexible drive beam and a working member, the flexible drive beam having a distal portion secured to the working member, the working member having an I-shaped configuration and including a first beam, a second beam, and a vertical strut, the vertical strut having a distal end and a proximal end and defining a recess that extends across the vertical strut from the distal end to the proximal end, the recess having a height that is greater than the width of the latch to facilitate movement of the latch within the recess, wherein the latch extends through the recess and is configured to couple the knife to the vertical strut of the working member, the latch movable within the recess of the vertical strut to facilitate movement of the knife in relation to the working member.
PCT/IB2024/053667 2023-04-17 2024-04-15 Surgical stapling device with floating knife Pending WO2024218633A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5865361A (en) 1997-09-23 1999-02-02 United States Surgical Corporation Surgical stapling apparatus
US8899462B2 (en) * 2011-10-25 2014-12-02 Covidien Lp Apparatus for endoscopic procedures
AU2015202577A1 (en) * 2010-10-01 2015-06-04 Covidien Lp Tissue stop for surgical instrument
US20220304679A1 (en) * 2021-03-24 2022-09-29 Ethicon Llc Method of using a powered stapling device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5865361A (en) 1997-09-23 1999-02-02 United States Surgical Corporation Surgical stapling apparatus
AU2015202577A1 (en) * 2010-10-01 2015-06-04 Covidien Lp Tissue stop for surgical instrument
US8899462B2 (en) * 2011-10-25 2014-12-02 Covidien Lp Apparatus for endoscopic procedures
US20220304679A1 (en) * 2021-03-24 2022-09-29 Ethicon Llc Method of using a powered stapling device

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