APPARATUS AND METHODS FOR FORMING GASTROINTESTINAL TISSUE APPROXIMATIONS

• US 20100010457A1
• Filed: 09/18/2009
• Published: 01/14/2010
• Est. Priority Date: 12/11/2002
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: SAADAT, Vahid C., SEYBOLD, Brent D., BRENNEMAN, Rodney, CHEN, Eugene, EWERS, Richard C., REYDEL, Boris, LAM, Cang
• Granted Patent: US 8,262,676 B2
• Time in Patent Office: Days
• US Class Current: 604/272
• 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
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• 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 proximal region and 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 at the distal region, the tissue grabbing assembly being configured to reversibly engage a tissue wall of the patient'"'"'s gastrointestinal lumen;

a first flexible tube disposed on the distal region such that the distal end of the first flexible tube is at a location initially proximal of the tissue grabbing assembly; and

an actuation mechanism for moving the tissue grabbing assembly to a tissue folding position proximal of the distal end of the first flexible tube to form a tissue fold, with the actuation mechanism including a pivot link attached to each of the tissue grabbing assembly and the first flexible tube and effecting a position of the tissue grabbing assembly relative to the distal end of the first flexible tube.

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 actuation mechanism for moving the tissue grabbing assembly between the tissue engaging position and the tissue folding position comprises a control wire.

5. The apparatus of claim 1 wherein the first flexible tube further comprises a bendable section that enables the tissue fold to be disposed substantially perpendicular to the distal end of the first flexible tube.

6. The apparatus of claim 1 further comprising an anchor delivery system configured to pierce the tissue fold in the vicinity of the distal end of the first flexible tube.

7. The apparatus of claim 6 wherein the anchor delivery system comprises a hollow needle for delivering an anchor assembly across the tissue fold.

8. The apparatus of claim 7, wherein the hollow needle 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.

9. The apparatus of claim 7 wherein the hollow needle 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.

10. The apparatus of claim 6 wherein the anchor delivery system comprises an anchor assembly disposed on or within a needle.

11. The apparatus of claim 10, wherein the anchor assembly comprises a pair of anchors coupled by a suture or wire.

12. The apparatus of claim 11, 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.

13. The apparatus of claim 12;

wherein the rod is configured to rotate about its longitudinal axis once deployed from the needle.

14. The apparatus of claim 11, wherein the wire is configured to be twisted to approximate the anchors.

15. The apparatus of claim 11, 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.

16. The apparatus of claim 11, wherein the anchors comprise oblong bodies.

17. Apparatus comprising:

a catheter;

a first tube attached to the catheter and having a bendable distal section;

a hollow needle within the first tube, with the hollow needle having a piercing tip;

a push rod within the hollow needle;

at least two anchor assemblies within the hollow needle, between the push rod and the piercing tip;

a second tube extendable through the catheter and having a bendable distal section;

a tissue grabber on the second tube; and

a link having a first end pivotally attached to the first tube and having a second end pivotally attached to the second tube, with the link limiting movement of the tissue grabber relative to the first tube.

18. The endoscopic apparatus of claim 17 with the second end of the link attached to the second tube between the tissue grabber and the bendable section of the second tube.

19. The apparatus of claim 17 with the first tube longitudinally fixed in position relative to the catheter.

20. The apparatus of claim 17 with the first tube having a distal end extending out of the catheter by a fixed length.

21. The apparatus of claim 17 with the link forming the only connection between the second tube and the first tube.

22. The apparatus of claim 17 with the first tube having a distal tip adjacent to the bendable section of the first tube, and with first end of the link pivotally attached to the first tube adjacent to the distal tip of the first tube, and with the second end of the link pivotally attached to the second tube adjacent to the tissue grabber.

23. The apparatus of claim 17 with the first tube having a distal tip, adjacent to the bendable front section of the first tube, and with the second tube moveable from an extended position where the distal tip of the first tube is substantially parallel with the second tube, and to the catheter, to a retracted position, where the distal tip of tile first tube is substantially perpendicular to a tissue fold grabbed by the tissue grabber.

24. Apparatus comprising:

a catheter;

a first tube attached to and longitudinally immovable relative to the catheter;

a bendable front section on the first tube;

a second tube longitudinally moveable relative to the first tube;

a bendable distal section on the second tube;

a tissue grabber on the second tube; and

a hinge assembly pivotally attaching the first tube to the second tube.