Kit for forming implants in wall of gastrointestinal tract

• US 7,846,085 B2
• Filed: 02/23/2004
• Issued: 12/07/2010
• Est. Priority Date: 08/13/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Gough, Edward J., Stein, Alan, Silverman, David E.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/785,713
• Publication Number:
  US 20040249239A1
• Time in Patent Office: 2,479 Days
• Field of Search: 600/29, 600/30, 600/350, 600/343, 600/361, 600/154, 606/193, 606/139, 606/144, 604/27, 604/48, 604/514, 604/890.1, 604/891.1, 128/903, 424/422, 424/423, 424/426, 424/450, 424/489, 525/937
• US Class Current: 600/29
• CPC Class Codes: A61B 1/00089 Hoods
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 5/0069 in the wall of the stomach

Abstract

A kit for treating a gastrointestinal tract of a mammal and including a package and a tubular needle, an end piece and a container of an implant-forming material carried within the package. The end piece has an outer surface provided with at least one recess and an internal passageway communicating with the recess. The end piece is mounted on the distal extremity of an elongate probe member and introduced into the upper portion of the gastrointestinal tract. A portion of the wall of the gastrointestinal tract is drawn into the recess and the tubular needle is extended through the elongate probe member and the internal passageway into the portion of the wall in the recess. Material from the container is loaded into the tubular needle and injected into the portion of the wall to form an implant in the wall.

Claims

1. A kit for use with an elongate probe member having proximal and distal extremities and an end face provided with a diameter to treat a wall forming the upper portion of a gastrointestinal tract in a body of a mammal comprising a package, a tubular needle adapted for slidable disposition in the elongate probe member carried within the package and having proximal and distal end portions, an end piece adapted to mount to the distal extremity of the elongate probe member carried within the package, the end piece having a diameter at least as large as the diameter of the end face so as to overlie the end face and an outer cylindrical surface and being provided with at least one recess opening onto the outer cylindrical surface and an internal passageway communicating with the recess, and a container of an implant-forming material carried within the package whereby the end piece is mounted on the distal extremity of the elongate probe member and introduced into the upper portion of the gastrointestinal tract where a portion of the wall is drawn into the recess and whereby the tubular needle is extended through the internal passageway into the portion of the wall in the recess and material is loaded into the tubular needle and injected into the portion of the wall to form an implant in the wall.

2. The kit of claim 1 wherein the implant-forming material includes a solution having a biocompatible polymer and a biocompatible solvent.

3. The kit of claim 2 wherein the solution of the biocompatible polymer and the biocompatible solvent has a composition having from about 2.5 to about 8.0 weight percent of a biocompatible polymer, from about 10 to about 40 weight percent of a water insoluble biocompatible contrast agent and from about 52 to about 87.5 weight percent of a biocompatible solvent.

4. The kit of claim 1 wherein the implant-forming material includes a biocompatible prepolymer whereby the prepolymer polymerizes in situ to form the implant in the wall.

5. The kit of claim 1 wherein the container further includes a contrast agent for facilitating visualization of the implant in the wall.

6. A kit for use with an elongate probe member having proximal and distal extremities and an end face provided with a diameter to treat a wall forming the upper portion of a gastrointestinal tract in a body of a mammal comprising a package, a tubular needle adapted for slidable disposition in the elongate probe member carried within the package and having proximal and distal end portions, an end piece adapted to mount to the distal extremity of the elongate probe member carried within the package, the end piece having a diameter at least as large as the diameter of the end face so as to overlie the end face and an outer cylindrical surface and being provided with at least one recess opening onto the outer cylindrical surface and an internal passageway communicating with the recess, a syringe removably couplable to the proximal end portion of the tubular needle carried within the package and a container of a solution for forming a nonbiodegradable solid in the wall carried within the package whereby the end piece is mounted on the distal extremity of the elongate probe member and introduced into the upper portion of the gastrointestinal tract where a portion of the wall is drawn into the recess and whereby the tubular needle is extended through the internal passageway into the portion of the wall in the recess and solution is loaded by the syringe into the tubular needle and injected into the portion of the wall to form a nonbiodegradable solid in the wall.

7. The kit of claim 6 wherein the tubular needle has a length so that when the distal end portion is in the vicinity of the lower esophageal sphincter the proximal end portion is outside of the body.

8. The kit of claim 6 wherein the solution includes a biocompatible polymer and a biocompatible solvent.

9. The kit of claim 6 further comprising an additional container of a biocompatible solvent carried within the package.

10. The kit of claim 6 further comprising a delivery mechanism for supplying a plurality of discrete preselected amounts of the solution from the syringe to the tubular needle for introduction into the wall.

11. The kit of claim 6 wherein the solution includes a biocompatible prepolymer whereby the prepolymer polymerizes in situ to form the nonbiodegradable solid in the wall.

12. The kit of claim 11 wherein the solution includes a biocompatible solvent.

13. The kit of claim 6 wherein the solution is a nonaqueous solution.

14. The kit of claim 6 wherein the solution includes a contrast agent for facilitating visualization of the nonbiodegradable solid in the wall.

15. The kit of claim 6 wherein the recess extends circumferentially around the outer cylindrical surface.

16. The kit of claim 6 wherein the end piece is provided with a plurality of circumferentially spaced-apart recesses in the outer cylindrical surface.

17. A kit for use with an elongate probe member having proximal and distal extremities to treat a wall forming the upper portion of a gastrointestinal tract in a body of a mammal comprising a package, a tubular needle adapted for slidable disposition in the elongate probe member carried within the package and having proximal and distal end portions, an end piece adapted to mount to the distal extremity of the elongate probe member carried within the package, the end piece having an outer cylindrical surface and being provided with a recess extending circumferentially around the entire outer cylindrical surface and a container of an implant-forming material carried within the package whereby the end piece is mounted on the distal extremity of the elongate probe member and introduced into the upper portion of the gastrointestinal tract where a portion of the wall is drawn into the recess and whereby the tubular needle is extended into the portion of the wall in the recess and material is loaded into the tubular needle and injected into the portion of the wall to form an implant in the wall.

18. The kit of claim 17 wherein the implant-forming material includes a solution having a biocompatible polymer and a biocompatible solvent.

19. The kit of claim 17 wherein the implant-forming material includes a biocompatible prepolymer whereby the prepolymer polymerizes in situ to form the implant in the wall.

20. The kit of claim 17 wherein the container further includes a contrast agent for facilitating visualization of the implant in the wall.

21. A kit for use with an elongate probe member having proximal and distal extremities and an end face provided with a diameter to treat a wall forming the upper portion of a gastrointestinal tract in a body of a mammal comprising a package, a tubular needle adapted for slidable disposition in the elongate probe member carried within the package and having proximal and distal end portions, an end piece adapted to mount to the distal extremity of the elongate probe member carried within the package, the end piece having a diameter approximating the diameter of the end face so as to overlie the entire end face and an outer cylindrical surface and being provided with at least one recess opening onto the outer cylindrical surface and an internal passageway communicating with the recess, and implant-forming material carried within the package whereby the end piece is mounted on the distal extremity of the elongate probe member and introduced into the upper portion of the gastrointestinal tract where a portion of the wall is drawn into the recess and whereby the tubular needle is extended through the internal passageway into the portion of the wall in the recess and material is loaded into the tubular needle and injected into the portion of the wall to form an implant in the wall.

22. The kit of claim 21 wherein the implant-forming material includes a solution having a biocompatible polymer and a biocompatible solvent.

23. The kit of claim 22 wherein the solution of the biocompatible polymer and the biocompatible solvent has a composition having from about 2.5 to about 8.0 weight percent of a biocompatible polymer, from about 10 to about 40 weight percent of a water insoluble biocompatible contrast agent and from about 52 to about 87.5 weight percent of a biocompatible solvent.

24. The kit of claim 21 wherein the implant-forming material includes a biocompatible prepolymer whereby the prepolymer polymerizes in situ to form the implant in the wall.

25. The kit of claim 21 wherein the implant-forming material includes a contrast agent for facilitating visualization of the implant in the wall.

26. A kit for use with an elongate probe member having proximal and distal extremities and an end face provided with a diameter to treat a wall forming the upper portion of a gastrointestinal tract in a body of a mammal comprising a package, a tubular needle adapted for slidable disposition in the elongate probe member carried within the package and having proximal and distal end portions, an end piece adapted to mount to the distal extremity of the elongate probe member carried within the package, the end piece having a diameter approximating the diameter of the end face so as to overlie the entire end face and an outer cylindrical surface and being provided with at least one recess opening onto the outer cylindrical surface and an internal passageway communicating with the recess whereby the end piece is mounted on the distal extremity of the elongate probe member and introduced into the upper portion of the gastrointestinal tract where a portion of the wall is drawn into the recess and whereby the tubular needle is extended through the internal passageway into the portion of the wall in the recess.

27. The kit of claim 26 wherein the recess extends circumferentially around the outer cylindrical surface.

28. The kit of claim 26 wherein the end piece is provided with a plurality of circumferentially spaced-apart recesses in the outer cylindrical surface.