Apparatus and methods for forming and securing gastrointestinal tissue folds

• US 8,216,260 B2
• Filed: 08/25/2008
• Issued: 07/10/2012
• Est. Priority Date: 12/11/2002
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Lam, Cang C., Ewers, Richard C., Saadat, Vahid, Khairkhanan, Alexander
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US12/198,056
• Publication Number:
  US 20090018552A1
• Time in Patent Office: 1,415 Days
• Field of Search: 606/151, 606/153, 606/213, 606/215, 606/216, 606/220, 606/221, 606/232, 600/104
• US Class Current: 606/153
• 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;

a trap mechanism at the proximal anchor 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;

with the trap mechanism comprising a spring within the proximal anchor.

2. Apparatus for securing a tissue fold within a patient, comprising:

an elongated body;

a hollow needle moveable within the elongated body;

an anchor assembly passable through the hollow needle and having first and second anchors connected by a suture, with the second anchor having a housing and with the suture extending through the housing; and

at least one trapping element moveable within the housing and configured to allow movement of the second anchor relative to the first anchor in only one direction.

3. The apparatus of claim 2, with the at least one trapping element locking onto the suture only when tension is applied to the suture between the first and second anchors, and between the second anchor and a proximal end of the elongated body.

4. The apparatus of claim 2, with the suture moveable from a first position relative to the trapping element, wherein the suture is free to move in both distal and proximal directions, and a second position wherein the suture is free to move only in the proximal direction.

5. The apparatus of claim 2 with the suture extending through the trapping element.

6. The apparatus of claim 2 with the suture wrapping around the trapping element.

7. The apparatus of claim 2 with the trapping element comprising a spring.

8. The apparatus of claim 2 comprising two trapping elements within the housing moveable relative to each other.

9. The apparatus of claim 8 with the trapping elements comprising substantially parallel rods.

10. The apparatus of claim 9 with the housing comprising a cylinder and with the suture extending through openings in a cylindrical sidewall of the cylinder, and with the rods substantially parallel to a longitudinal axis of the cylinder.

11. The apparatus of claim 2 with the housing comprising a cylinder and with the suture extending through openings in a cylindrical sidewall of the cylinder.

12. The apparatus of claim 2 with the housing comprising a hollow tube.

13. Apparatus for securing a tissue fold within a patient, comprising:

an elongated body;

a hollow needle moveable within the elongated body;

an anchor assembly passable through the hollow needle and having first and second anchors connected by a suture, with the second anchor having a housing and with the suture extending through the housing; and

at least one trapping element moveable within the housing, and the suture extending through the trapping element.

14. Apparatus for securing a tissue fold within a patient, comprising:

an elongated body;

a hollow needle moveable within the elongated body;

an anchor assembly passable through the hollow needle and having first and second anchors connected by a suture, with the second anchor having a housing and with the suture extending through the housing; and

at least one trapping element comprising a spring moveable within the housing.

15. Apparatus for securing a tissue fold within a patient, comprising:

an elongated body;

a hollow needle moveable within the elongated body;

an anchor assembly passable through the hollow needle and having first and second anchors connected by a suture, with the second anchor having a housing and with the suture extending through the housing; and

at least two trapping elements within the housing moveable relative to each other, with the trapping elements comprising substantially parallel rods.

16. Apparatus for securing a tissue fold within a patient, comprising:

an elongated body;

a hollow needle moveable within the elongated body;

an anchor assembly passable through the hollow needle and having first and second anchors connected by a suture, with the second anchor having a housing comprising a cylinder and with the suture extending through openings in a cylindrical sidewall of the cylinder; and

at least two trapping elements within the housing and moveable relative to each other, and with the trapping elements comprising rods substantially parallel to a longitudinal axis of the cylinder.