APPARATUS AND METHODS FOR FORMING AND SECURING GASTROINTESTINAL TISSUE FOLDS

• US 20090018552A1
• Filed: 08/25/2008
• Published: 01/15/2009
• Est. Priority Date: 12/11/2002
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Khairkhahan, Alexander, Saadat, Vahid C., Ewers, Rich, Lam, Cang
• Granted Patent: US 8,216,260 B2
• Time in Patent Office: Days
• 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 17/062 Needle manipulators
• 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 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• 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 2017/0458 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 2017/0462 One way system, i.e. also tensioning 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 2017/0649 : Coils or spirals
• 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
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

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. Adjustable anchor assemblies, as well as anchor delivery systems, are also provided.

Claims

1. Apparatus for securing a tissue fold within a patient, the apparatus comprising:

a plication apparatus having a distal region adapted to engage a tissue fold within a patient; and

an anchor assembly having proximal and distal anchors connected by a suture, said suture having a proximal end and a distal end, said anchor assembly being adapted for adjustment of the length of suture disposed between the proximal and distal anchors while the anchor assembly is disposed across the tissue fold;

an anchor delivery system adapted to deploy and secure the anchor assembly across the tissue fold, said anchor delivery system comprising a flexible delivery tube having a lumen, and a hollow needle disposed within the lumen;

wherein the anchor assembly passes through the hollow needle during delivery;

wherein the anchor delivery system further comprises a trap mechanism located substantially within a distal region of said anchor delivery system, said trap mechanism being adapted to reversibly trap the suture at or near its proximal end to facilitate adjustment of the length of suture disposed between the proximal and distal anchors, and wherein the trap mechanism is adapted to release the suture after the length of suture has been adjusted.

2. The apparatus of claim 1, further comprising an anchor pushrod in communication with an interior of the needle, the anchor pushrod adapted to eject the anchor assembly from the needle.

3. The apparatus of claim 1, further comprising a catheter, and wherein said anchor delivery system and said plication apparatus extend from a distal end of said cathether.

4. Apparatus for securing a tissue fold within a patient, the apparatus comprising:

an anchor delivery system adapted to deploy and secure an anchor assembly across a tissue fold, said anchor delivery system including an elongated body and a hollow needle disposed at or near a distal end of the elongated body;

wherein said anchor assembly has proximal and distal anchors connected by a suture, said suture having a proximal end and a distal end, said anchor assembly being adapted for adjustment of the length of suture disposed between the proximal and distal anchors while the anchor assembly is disposed across the tissue fold;

wherein the anchor delivery system further comprises a trap mechanism located substantially within a distal region of said anchor delivery system, said trap mechanism being adapted to reversibly trap the suture at or near its proximal end to facilitate adjustment of the length of suture disposed between the proximal and distal anchors, and wherein the trap mechanism is adapted to release the suture after the length of suture has been adjusted.

5. The apparatus of claim 4, further comprising a plication apparatus having a distal region adapted to engage a tissue fold within a patient.

6. The apparatus of claim 5, further comprising a catheter, and wherein said anchor delivery system and said plication apparatus extend from a distal end of said cathether.

7. The apparatus of claim 4, wherein the anchor assembly passes through the hollow needle during delivery.

8. The apparatus of claim 4, said anchor delivery system further comprising a flexible delivery tube having a lumen, with said elongated body disposed within the lumen.

9. Apparatus for securing a tissue fold within a patient, the apparatus comprising:

an anchor delivery system adapted to deploy and secure an anchor assembly across a tissue fold, said anchor delivery system including an elongated body and a hollow needle disposed at or near a distal end of the elongated body;

wherein said anchor assembly has proximal and distal anchors connected by a suture, said suture having a proximal end and a distal end, said anchor assembly being adapted for adjustment of the length of suture disposed between the proximal and distal anchors;

wherein the anchor delivery system further comprises a trap mechanism located substantially within a distal region of said anchor delivery system, said trap mechanism being adapted to reversibly trap the suture at or near its proximal end to facilitate adjustment of the length of suture disposed between the proximal and distal anchors, and wherein the trap mechanism is adapted to release the suture after the length of suture has been adjusted.

10. The apparatus of claim 9, further comprising a plication apparatus having a distal region adapted to engage a tissue fold within a patient.

11. The apparatus of claim 10, further comprising a catheter, and wherein said anchor delivery system and said plication apparatus extend from a distal end of said cathether.

12. The apparatus of claim 9, wherein the anchor assembly passes through the hollow needle during delivery.

13. The apparatus of claim 9, said anchor delivery system further comprising a flexible delivery tube having a lumen, with said elongated body disposed within the lumen.

14. A method for securing a tissue fold within a patient, the method comprising:

providing apparatus comprising an anchor assembly having proximal and distal anchors connected by an adjustable length of suture;

deploying the distal anchor on a distal side of the tissue fold;

deploying the proximal anchor on a proximal side of the tissue fold;

trapping a proximal end of the suture; and

adjusting the length of suture disposed between the proximal and distal anchors to secure the tissue fold.

15. The method of claim 14 further comprising:

providing an anchor delivery system;

disposing the anchor assembly within the anchor delivery system; and

advancing the anchor assembly to the tissue fold within the anchor delivery system, wherein adjusting the length of suture comprises adjusting the length of suture with the anchor delivery system.

16. The method of claim 15 further comprising:

providing plication apparatus; and

forming the tissue fold with the plication apparatus.

17. The method of claim 14, further comprising:

releasing the trapped proximal end of the suture.