Apparatus and methods for positioning and securing anchors

• US 7,736,378 B2
• Filed: 05/07/2004
• Issued: 06/15/2010
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: USGI Medical, Inc., USGI Medical Incorporated
• Original Assignee: USGI Medical, Inc.
• Inventors: Peh, Ruey-Feng, Khairkhahan, Alexander, Saadat, Vahid, Ewers, Richard C., Maahs, Tracy D., Flores, Jesus, Lam, Cang C.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/841,245
• Publication Number:
  US 20050251206A1
• Time in Patent Office: 2,230 Days
• Field of Search: 606/232, 606/233, 606/213, 606/220, 606/72, 606/74, 606/103, 227/66, 227/67, 241/15.R, 241/27, 241/28, 241/30, 241/31.R, 241/29.B, 241/29.C, 241/36.R, 411/29, 411/37
• US Class Current: 606/232
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• 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 2017/0459 : Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• 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 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 : with pre-tied sutures
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06028 : by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: Y10T 24/39 : Cord and rope holders
• CPC Class Codes: Y10T 24/3936 : Pivoted part
• CPC Class Codes: Y10T 24/3969 : Sliding part or wedge

Abstract

Apparatus and methods for positioning and securing anchors are disclosed herein. The anchors are adapted to be delivered and implanted into or upon tissue, particularly tissue within the gastrointestinal system of a patient. The anchor is adapted to slide uni-directionally over suture such that a tissue plication may be cinched between anchors. A locking mechanism either within the anchor itself of positioned proximally of the anchor may allow for the uni-directional translation while enabling the anchor to be locked onto the suture if the anchor is pulled, pushed, or otherwise urged in the opposite direction along the suture. This uni-directional anchor locking mechanism facilitates the cinching of the tissue plication between the anchors and it may be utilized in one or several anchors in cinching a tissue fold.

Claims

1. An anchor assembly for implantation in a body, comprising:

an anchor body adapted to be delivered through a hollow member for placement against a tissue surface;

a locking mechanism comprising a substantially cylindrical body having a proximal end and a distal end and defining a lumen for passage of a flexible member therethrough, and

a flexible member extending through at least a portion of said anchor body and through the lumen of said locking mechanism;

wherein substantially all of the locking mechanism is positioned proximally of and is separate from the anchor body and is slidably disposed on the flexible member, and wherein the locking mechanism has at least two arms biased to project in substantially opposing directions into the lumen for contact against the flexible member, with a first of the two arms being nearer to the proximal end of the cylindrical body and the second of the two arms being nearer to the distal end of the cylindrical body, such that the flexible member is uni-directionally advancable through the lumen relative to the anchor body.

2. The anchor of claim 1 wherein the anchor body comprises a T-anchor.

3. The anchor of claim 2 wherein the T-anchor has a cross-sectional shape selected from the group consisting of circles, rectangles, and squares.

4. The anchor of claim 1 wherein the anchor body comprises a basket anchor.

5. The anchor of claim 4 wherein the basket anchor is reconfigurable from a delivery configuration within the hollow member to an expanded configuration outside the hollow member.

6. The anchor of claim 1 wherein the hollow member is selected from the group consisting of tubular members, catheters, needles, and trocars.

7. The anchor of claim 1 wherein the flexible member comprises a length of suture.

8. The anchor of claim 7 wherein the length of suture comprises a monofilament, multifilament, elastic, or elastomeric material.

9. The anchor of claim 7 wherein the length of suture comprises a metallic material.

10. The anchor of claim 9 wherein the metallic material is selected from the group consisting of Nitinol, stainless steel, and Titanium.

11. The anchor of claim 1 wherein the at least two arms are each adapted to pivot about a base into an open position when the anchor body is advanced distally relative to the flexible member.

12. The anchor of claim 1 wherein the at least two arms are each adapted to pivot about a base into a closed position when the anchor body is advanced proximally relative to the flexible member.

13. The anchor of claim 1 wherein the locking mechanism is adapted to automatically impart the locking force upon the flexible member.

14. The anchor of claim 1 wherein the biased arms are adapted to cinch the flexible member against a surface of the lumen.

15. The anchor of claim 1 wherein the biased arms project at an angle proximally of the anchor body.

16. The anchor of claim 1 further comprising a plurality of additional arms each biased to project into the lumen.

17. The anchor of claim 16 wherein the plurality of additional arms are positioned in apposition to one another.

18. The anchor of claim 1 wherein the biased arms are adapted to project partially into the lumen.

19. An anchor assembly for implantation in a body, comprising:

an anchor body adapted to be delivered through a hollow member for placement against a tissue surface;

a locking mechanism comprising a substantially cylindrical body having a proximal end and a distal end, substantially all of which is positioned proximally of and which is separate from the anchor body, the substantially cylindrical body having at least two arms biased to project in substantially opposing directions at an angle relative to the anchor body, with a first of the two arms being nearer to the proximal end of the cylindrical body and the second of the two arms being nearer to the distal end of the cylindrical body, the locking mechanism defining a lumen therethrough, and

a flexible member extending through at least a portion of said anchor body and through the lumen of said locking mechanism;

wherein the arms define an opening for passage of the flexible member therethrough such that the flexible member is uni-directionally advancable through the opening relative to the anchor body.

20. The anchor of claim 19 wherein the anchor body comprises a T-anchor.

21. The anchor of claim 20 wherein the T-anchor has a cross-sectional shape selected from the group consisting of circles, rectangles, and squares.

22. The anchor of claim 19 wherein the anchor body comprises a basket anchor.

23. The anchor of claim 22 wherein the basket anchor is reconfigurable from a delivery configuration within the hollow member to an expanded configuration outside the hollow member.

24. The anchor of claim 19 wherein the hollow member is selected from the group consisting of tubular members, catheters, needles, and trocars.

25. The anchor of claim 19 wherein the flexible member comprises a length of suture.

26. The anchor of claim 25 wherein the length of suture comprises a monofilament, multifilament, elastic, or elastomeric material.

27. The anchor of claim 25 wherein the length of suture comprises a metallic material.

28. The anchor of claim 27 wherein the metallic material is selected from the group consisting of Nitinol, stainless steel, and Titanium.

29. The anchor of claim 19 wherein the at least two arms are each adapted to pivot about a base into an open position when the anchor body is advanced distally relative to the flexible member.

30. The anchor of claim 19 wherein the at least two arms are each adapted to pivot about a base into a closed position when the anchor body is advanced proximally relative to the flexible member.

31. The anchor of claim 19 wherein the locking mechanism is adapted to automatically impart the locking force upon the flexible member.

32. The anchor of claim 19 wherein the biased arms each project at an angle proximally of the anchor body.

33. The anchor of claim 19 wherein the opening is tapered.