# Patent

## Title
Surgical stapling instrument

## Abstract

A surgical stapling instrument comprising a handle assembly having a proximal end, an elongated body portion extending distally from the handle assembly, a head portion disposed adjacent a distal portion of the elongated body portion and including an anvil assembly and a shell assembly. The shell assembly includes a shell and a staple guide housing a plurality of staples. A flexible engagement structure attaches the staple guide to the shell.

## Background
This application claims priority from provisional application Ser. No. 61/255,544, filed Oct. 28, 2009, the entire contents of which are incorporated herein by reference.


BACKGROUND
1. Technical Field
The present disclosure relates generally to a surgical stapling device for applying surgical staples to body tissue. More particularly, the present disclosure relates to a surgical stapling device suitable for performing circular anastomosis and/or treatment to internal walls of hollow tissue organs.
2. Background of Related Art
Anastomosis is the surgical joining of separate hollow organ sections. Typically, an anastomosis procedure follows surgery in which a diseased or defective section of hollow tissue is removed and the remaining end sections are to be joined. Depending on the desired anastomosis procedure, the end sections may be joined by either circular, end-to-end or side-to-side organ reconstruction methods.
In a circular anastomosis procedure, the two ends of the organ sections are joined by means of a stapling instrument which drives a circular array of staples through the end section of each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free the tubular passage. Examples of instruments for performing circular anastomosis of hollow organs are described in U.S. Pat. Nos. 7,303,106 6,945,444, 6,053,390, 5,588,579, 5,119,983, 5,005,749, 4,646,745, 4,576,167, and 4,473,077. Typically, these instruments include an elongated shaft having a handle portion at a proximal end to actuate the instrument and a staple holding component disposed at a distal end. An anvil assembly including an anvil rod with attached anvil head is mounted to the distal end of the instrument adjacent the staple holding component. Opposed end portions of tissue of the hollow organ(s) to be stapled are clamped between the anvil head and the staple holding component. The clamped tissue is stapled by driving one or more staples from the staple holding component so that the ends of the staples pass through the tissue and are deformed by the anvil. An annular knife is concurrently advanced to core tissue within the hollow organ to free a tubular passage within the organ.
Besides anastomosis of hollow organs, surgical stapling devices for performing circular anastomosis have been used to treat internal hemorrhoids in the rectum. Typically, during use of a circular stapling device for hemorrhoid treatment, the anvil head and the staple holding component of the surgical stapling device are inserted through the anus and into the rectum with the anvil head and the staple holding component in an open or unapproximated position. Thereafter, a pursestring suture is used to pull the internal hemorrhoidal tissue towards the anvil rod. Next, the anvil head and the staple holding component are approximated to clamp the hemorrhoid tissue between the anvil head and the staple holding component. The stapling device is fired to remove the hemorrhoidal tissue and staple the cut tissue. In hemorrhoidectomy, the hemorrhoids are removed. Stapled hemorrhoidopexy is a surgical procedure in which the stapling device is used to remove tissue just above the hemorrhoids in order to pull the hemorrhoids back up inside the rectum and reduce the symptoms. The staples interrupt the blood flow of the superior hemorrhoidal arterial branches, cutting off the blood supply to the tissue, thus causing the hemorrhoids to shrink.
Several known circular staplers have a shell assembly which contains a stapler pusher and a staple guide which houses a plurality of staples in a plurality of annular rows. The staple guide in certain of these instruments is ultrasonically welded to the shell assembly. Although effective, alternative attachment methods could be advantageous from a securement and a manufacturing standpoint.
SUMMARY
The present disclosure provides in one aspect a surgical stapling instrument including a handle assembly, an elongated body portion, and a head portion. The head portion is disposed adjacent a distal portion of the elongated body portion and includes an anvil assembly and a shell assembly. The shell assembly includes a shell and a staple guide housing a plurality of staples. A flexible engagement structure attaches the staple guide to the shell.
In one embodiment, the flexible engagement structure includes at least one hook on the staple guide. The shell can include a locking aperture configured and dimensioned to receive the hook of the staple guide.
In another embodiment, the flexible engagement structure includes a flexible tab on the shell. The flexible tab can include an aperture to receive a hook on the staple guide. The hook can be substantially rigid.
In another embodiment, the shell assembly includes a plurality of projections extending distally to apply a distal force to the staple guide. The projections can be compressible by the staple guide.
The present disclosure provides in another aspect a surgical stapling instrument comprising a handle assembly including a movable handle for actuating the stapler, an elongated body portion extending distally from the handle assembly, and a head portion disposed adjacent a distal portion of the elongated body portion and including an anvil assembly and a shell assembly. The shell assembly includes a shell and a staple guide housing a plurality of staples. The staple guide includes a tab and the shell assembly includes a slotted region having a first slotted portion and a second slotted portion angled with respect to the first slotted portion. The tab is movable within the slotted region to attach the staple guide and shell assembly.
In one embodiment, the first slotted region extends substantially axially and the second slotted region extends substantially radially. In one embodiment, the second slotted region has a reduced diameter section having a dimension smaller than an outer dimension of the tab.



DESCRIPTION OF THE DRAWINGS
Various embodiment of the presently disclosed surgical stapling device are disclosed herein with reference to the drawings, wherein:
FIG. 1 is a perspective view of an embodiment of the presently disclosed surgical stapling instrument in an approximated position;
FIG. 2 is an exploded view of the shell assembly of the stapling instrument of FIG. 1;
FIG. 3 is an enlarged view of the staple guide of FIG. 2;
FIG. 4 is an enlarged view of the area of detail designated in FIG. 3 illustrating the flexible hook of the staple guide;
FIG. 5 is an enlarged view of the shell of FIGS. 1 and 2;
FIG. 6 is an enlarged view of the area of detail designated in FIG. 5 showing the ramp and locking aperture;
FIG. 7 is a side perspective view of the shell assembly of FIG. 2;
FIG. 8 is a sectional view of the shell assembly of FIG. 7 taken along lines 8-8 of FIG. 7;
FIG. 9 is a close up view in cross section of the area of detail designated in FIG. 8 showing engagement of the flexible hook of the staple guide with the locking aperture of the shell;
FIG. 10 is a cross sectional view of the shell assembly prior to attachment of the staple guide showing flexure of the flexible hook;
FIG. 11 is a close up view in cross section of the area of detail designated in FIG. 10;
FIG. 12 is a close up view similar to FIG. 11 showing engagement of the staple guide and shell in final assembly;
FIG. 13 is an exploded view of a shell assembly and staple guide of an alternate embodiment of the present disclosure;
FIG. 14 is a close up view of the area of detail designated in FIG. 13 showing the rigid hook of the staple guide;
FIG. 15 is a close up view of the area of detail designated in FIG. 13 showing the engagement tab of the shell;
FIG. 16 is a close up cross-sectional view showing initial engagement of the staple guide and shell of FIG. 13 causing flexure of the hook;
FIG. 17 is a close up cross-sectional view similar to FIG. 16 showing engagement of the staple guide and shell in final assembly;
FIG. 18 is an exploded view of a shell and staple guide of another alternate embodiment of the present disclosure;
FIG. 19 is a close up view of the area of detail designated in FIG. 18 showing the hook of the staple guide;
FIG. 20 is a close up cross-sectional view taken along 20-20 of FIG. 19 showing the engagement of the staple guide and shell in the final assembly;
FIG. 21 is an exploded view of a shell and staple guide of another alternate embodiment of the present disclosure;
FIG. 22 is a close up view of the area of detail designated in FIG. 21;
FIG. 23 is a close up view showing initial engagement of the locking tab of the staple guide of FIG. 21 in the slot of the shell;
FIG. 24 is a close up view of the locking tab of FIG. 23 moving radially in the slot of the shell;
FIG. 25 is a cross sectional view taken along line 25-25 of FIG. 24;
FIG. 26 is a close up view of the locking tab of FIG. 23 in the locking position within the slot of the shell; and
FIG. 27 is a cross sectional view taken along line 27-27 of FIG. 26.



DETAILED DESCRIPTION OF EMBODIMENTS
Embodiments of the presently disclosed surgical stapling instrument 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.
Throughout this description, the term “proximal” will refer to the portion of the instrument closer to the operator and the term “distal” will refer to the portion of the instrument further from the operator.
With initial reference to FIG. 1, an embodiment of the presently disclosed surgical stapling device is shown generally as reference number 10. Briefly, surgical stapling device 10 includes a handle assembly 12, an elongated body portion 14 including a curved elongated outer tube 15 extending from handle assembly 12, and a head portion 16 extending from outer tube 15. Alternately, in some surgical procedures, e.g., the treatment of hemorrhoids, the body portion can be substantially straight. The length, shape and/or the diameter of body portion 14 and head portion 16 may also be varied to suit a particular surgical procedure.
In the illustrated embodiments, handle assembly 12 includes a stationary handle 18, a firing trigger 20, a rotatable approximation knob 22 and an indicator 24. Head portion 16 includes an anvil assembly 30 and a shell assembly 31. Anvil assembly 30 is movable in relation to shell assembly 31 between spaced (unapproximated) and approximated positions. Anvil assembly includes an anvil shaft mounted (preferably removably mounted) to an anvil retainer of the surgical stapling instrument 10.
In operation, rotation of approximation knob 22 causes movement of anvil assembly 30 in relation to shell assembly 31 between spaced and approximated positions, as approximation knob 22 is mechanically engaged with an anvil retainer via bands which is connected to anvil assembly 30. It is envisioned that rotation of approximation knob 22 in a first direction (e.g., clockwise) causes proximal movement of anvil assembly 30 to an approximated position to clamp tissue between the anvil and shell assemblies and rotation of approximation knob 22 in a second opposite direction (e.g., counter-clockwise) causes distal movement of anvil assembly 30 to an unapproximated position.
Actuation of firing trigger 20 (i.e., pivoting in the direction toward the stationary handle 18), causes staples to be ejected from shell assembly 31 towards anvil assembly 30. That is, firing trigger 20 is disposed in mechanical cooperation with a staple pusher or pusher back 50 (FIG. 2) such that actuation of firing trigger 20 causes advancement of pusher 50 through the staple guide 60 and into contact with the staples 70 housed in an annular array(s) in staple guide 60. This forces the staples 70 out of staple pockets or slots 33 into staple deforming pockets of anvil assembly 30. Pusher 50 includes a plurality of distally extending pusher fingers 52 which contact the staples 70 to advance them into contact with the anvil. A circular knife 74 is frictionally retained with the central throughbore 51 of pusher back 50 to fixedly secure knife 74 in relation to pusher back 50. Knife 74 is advanceable with the pusher back 50 to sever tissue between the annular rows of staples 70. Throughbore 51 is slidably positioned about inner guide portion 35 of shell 31. Distal cylindrical section 53 of pusher 50 is slidably positioned within distal cylindrical section 34 of shell 31. The proximal end of pusher back 50 includes members 55 which are configured to lockingly engage with a pusher link (not shown). Shell 31 can also include vent holes 32.
Further details of the features of surgical stapling device 10, such as the approximation assembly and firing assembly, are disclosed in commonly-owned U.S. Pat. Nos. 7,303,106, 7,234,624 and 7,168,604, the entire contents of which are incorporated by reference herein.
FIGS. 2-12 illustrate a first embodiment of the flexible engagement structure for attaching the staple guide 60 to the shell assembly 31. With initial reference to FIGS. 3 and 4, a flexible hook 80 on an outer surface of staple guide 60 extends in a proximal direction, preferably terminating at the proximal end of staple guide 60. The hook 80 is proximal of flange 61 of staple guide 60. The hook can be substantially flush with the outer surface 63 of staple guide 60. Hook 80 has an angled proximal surface 82, angled with respect to a longitudinal or axial region 89 extending from the staple guide 60. The hook 80 is preferably formed integrally with the staple guide 60, however, alternatively, it could be a separate element(s) attached to the staple guide 60. Two or more hooks are preferably provided to engage at spaced regions along the shell 31. For example two hooks can be placed approximately 180 degrees apart, three hooks at approximately 120 degrees apart, etc. The illustrated embodiment shows four hooks 80 spaced approximately 90 degrees apart. Other spacings, including non-equidistant spacings of the hooks, are also contemplated.
Referring to FIGS. 5, 6 and 9, shell assembly 31 includes locking apertures 36, preferably spaced slightly proximally from the distal edge 31a of shell 31, each configured and dimensioned to receive a hook 80. Angled wall or ramp 37 on the inner wall of the shell 31 facilitates hook engagement as described below.
As can be appreciated by viewing FIGS. 10-12, during assembly when staple guide 60 is attached to the shell assembly 31 by placement in a direction of arrow A, each hook 80 initially flexes radially inwardly (downwardly in the orientation of FIG. 10) in the direction of arrow B as the surface of angled wall 37 of shell 31 is engaged by angled surface 82 of the hook 80 of staple guide 60. Upon sufficient distal advancement in manufacture in the direction of arrow A, the proximal end of hook 80 passes beyond angled surface 37 and beyond wall 38 and then being no longer biased radially inwardly (downwardly in the view of FIG. 11), can move radially outwardly (upwardly) in the direction of arrow C to its normal unstressed condition to extend within locking aperture 36. As shown, in this position, the engagement of shoulder 84 of hook 80 with wall surface 37a prevents distal movement of the staple guide 60 to retain it in position secured to the shell 31 (see also FIG. 9). As can be appreciated, wall surface 37a is part of shell 31 and is defined by aperture 36. During use, a distal force applied to the staple guide during manipulation of the instrument or firing of the staples will not dislodge the staple guide 60 from the shell assembly 31 since distal movement is prohibited by wall 37a. Each of the hooks 80 engages a corresponding locking aperture 36 in the same manner as described above. Note that preferably the hook 80 does not extend beyond the outer confines (outer diameter) of the aperture 36 so as to not extend past the outer surface 39 of shell 31.
In the alternate embodiment illustrated in FIGS. 13-17, a rigid hook is utilized. Shell 110 is identical to shell 31 of FIG. 2 except for the structure cooperating with the hooks of the staple guide. More specifically, shell 110 has a flexible tab 120 formed by cutouts 122, 124 in the distal end 112 of the shell 110. The flexible tab 120 has a locking aperture 126 formed therein. Staple guide 140 is identical to staple guide 60 of FIG. 2 except for the hook configuration. More specifically, staple guide 140 has a hook 142 formed thereon, which is preferably substantially rigid. As shown, the hook 142 extends proximally from staple guide 140 and at its proximal end has an angled proximal surface 144 and vertical surface 147 substantially perpendicular to a longitudinal axis of staple guide 140. A longitudinal or axial region 145 extends distally. A plurality of tabs 120 are provided in shell 110, each dimensioned and configured to receive a hook 142.
As can be appreciated by viewing FIGS. 16 and 17, when staple guide 140 is attached during assembly to the shell assembly 110 by placement in a direction of arrow D, the tab 120 of the shell 110 initially flexes radially away (upwardly in the orientation of FIG. 16) away from the shell 110 in the direction of arrow E as angled surface 144 of hook 142 engages the edge 121 of distal tab portion 123 of the tab 120. The edge 121 can optionally be angled to engage the angled surface 142 of hook 140. Upon sufficient distal advancement in manufacture in the direction of arrow D, the angled wall 144 of hook 140 passes beyond edge 121 and beyond distal tab portion 123, and then the distal tab portion 123, no longer biased upwardly (radially), can move downwardly (inwardly toward the longitudinal axis) in the direction of arrow G toward the shell 110 so the hook 142 is seated within locking aperture 126. As shown, in this position, the engagement of shoulder 145a of hook 142 with wall 127 of distal tab portion 123 prevents distal movement of the staple guide 140 to retain it in position. During use, a distal force applied to the staple guide 140 during manipulation of the instrument or firing of the staples will not dislodge the staple guide 140 from the shell assembly 110 since distal movement is prohibited by wall 127.
In the alternate embodiment of FIGS. 18-20, flexible engagement bumps are provided. Staple guide 170 is identical to staple guide 60 of FIG. 2 and shell 180 is identical to shell 31 of FIG. 2 except for the structure cooperating with the hooks of the staple guide and the flexible bumps. More specifically, staple guide 170 has a flexible hook 172 extending proximally. Shell 180 has a locking aperture 182 dimensioned and configured to receive the hook 172. Hook 172 flexes as it is inserted past wall 183 positioned distal of locking aperture 182. The distal end of the wall 183 preferably has an angled surface 185 cooperating with the angled surface 174 of hook 172 to facilitate insertion. During assembly, wall 183 biases hook 172 radially inwardly in a similar fashion as hook 84 of FIG. 2 to enable it to pass proximally beyond wall 183, and then the hook 172 returns to its normal position received in locking aperture 182 as shown in FIG. 20. During use, a distal force applied to staple guide 170 will not dislodge the staple guide 170 from shell assembly 180 since distal movement is prohibited by engagement of shoulder 175 with wall 189.
Shell 180 can also have a series of flexible bumps or projections 186 to enhance securement of the staple guide 170. Bumps 186 extend distally from distal edge 187 of shell 180. When the staple guide 170 is attached to the shell 180, the flexible bumps or projections 186 are pressed inwardly. As a result, after assembly, the bumps 186 provide a distal force on the staple guide 170, thereby forcing hook 172 (shoulder 175) distally against surface 189 of wall 183 to the extent there is any slack between the shoulder 175 of hook 172 and the wall 189 adjacent locking aperture 182 when assembled. Consequently, the bumps/projections 186 function similar to a spring biasing the staple guide 170 in a distal direction when assembled to the shell 180. It should be appreciated that the bumps or projections can be provided on the other embodiments of the shell disclosed herein to provide a distal biasing force if desirable.
FIGS. 21-27 illustrate another alternate embodiment for attaching the staple guide to the shell assembly utilizing a bayonet mount. Shell 210 is identical to shell 31 of FIG. 2 except for the structure cooperating with the tabs of the staple guide. More specifically, shell 210 has a slotted region 212. Slotted region 212 extends proximally from a distal edge 214 of the shell 210 in a longitudinal (axial) direction forming an axial slotted region 212a of slot 212. Slot 212 also has a radially extending region 212b transverse to the axial region 212a, thereby forming a substantially L-shape slotted configuration. A blocking indentation 213 extends into radial region 212b. For ease of explanation blocking recess or indentation 213 can be considered as dividing radial region 212b into two sections.
Staple guide 230 is identical to staple guide 60 of FIG. 2 except for the structure engaging the shell 210 for attachment thereto. More specifically, staple guide 230 has a locking tab 232 at a proximal edge 234. As can be appreciated by viewing FIGS. 23-27, when staple guide 230 is attached during assembly to the shell assembly 110 by placement in a direction of arrow E, the locking tab 232 enters the axial region 212a of slot 212. After the locking tab 232 is inserted to the edge 212c of axial region 212a (see FIG. 23), staple guide 230 is then rotated and the tab 232 is moved in the radial region 212b of slot 212 in the direction of arrow F of FIG. 24. Rotation continues until tab 232 is forced past blocking recess 213 as shown in FIG. 26. That is, as tab 232 moves along the radial region 212b of slot 212, it is forced past locking recess 213 which forms a reduced diameter region 212f of region 212b of slot 212 (The region 212f has a smaller dimension than a transverse dimension of the locking tab 232). Once moved past this reduced diameter region 212f, the region prevents withdrawal of the locking tab 232, i.e. movement in the direction opposite the direction of arrow F, unless a sufficient force is applied by rotation of the shell guide 230 to overcome the blocking recess (indentation) 213 and pass by the reduced diameter region. Note that the structure can be provided so that either the tab 232 flexes or the indented wall forming the blocking recess 213 flexes so the tab can move past the indentation. During use, a distal force applied to the staple guide 230 during manipulation of the instrument or firing of the staples will not dislodge the staple guide 230 from the shell assembly 210 since distal movement is prohibited by wall 233 and disconnection requires reverse rotation of the staple guide 230 to remove it from the slot 212.
It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of disclosed embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

## Claims

1. A surgical stapling instrument, comprising:
a handle assembly including a movable handle for actuating the stapler;
an elongated body portion extending distally from the handle assembly;
a head portion disposed adjacent a distal portion of the elongated body portion and including an anvil assembly and a shell assembly, the shell assembly including a shell and a staple guide housing a plurality of staples in an annular array, the shell including an annular opening to receive the staple guide and a locking aperture formed in an outer surface of the shell spaced proximally of the opening and defining a proximal wall and a distal wall, the shell including a ramp positioned distally of the locking aperture;
a pusher positioned within the shell and advanceable to advance the plurality of staples distally; and
a flexible engagement structure attaching the staple guide to the shell, the flexible engagement structure engageable with the locking aperture to limit distal movement of the staple guide, the flexible engagement structure including at least one hook disposed on the staple guide, the hook including an angled surface disposed on a proximal end thereof, and wherein the angled surface of the hook slidably contacts the ramp of the shell upon engagement between the staple guide and the shell and prior to the hook engaging the locking aperture.

2. The instrument of claim 1, wherein the flexible engagement structure includes a flexible tab on the shell.

3. The instrument of claim 2, wherein the flexible tab includes an aperture to receive a hook on the staple guide.

4. The instrument of claim 3, wherein the hook is substantially rigid.

5. The instrument of claim 3, wherein the flexible tab is positioned at the distalmost end of the shell.

6. The instrument of claim 1, further comprising at least one flexible projecting member compressible by the staple guide.

7. The instrument of claim 1, wherein the shell assembly includes a plurality of projections extending distally to apply a distal force to the staple guide.

8. The instrument of claim 7, wherein the projections are compressible by the staple guide.

9. The instrument of claim 7, wherein the projections extend from a distalmost end of the shell.

10. The instrument of claim 1, wherein the staple guide has a flange and the hook is positioned proximal of the flange.

11. The instrument of claim 1, wherein the hook is substantially flush with an outer surface of the staple guide.

12. The instrument of claim 1, wherein the flexible engagement structure comprises first and second hooks, the first and second hooks radially spaced to engage at spaced regions of the shell assembly.

13. The instrument of claim 12, wherein the hooks are spaced approximately 180 degrees apart.

14. The instrument of claim 1, wherein the hook has a shoulder engageable with a surface of the distal wall defined by the locking aperture.

15. The instrument of claim 1, wherein the hook does not extend beyond an outer surface of the shell.

16. The instrument of claim 12, wherein the second hook engages a second locking aperture formed in an outer surface of the shell spaced proximally from the opening.

17. The instrument of claim 1, wherein a distal shoulder of the flexible engagement structure engages the distal wall defined by the locking aperture.