Compressible tissue anchor assemblies

• US 20060217762A1
• Filed: 04/14/2006
• Published: 09/28/2006
• Est. Priority Date: 06/09/2004
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Ewers, Richard C., Maahs, Tracy D., Elmer, Marvin C.
• Granted Patent: US 7,678,135 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped 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 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter

Abstract

Apparatus & methods for optimizing anchoring force are described herein. In securing tissue folds, over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable arms configured to minimize contact area between the anchor and tissue. When the anchor is in its expanded configuration, a load is applied to the anchor until it is optimally configured to accommodate a range of deflections while the anchor itself exerts a substantially constant force against the tissue. Various devices, e.g., stops, spring members, fuses, strain gauges, etc., can be used to indicate when the anchor has been deflected to a predetermined level within the optimal range. Moreover, other factors to affect the anchor characteristics include, e.g., varying the number of arms or struts of the anchor, positioning of the arms, configuration of the arms, the length of the collars, etc.

Claims

1. An anchor for securing tissue, comprising:

a proximal collar;

a distal collar;

a biased element connected to the proximal and distal collars and which is adapted to urge the collars toward one another; and

a mesh surface extending between the proximal and distal collars.

2. The anchor of claim 1 wherein the mesh surface is pre-formed to have one or more radially-biased bulges such that compression of the mesh surface from a delivery configuration to a securement configuration forms a circumferential ring which inhibits passage of the anchor through a tissue surface.

3. The anchor of claim 2 wherein the mesh surface is pre-formed to have at least two radially-biased bulges.

4. The anchor of claim 3 wherein the mesh surface is further pre-formed to have at least one inwardly biased portion between the two radially-biased bulges.

5. The anchor of claim 4 where the inwardly biased portion is adapted to form a first diameter which is less than a second diameter of the two radially-biased bulges.

6. The anchor of claim 4 further comprising a ring or band formed at or about the inwardly biased portion for facilitating formation of the circumferential ring.

7. The anchor of claim 1 wherein the biased element comprises a spring.

8. The anchor of claim 7 wherein the spring extends between the proximal and distal collars within the mesh surface.

9. The anchor of claim 7 wherein the spring is comprised of a metal, metal alloy, polymeric material, or combination thereof.

10. The anchor of claim 9 wherein the spring is comprised of a material selected from the group consisting of stainless steeel, nickel, titanium, nitinol, plastic, elastomers, polyurethane, and salastic materials.

11. The anchor of claim 1 further comprising a basket anchor disposed within the mesh surface.

12. The anchor of claim 1 further comprising a length of suture routed through the proximal and distal collars.

13. The anchor of claim 1 wherein the proximal and distal collars are formed from the terminal ends of the biased element such that the proximal and distal collars and the biased element form a continuous structure.

14. An anchoring system for securing tissue, comprising:

a proximal collar;

a distal collar;

a spring element connected to the proximal and distal collars and which is adapted to urge the collars toward one another;

a mesh surface extending between the proximal and distal collars and surrounding the spring element; and

a length of suture passing through each collar and through the spring element.

15. The system of claim 14 wherein the mesh surface is pre-formed to have one or more radially-biased bulges such that compression of the mesh surface from a delivery configuration to a securement configuration forms a circumferential ring which inhibits passage of the anchor through a tissue surface.

16. The system of claim 15 wherein the mesh surface is pre-formed to have at least two radially-biased bulges.

17. The system of claim 16 wherein the mesh surface is further pre-formed to have at least one inwardly biased portion between the two radially-biased bulges.

18. The system of claim 17 where the inwardly biased portion is adapted to form a first diameter which is less than a second diameter of the two radially-biased bulges.

19. The system of claim 17 further comprising a ring or band formed at or about the inwardly biased portion for facilitating formation of the circumferential ring.

20. The system of claim 14 further comprising a needle catheter having a lumen defined therethrough within which each of the collars, spring element, and mesh surface is positionable.

21. The anchor of claim 14 wherein the proximal and distal collars are formed from the terminal ends of the biased element such that the proximal and distal collars and the biased element form a continuous structure.

22. A tissue anchor system for securing tissue, comprising:

a first tissue anchor having a first proximal collar, a first distal collar, a first biased element connected to the proximal and distal collars and which is adapted to urge the collars toward one another, and a first mesh surface extending between the proximal and distal collars;

a second tissue anchor having a second proximal collar, a second distal collar, a second biased element connected to the proximal and distal collars and which is adapted to urge the collars toward one another, and a second mesh surface extending between the proximal and distal collars;

a length of suture passing through the first and second tissue anchors such that a terminal end of the suture is disposed distally of or attached to the first tissue anchor; and

a locking mechanism slidably disposed along the length of suture at a position proximally of or attached to the second tissue anchor.

23. The system of claim 22 wherein at least one of the first mesh surface and the second mesh surface is pre-formed to have one or more radially-biased bulges such that compression of the first and/or second mesh surfaces from a delivery configuration to a securement configuration forms a circumferential ring which inhibits passage of the first and/or second tissue anchor through a tissue surface.

24. The system of claim 23 wherein at least one of the first mesh surface and the second mesh surface is pre-formed to have at least two radially-biased bulges.

25. The system of claim 24 wherein at least one of the first mesh surface and the second mesh surface is further pre-formed to have at least one inwardly biased portion between the two radially-biased bulges.

26. The system of claim 22 wherein at least one of the first biased element and the second biased element comprises a spring.

27. The system of claim 26 wherein the spring extends between the first proximal and distal collars.

28. The system of claim 26 wherein the spring extends between the second proximal and distal collars.

29. The system of claim 22 wherein the first proximal and distal collars are formed from the terminal ends of the first biased element such that the first proximal and distal collars and the first biased element form a continuous structure.

30. The system of claim 29 wherein the second proximal and distal collars are formed from the terminal ends of the second biased element such that the second proximal and distal collars and the second biased element form a continuous structure.

31. The system of claim 22 wherein the terminal end of the suture comprises a knot or projection which is inhibited from passing through the first tissue anchor.

32. The system of claim 22 wherein the length of suture passes through the first biased element of the first tissue anchor and the second biased element of the second tissue anchor.

33. The system of claim 22 wherein the locking mechanism comprises a cinch adapted to slide uni-directionally along the length of suture towards the second tissue anchor.

34. A method of deploying a tissue anchor, comprising:

delivering a tissue anchor having a proximal collar, a distal collar, and a mesh surface having a low-profile configuration extending between the collars;

deploying the tissue anchor against a tissue surface such that the distal and proximal collars are approximated at least partially towards one another via a spring element connected therebetween and wherein the mesh surface conforms to a partially expanded configuration; and

tensioning a length of suture between the distal and proximal collars to further expand the mesh surface into a fully deployed configuration against the tissue surface.

35. The method of claim 34 wherein delivering comprises passing a needle body through at least one tissue fold.

36. The method of claim 34 wherein deploying comprises ejecting the tissue anchor from a needle body.

37. The method of claim 36 wherein deploying comprises ejecting at least two tissue anchors from the needle body.

38. The method of claim 34 wherein deploying comprises conforming the mesh surface to a partially expanded configuration having one or more radially-biased bulges where compression of the mesh surface forms a circumferential ring.

39. The method of claim 38 wherein conforming the mesh surface comprises partially expanding the mesh surface having at least two radially-biased bulges.

40. The method of claim 34 wherein prior to tensioning a length, further comprising:

delivering a second tissue anchor having a second proximal collar, a second distal collar, and a second mesh surface having a low-profile configuration extending between the collars; and

deploying the second tissue anchor against a second tissue surface such that the second distal and proximal collars are approximated at least partially towards one another via a second spring element connected therebetween and where the second mesh surface conforms to a partially expanded configuration.

41. The method of claim 40 wherein the second tissue surface is located on a tissue fold opposite to the tissue surface.

42. The method of claim 40 wherein the second tissue surface is located on a tissue fold separate from the tissue surface.

43. The method of claim 40 wherein the second tissue surface is located along an edge of a tissue opening in apposition to the tissue surface.

44. The method of claim 43 wherein the tissue opening is surgically created.

45. The method of claim 43 wherein the tissue opening is naturally occurring.