Diaphysial cortical dowel

• US 5,814,084 A
• Filed: 01/16/1996
• Issued: 09/29/1998
• Est. Priority Date: 01/16/1996
• Status: Expired due to Term

• Current Assignee: RTI Surgical Incorporated
• Original Assignee: University of Florida (State University System of Florida)
• Inventors: Grooms, James M., Grivas, Nicholas E.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/587,070
• Time in Patent Office: 987 Days
• Field of Search: 623/16, 623/17
• US Class Current: 623/23.48
• CPC Class Codes: A61B 17/1635 for grafts, harvesting or transplants
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/30622 Implant for fusing a joint or bone material
• CPC Class Codes: A61F 2002/30772 Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30777 Oblong apertures
• CPC Class Codes: A61F 2002/30797 internally-threaded
• CPC Class Codes: A61F 2002/3082 : Grooves
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30871 : Trapezoidal threads
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device

Abstract

A dowel is provided by obtaining a plug from the shaft (diaphysis) of various long bones. The dowel has an intra-medullary canal which can be packed with any of a variety of osteogenic materials. The dowel has a cortical surface into which an instrument attachment hole may be machined and onto which an alignment mark may be inscribed for proper orientation of the intra-medullary canal. The dowel has a chamfered insertion end and has improved biomechanical and vertebral fusion induction properties as compared to standard dowels known in the art.

Claims

1. A diaphysial cortical bone dowel comprising a transverse bone plug obtained from a transverse cut in the diaphysis of a long bone having an intra-medullary canal, said plug having a canal running therethrough, wherein said canal is defined by the intra-medullary canal of said long bone and wherein said plug retains the natural architecture surrounding said intra-medullary canal.

2. The diaphysial cortical dowel of claim 1 having a chamfered end.

3. The diaphysial cortical dowel of claim 2 wherein the end opposite the chamfered end has an instrument attachment hole machined therein.

4. The diaphysial cortical dowel of claim 3 wherein the end having the instrument attachment hole also has a score mark inscribed therein.

5. The diaphysial dowel of claim 1 further comprising an external feature machined into the circumference of the dowel.

6. The diaphysial cortical dowel of claim 5 wherein said feature includes a groove.

7. The diaphysial cortical dowel of claim 5 wherein said feature includes threads formed along a portion of the length of the dowel.

8. The diaphysial cortical dowel of claim 1 having a length of between 8 mm and about 30 mm.

9. The diaphysial cortical dowel of claim 8 having a diameter of between about 10 mm and about 24 mm.

10. The diaphysial cortical dowel of claim 1 further comprising an osteogenic composition packed within said canal.

11. The diaphysial cortical dowel of claim 10 wherein said osteogenic composition is autogenous bone, hydroxyapatite, bioglass, a calcium phosphate ceramic or a mixture of these.

12. The diaphysial cortical dowel of claim 1 obtained as a transverse plug from the shaft of a donor'"'"'s fibula, radius, ulna, humerus, femur or tibia.

13. The diaphysial cortical dowel of claim 1 prepared by a process which comprises machining a transverse plug from a transverse cut in the diaphysis of a donor'"'"'s fibula, radius, ulna, humerus, femur or tibia, said plug having a diameter of between about 10 mm and about 24 mm and a length of between about 8 mm and about 30 mm such that the resulting plug retains the natural architecture surrounding the canal running therethrough, wherein said canal is defined by the intra-medullary canal of said long bone.

14. The diaphysial cortical dowel of claim 13 wherein said process of preparation further comprises chamfering one end of said plug to form a generally curved surface for ease of insertion of the dowel into an intervertebral cavity.

15. The diaphysial cortical dowel of claim 14 wherein said process of preparation further comprises machining an instrument attachment hole into the end of the dowel opposite the chamfered end and inscribing a score mark on the instrument attachment end of the dowel to allow for proper alignment of the intra-medullary canal.

16. A method of making a dowel which comprises machining a transverse plug as a transverse cut across the diaphysis of a donor'"'"'s fibula, radius, ulna, humerus, femur or tibia, said plug having a diameter of between about 10 mm and about 24 mm and a length of between about 8 mm and about 30 mm such that the resulting plug has, running through it, perpendicular to the long axis of the plug, a canal defined by a portion of the natural intra-medullary canal of the donor'"'"'s bone.

17. The method of claim 16 further comprising chamfering one end of said plug to form a generally curved surface for ease of insertion of the dowel into an intervertebral cavity.

18. The method of claim 16 further comprising machining an instrument attachment hole into the end of the dowel opposite the chamfered end.

19. The method of claim 18 further comprising inscribing a score mark on the instrument attachment end of the dowel to allow for proper alignment of the intra-medullary canal.

20. A method for fusing vertebrae which comprises making a cavity between the vertebrae to be fused and inserting therein a diaphysial cortical dowel comprising a transverse bone plug obtained from a transverse cut in the diaphysis of a long bone having an intra-medullary canal, wherein said canal is defined by the intra-medullary canal of said long bone, and wherein said plug retains the natural architecture surrounding the intra-medullary canal running therethrough.

21. The method of claim 20 further comprising retention of bone fragments obtained during the making of said cavity between said vertebrae to be fused and packing said bone fragments into the intramedullary canal of said diaphysial cortical dowel.

22. The method of claim 21 wherein said osteogenic composition is autogenous bone fragments obtained during the making of said cavity between said vertebrae to be fused, a bioceramic, bioglass, hydroxyapatite, calcium phosphate or a combination of these.

23. The method of claim 20 further comprising packing the intra-medullary canal of the diaphysial cortical dowel with an osteogenic composition.

24. An implant for insertion into at least one bore formed between opposing vertebrae of a spine where the vertebrae are separated by a space and each vertebra has end plates, the implant comprising:

(a) a solid generally cylindrical body having a first and a second end, and an outer surface, opposing sides and a longitudinal axis;

(b) the body having threads on a portion of the outer surface between the first and second end, the threads configured for threading into bone;

(c) the body including at least one through canal perpendicular to the longitudinal axis positioned between opposing sides, the through canal containing a biocompatible porous material for allowing the growth of bone through the canal; and

(d) the through canal being positioned between generally opposing sides of the body so as to provide contact between the biocompatible porous material and the end plates of the opposing vertebrae when the implant is inserted into at least one bore formed between opposing vertebrae;

provided that said implant is composed substantially of cortical bone, that said implant comprises a transverse plug obtained from a transverse cut across the diaphysis of a long bone, and that said canal is defined by the intra-medullary canal of a long bone, and wherein said body retains the natural architecture surrounding said intra-medullary canal.

25. A method for making an implant for insertion into a space formed between adjacent vertebrae comprising obtaining a plug of substantially cortical bone by cutting transversely across the diaphysis of a long bone such that a bone plug having a longitudinal axis is thereby produced having a canal running through the bone plug perpendicular to the longitudinal axis of the plug, wherein said canal is defined by the natural intra-medullary canal of said long bone, and wherein said plug retains the natural architecture surrounding the intra-medullary canal.

26. A diaphysial cortical bone dowel comprising a transverse bone plug obtained from a transverse cut in the diaphysis of a long bone having an intra-medullary canal, said plug comprising a canal running therethrough, wherein said canal is defined by a portion of the natural intra-medullary canal of said long bone.