Methods and apparatus for creating and regulating a gastric stoma

• US 20050192629A1
• Filed: 02/14/2005
• Published: 09/01/2005
• Est. Priority Date: 06/25/1999
• Status: Abandoned Application

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid, Brenneman, Rodney, Ewers, Richard C., Maahs, Tracy D., Swanstrom, Lee L.
• Application Number:
  US11/058,739
• Publication Number:
  US 20050192629A1
• Time in Patent Office: Days
• US Class Current: 606/221
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0403 Dowels other bone dowels A61B17/68; dowels for connecting prosthetic parts A61F2002/30433
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/1142 Purse-string sutures
• CPC Class Codes: A61F 5/0046 with wireless means
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

Apparatus and methods are provided for creating and regulating a gastric stoma by intraluminally reducing or partitioning a local cross-sectional area of the stomach, thereby inducing weight loss in obese patients. Various embodiments of stomas in accordance with the present invention are provided, as well as various regulation mechanisms for controlling or adjusting the size of the stoma.

Claims

1. A flow restriction apparatus for placement within a hollow body organ, comprising:

a plurality of anchors slidingly inter-connected via a drawstring,

wherein the plurality of anchors is adapted to adhere to an interior tissue wall within a hollow body organ, and

wherein each of the plurality of anchors is further adapted to draw towards an adjacent anchor upon tensioning of the partition such that the hollow body organ is restricted.

2. The apparatus of claim 1 further comprising a motor operably connected to the drawstring and adapted to tension the partition relative to the plurality of anchors.

3. The apparatus of claim 2 further comprising a reel about which the drawstring is wound and which is coupled to the motor.

4. The apparatus of claim 2 further comprising a power source in electrical communication with the motor.

5. The apparatus of claim 1 wherein each anchor comprises a substrate and a plurality of barbs adapted to adhere to the interior tissue wall, the plurality of barbs extending from a surface of the substrate.

6. The apparatus of claim 5 wherein the substrate comprises a flexible sheet of biocompatible material.

7. The apparatus of claim 1 wherein each anchor comprises a fixture point thereon or therein through which the partition is slidably disposed.

8. The apparatus of claim 7 wherein the fixture point comprises an eyelet through which the partition is threaded.

9. The apparatus of claim 1 further comprising a fastener slidably disposed along the drawstring.

10. The apparatus of claim 9 wherein the fastener is adapted to slide uni-directionally along the partition.

11. The apparatus of claim 1 further comprising a cuff adjacently positioned relative to the plurality of anchors and configured to engage the interior tissue wall and adapted to direct food to pass therethrough.

12. The apparatus of claim 1 wherein the plurality of anchors comprise a sieve-like configuration having partitions adapted to hinder the passage of food therethrough.

13. The apparatus of claim 1 wherein the plurality of anchors comprise an adjustable iris diaphragm valve having a plurality of overlapping elements rotatably coupled thereto.

14. A flow restriction system for distributing a force applied to a stoma within a hollow body organ, comprising:

a biocompatible mesh adapted to be formed about a stoma formed from tissue within the hollow body organ, the mesh being further adapted to distribute a force from the tissue surrounding the stoma over the mesh; and

a plurality of tissue anchors for adhering the mesh to the tissue surrounding the stoma.

15. The system of claim 14 wherein the mesh comprises a strip for placement against the tissue surrounding the stoma.

16. The system of claim 15 wherein the mesh strip has a length sufficient to extend along a length of a tissue ridge extending proximally of the stoma within the hollow body organ.

17. The system of claim 16 further comprising a second biocompatible mesh strip having a length sufficient to extend along a length of a second tissue ridge extending proximally of the stoma adjacent to the tissue ridge.

18. The system of claim 14 wherein the mesh has a tubular shape adapted for placement through the stoma.

19. The system of claim 18 wherein the tubular-shaped mesh is adapted to dynamically adjust its diameter when food is passed through the stoma.

20. The system of claim 18 wherein the tubular-shaped mesh comprises one or more collars adapted to limit the dynamic adjustment of the diameter.

21. The system of claim 18 further comprising a spring disposed over the mesh for limiting the dynamic adjustment of the diameter.

22. The system of claim 14 wherein the tissue anchors each comprise discrete anchors interconnected via a length of suture passing through the tissue surrounding the stoma.

23. A method of restricting flow through a stoma within a hollow body organ, comprising:

advancing a biocompatible mesh endoluminally into the hollow body organ;

forming the mesh onto tissue surrounding a stoma formed from tissue within the hollow body organ; and

securing the mesh onto the tissue.

24. The method of claim 23 wherein advancing a biocompatible mesh comprises advancing the mesh transesophageally into a stomach.

25. The method of claim 23 wherein forming the mesh onto tissue comprises positioning the mesh over the tissue surrounding the stoma.

26. The method of claim 23 wherein forming the mesh onto tissue comprises placing a tubularly-shaped mesh through the stoma.

27. The method of claim 26 further comprising dynamically adjusting a diameter of the tubularly-shaped mesh when food is passed therethrough.

28. The method of claim 27 further comprising limiting the dynamic adjustment of the diameter via one or more collars formed over the mesh.

29. The method of claim 27 further comprises limiting the dynamic adjustment of the diameter via a spring disposed over the mesh.

30. The method of claim 23 wherein forming the mesh onto tissue comprises positioning the mesh onto a length of a tissue ridge extending proximally of the stoma within the hollow body organ.

31. The method of claim 23 further comprising distributing a force experienced by the tissue surrounding the stoma via the mesh.