Sealed reloading assembly for a stapling device

Abstract

The present invention relates to a sealed reloading assembly for a stapling device, and in particular provides a stapling device comprising a handle assembly, an adapter assembly extending from the handle assembly, and a reloading assembly supported on a distal end portion of the adapter assembly. The reloading assembly comprises a housing shell, a staple cartridge, a first seal, a staple actuator, and a knife holder. The first seal is disposed within a cavity of the housing shell and defines a staple actuator opening and a knife holder opening. The staple actuator comprises a proximal leg extending proximally from the staple actuator and passing through the staple actuator opening of the first seal to provide a fluid seal therebetween. The knife holder comprises a proximal body portion extending proximally from the knife holder and passing through the knife holder opening of the first seal to provide a fluid seal therebetween.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 62 / 966,695, filed on January 28, 2020, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to surgical stapling devices, and more particularly, to surgical stapling devices and reloading assemblies for surgical stapling devices incorporating sealing arrangements. Background Art

[0004] Powered surgical stapling devices include a handle assembly, an adapter 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 adapter assembly. Some powered surgical stapling devices include a housing or reloading assembly having 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 staples from the staple cartridge. The annular knife is positioned radially inwardly of the annular rows of staples and can be moved from a retracted position to an advanced position to cut or coring tissue. The annular knife can move synchronously with the staple pusher or independently of the staple pusher to cut tissue during a surgical procedure such as stapling.

[0005] In some applications, some components of the stapling device are disposable, while other components are reusable after proper sterilization. Proper sterilization of the reusable components can be more difficult and time-consuming if contaminants can flow into the adapter assembly. Summary of the Invention

[0006] The present disclosure is directed to surgical stapling devices and to reloading assemblies for surgical stapling devices incorporating a sealing arrangement to prevent the ingress of fluids therein.

[0007] According to various aspects of the present disclosure, a stapling device includes a handle assembly, an adapter assembly extending from the handle assembly, and a reloading assembly supported on a distal end portion of the adapter assembly. The reloading assembly includes a housing, a staple cartridge, a first seal, a staple actuator, and a blade holder. The housing defines a cavity and has a proximal portion and a distal portion. The staple cartridge is supported on the distal portion of the housing. The first seal is disposed within the cavity and defines a staple actuator opening and a blade holder opening. The staple actuator is disposed within the cavity of the housing and is movable relative to the housing to eject a plurality of staples from the staple cartridge. The staple actuator includes a proximal leg extending proximally from the staple actuator and passing through the staple actuator opening of the first seal to provide a fluid-tight seal therebetween. The blade holder is disposed within the cavity of the housing and is movable relative to the housing. The blade holder includes a proximal body portion extending proximally from the blade holder and passing through the blade holder opening of the first seal to provide a fluid-tight seal therebetween.

[0008] In one aspect, the staple actuator defines a longitudinal aperture, and the knife holder is movable through the longitudinal aperture.

[0009] In one aspect, the reloading assembly further includes a knife secured to the knife holder, and the knife is movable with the knife holder when the knife holder moves.

[0010] In one aspect, the knife comprises an annular cutting edge.

[0011] In one aspect, the stapling device includes a coupling mechanism adapted to secure the reload assembly to the distal end portion of the adapter assembly.

[0012] In one aspect, the reloading assembly further comprises a cannula disposed within the cylindrical cavity defined by the housing shell, the cannula being configured to pass through a trocar receiving the adapter assembly therein. In one aspect, the reloading assembly further comprises a second seal operably coupled to an inner annular surface of the cannula such that a fluid seal is formed between the cannula and the trocar when the trocar is positioned through the cannula. In one aspect, the first seal defines a central opening, and the cannula is positioned through the central opening.

[0013] In one aspect, the staple actuator opening of the first seal is curved along a surface of the first seal to match the curved shape of the proximal legs of the staple actuator.

[0014] According to aspects of the present disclosure, a reloading assembly is provided, which includes a shell housing, a nail magazine, a first seal, a nail actuator and a knife holder. The shell housing defines a cavity and has a proximal portion and a distal portion. The nail magazine is supported on the distal portion of the shell housing. The first seal is disposed in the cavity and defines a nail actuator opening and a knife holder opening. The nail actuator is disposed in the cavity of the shell housing and is movable relative to the shell housing to eject a plurality of nails from the nail magazine. The nail actuator includes a proximal leg that extends proximally from the nail actuator and passes through the nail actuator opening of the first seal to provide a fluid seal therebetween. The knife holder is disposed in the cavity of the shell housing and is movable relative to the shell housing. The knife holder includes a proximal body portion that extends proximally from the knife holder and passes through the knife holder opening of the first seal to provide a fluid seal therebetween.

[0015] In one aspect, the staple actuator defines a longitudinal aperture, and the knife holder is movable through the longitudinal aperture.

[0016] In one aspect, the reloading assembly includes a knife secured to the knife holder and movable with the knife holder as the knife holder moves. The knife may include an annular cutting edge.

[0017] In one aspect, the reloading assembly further comprises a cannula disposed within the cylindrical cavity defined by the housing shell, the cannula being configured to pass through a trocar receiving the adapter assembly therein. In one aspect, the reloading assembly further comprises a second seal operably coupled to an inner annular surface of the cannula such that a fluid seal is formed between the cannula and the trocar when the trocar is positioned through the cannula. In one aspect, the first seal defines a central opening, and the cannula is positioned through the central opening.

[0018] In one aspect, the staple actuator opening of the first seal is curved along a surface of the first seal to match the curved shape of the proximal legs of the staple actuator.

[0019] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and 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 THE DRAWINGS

[0020] Various aspects of the present disclosure are described herein below with reference to the accompanying drawings, in which:

[0021] Figure 1 is a perspective view of a circular stapling device;

[0022] Figure 2 The handle assembly, adapter assembly, reloading assembly and Figure 1 A perspective view of an anvil of a circular stapling device;

[0023] Figure 3A yes Figure 2 a side perspective exploded view of a reloading assembly;

[0024] Figure 3B is a housing illustrated by a dotted line Figure 2 a rear perspective view of the reloading assembly;

[0025] Figure 4 yes Figure 2 a perspective view of a first seal and a second seal of a reload assembly;

[0026] Figure 5 It is along Figure 3B The line 5-5 is intercepted Figure 2 a rear cross-sectional view of the reloading assembly; and

[0027] Figure 6 It was taken along line 6-6 Figure 1 Side cross-sectional view of the distal portion of a circular stapling device. DETAILED DESCRIPTION

[0028] In this description, the term "proximal" is generally used to refer to that portion of the device that is closer to the clinician, and the term "distal" is generally used to refer to that portion of the device that is farther away from the clinician. Additionally, the term "clinician" is generally used to refer to medical staff, including doctors, nurses, and auxiliary staff.

[0029] Various aspects of the disclosed reloading assembly and stapling device utilizing the disclosed reloading assembly provide one or more seals that prevent fluid from entering the components of the reloading assembly and stapling device. The powered EEA adapter is a reusable device designed to be cleaned and reused in a variety of procedures. Because tissue and fluid can enter the device through the distal opening in the adapter, it is necessary to clean the interior of the adapter before reusing it. To facilitate this cleaning, the adapter's trocar is removed prior to cleaning to allow greater access to the interior of the adapter. This can present challenges in ensuring that the trocar is properly inserted and removed by the clinician.

[0030] This disclosure describes the use of a powered EEA (or other applicable medical device) for incorporating seals during reloading to prevent fluid from entering the device and components of the device including an adapter. One or more seals can combine to form a barrier to prevent body soils from entering the interior of the device.

[0031] According to the present disclosure, the trocar can be fixed to the reloading assembly and not removed therefrom for cleaning. This makes it less dependent on the clinician to assemble and disassemble the device, and reduces costs and the possibility of errors. By placing one or more seals in the reloading assembly, the adapter can be less complex and still allow cleaning of the device in the event of any small amount of dirt passing through the seals.

[0032] Figure 1 and 2 A circular stapling device 10 is illustrated, comprising a handle assembly 12, an elongated body or adapter assembly 14, a reloading assembly 16 removably supported on the adapter assembly 14, and a removably supported handle for reloading the reloading assembly 16 between an open position (not shown) and a clamping position (not shown). Figure 1 ) between the movable anvil assembly 20.

[0033] Reloading assembly 16 includes a proximal portion 16a that can be removably coupled to distal portion 14b of adapter assembly 14, and adapter assembly 14 includes a proximal portion 14a that can be removably coupled to handle assembly 12. Handle assembly 12 includes a fixed handle 22 that supports an actuation button 24 for controlling the operation of various functions of circular stapling device 10, including approximating reloading assembly 16 and anvil assembly 20, firing staples from reloading assembly 16, and tissue cutting or coring.

[0034] The circular stapling device 10 is described as a powered stapling device comprising a powered handle assembly 12 that can support one or more batteries (not shown). An adapter assembly 14 transfers power from the handle assembly 12 to a reload assembly 16 and anvil assembly 20, respectively, to staple and cut tissue. It is contemplated that the disclosed aspects can also be incorporated into stapling devices configured for use with robotic systems that do not include a handle assembly, or into stapling devices that include a manually actuated handle assembly.

[0035] Trocar assembly 50( Figure 2 ) is removably received within distal portion 14b of adapter assembly 14 and is configured to operably engage anvil assembly 20. Trocar assembly 50 includes and the trocar member is slidably disposed relative to housing 52 of group adapter assembly 14.

[0036] Figure 3AAn exploded view of the reloading assembly 16 is illustrated, which includes a housing shell 110, a staple actuator 112, a staple pushing member 112a, a knife carrier 114, an annular knife 116 supported on the knife carrier 114, a staple cartridge 118, and a plurality of staples 120 supported within the staple cartridge 118. The housing shell 110 includes an outer housing portion 121 and an inner housing portion 122, which are spaced apart from each other to define an annular cavity 124 positioned between the outer housing portion 121 and the inner housing portion 122. The inner housing portion 122 supports a sleeve 122a that provides stability to the housing shell 110. The staple actuator 112 and the staple pushing member 112a are movable from a retracted position to an advanced position within the annular cavity 124 of the housing shell 110 to eject staples 120 from the staple cartridge 118, as described in further detail below.

[0037] The staple cartridge 118 is annular and defines an annular array of staple recesses 126. Each staple recess 126 supports a staple 120. The staple actuator 112 and the staple pushing member 112a together define a longitudinal through-hole that receives the blade carriage 114. The staple actuator 112 has a distal portion that abuts a proximal portion of the staple pushing member 112a, such that distal movement of the staple actuator 112 within the housing shell 110 causes distal movement of the staple pushing member 112a within the housing shell 110. The staple pushing member 112a of the reloading assembly 16 has a plurality of fingers 130. Each of the plurality of fingers 130 is received within a corresponding one of the staple recesses 126 of the staple cartridge 118 and is movable through the corresponding staple recess 126 to eject a staple 120 from the staple recess 126 when the staple pushing member 112a moves from a retracted position to an advanced position within the housing shell 110.

[0038] The blade carrier 114 is received within the longitudinal through-bore of the staple actuator 112 and includes a distal body portion 140 and a plurality of spaced-apart, longitudinally extending proximal body portions 142. The distal body portion 140 and the proximal body portions 142 define a stepped central bore having a proximal portion 144a and a distal portion 144b. The proximal portion 144a of the stepped central bore of the blade carrier 114 is received around the inner housing portion 122 of the outer shell 110, allowing the blade carrier 114 to move within the staple actuator 112 around the inner housing portion 122 of the outer shell 110 between a retracted position and an advanced position. The annular blade 116 is coupled to or supported on the distal body portion 140 of the blade carrier 114. The proximal body portion 142 of the blade carrier 114 defines a slot 148 that receives the guide portion 115 of the outer shell 110 to constrain the blade carrier 114 to longitudinal movement within the outer shell 110.

[0039] The housing shell 110 includes a proximal portion 150 that supports a coupling mechanism 152. The coupling mechanism 152 can be used to removably couple the reloading assembly 16 to the stapling device 10 ( Figure 1 ) of the adapter assembly 14 to facilitate replacement of the reloading assembly 16 and reuse of the stapling device 10. The coupling mechanism 152 includes a retaining member 154 and a coupling member 156. The retaining member 154 secures the coupling member 156 to the housing shell 110. The coupling member 156 is received around the proximal portion 150 of the housing shell 110 and is configured to engage the adapter assembly 14 ( Figure 1 ) to couple the adapter assembly 14 to the reload assembly 16. It is contemplated that other types of coupling mechanisms may be used to secure the reload assembly 16 to the distal portion of the adapter assembly 14.

[0040] In certain aspects of the present disclosure, the reloading assembly 16 of the stapling device 10 is designed to be disposable, and the handle assembly 12 and the adapter assembly 14 are designed to be reprocessable or resterilized and reused. Thus, the reloading assembly 16 and the components forming the reloading assembly 16 are formed of materials such as plastic that are less expensive than materials such as stainless steel used to form the handle assembly 12 and / or the adapter assembly 14, but are not as durable as them.

[0041] The housing shell 110 of the reload assembly 16 is molded from a plastic material (e.g., polycarbonate, polyethylene, nylon, etc.) and includes a proximal portion 158 having a tubular extension 158a extending proximally from the outer housing portion 121 of the housing shell 110. The tubular extension 158a defines a proximal portion 158 sized to receive the distal portion 14b (e.g., Figure 2 The coupling mechanism 152 is supported around the tubular extension 158a of the proximal portion 158 of the outer shell 110 and can be used to secure the reload assembly 16 to the adapter assembly 14.

[0042] Figure 3B 、 5 6 illustrate a reloading assembly 16 including a first seal 300 and a second seal 400 configured to prevent fluid from entering components of the reloading assembly 16 and components of the stapling device 10 including the adapter assembly 14 to which the reloading assembly 16 is coupled. As described above, the reloading assembly 16 includes a housing shell 110 defining a cavity 124. The first seal 300 is disposed within the cavity 124 and defines a staple actuator opening 302, a blade holder opening 304, and a central opening 306.

[0043] The staple actuator 112 is disposed within the cavity 124 of the housing shell 110 and is movable relative to the housing shell 110 to eject a plurality of staples 120 from the staple cartridge 118. The staple actuator 112 includes proximally extending legs 113 that extend through staple actuator openings 302 of the first seal 300 such that the first seal provides a fluid seal around each proximally extending leg 113.

[0044] The blade carrier 114 is also disposed within the cavity 124 of the housing shell 110 and is movable relative to the housing shell 110. The blade carrier 114 includes a proximally extending body portion 142 that extends proximally through the blade carrier opening 304 of the first seal 300 to provide a fluid seal therearound.

[0045] like Figure 4 , in various aspects, the first seal 300 can include a plurality of staple actuator openings 302 and a plurality of knife carrier openings 304. Furthermore, in various aspects, one or more of the staple actuator openings 302 and knife carrier openings 304 can be curved along the surface of the first seal 300 to match the curved shape of the proximal legs 113 of the staple actuator 112 and the proximal body portion 142 of the knife carrier 114. As the staple actuator 112 is advanced distally to eject staples 120 from the staple cartridge 118, each proximal leg 113 of the staple actuator 112 slides through a corresponding staple actuator opening 302 of the first seal 300 while maintaining a fluid seal between each proximal leg 113 and the first seal 300. Similarly, as the blade carrier 114 is advanced distally to cut tissue, each proximal body portion 142 of the blade carrier 114 slides through a corresponding blade carrier opening 304 of the first seal 300 while maintaining a fluid seal between each proximal body portion 142 and the first seal 300. In this manner, a fluid seal is maintained between the distal portion of the reload assembly 16 (where tissue, fluid, and other contaminants are present) and the proximal portion of the reload assembly 16 (where the reload assembly 16 is coupled to other components of the surgical stapler 10 (e.g., the adapter assembly 14)).

[0046] As described above, the reloading assembly 16 includes a cannula 122a disposed within the cylindrical cavity 164 defined by the housing shell 110. The cannula 122a is configured to receive the trocar member 54 ( Figure 2). The second seal 400 is operably coupled to the inner annular surface 122b of the cannula 122a such that a fluid seal is formed between the cannula 122a and the cannula needle member 54 when the cannula needle member 54 is positioned therethrough. In one aspect, the second seal 400 is coupled to the inner annular surface 122b of the cannula 122a via an adhesive or glue and / or can be sized to provide a friction fit therein. Additionally or alternatively, a recess or protrusion (not shown) can be defined along the inner annular surface 122b of the cannula 122a, and the second seal 400 can be positioned within the recess or against the protrusion to accommodate longitudinal movement of the second seal 400 within the cannula 122a. Furthermore, a portion of the cannula 122a can be positioned through the central opening 306 of the first seal 300.

[0047] Those 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 contemplated that elements and features illustrated or described in conjunction with one exemplary embodiment may be combined with elements and features of another exemplary embodiment without departing from the scope of the present disclosure. Similarly, those skilled in the art will appreciate other features and advantages of the present disclosure based on the above-described embodiments. Therefore, the present disclosure is not limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims

1. A stapling device comprising: handle assembly; an adapter assembly extending from the handle assembly, the adapter assembly having a distal tip portion; and a reloading assembly supported on the distal end portion of the adapter assembly, the reloading assembly comprising: a housing shell defining a cavity and having a proximal portion and a distal portion; a staple cartridge supported on the distal portion of the housing shell, the staple cartridge supporting a plurality of staples; a first seal disposed within the cavity and defining a staple actuator opening and a knife holder opening; a staple actuator disposed within the cavity of the housing shell and movable relative to the housing shell to eject the plurality of staples from the staple cartridge, the staple actuator including a proximal leg extending through the staple actuator opening of the first seal to provide a fluid seal between the proximal leg and the first seal; and A blade holder is disposed within the cavity of the housing shell and is movable relative to the housing shell, the blade holder including a proximal body portion extending through the blade holder opening of the first seal to provide a fluid seal therebetween. 2 . The stapling device of claim 1 , wherein the staple actuator defines a longitudinal aperture, and the knife head is movable through the longitudinal aperture.

3. The stapling device according to claim 1, wherein the reloading assembly further comprises a knife fixed to the knife holder, and when the knife holder moves, the knife can move together with the knife holder. The stapling device of claim 3 , wherein the knife comprises an annular cutting edge. 5 . The stapling device of claim 1 , further comprising a coupling mechanism adapted to secure the reload assembly to the distal end portion of the adapter assembly.

6. The stapling device of claim 1 , wherein the housing shell defines a cylindrical cavity, the reloading assembly further comprises a cannula disposed within the cylindrical cavity, and the adapter assembly comprises a trocar, the cannula being configured to pass through the trocar in which the adapter assembly is received.

7. The stapling device of claim 6 , wherein the cannula defines an inner annular surface, and the reloading assembly further comprises a second seal received within the inner annular surface of the cannula such that a fluid seal is formed between the cannula and the cannula needle when the cannula needle is positioned through the cannula.

8. The stapling device of claim 6, wherein the first seal defines a central opening, and the sleeve is positioned through the central opening.

9. The stapling device of claim 1 , wherein the proximal leg of the staple actuator defines a curved shape, and the first seal defines a surface, and the staple actuator opening of the first seal is curved along the surface of the first seal to match the curved shape of the proximal leg of the staple actuator.

10. A reloading assembly comprising: a housing shell defining a cavity and having a proximal portion and a distal portion; a staple cartridge supported on the distal portion of the housing shell, the staple cartridge supporting a plurality of staples; a first seal disposed within the cavity and defining a staple actuator opening and a knife holder opening; a staple actuator disposed within the cavity of the housing shell and movable relative to the housing shell to eject the plurality of staples from the staple cartridge, the staple actuator including a proximal leg extending proximally from the staple actuator and through the staple actuator opening of the first seal to provide a fluid seal between the proximal leg and the first seal; and A blade holder is disposed within the cavity of the housing shell and is movable relative to the housing shell, the blade holder including a proximal body portion extending proximally from the blade holder and passing through the blade holder opening of the first seal to provide a fluid seal between the proximal body portion and the first seal.

11. The reload assembly of claim 10, wherein the staple actuator defines a longitudinal aperture and the knife head is movable through the longitudinal aperture.

12. The reload assembly of claim 10, further comprising a knife secured to the knife holder, the knife being movable with the knife holder when the knife holder moves.

13. The reload assembly of claim 12, wherein the knife comprises an annular cutting edge.

14. The reload assembly of claim 10, wherein the housing shell defines a cylindrical cavity, the reload assembly further comprising a cannula disposed within the cylindrical cavity, the cannula configured to pass through a trocar receiving an adapter assembly therein.

15. The reloading assembly of claim 14, wherein the cannula defines an inner annular surface, and the reloading assembly further comprises a second seal received within the inner annular surface of the cannula such that a fluid seal is formed between the cannula and the cannula needle when the cannula needle is positioned through the cannula.

16. The reload assembly of claim 14, wherein the first seal defines a central opening and the sleeve is positioned through the central opening.

17. A reloading assembly according to claim 10, wherein the proximal leg of the nail actuator defines a curved shape and the first seal defines a surface, and the nail actuator opening of the first seal is curved along the surface of the first seal to match the curved shape of the proximal leg of the nail actuator.

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