US11622767B2

US11622767B2 - Sealed trocar assembly for stapling device

Info

Publication number: US11622767B2
Application number: US17/151,796
Authority: US
Inventors: Joseph Eisinger
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2020-02-19
Filing date: 2021-01-19
Publication date: 2023-04-11
Also published as: US20210251632A1; EP3868310A1; EP3868310B1; CN113274083A

Abstract

A stapling device includes a handle assembly and an adaptor assembly extending from the handle assembly and including a sealed trocar assembly. The trocar assembly includes a trocar housing defining a lumen, an annular seal having an inner annular surface defining an inner opening, and a trocar disposed within the lumen of the trocar housing, through the inner opening of the annular seal, and movable through the lumen of the trocar and the inner opening of the annular seal, and a seal retainer operably coupled to the trocar housing and the annular seal. The trocar includes an elongate body portion having a distal end and a trocar member extending distally from the distal end of the elongate body portion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 62/978,339 filed Feb. 19, 2020, the entire disclosure of which is incorporated by reference herein.

FIELD

This disclosure is generally related to surgical stapling devices and, more particularly, to surgical stapling devices and components for surgical stapling devices that include a sealed configuration.

BACKGROUND

Powered surgical stapling devices include a handle assembly, an adaptor assembly including a distal portion supported on the handle assembly, and a tool assembly (e.g., a staple cartridge) supported on the distal portion of the adaptor assembly. Some tool assemblies include a shell or reload assembly that has a staple cartridge, a staple pusher, and an annular knife. The staple cartridge supports one or more annular rows of staples, and the staple pusher is movable within the staple cartridge to eject the staples from the staple cartridge. The annular knife is positioned radially inward of the annular rows of staples and is movable from a retracted position to an advanced position to cut or core tissue. The annular knife can be movable simultaneously with the staple pusher or independently of the staple pusher to cut tissue during a surgical procedure, e.g., an anastomosis procedure.

In some applications, some components of the stapling device are disposable while others are reusable after proper sterilization. Proper sterilization of reusable components is more difficult and time consuming if contaminants flow into the adaptor assembly.

SUMMARY

This disclosure is directed to a surgical stapling device and to trocar assemblies of adaptor assemblies for surgical stapling devices that include a sealed configuration to prevent ingress of fluids therein.

In accordance with aspects of the disclosure, a stapling device includes a handle assembly and an adaptor assembly extending from the handle assembly. The adaptor assembly includes a trocar assembly disposed within the adaptor assembly. The trocar assembly includes a trocar housing including an inner surface defining a lumen, an annular seal positioned within the lumen of the trocar housing and having an inner annular surface defining an inner opening, and a trocar disposed within the lumen of the trocar housing, extending through the inner opening of the annular seal, and movable through the lumen of the trocar and the inner opening of the annular seal, and a seal retainer operably coupled to the trocar housing. The seal retainer is positioned to retain the annular seal within the lumen of the trocar housing. The trocar includes an elongate body portion having a distal end and a trocar member extending distally from the distal end of the elongate body portion.

In an aspect, the inner annular surface of the annular seal is frictionally engaged to the elongate body portion of the trocar to form a fluid-tight seal between the annular seal and the trocar.

In an aspect, the seal retainer is fixedly coupled to the trocar housing.

In an aspect, the trocar housing has a distal end and the seal retainer has a proximal end and the proximal end of the seal retainer is secured to the distal end of the trocar housing.

In an aspect, the seal retainer includes a proximal lip and a distal lip and defines an inner annular region between the proximal lip and the distal lip.

In an aspect, the annular seal is disposed within the inner annular region of the seal retainer.

In an aspect, the annular seal includes an outer surface having a proximal lip and a distal lip extending radially outwardly from the outer surface of the annular seal.

In an aspect, the proximal lip and the distal lip of the annular seal are disposed within the inner annular region of the seal retainer to prevent axial movement of the annular seal as the trocar moves through the inner opening of the annular seal.

In an aspect, the annular seal includes a recessed region defined between the proximal lip of the annular seal and the distal lip of the annular seal. The proximal lip of the annular seal may be disposed within the inner annular region of the seal retainer and the distal lip of the seal retainer may be disposed within the recessed region of the annular seal to prevent axial movement of the annular seal as the trocar moves through the inner opening of the annular seal.

In an aspect, the elongate body portion has an outer surface defining a non-circular shape and the inner opening of the annular seal is dimensioned to correspond in shape to the non-circular shape of the outer surface of the elongate body portion.

In an aspect, the annular seal is formed of an elastomeric material configured to compress when the trocar is positioned through the inner opening of the annular seal.

In accordance with aspects of the disclosure, a trocar assembly is provided including a trocar housing including an inner surface defining a lumen, an annular seal positioned within the lumen of the trocar housing and having an inner annular surface defining an inner opening, and a trocar disposed within the lumen of the trocar housing, extending through the inner opening of the annular seal, and movable through the lumen of the trocar and the inner opening of the annular seal, and a seal retainer operably coupled to the trocar housing. The seal retainer is positioned to retain the annular seal within the lumen of the trocar housing. The trocar includes an elongate body portion having a distal end and a trocar member extending distally from the distal end of the elongate body portion.

In an aspect, the seal retainer is fixedly coupled to the trocar housing.

The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

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

FIG. 1 is a perspective view of a circular stapling device including aspects of the disclosure;

FIG. 2 is a perspective view of an adaptor assembly of the circular stapling device of FIG. 1 ;

FIG. 3 is a side view of a trocar assembly usable with the adaptor assembly of FIG. 2 ;

FIG. 4 is a partial exploded view of the trocar assembly of FIG. 3 ;

FIG. 5 is an enlarged view of the indicated area of detail shown in FIG. 4 including an annular seal of the trocar assembly of FIG. 3 ;

FIG. 6 is a side cross-sectional view of a distal portion of the adaptor assembly of FIG. 2 taken along section line 6-6;

FIG. 7 is an enlarged view of the indicated area of detail shown in FIG. 6 including the annular seal and a seal retainer of the trocar assembly of FIG. 3 ;

FIG. 8 is a perspective view of another trocar assembly including other aspects of the disclosure usable with the adaptor assembly of FIG. 2 ;

FIG. 9 is a perspective view of an annular seal of the trocar assembly of FIG. 8 ;

FIG. 10 is a side cross-sectional view of the trocar assembly of FIG. 8 taken along section line 10-10; and

FIG. 11 is an enlarged view of the indicated area of detail shown in FIG. 10 including the annular seal and a seal retainer of the trocar assembly of FIG. 8 .

DETAILED DESCRIPTION

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

The aspects of the disclosed trocar assembly and stapling device utilizing the disclosed trocar assembly provide one or more seals that prevent fluid ingress into components of the trocar assembly and stapling device. The powered circular stapling device adaptor is a reusable device that is designed to be cleaned and used again in several procedures. Because tissue, fluids, contaminants, and other biological matter can enter the device through a distal opening in the adaptor assembly and, in particular, about the trocar assembly, it is necessary to clean inside the adaptor assembly and its components prior to reuse. To assist with this cleaning, a trocar of the adaptor is removed prior to cleaning to allow greater access to the interior of the adaptor. Properly removing and reattaching the trocar can present challenges to clinicians and have a detrimental effect on the reliability of the stapling device.

The disclosure describes a powered, or non-powered, circular stapling device (or other applicable medical devices) that incorporates a seal in the trocar assembly to prevent fluid ingress into the device and components of the device including the adaptor assembly. The seal or seals can combine to create a barrier to entry of bodily soils to the interior of the device.

In accordance with this disclosure, a trocar assembly can be fixed to an adaptor assembly while the adaptor assembly is cleaned, thereby reducing the burden for clinicians to assemble and disassemble the device, cost, and potential for error. By placing one or more seals in the trocar assembly, the adaptor assembly can be less complex and still allow the device to be cleaned should any small amount of soil get past the seals.

FIG. 1 illustrates a circular stapling device 10 including a handle assembly 12, an elongate body or adaptor assembly 100, a reload assembly 16 releasably supported on the adaptor assembly 100, and an anvil assembly 25 releasably supported for movement in relation to the reload assembly 16 between an open position and a clamped position.

The reload assembly 16 includes a proximal portion 16 a that can be releasably coupled to a distal portion 100 b of the adaptor assembly 100 and the adaptor assembly 100 includes a proximal portion 100 a that can be releasably coupled to the handle assembly 12. The handle assembly 12 includes a stationary grip 22 that supports actuation buttons 27 for controlling operation of various functions of the circular stapling device 10 including approximation of the reload assembly 16 and anvil assembly 25, firing of staples from the reload assembly 16, and cutting or coring of tissue.

The circular stapling device 10 is illustrated as an electrically powered stapling device including an electrically powered handle assembly 12 that may support one or more batteries (not shown). The adaptor assembly 100 translates power from the handle assembly 12 to the reload and

anvil assemblies

16, 25, respectively, to staple and cut tissue. It is envisioned that the disclosed aspects could also be incorporated into a stapling device that is configured for use with a robotic system that does not include a handle assembly, or to a stapling device including a manually actuated handle assembly.

In certain aspects of the disclosure, the reload assembly 16 of the circular stapling device 10 is designed to be disposable and the handle assembly 12 and the adaptor assembly 100 are designed to be reprocessed or resterilized and reused. As such, the reload assembly 16 and components that form the reload assembly 16 are formed of materials, e.g., plastics, that are less costly and less durable than materials e.g., stainless steel, used to form the handle assembly 12 and/or the adaptor assembly 100. Additionally, prevention of contaminant ingress into the reusable components of the circular stapling device 10, such as the handle assembly 12 and the adaptor assembly 100, simplifies the sterilization process for these reusable components. In aspects of the disclosure, the adaptor assembly 100, and in particular, the trocar assembly 20 of the adaptor assembly 100 includes a seal (e.g., annular seal 300 of FIG. 5 or annular seal 500 of FIG. 9 ) to prevent the ingress of contaminants into and about the trocar assembly 20 and the adaptor assembly 100.

FIG. 2 illustrates a trocar assembly 20 received within the distal portion 100 b of the adaptor assembly 100 and configured to operably engage the anvil assembly 25 (FIG. 1 ). In aspects, the trocar assembly 20 is fixedly coupled to the adaptor assembly 100 and not removable therefrom. Alternatively, the trocar assembly 20 may be removably coupled to the adaptor assembly 100. A first aspect of the trocar assembly 20 is described as a trocar assembly 120 (FIGS. 3-7 ) and a second aspect of the trocar assembly 20 is described as a trocar assembly 420 (FIGS. 8-11 ). Throughout this description, the trocar assembly 120 and the trocar assembly 420 are referred to collectively as trocar assembly 20.

FIGS. 3-7 illustrate the trocar assembly 120 of the adaptor assembly 100 (FIG. 2 ) which includes a trocar housing 122, a trocar 123, a drive screw 126, an annular seal 300, and a seal retainer 350. The trocar 123 includes a trocar member 124, an elongate body portion 125, and a nut 129 having a threaded inner surface. The elongate body portion 125 extends distally from the nut 129. The trocar member 124 extends distally from the elongate body portion 125 and defines a tapered tip that is configured to pierce tissue. The trocar 123, which extends through the annular seal 300, is movably disposed within the trocar housing 122 and is movable relative to the trocar housing 122 via rotation of the drive screw 126. The trocar housing 122 defines first and second retaining

elements

123 a, 123 b for coupling the trocar housing 122 to the adaptor assembly 100 (FIG. 2 ) and preventing rotation of the trocar housing 122 within the adaptor assembly 100 as the drive screw 126 is rotated.

The drive screw 126 is operably received within a hollow portion of the elongate body portion 125 of the trocar 123 and is threadingly engaged with the threaded inner surface of the nut 129 of the trocar 123 for axially moving the trocar 123 relative to the trocar housing 122. In particular, rotation of the drive screw 126 effects axial movement of the nut 129 and the elongate body portion 125, and in turn, the trocar member 124 disposed at the distal end of the elongate body portion 125, along a longitudinal axis, relative to the trocar housing 122. The elongate body portion 125 may be rotatably fixed to the nut 129, to form a single unitary component, such that rotation of the nut 129 effects rotation of the elongate body portion 125 in addition to effecting axial movement of the elongate body portion 125.

The annular seal 300 has an inner annular surface 302 defining an inner opening 305 and is retained to the trocar housing 122 by the seal retainer 350. The inner opening 305 of the annular seal 300 is sized and dimensioned to correspond in shape and size of the elongate body portion 125 of the trocar 123. The inner annular surface 302 of the annular seal 300 is frictionally engaged to the elongate body portion 125 of the trocar 123 to form a fluid-tight seal between the annular seal 300 and the trocar 123 (e.g., an outer surface of the trocar 123) when the trocar 123 is positioned through the inner opening 305 of the annular seal 300. The seal retainer 350 is fixedly coupled to the trocar housing 122, for example at a distal end 122 b of the trocar housing 122, and defines an inner annular region 352 (as described below) that receives the annular seal 300. The seal retainer 350 may be coupled to the trocar housing 122 via welding, press-fit engagement, threaded coupling, as a separate component, or may be machined into the distal end 122 b of the trocar housing 122 as a single unitary component.

FIGS. 6 and 7 illustrate the fluid-tight seal formed between the annular seal 300 and the outer surface of the elongate body portion 125 of the trocar 123. Such a fluid-tight seal formed by the annular seal 300 prevents contaminants from entering into the components of the trocar assembly 120 and in turn, other portions of the adaptor assembly 100. The seal retainer 350 includes a proximal lip 351 a and a distal lip 351 b that define the inner annular region 352 between the proximal lip 351 a and the distal lip 351 b. The annular seal 300 is disposed, partially or entirely, within the inner annular region 352 of the seal retainer 350 to prevent axial movement of the annular seal 300 as the trocar 123 moves through the inner opening 305 of the annular seal 300.

In an aspect, the annular seal 300 (FIG. 5 ) includes a proximal lip 301 a and a distal lip 301 b extending radially outward from the outer surface of the annular seal 300 and radially inward from the inner annular surface 302 of the annular seal 300. The proximal lip 301 a and the distal lip 301 b of the annular seal 300 provide a more effective seal between the annular seal 300 and the trocar 123 and the annular seal 300 and the seal retainer 350.

The annular seal 300 may be formed of an elastomeric material such as rubber or other compressible or flexible material. The inner opening 305 of the annular seal 300 is dimensioned such that when the trocar 123 is positioned through the inner opening 305, the trocar 123 forces the annular seal 300 outwardly to compress against the seal retainer 350 against which the annular seal 300 rests. Thus, in an aspect, when the annular seal 300 is in a relaxed (e.g., non-flexed or non-compressed) condition, the diameter of the inner opening 305 of the annular seal 300 is equal to, or less than, the outer diameter of the elongate body portion 125 of the trocar 123.

FIGS. 8-11 illustrate alternative aspects of the disclosed trocar assembly 20 shown generally as trocar assembly 420, which includes a trocar housing 422, a trocar 423, a drive screw 426, an annular seal 500, and a seal retainer 550. The trocar 423 includes a trocar member 424 and an elongate body portion 425. The trocar member 424 extends distally from the elongate body portion 425 and defines a tapered tip that is configured to pierce tissue. The elongate body portion 425 includes a threaded portion 425 t defined along its inner surface. The trocar 123, which extends through the annular seal 500, is movably disposed within the trocar housing 422 and is movable relative to the trocar housing 422 via rotation of the drive screw 426. The trocar housing 422 defines a retaining element 423 a for coupling the trocar housing 422 to the adaptor assembly 100 (FIG. 2 ) and preventing rotation of the trocar housing 422 within the adaptor assembly 100 as the drive screw 126 is rotated.

The drive screw 426 is operably received within a hollow portion of the elongate body portion 425 of the trocar 423 and is threadingly engaged with the threaded portion 425 t of the elongate body portion 425 of the trocar 423 for axially moving the trocar 423 relative to the trocar housing 422. In particular, rotation of the drive screw 426 effects axial movement of the elongate body portion 425, and in turn, the trocar member 424 disposed at the distal end of the elongate body portion 425, along a longitudinal axis, relative to the trocar housing 422.

The annular seal 500 has an inner annular surface 502 defining an inner opening 505 and is retained to the trocar housing 422 by the seal retainer 550. The inner opening 505 of the annular seal 500 is sized and dimensioned to correspond in shape and size of the elongate body portion 425 of the trocar 423. The inner annular surface 502 of the annular seal 500 is frictionally engaged to the elongate body portion 425 of the trocar 423 to form a fluid-tight seal between the annular seal 500 and the trocar 423 (e.g., an outer surface of the trocar 423) when the trocar 423 is positioned through the inner opening 505 of the annular seal 500. The seal retainer 550 is fixedly coupled to the trocar housing 422, for example at a distal end 422 b of the trocar housing 422, and defines an inner annular region 552 (as described below) that receives a portion of the annular seal 500. The seal retainer 550 may be coupled to the trocar housing 422 via welding, press-fit engagement, threaded coupling, as a separate component, or may be machined into the distal end 422 b of the trocar housing 422 as a single unitary component.

FIGS. 10 and 11 illustrate the fluid-tight seal formed between the annular seal 500 and the outer surface of the elongate body portion 425 of the trocar 423. Such a fluid-tight seal formed by the annular seal 500 prevents contaminants from entering into the components of the trocar assembly 420 and in turn, other portions of the adaptor assembly 100. The seal retainer 550 includes a proximal lip 551 a and a distal lip 551 b that define the inner annular region 552 between the proximal lip 551 a and the distal lip 551 b. A portion of the annular seal 500 is disposed within the inner annular region 552 of the seal retainer 550 to prevent axial movement of the annular seal 500 as the trocar 423 moves through the inner opening 505 of the annular seal 500. In particular, the annular seal 500 includes a proximal lip 501 a and a distal lip 501 b extending radially outward from the outer surface of the annular seal 500 which define a recessed region 507 between the proximal lip 501 a and the distal lip 501 b. The proximal lip 501 a of the annular seal 500 is disposed within the inner annular region 552 of the seal retainer 550 and the distal lip 551 b of the seal retainer 550 is disposed within the recessed region 507 of the annular seal 500 to secure the annular seal 500 to the seal retainer 550 and provide a more effective seal between the annular seal 500 and the seal retainer 550 and to prevent axial movement of the annular seal 500 as the trocar 423 moves through the inner opening 505 of the annular seal 500.

Similar to the annular seal 300 (described above), the annular seal 500 may be formed of an elastomeric material such as rubber or other compressible, or flexible material. The inner opening 505 of the annular seal 500 is dimensioned such that when the trocar 423 is positioned through the inner opening 505, the trocar 423 forces the annular seal 500 outwardly to compress against the seal retainer 550 against which the annular seal 500 rests. Thus, in an aspect, when the annular seal 500 is in a relaxed (e.g., non-flexed or non-compressed) condition, the diameter of the inner opening 505 of the annular seal 500 is equal to, or less than, the outer diameter of the elongate body portion 425 of the trocar 423.

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 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

What is claimed is:

1. A stapling device comprising:

a handle assembly;

an adaptor assembly extending from the handle assembly, and including a trocar assembly, the trocar assembly including:

a trocar housing including an inner surface defining a lumen;

an annular seal positioned within the lumen of the trocar housing, the annular seal having an inner annular surface defining an inner opening;

a trocar disposed within the lumen of the trocar housing, extending through the inner opening of the annular seal, and movable through the lumen of the trocar housing and the inner opening of the annular seal, the trocar including an elongate body portion having a distal end and a trocar member extending distally from the distal end of the elongate body portion; and

a seal retainer operably coupled to the trocar housing, the seal retainer positioned to retain the annular seal within the lumen of the trocar housing.

2. The stapling device of claim 1, wherein the inner annular surface of the annular seal is frictionally engaged to the elongate body portion of the trocar to form a fluid-tight seal between the annular seal and the trocar.

3. The stapling device of claim 1, wherein the seal retainer is fixedly coupled to the trocar housing.

4. The stapling device of claim 3, wherein the trocar housing has a distal end and the seal retainer has a proximal end, the proximal end of the seal retainer being secured to the distal end of the trocar housing.

5. The stapling device of claim 1, wherein the seal retainer includes a proximal lip and a distal lip and defines an inner annular region between the proximal lip and the distal lip.

6. The stapling device of claim 5, wherein the annular seal is disposed within the inner annular region of the seal retainer.

7. The stapling device of claim 5, wherein the annular seal includes an outer surface including a proximal lip and a distal lip, the proximal lip and the distal lip of the outer surface of the annular seal extending radially outwardly from the outer surface of the annular seal.

8. The stapling device of claim 7, wherein the proximal lip and the distal lip of the annular seal are disposed within the inner annular region of the seal retainer to prevent axial movement of the annular seal as the trocar moves through the inner opening of the annular seal.

9. The stapling device of claim 7, wherein the annular seal includes a recessed region defined between the proximal lip of the annular seal and the distal lip of the annular seal, the proximal lip of the annular seal disposed within the inner annular region of the seal retainer and the distal lip of the seal retainer disposed within the recessed region of the annular seal.

10. A trocar assembly comprising:

a trocar housing including an inner surface defining a lumen;

a seal retainer operably coupled to the trocar housing, the seal retainer positioned to retain the annular seal within the lumen of the trocar housing, wherein the elongate body portion has an outer surface defining a non-circular shape and the inner opening of the annular seal is dimensioned to correspond in shape to the non-circular shape of the outer surface of the elongate body portion.

11. The trocar assembly of claim 10, wherein the inner annular surface of the annular seal is frictionally engaged to the elongate body portion of the trocar to form a fluid-tight seal between the annular seal and the trocar.

12. The trocar assembly of claim 10, wherein the seal retainer is fixedly coupled to the trocar housing.

13. The trocar assembly of claim 12, wherein the trocar housing has a distal end and the seal retainer has a proximal end, the proximal end of the seal retainer being secured to the distal end of the trocar housing.

14. The trocar assembly of claim 10, wherein the seal retainer includes a proximal lip and a distal lip and defines an inner annular region between the proximal lip and the distal lip.

15. The trocar assembly of claim 14, wherein the annular seal is disposed within the inner annular region of the seal retainer.

16. The trocar assembly of claim 14, wherein the annular seal includes an outer surface having a proximal lip and a distal lip, the proximal lip and the distal lip of the outer surface of the annular seal extending radially outwardly from the outer surface of the annular seal.

17. The trocar assembly of claim 16, wherein the proximal lip and the distal lip of the annular seal are disposed within the inner annular region of the seal retainer to prevent axial movement of the annular seal as the trocar moves through the inner opening of the annular seal.

18. The trocar assembly of claim 16, wherein the annular seal includes a recessed region defined between the proximal lip of the annular seal and the distal lip of the annular seal, the proximal lip of the annular seal disposed within the inner annular region of the seal retainer and the distal lip of the seal retainer disposed within the recessed region of the annular seal.

19. The trocar assembly of claim 10, wherein the annular seal is formed of an elastomeric material configured to compress when the trocar is positioned through the inner opening of the annular seal.

20. A trocar assembly comprising:

a trocar housing including an inner surface defining a lumen;

a seal retainer operably coupled to the trocar housing, the seal retainer positioned to retain the annular seal within the lumen of the trocar housing, wherein the trocar housing has a distal end and the seal retainer has a proximal end, the proximal end of the seal retainer being secured to the distal end of the trocar housing.