FLEXIBLE TIBIAL SHEATH

• US 20080133007A1
• Filed: 11/06/2007
• Published: 06/05/2008
• Est. Priority Date: 06/27/2003
• Status: Active Grant

• Current Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Donnelly, Lisa M., Cauldwell, Nathan S.
• Granted Patent: US 7,699,893 B2
• Time in Patent Office: Days
• US Class Current: 623/13.14
• 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 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Abstract

A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Claims

1. A graft fixation device for fixing a graft member within a bone tunnel, the device comprising a bioabsorbable radially expandable sheath having a slot-free closed distal tip with at least two sidewalls extending proximally therefrom and defining a central lumen, each sidewall having a substantially concave outer surface adapted to seat a graft member, and each side wall being at least partially separated by a longitudinally oriented opening extending from a proximal end along a substantial length of each sidewall and terminating at a position just proximal to the distal tip, wherein the substantially concave outer surface of each sidewall is configured to deform toward a circular geometry when a sheath expander is disposed within the central lumen of the radially expandable sheath so as to fix a graft member within a bone tunnel.

2. The graft fixation device of claim 1, wherein the distal tip is bullet-shaped with tapering sidewalls.

3. The graft fixation device of claim 1, wherein the concave outer surface comprises a flexion region formed by a thinned material.

4. The graft fixation device of claim 1, wherein the distal tip of the expandable sheath includes a bore extending therethrough for receiving a guide wire.

5. The graft fixation device of claim 1, further comprising a sheath expander disposable in the central lumen of the radially expandable sheath and configured to radially expand the concave outer surface of each sidewall toward a circular geometry.

6. The graft fixation device of claim 5, wherein the sheath expander comprises a tapered screw.

7. The graft fixation device of claim 5, wherein the sheath expander has a largest outer diameter that is greater than a largest inner diameter of the expandable sheath in an unexpanded state.

8. The graft fixation device of claim 1, wherein each sidewall includes surface features formed thereon.

9. The graft fixation device of claim 1, further comprising a stop member located on the proximal end of the radially expandable sheath and configured to prevent over-insertion of the radially expandable sheath into a bone tunnel.

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

an expandable sheath having an inner lumen extending between an open proximal end and a substantially closed distal tip, at least one sidewall of the expandable sheath having a substantially concave outer surface extending between the proximal end and the distal tip and configured to seat a graft therein, the concave outer surface being configuration to radially expand toward a circular geometry when a sheath expander is disposed within the inner lumen of the expandable sheath to thereby fix a graft member within a bone tunnel.

11. The graft fixation device of claim 10, wherein the expandable sheath includes at least two distinct sidewalls extending between the proximal end and the distal tip.

12. The graft fixation device of claim 11, wherein each sidewall is at least partially separated by a longitudinally extending opening that extends from the proximal end along a substantial length of each sidewall and terminates just proximal to the distal tip.

13. The graft fixation device of claim 12, wherein the distal tip is bullet-shaped with tapering sidewalls.

14. The graft fixation device of claim 10, wherein the concave outer surface comprises a flexion region formed by a thinned material.

15. The graft fixation device of claim 10, further comprising a sheath expander disposable in the inner lumen of the expandable sheath and configured to radially expand the concave outer surface of the at least one sidewall toward a circular geometry.

16. The graft fixation device of claim 15, wherein the sheath expander comprises a tapered screw.

17. The graft fixation device of claim 16, wherein the sheath expander has a largest outer diameter that is greater than a largest inner diameter of the expandable sheath in an unexpanded state.

18. The graft fixation device of claim 10, wherein the distal tip of the expandable sheath includes a bore extending therethrough for receiving a guide wire.

19. The graft fixation device of claim 10, wherein the at least one sidewall includes surface features formed thereon.

20. The graft fixation device of claim 10, further comprising a stop member located on the proximal end of the expandable sheath configured to prevent over-insertion of the expandable sheath into a bone tunnel.

21. The graft fixation device of claim 10, wherein the device is bioabsorbable.

22. The graft fixation device of claim 21, wherein the device is formed from a material having one or more polymers or copolymers formed of monomers selected from the group consisting of lactic acid, glycolic acid, and caprolactone.

23. The graft fixation device of claim 22, wherein the material further comprises tricalcium phosphate.