Method and apparatus for attaching tissue to bone, including the provision and use of a novel knotless suture anchor system

• US 10,092,285 B2
• Filed: 10/06/2015
• Issued: 10/09/2018
• Est. Priority Date: 07/17/2009
• Status: Active Grant

• Current Assignee: Stryker Puerto Rico Holdings BV (Stryker Corporation)
• Original Assignee: Pivot Medical, Inc. (Stryker Corporation)
• Inventors: Graul, Jeremy, Burley, J. Brook, Lantz, Andrew, Flom, James
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/876,091
• Publication Number:
  US 20160157848A1
• Time in Patent Office: 1,099 Days
• 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 2017/0422 by insertion of a separate member into the body of the anchor
• CPC Class Codes: A61B 2017/0424 the separate member staying in the anchor after placement
• 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 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot

Abstract

Apparatus for securing a suture to a bone, the apparatus comprising an elongated body having a distal end, a proximal end, and a lumen extending between the distal and proximal ends, the lumen comprising a distal section and a proximal section, the distal section having a wider diameter than the proximal section; an elongated element extending through the lumen; and a locking element mounted to the distal end of the elongated element and disposed in the distal section of the lumen; whereby, when the elongated body is disposed in bone, and a suture extends through at least a portion of the lumen, and the locking element is thereafter moved proximally, proximal movement of the locking element causes the elongated body to capture the suture to the elongated body, whereby to secure the suture to the bone.

Claims

1. Apparatus for securing a suture to a bone, the apparatus comprising:

an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen;

a window extending through the side wall of the elongated body and communicating with the lumen, the window being disposed in the vicinity of the intersection between the distal section of the lumen and the proximal section of the lumen and being sized to receive a suture therein;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end, wherein the elongated element comprises a stepped configuration having an enlarged distal section and a reduced proximal section; and

a locking element connected to the distal end of the elongated element and disposed in the distal section of the lumen;

whereby, when the elongated body is disposed in a bone, and a suture extends through the window, and the locking element is thereafter moved proximally, proximal movement of the locking element causes the locking element to capture the suture to the elongated body, whereby to secure the suture to the bone;

wherein the enlarged distal section of the elongated element is configured to pull through the locking element upon application of an appropriate force, whereby to separate the elongated element from the locking element before the locking element exits the proximal end of the elongated body.

2. Apparatus according to claim 1 wherein the locking element has a diameter greater than the proximal section of the lumen, whereby proximal movement of the locking element causes the elongated body to expand.

3. Apparatus according to claim 1 wherein the locking element has a diameter approximately equal to the proximal section of the lumen.

4. Apparatus according to claim 1 wherein the axis of the locking element is offset from the axis of the elongated body.

5. Apparatus according to claim 1 wherein the suture is attached to tissue.

6. Apparatus according to claim 1 wherein the elongated body comprises an external flat proximal to, and aligned with, the window.

7. Apparatus according to claim 1 wherein the elongated element comprises a rod.

8. Apparatus according to claim 1 wherein the locking element comprises a bore, and further wherein the elongated element is received in the bore.

9. Apparatus according to claim 1 wherein the force required to pull the locking element to capture the suture to the elongated body is less than the force required to pull the locking element out of the elongated body.

10. Apparatus according to claim 1 wherein the force required to pull the elongated element out of the elongated body is less than the force required to pull the locking element out of the elongated body.

11. Apparatus according to claim 1 wherein the locking element comprises a weakened section at its proximal end, and further wherein the weakened section is configured to break away from the remainder of the locking element when the enlarged distal section of the elongated element pulls through the locking element.

12. Apparatus according to claim 1 wherein the outside of the locking element comprises a plurality of ribs.

13. Apparatus according to claim 1 further comprising an inserter for manipulating the elongated body, wherein the inserter comprises a hollow tube having a lumen extending therethrough, wherein the lumen of the hollow tube communicates with the lumen of the elongated body, and further wherein the elongated element extends through the lumen of the hollow tube.

14. Apparatus according to claim 13 wherein the proximal end of the elongated element terminates in the inserter.

15. Apparatus according to claim 13 wherein the hollow tube comprises a window extending through the side wall of the hollow tube and communicating with the lumen of the hollow tube, the window being sized to receive a suture therein.

16. Apparatus according to claim 13 wherein the elongated body is held to the inserter by applying proximally-directed tension to the elongated element.

17. Apparatus according to claim 1 wherein the locking element comprises a stepped bore having an enlarged distal section and a reduced proximal section, and further wherein the enlarged distal section of the elongated element is sized to be received in the enlarged distal section of the locking element, and the reduced proximal section of the elongated element is sized to be received in the reduced proximal section of the locking element.

18. Apparatus according to claim 17 wherein the enlarged distal section of the elongated element has a larger diameter than the reduced proximal section of the locking element.

19. A method for securing a suture to a bone, the method comprising:

providing apparatus comprising;

an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen;

a window extending through the side wall of the elongated body and communicating with the lumen, the window being disposed in the vicinity of the intersection between the distal section of the lumen and the proximal section of the lumen and being sized to receive a suture therein;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end, wherein the elongated element comprises a stepped configuration having an enlarged distal section and a reduced proximal section; and

a locking element connected to the distal end of the elongated element and disposed in the distal section of the lumen;

extending the suture through the window;

positioning the elongated body in the bone; and

moving the locking element proximally, such that proximal movement of the locking element causes the locking element to capture the suture to the elongated body, whereby to secure the suture to the bone;

wherein the enlarged distal section of the elongated element is configured to pull through the locking element upon application of an appropriate force, whereby to separate the elongated element from the locking element before the locking element exits the proximal end of the elongated body.

20. A method according to claim 19 wherein proximal movement of the locking element expands the elongated body against the bone.

21. Apparatus for securing a suture to a bone, the apparatus comprising:

an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen;

a window extending through the side wall of the elongated body and communicating with the lumen, the window being disposed in the vicinity of the intersection between the distal section of the lumen and the proximal section of the lumen and being sized to receive a suture therein;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end, wherein the elongated element comprises a stepped configuration having an enlarged distal section and a reduced proximal section; and

a locking element connected to the distal end of the elongated element and disposed in the distal section of the lumen;

whereby, when the elongated body is disposed in a bone, and a suture extends through the window, and the locking element is thereafter moved proximally, proximal movement of the locking element causes the locking element to capture the suture to the elongated body, whereby to secure the suture to the bone;

wherein the elongated element is configured to disconnect from the locking element before the locking element exits the proximal end of the elongated body;

wherein the locking element comprises a stepped bore having an enlarged distal section and a reduced proximal section, and further wherein the enlarged distal section of the elongated element is sized to be received in the enlarged distal section of the locking element, and the reduced proximal section of the elongated element is sized to be received in the reduced proximal section of the locking element.

22. Apparatus according to claim 21 wherein the enlarged distal section of the elongated element has a larger diameter than the reduced proximal section of the locking element.

23. Apparatus for securing a suture to a bone, the apparatus comprising:

an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end, wherein the elongated element comprises a stepped configuration having an enlarged distal section and a reduced proximal section; and

a locking element connected to the distal end of the elongated element and disposed in the distal section of the lumen;

whereby, when the elongated body is disposed in a bone, and a suture extends through at least a portion of the lumen of the elongated body, and the locking element is thereafter moved proximally, proximal movement of the locking element causes the locking element to capture the suture to the elongated body, whereby to secure the suture to the bone;

wherein the enlarged distal section of the elongated element is configured to pull through the locking element upon application of an appropriate force, whereby to separate the elongated element from the locking element after the locking element captures the suture to the elongated body.

24. Apparatus according to claim 23 wherein the locking element has a diameter greater than the proximal section of the lumen, whereby proximal movement of the locking element causes the elongated body to expand.

25. Apparatus according to claim 23 wherein the locking element has a diameter approximately equal to the proximal section of the lumen.

26. Apparatus according to claim 23 wherein the axis of the locking element is offset from the axis of the elongated body.

27. Apparatus according to claim 23 wherein the suture is attached to tissue.

28. Apparatus according to claim 23 wherein the elongated element comprises a rod.

29. Apparatus according to claim 23 wherein the locking element comprises a bore, and further wherein the elongated element is received in the bore.

30. Apparatus according to claim 23 wherein the force required to pull the locking element to capture the suture to the elongated body is less than the force required to pull the locking element out of the elongated body.

31. Apparatus according to claim 23 wherein the force required to pull the elongated element out of the elongated body is less than the force required to pull the locking element out of the elongated body.

32. Apparatus according to claim 23 wherein the locking element comprises a weakened section at its proximal end, and further wherein the weakened section is configured to break away from the remainder of the locking element when the enlarged distal section of the elongated element pulls through the locking element.

33. Apparatus according to claim 23 wherein the outside of the locking element comprises a plurality of ribs.

34. Apparatus according to claim 23 further comprising an inserter for manipulating the elongated body, wherein the inserter comprises a hollow tube having a lumen extending therethrough, wherein the lumen of the hollow tube communicates with the lumen of the elongated body, and further wherein the elongated element extends through the lumen of the hollow tube.

35. Apparatus according to claim 34 wherein the proximal end of the elongated element terminates in the inserter.

36. Apparatus according to claim 34 wherein the hollow tube comprises a window extending through the side wall of the hollow tube and communicating with the lumen of the hollow tube, the window being sized to receive a suture therein.

37. Apparatus according to claim 34 wherein the elongated body is held to the inserter by applying proximally-directed tension to the elongated element.

38. Apparatus according to claim 23 wherein the locking element comprises a stepped bore having an enlarged distal section and a reduced proximal section, and further wherein the enlarged distal section of the elongated element is sized to be received in the enlarged distal section of the locking element, and the reduced proximal section of the elongated element is sized to be received in the reduced proximal section of the locking element.

39. Apparatus according to claim 38 wherein the enlarged distal section of the elongated element has a larger diameter than the reduced proximal section of the locking element.

40. A method for securing a suture to a bone, the method comprising:

providing apparatus comprising;

an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end, wherein the elongated element comprises a stepped configuration having an enlarged distal section and a reduced proximal section; and

a locking element connected to the distal end of the elongated element and disposed in the distal section of the lumen;

extending the suture through at least a portion of the lumen of the elongated body;

positioning the elongated body in the bone;

moving the locking element proximally, such that proximal movement of the locking element causes the locking element to capture the suture to the elongated body, whereby to secure the suture to the bone; and

applying an appropriate force to pull the enlarged distal section of the elongated element through the locking element, whereby to separate the elongated element from the locking element after the locking element captures the suture to the elongated body.

41. A method according to claim 40 wherein the locking element has a diameter approximately equal to the proximal section of the lumen.

42. A method according to claim 40 wherein the elongated element comprises a rod.

43. A method according to claim 40 wherein the locking element comprises a stepped bore having an enlarged distal section and a reduced proximal section, wherein the enlarged distal section of the elongated element is sized to be received in the enlarged distal section of the locking element, and the reduced proximal section of the elongated element is sized to be received in the reduced proximal section of the locking element, and further wherein the enlarged distal section of the elongated element has a larger diameter than the reduced proximal section of the locking element.

44. A method according to claim 40 wherein the force required to pull the locking element to capture the suture to the elongated body is less than the force required to pull the locking element out of the elongated body.

45. A method according to claim 40 wherein the force required to pull the elongated element out of the elongated body is less than the force required to pull the locking element out of the elongated body.