# Patent

## Title
Staple reload assembly with releasable knife

## Abstract

A surgical stapling device includes an anvil assembly and a reload assembly that includes a knife and a knife carrier. The knife is releasably coupled to the knife carrier and is embedded in a cut ring of the anvil assembly when the stapling device is fired. The knife is separable from the knife carrier upon application of a predetermined force on the knife. The predetermined force is applied to the knife after the stapling device is fired by moving the anvil assembly in relation to the reload assembly from a clamped position to an open position.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 62/981,636 filed Feb. 26, 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 circular surgical stapling devices that include a knife to cut tissue.
BACKGROUND
Circular stapling devices typically 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.
During an anastomosis procedure, two tubular sections of tissue are attached to one another and the tissues within the tubular sections are cored with the knife to define a hollow passage between the joined tubular sections. Generally, a tissue donut remains within the annular knife of the reload assembly after the tissue sections have been cut. When the reload assembly is removed from a patient, the tissue donut is removed from within the annular knife by the clinician.
After a circular stapling device is actuated to cut tissue during an anastomosis procedure, the knife is moved from an advanced position in which a cutting edge of the annular knife is exposed to a retracted position in which the cutting edge of the knife is recessed within the staple cartridge of the reload assembly and shielded. During removal of the tissue donut from within the annular knife, the cutting edge of the knife is pulled in a distal direction which may inadvertently expose the cutting edge of the knife. Exposure of the cutting edge of the knife presents a danger to the clinician handling the stapling device.
SUMMARY
The techniques of this disclosure generally relate to circular stapling devices having a knife to cut tissue. In aspects of the disclosure, the surgical stapling device includes an anvil assembly and a reload assembly that includes a knife and a knife carrier. The knife is releasably coupled to the knife carrier and is embedded in a cut ring of the anvil assembly when the stapling device is fired. The knife is separable from the knife carrier upon application of a predetermined force on the knife. The predetermined force is applied to the knife after the stapling device is fired by moving the anvil assembly in relation to the reload assembly from a clamped position to an open position.
One aspect of the disclosure is directed to a reload assembly including a shell housing, a staple cartridge, a staple pushing member, a knife carrier, and a knife. The shell housing defines a cavity and has a proximal portion and a distal portion. The staple cartridge is supported on the distal portion of the shell housing and supports a plurality of staples. The staple pushing member is movable within the shell housing between an advanced position and a retracted position to eject the plurality of staples from the staple cartridge. The staple pushing member defines a longitudinal bore. The knife carrier is supported within the longitudinal bore of the staple pushing member and has a distal portion defining a first engagement portion. The knife carrier is movable between retracted and advanced positions within the shell housing. The knife has a proximal portion and a distal portion. The proximal portion defines a second engagement portion that is coupled to the first engagement portion to releasably secure the knife to the knife carrier. The knife can be uncoupled from the first engagement portion of the knife carrier upon application of a predetermined force to the knife in a distal direction.
In aspects of the disclosure, the knife is annular.
In some aspects of the disclosure, the first engagement portion is defined by a plurality of resilient fingers formed on the distal portion of the knife carrier.
In certain aspects of the disclosure, each of plurality of resilient fingers defines a concave surface to define an annular recess about the distal portion of the knife carrier.
In aspects of the disclosure, the second engagement portion is formed on the proximal portion of the knife and includes an annular convex portion that is received within the annular recess defined by the plurality of resilient fingers of the knife carrier to releasably secure the knife to the knife carrier.
In aspects of the disclosure, the second engagement portion is formed on the proximal portion of the knife by inverting the proximal portion of the knife.
Another aspect of the disclosure is directed to a stapling device including an adaptor assembly, a reload assembly, and an anvil assembly. The adaptor assembly has a distal end portion. The reload assembly is secured to the distal end portion of the adaptor assembly and includes a shell housing, a staple cartridge assembly, a staple pushing member, a knife carrier, and a knife. The shell housing defines a cavity and has a proximal portion and a distal portion. The staple cartridge is supported on the distal portion of the shell housing and supports a plurality of staples. The staple pushing member is movable within the shell housing between an advanced position and a retracted position to eject the plurality of staples from the staple cartridge. The staple pushing member defines a longitudinal bore. The knife carrier is supported within the longitudinal bore of the staple pushing member and has a distal portion defining a first engagement portion. The knife carrier is movable between retracted and advanced positions within the shell housing. The knife has a proximal portion and a distal portion. The distal portion defines a cutting edge. The proximal portion defines a second engagement portion that is coupled to the first engagement portion to releasably secure the knife to the knife carrier. The knife can be uncoupled from the first engagement portion of the knife carrier upon application of a predetermined force to the knife in a distal direction. The anvil assembly is movable in relation to the staple cartridge between an open position and a clamped position and includes a cut ring formed of a material penetrable by the knife. The knife is embedded in the cut ring when the stapling device is fired and is separated from the knife carrier after the stapling device is fired upon movement of the anvil assembly from the clamped position to the open position.
Another aspect of the disclosure is directed to a knife assembly including a knife carrier and a knife. The knife carrier has a distal portion defining a first engagement portion. The knife has a proximal portion and a distal portion. The distal portion defines a cutting edge. The proximal portion defines a second engagement portion that is coupled to the first engagement portion to releasably secure the knife to the knife carrier. The knife can be uncoupled from the first engagement portion of the knife carrier upon application of a predetermined force to the knife.
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 and features of the disclosure are described with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views and:
FIG. 1 is a side perspective view of a surgical stapling device including a tool assembly having a reload assembly in accordance with aspects of the disclosure;
FIG. 2 is an enlarged view of a distal portion of the surgical stapling device shown in FIG. 1 with an anvil assembly removed;
FIG. 3 is a side perspective exploded view of the reload assembly of the surgical stapling device of FIG. 1;
FIG. 4 is an enlarged view of the indicated area of detail shown in FIG. 3;
FIG. 5 is a side perspective view of the knife carrier and annular knife of the surgical stapling device shown in FIG. 3
FIG. 6 is a cross-sectional view taken along section line 6-6 of FIG. 4 with the annular knife separated from the knife carrier;
FIG. 7 is a cross-sectional cutaway view through a distal portion of the knife carrier and the annular knife as the annular knife is moved into engagement with the knife carrier;
FIG. 8 is a cross-sectional cutaway view through the distal portion of the knife carrier and the annular knife with the annular knife engaged with the knife carrier;
FIG. 9 is a cross-sectional view through the distal portion of the knife carrier and the annular knife with the annular knife engaged with the knife carrier;
FIG. 10 is a cross-sectional view taken along section line 10-10 of FIG. 2 with the surgical stapling device in a clamped position;
FIG. 11 is a cross-sectional view taken along section line 11-11 of FIG. 2 with the surgical stapling device in a clamped and fired position;
FIG. 12 is a cross-sectional view taken along section line 11-11 of FIG. 2 with the surgical stapling device in the fired position as the surgical stapling device is moved towards an unclamped position;
FIG. 13 is a cross-sectional view taken along section line 11-11 of FIG. 2 after the surgical stapling device is fired as the surgical stapling device is moved to an unclamped position and the annular knife is separated from the knife carrier;
FIG. 14 is a cross-sectional view of the distal portion of the surgical stapling device shown in FIG. 1 with the surgical stapling device in the fired, unclamped position, an anvil assembly in a tilted position, and the annular knife separated from the knife carrier; and
FIG. 15 is a side perspective view of the distal portion of the surgical stapling device shown in FIG. 14 with the surgical stapling device in the unclamped, fired position and the annular knife separated from the knife carrier.



DETAILED DESCRIPTION
The disclosed surgical stapling device including a reload assembly including various aspects of the disclosure 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 disclosed aspects 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 addition, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.
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.
This disclosure is directed to a circular surgical stapling device that includes a reload assembly having a knife carrier that is releasably coupled to a knife having a cutting edge and can be separated from the knife carrier upon application of a predetermined force to the knife. The knife is positioned to engage and penetrate a cut ring assembly on an anvil assembly of the stapling device when the stapling device is fired. Engagement of the knife with the cut ring assembly is sufficient to disengage the knife from the knife carrier when the knife carrier returned to a retracted position after the stapling device has been fired. When the knife disengages from the knife carrier, a cutting edge of the knife is embedded in the cut ring assembly to shield the cutting edge of the knife from a clinician.
FIG. 1 illustrates a circular stapling device 10 including a reload assembly in accordance with aspects of the disclosure shown generally as a reload assembly 100. The circular stapling device 10 includes a handle or actuator assembly 12, an elongate body or adaptor assembly 14, the reload assembly 100, and an anvil assembly 18 that is supported for movement in relation to the reload assembly 100 between an unclamped position and a clamped position (FIG. 10). In aspects of the disclosure, the reload assembly 100 includes a proximal portion 102 that is releasably coupled to a distal portion of the adaptor assembly 14 and the adaptor assembly 14 includes a proximal portion that is releasably coupled to the handle assembly 12. Alternately, it is envisioned that the reload assembly 100 can be fixedly secured to the adaptor assembly 14 and/or the adaptor assembly can be fixedly secured to the handle assembly 12. The handle assembly 12 includes a body 22 that defines a stationary hand grip 22a that supports actuation buttons 24 for controlling operation of various functions of the circular stapling device 10 including approximation of the reload assembly 100 and anvil assembly 18, firing of staples from the reload assembly 100, and cutting or coring of tissue as described in further detail below.
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 14 translates power from the handle assembly 12 to the reload and anvil assemblies 100, 18, respectively, to staple and cut tissue. Examples of electrically powered stapling devices can be found in U.S. Pat. Nos. 9,055,943, 9,023,014, and U.S. Publication Nos. 2018/0125495, and 2017/0340351. Alternately, it is envisioned that aspects of the reload assembly 100 disclosed herein could also be incorporated into a manually powered stapling device such as disclosed in, e.g., U.S. Pat. No. 7,303,106 (the '106 Patent), or a stapling device that is configured for use with a robotic system as disclosed in, e.g., U.S. Pat. No. 9,962,159, that does not include a handle assembly.
FIGS. 2 and 3 illustrate the reload assembly 100 which includes a shell housing 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 shell housing 110 includes an outer housing portion 121 and an inner housing portion 122 that are spaced from each other to define an annular cavity 124. The staple actuator 112 and the staple pushing member 112a are movable within the annular cavity 124 of the shell housing 110 from a retracted position to an advanced position to eject the staples 120 from the staple cartridge 118.
The staple cartridge 118 is annular and defines annular rows of staple pockets 126. Each of the staple pockets 126 supports one of the staples 120. The staple actuator 112 and the staple pushing member 112a define a longitudinal through bore 128 (FIG. 10) that receives the knife carrier 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 shell housing 110 causes distal movement of the staple pushing member 112a within the shell housing 110. The staple pushing member 112a of the reload assembly 100 has a plurality of fingers 130 (FIG. 3). Each of the plurality of fingers 130 is received within a respective one of the staple pockets 126 of the staple cartridge 118 and is movable through the respective staple pocket 126 to eject the staples 120 from the staple pockets 126 when the staple pushing member 112a is moved from a retracted position (FIG. 10) to an advanced position (FIG. 11) within the shell housing 110.
The knife carrier 114 is received within the longitudinal through bore 128 of the staple actuator 112 and includes a distal portion 140 and a plurality of spaced longitudinally extending proximal portions 142 (FIG. 3). The distal portion 140 and the proximal portions 142 define a stepped central bore that receives the inner housing portion 122 (FIG. 3) of the shell housing 110 such that the knife carrier 114 is movable within the staple actuator 112 about the inner housing portion 122 of the shell housing 110 between a retracted position (FIG. 10) and an advanced position (FIG. 11). The proximal portions 142 of the knife carrier 114 defines slots 148 that receive guide portions 110a of the shell housing 110 to limit the knife carrier 114 to longitudinal movement within the shell housing 110.
The shell housing 110 includes a proximal portion 158 that supports a coupling mechanism 160 (FIG. 3) that releasably couples the reload assembly 100 to the adaptor assembly 14 of the stapling device 10 (FIG. 1) to facilitate replacement of the reload assembly 100 and reuse of the stapling device 10. The coupling mechanism 160 includes a retaining member 162 and a coupling member 164. The retaining member 162 secures the coupling member 164 about the proximal portion 158 of the shell housing 110. The coupling member 164 is received about the proximal portion 158 of the shell housing 110 and engages the distal portion 14a (FIG. 1) of the adaptor assembly 14 to couple the adaptor assembly 14 to the reload assembly 100. It is envisioned that other coupling mechanisms can be used to secure the reload assembly 100 to the adaptor 14.
FIGS. 4-6 illustrate the distal portion 140 of the knife carrier 114 and the annular knife 116 of the reload assembly 100. The distal portion 140 of the knife carrier 114 is substantially cylindrical and includes an area of reduced diameter 170. In aspects of the disclosure, the area of reduced diameter 170 is defined in part by a plurality of resilient fingers or detents 172. Each of the plurality of resilient fingers 172 includes an engagement portion 174 that releasably engages the annular knife 116 to secure the annular knife 116 to the knife carrier 114. In certain aspects of the disclosure, the engagement portion 174 of each of the resilient fingers 172 defines an outwardly facing concave surface 174a such that the area of reduced diameter 170 on the distal portion 140 of the knife carrier 114 defines an annular recess.
The annular knife 116 includes a body 180 that has an annular cutting edge 182 at its distal end and an engagement portion 184 on its proximal end portion. In aspects of the disclosure, the engagement portion 184 on the proximal end of the annular knife 116 includes an annular or substantially annular convex portion 186 (FIG. 6) that is received within the annular recess defined by the engagement portion 174 of the resilient fingers 172 to releasably secure the annular knife 116 to the distal portion 140 of the knife carrier 114. In certain aspects of the disclosure, the engagement portion 184 on the proximal end portion of the annular knife 116 is formed by curling or inverting the proximal end portion of the annular knife 116 inwardly upon itself.
FIGS. 7-9 illustrate the annular knife 116 as the annular knife 116 is coupled to the distal portion 140 of the knife carrier 114. In order to couple the annular knife 116 to the knife carrier 114, the proximal end portion of the annular knife 116 is aligned with the distal portion 140 of the knife carrier 114 and the annular knife 116 is moved in the direction indicated by arrow “A” in FIG. 7 towards the knife carrier 114. When the engagement portion 184 on the proximal end portion of the annular knife 116 engages the resilient fingers 172 on the distal portion 184 of the knife carrier 114, the resilient fingers 172 are deformed inwardly in the direction indicated by arrow “B” in FIG. 7 to allow the engagement portion 184 on the proximal end of the annular knife 116 to pass over the resilient fingers 172 and into the annular recess defined by the concave surfaces 174a of the resilient fingers 172. When the engagement portion 184 of the annular knife 116 passes over the resilient fingers 172 and into the annular recess defined by the resilient fingers 172, the resilient fingers 172 return to their non-deformed positions in the direction of arrow “C” in FIG. 8 to retain the annular knife 116 on the distal portion of the knife carrier 114. The annular knife 116 will remain on the distal portion of the knife carrier 114 until a pre-determined force is applied to the annular knife 116 sufficient to disengage the engagement portion 184 on the proximal end of the annular knife 116 from within the annular recess defined by the concave surfaces 174a of the resilient fingers 172. The pre-determined force can be set to a desirable level by selecting a material used to form fingers 172 of the knife carrier 114 having the appropriate resilience and/or thickness.
It is envisioned that the engagement portions of the knife carrier 114 and the annular knife 116 may have a variety of different configurations not shown here that function to releasably couple the annular knife 116 with the knife carrier 114. It is also envisioned that the engagement portions of the annular knife 116 and the knife carrier 114 can be configured to interlock, operate via friction, and/or fracture.
FIG. 10 illustrates the reload assembly 100 and the anvil assembly 18 of the stapling device 10 in the clamped, non-fired position with the staple actuator 112, the stapling pushing member 112a, the knife carrier 114, and the annular knife 116 in their retracted positions and the anvil assembly 18 in juxtaposed alignment with the staple cartridge 118. In this position, the annular cutting edge 182 is recessed within the staple cartridge 118.
As illustrated, the anvil assembly 18 includes an anvil head 30 that is pivotably supported on a center rod 32. The anvil head 30 can pivot on the center rod 32 from an operative position (FIG. 10) to a tilted or reduced profile position (FIG. 14). For a description of the operation of exemplary aspects of an anvil assembly including a tiltable anvil head, see the '106 Patent. The anvil head 30 supports a cut ring assembly 40 that includes a cut ring 42 that is aligned with the cutting edge 182 of the knife 116. The cut ring 42 is formed of a material that can be penetrated by the cutting edge 182 of the knife 116 when the knife 116 is advanced into the cut ring 42 as the stapling device 10 (FIG. 1) is fired.
FIG. 11 illustrates the reload assembly 100 and anvil assembly 18 of the stapling device 10 in the clamped and fired position. In this position, the staple actuator 112 and the stapling pushing member 112a have moved in the direction indicated by arrows “D” to an advanced position to eject the staples 120 from the staple cartridge 118 into the anvil head 30. In addition, the knife carrier 114 and the annular knife 116 which is coupled to the distal portion 140 of the knife carrier 114 have moved in the direction of arrows “E” to their advanced positions to advance the cutting edge 182 of the annular knife 116 into a cut ring 42 of the anvil assembly 18. In this position, the distal portion of the annular knife 116 is embedded in the cut ring 42 of the anvil assembly 18.
FIGS. 12 and 13 illustrate the reload assembly 100 and anvil assembly 18 of the stapling device 10 in the fired position as the anvil assembly 18 is moved from a clamped position in which the anvil head 30 is in juxtaposed alignment with the staple cartridge 118 towards an open position in which the anvil head 30 is spaced from the staple cartridge 118. In this position, the anvil assembly 18 is moved in the direction of arrows “F” away from the knife carrier 114. Since the annular knife 116 is embedded in the cut ring 42 of the anvil head 30, movement of the anvil head 30 in the direction of arrows “F” will move the knife carrier 114 in the direction of arrows “G” as shown in FIG. 12. When the knife carrier 114 is restricted from any further distal movement within the shell housing 110, further distal movement of the anvil head 30 in relation to the knife carrier 114 in the direction of arrows “H” in FIG. 13 will cause the engagement portion 184 on the proximal portion of the annular knife 116 to apply a force on the resilient fingers 172 on the distal end of the knife carrier 114 to disengage the annular knife 116 from the knife carrier 114. The cutting edge 182 of the annular knife 116 will remain embedded in the cut ring 42 of the cut ring assembly 40 in the anvil head 30 of the anvil assembly 18 to safely shield the clinician from the cutting edge 182 of the annular knife 116.
FIGS. 14 and 15 illustrate the reload assembly 100 and the anvil assembly 18 of the stapling device 10 with the anvil head 30 of the anvil assembly 18 in the tilted position and the annular knife 116 embedded in the cut ring 42 of the cut ring assembly 40 of the anvil assembly 18. The anvil head 30 is urged to the tilted position by a biasing mechanism 50 supported within the center rod 32 of the anvil assembly 18. For a detailed description of exemplary aspects of the biasing mechanism 50, see, e.g., the '106 patent.
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

1. A reload assembly comprising:
a shell housing defining a cavity and having a proximal portion and a distal portion;
a staple cartridge supported on the distal portion of the shell housing, the staple cartridge supporting a plurality of staples;
a staple pushing member movable within the shell housing between an advanced position and a retracted position to eject the plurality of staples from the staple cartridge, the staple pushing member defining a longitudinal bore;
a knife carrier supported within the longitudinal bore of the staple pushing member, the knife carrier having a distal portion defining a first engagement portion including a plurality of resilient fingers formed on the distal portion of the knife carrier, each of plurality of resilient fingers having a concave surface to define an annular recess about the distal portion of the knife carrier, the knife carrier movable between retracted and advanced positions within the shell housing; and
a knife having a proximal portion and a distal portion, the proximal portion defining a second engagement portion that is coupled to the first engagement portion to releasably secure the knife to the knife carrier, wherein one of the first engagement portion or the second engagement portion is formed of a resilient material such that the knife can be uncoupled from the first engagement portion of the knife carrier upon application of a predetermined force to the knife in a distal direction,
wherein the second engagement portion formed on the proximal portion of the knife includes an annular convex portion that is received within the annular recess defined by the plurality of resilient fingers of the knife carrier to releasably secure the knife to the knife carrier, the resilient fingers flexing outwardly upon application of the predetermined force to the knife to facilitate release of the knife from the knife carrier, and wherein the second engagement portion is formed on the proximal portion of the knife by inverting the proximal portion of the knife.

2. The stapling device of claim 1, wherein the anvil assembly includes an anvil head and a center rod, the anvil head pivotably coupled to the center rod and movable from an operative position to a tilted position.

3. A knife assembly comprising:
a knife carrier having a distal portion defining a first engagement portion defined by a plurality of resilient fingers formed on the distal portion of the knife carrier, each of the plurality of resilient fingers having a concave surface to define an annular recess about the distal portion of the knife carrier; and
an annular knife having a proximal portion and a distal portion, the distal portion defining a cutting edge, the proximal portion defining a second engagement portion that is coupled to the first engagement portion to releasably secure the knife to the knife carrier, one of the first or second engagement portions formed of a resilient material that is deformable to allow the first engagement portion to separate from the first engagement portion, wherein the knife can be uncoupled from the first engagement portion of the knife carrier upon application of a predetermined force to the knife,
wherein the second engagement portion formed on the proximal portion of the knife includes an annular convex portion that is received within the annular recess defined by the plurality of resilient fingers of the knife carrier to releasably secure the knife to the knife carrier, the resilient fingers deforming outwardly upon application of the predetermined force to the knife to facilitate release of the knife from the knife carrier, and wherein the second engagement portion is formed on the proximal portion of the knife by inverting the proximal portion of the knife.