# Patent

## Title
Surgical stapler with suture locator

## Abstract

An anvil assembly comprising an anvil shaft and an anvil head, the anvil head having anvil depressions for forming surgical staples, and the anvil head mounted to the anvil shaft. The anvil shaft has a longitudinal axis and a helical slot formed therein. A disc is movable along the slot to a selected position to selectively adjust the positioning of a purse string suture.

## Background
This application claims priority from provisional application Ser. No. 61/144,488, filed Jan. 14, 2009, the entire contents of which are incorporated herein by reference.


BACKGROUND
1. Technical Field
The present disclosure relates to a surgical stapling device and more particularly to a surgical stapling device suitable for treatment of internal hemorrhoids.
2. Background of Related Art
Anastomosis is the surgical joining of separate hollow organ sections. In known circular anastomosis procedures, two ends of organ sections are joined by means of a stapling device which drives a circular array of staples through each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free a tubular passage. Examples of such devices are described in U.S. Pat. Nos. 7,234,624, 6,945,444, 6,053,390, 5,588,579, 5,119,983, 4,646,745, 4,576,167, 4,473,077.
Typically the circular stapling device has an elongated shaft having a handle portion at a proximal end and a staple cartridge at a distal end. An anvil assembly including an anvil rod with an attached anvil head is mounted to the distal end of the device. The anvil is approximated to clamp tissue between the staple holding component and the anvil. The clamped tissue is stapled by actuation of the handle portion to drive circular arrays of staples through the tissue and into anvil depressions on the anvil head to form the staples. An annular knife is advanced with the handle actuation to core tissue inboard of the staple array.
Surgical stapling devices for performing circular anastomosis have also been used to treat hemorrhoids in the rectum. Hemorrhoids are masses of tissue in the anus containing enlarged blood vessels. Internal hemorrhoids are inside the anal canal; external hemorrhoids lie outside the anal canal. Hemorrhoidectomy is a surgical procedure in which the hemorrhoids are removed. Stapled hemorrhoidopexy is a surgical procedure in which a 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, thus causing the hemorrhoids to shrink. This is used for treatment of internal hemorrhoids.
During the use of a circular stapling device for hemorrhoid treatment, the anvil head and the staple holding component of the device are inserted through and into the rectum with the anvil head and the stapling holding component in an open or unapproximated position. Thereafter, a purse string suture is used to pull the internal hemorrhoidal tissue and/or mucosal tissue toward the anvil rod. Next, the anvil head and the staple holding component are approximated to clamp the hemorrhoidal tissue and/or mucosal tissue between the anvil head and the staple holding component. The stapling device is fired to remove the hemorrhoidal tissue and/or mucosal tissue and staple the cut tissue.
It would be advantageous to provide a device with an option to adjust the amount of tissue for purse stringing to enhance control over the amount of tissue removed.
SUMMARY
The present disclosure provides an anvil assembly comprising an anvil shaft and an anvil head, the anvil head having anvil depressions for forming surgical staples. The anvil head is mounted to the anvil shaft. The anvil shaft has a longitudinal axis and a helical slot formed therein. A rotatable disc composed of two separate components is movable along the slot to a selected position to selectively adjust the amount of tissue for purse stringing. The disc can also be used to adjust the tension on a purse string suture placed about the anvil shaft. The disc has an internal thread to threadingly engage the helical slot of the anvil shaft.
In one embodiment, the two components of the disc are attached by a pin and slot arrangement.
The anvil assembly preferably has a mounting structure on the anvil shaft for releasably mounting the anvil shaft to a stapling instrument.
The present disclosure also provides a surgical stapler comprising a handle assembly, an elongated body portion extending distally from the handle assembly and a head portion disposed adjacent a distal end of the elongated body portion and including an anvil assembly and a shell assembly. The anvil assembly is movable in relation to the shell assembly between spaced and approximated positions. The anvil assembly has an anvil head and an anvil shaft with a helical slot formed therein. A rotatable disc composed of two components attachable to each other is movable along the helical slot to a selected position to adjust the amount of tissue drawn into the shell assembly by a purse string suture.
In a preferred embodiment, the anvil shaft is removably mounted to an anvil retainer of the stapler.



BRIEF DESCRIPTION OF THE DRAWINGS
Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
FIG. 1 is a perspective view of a first embodiment of the surgical stapler of the present disclosure;
FIG. 1A is a longitudinal cross-sectional view of the surgical stapler of FIG. 1;
FIG. 1B is a cross-sectional view of the anvil retainer of the stapler of FIG. 1;
FIG. 1C is a side view of the connector of the stapler of FIG. 1;
FIGS. 1D and 1E are cross-sectional views of portions of the shell assembly of FIG. 1;
FIG. 2 is a close up perspective view of the anvil assembly and shell assembly of FIG. 1;
FIG. 3 is a perspective view of the disc of FIG. 1;
FIG. 4 is a perspective view of an alternate embodiment of the disc composed of two attachable components;
FIG. 5 is a close up side view of the anvil assembly and shell assembly of FIG. 1 with the disc shown in cross-section; and
FIG. 6 is a side view illustrating placement of the purse string suture in an anvil assembly of the present disclosure.



DETAILED DESCRIPTION OF EMBODIMENTS
The presently disclosed surgical stapler 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 stapler closer to the operator and the term “distal” will refer to the portion of the instrument further from the operator. The presently disclosed stapler is particularly suited for surgical procedures for the treatment of colon prolapse and hemorrhoids, although it can be used for other procedures.
FIGS. 1 and 1A illustrate one embodiment of the presently disclosed hemorrhoid stapler 10. Briefly, surgical stapler 10 includes a handle assembly 12, a central body or elongated portion 14 and a distal head portion 16. Head portion 16 includes an anvil assembly 18 and a shell assembly 20. Except where otherwise noted, the components of stapler 10 are generally formed from thermoplastics including polycarbonates, and metals including stainless steel and aluminum. The particular material selected to form a particular component will depend upon the strength requirements of the particular component. For example, the anvil may be formed from a metal such as stainless steel, whereas portions of handle assembly 12 may be formed from thermoplastic such as a polycarbonate. Alternately, other materials having the requisite strength requirements which are suitable for surgical use may be used to form the components of stapler 10.
Handle assembly 12 includes a stationary handle 22, a firing trigger 24, an approximation knob 26, an indicator assembly 28, and a lockout mechanism 30. Approximation knob 26 functions to retract and advance a drive screw 32 to advance or retract anvil assembly 18 in relation to cartridge assembly 20. Firing trigger 24 functions to advance a pusher link 34 to actuate a pusher to eject staples from shell assembly 20. Each of the components of handle assembly 12 identified above are substantially as described in U.S. Pat. No. 7,303,106 (“'106 patent”) entitled “Surgical Stapling Device With Visual Indicator” which issued on Dec. 4, 2007. The '106 patent is incorporated herein by reference in its entirety. Accordingly, these components and assemblies will not be described in detail herein.
Referring to FIGS. 1A-1C, an anvil retainer 36 is secured to a distal end of drive screw 32 by a connector 38. Anvil retainer 36 includes a body 40 defining an elongated bore 42. A proximal end 40a of body 40 includes a longitudinal slot 44 and a pair of transverse throughbores 46. A distal end 40b of body 40 includes three segmented flexible arms 48. Each of the arms 48 has an inner retention surface 50 which will be described in further detail below.
Connector 38 includes a central body 52 having a proximal extension 54 and a distal extension 56. Proximal extension 54 is dimensioned to be received within a slot (not shown) formed in the distal end of drive screw 32. Extension 54 and the distal end of drive screw 32 each define a transverse throughbore for receiving a pin, rivet, screw or the like 60 for fixedly securing connector 38 to drive screw 32. Distal extension 56 is dimensioned to be received within slot 44 of body 40 of anvil retainer 36. Extension 56 includes a pair of spaced throughbores which align with throughbores 46 of anvil retainer 36 and are dimensioned to receive pins, screws, rivets or the like 62 to fixedly secure anvil retainer 36 to connector 38. Although pins, screws, rivets or the like are specifically disclosed for securing connector 38 to drive screw 32 and anvil retainer 36, other known fastening techniques are envisioned, e.g., welding, crimping, and interlocking structure. In an alternate embodiment, the connector and anvil retainer can be replaced with a single part, e.g. an elongated anvil retainer, having an extended length to function similarly to the extended length resulting from the provision of connector 38.
Referring to FIGS. 2 and 5, anvil assembly 18 includes an anvil shaft or center rod 64 and an anvil head 66. Anvil shaft 64 includes a tapered proximal blunt end 64a (FIG. 1A) and an opposite distal end for mounting to anvil post 68 of anvil head 66. A pin 72 (or alternatively a screw, rivet or the like) mounts the anvil post 68 to anvil shaft 64. It should be appreciated, that anvil post 68 can be pivotally mounted to anvil shaft 64 so that the anvil can move between an operative non-tilted position to a tilted position. This is described in detail in U.S. Pat. No. 7,303,106, the entire contents of which is incorporated herein by reference. Alternatively the anvil can be fixedly (non-pivotably) mounted to the anvil shaft 64.
Anvil shaft 64 includes a stepped surface or ring 74 which is configured to engage retention surfaces 50 (FIG. 1B) of flexible arms 48 to releasably secure anvil shaft 64 to anvil retainer 36. An orientation groove or grooves is provided in anvil shaft 64 beneath spines 76 to effect proper alignment of splines 76 about shaft 64 to facilitate proper alignment of anvil assembly 18 and shell assembly 20 when anvil assembly 18 is retracted towards shell assembly 20.
Anvil shaft 64 also includes over-molded splines 76. Splines 76 function as known in the art to properly align anvil assembly 18 with shell assembly 20 (FIG. 1). Alternatively, the anvil shaft can have machined splines.
Anvil shaft 64 has a helical cam slot or groove 78 formed therein. An adjustable movable member 79 having an internal thread 81 engages the helical slot 78 on the anvil shaft 64. The movable member 79 is rotated to slide in an adjustable nut fashion either distally or proximally along slot 78 and therefore along anvil shaft 64 to adjust the positioning of the purse string and/or the tension on the purse string as described below.
In the embodiment of FIGS. 2 and 3, the movable (rotatable) member is in the form of a unitary disc 79. In the alternate embodiment of FIG. 4, disc 179 is composed of two components 179a, 179b. The components 179a, 179b are shown attached by a pin 182/slot 184 arrangement, although other structures for attaching the two components are also contemplated. This two component version 179 eases assembly as each disc half is placed over the anvil shaft 64 and then fitted together. It also enables the disc to be removed by the user if not desired or be provided as an optional accessory to be placed on the anvil shaft if the surgeon desires such selective adjustment of the purse string suture.
The disc is configured to provide a locator for a purse-string suture, creating a region or stop to retain the suture. The disc 79, 179 enables the user to decide the amount of tissue desired for purse stringing, e.g. moving the disc to a more proximal position (i.e. further from the anvil head) would enable additional tissue to be taken and presented for stapling. Thus, the disc can be moved to a selected position prior to securing the purse string around the anvil shaft 64.
The disc 79, 179 can also be used as a tissue tensioner. In this manner, after the purse string suture is placed about the anvil shaft 64, the disc can be rotated along the helical slot (proximally) to apply additional tension to the suture to present additional tissue in the shell assembly for subsequent stapling.
The disc 79 has a distal surface 82 closer to the anvil head and a proximal surface 84 closer to the shell assembly. Both the proximal and distal surfaces 82, 84 are preferably angled, with the distal surface angled such that the surface angles in a proximal direction and the proximal surface angled so the surface angles in a distal direction. This is best shown in FIG. 5.
As discussed above, anvil retainer 36 (FIG. 1B) defines an elongated bore 42 which is dimensioned to receive anvil shaft 64 such that stepped surface 74 of shaft 64 engages retention surface 50 to releasably secure anvil assembly 18 to anvil retainer 36. In one embodiment, anvil shaft 64 is of a length to protrude from the anus when properly positioned during a surgical procedure to treat colon prolapse. By protruding from the anus, the interface between the anvil shaft 64 and anvil retainer 36 is exposed and visible for attachment. For example, in one embodiment, shaft 64 extends outwardly from a face 86 (FIG. 2) of anvil head 66 a distance greater than about three inches, and for example extends outwardly from face 86 of anvil head 66 a distance of about 3.55 inches. In another embodiment, the shaft extends outwardly a distance of greater than about five inches, and for example extends about 5.234 inches.
Anvil head 66 is shown with a low distal profile, however, other shapes are contemplated such as the bulbous, smoothly contoured anvil 266 illustrated in FIG. 3A. Bulbous portion 296 facilitates insertion of head 266 through a purse string suture. The anvil head 266 can be attached to the anvil shafts disclosed herein.
Referring to FIGS. 1A, 1D and 1E, shell assembly 20 is secured to the distal end of central body portion 14 in a manner substantially similar to that described in the '106 patent incorporated herein by reference. Shell assembly 20 includes a shell or housing 98, a pusher back 100, a cylindrical knife 102, and a staple guide 104. Staple guide 104 houses one or more rows of staples (not shown).
Shell 98 includes an outer housing portion 106 and an inner guide portion 108 having grooves 110 for mating with splines 76 on anvil shaft 64. Outer housing portion 106 defines a throughbore 112 having a distal cylindrical section 114, a central conical section 116 and a proximal smaller diameter cylindrical section 118. A plurality of openings 120 are formed in conical section 116. Openings 116 are dimensioned to permit fluid and tissue passage during operation of stapler 10. A pair of diametrically opposed flexible engagement members 122 are formed on proximal cylindrical section 118 of shell 98. Engagement members 122 are positioned to be received in openings formed on a distal end of body portion 14 to secure shell 98 to body portion 14. Vent holes 29 (FIG. 1) are provided in shell assembly 20.
Pusher back 100 includes a central throughbore 124 which is slidably positioned about inner guide portion 108 of shell 98. Pusher back 100 includes a distal cylindrical section 126 which is slidably positioned within distal cylindrical section 114 of shell 98, a central conical section 128 and a proximal smaller diameter cylindrical section 130. The proximal end of pusher back 100 includes members 132 which are configured to lockingly engage with a pusher link of stapler 10 as described in the '106 patent incorporated by reference herein. Pusher back 100 also defines a receptacle 133 for receiving excised tissue. Receptacle 133 is configured to have a depth of between about 0.75 inches and about 2.00 inches. In one embodiment, receptacle 133 has a depth of about 1.33 inches.
The distal end of pusher back 100 includes a pusher 134 (FIG. 1E). Pusher 134 includes a multiplicity of distally extending fingers 136 dimensioned to be slidably received within slots (not shown) formed in staple guide 104 to eject staples (not shown) therefrom. Cylindrical knife 102 is retained within the central throughbore of pusher back 100 to fixedly secure knife 102 in relation to pusher 134. Knife 102 may be retained within pusher back 100 using adhesives, crimping, pins, friction, etc. The distal end of knife 102 includes a circular cutting edge.
The rigid bushing 140 is supported in the proximal end of inner guide portion 108 of shell 98. Bushing 140 defines a throughbore dimensioned to slidably receive anvil retainer 36 and anvil shaft 64 of anvil assembly 18. Bushing 140 provides lateral support for flexible arms 48 of anvil retainer 36 when the anvil assembly 18 has been approximated to prevent disengagement of anvil assembly 18 from anvil retainer 36. In the unapproximated position, flexible arms 48 are positioned externally of bushing 140 to permit flexing of the arms for removal of anvil assembly 18 from retainer 36.
As discussed above, stapler 10 is particularly suitable for use in surgical procedures for treating colon prolapse. During such procedure, an access port can be inserted into the anus to facilitate access to the prolapsed colon. Next, a purse string suture is placed into, above or in the vicinity of the colon prolapse. Disc member 79 (or 179) is rotated for movement along the anvil shaft 64 to a selected position, depending on the amount of tissue desired to be drawn in the shell assembly and presented for stapling, and the anvil assembly 18 is inserted through the access portion into the anus and rectum. Thereafter, the purse string suture (FIG. 6) is placed about the anvil shaft 64 abutting the disc 79, 179 which retains the suture position. A greater amount of tissue will be drawn into shell assembly 20 by retaining the purse string suture against a more proximal position of the disc. The suture ends are tightened and pulled toward the user, therefore pulling the tissue proximally. The surgeon can then visualize the tissue to be stapled, i.e. the tissue donut to be removed. The stapling instrument, e.g. instrument 10 of FIG. 1, is inserted through the port and attached to the anvil assembly, with the elongated anvil shaft and elongated instrument shaft providing increased visibility. At any point, if desired, the disc 79, 179 can be rotated to a more proximal position to apply additional tension on the suture. Anvil assembly 18 and shell assembly 20 are then approximated via knob 26 to draw the prolapsed colon into shell assembly 20.
When surgical stapler 10 is fully approximated, firing trigger 24 can be actuated or fired in a manner described in the '106 patent to staple, sever and allow removal of a portion of the prolapsed colon. Thereafter, the stapler is at least partially unapproximated and removed from the anus with the excised tissue contained within receptacle 133 of pusher back 100 within shell assembly 20. In the embodiments where a tilting anvil is used, after the firing step and sufficient movement of the anvil away from the shell assembly 20, the anvil will tilt (not shown) to its inoperative position to facilitate removal.
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 preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

## Claims

1. An anvil assembly comprising an anvil shaft and an anvil head, the anvil head having anvil depressions for forming surgical staples, the anvil head mounted to the anvil shaft, the anvil shaft having a longitudinal axis and a helical slot formed therein, and a rotatable disc, composed of two separate components, the two separate components being attachable about the anvil shaft such that the disc is movable along the slot to a selected position to selectively adjust the positioning of a purse string suture.

2. The anvil assembly of claim 1, wherein the two components of the disc are attached by a pin and slot arrangement.

3. The anvil assembly of claim 1, further comprising a mounting structure on the anvil shaft for releasably mounting the anvil shaft to a stapling instrument.

4. The anvil assembly of claim 1, wherein the rotatable disc has a convex surface on a proximal side.

5. The anvil assembly of claim 1, wherein the rotatable disc has a convex surface on a distal side.

6. The anvil assembly of claim 1, wherein a distal surface and a proximal surface of the disc are angled.

7. A surgical stapler comprising;
a handle assembly;
an elongated body portion extending distally from the handle assembly; and
a head portion disposed adjacent a distal end of the elongated body portion and including an anvil assembly and a shell assembly, the anvil assembly being movable in relation to the shell assembly between spaced and approximated positions, the anvil assembly having an anvil head and an anvil shaft having a helical slot formed therein, a rotatable disc composed of two components attachable to each other about the anvil shaft such that the disc is movable along the slot to a selected position to adjust the amount of tissue drawn into the shell assembly by a purse string suture.

8. The surgical stapler of claim 7, wherein the rotatable disc has a convex surface on a proximal side.

9. The surgical stapler of claim 7, wherein the rotatable disc has a convex surface on a distal side.

10. The surgical stapler of claim 9, wherein the anvil shaft is removably mounted to an anvil retainer of the stapler.

11. The surgical stapler of claim 7, wherein a distal surface and a proximal surface of the disc are angled.