Knotless bioabsorbable suture anchor system and method

• US 6,641,596 B1
• Filed: 10/18/2000
• Issued: 11/04/2003
• Est. Priority Date: 10/18/2000
• Status: Expired due to Term

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Lizardi, Jose′ E.
• Primary Examiner(s): Vanatta, A.
• Application Number:
  US09/691,685
• Time in Patent Office: 1,112 Days
• Field of Search: 606/232, 606/72, 606/73, 606/88, 606/96, 606/86, 606/139, 606/144, 606/148, 606/224, 606/225, 606/222, 606/228, 411/75, 411/80, 411/354, 411/355, 411/511
• US Class Current: 606/232
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0424 the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0432 the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0438 slotted, i.e. having a longitudinal slot for enhancing their elasticity
• 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: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• CPC Class Codes: Y10S 606/908 Bioabsorbable material
• CPC Class Codes: Y10S 606/91 Polymer

Abstract

A knotless suture system for anchoring tissue to bone is provided. The system includes a suture anchor configured to radially expand into bone. The suture anchor has a proximal end and a distal end with a bore formed therein. The system further includes a first loop of suture thread attached to the distal end of the suture anchor, a suture needle, and a second loop of suture thread attached to the needle and interlocked with the first loop of suture thread. The system also includes an expander pin that is configured and sized for insertion into the bore of the suture anchor, causing the anchor to radially expand from a first outer diameter to a second outer diameter. A method is also provided by which a detached tissue may be securely attached to bone in an anatomically correct position without the need to tie a knot.

Claims

1. A system for anchoring tissue to bone, comprising:

a suture anchor having proximal and distal ends, wherein a suture-engaging tip is present at the distal end of the anchor and a separate, radially expandable sleeve, having a bore formed longitudinally therein, is attached to the suture-engaging tip and forms a proximal end of the suture anchor;

a first loop of suture thread attached to the suture-engaging tip;

a second loop of suture thread interlocked with the first loop of suture thread; and

a suture needle having a first, tissue penetrating end and a second, trailing end, wherein the suture needle is attached to the second loop of suture thread.

2. The system of claim 1, further comprising an expander pin adapted to be inserted into the bore of the sleeve to effect radial expansion of the sleeve.

3. The system of claim 2, wherein the expandable sleeve has two substantially flat, longitudinally extending portions formed on opposite sides of the sleeve, between a proximal end and a distal end of the sleeve.

4. The system of claim 3, wherein a proximal end of the tip includes a first threaded region and a distal end of the sleeve includes a complementary threaded region, enabling the tip to be threadingly connected to the sleeve.

5. The system of claim 4, wherein the proximal end of the tip has an internally threaded bore formed therein.

6. The system of claim 5, wherein the first threaded region of the tip is formed on an outer surface of the tip.

7. The system of claim 6, further comprising an elongate insertion tool having a proximal, handle end, an externally threaded distal end that is matable with the internally threaded bore of the tip, and a shaft that is able to be disposed within the bore of the sleeve in a clearance fit.

8. The system of claim 7, wherein the expander pin has a longitudinal bore extending therethrough from a proximal end to a distal end thereof, the longitudinal bore having an inner diameter enabling it to be disposed on the shaft of the insertion tool in a first position proximally adjacent to and abutting the sleeve, and selectively moveable to a second position disposed between the shaft and an inner surface of the sleeve in an interference fit with the sleeve.

9. The system of claim 8, wherein the positioning of the expander pin in the second position causes the sleeve to radially expand from a first outer diameter to a second outer diameter.

10. The system of claim 9, wherein the difference between the first diameter and the second diameter is in the range of about 1.0 to 1.5 mm.

11. The system of claim 10, wherein the expander pin is formed from a bioabsorbable material.

12. The system of claim 11, wherein the pin is made from a material selected from the group consisting of polylactic acid and polysulfone.

13. The system of claim 11, wherein the expandable sleeve is formed from a polymeric material.

14. The system of claim 13, wherein the expandable sleeve is made from a material selected from the group consisting of high density polyethylene and polypropylene.

15. The system of claim 1, wherein the tip includes a suture thread-engaging groove for seating a portion of the first loop of suture thread.

16. The system of claim 1, wherein the expandable sleeve comprises at least one external surface feature effective to enhance bone engagement.

17. The system of claim 16, wherein the at least one surface feature comprises a plurality of ridges.

18. The system of claim 10, wherein the expander pin includes at least one surface feature effective to assist in the radial expansion of the sleeve.

19. The system of claim 18, wherein the at least one surface feature of the expander pin comprises a plurality of tapered ridges wherein a diameter of the expander pin at a distal part of the ridge is smaller than a diameter of the expander pin at a proximal part of the ridge.

20. A system for anchoring tissue to bone, comprising:

an expandable base member having a distal end and a proximal end, the proximal end having a bore extending longitudinally therein and at least part of the proximal end being selectively radially expandable;

a first loop of suture thread attached to the base member;

a second loop of suture thread interlocked with the first loop of suture thread;

a suture needle having a first, tissue penetrating end and a second, trailing end, wherein the suture needle is attached to the second loop of suture thread; and

an expander pin, selectively disposable within the bore of the base member to radially expand the base member from a first outer diameter to a second outer diameter.

21. The system of claim 20, wherein the distal end of the base member includes a suture thread-engaging groove.

22. The system of claim 20, wherein the proximal end of the base member includes two opposed sides, each having a longitudinally extending slit formed therein.

23. The system of claim 22, wherein the two opposed sides are substantially flat.

24. The system of claim 22, wherein the proximal end of the base member has two opposed, radially expandable sides, the radially expandable sides being adjacent to the two opposed sides.

25. The system of claim 24, wherein the two opposed radially expandable sides each have at least one bone engaging positive surface feature formed therein.

26. The system of claim 25, wherein the bone engaging positive surface feature is a ridge having a distally facing ramped surface and a proximally facing surface with an end wall that is substantially perpendicular to a longitudinal axis of the member base.

27. The system of claim 26, wherein the expander pin includes wedge-like positive surface features effective to interact with the longitudinally extending slits of the base member to radially expand the proximal end of the base member.

28. The system of claim 20, wherein the bore of the base member has internal threads formed at a distal portion of the bore.

29. The system of claim 28, further comprising an elongate insertion tool having a proximal, handle end, a distal end with external threads formed therein, wherein the external threads are complementary to the internal threads of the base member, and a shaft that is able to be disposed within the bore of the base member in a clearance fit.

30. The system of claim 29, wherein the insertion tool further includes a pusher member slidably mounted around the shaft, the pusher member having a distal end proximally adjacent to and abutting a proximal end of the expander pin, such that the pusher member can be selectively advanced to be positioned between the shaft and an inner surface of the proximal end of the base member to effect the radial expansion of the base member.

31. The system of claim 30, wherein the difference between the first diameter and the second diameter is in the range of 1.0 to 1.5 mm.

32. The system of claim 27, wherein the longitudinally extending slits of the base member have a shape complementary to the wedge-like positive surface features of the expander pin and a size sufficient to receive the wedge-like positive surface features.

33. The system of claim 32, wherein positioning the expansion pin within the base member causes an irreversible interlocking of the wedge-like positive surface within the longitudinally extending slits.

34. The system of claim 20, wherein the base member is formed from a bioabsorbable material.

35. The system of claim 34, wherein the bioabsorbable material is selected from the group consisting of polylactic acid and polysulfone.

36. The system of claim 20, wherein the expansion pin is formed from a bioabsorbable material.

37. The system of claim 36, wherein the bioabsorbable material is selected from the group consisting of polylactic acid and polysulfone.

38. A suture anchor, comprising:

a first component including a tip having a suture thread-engaging groove formed therein, and a through-hole extending through the tip in a direction transverse to a longitudinal axis of the suture anchor;

a second component having an external surface with at least one positive surface feature formed thereon, at least a portion of the second component being selectively radially expandable; and

a bore extending into the second component of the suture anchor from the proximal end thereof, the bore being parallel with the longitudinal axis of the suture anchor.

39. The suture anchor of claim 38, wherein the first component is separate from the second component.

40. The suture anchor of claim 39, wherein the first component and the second component are threadingly engaged with each other.

41. The suture anchor of claim 39, wherein the bore extends entirely through the second component of the suture anchor from a proximal end to a distal end thereof.

42. The suture anchor of claim 41, wherein the at least one positive surface feature comprises a plurality of wedge-like fins.

43. The suture anchor of claim 42, wherein each wedge-like fin has a ramped surface distal of a distal facing endwall that is substantially transverse to the longitudinal axis of the suture anchor.

44. The suture anchor of claim 43, wherein the suture anchor further comprises a separate expansion element having an outside diameter sufficient to fit within the bore of the second component in an interference fit to cause the second component to radially expand.

45. The suture anchor of claim 44, wherein the external surface of the expansion element has at least one positive surface feature effective to assist in the radial expansion of the second component from a first diameter to a second diameter.

46. The suture anchor of claim 45, wherein the positive surface feature is a wedge-like structure having a proximal portion that is raised relative to a distal end thereof.

47. The suture anchor of claim 46, wherein a distal portion of the bore includes internal threads.

48. The suture anchor of claim 39, wherein the tip is made from a material selected from the group consisting of polylactic acid and polysulfone.

49. The suture anchor of claim 39, wherein the second component is made from a material selected from the group consisting of high density polyethylene and polypropylene.

50. The suture anchor of claim 44, wherein the expansion element is bioabsorbable and is made from a material selected from the group consisting of polylactic acid and polysulfone.

51. The suture anchor of claim 45, wherein the difference between the first diameter and the second diameter is in the range of about 1.0 to 1.5 mm.

52. The suture anchor of claim 38, wherein the first and second components of the suture anchor are made from the same material and are integral with each other.

53. The suture anchor of claim 52, wherein a proximal end of the second component has longitudinally extending slits formed therein on opposite sides of the second component.

54. The suture anchor of claim 52, wherein the bore terminates proximal of the through-hole and does not communicate with the through-hole.

55. The suture anchor of claim 54, wherein the at least one positive surface feature comprises a plurality of wedge-like fins.

56. The suture anchor of claim 55, wherein each wedge-like fin has a ramped surface distal of a distal facing endwall that is substantially transverse to the longitudinal axis of the suture anchor.

57. The suture anchor of claim 56, wherein the suture anchor further comprises a separate expansion element having an outside diameter sufficient to enable the expansion element to fit within the bore of the second component in an interference fit to effect radial expansion of the second component from a first diameter to a second diameter.

58. The suture anchor of claim 57, wherein the external surface of the expansion element has at least one positive surface feature effective to assist in the radial expansion of the second component from the first diameter to the second diameter.

59. The suture anchor of claim 58, wherein the expansion element has at least two positive surface features on opposite sides of the expansion element and each positive surface feature includes at least one wedge-like structure having a proximal portion that is raised relative to a distal end thereof.

60. The suture anchor of claim 59, wherein each of the at least one wedge-like structures is complementary in shape to the slits of the suture anchor.

61. The suture anchor of claim 59, wherein each of the at least one wedge-like structures has dimensions that enable it to fit within and irreversibly interlock with the slits of the suture anchor.

62. The suture anchor of claim 57, wherein the difference between the first diameter and the second diameter is in the range of about 1.0 to 1.5 mm.

63. The suture anchor of claim 52, wherein the suture anchor is made from a material selected from the group consisting of high density polyethylene and polypropylene.

64. The suture anchor of claim 57, wherein the expansion element is bioabsorbable.

65. The suture anchor of claim 64, wherein the expansion element is made from a material selected from the group consisting of polylactic acid and polysulfone.