Method and Apparatus for Fixation of an ACL Graft

• US 20110218625A1
• Filed: 05/17/2011
• Published: 09/08/2011
• Est. Priority Date: 02/03/2006
• Status: Active Grant

• Current Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Stone, Kevin T., Denham, Gregory J., Conner, Nathanael K., Berelsman, Brian K.
• Granted Patent: US 8,968,364 B2
• Time in Patent Office: Days
• US Class Current: 623/13.14
• 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: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• 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 2002/0841 Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire
• CPC Class Codes: A61F 2002/0852 Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

A system for use in graft fixation in a knee reconstruction procedure can include a first femoral fixation member adapted to be retained relative to a first end of a femoral tunnel and a first self-locking adjustable flexible member construct having a passage portion with a pair of free ends and a pair of self-locking adjustable loops. The first flexible member construct can be interconnected to the first femoral fixation member. A second femoral fixation member can be coupled to the first flexible member construct and can be adapted to be positioned in the femoral tunnel relative to a second end of the femoral tunnel adjacent a joint space between the femur and a tibia. A second self-locking adjustable flexible member construct having a passage portion with a pair of free ends and a pair of self-locking adjustable loops can be interconnected to the second femoral fixation member.

Claims

1. A system for use in graft fixation in a knee reconstruction procedure, comprising:

a first femoral fixation member adapted to be retained relative to a first end of a femoral tunnel in a femur;

a first self-locking adjustable flexible member construct having a first passage portion with a first pair of free ends and a first pair of self-locking adjustable loops, the first flexible member construct being interconnected to the first femoral fixation member;

a second femoral fixation member coupled to the first flexible member construct and adapted to be positioned within the femoral tunnel relative to a second end of the femoral tunnel adjacent to a joint space between the femur and a tibia; and

a second self-locking adjustable flexible member construct having a second passage portion with a second pair of free ends and a second pair of self-locking adjustable loops, the second flexible member construct being interconnected to the second femoral fixation member.

2. The system of claim 1, wherein the second flexible member construct is directly coupled to the first flexible member construct.

3. The system of claim 1, wherein the first femoral fixation member includes a toggle bar fixation member adapted to be received through the femoral tunnel and retained relative to an outer surface of the femur adjacent the first end of the femoral tunnel.

4. The system of claim 1, wherein the second femoral fixation member includes a first portion having a first diameter and defining an aperture adjacent a first end thereof, and a plurality of leg members extending from the first portion and defining a distal end of the second femoral fixation member, the plurality of leg members being biased radially outward as they extend from the first portion to the distal end such that the distal end of the second femoral fixation member includes a larger diameter than the proximal end, the aperture receiving a portion of the second flexible member construct therethrough.

5. The system of claim 4, wherein the plurality of leg members are adapted to resist movement of the second femoral fixation member relative to the femoral tunnel.

6. The system of claim 1, wherein the second femoral fixation member includes a body having a first portion and a second portion, the first portion including a cylindrical shape and having a plurality of ribs about an outer surface thereof and defining an aperture adjacent a proximal end, the second portion extending from the first portion to a distal end of the second femoral fixation member and defining an opening therethrough adapted to receive at least one of the second flexible member construct and the graft therethrough.

7. The system of claim 6, wherein the first flexible member construct is interconnected to the second femoral fixation member via the aperture and the second flexible member construct is interconnected to the second femoral fixation member via the opening.

8. The system of claim 1, further comprising a third fixation member configured to be coupled to the second flexible member construct and adapted to be received in a tibial tunnel to fix the graft relative thereto.

9. The system of claim 8, wherein the third fixation member includes a body having four radially outwardly extending protrusions extending axially from a proximal end toward a distal end of the body, the protrusions forming four axially extending concave regions each adapted to receive a portion of the graft therein, the third fixation member configured to be positioned about the adjustable loops of the second flexible member construct and adapted to be drawn into the tibial tunnel.

10. The system of claim 9, wherein the distal end of the body of the third fixation member includes a plurality of radially outwardly extending tabs adapted to limit travel of the third fixation member into a bone tunnel.

11. The system of claim 9, wherein the four protrusions each include a stepped configuration forming at least one shoulder such that the distal end includes a larger diameter then the proximal end, the distal end including a projection having a notch formed therein configured to receive a portion of the second flexible member construct.

12. The system of claim 8, wherein the third fixation member includes:

a sheath member having a plurality of axially extending legs biased radially outward in a direction from a proximal end to a distal end of the sheath member such that the distal end of the sheath member includes a greater diameter than the proximal end; and

a plug member sized and shaped to be received within the plurality of legs of the sheath member so as to expand the sheath member upon being received therein, the plug member including an aperture at a proximal end and an increasing diameter in a direction toward a distal end thereof, the plug member being interconnected to the second flexible member construct.

13. The system of claim 12, wherein the sheath member is slidably coupled to the second flexible member construct and includes a plurality of radially outwardly extending tabs at the distal end thereof adapted to limit travel of the sheath member relative to the tibial tunnel.

14. The system of claim 8, wherein the third fixation member includes:

a head portion and a body portion, the head portion having a roughened graft engaging surface on a distal side thereof and an aperture extending therethrough transverse to a longitudinal axis of the third fixation member, the body portion extending from the head portion and adapted to be received in the tibial tunnel about the graft, the head portion having a larger diameter than the body portion; and

a fastener configured to be received through the aperture and adapted to fix the third fixation member to the tibia.

15. The system of claim 1, further comprising:

a first tibial fixation member adapted to be retained relative to a first end of a tibial tunnel in a tibia adjacent a joint space between the femur and the tibia;

a third self-locking adjustable flexible member construct having a third passage portion with a third pair of free ends and a third pair of self-locking adjustable loops, the third flexible member construct being coupled to the first fixation member; and

a second tibial fixation member configured to be coupled to the third flexible member construct and adapted to be positioned in the tibial tunnel relative to a second end of the tibial tunnel opposite the first end of the tibial tunnel.

16. A method of graft fixation for use in a knee reconstruction procedure, comprising:

forming a femoral tunnel in a femur and a tibial tunnel in a tibia, the femoral tunnel having a first end adjacent to a joint space between the femur and the tibia, and the tibial tunnel having a first end adjacent to the joint space and an opposite second end spaced apart from the joint space;

positioning a first femoral fixation member coupled to a first self-locking adjustable flexible member construct into the femoral tunnel and retaining the first femoral fixation member relative to the femoral tunnel, the first flexible member construct including a first pair of adjustable loops;

tensioning free ends of the first flexible member construct to reduce a size of the first pair of adjustable loops and draw the graft into the femoral tunnel;

passing the graft through the tibial tunnel;

tensioning the graft relative to the femoral and tibial tunnels;

implanting a fixation member relative to the tibial tunnel to fix the tensioned graft to the tibia; and

implanting a second femoral fixation member in the femoral tunnel such that a distal end of the second femoral fixation member is positioned adjacent the first end of the femoral tunnel to fix the graft relative to the first end of the femoral tunnel.

17. The method of claim 16, wherein tensioning free ends of the first flexible member construct to reduce a size of the first pair of adjustable loops and draw the graft into the femoral tunnel includes tensioning the free ends of the first flexible member construct to draw the graft and a second self-locking adjustable flexible member construct coupled to the first flexible member construct through the joint space and into the femoral tunnel.

18. The method of claim 17, further comprising positioning graft strands of the graft around the first pair of adjustable loops extending from the femoral tunnel before tensioning the free ends of the first flexible member construct.

19. The method of claim 17, wherein the second flexible member construct is directly interconnected to the first flexible member construct.

20. The method of claim 17, wherein implanting a second femoral fixation member in the femoral tunnel such that a distal end of the second femoral fixation member is positioned adjacent the first end of the femoral tunnel includes tensioning free ends of the second flexible member construct to draw the second femoral fixation member through the joint space and into the femoral tunnel.

21. The method of claim 20, further comprising compressing leg members of the second femoral fixation member upon implanting the second femoral fixation member in the femoral tunnel so as to compress the graft between the leg members and the femoral tunnel and resist movement of the second femoral fixation member relative to the femoral tunnel.

22. The method of claim 16, further comprising:

passing the graft through an opening in the second femoral fixation member before drawing the second femoral fixation member into the femoral tunnel, the second femoral fixation member being interconnected to the first flexible member construct; and

tensioning the free ends of the first flexible member construct to reduce a size of the first pair of adjustable loops and draw the second femoral fixation member and the graft into the femoral tunnel.

23. The method of claim 22, further comprising tensioning the free ends of the first flexible member construct to draw the second femoral fixation member into the femoral tunnel such that a distal end of the second femoral fixation member supporting the graft strands is positioned adjacent the first end of the femoral tunnel.

24. The method of claim 17, wherein implanting a fixation member relative to the tibial tunnel includes:

coupling a second pair of adjustable loops of the second flexible member construct to the fixation member, the second flexible member construct being interconnected to the first flexible member construct via the second femoral fixation member; and

tensioning free ends of the second flexible member construct to reduce a size of the second pair of adjustable loops and draw the fixation member into the tibial tunnel about the graft to fix the graft to the tibia.

25. The method of claim 24, further comprising:

moving the tibia relative to the femur after implanting the fixation member in the tibial tunnel; and

tensioning the free ends of the first flexible member construct to reduce a size of the first adjustable loops and apply additional tension to the graft strands after moving the tibia relative to the femur.

26. The method of claim 24, further comprising drawing the fixation member into the tibial tunnel using the second flexible member construct until radially outwardly extending projections on a distal end of the fixation member engage an outer surface of the tibia adjacent the tibial tunnel.

27. The method of claim 24, wherein coupling the second pair of adjustable loops of the second self-locking adjustable flexible member construct to the fixation member includes coupling the second pair of adjustable loops about a distal end of the fixation member and along notches in opposed lateral sides of the fixation member.

28. The method of claim 24, further comprising:

forming a counterbore at the second end of the tibial tunnel; and

wherein tensioning free ends of the second flexible member construct to reduce a size of the second pair of adjustable loops and draw the fixation member into the tibial tunnel about the graft to fix the graft to the tibia includes tensioning the free ends of the second flexible member construct to reduce a size of the second pair of adjustable loops and draw the fixation member into the counterbore to fix the graft to the tibia.

29. The method of claim 17, wherein implanting a fixation member into the tibial tunnel to fix the tensioned graft to the tibia includes:

positioning a sheath member coupled to a second pair of adjustable loops of the second flexible member construct into the tibial tunnel about the graft; and

tensioning free ends of the second flexible member construct to reduce a size of the second pair of adjustable loops and draw a plug member interconnected to the second pair of adjustable loops into an inside of the sheath member to expand the sheath member against the graft and tibial tunnel to fix the graft to the tibia.

30. The method of claim 29, wherein positioning a sheath member includes positioning a sheath member having plurality of leg members into the tibial tunnel such that radially outwardly extending tabs at a distal end of the leg members engage an outer surface of the tibia adjacent the tibial tunnel.

31. A method of graft fixation for use in a knee reconstruction procedure, comprising:

forming a femoral tunnel in a femur and a tibial tunnel in a tibia, the femoral tunnel having a first end adjacent to a joint space between the femur and the tibia, and the tibial tunnel having a first end adjacent to the joint space and an opposite second end spaced apart from the joint space;

positioning a first femoral fixation member coupled to a first self-locking adjustable flexible member construct into the femoral tunnel and retaining the first femoral fixation member relative to the femoral tunnel, the first flexible member construct including a first pair of adjustable loops;

coupling the graft to the first pair of adjustable loops of the first flexible member construct;

tensioning free ends of the first flexible member construct to reduce a size of the first pair of adjustable loops and draw the graft and a portion of a second flexible member construct coupled to the first flexible member construct into the femoral tunnel, the second flexible member construct including a second pair of adjustable loops;

passing the graft through the tibial tunnel;

tensioning the graft relative to the femoral and tibial tunnels;

implanting a fixation member into the tibial tunnel to fix the tensioned graft to the tibia; and

implanting a second femoral fixation member relative to the femoral tunnel such that a distal end of the second femoral fixation member is positioned adjacent the first end of the femoral tunnel to fix the tensioned graft relative to the first end of the femoral tunnel.

32. The method of claim 31, wherein implanting a second femoral fixation member into the femoral tunnel includes tensioning free ends of the second flexible member construct to reduce a size of the second pair of adjustable loops and draw the second femoral fixation member through the joint space into the femoral tunnel such that radially outwardly extending leg members of the second femoral fixation member are compressed against the femoral tunnel.

33. The method of claim 32, wherein the first flexible member construct is directly coupled to the second flexible member construct.

34. The method of claim 31, wherein coupling the graft to the first pair of adjustable loops includes coupling the graft to an opening in the second femoral fixation member, the second femoral fixation member being interconnected via an aperture to the first pair of adjustable loops of the first flexible member construct;

and

wherein tensioning free ends of the first flexible member construct includes tensioning free ends of the first flexible member construct to reduce a size of the first pair of adjustable loops and draw the second femoral fixation member and the graft into the femoral tunnel such that the distal end of the second femoral fixation member is positioned adjacent the first end of the femoral tunnel to fix the tensioned graft relative to the first end of the femoral tunnel.

35. The method of claim 34, wherein implanting a fixation member relative to the tibial tunnel to fix the tensioned graft to the tibia includes:

coupling the fixation member to the second pair of adjustable loops that extend from the second end of the tibial tunnel such that a portion of the second pair of adjustable loops are received in a notch of the fixation member; and

tensioning free ends of the second flexible member construct to reduce a size of the second pair of adjustable loops and draw the fixation member into the tibial tunnel to fix the graft to the tibia.

36. The method of claim 35, further comprising implanting the second femoral fixation member after drawing the fixation member into the tibial tunnel.

37. The method of claim 34, further comprising drawing the second femoral fixation member and the graft into the femoral tunnel through the joint space so as to bypass the tibial tunnel.

38. The method of claim 31, wherein the femoral tunnel includes a second end opposite the first end adjacent the joint space such that the femoral tunnel extends through a portion of the femur.