Sheaths for implantable fixation devices

• US 6,746,483 B1
• Filed: 03/16/2000
• Issued: 06/08/2004
• Est. Priority Date: 03/16/2000
• Status: Expired due to Term

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Ek, Steven, Bojarski, Ray, Torrie, Paul Alexander, Harvie, Fraser
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): BARRETT, THOMAS C
• Application Number:
  US09/526,960
• Time in Patent Office: 1,545 Days
• Field of Search: 623/13-1-
• 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: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/8861 Apparatus for manipulating flexible wires or straps devices for inserting Kirschner wires A61B17/1697
• CPC Class Codes: A61B 17/8869 Tensioning devices
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2002/0864 Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30914 Details of the mesh structure, e.g. disposition of the woven warp and weft wires
• CPC Class Codes: A61F 2002/30919 Sleeves
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: Y10S 623/908 : Bone

Abstract

Sheaths for implantable fixation devices have a flexible body with a perforated wall, and an interior of the body is sized and shaped to receive the fixation device. Sheaths include a plurality of flexible or inflexible tubes arranged to form a ring, where the central cavity defined by the ring is sized and shaped to receive the fixation device.

Claims

1. A combination comprising:

a sheath including a flexible body defining a tube having two ends, each end having an opening of substantially the same dimensions, the tube having a relieved wall and defining an interior sized and shaped to receive both a shaft of a bone screw and a soft tissue graft; and

a bone screw having a shaft sized and shaped to fit within the interior of the sheath.

2. A combination comprising:

a sheath including a flexible body defining a tube having two ends, each end having an opening of substantially the same dimensions, the tube having a perforated relieved wall defining an interior sized and shaped to receive a soft tissue fixation device that is configured to be inserted into a bone tunnel; and

the soft tissue fixation device.

3. The sheath of claim 2, wherein the wall defines a plurality of holes therethrough.

4. The sheath of claim 3, wherein the body comprises strands that form a mesh structure, the strands defining spaces therebetween that define the holes.

5. A combination comprising:

a sheath including a flexible body defining a tube having two ends, each end having an opening of substantially the same dimensions, the tube having a relieved wall with a major portion of the wall being open, the wall defining an interior sized and shaped to receive a soft tissue fixation device that is configured to be inserted into a bone tunnel; and

the soft tissue fixation device.

6. A combination comprising:

a sheath including a flexible body having a roughened exterior surface and defining a tube having two ends, each end having an opening of substantially the same dimensions, the tube having a relieved wall and defining an interior sized and shaped to receive a soft tissue fixation device that is configured to be inserted into a bone tunnel; and

the soft tissue fixation device.

7. A combination comprising:

a sheath including a flexible body defining a tube having two ends, each end having an opening of substantially the same dimensions, the tube having a relieved wall and defining an interior sized and shaped to receive a fixation device and a soft tissue graft; and

the fixation device.

8. The combination of claim 7, wherein each opening is circular.

9. The combination of claim 7, wherein the body is made from a bioabsorbable material.

10. The combination of claim 7, wherein the tube comprises a biocompatible material selected from the group consisting of hydroxyapatite, polylactic acid, and polylactic glycolic acid.

11. The combination of claim 7, wherein the wall has a thickness less than about 0.3 mm.

12. The combination of claim 7, wherein the body is integrally formed.

13. The combination of claim 7, further comprising a therapeutic agent in contact with the body.

14. The combination of claim 13, wherein the therapeutic agent is an osteoinductive agent.

15. The combination of claim 13, wherein the therapeutic agent is a growth factor.

16. The combination of claim 13, wherein the therapeutic agent is disposed on at least a portion of an exterior surface of the body.

17. The sheath of claim 13, wherein the therapeutic agent is integrated into a material that forms the body.

18. The combination of claim 7, wherein the fixation device is a bone screw, the bone screw having a shaft sized and shaped to fit within the interior of the sheath.

19. The combination of claim 18, wherein the soft tissue graft and the shaft of the bone screw fits snugly within the interior of the sheath.

20. The combination of claim 18, wherein the tube is sized and shaped to snugly receive the shaft of the bone screw and the soft tissue graft.

21. The sheath of claim 20, wherein the tube is conformable to a shape of the shaft of the bone screw and the soft tissue graft.

22. A combination comprising:

a sheath including a flexible body defining a tube having two ends, each end having an opening of substantially the same dimensions, the tube having a relieved wall and defining an interior sized and shaped to receive a bone screw; and

a bone screw having a shaft sized and shaped to fit snugly within the interior of the sheath, the shaft including generally rounded screw threads.

23. A combination comprising:

a sheath including a flexible body having two ends, each end having an opening of substantially the same dimensions, the body having a relieved wall and defining an interior sized and shaped to receive the shaft of a bone screw, and

the bone screw having a shaft sized and shaped to fit snugly within the interior of the sheath, the shaft including generally rounded screw threads.

24. The combination of claim 23, wherein the body is conformable to a shape of the shaft of the bone screw.

25. The combination of claim 23, wherein the body is sized and shaped to receive both the shaft of the bone screw and a soft tissue graft.

26. The combination of claim 23, wherein each opening is circular.

27. The combination of claim 23, wherein the body defines a first tube and a second tube connected to the first tube, the first tube being sized and shaped to receive the shaft of the bone screw and the second tube being sized and shaped to receive a portion of a soft tissue graft.

28. The combination of claim 23, wherein the sheath includes a plurality of generally parallel tubes arranged to form a ring, a portion of each tube forming a portion of the relieved wall of the flexible body.

29. The combination of claim 28, wherein at least some of the tubes are sized and shaped to receive a portion of a soft tissue graft.

30. The combination of claim 28, wherein the ring defines a central cavity between the tubes that comprises the interior sized and shaped to receive the bone screw.

31. The combination of claim 23, wherein the relieved wall is perforated.

32. The combination of claim 31, wherein the wall defines a plurality of holes therethrough.

33. The combination of claim 32, wherein the body comprises strands that form a mesh structure, the strands defining spaces therebetween that define the holes.

34. The combination of claim 23, wherein a major portion of the wall is open.