Interlocking tissue anchor apparatus and methods

• US 7,601,159 B2
• Filed: 09/30/2004
• Issued: 10/13/2009
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid, Ewers, Richard C., Maahs, Tracy D., Lam, Cang C., Rothe, Chris
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US10/955,244
• Publication Number:
  US 20050251202A1
• Time in Patent Office: 1,839 Days
• Field of Search: 606/153, 606/232, 606/213, 606/143, 606/139
• US Class Current: 606/139
• 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 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• 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 2017/0488 : 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 2017/06052 : 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 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue

Abstract

Interlocking tissue anchor apparatus and methods are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. Anchor assemblies can be delivered via the tissue manipulation assembly into or through the tissue. The anchors can incorporate various temporary interlocking features or spacing elements between one another to ensure that an anchor is not prematurely ejected from the needle assembly. This allows the anchor assembly to be advanced distally as well as withdrawn proximally within a deployment sheath while avoiding inadvertently ejecting an anchor.

Claims

1. A tissue anchor for controlled delivery by a delivery device having a lateral constraining member, comprising:

a first anchor body adapted for placement into or against a region of tissue, said first anchor body having a proximal collar, a distal collar, and a central portion extending between said proximal and distal collars, and with the proximal collar, distal collar, and central portion defining a lumen extending through the first anchor body;

a suture extending through the first anchor body lumen such that the first anchor body is able to be advanced over the suture;

a second member adapted for temporary engagement with the first anchor body and having a first position in which the second member is substantially aligned with the first anchor body;

a lateral constraining member in contact with each of said first anchor body and said second member and adapted to maintain the first anchor body and second member in the first position, said lateral constraining member comprising a flexible tubular sheath having a tissue penetrating tip at a distal end;

a first locking feature located on at least one end of the first anchor body which is adapted to interlock with a corresponding second locking feature on the second member when the first anchor body and the second member are in contact with the lateral constraining member and are in the first position, and which is adapted to release from the corresponding second locking feature on the second member when the first anchor body is not in contact with the lateral constraining member and the first anchor and second member are not maintained in the first position; and

a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members, wherein said flexible tubular sheath has a first position in which the tissue penetrating tip is located outside of the space between said first and second extension members and a second position in which the tissue penetrating tip is located within the space between said first and second extension members.

2. The tissue anchor of claim 1 wherein the anchor body has a first low-profile configuration when in contact with the lateral constraining member and a second expanded configuration when deployed from the lateral constraining member for placement into or against the region of tissue.

3. The tissue anchor of claim 1 wherein the anchor body is comprised of a shape memory alloy.

4. The tissue anchor of claim 3 wherein the anchor body is comprised of Nitinol.

5. The tissue anchor of claim 1 wherein the anchor body comprises a plurality of struts extending between the distal collar and the proximal collar.

6. The tissue anchor of claim 1 wherein the first locking feature is located on the proximal collar of the anchor body.

7. The tissue anchor of claim 6 wherein an additional locking feature is further located on the distal collar of the anchor body.

8. The tissue anchor of claim 6 wherein the corresponding second locking feature is located on a distal collar of a second anchor body collinearly adjacent proximal to the anchor body.

9. The tissue anchor of claim 8 wherein the second anchor body further comprises a third locking feature located on a proximal collar of the second anchor body.

10. The tissue anchor of claim 9 further comprising an elongate pusher having a fourth locking feature corresponding with the third locking feature of the second anchor body.

11. The tissue anchor of claim 1 wherein the corresponding second locking feature is located on a distal end of an elongate pusher.

12. The tissue anchor of claim 1 wherein the first locking feature comprises a curved proximal feature adapted to interlock with a corresponding second curved feature.

13. A tissue anchor assembly, comprising:

a first anchor, said first anchor having a proximal collar, a distal collar, and a central portion extending between said proximal and distal collars, and with the proximal collar, distal collar, and central portion defining a lumen extending through the first anchor;

a flexible element extending through the first anchor lumen such that the first anchor is able to be advanced over the flexible element;

a first interlocking feature on the first anchor;

a second anchor;

a second interlocking feature on the second anchor;

a delivery sheath having an inner surface in contact with an outer surface of the first anchor and an outer surface of the second anchor, said delivery sheath comprising a flexible tubular sheath having a tissue penetrating tip at a distal end;

with the first and second interlocking features holding the first and second anchors together while the first and second anchors are in contact with the inner surface of the delivery sheath, and allowing the first and second anchors to separate, when they are no longer in contact with the inner surface of the delivery sheath; and

a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members, wherein said flexible tubular sheath has a first position in which the tissue penetrating tip is located outside of the space between said first and second extension members and a second position in which the tissue penetrating tip is located within the space between said first and second extension members.

14. The assembly of claim 13 with the flexible element comprising at least one suture extending through the first anchor and the second anchor.

15. The assembly of claim 13 wherein the first and second interlocking features comprise circumferential tabs.

16. The assembly of claim 13 wherein the first and second interlocking features comprise curved tab features.

17. The assembly of claim 13 wherein the first anchor is adapted to reconfigure itself into an expanded configuration when released from the delivery sheath.

18. The assembly of claim 13 the first anchor having a first end and with the first interlocking feature adjacent to the first end of the first anchor, and with the second anchor having a second end and with the second interlocking feature adjacent to the second end of the second anchor.

19. A tissue anchor for use within a patient'"'"'s body, comprising:

a delivery sheath having an inner surface defining a lumen, said delivery sheath comprising a flexible tubular sheath having a tissue penetrating tip at a distal end;

a tissue anchor body having a first end and a second end, and with the tissue anchor body reconfigurable from a low profile delivery configuration to a radially expanded deployment configuration, said tissue anchor body having a first collar at the first end, a second collar at the second end, and a central portion extending between the first and second collars, and with the first collar, second collar, and central portion defining a lumen extending through the tissue anchor body;

a flexible element extending through the tissue anchor body lumen such that the tissue anchor body is able to be advanced over the flexible element;

a first interlocking element at the first end of the tissue anchor body adapted to interlock with a complementary interlocking element on an adjacent tissue anchor only when the tissue anchor body is within the delivery sheath lumen; and

a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members, wherein said flexible tubular sheath has a first position in which the tissue penetrating tip is located outside of the space between said first and second extension members and a second position in which the tissue penetrating tip is located within the space between said first and second extension members.

20. The tissue anchor of claim 19 further comprising a second interlocking element at the second end of the tissue anchor body, with the second interlocking element symmetrical with the first interlocking element.

21. The tissue anchor of claim 19 wherein the tissue anchor body is substantially tubular when in the low profile delivery configuration.

22. The tissue anchor of claim 19 with the first interlocking element on the first collar and with a second interlocking element on the second collar.