Tissue integration design for seamless implant fixation

• US 9,364,330 B2
• Filed: 06/24/2004
• Issued: 06/14/2016
• Est. Priority Date: 06/25/2003
• Status: Active Grant

• Current Assignee: Biedermann Technologies GmbH & Co. KG
• Original Assignee: Biedermann Technologies GmbH & Co. KG
• Inventors: Lindsey, Ronald W., Gugala, Zbigniew, Latta, Loren L.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US10/876,398
• Publication Number:
  US 20050015154A1
• Time in Patent Office: 4,373 Days
• Field of Search: 623/17.11, 623/17.16, 606/246, 606/249
• US Class Current: 1/1
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 17/742 having one or more longitudinal elements oriented along or parallel to the axis of the neck
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/42 for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2002/30235 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 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00413 : Coating made of cobalt or of Co-based alloys
• CPC Class Codes: A61F 2310/00592 : Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Abstract

The present invention relates to orthopaedic implants having a fenestrated hollow shell and a biologic core. These design features provide an improved interface between the implant and the surrounding tissue, aiding fixation, and provide a vehicle for applying new bone healing and enhancing modalities, such as gene therapy, tissue engineering, and growth factors.

Claims

1. A musculo-skeletal implant comprising:

a biologic core material;

a fenestrated shell component comprising at least an outer fenestrated shell connected to an inner fenestrated shell, each of the inner and outer fenestrated shells defining a fenestrated tubular wall of intercrossing members to form a mesh, one wall inside the other and mostly spaced apart from each other to define a mostly open chamber therebetween, the inner tubular wall further defining and located entirely around a hollow bore therein, the fenestrated shell being permanently fixable with a host body tissue by integration of at least one of the inner and outer fenestrated shells therewith;

wherein the fenestrated shell component further comprises interconnecting members extending between an outside of the inner shell and an inside of the outer shell and that are located entirely between ends of the inner and outer shells, the inner and outer shells being interconnected with the interconnecting members;

wherein the tubular walls together define an open first end between the tubular walls;

wherein the biologic core material is located in the open chamber between the inner and outer shells;

wherein the biologic core material is small enough to enter the open chamber through the open first end between the tubular walls and large enough to be contained by the inner and outer fenestrated shells in the open chamber;

wherein each fenestrated tubular wall comprises openings large enough to permit bone material to grow into the open chamber between the walls; and

wherein the fenestrated tubular wall of the outer shell is exposed to permit contact with body tissue.

2. The musculo-skeletal implant of claim 1, wherein the fenestrated shell component comprises titanium.

3. The musculo-skeletal implant of claim 1, wherein the fenestrated shell component comprises ceramic material.

4. The musculo-skeletal implant of claim 1, wherein the fenestrated shell component comprises cobalt-chromium.

5. The musculo-skeletal implant of claim 1, wherein the fenestrated shell component comprises diamond shaped fenestrations.

6. The musculo-skeletal implant of claim 1, wherein each of the fenestrated shells of the fenestrated shell component has a honeycomb pattern, a round pattern, a triangular pattern or any combination thereof.

7. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises bone tissue.

8. The musculo-skeletal implant of claim 7, wherein the bone tissue comprises autogenous bone.

9. The musculo-skeletal implant of claim 7, wherein the bone tissue comprises musculo-skeletal autografts, musculo-skeletal allografts, musculo-skeletal xenografts, or any combination thereof.

10. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises osteogenic bone graft substitutes, osteoinductive bone graft substitutes, osteoconductive bone graft substitutes or any combination thereof.

11. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises fibrogenic graft materials, fibroinductive graft materials, fibropromotive graft materials, fibroconductive graft materials, and any combination thereof.

12. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises chondrogenic graft materials, chondroinductive graft materials, chondropromotive graft materials, chondroconductive graft materials, and any combination thereof.

13. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises genetic material.

14. The musculo-skeletal implant of claim 13, wherein the genetic material comprises nucleic acids, plasmids, or vectors.

15. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises synthetic materials.

16. The musculo-skeletal implant of claim 15, wherein the synthetic materials are selected from the group consisting of ceramics, cement, polymers, and combinations thereof.

17. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises a growth factor.

18. The musculo-skeletal implant of claim 17, wherein the growth factor comprises a substance which promotes bone growth.

19. The musculo-skeletal implant of claim 18, wherein the substance comprises bone morphogenetic protein.

20. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises a therapeutic agent.

21. The musculo-skeletal implant of claim 20, wherein the therapeutic agent comprises a drug substance.

22. The musculo-skeletal implant of claim 1, wherein the vertebral implant is a spin disk implant.

23. The musculo-skeletal implant of claim 1, wherein the implant comprises bone implant hardware.

24. The musculo-skeletal implant of claim 23, wherein the bone implant hardware is selected from the group consisting of bone nails, bone screws, bone rods, and bone plates.

25. The musculo-skeletal implant of claim 23, wherein the bone implant hardware comprises a bone reinforcement implant.

26. The musculo-skeletal implant of claim 1, further comprising a coating of material on at least a part of its surface.

27. The musculo-skeletal implant of claim 26, wherein said coating material is hydroxyapatite.

28. The musculo-skeletal implant of claim 1, further comprising a solid, non-fenestrated portion.

29. The musculo-skeletal implant of claim 1, wherein each fenestrated shell has sufficient integrity to maintain its form against its own weight.

30. The musculo-skeletal implant of claim 1, wherein the fenestrated shells comprise two concentrically positioned cylinders.

31. The musculo-skeletal implant of claim 1, wherein the two fenestrated shells are interconnected by an interconnection structure between an inner wall of the outer fenestrated shell and an outer wall of the inner fenestrated shell.

32. The musculo-skeletal implant of claim 1, wherein at least one of the annular chamber and the hollow bore is packed with bone graft, cement or other material.

33. The musculo-skeletal implant of claim 1, wherein the biologic core material comprises biologic tissue.

34. The musculo-skeletal implant of claim 1, wherein at least one of the annular chamber and the hollow bore is packed with a biologic tissue.

35. The musculo-skeletal implant of claim 1, wherein the implant is a dental impplant.

36. The musculo-skeletal of claim 1, wherein the implant comprises a joint prosthesis.

37. The musculo-skeletal implant of claim 36, wherein the joint prosthesis is selected from the group consisting of hip implants, knee implants, ankle implants, wrist implants, elbow implants, finger implants, foot implants, toe implants, and shoulder implants.

38. The musculo-skeletal implant of claim 36, wherein the joint prosthesis is a vertebral implant.

40. The musculo-skeletal implant of claim 1, wherein the interconnecting members are oriented substantially in radial direction traverse to a longitudinal axis of the implant.

39. The musculo-skeletal implant 1, wherein the implant comprises an extracorporeal prosthesis portion.

41. A musculo-skeletal implant comprising:

a solid non-fenestrated portion configured to be located outside a bone;

a biologic core material;

a fenestrated shell component attached to the solid non-fenestrated portion and configured to be at least partly implanted inside the bone, the fenestrated shell component comprising at least an outer fenestrated shell connected to an inner fenestrated shell, each of the inner and outer fenestrated shells defining a fenestrated tubular wall of intercrossing members to form a mesh, one wall inside the other and mostly spaced apart from each other to define a mostly open chamber therebetween, the inner tubular wall further defining and located entirely around a hollow bore therein, the fenestrated shell component being permanently fixable with a host body tissue by integration of at least one of the inner and outer fenestrated shells therewith;

wherein the fenestrated shell component further comprises interconnecting members extending between an outside of the inner shell and an inside of the outer shell and that are located entirely between ends of the inner and outer shells, the inner and outer shells being interconnected with the interconnecting members;

wherein the tubular walls together define an open first end between the tubular walls;

wherein the biologic core material is located in the open chamber between the inner and outer shells;

wherein the biologic core material is small enough to enter the open chamber through the open first end between the tubular walls and large enough to be contained by the inner and outer fenestrated shells in the open chamber;

wherein each fenestrated tubular wall comprises openings large enough to permit bone material to grow into the open chamber between the walls; and

wherein the fenestrated tubular wall of the outer shell is exposed to permit contact with body tissue.

42. A musculo-skeletal implant comprising:

a biologic core material;

a fenestrated shell component comprising at least an outer fenestrated shell connected to an inner fenestrated shell, each of the inner and outer fenestrated shells defining a fenestrated tubular wail of intererossing members to form a mesh, one wall inside the other and mostly spaced apart from each other to define a mostly open chamber therebetween, the inner tubular wall further defining and located entirely around a hollow bore therein, the fenestrated shell component being permanently fixable with a host body tissue by integration of at least one of the inner and outer fenestrated shells therewith;

wherein the fenestrated shell component further comprises interconnecting members extending between an outside of the inner shell and an inside of the outer shell and that are located between ends of the inner and outer shells, the inner and outer shells being interconnected with the interconnecting members, at least one of the interconnecting members being located at an outermost edge of the fenestrated shell component;

wherein the tubular walls together define an open first end between the tubular walls;

wherein the biologic core material is located in the open chamber between the inner and outer shells;

wherein the biologic core material is small enough to enter the open chamber through the open first end between the tubular walls and large enough to be contained by the inner and outer fenestrated shells in the open chamber;

wherein each fenestrated tubular wall comprises openings large enough to permit bone material to grow into the open chamber between the walls; and

wherein the fenestrated tubular wall of the outer shell is exposed to permit contact with body tissue.