Bone fastener and instrument for insertion thereof

• US 6,589,244 B1
• Filed: 04/23/2001
• Issued: 07/08/2003
• Est. Priority Date: 02/14/1996
• Status: Expired due to Fees

• Current Assignee: Biomet Microfixation LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Walter Lorenz Surgical, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Sevrain, Lionel C., Shearin, Alan, Sevrain, Christophe J. P.
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/840,198
• Time in Patent Office: 806 Days
• Field of Search: 606/72, 606/73, 606/104, 606/213, 411/40, 411/43, 411/34, 411/38, 411/173, 411/176, 411/177, 411/185, 411/187, 411/338, 411/339, 411/366
• US Class Current: 606/916
• CPC Class Codes: A61B 17/688 for reattaching pieces of the skull
• CPC Class Codes: A61B 17/8888 at its central region
• CPC Class Codes: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: Y10S 606/907 Composed of particular material or coated
• CPC Class Codes: Y10S 606/908 Bioabsorbable material

Abstract

A bone member fastener for closing a craniotomy includes a cap and a base interconnected by a narrow cylindrical collar. The cap has an externally threaded stud that screws into an internally threaded bore of the collar, thereby allowing the cap and base to be brought into clamping engagement against the internal and external faces of a bone plate and surrounding bone. In a particularly disclosed embodiment, the base of the fastener is placed below a craniotomy hole with the collar projecting into the hole, and the stud of the cap is screwed into the bore of the base from above the hole to clamp a bone flap against the surrounding cranium. This device provides a method of quickly and securely replacing a bone cover into a craniotomy. The distance between the cap and base can be selected by how far the threaded stud of the cap is advanced into the internally threaded collar. The fastener is therefore adaptable for use in several regions of the skull having various thicknesses. An insertion tool with a long handle permits safe and convenient placement of the base between the brain and the internal face of the bone plate. Some disclosed embodiments of the fastener have a cap and base that conform to the curved surface of the skull, for example by having an arcuate shape or flexible members that conform to the curvature of the bone plate and surrounding cranial bone as the fastener is tightened.

Claims

1. A bone fastener and surgical instrument used for holding internal and external surfaces of a cranial bone cover relative to internal and external surfaces of surrounding cranial bone, said bone fastener and said surgical instrument comprising:

a bone fastener including,

a first fastening member having a first inner face and a first outer face,

a second fastening member having a second inner face and a second outer face, and

an elongated member extending from said first fastening member; and

a surgical instrument having a first engagement member operable to engage said elongated member extending from said first fastening member and a second member operable to adjustably position said second fastening member relative to said first fastening member by engaging said second fastening member with said elongated member, wherein upon adjustably positioning said second fastening member relative to said first fastening member with said surgical instrument, the internal and external surfaces of the cranial bone cover and the surrounding cranial bone are engaged by said first inner face of said first fastening member and said second inner face of said second fastening member to fix a first transverse face of the cranial bone cover in apposition with a second transverse face of the surrounding cranial bone and position the internal and external surfaces of the cranial bone cover substantially co-planar with the internal and external surfaces of the surrounding cranial bone.

2. The bone fastener and surgical instrument as defined in claim 1 wherein said bone fastener further includes a plurality of barbs extending from said first fastening member operable to engage the internal surfaces of the cranial bone cover and the surrounding cranial bone.

3. The bone fastener and surgical instrument as defined in claim 2 wherein said plurality of barbs are circumferentially spaced about said first fastening member.

4. The bone fastener and surgical instrument as defined in claim 1 further comprising a plurality of first fastening members having different sizes and a plurality of second fastening members having different sizes.

5. The bone fastener and surgical instrument as defined in claim 1 wherein said elongated member includes a plurality of radially extending projections extending from at least a portion of a sidewall of said elongated member.

6. The bone fastener and surgical instrument as defined in claim 5 wherein said radially extending projections extend from at least a portion of an internal sidewall of a cylindrical collar and said second fastening member includes a threaded stud extending from said second fastening member.

7. The bone fastener and surgical instrument as defined in claim 6 wherein said second fastening member is adjustably positioned relative to said first fastening member by threadably engaging said threaded stud with said cylindrical collar.

8. The bone fastener and surgical instrument as defined in claim 5 wherein said radially extending projections extend from at least a portion of an internal sidewall of a cylindrical collar.

9. The bone fastener and surgical instrument as defined in claim 8 wherein said radially extending projections extend from at least a portion of an outer sidewall of a cylindrical stud.

10. The bone fastener and surgical instrument as defined in claim 1 wherein said first fastening member and said second fastening member are formed from a biocompatible material selected from a group consisting of stainless steel, titanium alloy, titanium, polyglycic acid, silicon rubber, Teflon and nylon.

11. The bone fastener and surgical instrument as defined in claim 1 wherein said first fastening member is a first circular disk and said second fastening member is a second circular disk.

12. The bone fastener and surgical instrument as defined in claim 11 wherein said second outer face of said second fastening member is a convex outer face.

13. The bone fastener and surgical instrument as defined in claim 1 wherein said first engagement member is a cylindrical rod operable to threadably engage said elongated member.

14. The bone fastener and surgical instrument as defined in claim 13 wherein said second member is a tubular sleeve operable to rotatably receive said cylindrical rod.

15. The bone fastener and surgical instrument as defined in claim 14 wherein said sleeve includes an attachment mechanism operable to engage said first fastening member.

16. The bone fastener and surgical instrument as defined in claim 1 wherein said elongated member is integral with said first fastening member.

17. The bone fastener and surgical instrument as defined in claim 1 wherein said second fastening member includes a second elongated member extending from said second fastening member, said second elongated member operable to engage said elongated member extending from said first fastening member.

18. A method of holding internal and external surfaces of a cranial bone cover relative-to internal and external surfaces of surrounding cranial bone, said method comprising:

performing an osteonomy to form the cranial bone cover having a first transverse face between the internal and external surfaces of the cranial bone cover and a second transverse face between the internal and external surfaces of the surrounding cranial bone;

providing a first fastening member having a first inner face and a first outer face;

providing a second fastening member having a second inner face and a second outer face;

providing an elongated member extending from the first fastening member;

providing an instrument having a first engagement member operable to engage the elongated member extending from the first fastening member and a second member operable to move the first fastening member relative to the second fastening member;

using the instrument to adjustably position the second fastening member relative to the first fastening member by engaging the second fastening member with the elongated member; and

engaging the internal and external surfaces of the cranial bone cover and the surrounding cranial bone with the first inner face of the first fastening member and the second inner face of the second fastening member to fix the first transverse face of the cranial bone cover in apposition with the second transverse face of the surrounding cranial bone and position the internal and external surfaces of the cranial bone cover substantially co-planar with the internal and external surfaces of the surrounding cranial bone.

19. The method as defined in claim 18 further comprising providing a plurality of barbs extending from the first fastening member and engaging the plurality of barbs relative to the internal surfaces of the cranial bone cover and the surrounding cranial bone.

20. The method as defined in claim 18 further comprising providing a plurality of first fastening members having different sizes and a plurality of second fastening members having different sizes and selecting an appropriately sized first fastening member and a second fastening member.

21. The method as defined in claim 18 further comprising providing radially extending projections extending from at least a portion of a sidewall of the elongated member.

22. The method as defined in claim 21 wherein the radially extending projections extend from at least a portion of an internal sidewall of a cylindrical collar and the second fastening member is provided with a threaded stud extending from the second fastening member.

23. The method as defined in claim 22 wherein the second fastening member is adjustably positioned relative to the first fastening member by threadably engaging the threaded stud with the cylindrical collar.

24. The method as defined in claim 18 wherein the first fastening member and the second fastening member are formed from a biocompatible material selected from a group consisting of stainless steel, titanium alloy, titanium, polyglycic acid, silicon rubber, Teflon and nylon.

25. The method as defined in claim 18 further comprising securing the first engagement member to the elongated member.

26. The method as defined in claim 25 further comprising securing the first engagement member to the elongated member by threadably coupling the first engagement member with the elongated member.

27. The method as defined in claim 26 further comprising attaching the second member to the first fastening member and rotating the first engagement member relative to the second member.

28. A method of holding internal and external surfaces of a cranial bone cover relative to internal and external surfaces of surrounding cranial bone, said method comprising:

performing an osteonomy to form the cranial bone cover having a first transverse face between the internal and external surfaces of the cranial bone cover and a second transverse face between the internal and external surfaces of the surrounding cranial bone;

providing a first fastening member having a first inner face and a first outer face;

providing a second fastening member having a second inner face and a second outer face;

providing an elongated member extending from the first fastening member having a sidewall with a plurality of radially extending projections extending from at least a portion of the sidewall;

providing a first engagement member operable to engage the elongated member extending from the first fastening member;

positioning the first inner face of the first fastening member relative to the internal surfaces of the cranial bone cover and the surrounding cranial bone;

engaging the elongated member with the first engagement member to secure the first fastening member to the first engagement member;

providing a second member operable to engage the second fastening member;

using the first engagement member and the second member to adjustably position the second fastening member relative to the first fastening member by allowing the radially extending projections on the sidewall of the elongated member to engage the second fastening member; and

engaging the internal and external surfaces of the cranial bone cover and the surrounding cranial bone with the first inner face of the first fastening member and the second inner face of the second fastening member to fix the first transverse face of the cranial bone cover in apposition with the second transverse face of the surrounding cranial bone and position the internal and external surfaces of the cranial bone cover substantially co-planar with the internal and external surfaces of the surrounding cranial bone.

29. The method as defined in claim 28 further comprising providing a plurality of barbs extending from the first fastening member and engaging the plurality of barbs relative to the internal surfaces of the cranial bone cover and the surrounding cranial bone.

30. The method as defined in claim 28 further comprising providing a plurality of first fastening member having different sizes and a plurality of second fastening members having different sizes and selecting an appropriately sized first fastening member and a second fastening member.

31. The method as defined in claim 28 wherein the radially extending projections extend from at least a portion of an internal sidewall of a cylindrical collar and the second fastening member is provided with a threaded stud extending from the second fastening member.

32. The method as defined in claim 31 wherein the second fastening member is adjustably positioned relative to the first fastening member by threadably engaging the threaded stud with the cylindrical collar.

33. The method as defined in claim 28 wherein the first fastening member and the second fastening member are formed from a biocompatible material selected from a group consisting of stainless steel, titanium alloy, titanium, polyglycic acid, silicon rubber, Teflon and nylon.

34. The method as defined in claim 28 further comprising securing the first engagement member to the elongated member.

35. The method as defined in claim 34 further comprising securing the first engagement member to the elongated member by threadably coupling the first engagement member with the elongated member.

36. The method as defined in claim 35 further comprising attaching the second member to the first fastening member and rotating the first engagement member relative to the second member.