WO2018161315A1 - Method and device for loading a staple guide - Google Patents

Method and device for loading a staple guide Download PDF

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Publication number
WO2018161315A1
WO2018161315A1 PCT/CN2017/076163 CN2017076163W WO2018161315A1 WO 2018161315 A1 WO2018161315 A1 WO 2018161315A1 CN 2017076163 W CN2017076163 W CN 2017076163W WO 2018161315 A1 WO2018161315 A1 WO 2018161315A1
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WO
WIPO (PCT)
Prior art keywords
press
stapling device
staple guide
shell housing
shell
Prior art date
Application number
PCT/CN2017/076163
Other languages
French (fr)
Inventor
Zhaokai Wang
Xiliang Zhang
Original Assignee
Covidien Lp
Covidien (China) Medical Devices Technology Co., Ltd.
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, Covidien (China) Medical Devices Technology Co., Ltd. filed Critical Covidien Lp
Priority to PCT/CN2017/076163 priority Critical patent/WO2018161315A1/en
Publication of WO2018161315A1 publication Critical patent/WO2018161315A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115Staplers for performing anastomosis in a single operation
    • A61B17/1155Circular staplers comprising a plurality of staples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477Coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • A61B2017/0053Loading magazines or sutures into applying tools

Definitions

  • the present disclosure is directed to a method and device for loading a staple guide into a stapling device, and more particularly, to a method and device for loading a staple guide into a shell assembly of a circular stapling device.
  • Circular stapling devices typically include a shell assembly that includes a shell housing, a staple guide that is supported within a distal end of the shell housing, a plurality of staples, and a pusher back that is supported within the shell housing.
  • the staple guide defines a plurality of staple receiving pockets. Each of the staple receiving pockets receives a staple of the plurality of staples.
  • the pusher back includes a plurality of fingers, each of the fingers being received within a respective one of the stapling pockets of the staple guide. The pusher back is movable within the shell housing to eject the staples from the staple guide.
  • One aspect of the disclosure is directed to a method of loading a staple guide into a shell assembly of a stapling device.
  • the method includes clamping the stapling device to a loading station having first and second presses; actuating the first press to operate a firing trigger of the stapling device to advance a pusher back of the shell assembly from a retracted position to a partially fired position; manually placing the staple guide adjacent a distal end of the shell housing such that fingers of the pusher back are partially received within staple receiving slots of the staple guide; and actuating the second press to advance a press tool supported on the second press into the distal end of the shell housing to simultaneously advance the staple guide into the shell housing of the stapling device and to return the pusher back to its retracted position.
  • the staple guide includes an annular flange defining a shoulder and the shell housing has a distal edge
  • actuating the second press includes advancing the staple guide into the shell housing until the shoulder of the annular flange engages the distal edge of the shell housing.
  • clamping the stapling device to the loading station includes using a first clamping mechanism of the loading station to secure a first end of the stapling device to the loading station and using a second clamping mechanism to secure a second end of the stapling device to the loading station.
  • clamping the stapling device to the loading station includes using a third clamping mechanism to secure a central portion of the stapling device to the loading station.
  • actuating the first press to operate a firing trigger includes advancing a plunger of the first press into engagement with a firing trigger of the stapling device to move the firing trigger through a portion of a firing stroke.
  • actuating the second press to advance the press tool includes advancing a plunger of the second press to advance the press tool into the distal end of the shell housing of the stapling device.
  • the press tool includes a small diameter portion and a large diameter portion and actuating the second press to advance the press tool includes advancing the press tool such that the small diameter portion engages the pusher back of the shell assembly and the large diameter portion engages the staple guide.
  • manually placing the staple guide adjacent a distal end of the shell housing includes aligning a longitudinal rib of the staple guide with a guide slot defined in the shell housing.
  • manually placing the staple guide adjacent a distal end of the shell housing includes aligning tabs of the staple guide with openings defined in the shell housing.
  • the loading station includes a base member, a clamping mechanism supported on the base member, a first press, and a second press.
  • the clamping mechanism is configured to secure the stapling device to the base member.
  • the first press is supported on the base member and includes a first plunger that is positioned to operate a firing trigger of the stapling device.
  • the second press is supported on the base member and includes a second plunger and a press tool supported on the second plunger. The second press is positioned such that the press tool is movable into the shell housing of the stapling device to load the staple guide into the shell housing.
  • the press tool includes a small diameter portion and a large diameter portion.
  • the small diameter portion is dimensioned to extend into the shell housing into engagement with a pusher back of the shell assembly and the large diameter portion is positioned to simultaneously engage the staple guide.
  • the clamping mechanism includes a first clamping mechanism that is positioned to secure a first portion of the stapling device to the base member and a second clamping mechanism that is positioned to secure a second portion of the stapling device to the base member.
  • the clamping mechanism includes a third clamping mechanism that is positioned to secure a third portion of the stapling device to the base member.
  • the first press includes a compliant tip that is positioned to engage the firing trigger of the stapling device.
  • the first press includes a biasing member positioned to urge the compliant tip towards the firing trigger.
  • FIG. 1 is a side perspective view of an exemplary embodiment a circular stapling device including a tool assembly having a shell assembly and an anvil assembly with the tool assembly in an unclamped position;
  • FIG. 2 is a side perspective view from a distal end of the shell assembly of the circular stapling device shown in FIG. 1;
  • FIG. 3 is a side perspective view from a distal end of the shell assembly of the circular stapling device shown in FIG. 2 with a staple cartridge of the shell assembly removed from a shell housing of the shell assembly;
  • FIG. 4 is a side perspective view of a pusher back and the staple guide of the shell assembly shown in FIG. 3;
  • FIG. 5A is a side view of the circular stapling device shown in FIG. 1 supported within a loading station prior to placement of the staple guide within the shell housing of the shell assembly and with the pusher back retracted within the shell housing;
  • FIG. 5B is a side perspective view of the shell assembly of the circular stapling device shown in FIG. 5A with the staple guide removed from the shell assembly and the pusher back retracted within the shell housing;
  • FIG. 5C is a cross-sectional view taken along section lines 5C-5C of FIG. 5B;
  • FIG. 6A is a side view of the circular stapling device shown in FIG. 5A supported within the loading station prior to placement of the staple guide within the shell housing of the shell assembly and with a first press actuated to advance the pusher back to a half-firing position within the shell housing;
  • FIG. 6B is a side perspective view of the shell assembly of the circular stapling device shown in FIG. 6A with the staple guide removed from the shell assembly and the pusher back advanced to a half-firing position within the shell housing;
  • FIG. 6C is a cross-sectional view taken along section lines 6C-6C of FIG. 6B;
  • FIG. 7A is a side view of the circular stapling device shown in FIG. 6A supported within the loading station with the staple guide manually positioned within the shell housing of the shell assembly and the first press actuated to advance the pusher back to a half-firing position within the shell housing;
  • FIG. 7B is a side perspective view of the shell assembly of the circular stapling device shown in FIG. 7A with the pusher back removed from the shell housing and the staple guide separated from the shell housing;
  • FIG. 7C is a side perspective view of a tool of a second press of the loading station shown in FIG. 7A;
  • FIG. 7D is a side cross-sectional view of the shell assembly and second press tool shown in FIG. 7A prior to actuation of the second press tool;
  • FIG. 8A is a side view of the circular stapling device shown in FIG. 7A supported within the loading station with the staple guide manually positioned within the shell housing of the shell assembly, the first press returned to an unactuated position, and the second press tool actuated to load the staple guide into the shell housing to return the pusher back to a retracted position within the shell housing;
  • FIG. 8B is a side cross-sectional view of the shell assembly and second press tool shown in FIG. 7d after the second press tool is actuated to load the staple guide into the shell housing and return the pusher back to its retracted position;
  • FIG. 8C is a side view of the shell assembly of the stapling device shown in FIG. 1 after the staple guide is loaded into the shell housing;
  • FIG. 8D is a cross-sectional view taken along section lines 8D-8D of FIG. 8C.
  • proximal is used generally to refer to that portion of the device that is closer to a clinician
  • distal is used generally to refer to that portion of the device that is farther from the clinician
  • endoscopic is used generally to refer to endoscopic, laparoscopic, arthroscopic, and/or any other procedure conducted through small diameter incision or cannula.
  • clinician is used generally to refer to medical personnel including doctors, nurses, and support personnel.
  • the presently disclosed device for loading a staple guide into a shell assembly of a circular stapling device includes a loading station having a base member, a clamping mechanism supported on the base member to secure the stapling device to the loading station, a first press supported on the base member that can be actuated to operate a firing trigger of the stapling device to advance a pusher back of the shell assembly from a retracted position to a partially fired position, and a second press supported on the base member that can be actuated to advance a press tool into a shell housing of the shell assembly to insert the staple guide into the shell housing while simultaneously returning the pusher back to its retracted position.
  • the method of loading the staple guide into the shell assembly of the stapling device includes clamping the stapling device to the loading station; actuating the first press to operate a firing trigger to advance a pusher back of the shell assembly to a partially fired position; manually placing the staple guide adjacent a distal end of the shell housing such that fingers of the pusher back are partially received within staple receiving slots of the staple guide; and actuating the second press to advance the press tool into the distal end of the shell housing to load the staple guide into the shell housing and to return the pusher back to its retracted position.
  • the presently disclosed stapling device shown generally as 10 includes a handle assembly 12, an elongate body portion 14 that extends distally from the handle assembly 12, and a tool assembly 16 that is supported on a distal portion of the elongate body portion 14.
  • the tool assembly 16 includes a cartridge or shell assembly 18 that supports a staple guide 20, and an anvil assembly 22 that is movable in relation to the staple guide 20 between unclamped and clamped positions.
  • the anvil assembly 22 supports an anvil 22a.
  • the handle assembly 12 includes an approximation knob 24 that operates an approximation mechanism (not shown) to move the anvil assembly 22 between unclamped and clamped positions, a firing trigger 26 that that operates a firing mechanism (not shown) to fire staples (not shown) from the staple guide 20 into tissue, and a firing trigger lockout 29 that is pivotally supported on the handle assembly 12 and is positioned to prevent inadvertent firing of the stapling device 10.
  • an exemplary circular stapling device including known approximation, firing, and lockout mechanisms, see U.S. Patent No. 7,857,187 ( “the ‘187 Patent” ) which is incorporated herein by reference in its entirety.
  • the stapling device 10 is shown and described as being a manually powered device, it is envisioned that the stapling device 10 can be an electrically powered device such as described in U.S. Patent Publication Nos. 2015/0048140 and 2015/0014392 which are incorporated herein by reference in their entirety.
  • the staple guide 20 of the shell assembly 18 and the anvil 22a of the anvil assembly 22 has an annular configuration.
  • the anvil assembly 22 is movable in relation to the shell assembly 18 from the unclamped position to the clamped position to move the anvil 22a into juxtaposed alignment with the staple guide 20.
  • the staple guide 20 defines annular arrays of staple receiving slots 28 that are aligned with staple deforming recesses (not shown) of the anvil 22a when the staple guide 20 and the anvil 22a are properly aligned such that staples ejected from the staple receiving slots 28 of the staple guide 20 are deformed within the staple receiving recesses of the anvil 22a when the stapling device 10 is fired.
  • the staple guide 20 includes a distal annular flange 23 defining a proximal shoulder 23a that is positioned to abut a distal edge 34a of an outer housing portion 34 of the shell housing 30 when the staple guide 20 is loaded into the shell housing 30.
  • the shell assembly 18 also includes a shell housing 30 including the outer housing portion 34 and an inner housing portion 36, a pusher back 38, and an annular knife 40.
  • the outer housing portion 34 and the inner housing portion 36 define an annular channel 42 that receives the pusher back 38 for movement between retracted and fired positions.
  • the staple guide 20 is supported on a distal portion of the outer housing portion 34 of the shell housing 30.
  • the pusher back 38 includes a proximal base portion 43 and a distal portion including annular arrays of fingers 44.
  • the annular arrays of fingers 44 are received within the annular arrays of staple receiving slots 28 of the staple guide 20 when the shell assembly 18 of the stapling device 10 is assembled such that advancement of the pusher back 38 within the shell housing 30 from the retracted position to the fired position causes staples to be ejected from the staple guide 20.
  • the proximal base portion 43 of the pusher back 38 includes flexible arms 46 that are configured to secure the pusher back 38 to a pusher (not shown) supported within the elongate body portion 14 of the stapling device 10 (FIG. 1) .
  • U.S. Patent No. 6,945,444 discloses components of a circular stapling device in detail including the pusher of the elongated body portion and the pusher back of the shell assembly.
  • the ‘444 Patent is incorporated herein by reference in its entirety.
  • the staple guide 20 includes tabs 50 positioned about a periphery of the staple guide 20 and longitudinal ribs 52. Each of the tabs 50 has a proximal surface 50a that is tapered.
  • the outer housing portion 34 of the shell housing 30 defines openings 56 and guide slots 58.
  • the openings 56 in the outer housing portion 34 is configured to receive the tabs 50 of the staple guide 20 to secure the staple guide 20 within the distal end of the shell housing 30.
  • the tapered proximal surfaces 50a of the tabs 50 allow the staple guide 20 to move along an inner surface of the inner housing portion 36 of the shell housing 30 and into the openings 56, but prevent distal movement of the tabs 50 from within the openings 56.
  • the longitudinal rib 52 of the staple guide 20 is received within the guide slot 58 of the outer housing portion 34 to properly align the staple guide 20 within the shell housing 30.
  • a staple guide loading station 60 includes clamp mechanisms that are configured to grip the stapling device 10 and hold the stapling device 10 stationary on the loading station 60.
  • the clamp mechanisms are supported on a base member 100 of the loading station 60.
  • the loading station 60 includes a first clamp mechanism 62, a second clamp mechanism 64 and a third clamp mechanism 66.
  • the first clamp mechanism 62 is positioned on the loading station 60 to grip the handle portion 12 of the stapling device 10
  • the second clamp mechanism 64 is positioned on the loading station 60 to grip a proximal portion of the elongate body portion 14 of the stapling device 10
  • the third clamp mechanism 66 is positioned on the loading station 60 to grip a distal portion of the elongate body portion 14 of the stapling device 10.
  • the loading station 60 may include one or more clamping mechanisms.
  • the clamping mechanisms can include any device capable of gripping a portion of the surgical stapling device.
  • each of the clamping mechanisms can include two jaws 70, 72 that are movable in relation to each other to grip a portion of the stapling device 10.
  • the clamp mechanisms can include a resilient member that defines an expandable slot for receiving and gripping a portion of the surgical device 10.
  • the loading unit 60 also includes a first press 74 and a second press 76.
  • the first press 74 is positioned adjacent to where the firing trigger 26 of the surgical stapling 10 is positioned when the stapling device 10 is secured to the loading unit 60.
  • the first press 74 includes a plunger 78 and an actuator 80.
  • the plunger 78 is movable towards the firing trigger 26 to move the firing trigger 26 from a non-actuated position through a portion of a firing stroke to move the pusher back 38 from a retracted position (FIG. 5C) to a partially fired position (FIG. 6C) as discussed in further detail below.
  • the first press 74 may include a compliant tip 82 and a biasing member 84 that is positioned to urge the plunger 78 towards the firing trigger 26 of the stapling device 10.
  • the second press 76 is supported on the base member 100 of the loading station 60 adjacent to where the tool assembly 16 of the surgical stapling 10 is positioned when the stapling device 10 is secured to the loading unit 60.
  • the second press 76 includes a plunger 88, an actuator 90, and a press tool 92.
  • the press tool 92 is supported on one end of the plunger 88 and is movable into a distal end of the shell housing 30 in response to advancement of the plunger 88 to load the staple guide 20 into the shell housing 30 as discussed in detail below.
  • the press tool 92 includes a cylindrical stepped body having a small diameter portion 94 dimensioned to be received within the annular knife 40 of the shell assembly 18 and a large diameter portion 96 that is dimensioned to extend over a distal face 98 (FIG. 3) of the staple guide 20.
  • the stapling device 10 prior to loading the staple guide 20 into the shell housing 30, the stapling device 10 is secured onto the base member 100 of the loading station 60 by positioning the stapling device 10 within the clamp mechanisms 62-64.
  • the small diameter portion 94 of the press tool 92 is located in front of the shell assembly 18 in a position to be received within the annular knife 40 (FIG. 5B) at the distal end of the shell assembly 18 and the large diameter portion 96 of the press tool 92 is positioned to extend over the open distal end (FIG. 20) of the shell housing 30.
  • the pusher back 38 is initially located in a retracted position within the shell housing 30 such that the fingers 44 of the pusher back 38 are recessed within the shell housing 30.
  • the plunger 78 of the first press 74 is retracted such that the firing trigger 26 is in a non-actuated position.
  • the first press 74 is actuated to move the firing trigger 26 partially through a firing stroke. Actuating the first press 74 advances the plunger 78 in the direction indicated by arrow “A” in FIG. 6A into engagement with the firing trigger 26 to pivot the firing trigger 26 towards the handle assembly 12 of the stapling device 10. As the firing trigger 26 pivots through the firing stroke, the pusher back 38 is advanced within the shell housing 30 to a partially fired position in which the fingers 44 and annular knife 40 extend from the distal end of the shell housing 30.
  • the staple guide 20 is manually positioned adjacent the distal end of the shell housing 30 such that the fingers 44 of the pusher back 38 are partially received in respective staple receiving slots 28 of the staple guide 20 (FIG. 7D) .
  • the longitudinal rib 52 of the staple guide 20 is aligned with the guide slot 58 defined in the distal end of the shell housing 30 to properly orient the staple guide 20 within the shell housing 30 (FIG. 7B) .
  • Positioning the longitudinal rib 52 of the staple guide 20 partially within the guide slot 58 also positions the tabs 50 of the staple guide 20 into alignment with the openings 50 in the shell housing 30 (FIG. 7B) .
  • the press tool 92 of the second press 76 is positioned to align the small diameter portion 94 of the press tool 92 with a bore 40a defined by the annular knife 40 of the shell assembly 18 and to align the large diameter portion 96 of the press tool 92 with the distal face 98 (FIG. 7D) of the staple guide 20.
  • the second press 76 is actuated to simultaneously advance the staple guide 20 in the direction indicated by arrows “D” in FIG. 8B fully into the shell housing 30.
  • the longitudinal rib 52 is fully advanced into the guide slot 58 of the outer housing portion 34 of the shell housing 30 and the tabs 50 are received in the openings 56 of the shell housing 30.
  • the shoulder 23a of the distal annular flange 23 of the staple guide 20 engages the distal edge 34a of the shell housing 30, the staple guide 20 is fully loaded into the shell housing 30 (FIG. 8B) .
  • the pusher back 38 is urged from the partially fired position back to its retracted position by the small diameter portion 94 of the press tool 92. As best seen in FIG. 8A, movement of the pusher back 38 to its retracted position returns the firing trigger 26 to its unactuated position against the force of the biasing member 84 of the first press 74.
  • the presently disclosed method and device for loading the staple guide 20 into the shell housing 30 of the shell assembly 18 allows for the partial advancement of the pusher back 38 to facilitate manual alignment of the staple guide 20 in relation to the pusher back 38.
  • the second press 76 and press tool 92 facilitate simultaneous automatic loading of the staple guide 20 into the shell housing 30 and return of the pusher back 38 to its retracted position to maintain the alignment between the staple guide 20 and the pusher back 38.

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Abstract

A method of loading a staple guide (20) into a shell assembly (18) of a stapling device (10) includes clamping the stapling device to a loading station (60); actuating a first press (74) to operate a firing trigger (26) to advance a pusher back (38) of the shell assembly to a partially fired position; manually placing the staple guide adjacent a distal end of a shell housing (30) such that fingers (44) of the pusher back are received within staple receiving slots (28) of the staple guide; and actuating a second press (76) to advance a press tool (92) into the distal end of the shell housing to load the staple guide into the shell housing and returning the pusher back to its retracted position. A device for loading a staple guide into a shell assembly of a circular stapling device includes a loading station (60) having a base member (100), a clamp mechanism (62, 64, 66) configured to secure the stapling device to the base member, a first press (74) that can be actuated to operate a firing trigger (26) of the stapling device, and a second press (76). The second press when actuated simultaneously advances a press tool (92) into a shell housing (30) of the shell assembly to insert the staple guide into the shell housing and retracts a pusher back (38) of the shell assembly to a retracted position to maintain alignment between the pusher back and the staple guide.

Description

METHOD AND DEVICE FOR LOADING A STAPLE GUIDE BACKGROUND
1. Technical Field
The present disclosure is directed to a method and device for loading a staple guide into a stapling device, and more particularly, to a method and device for loading a staple guide into a shell assembly of a circular stapling device.
2. Background of Related Art
Circular stapling devices typically include a shell assembly that includes a shell housing, a staple guide that is supported within a distal end of the shell housing, a plurality of staples, and a pusher back that is supported within the shell housing. The staple guide defines a plurality of staple receiving pockets. Each of the staple receiving pockets receives a staple of the plurality of staples. The pusher back includes a plurality of fingers, each of the fingers being received within a respective one of the stapling pockets of the staple guide. The pusher back is movable within the shell housing to eject the staples from the staple guide.
During known methods of assembling the shell assembly, it has proven difficult to maintain alignment of the staple guide within the shell housing such that the fingers of the pusher back are properly aligned within the staple receiving pockets of the staple guide. When the fingers of the pusher back are not properly aligned with the staple receiving pockets of the staple guide, proper formation of the staples may be prevented.
A continuing need exists for a method and device for loading a staple guide into a shell assembly of a circular stapling device such that the  components of the shell assembly are properly aligned to facilitate proper formation of staples.
SUMMARY
One aspect of the disclosure is directed to a method of loading a staple guide into a shell assembly of a stapling device. The method includes clamping the stapling device to a loading station having first and second presses; actuating the first press to operate a firing trigger of the stapling device to advance a pusher back of the shell assembly from a retracted position to a partially fired position; manually placing the staple guide adjacent a distal end of the shell housing such that fingers of the pusher back are partially received within staple receiving slots of the staple guide; and actuating the second press to advance a press tool supported on the second press into the distal end of the shell housing to simultaneously advance the staple guide into the shell housing of the stapling device and to return the pusher back to its retracted position.
In embodiments, the staple guide includes an annular flange defining a shoulder and the shell housing has a distal edge, and actuating the second press includes advancing the staple guide into the shell housing until the shoulder of the annular flange engages the distal edge of the shell housing.
In some embodiments, clamping the stapling device to the loading station includes using a first clamping mechanism of the loading station to secure a first end of the stapling device to the loading station and using a second clamping mechanism to secure a second end of the stapling device to the loading station.
In certain embodiments, clamping the stapling device to the loading station includes using a third clamping mechanism to secure a central portion of the stapling device to the loading station.
In embodiments, actuating the first press to operate a firing trigger includes advancing a plunger of the first press into engagement with a firing trigger of the stapling device to move the firing trigger through a portion of a firing stroke.
In some embodiments, actuating the second press to advance the press tool includes advancing a plunger of the second press to advance the press tool into the distal end of the shell housing of the stapling device.
In certain embodiments, the press tool includes a small diameter portion and a large diameter portion and actuating the second press to advance the press tool includes advancing the press tool such that the small diameter portion engages the pusher back of the shell assembly and the large diameter portion engages the staple guide.
In embodiments, manually placing the staple guide adjacent a distal end of the shell housing includes aligning a longitudinal rib of the staple guide with a guide slot defined in the shell housing.
In some embodiments, manually placing the staple guide adjacent a distal end of the shell housing includes aligning tabs of the staple guide with openings defined in the shell housing.
Another aspect of the disclosure is directed to a loading station for loading a shell assembly of a stapling device with a staple guide. The loading station includes a base member, a clamping mechanism supported on the base member, a first press, and a second press. The clamping mechanism is configured to secure the stapling device to the base member. The first press is supported on the base member and includes a first plunger that is positioned to operate a firing trigger of the stapling device. The second press is supported on the base member and includes a second plunger and a press tool supported on the second plunger. The second press is positioned such that the press tool is  movable into the shell housing of the stapling device to load the staple guide into the shell housing.
In embodiments, the press tool includes a small diameter portion and a large diameter portion. The small diameter portion is dimensioned to extend into the shell housing into engagement with a pusher back of the shell assembly and the large diameter portion is positioned to simultaneously engage the staple guide.
In some embodiments, the clamping mechanism includes a first clamping mechanism that is positioned to secure a first portion of the stapling device to the base member and a second clamping mechanism that is positioned to secure a second portion of the stapling device to the base member.
In certain embodiments, the clamping mechanism includes a third clamping mechanism that is positioned to secure a third portion of the stapling device to the base member.
In embodiments, the first press includes a compliant tip that is positioned to engage the firing trigger of the stapling device.
In some embodiments, the first press includes a biasing member positioned to urge the compliant tip towards the firing trigger.
BRIEF DESCRIPTION OF THE DRAWINGS
Various embodiments of the presently disclosed method and device for loading a staple guide into a shell assembly of a circular stapling device are described herein below with reference to the drawings, wherein:
FIG. 1 is a side perspective view of an exemplary embodiment a circular stapling device including a tool assembly having a shell assembly and an anvil assembly with the tool assembly in an unclamped position;
FIG. 2 is a side perspective view from a distal end of the shell assembly of the circular stapling device shown in FIG. 1;
FIG. 3 is a side perspective view from a distal end of the shell assembly of the circular stapling device shown in FIG. 2 with a staple cartridge of the shell assembly removed from a shell housing of the shell assembly;
FIG. 4 is a side perspective view of a pusher back and the staple guide of the shell assembly shown in FIG. 3;
FIG. 5A is a side view of the circular stapling device shown in FIG. 1 supported within a loading station prior to placement of the staple guide within the shell housing of the shell assembly and with the pusher back retracted within the shell housing;
FIG. 5B is a side perspective view of the shell assembly of the circular stapling device shown in FIG. 5A with the staple guide removed from the shell assembly and the pusher back retracted within the shell housing;
FIG. 5C is a cross-sectional view taken along section lines 5C-5C of FIG. 5B;
FIG. 6A is a side view of the circular stapling device shown in FIG. 5A supported within the loading station prior to placement of the staple guide within the shell housing of the shell assembly and with a first press actuated to advance the pusher back to a half-firing position within the shell housing;
FIG. 6B is a side perspective view of the shell assembly of the circular stapling device shown in FIG. 6A with the staple guide removed from the shell assembly and the pusher back advanced to a half-firing position within the shell housing;
FIG. 6C is a cross-sectional view taken along section lines 6C-6C of FIG. 6B;
FIG. 7A is a side view of the circular stapling device shown in FIG. 6A supported within the loading station with the staple guide manually positioned within the shell housing of the shell assembly and the first press  actuated to advance the pusher back to a half-firing position within the shell housing;
FIG. 7B is a side perspective view of the shell assembly of the circular stapling device shown in FIG. 7A with the pusher back removed from the shell housing and the staple guide separated from the shell housing;
FIG. 7C is a side perspective view of a tool of a second press of the loading station shown in FIG. 7A;
FIG. 7D is a side cross-sectional view of the shell assembly and second press tool shown in FIG. 7A prior to actuation of the second press tool;
FIG. 8A is a side view of the circular stapling device shown in FIG. 7A supported within the loading station with the staple guide manually positioned within the shell housing of the shell assembly, the first press returned to an unactuated position, and the second press tool actuated to load the staple guide into the shell housing to return the pusher back to a retracted position within the shell housing;
FIG. 8B is a side cross-sectional view of the shell assembly and second press tool shown in FIG. 7d after the second press tool is actuated to load the staple guide into the shell housing and return the pusher back to its retracted position;
FIG. 8C is a side view of the shell assembly of the stapling device shown in FIG. 1 after the staple guide is loaded into the shell housing; and
FIG. 8D is a cross-sectional view taken along section lines 8D-8D of FIG. 8C.
DETAILED DESCRIPTION OF EMBODIMENTS
The presently disclosed method and 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. In this  description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term “endoscopic” is used generally to refer to endoscopic, laparoscopic, arthroscopic, and/or any other procedure conducted through small diameter incision or cannula. In addition, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel.
The presently disclosed device for loading a staple guide into a shell assembly of a circular stapling device ( “stapling device” ) includes a loading station having a base member, a clamping mechanism supported on the base member to secure the stapling device to the loading station, a first press supported on the base member that can be actuated to operate a firing trigger of the stapling device to advance a pusher back of the shell assembly from a retracted position to a partially fired position, and a second press supported on the base member that can be actuated to advance a press tool into a shell housing of the shell assembly to insert the staple guide into the shell housing while simultaneously returning the pusher back to its retracted position. The method of loading the staple guide into the shell assembly of the stapling device includes clamping the stapling device to the loading station; actuating the first press to operate a firing trigger to advance a pusher back of the shell assembly to a partially fired position; manually placing the staple guide adjacent a distal end of the shell housing such that fingers of the pusher back are partially received within staple receiving slots of the staple guide; and actuating the second press to advance the press tool into the distal end of the shell housing to load the staple guide into the shell housing and to return the pusher back to its retracted position.
Referring to FIGS. 1-4, the presently disclosed stapling device shown generally as 10 includes a handle assembly 12, an elongate body portion  14 that extends distally from the handle assembly 12, and a tool assembly 16 that is supported on a distal portion of the elongate body portion 14. The tool assembly 16 includes a cartridge or shell assembly 18 that supports a staple guide 20, and an anvil assembly 22 that is movable in relation to the staple guide 20 between unclamped and clamped positions. The anvil assembly 22 supports an anvil 22a. The handle assembly 12 includes an approximation knob 24 that operates an approximation mechanism (not shown) to move the anvil assembly 22 between unclamped and clamped positions, a firing trigger 26 that that operates a firing mechanism (not shown) to fire staples (not shown) from the staple guide 20 into tissue, and a firing trigger lockout 29 that is pivotally supported on the handle assembly 12 and is positioned to prevent inadvertent firing of the stapling device 10. For a detailed description of an exemplary circular stapling device including known approximation, firing, and lockout mechanisms, see U.S. Patent No. 7,857,187 ( “the ‘187 Patent” ) which is incorporated herein by reference in its entirety.
Although the presently disclosed stapling device 10 is shown and described as being a manually powered device, it is envisioned that the stapling device 10 can be an electrically powered device such as described in U.S. Patent Publication Nos. 2015/0048140 and 2015/0014392 which are incorporated herein by reference in their entirety.
The staple guide 20 of the shell assembly 18 and the anvil 22a of the anvil assembly 22 has an annular configuration. The anvil assembly 22 is movable in relation to the shell assembly 18 from the unclamped position to the clamped position to move the anvil 22a into juxtaposed alignment with the staple guide 20. The staple guide 20 defines annular arrays of staple receiving slots 28 that are aligned with staple deforming recesses (not shown) of the anvil 22a when the staple guide 20 and the anvil 22a are properly aligned such that  staples ejected from the staple receiving slots 28 of the staple guide 20 are deformed within the staple receiving recesses of the anvil 22a when the stapling device 10 is fired. The staple guide 20 includes a distal annular flange 23 defining a proximal shoulder 23a that is positioned to abut a distal edge 34a of an outer housing portion 34 of the shell housing 30 when the staple guide 20 is loaded into the shell housing 30.
Referring to FIGS. 2 and 3, the shell assembly 18 also includes a shell housing 30 including the outer housing portion 34 and an inner housing portion 36, a pusher back 38, and an annular knife 40. The outer housing portion 34 and the inner housing portion 36 define an annular channel 42 that receives the pusher back 38 for movement between retracted and fired positions. The staple guide 20 is supported on a distal portion of the outer housing portion 34 of the shell housing 30.
The pusher back 38 includes a proximal base portion 43 and a distal portion including annular arrays of fingers 44. The annular arrays of fingers 44 are received within the annular arrays of staple receiving slots 28 of the staple guide 20 when the shell assembly 18 of the stapling device 10 is assembled such that advancement of the pusher back 38 within the shell housing 30 from the retracted position to the fired position causes staples to be ejected from the staple guide 20. The proximal base portion 43 of the pusher back 38 includes flexible arms 46 that are configured to secure the pusher back 38 to a pusher (not shown) supported within the elongate body portion 14 of the stapling device 10 (FIG. 1) . Movement of the pusher in response to operation of the firing trigger 26 causes movement of the pusher back 38 within the shell housing 30 from the retracted position to the fired position. U.S. Patent No. 6,945,444 ( “the ‘444 Patent” ) discloses components of a circular stapling device in detail including the pusher  of the elongated body portion and the pusher back of the shell assembly. The ‘444 Patent is incorporated herein by reference in its entirety.
The staple guide 20 includes tabs 50 positioned about a periphery of the staple guide 20 and longitudinal ribs 52. Each of the tabs 50 has a proximal surface 50a that is tapered. The outer housing portion 34 of the shell housing 30 defines openings 56 and guide slots 58. The openings 56 in the outer housing portion 34 is configured to receive the tabs 50 of the staple guide 20 to secure the staple guide 20 within the distal end of the shell housing 30. The tapered proximal surfaces 50a of the tabs 50 allow the staple guide 20 to move along an inner surface of the inner housing portion 36 of the shell housing 30 and into the openings 56, but prevent distal movement of the tabs 50 from within the openings 56. The longitudinal rib 52 of the staple guide 20 is received within the guide slot 58 of the outer housing portion 34 to properly align the staple guide 20 within the shell housing 30.
Referring to FIG. 5A, a staple guide loading station 60 includes clamp mechanisms that are configured to grip the stapling device 10 and hold the stapling device 10 stationary on the loading station 60. The clamp mechanisms are supported on a base member 100 of the loading station 60. In embodiments, the loading station 60 includes a first clamp mechanism 62, a second clamp mechanism 64 and a third clamp mechanism 66. The first clamp mechanism 62 is positioned on the loading station 60 to grip the handle portion 12 of the stapling device 10, the second clamp mechanism 64 is positioned on the loading station 60 to grip a proximal portion of the elongate body portion 14 of the stapling device 10, and the third clamp mechanism 66 is positioned on the loading station 60 to grip a distal portion of the elongate body portion 14 of the stapling device 10. Alternately, the loading station 60 may include one or more clamping mechanisms. In embodiments, the clamping mechanisms can include  any device capable of gripping a portion of the surgical stapling device. For example, each of the clamping mechanisms can include two  jaws  70, 72 that are movable in relation to each other to grip a portion of the stapling device 10. Alternately, the clamp mechanisms can include a resilient member that defines an expandable slot for receiving and gripping a portion of the surgical device 10.
The loading unit 60 also includes a first press 74 and a second press 76. The first press 74 is positioned adjacent to where the firing trigger 26 of the surgical stapling 10 is positioned when the stapling device 10 is secured to the loading unit 60. The first press 74 includes a plunger 78 and an actuator 80. The plunger 78 is movable towards the firing trigger 26 to move the firing trigger 26 from a non-actuated position through a portion of a firing stroke to move the pusher back 38 from a retracted position (FIG. 5C) to a partially fired position (FIG. 6C) as discussed in further detail below. The first press 74 may include a compliant tip 82 and a biasing member 84 that is positioned to urge the plunger 78 towards the firing trigger 26 of the stapling device 10.
The second press 76 is supported on the base member 100 of the loading station 60 adjacent to where the tool assembly 16 of the surgical stapling 10 is positioned when the stapling device 10 is secured to the loading unit 60. The second press 76 includes a plunger 88, an actuator 90, and a press tool 92. The press tool 92 is supported on one end of the plunger 88 and is movable into a distal end of the shell housing 30 in response to advancement of the plunger 88 to load the staple guide 20 into the shell housing 30 as discussed in detail below. The press tool 92 includes a cylindrical stepped body having a small diameter portion 94 dimensioned to be received within the annular knife 40 of the shell assembly 18 and a large diameter portion 96 that is dimensioned to extend over a distal face 98 (FIG. 3) of the staple guide 20.
Referring to FIGS. 5A-5C, prior to loading the staple guide 20 into the shell housing 30, the stapling device 10 is secured onto the base member 100 of the loading station 60 by positioning the stapling device 10 within the clamp mechanisms 62-64. When the stapling device 10 is secured onto the loading station 60, the small diameter portion 94 of the press tool 92 is located in front of the shell assembly 18 in a position to be received within the annular knife 40 (FIG. 5B) at the distal end of the shell assembly 18 and the large diameter portion 96 of the press tool 92 is positioned to extend over the open distal end (FIG. 20) of the shell housing 30. The pusher back 38 is initially located in a retracted position within the shell housing 30 such that the fingers 44 of the pusher back 38 are recessed within the shell housing 30. In addition, the plunger 78 of the first press 74 is retracted such that the firing trigger 26 is in a non-actuated position.
Referring to FIGS. 6A-6C, prior to positioning the staple guide 20 within the shell housing 30, the first press 74 is actuated to move the firing trigger 26 partially through a firing stroke. Actuating the first press 74 advances the plunger 78 in the direction indicated by arrow “A” in FIG. 6A into engagement with the firing trigger 26 to pivot the firing trigger 26 towards the handle assembly 12 of the stapling device 10. As the firing trigger 26 pivots through the firing stroke, the pusher back 38 is advanced within the shell housing 30 to a partially fired position in which the fingers 44 and annular knife 40 extend from the distal end of the shell housing 30.
Referring to FIGS. 7A-7D, after the annular knife 40 and the fingers 44 of the pusher back 38 are extended through the distal end of the shell housing 30 by actuating the first press 74, the staple guide 20 is manually positioned adjacent the distal end of the shell housing 30 such that the fingers 44 of the pusher back 38 are partially received in respective staple receiving slots 28 of  the staple guide 20 (FIG. 7D) . As the staple guide 20 is positioned adjacent the distal end of the shell housing 30, the longitudinal rib 52 of the staple guide 20 is aligned with the guide slot 58 defined in the distal end of the shell housing 30 to properly orient the staple guide 20 within the shell housing 30 (FIG. 7B) . Positioning the longitudinal rib 52 of the staple guide 20 partially within the guide slot 58 also positions the tabs 50 of the staple guide 20 into alignment with the openings 50 in the shell housing 30 (FIG. 7B) .
After the staple guide 20 is aligned with the shell housing 30 and the fingers 44 of the pusher back 38 are partially received within the staple receiving slots 28 of the staple guide 20, the press tool 92 of the second press 76 is positioned to align the small diameter portion 94 of the press tool 92 with a bore 40a defined by the annular knife 40 of the shell assembly 18 and to align the large diameter portion 96 of the press tool 92 with the distal face 98 (FIG. 7D) of the staple guide 20.
Referring to FIGS 8A-8D, after the staple guide 20 is aligned with the shell housing 30 with the press tool 92 of the second press 76 positioned in front of the staple guide 20, the second press 76 is actuated to simultaneously advance the staple guide 20 in the direction indicated by arrows “D” in FIG. 8B fully into the shell housing 30. As this occurs, the longitudinal rib 52 is fully advanced into the guide slot 58 of the outer housing portion 34 of the shell housing 30 and the tabs 50 are received in the openings 56 of the shell housing 30. When the shoulder 23a of the distal annular flange 23 of the staple guide 20 engages the distal edge 34a of the shell housing 30, the staple guide 20 is fully loaded into the shell housing 30 (FIG. 8B) . As the staple guide 20 is loaded into the shell housing 30 by the large diameter portion 96 of the press tool 92, the pusher back 38 is urged from the partially fired position back to its retracted position by the small diameter portion 94 of the press tool 92. As best seen in  FIG. 8A, movement of the pusher back 38 to its retracted position returns the firing trigger 26 to its unactuated position against the force of the biasing member 84 of the first press 74.
The presently disclosed method and device for loading the staple guide 20 into the shell housing 30 of the shell assembly 18 allows for the partial advancement of the pusher back 38 to facilitate manual alignment of the staple guide 20 in relation to the pusher back 38. The second press 76 and press tool 92 facilitate simultaneous automatic loading of the staple guide 20 into the shell housing 30 and return of the pusher back 38 to its retracted position to maintain the alignment between the staple guide 20 and the pusher back 38.
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 embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims (15)

  1. The method of loading a staple guide into a shell assembly of a stapling device comprising:
    clamping the stapling device to a loading station including first and second presses;
    actuating the first press to operate a firing trigger of the stapling device to advance a pusher back of the shell assembly from a retracted position to a partially fired position;
    manually placing the staple guide adjacent a distal end of the shell housing such that fingers of the pusher back are received within staple receiving slots of the staple guide; and
    actuating the second press to advance a press tool supported on the second press into the distal end of the shell housing to simultaneously advance the staple guide into the shell housing of the stapling device and to return the pusher back to its retracted position.
  2. The method of claim 1, wherein the staple guide includes an annular flange defining a shoulder and the shell housing has a distal edge, and actuating the second press includes advancing the staple guide into the shell housing until the shoulder of the annular flange engages the distal edge of the shell housing.
  3. The method of claim 1, wherein clamping the stapling device to the loading station includes using a first clamping mechanism of the loading station to secure a first end of the stapling device to the loading station and using a second clamping mechanism to secure a second end of the stapling device to the loading station.
  4. The method of claim 3, wherein clamping the stapling device to the loading station includes using a third clamping mechanism to secure a central portion of the stapling device to the loading station.
  5. The method of claim 1, wherein actuating the first press to operate a firing trigger includes advancing a plunger of the first press into engagement with the firing trigger of the stapling device to move the firing trigger through a portion of a firing stroke.
  6. The method of claim 1, wherein actuating the second press to advance the press tool includes advancing a plunger of the second press to advance the press tool into the distal end of the shell housing of the stapling device.
  7. The method of claim 6, wherein the press tool includes a small diameter portion and a large diameter portion and actuating the second press to advance the press tool includes advancing the press tool such that the small diameter portion engages the pusher back of the shell assembly and the large diameter portion engages the staple guide of the shell assembly.
  8. The method of claim 1, wherein manually placing the staple guide adjacent a distal end of the shell housing includes aligning a longitudinal rib of the staple guide with a guide slot defined in the shell housing.
  9. The method of claim 8, wherein manually placing the staple guide adjacent a distal end of the shell housing includes aligning tabs of the staple guide with openings defined in the shell housing.
  10. A loading station for loading a shell assembly of a stapling device with a staple guide, the loading station comprising:
    a base member;
    a clamping mechanism supported on the base member, the clamping mechanism being configured to secure the stapling device to the base member;
    a first press supported on the base member and including a first plunger, the first plunger being positioned to operate a firing trigger of the stapling device; and
    a second press supported on the base member, the second press including a second plunger and a press tool supported on the second plunger, the second press being positioned such that the press tool is movable into the shell housing of the stapling device to load the staple guide into the shell housing.
  11. The loading station of claim 10, wherein the press tool includes a small diameter portion and a large diameter portion, the small diameter portion being dimensioned to extend into the shell housing into engagement with a pusher back of the shell assembly and the large diameter portion being positioned to simultaneously engage the staple guide.
  12. The loading station of claim 9, wherein the clamping mechanism includes a first clamping mechanism that is positioned to secure a first portion of the stapling device to the base member and a second clamping mechanism that is positioned to secure a second portion of the stapling device to the base member.
  13. The loading station of claim 12, wherein the clamping mechanism includes a third clamping mechanism that is positioned to secure a third portion of the stapling device to the base member.
  14. The loading station of claim 10, wherein the first press includes a compliant tip that is positioned to engage the firing trigger of the stapling device.
  15. The loading station of claim 14, wherein the first press includes a biasing member positioned to urge the compliant tip towards the firing trigger.
PCT/CN2017/076163 2017-03-09 2017-03-09 Method and device for loading a staple guide WO2018161315A1 (en)

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Cited By (1)

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CN111466984A (en) * 2019-01-24 2020-07-31 苏州英途康医疗科技有限公司 Anastomat handle system and anastomat

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CN2495264Y (en) * 2001-08-27 2002-06-19 马剑文 Assembling clamp for needle-against base for tubular type anastomosis performing implement
CN2772449Y (en) * 2004-06-24 2006-04-19 马剑文 Rolled pressed connector for nail cartridge of tubular anastomat and casing
US20130056517A1 (en) * 2009-10-28 2013-03-07 Covidien Lp Surgical stapling instrument
US20150209032A1 (en) * 2012-01-12 2015-07-30 Covidien Lp Sliding sleeve for circular stapling instrument reloads
CN105748126A (en) * 2015-01-07 2016-07-13 柯惠Lp公司 Loading unit retention clip for surgical stapling instrument

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2495264Y (en) * 2001-08-27 2002-06-19 马剑文 Assembling clamp for needle-against base for tubular type anastomosis performing implement
CN2772449Y (en) * 2004-06-24 2006-04-19 马剑文 Rolled pressed connector for nail cartridge of tubular anastomat and casing
US20130056517A1 (en) * 2009-10-28 2013-03-07 Covidien Lp Surgical stapling instrument
US20150209032A1 (en) * 2012-01-12 2015-07-30 Covidien Lp Sliding sleeve for circular stapling instrument reloads
CN105748126A (en) * 2015-01-07 2016-07-13 柯惠Lp公司 Loading unit retention clip for surgical stapling instrument

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111466984A (en) * 2019-01-24 2020-07-31 苏州英途康医疗科技有限公司 Anastomat handle system and anastomat
CN111466984B (en) * 2019-01-24 2021-09-03 苏州英途康医疗科技有限公司 Anastomat handle system and anastomat

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