Methods for reduction of a gastric lumen

• US 7,942,884 B2
• Filed: 07/01/2003
• Issued: 05/17/2011
• Est. Priority Date: 12/11/2002
• Status: Active Grant

• Current Assignee: USGI Medical, Inc., USGI Medical Incorporated
• Original Assignee: USGI Medical, Inc.
• Inventors: Vahid, Saadat, Brenneman, Rodney, Chen, Eugene, Ewers, Richard C.
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US10/612,491
• Publication Number:
  US 20040167546A1
• Time in Patent Office: 2,877 Days
• Field of Search: 606/153, 606/151, 606/144, 606/167, 606/139, 606232-236, 606/148, 128/898, 446/266, 446420-421
• US Class Current: 606/139
• 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 17/3468 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 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• 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

A method of reducing the cross-sectional area of a gastrointestinal lumen is provided wherein a delivery catheter having a needle, one or more anchors disposed within the needle and a suture coupled to each anchor is advanced into the gastrointestinal lumen, the needle extended through the tissue wall, and an anchor ejected from a distal tip of the needle through the tissue wall. The needle is then repositioned against an opposing tissue wall, another anchor deployed from the needle through the opposing tissue wall, and the tissue walls approximated by applying tension to the sutures.

Claims

1. A method for delivering an anchor for use in a gastric reduction system for reducing the cross-sectional area of a gastrointestinal lumen, comprising:

providing a delivery catheter having a needle translatably disposed therein, a distal end, a stabilization device disposed at the distal end and one or more anchors disposed within the needle, with at least one of the anchors comprising a sleeve of braided material and an eyelet for attaching the anchor to a suture;

advancing the delivery catheter into the gastrointestinal lumen;

engaging the stabilization device to a tissue wall of the gastrointestinal lumen;

advancing the needle through the tissue wall;

ejecting an anchor from a distal tip of the needle, the anchor having a suture attached thereto;

withdrawing the needle from the tissue wall whereby the suture is extended through the tissue wall; and

translating a fastener over the suture whereby a tension force is created on the suture and a tissue fold is maintained in the tissue wall.

2. The method of claim 1, further comprising:

providing an imaging element in the vicinity of the distal end of the delivery catheter; and

using the imaging element to provide visual guidance during engagement of the stabilization device to the tissue wall.

3. The method of claim 1, wherein ejecting an anchor from a distal tip of the needle comprises translating a push rod disposed in the needle.

4. The method of claim 1, wherein the stabilization device comprises a coil having a sharpened tip, and engaging the stabilization device to the tissue wall comprises rotating the coil to engage the coil into the tissue wall.

5. The method of claim 1, wherein advancing the needle through the tissue wall further comprises translating the needle distally through the delivery catheter.

6. A method comprising:

providing a delivery catheter including a piercing element within the catheter, one or more anchors within the catheter and a suture coupled to the anchors, with at least one of the anchors comprising a sleeve of braided material and an eyelet for coupling the anchor to the suture;

advancing the delivery catheter into the gastrointestinal tract of a patient;

advancing the piercing element through a first tissue wall, and then through a second tissue wall;

ejecting a first anchor from the piercing element on a first side of the first tissue wall, and ejecting a second anchor from the piercing element on a second side of the second tissue wall; and

advancing a fastener over the suture whereby a tension is applied to the suture, the fastener comprising a collar having a central channel through which the suture extends;

such that the first and second anchors and the suture hold the first tissue wall adjacent to the second tissue wall.

7. The method of claim 6, further comprising:

providing a stabilization device on the delivery catheter; and

engaging the stabilization device to the first tissue wall before advancing the catheter through the first tissue wall.

8. The method of claim 7, wherein the stabilization device comprises a tissue holding element.

9. The method of claim 6, further comprising:

providing an imaging element in the vicinity of the distal end of the delivery catheter; and

using the imaging element to provide visual guidance.

10. The method of claim 6 wherein bringing the first and second tissue walls adjacent results in reducing the cross sectional area of an opening in the patient.

11. The method of claim 6 wherein bringing the first and second tissue walls adjacent results in reducing the volume of an organ of the patient.

12. A method for creating a gastrointestinal tissue fold, comprising:

providing a delivery catheter having a translatable needle and an anchor disposed within the needle and a suture coupled to the anchor, the anchor comprising a sleeve of braided material and an eyelet for coupling the anchor to a suture;

engaging and pulling a tissue wall of the gastrointestinal lumen to create a tissue fold;

extending the needle through the tissue fold;

ejecting the anchor from the needle;

withdrawing the needle from the tissue fold whereby the suture is extended through the tissue fold;

translating a fastener over the suture; and

maintaining the tissue fold via the anchor and the suture.

13. The method of claim 12, further comprising:

providing a second anchor including a suture coupled thereto; and

creating a second tissue fold on an opposing tissue wall.

14. A method comprising:

moving a catheter into a patient;

holding a tissue fold within the patient;

extending a piercing element from the catheter through the tissue fold;

moving a first anchor out from the piercing element, on a first side of the tissue fold;

withdrawing the piercing element from the tissue fold;

moving a second anchor out from the piercing element, on a second side of the tissue fold, with at least one of the first anchor and the second anchor comprising a sleeve of braided material and an eyelet for coupling the anchor to a connection element;

holding the tissue fold via a connection element connecting the first and second anchors; and

advancing a fastener over said connection element to apply a tension force on said connection element.

15. The method of claim 14 wherein forming the tissue fold results in reducing the cross sectional area of a lumen in the patient.

16. The method of claim 14 wherein forming the tissue fold reduces the volume of an organ in the patient.

17. A method of creating a tissue fold comprising:

moving a catheter to a surgical site of a patient;

engaging and pulling a tissue wall to form a tissue fold;

pushing a piercing element extending out of the catheter through the tissue fold;

ejecting a first anchor from the piercing element;

withdrawing the piercing element from the tissue fold;

ejecting a second anchor from the piercing element, said second anchor being connected to said first anchor by a suture, with at least one of the first anchor and the second anchor comprising a sleeve of braided material and an eyelet for coupling the anchor to the suture; and

advancing a fastener over said suture to apply a tension force on said suture;

with the anchors and the suture maintaining the tissue fold.

18. A method comprising:

providing a system having a delivery catheter having a translatable needle and anchors disposed within the needle, and a suture coupled to the anchors, with at least one of the anchors comprising a sleeve of braided material and an eyelet for coupling the anchor to the suture;

engaging and pulling a tissue wall of the gastrointestinal tract of a patient to create a tissue fold;

extending the needle through the tissue fold;

placing an anchor on one side of the tissue fold;

releasing the tissue fold;

placing an anchor on the opposite side of the tissue fold, with the anchors connected to each other via the suture; and

advancing a fastener over said suture to apply a tension force on said suture;

with the anchors and suture maintaining the tissue fold after the tissue fold is released.

19. A method comprising:

moving a catheter into a patient;

holding a tissue fold within the patient;

extending a piercing element from the catheter through the tissue fold;

moving a first anchor out from the piercing element, on a first side of the tissue fold;

withdrawing the piercing element from the tissue fold;

moving a second anchor out from the piercing element, on a second side of the tissue fold, with at least one of the first anchor and the second anchor comprising a sleeve of braided material and an eyelet for coupling the anchor to a connection element; and

holding the tissue fold via a connection element connecting the first and second anchors.

20. A method comprising:

moving a catheter having a tissue grasper and a piercing element into a patient;

holding a tissue fold within the patient with the tissue grasper;

extending the piercing element from the catheter through the tissue fold;

moving a first anchor out from the piercing element, on a first side of the tissue fold;

withdrawing the piercing element from the tissue fold;

moving a second anchor out from the piercing element, on a second side of the tissue fold, with at least one of the first anchor and the second anchor comprising a sleeve of braided material and an eyelet for coupling the anchor to a connection element; and

holding the tissue fold via a connection element connecting the first and second anchors.