Apparatus and methods for forming gastrointestinal tissue approximations

• US 20040116949A1
• Filed: 08/11/2003
• Published: 06/17/2004
• Est. Priority Date: 12/11/2002
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Brenneman, Rodney, Chen, Eugene, Ewers, Richard C., Reydel, Boris, Seybold, Brent D., Saadat, Vahid C., Lam, Cang
• Granted Patent: US 7,618,426 B2
• Time in Patent Office: Days
• US Class Current: 606/167
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point, moving the first tissue contact point from a position initially distal to a second tissue contact point to a position proximal of the second contact point to form a tissue fold, and extending an anchor assembly through the tissue fold near the second tissue contact point.

Claims

1. Apparatus for forming a tissue fold in a tissue wall of a gastrointestinal lumen, comprising:

a catheter having a flexible tube with a distal region, the catheter adapted to be inserted via a patient'"'"'s esophagus to position the distal region in the patient'"'"'s gastrointestinal lumen;

a tissue grabbing assembly disposed on the distal region, the tissue grabbing assembly defining a first tissue contact point for engaging a tissue wall of the patient'"'"'s gastrointestinal lumen;

a second tissue contact point disposed on the distal region at a location initially proximal of the first tissue contact point; and

means for moving the first tissue contact point to a tissue engaging position proximal of the second tissue contact point to a tissue folding position proximal of the second tissue contact point to form a tissue fold.

2. The apparatus of claim 1, wherein the tissue grabbing assembly comprises one or more needles or barbs.

3. The apparatus of claim 1, wherein the tissue grabbing assembly comprises a pair of jaws movable between an open position and a closed position.

4. The apparatus of claim 1, wherein the tissue grabbing assembly comprises a treadmill assembly.

5. The apparatus of claim 1 wherein the means for moving the first tissue contact point between the tissue engaging position and the tissue folding position comprises a control wire.

6. The apparatus of claim 1 wherein the means for moving the first tissue contact point between the tissue engaging position and the tissue folding position comprises a hinge assembly.

7. The apparatus of claim 1 wherein the means for moving the first tissue contact point between the tissue engaging position and the tissue folding position comprises a conveyor.

8. The apparatus of claim 1 wherein the distal region further comprises a bendable section that enables the tissue fold to be disposed substantially perpendicular to the second tissue contact point.

9. The apparatus of claim 1 further comprising an anchor delivery system configured to pierce the tissue fold in the vicinity of the second tissue contact point.

10. The apparatus of claim 9 wherein the anchor delivery system comprises means for delivering an anchor assembly across the tissue fold.

11. The apparatus of claim 10, wherein the means for delivering an anchor assembly across the tissue fold is adapted to deliver the anchor assembly across the muscularis and serosa layers of the tissue wall.

12. The apparatus of claim 10 wherein the means for delivering an anchor assembly across the tissue fold further is configured to deploy an anchor assembly on a distal side of the tissue fold.

13. The apparatus of claim 9 wherein in the anchor delivery system comprises an anchor assembly disposed on or within a needle.

14. The apparatus of claim 13, wherein the anchor assembly comprises a pair of anchors coupled by a suture or wire.

15. The apparatus of claim 14, wherein at least one of the anchors comprises a rod having a reduced delivery profile in which a longitudinal axis of the rod is substantially parallel to a longitudinal axis of the needle.

16. The apparatus of claim 15, wherein the rod is configured to rotate about its longitudinal axis once deployed from the needle.

17. The apparatus of claim 14, wherein the wire is configured to be twisted to approximate the anchors.

18. The apparatus of claim 14, wherein at least one of the anchors comprises a semi-cylindrical base and a pivoting rod that may be articulated between expanded and reduced delivery profiles.

19. The apparatus of claim 14, wherein the anchors comprise oblong bodies.

20. A method of forming a tissue fold in a tissue wall of a gastrointestinal lumen, comprising:

providing a catheter having a flexible tube with a distal region defining a first tissue contact point and a second tissue contact point;

positioning the distal region in a gastrointestinal lumen so that the first tissue contact point is disposed adjacent a tissue wall;

engaging and stretching the tissue wall at the point of engagement with the first tissue contact point;

contacting the second tissue contact point against the tissue wall; and

moving the first tissue contact point from a position initially distal to the second tissue contact point to a position proximal of the second tissue contact point to form a tissue fold.

21. The method of claim 20, wherein the first tissue contact point comprises a tissue grabbing assembly and engaging and stretching the tissue wall at the point of engagement with the first tissue contact point comprises engaging and stretching the tissue wall with the tissue grabbing assembly.

22. The method of claim 20, wherein the tissue grabbing assembly comprises one or more needles or barbs, and engaging and stretching the tissue wall at the point of engagement with the first tissue contact point comprises engaging and stretching the tissue wall with the one or more needles or barbs.

23. The method of claim 21, wherein the tissue grabbing assembly comprises a treadmill assembly and engaging and stretching the tissue wall at the point of engagement with the first tissue contact point comprises engaging and stretching the tissue wall at a series of points along the treadmill assembly.

24. The method of claim 20 further comprising bending the distal region of the catheter so that the tissue fold is oriented substantially perpendicular to the second tissue contact point.

25. The method of claim 20 further comprising:

piercing the tissue wall in the vicinity of the second tissue contact point; and

delivering an anchor assembly across the tissue fold.

26. The method of claim 25, wherein delivering an anchor assembly across the tissue fold includes delivering the anchor assembly across the muscularis and serosa layers of the tissue wall.

27. The method of claim 25, wherein delivering an anchor assembly across the tissue fold further comprises delivering the anchor assembly along or through a needle or obturator.

28. The method of claim 25 wherein delivering an anchor assembly across the tissue fold further comprises deploying an anchor assembly on a distal side of the tissue fold.