US20070181631A1 - Apparatus for performing trans-anal resection - Google Patents

Abstract

A surgical instrument adapted for applying a plurality of surgical fasteners to body tissue includes a frame having a proximal end and a distal end, with a handle positioned at the proximal end and an end effector positioned at the distal end. The end effector is shaped and dimensioned for supporting a cartridge module. A firing mechanism is associated with the end effector and the cartridge module for selective actuation. The end effector has a radius of curvature optimized for a trans-anal resection such that the end effector has a curvature of at most approximately a 40 mm diameter.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to a surgical stapling and cutting instrument adapted for use in trans-anal resection and an associated method for performing trans-anal resection. More particularly, the present invention relates to a surgical stapling and cutting instrument having a curvature particularly adapted to fit within the rectum adjacent the anal canal for the performance of the trans-anal resection as well as the method for using the surgical stapling and cutting instrument.
• 2. Description of the Prior Art
• Surgical stapling and cutting instruments are commonly utilized in the diagnosis and treatment of pathologies treated by staple resection. Surgical stapling instruments provide a mechanism to extend the transluminal exploitation of mechanical suturing devices introduced via the anal canal, mouth, stomach and service accesses. Although surgical stapling and cutting instruments are most commonly utilized with rectal pathologies, surgical stapling and cutting instruments may be used in a variety of environments.
• Surgical stapling and cutting instruments generally include a support frame, an anvil attached to the support frame and a cartridge module carrying a plurality of staples. The instruments also include a driver within the cartridge module which pushes all of the staples out simultaneously into the anvil to form the staples into a generally B-shape, suturing tissue together. In addition, these instruments include approximation mechanisms for moving the cartridge module from a spaced position relative to the anvil to accept tissue therebetween to a closed position where the tissue is clamped between the anvil and the cartridge module. Finally, the instruments include a firing means for moving the staple driver forward to form the staples against the anvil.
• In addition to other procedures, surgical stapling and cutting instruments have been utilized in conjunction with trans-anal resections. Trans-anal resection is a surgical procedure utilized to remove tissue, for example, tumorous tissue, within the rectum by operating through the anus. This procedure is commonly performed to treat early stage rectal cancer or rectal tumors close to the anus. In accordance with this procedure, a section of the rectum is removed and the remaining opposed edges are coupled to complete the linking of the anus with the remainder of the rectum.
• With the foregoing in mind, those skilled in the art will appreciate the need for more advanced procedures relating to trans-anal resection, as well as the need for advanced instruments specifically designed to facilitate the advanced surgical procedures. The present invention addresses this need through the provision of a technique for trans-anal resection and an associated curved cutter stapler adapted for assisting in the performance of the procedure.
SUMMARY OF THE INVENTION
• It is, therefore, an object of the present invention to provide a surgical instrument adapted for applying a plurality of surgical fasteners to body tissue. The surgical instrument includes a frame having a proximal end and a distal end, with a handle positioned at the proximal end and an end effector positioned at the distal end. The end effector is shaped and dimensioned for supporting a cartridge module. A firing mechanism is associated with the end effector and the cartridge module for selective actuation. The end effector has a radius of curvature optimized for a trans-anal resection such that the end effector has a curvature of at most approximately a 40 mm diameter.
• It is also an object of the present invention to provide a surgical instrument wherein the end effector has a curvature of between approximately a 20 mm diameter and approximately a 40 mm diameter.
• It is another object of the present invention to provide a surgical instrument wherein the end effector has a curvature adapted to fit within an envelope having a diameter of approximately 40 mm.
• It is a further object of the present invention to provide a surgical instrument wherein the end effector has a curvature of approximately a 36 mm diameter.
• It is also another object of the present invention to provide a surgical kit adapted for the performance of trans-anal resection. The surgical kit includes a surgical instrument as described above and a dilator having an opening with a curvature of at most approximately a 40 mm diameter.
• It is a further object of the present invention to provide a surgical instrument wherein the dilator has a curvature of approximately 40 mm.
• Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of the surgical stapler in accordance with the present invention.
• FIG. 2 is perspective view of the surgical stapler with the cartridge module removed.
• FIG. 3 is a perspective view of the surgical stapler with the cartridge housing moved to an intermediate position.
• FIG. 4 is a perspective view of the surgical stapler with the cartridge housing moved to a closed position.
• FIG. 5 is a perspective view of the surgical stapler with the firing trigger in a firing position.
• FIG. 6 is a front perspective view of the cartridge module with the retainer secured thereto.
• FIG. 7 is a front perspective view of the cartridge module with the retainer removed.
• FIGS.8 to16 disclose the various steps in performing a trans-anal resection in accordance with the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as the basis for teaching one skilled in the art how to make and/or use the invention.
• Referring toFIG. 1 in combination with FIGS.2 to5, there is shown a surgical stapling and cutting instrument, in particular, a linearsurgical stapler20 which is designed to staple and cut tissue. The linearsurgical stapler20 has ahandle21 at a first proximal end and anend effector80 at an opposite distal end. Theend effector80 is curved in accordance with a preferred embodiment of the present invention. Right and left hand structural plates (often called “handle plates”)34,35, respectively, connect thehandle21 to theend effector80 of the instrument (the lefthand handle plate35 is removed and not shown inFIG. 1). Thehandle21 has aright hand shroud22 coupled to a left hand shroud (the left hand shroud is not shown inFIG. 1). Thehandle21 also has abody portion23 to grip and maneuver the linear surgical stapler20 (see FIGS.2 to5).
• The linearsurgical stapler20 in accordance with the present invention is particularly adapted for use in the performance of trans-anal resection. In particular, access to, and the performance of procedures adjacent to, the anus are made difficult by the limited size of the anus and rectum. The presentsurgical stapler20 is specifically shaped and dimensioned for access through the anus and alignment within the rectum during trans-anal resection. In particular, theend effector80 of the linearsurgical stapler20 is adapted to fit and function within a circular envelope having a diameter of at most 40 mm. With this in mind, and in accordance with a preferred embodiment of the present invention, the linearsurgical stapler20 has a distal end with atissue end effector80 having a curvature between a diameter of approximately 20 mm to approximately 40 mm, and more preferably, approximately 36 mm, in order to fit into a minimum oval envelope permitting passage through the anus and performance of a rectal resection procedure. In accordance with a preferred embodiment, an effector having a curvature with a diameter of approximately 36 mm would be structured such that it defines an arc length of approximately 30 mm.
• Theend effector80 is a surgical fastening assembly that includes a cartridge module120 (seeFIGS. 6 and 7) and a C-shaped supportingstructure81. The term C-shaped is used throughout the specification to describe the concave nature of the supportingstructure81 and thecartridge module120. The C-shaped construction facilitates enhanced functionality and the use of the term “C-shaped” in the present specification should be construed to include a variety of concave shapes which would similarly enhance the functionality of surgical stapling and cutting instruments. Thedistal end30 of aclosure member28 is disposed to receive thecartridge module120. Theend effector80 also includes a safety lockout mechanism (not shown) for preventing the firing of a previously firedcartridge module120. Thecartridge module120 contains acartridge housing121 coupled to an anvil122. Thecartridge module120 also includes aretaining pin125, a knife126, aremovable retainer160, atissue contacting surface127 which displays a plurality of staple-containingslots128 in staggered formation in one or more rows (that is, staple lines) on either side of the knife126. Staples (not shown) are fired from thecartridge housing121 against the staple-forming surface129 of the anvil122 that faces the tissue-contactingsurface127 of thecartridge housing121.
• As will become apparent based upon the following disclosure, the present linearsurgical stapler20 is designed as a multiple firing device with areplaceable cartridge module120. However, it should be understood that many of the underlying concepts of the present invention may be equally applied in single firing devices without departing from the spirit of the present invention. While thepresent end effector80 is disclosed below as being adapted for use in conjunction with areplaceable cartridge module120 having various components, the concepts underlying the present invention could be applied to a variety of end effectors and cartridge module constructions without departing from the spirit of the present invention.
• The supportingstructure81 of theend effector80 is respectively attached to the right and lefthandle plates34,35, by ashoulder rivet82 andposts83 which extend from the supportingstructure81 into receiving holes in thehandle plates34,35. In accordance with a preferred embodiment of the present invention, the supportingstructure81 is formed via a single piece construction. More specifically, the supportingstructure81 is formed by extrusion, for example, of aluminum, with subsequent machining to create the supportingstructure81 disclosed in accordance with the present invention. By constructing the supportingstructure81 in this manner, multiple parts are not required and the associated cost of manufacture and assembly is substantially reduced. In addition, it is believed the unitary structure of the supportingstructure81 enhances the overall stability of the present linearsurgical stapler20. In addition, the unitary extruded structure of the supportingstructure81 provides for a reduction in weight, easier sterilization since cobalt irradiation will effectively penetrate the extruded aluminum and less trauma to tissue based upon the smooth outer surface achieved via extrusion.
• Thehandle21 of the linearsurgical stapler20 includes ahand grip24 which the surgeon grasps with the palm of his hand (see FIGS.2 to5). Thehand grip24 is composed of a right hand shroud handle25 (seeFIG. 1) and a left hand shroud handle (the left hand shroud handle is not shown inFIG. 1). Pivotally extending from the underside of thehandle21 are aclosure trigger26 and a firingtrigger27. The linearsurgical stapler20 illustrated inFIG. 1 is shown with the closure and firing triggers26,27 in their unactuated positions and with acartridge module120 inserted and theretainer160 removed. Consequently, thecartridge housing121 is spaced from the anvil122 for the placement of tissue between thecartridge housing121 and the anvil122.
• Thehandle21 of the linearsurgical stapler20 contains a tissue retaining pin actuation mechanism100. The tissue retaining pin actuation mechanism100 includes a saddle shaped slide101 positioned on the top surface of thehandle21. Manual movement of the slide101 results in distal movement of thepush rod102. Thepush rod102 is coupled to the retainingpin125 of thecartridge module120. The distal movement or proximal retraction of thepush rod102 results in corresponding movement of the retainingpin125. The retaining pin actuation mechanism100 is also releasably coupled to theclosure trigger26 within thehandle21 such that actuation of theclosure trigger26 will result in automatic distal movement of the retainingpin125 if it has not already been manually moved to its most proximal position.
• Referring briefly to FIGS.2 to5, there is illustrated what happens when thecartridge module120 is loaded and the closure and firing triggers26,27 are sequentially squeezed toward thehand grip24 to actuate theend effector80 of the linearsurgical stapler20. The linearsurgical stapler20 is loaded with thecartridge module120, as shown inFIG. 2, and theretainer160 is removed. The linearsurgical stapler20 is now ready to receive tissue as shown inFIG. 1.
• When theclosure trigger26 is partially squeezed to rest in its first detent position shown inFIG. 3, thecartridge housing121 moves from its fully opened position to an intermediate position between the open and closed positions as discussed below in greater detail. Simultaneously, the tissue retaining pin actuation mechanism100 moves the retainingpin125 forward from thecartridge housing121 through an opening in the anvil122. In this position, tissue which has been placed between thecartridge housing121 and the anvil122 can be properly positioned, and the retention of the tissue between thecartridge housing121 and the anvil122 is assured. Therefore, when theclosure trigger26 has been actuated to its intermediate position, thecartridge housing121 and anvil122 are correspondingly positioned in their tissue retaining positions.
• When theclosure trigger26 is fully squeezed so that it is adjacent the forward end of thehand grip24, as illustrated inFIG. 4, thetissue contacting surface127 of thecartridge housing121 and the staple-forming surface129 of the anvil122 are adjacent to each other, and the properly positioned and retained tissue is consequently fully clamped. Additionally, the firingtrigger27 has rotated counterclockwise toward thehandgrip24 to enable the surgeon to grasp the firingtrigger27 for the firing of staples. Accordingly, the firingtrigger27 is now in position for the surgeon to squeeze it to staple and cut the tissue. When the firingtrigger27 has been fully squeezed to fire the staples, as shown inFIG. 5, the firingtrigger27 tests in near proximity to theclosure trigger26.
• The present linear surgical stapler is constructed in a manner similar to commonly owned and copending applications. As such, further details regarding the structure and operation of the linearsurgical stapler20 may be found in commonly owned U.S. patent application Ser. No. 11/014,910, filed Dec. 20, 2004, entitled “CURVED CUTTER STAPLER SHAPED FOR MALE PELVIS”, which is incorporated herein by reference.
• In practice, and referring toFIGS. 8 and 9, thecurved cutter stapler20 is used in conjunction with adilator224 and aspreader226 in the performance of trans-anal resection in the following manner. Once the portion of therectum200 requiring resection is identified, the area is prepared in a conventional manner. In particular, and referring toFIG. 10, adilator224 is inserted and secured via a plurality ofsutures201 within the rectum. As mentioned above, the preferred envelope in which theend effector80 must work has a diameter of approximately less than 40 mm. This is because adilator224 having a diameter of approximately 40 mm is preferably used in conjunction with the present procedure. Although a dilator having a diameter of approximately 40 mm is used in accordance with the present invention as this is believed to be the largest size dilator which can be used with most patients, those skilled in the art will appreciate that some patients will not accommodate a dilator of 40 mm and, therefore, dilators ranging in size from approximately 30 mm to approximately 40 mm are contemplated for use in accordance with the present invention. Similarly, aspreader226 with a curvature slightly smaller than that of thedilator224 may be used in conjunction with the present invention.
• Thereafter, and with reference to FIGS.11 to16, afirst whip stitch202 is secured about therectum200 from a one o'clock position to an eleven o'clock position. The deep bites of thewhip stitch202 capture and fold therectum wall204 in a desired manner. In addition to the placement of awhip stitch202 as discussed above, atraction suture206 is positioned beneath thewhip stitch202 and is used to maintain tension on the tissue as the procedure is performed. Thereafter, a traditional linear surgical stapling instrument well known to those skilled in the art is positioned between thewhip stitch202 and thetraction suture206 to create alongitudinal staple line208 in therectal wall204 at a position approximately at one o'clock. Thereafter, thepresent instrument20 is placed in therectal canal200 and is positioned for capturing therectal wall204 held by thefirst whip stitch202 positioned between one o'clock and ten o'clock. Theinstrument20 is fired and a circumferential firststaple line210 extending from one o'clock to ten o'clock is created. Once this portion of the resection is completed, asecond whip stitch203 is placed from ten o'clock to seven o'clock to capture therectal wall204. Theinstrument20 is then once again placed in therectal canal200 to capture therectal wall204 held by thesecond whip stitch203 from ten o'clock to seven o'clock and theinstrument20 is fired creating astaple line212 thereacross. In accordance with a preferred embodiment of the present invention, a figure eightsuture211 is then placed at the junction of the first and secondstaple lines210,212. Thereafter, athird whip stitch205 is placed from seven o'clock to four o'clock and theinstrument20 is positioned and fired once again creating a thirdstaple line214 extending from seven o'clock to four o'clock. As with the prior step, a figure eightsuture213 is placed at the junction of the second and thirdstaple lines212,214. Finally, the steps are repeated until the complete rectal section is fully stapled and resected adding a fourthstaple line218 and a figure eightsuture215.
• While the preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention.

Claims (19)

1. A surgical instrument adapted for applying a plurality of surgical fasteners to body tissue, the surgical instrument comprising:

a frame having a proximal end and a distal end, with a handle positioned at the proximal end and an end effector positioned at the distal end;

the end effector being shaped and dimensioned for supporting a replaceable cartridge module including a cartridge housing coupled to an anvil;

a firing mechanism is associated with the end effector and the cartridge module for selective actuation; and

wherein the end effector has a radius of curvature optimized for a trans-anal resection such that the end effector has a curvature of at most approximately a 40 mm diameter.

2. The surgical instrument according toclaim 1, wherein the end effector has a curvature of between approximately a 20 mm diameter and approximately a 40 mm diameter.

3. The surgical instrument according toclaim 1, wherein the end effector has curvature adapted to fit within an envelope having a diameter of approximately 40 mm.

4. The surgical instrument according toclaim 1, wherein the end effector has a curvature of approximately a 36 mm diameter.

5. A surgical kit adapted for the performance of trans-anal resection, the surgical kit comprising:

a surgical instrument comprising a frame having a proximal end and a distal end, with a handle positioned at the proximal end and an end effector positioned at the distal end, the end effector being shaped and dimensioned for supporting a replaceable cartridge module including a cartridge housing coupled to an anvil, a firing mechanism is associated with the end effector and the cartridge module for selective actuation, and wherein the end effector has a radius of curvature optimized for a trans-anal resection such that the end effector has a curvature of at most approximately a 40 mm diameter; and

a dilator having an opening with a curvature of at most approximately a 40 mm diameter.

6. The surgical kit according toclaim 5, wherein the end effector has a curvature of between approximately a 20 mm diameter and approximately a 40 mm diameter.

7. The surgical kit according toclaim 5, wherein the end effector has a curvature of approximately a 36 mm diameter.

8. The surgical kit according toclaim 7, wherein the dilator has a curvature of approximately 40 mm.

9. The surgical kit according toclaim 5, wherein the dilator has a curvature of approximately 40 mm.

10. The surgical instrument according toclaim 1, wherein the the cartridge module includes a retaining pin.

11. The surgical instrument according toclaim 1, wherein the cartridge module includes a removable retainer.

12. The surgical instrument according toclaim 1, wherein the end effector includes a supporting structure formed via a single piece construction.

13. The surgical instrument according toclaim 12, wherein the supporting structure is formed by extrusion.

14. The surgical kit according toclaim 5, wherein the the cartridge module includes a retaining pin.

15. The surgical kit according toclaim 5, wherein the cartridge module includes a removable retainer.

16. The surgical kit according toclaim 5, wherein the end effector includes a supporting structure formed via a single piece construction.

17. The surgical kit according toclaim 16, wherein the supporting structure is formed by extrusion.

18. The surgical kit according toclaim 5, further including a spreader.

19. The surgical kit according toclaim 18, wherein the spreader has a curvature slightly smaller than that of the dilator.

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