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

• US 9,149,268 B2
• Filed: 03/14/2013
• Issued: 10/06/2015
• 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): Dornbusch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US13/830,501
• Publication Number:
  US 20130204298A1
• Time in Patent Office: 936 Days
• Field of Search: 606/53, 606/60, 606/86.R, 606/104, 606/139, 606/144, 606/148, 606/151, 606/232, 606/300, 606/326, 606/327, 606/916, 411/34, 411/35, 411/38, 411/44, 411/45, 411/54, 411/54.1, 411/56, 411/57.1, 411/58, 411/59, 411/60.1, 411/390, 411/490, 411/498, 623/13.14, 244/53
• US Class Current: 1/1
• 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 first object to a second object, including an elongated body having a lumen extending between distal and proximal ends, the lumen comprising distal and proximal sections, the distal section having a wider diameter than the proximal section; a window extending through the side wall of the elongated body, in the vicinity of the intersection between the distal and proximal sections, and communicating with the lumen; an elongated element comprising proximal and distal ends and extending through the lumen; and a locking element mounted to the distal end of the elongated element and disposed in the distal section; whereby, when the elongated body is disposed in a second object, and a first object extends through the window, proximal movement of the locking element causes the elongated body to capture the first object to the elongated body, whereby to secure the first object to the second object.

Claims

1. Apparatus for securing a first object to a second object, 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 the first object therein;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end;

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

an inserter comprising a hollow tube having a distal end, a proximal end and a passageway extending between the distal end and the proximal end, wherein the distal end of the hollow tube is configured to releasably connect with the proximal end of the elongated body so that the passageway of the hollow tube communicates with the lumen of the elongated body, and further wherein the hollow tube comprises an opening extending through the side wall of the hollow tube and communicating with the passageway of the hollow tube, the opening being sized to receive the first object therein;

wherein the inserter further comprises a retractable sheath coaxially mounted over the hollow tube, the retractable sheath having a distal end and a proximal end, the distal end of the retractable sheath comprising a slot, the slot overlying at least a portion of the opening of the inserter and at least a portion of the window of the elongated body and being sized to receive the first object therein;

wherein the slot of the retractable sheath, the window of the elongated body, the lumen of the elongated body, the passageway of the hollow tube and the opening of the hollow tube together form a continuous pathway for receiving the first object so that the first object may pass from outside of the retractable sheath, into the elongated body, through the lumen of the elongated body, through the passageway of the hollow tube and out of the hollow tube to a region outside of the retractable sheath;

whereby, when the elongated body is disposed in a second object, and the first object extends along the continuous pathway, and the locking element is thereafter moved proximally, proximal movement of the locking element causes the elongated body to capture the first object to the elongated body, whereby to secure the first object to the elongated body and hence to the second object.

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 first object comprises suture.

6. Apparatus according to claim 1 wherein the second object comprises bone.

7. Apparatus according to claim 1 wherein the first object comprises suture which is attached to tissue, and the second object comprises bone.

8. Apparatus according to claim 7 wherein the tissue comprises the labrum, and the bone comprises the acetabulum.

9. Apparatus according to claim 1 wherein the elongated body is generally cylindrical.

10. Apparatus according to claim 9 wherein the elongated body comprises ribs.

11. Apparatus according to claim 9 wherein the elongated body comprises an external flat proximal to, and aligned with, the opening.

12. Apparatus according to claim 1 wherein the locking element is generally cylindrical.

13. Apparatus according to claim 1 wherein the elongated element is generally cylindrical.

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

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

16. 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 elongated element comprises a stepped configuration 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.

17. Apparatus according to claim 16 wherein the enlarged distal section of the elongated element is configured to pull through the reduced proximal section of the locking element upon application of an appropriate force, whereby to separate the elongated element from 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. Apparatus according to claim 17 wherein the force required to pull the enlarged distal section of the elongated element through the reduced proximal section of the locking element is greater than the force required to pull the locking element through the elongated body when the first object is in the elongated body.

20. Apparatus according to claim 17 wherein the force required to pull the enlarged distal section of the elongated element through the reduced proximal section of the locking element is less than the force required to pull the locking element through the elongated body.

21. Apparatus according to claim 17 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 reduced proximal section of the locking element.

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

23. Apparatus according to claim 22 wherein the ribs are evenly spaced.

24. Apparatus according to claim 22 wherein the ribs are non-evenly spaced.

25. Apparatus according to claim 22 wherein at least one rib on the locking element is more compliant than at least one other rib on the locking element.

26. Apparatus according to claim 25 wherein the at least one more compliant rib is disposed proximal to the at least one other rib.

27. Apparatus according to claim 1 wherein the proximal section of the lumen comprises threads.

28. Apparatus according to claim 1 wherein the locking element comprises a flange at its distal end, and further wherein the flange has a diameter greater than the distal section of the lumen.

29. Apparatus according to claim 1 wherein the elongated element extends through the lumen of the hollow tube.

30. Apparatus according to claim 29 wherein the proximal end of the elongated element terminates in the inserter.

31. Apparatus according to claim 1 wherein the elongated body is held to the inserter with a male-female connection.

32. Apparatus according to claim 31 wherein the male-female connection is non-circular.

33. Apparatus according to claim 1 wherein the retractable sheath comprises a first extended position and a second retracted position, and further wherein the retractable sheath is disposed coaxially over at least a portion of the elongated body when the retractable sheath is in its first extended position, and the retractable sheath is withdrawn from the elongated body when the retractable sheath is in its second retracted position.

34. Apparatus according to claim 33 wherein the distal end of the elongated body protrudes from the retractable sheath when the retractable sheath is in its first extended position.

35. Apparatus according to claim 33 wherein the retractable sheath is spring-biased to its first extended position.

36. Apparatus according to claim 1 wherein the elongated element comprises a pull suture, an enlargement and a connecting suture connecting the pull suture to the enlargement.

37. Apparatus according to claim 1 further comprising a second window extending through the side wall of the elongated body and communicating with the lumen, the second window being sized to receive a first object therein.

38. Apparatus according to claim 37 wherein the second window is diametrically opposed to the window.

39. Apparatus according to claim 38 wherein the second window is longitudinally offset from the window.

40. A method for securing a first object to a second object, 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 the first object therein;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end;

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

an inserter comprising a hollow tube having a distal end, a proximal end and a passageway extending between the distal end and the proximal end, wherein the distal end of the hollow tube is configured to releasably connect with the proximal end of the elongated body so that the passageway of the hollow tube communicates with the lumen of the elongated body, and further wherein the hollow tube comprises an opening extending through the side wall of the hollow tube and communicating with the passageway of the hollow tube, the opening being sized to receive the first object therein;

wherein the inserter further comprises a retractable sheath coaxially mounted over the hollow tube, the retractable sheath having a distal end and a proximal end, the distal end of the retractable sheath comprising a slot, the slot overlying at least a portion of the opening of the inserter and at least a portion of the window of the elongated body and being sized to receive the first object therein;

wherein the slot of the retractable sheath, the window of the elongated body, the lumen of the elongated body, the passageway of the hollow tube and the opening of the hollow tube together form a continuous pathway for receiving the first object so that the first object may pass from outside of the retractable sheath, into the elongated body, through the lumen of the elongated body, through the passageway of the hollow tube and out of the hollow tube to a region outside of the retractable sheath;

passing the first object from outside of the retractable sheath, into the elongated body, through the lumen of the elongated body, through the passageway of the hollow tube and out of the hollow tube to a region outside of the retractable sheath so that the first object extends along the continuous pathway;

advancing the inserter towards the second object so that the retractable sheath engages the second object, is retracted and so that the elongated body is positioned in the second object; and

moving the locking element proximally, such that proximal movement of the locking element causes the elongated body to capture the first object to the elongated body, whereby to secure the first object to the elongated body and hence to the second object.

41. A method according to claim 40 wherein proximal movement of the locking element expands the elongated body against the second object.