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WO2025088535A1 - Surgical stapling device with a replaceable staple cartridge having a cutting knife - Google Patents

Surgical stapling device with a replaceable staple cartridge having a cutting knife Download PDF

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Publication number
WO2025088535A1
WO2025088535A1 PCT/IB2024/060469 IB2024060469W WO2025088535A1 WO 2025088535 A1 WO2025088535 A1 WO 2025088535A1 IB 2024060469 W IB2024060469 W IB 2024060469W WO 2025088535 A1 WO2025088535 A1 WO 2025088535A1
Authority
WO
WIPO (PCT)
Prior art keywords
knife
assembly
stapling device
surgical stapling
actuation sled
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/IB2024/060469
Other languages
French (fr)
Inventor
Justin P. WILLIAMS
David A. Nicholas
David M. Farascioni
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
Publication of WO2025088535A1 publication Critical patent/WO2025088535A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B17/07207—Surgical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B2017/07214—Stapler heads
    • A61B2017/0725—Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07278—Stapler heads characterised by its sled or its staple holder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07285—Stapler heads characterised by its cutter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs

Definitions

  • the disclosure is directed to surgical stapling devices and, more particularly, to surgical stapling devices having replaceable staple cartridges with a cutting knife.
  • Surgical stapling devices for simultaneously stapling and cutting tissue are well known in the art and include a tool assembly and a drive assembly.
  • the tool assembly includes an anvil assembly and a cartridge assembly having a channel member and a staple cartridge that is received within the channel member.
  • the staple cartridge includes a cartridge body that defines a knife slot and supports staples, pushers, and an actuation sled.
  • the drive assembly is movable through the cartridge body to move the actuation sled into sequential engagement with the pushers to sequentially eject the staples from the cartridge body.
  • the drive assembly includes a laminated beam that is coupled to an I-beam that includes a vertical strut that is movable through the knife slot and defines a cutting edge for cutting tissue.
  • these stapling devices may include a tool assembly that articulates, the articulation is limited to articulation about a single axis. This drive assembly configuration is not suitable for wristed stapling devices for robotic stapling systems that require articulation about multiple axes.
  • wristed stapling devices typically include a drive member that includes a push pull cable that is coupled to the I-beam of the drive assembly.
  • the I-beam When using a drive assembly having a push pull cable, the I-beam must be thinner to provide additional material in the cartridge body to support the push pull cable. The cutting edge on the I-beam in such devices may not be suitable for multiple firings.
  • This disclosure is directed to a surgical stapling device that includes a tool assembly and a drive assembly for actuating the tool assembly.
  • the tool assembly includes an anvil, a cartridge assembly, and a mounting member.
  • the cartridge assembly includes a channel member that defines cavity and a staple cartridge that is releasably supported within the cavity.
  • the staple cartridge has an actuation sled and knife assembly including a knife that is rotatably supported on the actuation sled.
  • the drive assembly includes a push pull cable and an I-beam that is supported on the distal portion of the push pull cable.
  • the push pull cable has a non-circular portion that is received within a correspondingly shaped channel in the cartridge body to stabilize the push pull cable.
  • a surgical stapling device including an elongated body and a tool assembly.
  • the elongated body has a proximal portion and a distal portion.
  • the tool assembly is supported on the distal portion of the elongated body and includes a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position.
  • the cartridge assembly includes a staple cartridge having a cartridge body, staples, pushers, and an actuation sled and knife assembly.
  • the cartridge body defines a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, and the staples are received within the staple receiving pockets of the cartridge body.
  • the drive assembly is movable between a drive retracted position and a drive advanced position through a drive clamped position to move the tool assembly between the open position and the clamped position and to subsequently advance the actuation sled from the sled retracted position to the sled advanced position.
  • the actuation sled includes a bottom wall, a central portion, and ramps positioned on opposite sides of the central portion, and the central portion and the ramps extend upwardly from the bottom wall of the actuation sled.
  • the bottom wall of the actuation sled defines a longitudinal slot that extends proximally from and communicates with the opening, and the elongated arm of the knife is received within the longitudinal slot when the knife is in the lowered position.
  • the central portion of the actuation sled includes an overhang that is positioned over the opening and over the hub of the knife.
  • the hub of the knife has a diameter and the opening in the bottom wall of the actuation sled has a width, and the diameter of the hub is greater than the width of the opening.
  • the push pull cable includes a center cable formed of metal, and the non-circular portion of the push pull cable is secured to the center cable and is formed from plastic.
  • an actuation sled and knife assembly that includes an actuation sled and a knife.
  • the actuation sled has a bottom wall, a central portion, and ramps. The central portion and the ramps extend upwardly from the bottom wall, and the bottom wall defines an opening.
  • the knife is supported on the actuation sled and is movable between a lowered position and a raised position.
  • the knife includes a hub, an elongated arm extending proximally from the hub, and a cutting member that is supported on the elongated arm.
  • the hub is rotatably supported on the actuation sled within the opening.
  • a surgical stapling device that includes an elongated body, a tool assembly, and a drive assembly.
  • the elongated body has a proximal portion and a distal portion.
  • the tool assembly is supported on the distal portion of the elongated body and includes a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position.
  • the cartridge assembly includes a staple cartridge that has a cartridge body, staples, pushers, and an actuation sled.
  • the cartridge body defines a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, and the staples are received within the staple receiving pockets of the cartridge body.
  • the cartridge body defines a longitudinal channel that has a non-circular configuration, and the actuation sled is movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body.
  • the drive assembly includes a push pull cable and an I- beam.
  • the push pull cable has a distal portion secured to the I-beam and a non-circular portion that is received within the longitudinal channel defined by the cartridge body.
  • the drive assembly is movable between a drive retracted position and a drive advanced position through a drive clamped position to move the tool assembly between the open position and the clamped position and to subsequently advance the actuation sled from the sled retracted position to the sled advanced position.
  • FIG. 1 is side perspective view of a stapling device according to aspects of the disclosure including a tool assembly in an open position;
  • FIG. 2 is an exploded, side perspective view of the tool assembly and a drive assembly of the stapling device shown in FIG. 1 ;
  • FIG. 2A is a cross-sectional view taken along section line 2A-2A of FIG. 2;
  • FIG. 2B is a cross-sectional view taken along section line 2B-2B of FIG. 2;
  • FIG. 3 is an exploded, side perspective view of a staple cartridge of the tool assembly shown in FIG. 2;
  • FIG. 4 is an enlarged view of the indicated area of detail shown in FIG. 3 showing an actuation sled and knife assembly of the staple cartridge;
  • FIG. 5 is a perspective view from the bottom of the actuation sled and knife assembly shown in FIG. 4;
  • FIG. 6 is an exploded perspective view from above of the actuation sled and knife assembly shown in FIG. 5;
  • FIG. 7 is an enlarged view of the indicated area of detail shown in FIG. 2 showing an I-beam of the drive assembly
  • FIG. 8 is a side perspective view of a cartridge body of the staple cartridge of the tool assembly shown in FIG. 2;
  • FIG. 9 is a cross-sectional view taken along section line 9-9 of FIG. 8;
  • FIG. 9A is a perspective view from above the proximal portion of the tool assembly shown in FIG. 1 with the anvil removed and the I-beam of the drive assembly shown partly in phantom;
  • FIG. 10 is a cross-sectional view taken along section line 10-10 of FIG. 1 showing the tool assembly in an open position;
  • FIG. 11 is an enlarged view of the indicated area of detail shown in FIG. 10;
  • FIG. 12 is a side cross-sectional cut-away view of a distal portion of an elongated body and a proximal portion of the tool assembly of the stapling device shown in FIG. 1 as the drive assembly moves from a retracted position towards an advanced position to move the tool assembly from the open position to the clamped position;
  • FIG. 13 is a side cross-sectional cut-away view of a distal portion of the elongated body and the tool assembly of the stapling device shown in FIG. 1 as the drive assembly moves from the retracted position towards the advanced position to advance the actuation sled from a sled retracted position to a sled advanced position;
  • FIG. 14 is a cross-sectional view taken along section line 14-14 of FIG. 13;
  • FIG. 15 is a side cross-sectional, cutaway view of a distal portion of the tool assembly shown in FIG. 13 as the drive assembly is moved from the advanced position towards the retracted position;
  • FIG. 16 is a side cross-sectional, cutaway view of the distal portion of the tool assembly shown in FIG. 15 as the drive assembly is moved further towards the retracted position;
  • FIG. 17 is a side cross-sectional, cutaway view of the distal portion of the tool assembly shown in FIG. 16 as the drive assembly is moved even further towards the retracted position;
  • FIG. 18 is a side cross-sectional, cutaway view of the proximal portion of the tool assembly shown in FIG. 17 with the drive assembly in the retracted position.
  • the term “endoscopic” is used to include endoscopic, laparoscopic, arthroscopic, and any other procedure conducted through small incisions, or cannulas positioned through small incisions in the skin.
  • proximal is used generally to refer to that portion of the device that is closer to a clinician during use of the stapling device in its customary manner
  • distal is used generally to refer to that portion of the device that is farther from the clinician during use of the stapling device in its customary manner.
  • the term “clinician” 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 disclosed surgical stapling device includes a tool assembly and a drive assembly for actuating the tool assembly.
  • the tool assembly includes an anvil, a cartridge assembly, and a mounting member.
  • the cartridge assembly includes a channel member that defines cavity and a staple cartridge that is releasably supported within the cavity.
  • the staple cartridge has an actuation sled and knife assembly including a knife that is rotatably supported on an actuation sled.
  • the drive assembly includes a push pull cable and an I-beam that is supported on the distal portion of the push pull cable, and the push pull cable has a non-circular portion that is received within a correspondingly shaped channel in the cartridge body to stabilize the push pull cable.
  • FIG. 1 illustrates a surgical stapling device according to aspects of the disclosure shown generally as stapling device 10.
  • the stapling device 10 includes a handle assembly 12, an elongated body 14, and a tool assembly 16.
  • the elongated body 14 defines a longitudinal axis “X” (FIG. 1).
  • the handle assembly 12 includes a body 18 that defines a hand grip 18a, a plurality of actuator buttons 20, and a rotation knob 22.
  • the rotation knob 22 is rotatably supported on a distal portion of the body 18 of the handle assembly 12 and supports the elongate body 14 to facilitate rotation of the elongated body 14 and the tool assembly 16 in relation to the handle assembly 12 about the longitudinal axis “X”.
  • the actuator buttons 20 control operation of the various functions of the stapling device 10 including clamping, firing, and cutting of tissue.
  • the rotation knob 22 supports an articulation lever 23 that is operable to pivot the tool assembly 16 about an axis transverse to the longitudinal axis “X” of the elongated body 14.
  • the stapling device 10 is illustrated as an electrically powered stapling device, it is envisioned that the disclosed tool assembly 16 would also be suitable for use with manually powered surgical stapling devices and robotically operated stapling devices.
  • U.S. Patent No. 9,055,943 discloses a surgical stapling device including a powered handle assembly
  • U.S. Patent No. 6,241,139 discloses a surgical stapling device including a manually actuated handle assembly
  • U.S Patent No. 9,962,159 discloses a stapling device that is configured for use with a robotic system.
  • FIG. 2 illustrates the tool assembly 16 which includes an anvil 24, a cartridge assembly 26, and a mounting member 28.
  • the cartridge assembly 26 includes a staple cartridge 30 and a channel member 32 that defines a recess 32a that receives the staple cartridge 30.
  • the staple cartridge 30 is releasably supported within the recess 32a of the channel member 32 and is replaceable to facilitate reuse of the stapling device 10.
  • the staple cartridge 30 is supported on a spring 33, e.g., a wave spring, that is supported on the channel member 32 within the recess 32a to allow the staple cartridge 30 to float or move vertically within the recess 32a in relation to the anvil 24.
  • a spring 33 e.g., a wave spring
  • the anvil 24 is coupled to the channel member 32 of the cartridge assembly 26 to facilitate movement of the tool assembly 16 between an open position and a clamped position.
  • the anvil 24 is fixedly secured to the mounting member 28 and the channel member 32 is pivotally coupled to the mounting member 28 with pins 34.
  • the pins 34 extend through openings 36 formed in a proximal portion of the anvil 24 and through openings 38 formed in a proximal portion of the channel member 32 into holes 40 formed in the mounting member 28.
  • the channel member 32 is shown to pivot in relation to the mounting member 28, it is envisioned that the channel member 32 could be fixedly secured to the mounting member 28 and the anvil 24 could be pivotally coupled to the mounting member 28.
  • FIG. 2 and 2A illustrate the mounting member 28 which is secured to the proximal portions of the anvil 24 and the channel member 32 of the cartridge assembly 26.
  • the proximal portion of the mounting member 28 is pivotably coupled to the distal portion of the elongated body 14 to facilitate articulation of the tool assembly 16 in relation to the elongated body 14.
  • the mounting member 28 defines a through bore 28a (FIG. 2A) that extends longitudinally through the mounting member 28.
  • the distal portion of the mounting member 28 also defines a slot 28b that is aligned with the knife slot 52 in the cartridge body 42 and communicates with opposite sides of the through bore 28a.
  • the mounting member 28 includes extensions 29 that extend distally from the distal portion of the mounting member 28 and define the distal portion of the through bore 28a.
  • the through bore 28a has a non-circular configuration.
  • the through bore 28a has a square or rectangular configuration although other configurations are envisioned.
  • the through bore 28a has a circular configuration.
  • FIGS. 4-6 illustrate the actuation sled and knife assembly 44 of the staple cartridge 30 that includes an actuation sled 56 and a knife 58.
  • the actuation sled 56 is movable within the cartridge body 42 (FIG. 3) from a sled retracted position to a sled advanced position and includes a bottom wall 60, a central portion 62, and ramps 64 that are positioned on opposite sides of the central portion 62 of the body 42.
  • the bottom wall 60 of the actuation sled 56 is movable along an inner surface of the base plate 50 of the staple cartridge 30 from a sled retracted position to a sled advanced position.
  • the central portion 62 and the ramps 64 extend upwardly from the bottom wall 60 through the body 42 of the staple cartridge 30.
  • the ramps 64 have cam surfaces 64a that are positioned to engage the pushers 46 as the actuation sled 56 moves from the sled retracted position towards the sled advanced position to sequentially eject the staples 48 from the cartridge body 42.
  • the bottom wall 60 of the actuation sled 56 defines an opening 66 (FIG. 5) and a longitudinal slot 68 that communicates with the opening 66.
  • the opening 66 is positioned beneath the central portion 62 in a distal portion of the actuation sled 56 and can have a rectangular configuration.
  • the central portion 62 of the actuation sled 56 includes a proximally extending overhang 70 that is positioned above the opening 66.
  • the knife 58 is rotatably supported on the actuation sled 56 and includes a hub 74, an elongated arm 76, and a cutting member 78.
  • the hub 74, the elongated arm 76, and the cutting member 78 are integrally formed from a metal or plastic material.
  • the hub 74 is formed on a distal portion of the elongated arm 76 and the cutting member 78 is formed on a proximal portion of the elongated arm 76.
  • the hub 74 has a cylindrical configuration that defines a diameter “D” (FIG. 6), and the opening 66 in the bottom wall 60 (FIG.
  • the actuation sled 56 defines a width “W” that is smaller than the diameter “D” of the hub 74.
  • the hub 74 is partially received within the opening 66 beneath the overhang 70 such that the knife 58 is rotatable on the actuation sled 56 from a lowered position (FIG. 11) to a raised position (FIG. 12).
  • the hub 74 of the knife 58 defines a pivot axis that is transverse to a longitudinal axis of the channel member 32 and about which the knife 58 rotates or pivots between the lowered position and the raised position.
  • the elongated arm 76 of the knife 58 extends proximally from the hub 74 and includes a linear or substantially linear portion 76a and a curved portion 76b.
  • the linear portion 76a is received within the longitudinal slot 68 in the bottom wall 60 of the actuation sled 56 and the curved portion 76a extends upwardly and proximally from the bottom wall 60 of the actuation sled 56 to a position proximally of the actuation sled 56.
  • the cutting member 78 is formed on the proximal end of the elongated arm 76 and extends upwardly from the curved portion 76b of the elongated arm 76.
  • the cutting member 78 of the knife 58 includes a distally facing cutting edge 82 and a curved proximally facing abutment surface 84 that is positioned proximally of the actuation sled 56.
  • FIGS. 2 and 7 illustrate a drive assembly 90 of the stapling device 10 (FIG. 1) which includes a push pull cable 92 and an I-beam 94 that is secured to the distal portion of the push pull cable 92.
  • the I-beam 94 includes an upper beam 96, a lower beam 98, and a vertical strut 100 that extends between and fixedly secures the upper beam 96 to the lower beam 98.
  • the vertical strut 100 includes an angled distal surface 100a and has a narrow width that is dimensioned to be received within the slot 28b in the mounting member 28 and the knife slot 52 in the cartridge body 42.
  • the drive assembly 90 is movable between a drive retracted position and a drive advanced position to actuate the tool assembly 16.
  • the drive assembly 90 When the drive assembly 90 is moved from the drive retracted position to a drive clamped position located between the drive retracted position and the drive advanced position, the upper beam 96 of the I-beam 94 engages the anvil 24 and the lower beam 98 of the I-beam 94 engages the channel member 32 of the cartridge assembly 26 to initially move the tool assembly 16 from the open position to the clamped position.
  • the I-beam 94 engages and advances the actuation sled and knife assembly 44 to move the actuation sled 56 from the sled retracted position to the sled advanced position to cut tissue clamped between the anvil 24 and the staple cartridge 30 and to eject the staples 48 from the cartridge body 42.
  • the anvil 24 defines a channel 102 (FIG. 10) that receives the upper beam 96 and the channel member 32 includes an outer surface 104 (FIG. 10) that is engages the lower beam 98 to moves the tool assembly 16 from the open position to the clamped position.
  • the I-beam 94 also includes a cam strap 108 that extends distally from about the vertical strut 100 and defines a slot 110 that is positioned above the knife 58 when the knife 58 is in the lowered position and the actuation sled 56 is in the sled retracted position and receives the cutting member 78 of the knife 58 is in the raised position.
  • the cam strap 108 is formed integrally with the vertical strut 100 of the I-beam 94 and has a configuration that corresponds to the configuration of a longitudinal channel 122 defined by the cartridge body 42 (FIG. 14).
  • the push pull cable 92 has a distal portion 112 that is fixedly secured to the I-beam 94.
  • the distal portion 112 of the push pull cable 94 is received within an opening (not shown) defined in the proximal portion of the I-beam 94 to secure the push pull cable 94 to the I-beam 94.
  • the distal portion 112 of the push pull cable 92 has a cross-section having a cylindrical configuration.
  • the distal portion 112 of the push pull cable 92 can be secured to the I-beam 94 using any known fastening technique, e.g., welding, and can have a variety of different cross-sectional configurations.
  • the push pull cable 92 includes a non-circular portion 114 that is received within the through bore 28a of the mounting member 28 and the cartridge body 42.
  • the push pull cable 92 includes a center cable 92a and the non-circular portion 114 is over-molded or secured about the center cable 92a.
  • the length of the non-circular portion 114 of the push pull cable 92 should be substantially equal to or greater than the length of the distance between a proximal portion of the mounting member 28 and the distal end of the cartridge body 42.
  • the non-circular portion 114 of the push pull cable 92 has a square or rectangular cross-sectional configuration although other non-circular configurations are envisioned.
  • the center cable 92a of the push pull cable 92 is metal stranded cable and the non-circular portion 114 is formed from plastic or rubber. It is envisioned that a variety of different metals and plastics can be used to form the push pull cable 92.
  • FIGS. 8 and 9 illustrate the cartridge body 42 of the staple cartridge 30 which defines channels 120 that receive the ramps 64 of the actuation sled 56 and a longitudinal channel 122 that receives the non-circular portion 114 of the push pull cable 92.
  • the channel 122 of the cartridge body 42 has a shape that corresponds to the shape of the non-circular portion 114 of the push pull cable 92.
  • the dimensions of the channel 122, and of the through bore 28a of the mounting member 28 are slightly larger than the dimensions of the non- circular portion 114 of the push pull cable 92 such that the non-circular portion 114 of the push pull cable 92 can float or move vertically within the channel 122 of the cartridge body 42 and the through bore 28a of the mounting member 28.
  • the cartridge body 42 can move or float within the recess 32a of the channel member 32 of the cartridge assembly 26 via compression of the spring 33 (FIG. 2) to compensate for tissues of different thicknesses.
  • FIG. 9A illustrates the tool assembly 16 and the drive assembly 90 assembled with the anvil 24 removed from the tool assembly 16, the drive assembly 90 in the drive retracted position, and the actuation sled in the sled retracted position.
  • the I-beam 94 of the drive assembly 90 is aligned with the mounting member 28 with the vertical strut 100 of the I-beam 94 received within the slot 28b of the mounting member 28, and the non-circular portion 114 of the push pull cable 92 is received within the through bore 28a of the mounting member 28.
  • the I-beam 94 is also spaced proximally of the actuation sled and knife assembly 44 with the cam strap 108 of the I-beam 94 positioned within the through bore 28a of the mounting member 28.
  • FIGS. 10 and 11 illustrate the tool assembly 16 in the open position with the drive assembly in the drive retracted position and the actuation sled and knife assembly 44 in the sled retracted position.
  • the angled distal surface 100a of the I-beam 94 is in close approximation or engaged with the abutment surface 84 of the cutting member 78 of the knife 58, and the knife 58 is in the lowered position.
  • the cam strap 108 is positioned above the cutting member 78 of the knife 58.
  • the non-circular portion 114 of the push pull cable 90 is received within the through bore 28a of the mounting member 28.
  • FIG. 12 illustrates the drive assembly 90 as the drive assembly 28 is moved from the drive retracted position to the drive clamped position.
  • the angled distal surface 101a of the I-beam 94 engages the abutment surface 84 of the cutting member 78 of the knife 58 to rotate the knife 58 in the direction indicated by arrow “B” from the lowered position to the raised position.
  • the cutting member 78 passes through the slot 110 of the cam strap 108 and is positioned above the cam strap 108.
  • the upper beam 96 and the lower beam 98 engage the anvil 24 and the channel member 32, respectively, to move the cartridge assembly 26 in the direction indicated by arrow “C” and move the tool assembly 16 from the open position to the clamped position.
  • the cutting member 78 of the knife 58 engages the underside of the upper beam 96.
  • the non-circular portion 114 of the push pull cable 92 is received within the channel 122 of the cartridge body 42 to reinforce the push pull cable 92 as the push pull cable 92 advances the actuation sled and knife assembly 44 through the staple cartridge 30.
  • FIGS. 15-18 illustrate the drive assembly 90 as the drive assembly 90 is moved from the drive advanced position back to the drive retracted position.
  • the actuation sled and knife assembly 44 After the actuation sled and knife assembly 44 reach the sled advanced position and the drive assembly 90 is retracted in the direction indicated by arrow “D” in FIGS. 15-17, the actuation sled and knife assembly 44 remains in the sled advanced position.
  • the cam strap 108 engages the elongated arm 76 of the knife 58 and the cutting member 78 of the knife 58 to urge the knife 58 in the direction indicated by arrow “E” in FIGS. 15 and 16 to move the knife 58 back to the lowered position.
  • the cam strap 108 moves proximally of the knife 58, the drive assembly 90 returns to the drive retracted position to return the tool assembly to the open position (FIG.18).
  • a surgical stapling device comprising: an elongated body having a proximal portion and a distal portion; a tool assembly supported on the distal portion of the elongated body, the tool assembly including a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position, the cartridge assembly including a staple cartridge having a cartridge body, staples, pushers, and an actuation sled and knife assembly, the cartridge body defining a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, the staples received within the staple receiving pockets of the cartridge body, the cartridge body defining a longitudinal channel having a non-circular configuration, the actuation sled and knife assembly including an actuation sled and a knife, the knife supported on the actuation sled and movable between a lowered position and a raised position, the actuation sled movable from a sled retracted position to a sled
  • Example 2 The surgical stapling device of example 1, wherein the non- circular portion of the channel and the non-circular portion of the push pull cable have rectangular configurations.
  • Example 3 The surgical stapling device of example 2, wherein the longitudinal channel is dimensioned to allow the non-circular portion of the push pull cable to move towards and away from the anvil within the cartridge body.
  • Example 4 The surgical stapling device of example 1, further including a handle assembly coupled to the proximal portion of the elongated body.
  • Example s The surgical stapling device of example 1, wherein the knife is pivotally supported on the actuation sled.
  • Example 6 The surgical stapling device of example 5, wherein the knife includes a hub, an elongated arm extending proximally from the hub, and a cutting member supported on the elongated arm, the hub rotatably supported on the actuation sled.
  • Example 7 The surgical stapling device of example 6, wherein the actuation sled includes a bottom wall, a central portion, and ramps positioned on opposite sides of the central portion, the central portion and the ramps extending upwardly from the bottom wall of the actuation sled.
  • Example 8 The surgical stapling device of example 7, wherein the bottom wall defines an opening, and the hub of the knife is received within the opening.
  • Example 9 The surgical stapling device of example 8, wherein the bottom wall of the actuation sled defines a longitudinal slot that extends proximally from and communicates with the opening, the elongated arm of the knife received within the longitudinal slot when the knife is in the lowered position.
  • Example 10 The surgical stapling device of example 9, wherein the central portion of the actuation sled includes an overhang that is positioned over the opening and over the hub of the knife.
  • Example 11 The surgical stapling device of example 10, wherein the push pull cable includes a center cable formed of metal, and the non-circular portion of the push pull cable is secured to the center cable and is formed from plastic.
  • An actuation sled and knife assembly comprising: an actuation sled having a bottom wall, a central portion, and ramps, the central portion and ramps extending upwardly from the bottom wall, and the bottom wall defining an opening; and a knife supported on the actuation sled and movable between a lowered position and a raised position, the knife including a hub, an elongated arm extending proximally from the hub, and a cutting member supported on the elongated arm, the hub rotatably supported on the actuation sled within the opening.
  • Example 13 The actuation sled and knife assembly of example 12, wherein the bottom wall of the actuation sled defines a longitudinal slot, and the elongated arm of the knife is positioned within the longitudinal slot when the knife is in the lowered position.
  • Example 14 The actuation sled and knife assembly of example 13, wherein the central portion of the actuation sled includes an overhang that is positioned over the opening and over the hub of the knife.
  • Example 15 The actuation sled and knife assembly of example 14, wherein the hub of the knife has a diameter and the opening in the bottom wall of the actuation sled has a width, the diameter of the hub being greater than the width of the opening.
  • a surgical stapling device comprising: an elongated body having a proximal portion and a distal portion; a tool assembly supported on the distal portion of the elongated body, the tool assembly including a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position, the cartridge assembly including a staple cartridge having a cartridge body, staples, pushers, and an actuation sled, the cartridge body defining a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, the staples received within the staple receiving pockets of the cartridge body, the cartridge body defining a longitudinal channel that has a non-circular configuration, the actuation sled movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body; and a drive assembly including a push pull cable and an I-beam, the push pull cable having a distal portion secured to the I-beam and a
  • Example 17 The surgical stapling device of example 16, wherein the non- circular portions of the longitudinal channel and the push pull cable have a rectangular configurations.
  • Example 18 The surgical stapling device of example 16, wherein the longitudinal channel is dimensioned to allow the push pull cable to move towards and away from the anvil within the cartridge body.
  • Example 19 The surgical stapling device of example 16, further including a knife supported on the actuation sled, the knife movable between a lowered position and a raised position.
  • Example 20 The surgical stapling device of example 19, wherein the knife includes a hub, an elongated arm extending proximally from the hub, and a cutting member supported on the elongated arm, the hub rotatably supported on the actuation sled.

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Abstract

A surgical stapling device includes a tool assembly and a drive assembly for actuating the tool assembly. The tool assembly includes an anvil and a cartridge assembly having a channel member that defines cavity and a staple cartridge that is releasably supported within the cavity. The staple cartridge includes an actuation sled and knife assembly with a knife that is rotatably supported on an actuation sled. The drive assembly includes a push pull cable and an I-beam that is secured to the distal portion of the push pull cable, and the push pull cable has a non-circular portion that is received within a correspondingly shaped channel in the cartridge body to stabilize the push pull cable.

Description

SURGICAL STAPLING DEVICE WITH A REPLACEABLE STAPLE CARTRIDGE HAVING A CUTTING KNIFE
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of the filing date of provisional U.S. Patent Application No. 63/593,275 filed on October 26, 2023, the entire content of each of which is incorporated herein by reference.
FIELD
[0002] The disclosure is directed to surgical stapling devices and, more particularly, to surgical stapling devices having replaceable staple cartridges with a cutting knife.
BACKGROUND
[0003] Surgical stapling devices for simultaneously stapling and cutting tissue are well known in the art and include a tool assembly and a drive assembly. The tool assembly includes an anvil assembly and a cartridge assembly having a channel member and a staple cartridge that is received within the channel member. Typically, the staple cartridge includes a cartridge body that defines a knife slot and supports staples, pushers, and an actuation sled. The drive assembly is movable through the cartridge body to move the actuation sled into sequential engagement with the pushers to sequentially eject the staples from the cartridge body.
[0004] In some stapling devices, the drive assembly includes a laminated beam that is coupled to an I-beam that includes a vertical strut that is movable through the knife slot and defines a cutting edge for cutting tissue. Although these stapling devices may include a tool assembly that articulates, the articulation is limited to articulation about a single axis. This drive assembly configuration is not suitable for wristed stapling devices for robotic stapling systems that require articulation about multiple axes.
[0005] Typically, wristed stapling devices include a drive member that includes a push pull cable that is coupled to the I-beam of the drive assembly. When using a drive assembly having a push pull cable, the I-beam must be thinner to provide additional material in the cartridge body to support the push pull cable. The cutting edge on the I-beam in such devices may not be suitable for multiple firings.
[0006] A continuing need exists for a wristed stapling device having a drive assembly with a push pull cable that is suitable for use for multiple firings.
SUMMARY [0007] This disclosure is directed to a surgical stapling device that includes a tool assembly and a drive assembly for actuating the tool assembly. The tool assembly includes an anvil, a cartridge assembly, and a mounting member. The cartridge assembly includes a channel member that defines cavity and a staple cartridge that is releasably supported within the cavity. The staple cartridge has an actuation sled and knife assembly including a knife that is rotatably supported on the actuation sled. The drive assembly includes a push pull cable and an I-beam that is supported on the distal portion of the push pull cable. The push pull cable has a non-circular portion that is received within a correspondingly shaped channel in the cartridge body to stabilize the push pull cable.
[0008] Aspects of this disclosure are directed to a surgical stapling device including an elongated body and a tool assembly. The elongated body has a proximal portion and a distal portion. The tool assembly is supported on the distal portion of the elongated body and includes a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position. The cartridge assembly includes a staple cartridge having a cartridge body, staples, pushers, and an actuation sled and knife assembly. The cartridge body defines a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, and the staples are received within the staple receiving pockets of the cartridge body. The cartridge body defines a longitudinal channel that has a non-circular configuration. The actuation sled and knife assembly includes an actuation sled and a knife, and the knife is supported on the actuation sled and is movable between a lowered position and a raised position. The actuation sled is movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body. The drive assembly includes a push pull cable and an I-beam. The push pull cable has a distal portion secured to the I-beam and a non- circular portion that is received within the longitudinal channel defined by the cartridge body. The drive assembly is movable between a drive retracted position and a drive advanced position through a drive clamped position to move the tool assembly between the open position and the clamped position and to subsequently advance the actuation sled from the sled retracted position to the sled advanced position.
[0009] In aspects of the disclosure, the non-circular portion of the longitudinal channel and the non-circular portion of the push pull cable have rectangular configurations. [0010] In some aspects of the disclosure, the longitudinal channel is dimensioned to allow non-circular portion of the push pull cable to move towards and away from the anvil within the cartridge body.
[0011] In certain aspects of the disclosure, the stapling device includes a handle assembly that is coupled to the proximal portion of the elongate body.
[0012] In aspects of the disclosure, the knife is pivotally supported on the actuation sled.
[0013] In some aspects of the disclosure, the knife includes a hub, an elongated arm extending proximally from the hub, and a cutting member that is supported on the elongated arm, and the hub is rotatably supported on the actuation sled.
[0014] In certain aspects of the disclosure, the actuation sled includes a bottom wall, a central portion, and ramps positioned on opposite sides of the central portion, and the central portion and the ramps extend upwardly from the bottom wall of the actuation sled.
[0015] In aspects of the disclosure, the bottom wall defines an opening, and the hub of the knife is received within the opening.
[0016] In some aspects of the disclosure, the bottom wall of the actuation sled defines a longitudinal slot that extends proximally from and communicates with the opening, and the elongated arm of the knife is received within the longitudinal slot when the knife is in the lowered position.
[0017] In certain aspects of the disclosure, the central portion of the actuation sled includes an overhang that is positioned over the opening and over the hub of the knife.
[0018] In aspects of the disclosure, the hub of the knife has a diameter and the opening in the bottom wall of the actuation sled has a width, and the diameter of the hub is greater than the width of the opening.
[0019] In some aspects of the disclosure, the push pull cable includes a center cable formed of metal, and the non-circular portion of the push pull cable is secured to the center cable and is formed from plastic.
[0020] Other aspects of the disclosure are directed to an actuation sled and knife assembly that includes an actuation sled and a knife. The actuation sled has a bottom wall, a central portion, and ramps. The central portion and the ramps extend upwardly from the bottom wall, and the bottom wall defines an opening. The knife is supported on the actuation sled and is movable between a lowered position and a raised position. The knife includes a hub, an elongated arm extending proximally from the hub, and a cutting member that is supported on the elongated arm. The hub is rotatably supported on the actuation sled within the opening.
[0021] Other aspects of the disclosure are directed to a surgical stapling device that includes an elongated body, a tool assembly, and a drive assembly. The elongated body has a proximal portion and a distal portion. The tool assembly is supported on the distal portion of the elongated body and includes a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position. The cartridge assembly includes a staple cartridge that has a cartridge body, staples, pushers, and an actuation sled. The cartridge body defines a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, and the staples are received within the staple receiving pockets of the cartridge body. The cartridge body defines a longitudinal channel that has a non-circular configuration, and the actuation sled is movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body. The drive assembly includes a push pull cable and an I- beam. The push pull cable has a distal portion secured to the I-beam and a non-circular portion that is received within the longitudinal channel defined by the cartridge body. The drive assembly is movable between a drive retracted position and a drive advanced position through a drive clamped position to move the tool assembly between the open position and the clamped position and to subsequently advance the actuation sled from the sled retracted position to the sled advanced position.
[0022] Other features of the disclosure will be appreciated from the following description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Various aspects of the disclosure are described herein below with reference to the drawings, wherein:
[0024] FIG. 1 is side perspective view of a stapling device according to aspects of the disclosure including a tool assembly in an open position;
[0025] FIG. 2 is an exploded, side perspective view of the tool assembly and a drive assembly of the stapling device shown in FIG. 1 ;
[0026] FIG. 2A is a cross-sectional view taken along section line 2A-2A of FIG. 2;
[0027] FIG. 2B is a cross-sectional view taken along section line 2B-2B of FIG. 2;
[0028] FIG. 3 is an exploded, side perspective view of a staple cartridge of the tool assembly shown in FIG. 2; [0029] FIG. 4 is an enlarged view of the indicated area of detail shown in FIG. 3 showing an actuation sled and knife assembly of the staple cartridge;
[0030] FIG. 5 is a perspective view from the bottom of the actuation sled and knife assembly shown in FIG. 4;
[0031] FIG. 6 is an exploded perspective view from above of the actuation sled and knife assembly shown in FIG. 5;
[0032] FIG. 7 is an enlarged view of the indicated area of detail shown in FIG. 2 showing an I-beam of the drive assembly;
[0033] FIG. 8 is a side perspective view of a cartridge body of the staple cartridge of the tool assembly shown in FIG. 2;
[0034] FIG. 9 is a cross-sectional view taken along section line 9-9 of FIG. 8;
[0035] FIG. 9A is a perspective view from above the proximal portion of the tool assembly shown in FIG. 1 with the anvil removed and the I-beam of the drive assembly shown partly in phantom;
[0036] FIG. 10 is a cross-sectional view taken along section line 10-10 of FIG. 1 showing the tool assembly in an open position;
[0037] FIG. 11 is an enlarged view of the indicated area of detail shown in FIG. 10;
[0038] FIG. 12 is a side cross-sectional cut-away view of a distal portion of an elongated body and a proximal portion of the tool assembly of the stapling device shown in FIG. 1 as the drive assembly moves from a retracted position towards an advanced position to move the tool assembly from the open position to the clamped position;
[0039] FIG. 13 is a side cross-sectional cut-away view of a distal portion of the elongated body and the tool assembly of the stapling device shown in FIG. 1 as the drive assembly moves from the retracted position towards the advanced position to advance the actuation sled from a sled retracted position to a sled advanced position;
[0040] FIG. 14 is a cross-sectional view taken along section line 14-14 of FIG. 13;
[0041] FIG. 15 is a side cross-sectional, cutaway view of a distal portion of the tool assembly shown in FIG. 13 as the drive assembly is moved from the advanced position towards the retracted position; [0042] FIG. 16 is a side cross-sectional, cutaway view of the distal portion of the tool assembly shown in FIG. 15 as the drive assembly is moved further towards the retracted position;
[0043] FIG. 17 is a side cross-sectional, cutaway view of the distal portion of the tool assembly shown in FIG. 16 as the drive assembly is moved even further towards the retracted position; and
[0044] FIG. 18 is a side cross-sectional, cutaway view of the proximal portion of the tool assembly shown in FIG. 17 with the drive assembly in the retracted position.
DETAILED DESCRIPTION
[0045] 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 aspects of the disclosure 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.
[0046] In this description, the term “endoscopic” is used to include endoscopic, laparoscopic, arthroscopic, and any other procedure conducted through small incisions, or cannulas positioned through small incisions in the skin. In addition, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician during use of the stapling device 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 during use of the stapling device 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.
[0047] The disclosed surgical stapling device includes a tool assembly and a drive assembly for actuating the tool assembly. The tool assembly includes an anvil, a cartridge assembly, and a mounting member. The cartridge assembly includes a channel member that defines cavity and a staple cartridge that is releasably supported within the cavity. The staple cartridge has an actuation sled and knife assembly including a knife that is rotatably supported on an actuation sled. The drive assembly includes a push pull cable and an I-beam that is supported on the distal portion of the push pull cable, and the push pull cable has a non-circular portion that is received within a correspondingly shaped channel in the cartridge body to stabilize the push pull cable.
[0048] FIG. 1 illustrates a surgical stapling device according to aspects of the disclosure shown generally as stapling device 10. The stapling device 10 includes a handle assembly 12, an elongated body 14, and a tool assembly 16. The elongated body 14 defines a longitudinal axis “X” (FIG. 1). The handle assembly 12 includes a body 18 that defines a hand grip 18a, a plurality of actuator buttons 20, and a rotation knob 22. The rotation knob 22 is rotatably supported on a distal portion of the body 18 of the handle assembly 12 and supports the elongate body 14 to facilitate rotation of the elongated body 14 and the tool assembly 16 in relation to the handle assembly 12 about the longitudinal axis “X”. The actuator buttons 20 control operation of the various functions of the stapling device 10 including clamping, firing, and cutting of tissue. In aspects of the disclosure, the rotation knob 22 supports an articulation lever 23 that is operable to pivot the tool assembly 16 about an axis transverse to the longitudinal axis “X” of the elongated body 14. Although the stapling device 10 is illustrated as an electrically powered stapling device, it is envisioned that the disclosed tool assembly 16 would also be suitable for use with manually powered surgical stapling devices and robotically operated stapling devices. U.S. Patent No. 9,055,943 discloses a surgical stapling device including a powered handle assembly, U.S. Patent No. 6,241,139 discloses a surgical stapling device including a manually actuated handle assembly, and U.S Patent No. 9,962,159 discloses a stapling device that is configured for use with a robotic system.
[0049] FIG. 2 illustrates the tool assembly 16 which includes an anvil 24, a cartridge assembly 26, and a mounting member 28. The cartridge assembly 26 includes a staple cartridge 30 and a channel member 32 that defines a recess 32a that receives the staple cartridge 30. In aspects of the disclosure, the staple cartridge 30 is releasably supported within the recess 32a of the channel member 32 and is replaceable to facilitate reuse of the stapling device 10. In some aspects of the disclosure, the staple cartridge 30 is supported on a spring 33, e.g., a wave spring, that is supported on the channel member 32 within the recess 32a to allow the staple cartridge 30 to float or move vertically within the recess 32a in relation to the anvil 24. The anvil 24 is coupled to the channel member 32 of the cartridge assembly 26 to facilitate movement of the tool assembly 16 between an open position and a clamped position. In aspects of the disclosure, the anvil 24 is fixedly secured to the mounting member 28 and the channel member 32 is pivotally coupled to the mounting member 28 with pins 34. The pins 34 extend through openings 36 formed in a proximal portion of the anvil 24 and through openings 38 formed in a proximal portion of the channel member 32 into holes 40 formed in the mounting member 28. Although the channel member 32 is shown to pivot in relation to the mounting member 28, it is envisioned that the channel member 32 could be fixedly secured to the mounting member 28 and the anvil 24 could be pivotally coupled to the mounting member 28.
[0050] FIG. 2 and 2A illustrate the mounting member 28 which is secured to the proximal portions of the anvil 24 and the channel member 32 of the cartridge assembly 26. The proximal portion of the mounting member 28 is pivotably coupled to the distal portion of the elongated body 14 to facilitate articulation of the tool assembly 16 in relation to the elongated body 14. The mounting member 28 defines a through bore 28a (FIG. 2A) that extends longitudinally through the mounting member 28. The distal portion of the mounting member 28 also defines a slot 28b that is aligned with the knife slot 52 in the cartridge body 42 and communicates with opposite sides of the through bore 28a. In aspects of the disclosure, the mounting member 28 includes extensions 29 that extend distally from the distal portion of the mounting member 28 and define the distal portion of the through bore 28a. In some aspects of the disclosure, the through bore 28a has a non-circular configuration. In certain aspects of the disclosure, the through bore 28a has a square or rectangular configuration although other configurations are envisioned. In some aspects of the disclosure, the through bore 28a has a circular configuration.
[0051] FIG. 3 illustrates the staple cartridge 30 includes a cartridge body 42, an actuation sled and knife assembly 44, pushers 46, staples 48, and a base plate 50. The cartridge body 42 includes a tissue engaging surface 42a and defines a central knife slot 52 and staple receiving pockets 54. The cartridge body 42 also includes spaced proximally extending fingers 55. In aspects of the disclosure, the staple receiving pockets 54 are aligned in rows that are positioned on each side of the central knife slot 52. Although three rows of staple receiving pockets 54 are shown on each side of the central knife slot 52, it is envisioned that the cartridge body 42 can define one or more rows of staple receiving pockets 54 on each side of the central knife slot 52. Each of the staple receiving pockets 54 receives one of the staples 48 and a pusher 46. The pushers 46 support the staples 48 within the staple receiving pockets 54 and are movable within the staple receiving pockets 54 to eject the staples from the cartridge body 42. The base plate 50 is secured to the bottom of the cartridge body 42 to prevent the pushers 46 and staples 48 from falling from the cartridge body 42 during shipping and storage of the staple cartridge 30.
[0052] FIGS. 4-6 illustrate the actuation sled and knife assembly 44 of the staple cartridge 30 that includes an actuation sled 56 and a knife 58. The actuation sled 56 is movable within the cartridge body 42 (FIG. 3) from a sled retracted position to a sled advanced position and includes a bottom wall 60, a central portion 62, and ramps 64 that are positioned on opposite sides of the central portion 62 of the body 42. The bottom wall 60 of the actuation sled 56 is movable along an inner surface of the base plate 50 of the staple cartridge 30 from a sled retracted position to a sled advanced position. The central portion 62 and the ramps 64 extend upwardly from the bottom wall 60 through the body 42 of the staple cartridge 30. The ramps 64 have cam surfaces 64a that are positioned to engage the pushers 46 as the actuation sled 56 moves from the sled retracted position towards the sled advanced position to sequentially eject the staples 48 from the cartridge body 42. The bottom wall 60 of the actuation sled 56 defines an opening 66 (FIG. 5) and a longitudinal slot 68 that communicates with the opening 66. The opening 66 is positioned beneath the central portion 62 in a distal portion of the actuation sled 56 and can have a rectangular configuration. The central portion 62 of the actuation sled 56 includes a proximally extending overhang 70 that is positioned above the opening 66.
[0053] The knife 58 is rotatably supported on the actuation sled 56 and includes a hub 74, an elongated arm 76, and a cutting member 78. In aspects of the disclosure, the hub 74, the elongated arm 76, and the cutting member 78 are integrally formed from a metal or plastic material. The hub 74 is formed on a distal portion of the elongated arm 76 and the cutting member 78 is formed on a proximal portion of the elongated arm 76. In aspects of the disclosure, the hub 74 has a cylindrical configuration that defines a diameter “D” (FIG. 6), and the opening 66 in the bottom wall 60 (FIG. 5) of the actuation sled 56 defines a width “W” that is smaller than the diameter “D” of the hub 74. The hub 74 is partially received within the opening 66 beneath the overhang 70 such that the knife 58 is rotatable on the actuation sled 56 from a lowered position (FIG. 11) to a raised position (FIG. 12). The hub 74 of the knife 58 defines a pivot axis that is transverse to a longitudinal axis of the channel member 32 and about which the knife 58 rotates or pivots between the lowered position and the raised position. [0054] The elongated arm 76 of the knife 58 extends proximally from the hub 74 and includes a linear or substantially linear portion 76a and a curved portion 76b. When the knife 58 is in the lowered position, the linear portion 76a is received within the longitudinal slot 68 in the bottom wall 60 of the actuation sled 56 and the curved portion 76a extends upwardly and proximally from the bottom wall 60 of the actuation sled 56 to a position proximally of the actuation sled 56. The cutting member 78 is formed on the proximal end of the elongated arm 76 and extends upwardly from the curved portion 76b of the elongated arm 76. The cutting member 78 of the knife 58 includes a distally facing cutting edge 82 and a curved proximally facing abutment surface 84 that is positioned proximally of the actuation sled 56.
[0055] FIGS. 2 and 7 illustrate a drive assembly 90 of the stapling device 10 (FIG. 1) which includes a push pull cable 92 and an I-beam 94 that is secured to the distal portion of the push pull cable 92. The I-beam 94 includes an upper beam 96, a lower beam 98, and a vertical strut 100 that extends between and fixedly secures the upper beam 96 to the lower beam 98. The vertical strut 100 includes an angled distal surface 100a and has a narrow width that is dimensioned to be received within the slot 28b in the mounting member 28 and the knife slot 52 in the cartridge body 42. The drive assembly 90 is movable between a drive retracted position and a drive advanced position to actuate the tool assembly 16. When the drive assembly 90 is moved from the drive retracted position to a drive clamped position located between the drive retracted position and the drive advanced position, the upper beam 96 of the I-beam 94 engages the anvil 24 and the lower beam 98 of the I-beam 94 engages the channel member 32 of the cartridge assembly 26 to initially move the tool assembly 16 from the open position to the clamped position. Subsequently, when the drive assembly 90 is moved from the drive clamped position to the drive advanced position, the I-beam 94 engages and advances the actuation sled and knife assembly 44 to move the actuation sled 56 from the sled retracted position to the sled advanced position to cut tissue clamped between the anvil 24 and the staple cartridge 30 and to eject the staples 48 from the cartridge body 42.
[0056] In aspects of the disclosure, the anvil 24 defines a channel 102 (FIG. 10) that receives the upper beam 96 and the channel member 32 includes an outer surface 104 (FIG. 10) that is engages the lower beam 98 to moves the tool assembly 16 from the open position to the clamped position. The I-beam 94 also includes a cam strap 108 that extends distally from about the vertical strut 100 and defines a slot 110 that is positioned above the knife 58 when the knife 58 is in the lowered position and the actuation sled 56 is in the sled retracted position and receives the cutting member 78 of the knife 58 is in the raised position. In aspects of the disclosure, the cam strap 108 is formed integrally with the vertical strut 100 of the I-beam 94 and has a configuration that corresponds to the configuration of a longitudinal channel 122 defined by the cartridge body 42 (FIG. 14).
[0057] The push pull cable 92 has a distal portion 112 that is fixedly secured to the I-beam 94. In some aspects of the disclosure, the distal portion 112 of the push pull cable 94 is received within an opening (not shown) defined in the proximal portion of the I-beam 94 to secure the push pull cable 94 to the I-beam 94. In some aspects of the disclosure, the distal portion 112 of the push pull cable 92 has a cross-section having a cylindrical configuration. Alternately, the distal portion 112 of the push pull cable 92 can be secured to the I-beam 94 using any known fastening technique, e.g., welding, and can have a variety of different cross-sectional configurations. The push pull cable 92 includes a non-circular portion 114 that is received within the through bore 28a of the mounting member 28 and the cartridge body 42. In some aspects of the disclosure, the push pull cable 92 includes a center cable 92a and the non-circular portion 114 is over-molded or secured about the center cable 92a. The length of the non-circular portion 114 of the push pull cable 92 should be substantially equal to or greater than the length of the distance between a proximal portion of the mounting member 28 and the distal end of the cartridge body 42. In aspects of the disclosure, the non-circular portion 114 of the push pull cable 92 has a square or rectangular cross-sectional configuration although other non-circular configurations are envisioned. In certain aspects of the disclosure, the center cable 92a of the push pull cable 92 is metal stranded cable and the non-circular portion 114 is formed from plastic or rubber. It is envisioned that a variety of different metals and plastics can be used to form the push pull cable 92.
[0058] FIGS. 8 and 9 illustrate the cartridge body 42 of the staple cartridge 30 which defines channels 120 that receive the ramps 64 of the actuation sled 56 and a longitudinal channel 122 that receives the non-circular portion 114 of the push pull cable 92. The channel 122 of the cartridge body 42 has a shape that corresponds to the shape of the non-circular portion 114 of the push pull cable 92. In aspects of the disclosure, the dimensions of the channel 122, and of the through bore 28a of the mounting member 28, are slightly larger than the dimensions of the non- circular portion 114 of the push pull cable 92 such that the non-circular portion 114 of the push pull cable 92 can float or move vertically within the channel 122 of the cartridge body 42 and the through bore 28a of the mounting member 28. By allowing the push pull cable 92 to float within the cartridge body 42 and the mounting member 28, the cartridge body 42 can move or float within the recess 32a of the channel member 32 of the cartridge assembly 26 via compression of the spring 33 (FIG. 2) to compensate for tissues of different thicknesses.
[0059] FIG. 9A illustrates the tool assembly 16 and the drive assembly 90 assembled with the anvil 24 removed from the tool assembly 16, the drive assembly 90 in the drive retracted position, and the actuation sled in the sled retracted position. When the staple cartridge 30 is loaded into the channel member 32, the extensions 29 of the mounting member 28 are received between the proximally extending fingers 55 (FIG. 2) of the cartridge body 42 such that the through bore 28a of the mounting member 28 is aligned with the channel 122 of the cartridge body 42 of the staple cartridge 30. In this position, the I-beam 94 of the drive assembly 90 is aligned with the mounting member 28 with the vertical strut 100 of the I-beam 94 received within the slot 28b of the mounting member 28, and the non-circular portion 114 of the push pull cable 92 is received within the through bore 28a of the mounting member 28. The I-beam 94 is also spaced proximally of the actuation sled and knife assembly 44 with the cam strap 108 of the I-beam 94 positioned within the through bore 28a of the mounting member 28.
[0060] FIGS. 10 and 11 illustrate the tool assembly 16 in the open position with the drive assembly in the drive retracted position and the actuation sled and knife assembly 44 in the sled retracted position. In this position, the angled distal surface 100a of the I-beam 94 is in close approximation or engaged with the abutment surface 84 of the cutting member 78 of the knife 58, and the knife 58 is in the lowered position. The cam strap 108 is positioned above the cutting member 78 of the knife 58. In the drive retracted position, the non-circular portion 114 of the push pull cable 90 is received within the through bore 28a of the mounting member 28.
[0061] FIG. 12 illustrates the drive assembly 90 as the drive assembly 28 is moved from the drive retracted position to the drive clamped position. When the drive assembly 90 is moved from the drive retracted position to the drive clamped position in the direction indicated by arrow “A”, the angled distal surface 101a of the I-beam 94 engages the abutment surface 84 of the cutting member 78 of the knife 58 to rotate the knife 58 in the direction indicated by arrow “B” from the lowered position to the raised position. In the raised position, the cutting member 78 passes through the slot 110 of the cam strap 108 and is positioned above the cam strap 108. Simultaneously, the upper beam 96 and the lower beam 98 engage the anvil 24 and the channel member 32, respectively, to move the cartridge assembly 26 in the direction indicated by arrow “C” and move the tool assembly 16 from the open position to the clamped position. When the knife 58 is in the raised position, the cutting member 78 of the knife 58 engages the underside of the upper beam 96.
[0062] FIGS. 13 and 14 illustrate the tool assembly 16 as the drive assembly 90 is moved from the drive clamped position to the drive advanced position. As the drive assembly 90 moves from the drive clamped position towards the drive advanced position in the direction indicated by arrow “A” in FIG. 13, the vertical strut 100 of the I-beam 94 engages the actuation sled 56 and moves the actuation sled and knife assembly 44 through the cartridge body 42 of the staple cartridge 30 from the sled retracted position to the sled advanced position. As the drive assembly 90 moves through the cartridge body 42, the non-circular portion 114 of the push pull cable 92 is received within the channel 122 of the cartridge body 42 to reinforce the push pull cable 92 as the push pull cable 92 advances the actuation sled and knife assembly 44 through the staple cartridge 30.
[0063] FIGS. 15-18 illustrate the drive assembly 90 as the drive assembly 90 is moved from the drive advanced position back to the drive retracted position. After the actuation sled and knife assembly 44 reach the sled advanced position and the drive assembly 90 is retracted in the direction indicated by arrow “D” in FIGS. 15-17, the actuation sled and knife assembly 44 remains in the sled advanced position. As the drive assembly 90 moves from the drive advanced position, the cam strap 108 engages the elongated arm 76 of the knife 58 and the cutting member 78 of the knife 58 to urge the knife 58 in the direction indicated by arrow “E” in FIGS. 15 and 16 to move the knife 58 back to the lowered position. When the cam strap 108 moves proximally of the knife 58, the drive assembly 90 returns to the drive retracted position to return the tool assembly to the open position (FIG.18).
[0064] 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 other aspects of the disclosure without departing from the scope of the disclosure. One skilled in the art will appreciate further features and advantages of the disclosure based on the above-described 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.
[0065] Aspects of this disclosure may be further described by reference to the following examples:
[0066] Example 1. A surgical stapling device comprising: an elongated body having a proximal portion and a distal portion; a tool assembly supported on the distal portion of the elongated body, the tool assembly including a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position, the cartridge assembly including a staple cartridge having a cartridge body, staples, pushers, and an actuation sled and knife assembly, the cartridge body defining a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, the staples received within the staple receiving pockets of the cartridge body, the cartridge body defining a longitudinal channel having a non-circular configuration, the actuation sled and knife assembly including an actuation sled and a knife, the knife supported on the actuation sled and movable between a lowered position and a raised position, the actuation sled movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body; and a drive assembly including a push pull cable and an I-beam, the push pull cable having a distal portion secured to the I-beam and a non-circular portion that is received within the longitudinal channel defined by the cartridge body, the drive assembly movable between a drive retracted position and a drive advanced position through a drive clamped position to move the tool assembly between the open position and the clamped position and to subsequently advance the actuation sled from the sled retracted position to the sled advanced position.
[0067] Example 2. The surgical stapling device of example 1, wherein the non- circular portion of the channel and the non-circular portion of the push pull cable have rectangular configurations.
[0068] Example 3. The surgical stapling device of example 2, wherein the longitudinal channel is dimensioned to allow the non-circular portion of the push pull cable to move towards and away from the anvil within the cartridge body.
[0069] Example 4. The surgical stapling device of example 1, further including a handle assembly coupled to the proximal portion of the elongated body. [0070] Example s. The surgical stapling device of example 1, wherein the knife is pivotally supported on the actuation sled.
[0071] Example 6. The surgical stapling device of example 5, wherein the knife includes a hub, an elongated arm extending proximally from the hub, and a cutting member supported on the elongated arm, the hub rotatably supported on the actuation sled.
[0072] Example 7. The surgical stapling device of example 6, wherein the actuation sled includes a bottom wall, a central portion, and ramps positioned on opposite sides of the central portion, the central portion and the ramps extending upwardly from the bottom wall of the actuation sled.
[0073] Example 8. The surgical stapling device of example 7, wherein the bottom wall defines an opening, and the hub of the knife is received within the opening.
[0074] Example 9. The surgical stapling device of example 8, wherein the bottom wall of the actuation sled defines a longitudinal slot that extends proximally from and communicates with the opening, the elongated arm of the knife received within the longitudinal slot when the knife is in the lowered position.
[0075] Example 10. The surgical stapling device of example 9, wherein the central portion of the actuation sled includes an overhang that is positioned over the opening and over the hub of the knife.
[0076] Example 11. The surgical stapling device of example 10, wherein the push pull cable includes a center cable formed of metal, and the non-circular portion of the push pull cable is secured to the center cable and is formed from plastic.
[0077] Example 12. An actuation sled and knife assembly comprising: an actuation sled having a bottom wall, a central portion, and ramps, the central portion and ramps extending upwardly from the bottom wall, and the bottom wall defining an opening; and a knife supported on the actuation sled and movable between a lowered position and a raised position, the knife including a hub, an elongated arm extending proximally from the hub, and a cutting member supported on the elongated arm, the hub rotatably supported on the actuation sled within the opening.
[0078] Example 13. The actuation sled and knife assembly of example 12, wherein the bottom wall of the actuation sled defines a longitudinal slot, and the elongated arm of the knife is positioned within the longitudinal slot when the knife is in the lowered position. [0079] Example 14. The actuation sled and knife assembly of example 13, wherein the central portion of the actuation sled includes an overhang that is positioned over the opening and over the hub of the knife.
[0080] Example 15. The actuation sled and knife assembly of example 14, wherein the hub of the knife has a diameter and the opening in the bottom wall of the actuation sled has a width, the diameter of the hub being greater than the width of the opening.
[0081] Example 16. A surgical stapling device comprising: an elongated body having a proximal portion and a distal portion; a tool assembly supported on the distal portion of the elongated body, the tool assembly including a cartridge assembly and an anvil that are coupled together such that the tool assembly is movable between an open position and a clamped position, the cartridge assembly including a staple cartridge having a cartridge body, staples, pushers, and an actuation sled, the cartridge body defining a knife slot and staple receiving pockets positioned on opposite sides of the knife slot, the staples received within the staple receiving pockets of the cartridge body, the cartridge body defining a longitudinal channel that has a non-circular configuration, the actuation sled movable from a sled retracted position to a sled advanced position to eject the staples from the cartridge body; and a drive assembly including a push pull cable and an I-beam, the push pull cable having a distal portion secured to the I-beam and a non-circular portion that is received within the longitudinal channel defined by the cartridge body, the drive assembly movable between a drive retracted position and a drive advanced position through a drive clamped position to move the tool assembly between the open position and the clamped position and to subsequently advance the actuation sled from the sled retracted position to the sled advanced position.
[0082] Example 17. The surgical stapling device of example 16, wherein the non- circular portions of the longitudinal channel and the push pull cable have a rectangular configurations.
[0083] Example 18. The surgical stapling device of example 16, wherein the longitudinal channel is dimensioned to allow the push pull cable to move towards and away from the anvil within the cartridge body.
[0084] Example 19. The surgical stapling device of example 16, further including a knife supported on the actuation sled, the knife movable between a lowered position and a raised position. [0085] Example 20. The surgical stapling device of example 19, wherein the knife includes a hub, an elongated arm extending proximally from the hub, and a cutting member supported on the elongated arm, the hub rotatably supported on the actuation sled.

Claims

WHAT IS CLAIMED IS:
1. A surgical stapling device (10) comprising: an elongated body (14) having a proximal portion and a distal portion; a tool assembly (16) supported on the distal portion of the elongated body (14), the tool assembly (16) including a cartridge assembly (26) and an anvil (24) that are coupled together such that the tool assembly (16) is movable between an open position and a clamped position, the cartridge assembly (26) including a staple cartridge (30) having a cartridge body (42), staples (48), pushers (46), and an actuation sled and knife assembly (44), the cartridge body (42) defining a knife slot (52) and staple receiving pockets (54) positioned on opposite sides of the knife slot (52), the staples (48) received within the staple receiving pockets (54) of the cartridge body (42), the cartridge body (42) defining a longitudinal channel (122) having a non-circular configuration, the actuation sled and knife assembly (44) including an actuation sled (56) and a knife (58), the knife (58) supported on the actuation sled (56) and movable between a lowered position and a raised position, the actuation sled (56) movable from a sled retracted position to a sled advanced position to eject the staples (48) from the cartridge body (42); and a drive assembly (90) including a push pull cable (92) and an I-beam (94), the push pull cable (92) having a distal portion secured to the I-beam (94) and a non-circular portion (114) that is received within the longitudinal channel (122) defined by the cartridge body (42), the drive assembly (90) movable between a drive retracted position and a drive advanced position through a drive clamped position to move the tool assembly (16) between the open position and the clamped position and to subsequently advance the actuation sled (56) from the sled retracted position to the sled advanced position.
2. The surgical stapling device (10) according to claim 1, wherein the non-circular portion (114) of the longitudinal channel (122) and the non-circular portion (114) of the push pull cable (92) have rectangular configurations.
3. The surgical stapling device (10) according to any of the preceding claims, wherein the longitudinal channel (122) is dimensioned to allow the non-circular portion (114) of the push pull cable (92) to move towards and away from the anvil (24) within the cartridge body (42).
4. The surgical stapling device (10) according to any of the preceding claims, further including a handle assembly (12) coupled to the proximal portion of the elongated body (14).
5. The surgical stapling device (10) according to any of the preceding claims, wherein the knife (58) is pivotally supported on the actuation sled (56).
6. The surgical stapling device (10) according to any of the preceding claims, wherein the knife (58) includes a hub (74), an elongated arm (76) extending proximally from the hub (74), and a cutting member supported on the elongated arm (76), the hub (74) rotatably supported on the actuation sled (56).
7. The surgical stapling device (10) according to any of the preceding claims, wherein the actuation sled (56) includes a bottom wall (60), a central portion (62), and ramps (64) positioned on opposite sides of the central portion (62), the central portion (62) and the ramps (64) extending upwardly from the bottom wall (60) of the actuation sled (56).
8. The surgical stapling device (10) according to claim 7, wherein the bottom wall (60) defines an opening (66), and the hub (74) of the knife (58) is received within the opening (66).
9. The surgical stapling device (10) according to claim 8, wherein the bottom wall (60) of the actuation sled (56) defines a longitudinal slot (68) that extends proximally from and communicates with the opening (60), the elongated arm (76) of the knife (58) received within the longitudinal slot (68) when the knife (58) is in the lowered position.
10. The surgical stapling device (10) according to any of claims 7-9, wherein the central portion (62) of the actuation sled (56) includes an overhang (70) that is positioned over the opening (60) and over the hub (74) of the knife (58).
11. The surgical stapling device (10) according to any of the preceding claims, wherein the push pull cable (92) includes a center cable (92a) formed of metal, and the non-circular portion (114) of the push pull cable (92) is secured to the center cable (92a) and is formed from plastic.
12. The surgical stapling device (10) according to any of the preceding claims, wherein the cartridge assembly (26) includes a channel member (32) that defines a recess (32a) that receives the staple cartridge (30).
13. The surgical stapling device (10) according to claim 12, further including a spring positioned within the recess defined by the channel member, the spring (33) supporting the staple cartridge (30) to allow the staple cartridge (30) to float within the recess.
14. The surgical stapling device (10) according to claim 12, wherein the spring (33) is a wave spring.
15. The surgical stapling device (10) according to any of the preceding claims, wherein the tool assembly (16) is pivotably coupled to the elongated body (14).
PCT/IB2024/060469 2023-10-26 2024-10-24 Surgical stapling device with a replaceable staple cartridge having a cutting knife Pending WO2025088535A1 (en)

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US202363593275P 2023-10-26 2023-10-26
US63/593,275 2023-10-26

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Citations (8)

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US6241139B1 (en) 1997-09-23 2001-06-05 Keith L. Milliman Surgical stapling apparatus
US9055943B2 (en) 2007-09-21 2015-06-16 Covidien Lp Hand held surgical handle assembly, surgical adapters for use between surgical handle assembly and surgical end effectors, and methods of use
US9962159B2 (en) 2002-04-25 2018-05-08 Covidien Lp Surgical instruments including MEMS devices
US20220183686A1 (en) * 2019-04-15 2022-06-16 Intuitive Surgical Operations, Inc. Staple cartridge for a surgical instrument
US20220304679A1 (en) * 2021-03-24 2022-09-29 Ethicon Llc Method of using a powered stapling device
US20230051361A1 (en) * 2021-08-16 2023-02-16 Cilag Gmbh International Methods of operating a robotic surgical stapler
US20230120209A1 (en) * 2021-10-20 2023-04-20 Cilag Gmbh International Lockout arrangements for surgical instruments
US11707277B2 (en) * 2021-08-20 2023-07-25 Covidien Lp Articulating surgical stapling apparatus with pivotable knife bar guide assembly

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6241139B1 (en) 1997-09-23 2001-06-05 Keith L. Milliman Surgical stapling apparatus
US9962159B2 (en) 2002-04-25 2018-05-08 Covidien Lp Surgical instruments including MEMS devices
US9055943B2 (en) 2007-09-21 2015-06-16 Covidien Lp Hand held surgical handle assembly, surgical adapters for use between surgical handle assembly and surgical end effectors, and methods of use
US20220183686A1 (en) * 2019-04-15 2022-06-16 Intuitive Surgical Operations, Inc. Staple cartridge for a surgical instrument
US20220304679A1 (en) * 2021-03-24 2022-09-29 Ethicon Llc Method of using a powered stapling device
US20230051361A1 (en) * 2021-08-16 2023-02-16 Cilag Gmbh International Methods of operating a robotic surgical stapler
US11707277B2 (en) * 2021-08-20 2023-07-25 Covidien Lp Articulating surgical stapling apparatus with pivotable knife bar guide assembly
US20230120209A1 (en) * 2021-10-20 2023-04-20 Cilag Gmbh International Lockout arrangements for surgical instruments

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