Flexible tibial sheath

• US 8,435,293 B2
• Filed: 02/05/2008
• Issued: 05/07/2013
• 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.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US12/025,927
• Publication Number:
  US 20080161806A1
• Time in Patent Office: 1,918 Days
• Field of Search: 623 1311- 132, 606/60, 606/151, 606/232
• 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 method for fixing a ligament graft in a bone tunnel comprising the steps of:

forming a bone tunnel through bone;

providing a ligament graft fixation system having an expandable sheath having proximal and distal ends with at least two sidewalls extending therebetween and defining a central lumen, each sidewall being spaced apart from one another by a longitudinally oriented open slot at a proximal-most end of the expandable sheath and extending along a substantial length of each sidewall;

inserting the expandable sheath into the bone tunnel while tensioning an end of a graft member outside of the tunnel, such that the graft member is positioned between one of the sidewalls of the expandable sheath and the bone tunnel;

inserting an expansion plug into the expandable sheath to expand a region of each sidewall of the expandable sheath thereby compressing the graft member between at least one of the sidewalls and the bone tunnel to thereby fix the graft member within the bone tunnel.

2. The method of claim 1, wherein two adjacent sidewalls are connected at the proximal end by a stop member, and wherein the stop member abuts an opening of the bone tunnel to prevent over-insertion of the expandable sheath into the bone tunnel.

3. The method of claim 1, wherein inserting the expansion plug into the expandable sheath expands the sidewalls at longitudinally oriented flexion regions to deform the sheath toward a circular geometry.

4. The method of claim 3, wherein the sidewalls of the expandable sheath deform to change from a concave shape toward a convex shape to conform with an outer diameter of the expansion plug.

5. The method of claim 1, further comprising seating a graft member in each sidewall of the expandable sheath.

6. The method of claim 5, wherein inserting the expansion plug into the expandable sheath expands a region of each sidewall such that the expandable sheath has a shape that conforms to a shape of the expansion plug.

7. The method of claim 1, wherein the longitudinally oriented slot extends from a proximal-most end of the expandable sheath and terminates at a position just proximal to the distal end of the expandable sheath.

8. The method of claim 1, wherein distal ends of the sidewalls are attached together.

9. The method of claim 1, wherein each sidewall is distinct and separate from one another.

10. The method of claim 1, wherein the region of each sidewall are expanded without breaking apart from one another during expansion thereof to fix the graft member within the bone tunnel.

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

forming a bone tunnel in bone;

inserting an expandable sheath into the bone tunnel while tensioning an end of a graft member outside of the tunnel, the graft member having a plurality of strands, each strand being seated in an outer surface of one of a plurality of sidewalls of the expandable sheath such that each strand of the graft member is positioned between a sidewall of the expandable sheath and the bone tunnel, the sidewalls being spaced apart from one another at least a proximal-most end thereof such that longitudinal sides of adjacent ones of the sidewalls define open space extending therebetween; and

inserting an expansion plug into the expandable sheath to cause a portion of each of the plurality of sidewalls of the expandable sheath to expand such that the sidewalls compress each strand of the graft member between a wall of the bone tunnel and one of the plurality of sidewalls of the sheath, wherein the sidewalls move radially outward and away from one another without breaking apart from one another during any radially outward expansion thereof.

12. The method of claim 11, wherein the expandable sheath includes two adjacent sidewalls connected at a proximal end by a stop member, and wherein the stop member abuts an opening of the bone tunnel to prevent over-insertion of the expandable sheath into the bone tunnel.

13. The method of claim 11, wherein each strand of the graft member is seated in a concave outer surface of one of the plurality of sidewalls of the expandable sheath.

14. The method of claim 11, wherein inserting the expansion plug into the expandable sheath expands the region of each sidewall to have a shape that conforms to a shape of the expansion plug.

15. The method of claim 11, wherein the expandable sheath deforms toward a circular geometry to conform with an outer diameter of the expansion plug.

16. The method of claim 11, wherein the sidewalls are spaced apart from one another at the proximal-most end thereof by a longitudinally oriented slot extending along a substantial length of each sidewall.

17. The method of claim 16, wherein distal ends of the sidewalls are attached to one another, proximal portions of the first and third sidewalls are not attached to one another, and proximal portions of the second and fourth sidewalls are not attached to one another.

18. The method of claim 11, wherein distal ends of the sidewalls are attached to one another.

19. A method for fixing a ligament graft in a bone tunnel, comprising:

seating a first leg of a first graft strand within a first sidewall of an expandable sheath;

seating a second leg of the first strand within a second sidewall of the expandable sheath that is opposite to the first sidewall of the expandable sheath;

seating a first leg of a second graft strand within a third sidewall of the expandable sheath;

seating a second leg of the second strand within a fourth sidewall of the expandable sheath that is opposite to the third sidewall of the expandable sheath;

inserting the expandable sheath with the first and second graft strands seated therein into a bone tunnel; and

inserting an expandable plug into the expandable sheath to cause a region of each sidewall to expand to compress the first and second strands between the sidewalls and the bone tunnel, and to cause at least a proximal portion of the first, second, third, and fourth sidewalls to move radially outward relative to one another, wherein the first, second, third, and fourth sidewalls are separated along a substantial portion thereof such that the first, second, third, and fourth sidewalls do not break apart from one another throughout an entirety of a range of their radially outward movement to compress the first and second strands between the sidewalls and the bone tunnel.

20. The method of claim 19, wherein each sidewall includes longitudinally oriented flexion regions that allow the region of each sidewall to expand.