FEMORAL FIXATION

• US 20080161864A1
• Filed: 09/29/2006
• Published: 07/03/2008
• Est. Priority Date: 09/29/2006
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Beck, Charles, Lizardi, Jose E.
• Granted Patent: US 8,226,714 B2
• Time in Patent Office: Days
• US Class Current: 606/326
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• 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 2002/0852 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 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

Various methods and devices are provided for a graft fixation device for fixing a graft member within a bone tunnel. In one embodiment, a graft fixation device is provided having a radially expandable sheath adapted to be disposed within a bone tunnel, and a sheath expander adapted to be received within the radially expandable sheath to expand the sheath and thereby anchor a graft between the sheath and the bone tunnel. In an exemplary embodiment, the graft fixation device is particularly useful to affix a graft within a femoral tunnel.

Claims

1. A graft fixation device for fixing a graft member within a bone tunnel, the device comprising:

a radially expandable sheath having proximal and distal ends with three sidewalls extending therebetween and defining a central lumen, the sheath having a substantially triangular cross-sectional shape; and

a sheath expander adapted to be disposed in the central lumen of the radially expandable sheath and configured to flex the three sidewalls to radially expand the sheath so as to fix the graft member within a bone tunnel.

2. The graft fixation device of claim 1, wherein the three sidewalls are at least partially separated by three longitudinally oriented slots extending therebetween.

3. The graft fixation device of claim 2, wherein the three sidewalls are each connected by a proximal attachment point and a distal attachment point, and wherein the slots extend between the proximal and distal attachment points.

4. The graft fixation device of claim 1, wherein the three sidewalls comprise first, second, and third sidewalls, and wherein the first and second sidewalls have a substantially concave outer surface adapted to seat a graft member, and the third sidewall has a substantially convex outer surface adapted to engage a bone tunnel.

5. The graft fixation device of claim 4, wherein the first and second sidewalls include surface features formed within the concave outer surface thereof and adapted to engage the graft member, and the third sidewall includes surface features formed on the convex outer surface thereof and adapted to engage bone within the bone tunnel.

6. The graft fixation device of claim 5, wherein the surface features on the first, second, and third sidewalls extend in a radial direction.

7. The graft fixation device of claim 1, wherein a proximal-most end of the radially expandable sheath is angled relative to a longitudinal axis of the radially expandable sheath.

8. The graft fixation device of claim 1, wherein the sheath expander and a distal-most end of the radially expandable sheath each include a lumen extending longitudinally therethrough for receiving a guide wire.

9. The graft fixation device of claim 1, wherein the radially expandable sheath includes a stop member formed on a proximal end thereof and adapted to prevent over-insertion of the radially expandable sheath into a bone tunnel.

10. The graft fixation device of claim 1, wherein the sheath expander comprises a tapered screw.

11. The graft fixation device of claim 10, wherein the sheath expander has a maximum outer diameter that is greater than a maximum inner diameter of the radially expandable sheath in an unexpanded state.

12. The graft fixation device of claim 1, wherein the sheath expander and the radially expandable sheath are formed from a bioabsorbable material.

13. The graft fixation device of claim 1, wherein the distal end of the radially expandable sheath includes a cradle for seating a graft therein.

14. The graft fixation device of claim 1, wherein at least one sidewall of the radially expandable sheath includes a conical taper formed on an inner surface of a proximal end thereof to align the sheath expander with the radially expandable sheath.

15. A graft fixation device, comprising:

an elongate expandable sheath having three sidewalls extending between proximal and distal ends, the three sidewalls being attached to one another at a proximal attachment point and a distal attachment point, and being separated from one another by three longitudinal slots extending between the proximal and distal attachment points; and

an expander disposable within the expandable sheath and adapted to expand the sheath such that the proximal attachment points break to separate the sidewalls at the proximal end of the sheath.

16. A graft fixation device of claim 15, wherein the sidewalls comprise first, second, and third sidewalls, and wherein the first and second sidewalls have a substantially concave outer surface adapted to seat a graft member, and the third sidewall has a substantially convex outer surface adapted to engage a bone tunnel.

17. A graft fixation device of claim 15, further comprising radially oriented ridges formed on the three sidewalls.

18. A graft fixation device of claim 15, wherein a proximal-most end of the elongate expandable sheath is angled relative to a longitudinal axis of the elongate expandable sheath.

19. A graft fixation device of claim 15, wherein the distal end of the radially expandable sheath includes a cradle for seating a graft therein.

20. A method for fixing a ligament graft in a bone tunnel comprising the steps of:

positioning a leading end of a graft within a femoral tunnel, the graft having a trailing end that extends through a tibial tunnel;

inserting a flexible sheath into the femoral tunnel, the flexible sheath having a substantially triangular cross-sectional shape such that flexible sheath positions the graft on a posterior side of the femoral tunnel;

inserting an expansion plug into the flexible sheath to expand the flexible sheath and thereby fix the leading end of the graft within the femoral tunnel.

21. The method of claim 20, further comprising inserting a graft fixation device into the tibial tunnel to fix the trailing end of the graft within the tibial tunnel.

22. The method of claim 20, wherein the graft includes two strands, each strand being looped at the leading end of the graft around a distal end of the flexible sheath.

23. The method of claim 22, wherein the flexible sheath includes a cradle disposed on a distal end thereof for securing the strands at the leading end of the graft.

24. The method of claim 20, wherein positioning comprises looping the leading end of the graft around a length of suture, and pulling the suture through the tibial and femoral tunnels to pull the leading end of the graft into the femoral tunnel.

25. A method for fixing a ligament graft in a bone tunnel comprising the steps of:

positioning a leading end of a graft within a femoral tunnel, the graft having an anteromedial and posterolateral bundles with trailing ends that extend through a tibial tunnel;

inserting a flexible sheath into the femoral tunnel, the flexible sheath having a configuration that positions the anteriomedial and posterolateral bundles on a posterior side of the femoral tunnel and in an anatomic position that mimics a position of native anteriomedial and posterolateral graft bundles;

inserting an expansion plug into the flexible sheath to expand the flexible sheath and thereby fix the leading end of the graft within the femoral tunnel.