WO2023230966A1

WO2023230966A1 - Anvil assembly for surgical stapling device

Info

Publication number: WO2023230966A1
Application number: PCT/CN2022/096699
Authority: WO
Inventors: Zhaokai Wang; Xiliang Zhang; Peng ZHA; Gainan SUN; Chunhui Zhu
Original assignee: Covidien Lp
Priority date: 2022-06-01
Filing date: 2022-06-01
Publication date: 2023-12-07

Abstract

A surgical stapling device includes an anvil assembly that includes an anvil plate that defines a plane and includes staple forming pockets recessed below the plane. The staple forming pockets are configured to reduce firing forces required to actuate the stapling device.

Description

ANVIL ASSEMBLY FOR SURGICAL STAPLING DEVICE

FIELD

This disclosure is generally related to surgical stapling devices and, more particularly, to an anvil assembly for a surgical stapling device configured to reduce firing forces.

BACKGROUND

Surgical stapling devices are used during a variety of surgical procedures to expedite cutting and suturing of tissue while minimizing trauma to a patient. Typically, stapling devices have an end effector or tool assembly that includes a cartridge assembly that supports staples and an anvil assembly that is configured to form the staples ejected from the cartridge assembly. The cartridge and anvil assemblies are coupled together and movable in relation to each other between unclamped and clamped positions.

Surgical stapling devices are configured for manual and powered operation. Stapling devices configured for manual operation include a handle assembly that has a trigger that can be manually compressed by a clinician through one or more actuation strokes to move the tool assembly from the unclamped position to the clamped position and to eject the staples from the cartridge assembly. Typically, the trigger is coupled to a firing rod or thrust bar that is longitudinally movable in response to movement of the trigger through one or more actuation strokes to advance a drive member into one or more pushers within a staple cartridge of the cartridge assembly to eject the staples from the cartridge assembly into the anvil assembly. The staples are ejected from the staple cartridge into staple forming pockets of the anvil assembly to form the staples in tissue.

In some stapling devices, the pushers are sequentially engaged by the drive member to sequentially form the staples against the anvil assembly. In other stapling devices, the drive member advances the pusher to simultaneously eject all the staples into the anvil assembly. In either case, the force required to eject the staples from the staple cartridge may be high making it difficult for a clinician to operate the trigger.

A continuing need exists in the art for a surgical stapling device that includes an anvil assembly that is configured to minimize the force required to form the staples.

SUMMARY

This disclosure is directed to a surgical stapling device that includes an anvil plate that defines a plane and includes staple forming pockets recessed below the plane. The staple forming pockets are configured to reduce firing forces required to actuate the stapling device.

Aspects of the disclosure are directed to a surgical stapling device including a handle assembly having a trigger, an elongate body, and an end effector. The elongate body defines a longitudinal axis and has a proximal portion and a distal portion. The proximal portion is coupled to the handle assembly. The end effector is supported on the distal portion of the elongate body and includes an end effector frame, a cartridge assembly, and an anvil assembly. The end effector frame has a first transverse portion, a second transverse portion, and a longitudinal portion that extends between the first and second transverse portions to support the first transverse portion in spaced relation to the second transverse portion and define a gap. The distal portion of the elongate body is secured to the end effector. The anvil assembly is supported on the first transverse portion of the end effector frame, and the cartridge assembly is supported within the gap and is movable in relation to the anvil assembly between unclamped and clamped positions. The anvil assembly includes an anvil plate that defines a plane and includes staple forming pockets recessed below the plane. Each of the staple forming pockets includes a first pocket portion, a second pocket portion, and an intermediate portion that extends in a direction parallel to the longitudinal axis “X” of the elongate body between and into the first and second pocket portions. The first and second pocket portions each have a circular configuration with a sloped wall that curves downwardly towards the intermediate portion. The intermediate portion has a staple forming surface having first and second curved sections and a linear section positioned between the first and second curved sections. The first and second curved sections are positioned within the first and second pocket portions. Each of the first and second curved sections of the staple forming surface of the intermediate portion has an entrance portion and an exit portion. The exit portion of each of the first and second curved sections has a tangent that intersects the plane defined by the anvil plate to define an exit angle “α” of between about 50 degrees and about 60 degrees.

Other aspects of the disclosure are directed to an end effector including an end effector frame, an anvil assembly, and a cartridge assembly. The end effector frame has a first transverse portion, a second transverse portion, and a longitudinal portion that extends between the first and second transverse portions to support the first transverse portion in spaced relation to the second transverse portion and define a gap. The anvil assembly is supported on the first transverse portion of the end effector frame. The cartridge assembly is supported within the gap and is movable in relation to the anvil assembly between unclamped and clamped positions. The anvil assembly includes an anvil plate that defines a plane and includes staple forming pockets recessed below the plane. Each of the staple forming pockets includes a first pocket portion, a second pocket portion, and an intermediate portion that extends between and into the first and second pocket portions. The first and second pocket portions each have a circular configuration with a sloped wall that curves downwardly towards the intermediate portion. The intermediate portion has a staple forming surface having first and second curved sections and a linear section positioned between the first and second curved sections. The first and second curved sections are positioned within the first and second pocket portions. Each of the first and second curved sections of the staple forming surface of the intermediate portion has an entrance portion and an exit portion. The exit portion of each of the first and second curved sections has a tangent that intersects the plane defined by the anvil plate at an exit angle “α” of between about 50 degrees and about 60 degrees.

Other aspects of the disclosure are directed to an anvil assembly including an anvil plate that defines a plane and includes staple forming pockets recessed below the plane. Each of the staple forming pockets includes a first pocket portion, a second pocket portion, and an intermediate portion that extends between and into the first and second pocket portions. The first and second pocket portions each have a circular configuration with a sloped wall that curves downwardly towards the intermediate portion. The intermediate portion has a staple forming surface having first and second curved sections and a linear section positioned between the first and second curved sections. The first and second curved sections are positioned within the first and second pocket portions. Each of the first and second curved sections of the staple forming surface of the intermediate portion has an entrance portion and an exit portion. The exit portion of each of the first and second curved sections has a tangent that defines an exit angle “α” of between about 50 degrees and about 60 degrees.

In aspects of the disclosure, the exit angle “α” is about 55 degrees.

In some aspects of the disclosure, the entrance portion has a tangent that defines an entrance angle “β” of between about 25 degrees and 35 degrees.

In certain aspects of the disclosure, the stapling device includes a clamp member that has a distal portion that defines a pocket, and the cartridge assembly is received within the pocket.

In aspects of the disclosure, the pocket is positioned within the gap defined by the end effector frame, and the clamp member is movable to move the cartridge assembly in relation to the anvil between unclamped and clamped positions.

In some aspects of the disclosure, the stapling device includes a thrust bar having a distal portion that is received within the cartridge assembly and movable between retracted and advanced positions to eject staples from the cartridge assembly.

In certain aspects of the disclosure, the cartridge assembly is releasably received within the pocket of the clamp member.

In aspects of the disclosure, the anvil plate defines a knife slot and the staple forming pockets are positioned in rows on each side of the knife slot.

In some aspects of the disclosure, the anvil plate includes two rows of staple forming pockets on one side of the knife slot and three rows of staple forming pockets on an opposite side of the knife slot.

Other features of the disclosure will be appreciated from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the disclosure are described herein below with reference to the drawings, wherein:

FIG. 1 is a side perspective view of a surgical stapling device according to aspects of the disclosure in an unclamped, pre-fired position;

FIG. 1A is a side perspective view of the end effector of the surgical stapling device shown in FIG. 1 with a cartridge assembly separated from an end effector frame;

FIG. 2 is an enlarged view of the indicated area of detail shown in FIG. 1 illustrating staple forming pockets of an anvil assembly of the stapling device shown in FIG. 1;

FIG. 3A is a cross-sectional view taken along section line 3-3 of FIG. 2;

FIG. 3B is a cross-sectional view taken along section line 3B-3B of FIG. 3A;

FIG. 4 is a graph showing the force versus time during firing of the stapling device;

FIG. 5 is a side view of a staple formed with the anvil assembly shown in FIG. 3; and

FIG. 6 is a side view of a staple formed with a conventional anvil assembly.

DETAILED DESCRIPTION

The disclosed surgical stapling device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the 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.

In this description, 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. In addition, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel. Further, 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.

This disclosure is directed to a surgical stapling device that includes an anvil assembly having staple forming pockets that are configured to reduce the forces required to fire staples from the stapling device.

FIGS. 1 and 1A illustrate 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 elongate body 14 that extends distally from the handle assembly 12, and an end effector 16 that is supported on a distal portion of the elongate body 14. The elongate body 14 defines a longitudinal axis “X” . The handle assembly 12 includes a housing 18 that defines a stationary handle 20 and supports a trigger 22. In aspects of the disclosure, the trigger 22 is supported by the housing 18 to pivot towards the stationary handle 20 between non-actuated and actuated positions to actuate the end effector 16, i.e., move the end effector 16 between open and clamped positions and fire the stapling device 10. The handle assembly 12 also supports two buttons 26 (only one is shown) , one positioned on each side of the housing 18, that are movable along the housing 18 to advance and retract an alignment pin pusher 30. The handle assembly 12 also includes a release button 28 that can be depressed to move the end effector 16 from the clamped position to the open position. For a more detailed description of a representative handle assembly 12, see, e.g., U.S. Patent No. 6,817,508 ( “the ’508 Patent” ) .

The stapling device 10 includes a frame 32 that extends from within the handle assembly 12 to the end effector 16 and includes a distal portion 32a that supports the end effector 16. The frame 32 includes spaced frame members 34 that define a channel 36 that receives a thrust bar 33 (FIG. 1A) and the alignment pin pusher 30. The thrust bar 33 is movable within the channel 36 between retracted and advanced positions in response to movement of the trigger 22 to actuate the stapling device 10. The channel 36 defined by the frame members 34 also receives a clamp member 40 (FIG. 1A) that extends into the end effector 16 and includes a distal portion 40a that defines a pocket 40b that receives a cartridge assembly 38. The thrust bar 33 has a distal portion that is received within the cartridge assembly 38. When the thrust bar is moved between the retracted and advanced positions, staples 100 (FIG. 5) are ejected from the cartridge assembly 38. For a more detailed description of the interaction between the trigger 22, the thrust bar, and the clamp member 40, see the ’508 Patent.

The end effector 16 includes the cartridge assembly 38, an end effector frame 42, and an anvil assembly 44. The end effector frame 42 is secured to the distal portion 32a (FIG. 1) of the frame 32 of the stapling device 10 (FIG. 1) by, e.g., rivets 45, and includes a distal transverse portion 46, a proximal transverse portion 48, and a longitudinal portion 50 that connects the distal transverse portion 46 to the proximal transverse portion 48. The distal and proximal

transverse portions

46, 48 are spaced from each other to define a gap 52. In some aspects of the disclosure, the distal and proximal

transverse portions

46, 48 are curved along axes transverse to the longitudinal axis “X” of the elongate body 14 of the stapling device 10 (FIG. 1) . The cartridge assembly 38 is releasably supported on the distal portion 40a of the clamp member 40 and is movable within the gap 52 between unclamped and clamped positions. For a detailed description of the distal portion of an exemplary stapling device, see WO 2021/022407 which is incorporated herein by reference in its entirety.

The anvil assembly 44 is supported on the distal transverse portion 46 of the end effector frame 42 and includes an anvil plate 54 (FIG. 2) . The anvil plate 54 is positioned in juxtaposed opposition to a distal face 38a of the cartridge assembly 38 when the cartridge assembly 38 is in the clamped position and defines a knife slot 56 and staple forming pockets 58 on opposite sides of the knife slot 56. In aspects of the disclosure, the staple forming pockets 58 are aligned in one or more rows on each side of the knife slot 56 although other pocket configurations are envisioned. It is envisioned that the number of rows of staple forming pockets 58 may be the same on each side of the knife slot 56, or alternatively, may be different. In some aspects of the disclosure, the anvil plate 54 defines two rows of staple forming pockets 58 on one side of the knife slot 56 and three rows of staple forming pockets 58 formed on the other side of the knife slot 56.

FIG. 1A illustrates the cartridge assembly 38 which includes a cartridge body 60 that defines a knife slot 62 and staple receiving slots 64 positioned on opposite sides of the knife slot 62. Each of the staple receiving slots (not shown) is aligned with a respective one of the staple forming pockets 58 of the anvil plate 54 and receives a staple 60 (FIG. 5) . When the cartridge assembly 38 is moved from the unclamped position to the clamped position by moving the clamp member 40 from a retracted position to an advanced position, the distal face 38a of the cartridge body 60 of the cartridge assembly 38 is positioned in juxtaposed alignment with the anvil assembly 44 such that the staple forming pockets 58 of the anvil assembly 44 are aligned with respective staple receiving slots 64 of the cartridge assembly 38.

FIGS. 2 and 3 illustrate the anvil assembly 44 including the anvil plate 54 and the staple forming pockets 58. Each of the staple forming pockets 58 of the anvil assembly 44 includes a first pocket portion 70, a second pocket portion 72, and an intermediate portion 74 that extends in a direction parallel to the longitudinal axis “X” of the elongate body 14 and connects that first pocket portion 70 with the second pocket portion 72. The intermediate portion 74 extends longitudinally at least partially across the first and

second pocket portions

70, 72 and includes a staple forming surface 76. The first and

second pocket portions

70, 72 each have a circular configuration with a sloped wall that curves downwardly towards the intermediate portion 74. The staple forming surface 76 of the intermediate portion 74 is linear in a direction transverse to the longitudinal axis “X” (FIG. 3A) and curved in a direction parallel to the longitudinal axis “X” .

The staple forming surface 76 of the intermediate portion 74 of each of the staple forming pockets 58 of the anvil assembly 44 defines first and second

curved sections

80 and 82 and a linear section 84 positioned between the first and second

curved sections

80 and 82. Each of the

curved sections

80 and 82 of the staple forming surface 76 of the intermediate portion 74 defines a concavity that includes an entrance portion 86 and an exit portion 88. The entrance portion 86 is spaced from the linear section 84 and the exit portion 88 is positioned adjacent the linear section 84. In aspects of the disclosure, the entrance portion 86 has a tangent “A” that defines an angle “β” with a plane defined by the anvil plate 54 of between about 25 degrees and about 35 degrees. The exit portion 88 is positioned adjacent to the linear portion and has a tangent “B” that defines an angle “α” with the plane defined by the anvil plate 54 of between about 50 and 60 degrees. In some aspects of the disclosure, the angle “α” is about 55 degrees.

In current anvil assemblies, the exit portion 88 of the

curved sections

80 and 82 of the staple forming surface 76 defines an angle “Ω” which is about 35 degrees. As described above, the angle “α” is greater than the angle “Ω” , i.e., the exit angle “α” of the

curved sections

80 and 82 of the anvil assembly 44 is steeper than that currently known.

FIG. 4 illustrates a chart showing the force required to fire the stapling device 10 (FIG. 1) over time (constant firing speed) with the currently known anvil geometry “Z” and the disclosed anvil geometry “X” . Reference “L” indicates the location of a firing stroke in which the staples begin forming against the anvil pale 54 and reference “M” indicates the location in which staples near final formation against the anvil pale 54. As shown, by increasing the angle of the exit portions 88 of the

curved sections

80 and 82 of the staple forming pockets 58 of the anvil assembly 44, the maximum force required to firing the stapling device is reduced from 9.45N to 8.82N. This reduction in maximum firing force alleviates strain on a hand of a clinician.

FIGS. 5 illustrates a staple 100 formed with the presently disclosed anvil assembly 44. The staple 100 includes legs 102 and a back span 104. As illustrated, the staple 100 is formed into a modified B-configuration with distal ends of staple legs 102 extending outwardly towards the proximal portion of the legs 102.

FIG. 6 illustrates a staple 100’ formed with known assemblies. As illustrated, the staple 100 is formed into a B-configuration with the distal ends of the staple legs 102’ extending in a direction substantially parallel to the proximal portion of the legs 102’.

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 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 aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims

A surgical stapling device comprising:

a handle assembly having a trigger;

an elongate body defining a longitudinal axis and having a proximal portion and a distal portion, the proximal portion coupled to the handle assembly; and

an end effector supported on the distal portion of the elongate body, the end effector including an end effector frame, a cartridge assembly, and an anvil assembly, the end effector frame having a first transverse portion, a second transverse portion, and a longitudinal portion that extends between the first and second transverse portions to support the first transverse portion in spaced relation to the second transverse portion and define a gap, the distal portion of the elongate body secured to the end effector, the anvil assembly supported on the first transverse portion of the end effector frame, and the cartridge assembly supported within the gap and movable in relation to the anvil assembly between unclamped and clamped positions;

wherein the anvil assembly includes an anvil plate that defines a plane and includes staple forming pockets recessed below the plane, each of the staple forming pockets including a first pocket portion, a second pocket portion, and an intermediate portion that extends in a direction parallel to the longitudinal axis “X” of the elongate body between and into the first and second pocket portions, the first and second pocket portions each have a circular configuration with a sloped wall that curves downwardly towards the intermediate portion, the intermediate portion has a staple forming surface having first and second curved sections and a linear section positioned between the first and second curved sections, the first and second curved sections positioned within the first and second pocket portions, each of the first and second curved sections of the staple forming surface of the intermediate portion having an entrance portion and an exit portion, wherein the exit portion of each of the first and second curved sections has a tangent that intersects the plane defined by the anvil plate to define an exit angle “α” of between about 50 degrees and 60 degrees.
The surgical stapling device of claim 1, wherein the exit angle “α” is about 55 degrees.
The surgical stapling device of claim 1, wherein the entrance portion has a tangent that defines an entrance angle “β” of between about 25 degrees and 35 degrees.
The surgical stapling device of claim 1, further including a clamp member having a distal portion that defines a pocket, the cartridge assembly received within the pocket.
The surgical stapling device of claim 4, wherein the pocket is positioned within the gap defined by the end effector frame, and the clamp member is movable to move the cartridge assembly in relation to the anvil between unclamped and clamped positions.
The surgical stapling device of claim 5, further including a thrust bar having a distal portion received within the cartridge assembly, the thrust bar movable between retracted and advanced positions to eject staples from the cartridge assembly.
The surgical stapling device of claim 4, wherein the cartridge assembly is releasably received within the pocket of the clamp member.
The surgical stapling device of claim 1, wherein the anvil plate defines a knife slot and the staple forming pockets are positioned in rows on each side of the knife slot.
The surgical stapling device of claim 8, wherein the anvil plate includes two rows of staple forming pockets on one side of the knife slot and three rows of staple forming pockets on an opposite side of the knife slot.
An end effector comprising:

an end effector frame having a first transverse portion, a second transverse portion, and a longitudinal portion that extends between the first and second transverse portions to support the first transverse portion in spaced relation to the second transverse portion and define a gap;

an anvil assembly supported on the first transverse portion of the end effector frame; and

a cartridge assembly supported within the gap and movable in relation to the anvil assembly between unclamped and clamped positions;

wherein the anvil assembly includes an anvil plate that defines a plane and includes staple forming pockets recessed below the plane, each of the staple forming pockets including a first pocket portion, a second pocket portion, and an intermediate portion that extends between and into the first and second pocket portions, the first and second pocket portions each have a circular configuration with a sloped wall that curves downwardly towards the intermediate portion, the intermediate portion having a staple forming surface having first and second curved sections and a linear section positioned between the first and second curved sections, the first and second curved sections positioned within the first and second pocket portions, each of the first and second curved sections of the staple forming surface of the intermediate portion having an entrance portion and an exit portion, wherein the exit portion of each of the first and second curved sections has a tangent that intersects the plane defined by the anvil plate to define an exit angle “α” of between about 50 degrees and 60 degrees.
The end effector of claim 10, wherein the exit angle “α” is about 55 degrees.
The end effector of claim 10, wherein the entrance portion has a tangent that defines an entrance angle “β” of between about 25 degrees and 35 degrees.
The end effector of claim 1, wherein the anvil plate defines a knife slot and the staple forming pockets are positioned in rows on each side of the knife slot.
The end effector of claim 13, wherein the anvil plate includes two rows of staple forming pockets on one side of the knife slot and three rows of staple forming pockets on an opposite side of the knife slot.
An anvil assembly comprising:

an anvil plate that defines a plane and includes staple forming pockets recessed below the plane, each of the staple forming pockets including a first pocket portion, a second pocket portion, and an intermediate portion that extends between and into the first and second pocket portions, the first and second pocket portions each have a circular configuration with a sloped wall that curves downwardly towards the intermediate portion, the intermediate portion having a staple forming surface that is having first and second curved sections and a linear section positioned between the first and second curved sections, the first and second curved sections positioned within the first and second pocket portions, each of the first and second curved sections of the staple forming surface of the intermediate portion having an entrance portion and an exit portion, wherein the exit portion of each of the first and second curved sections has a tangent that intersects the plane defined by the anvil plate to define an exit angle “α” of between about 50 degrees and 60 degrees.
The anvil assembly of claim 15, wherein the exit angle “α” is about 55 degrees.
The anvil assembly of claim 15, wherein the entrance portion has a tangent that defines an entrance angle “β” of between about 25 degrees and 35 degrees.
The anvil assembly of claim 15, wherein the anvil plate defines a knife slot and the staple forming pockets are positioned in rows on each side of the knife slot.
The anvil assembly of claim 18, wherein the anvil plate includes two rows of staple forming pockets on one side of the knife slot and three rows of staple forming pockets on an opposite side of the knife slot.
The anvil assembly of claim 18, wherein the anvil plate includes rows of staple forming pockets on each side of the knife slot.