Linear clamps for anastomosis

• US 8,728,103 B2
• Filed: 05/13/2010
• Issued: 05/20/2014
• Est. Priority Date: 06/26/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Surti, Vihar, McLawhorn, Tyler, Ducharme, Richard W.
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US12/779,378
• Publication Number:
  US 20100331866A1
• Time in Patent Office: 1,468 Days
• Field of Search: 606153-156, 606/151, 606/157, 606/213, 606/215, 606/216, 606/221, 244/55, 244/85, 24487-488, 24530-531
• US Class Current: 606/153
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

The present embodiments provide medical apparatuses, systems, and methods for rapidly forming an anastomosis between two viscera. The medical apparatus generally comprises two bases with two clamp members rotatably attached to the bases, the clamp members being capable of compressing tissue. The system generally comprises positioning and then deploying the medical apparatus between and within two stomas via an elongate member. The method generally comprises using the medical system to create an anastomosis between the stomach and the jejunum.

Claims

1. An apparatus for facilitating the creation of an anastomosis in bodily tissue, the apparatus comprising:

a first base positioned opposite from a second base to define an interior space therebetween, the bases and interior space defining a longitudinal axis and a lateral axis, the first and second bases being comprised of a degradable or resorbable material;

a first clamp member having a proximal portion and a distal portion, the first clamp member being separate and distinct from both bases and attached thereto and projecting laterally therefrom, wherein the proximal portion and the distal portion are rotatable relative to the first and second bases;

a second clamp member having a proximal portion and a distal portion, the second clamp member being separate and distinct from both bases and attached thereto and projecting laterally therefrom, wherein the proximal portion and the distal portion are rotatable relative to the first and second bases;

the first and second clamp members each operable between a delivery state and a deployed state, the first and second clamp members being biased towards the deployed state, the deployed state of the first clamp member defining a first interior space in communication with the interior space, and the deployed state of the second clamp member defining a second interior space in communication with the interior space;

the delivery state of the first clamp member having the proximal portion and the distal portion rotated away from each other, the delivery state of the second clamp member having the proximal portion and the distal portion rotated away from each other; and

the deployed state of the first clamp member having the proximal portion and the distal portion of the first clamp member in close proximity to each other to hold the bodily tissue therebetween, the deployed state of the second clamp member having the proximal portion and the distal portion of the second clamp member in close proximity to each other to hold the bodily tissue therebetween.

2. The apparatus of claim 1 wherein the first and second clamp members separate upon the material of the first and second bases becoming degraded or resorbed, and wherein the first and second clamp members are sized to separately pass naturally through a gastrointestinal tract of a patient.

3. The apparatus of claim 1 wherein the first and second clamp members each extend laterally away from the first and second bases a distance ranging from about 4 cm to about 12 cm.

4. The apparatus of claim 1 wherein the interior space is adapted to fit over an endoscope.

5. The apparatus of claim 1 wherein the clamp members are comprised of a shape-memory material.

6. The apparatus of claim 1 wherein the first and second clamp members project laterally away from the first and second bases in opposite directions.

7. The apparatus of claim 1 wherein each proximal portion is comprised of one wire and each distal portion is comprised of a separate wire.

8. A medical system comprising the apparatus of claim 1, and further comprising:

an elongate member defining a longitudinal axis,

the interior space sized to slidably receive the elongate member;

a delivery member for ejecting the apparatus off of the elongate member; and

at least one retainer for maintaining the distal portions of each clamp member in the delivery state and maintaining the proximal portions of each clamp member in the delivery state, the apparatus being held on an exterior of the elongate member in the delivery state such that the relative longitudinal position of the apparatus on the elongate member is maintained during advancement of the elongate member.

10. The medical system of claim 8 wherein the at least one retainer is an elastic band.

11. The medical system of claim 8 wherein the at least one retainer is an overtube that maintains the proximal portions and the distal portions of the clamp members in the delivery state.

12. The medical system of claim 8 wherein the proximal and distal portions of both the first and second clamp members are rotated away from each other and beyond the longitudinal axis in their respective delivery states, the elongate member maintaining the position of the proximal and distal portions in their delivery states.

13. The medical system of claim 8 wherein the proximal and distal portions of both the first and second clamp members are semi-annular in shape.

14. The system of claim 8, wherein the first and second bases each have a curved inner surface having a curvature facing the interior space.

15. The system of claim 14, wherein the curvature is semi-circular.

16. The system of claim 8, wherein the apparatus remains generally stationary relative to the elongated member in the delivery state during advancement of the elongate member.

17. The apparatus of claim 1, wherein the proximal portions and distal portions of the first and second clamp members are concentrically arranged in the deployed state.

18. The apparatus of claim 1, wherein the first and second clamp members are formed of material that is not degradable or resorbable.

9. The medical system of 8 wherein the at least one retainer is a suture.

19. A method of forming an anastomosis, the method comprising the steps of:

creating a stoma in a first bodily wall;

creating a stoma in a second bodily wall;

providing a medical system comprising an apparatus that comprises a first base and a second base with a first and second clamp member attached to the bases, the clamp members having proximal portions and distal portions that are rotatably attached to the bases, the clamp members each having a deployed state wherein the proximal portion of the first clamp member is about parallel to the distal portion of the first clamp member and the proximal portion of the second clamp member is about parallel to the distal portion of the second clamp member, the clamp members each having a delivery state wherein the proximal portion and the distal portion of the first clamp member rotate longitudinally away from each other and the proximal portion and the distal portion of the second clamp member rotate longitudinally away from each other, and the bases adapted to fit over an elongate member;

inserting the apparatus into a bodily lumen;

positioning the distal portions of the first and second clamp members through the stoma in the second bodily wall so that the distal portions are on the distal side of the second bodily wall;

rotating the distal portions of the clamp members from the delivery state to the deployed state wherein the distal portions of the clamp members rotate laterally away from each other to press against an interior surface of the second bodily wall;

rotating the proximal portions of the clamp members from the delivery state to the deployed state wherein the proximal portions of the clamp members rotate laterally away from each other to press against an interior surface of the first bodily wall;

compressing the first and second bodily walls together and holding them proximate to each other after the clamp members have been rotated to the deployed state; and

,

after compressing the first and second bodily walls together, simultaneously cutting the tissue of the first and second bodily walls to enlarge the size of the stomas.

20. The method of claim 19 wherein the pressure exerted by the clamp members in their deployed states maintains the stoma of the first bodily wall adjacent to the stoma of the second bodily wall.

21. The method of claim 19 wherein the two bases of the apparatus maintain the stomas of the first and second bodily walls.

22. The method of claim 19 wherein the bases are comprised of degradable or resorbable materials.

23. The method of claim 19 wherein the distal portions of the clamp members rotate to the deployed state after releasing a first retainer, and the proximal portions of the clamp members rotate to the deployed state after releasing a second retainer, or alternatively further releasing the first retainer.