Intervertebral implant with movement resistant structure

• US 7,833,245 B2
• Filed: 07/12/2002
• Issued: 11/16/2010
• Est. Priority Date: 07/12/2001
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Osteotech Incorporated (Medtronic Plc)
• Inventors: Kaes, David R., Morris, John W., Winterbottom, John, Geisler, Fred, Shimp, Lawrence A.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): WOODALL, NICHOLAS W
• Application Number:
  US10/483,804
• Publication Number:
  US 20040249377A1
• Time in Patent Office: 3,049 Days
• Field of Search: 606/61, 606/69, 606/70, 606/71, 623/17.11, 623/17.12, 623/17.13, 623/17.14, 623/17.15, 623/17.16
• US Class Current: 606/246
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• 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 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30176 V-shaped
• CPC Class Codes: A61F 2002/30354 Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30492 using a locking pin
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30777 Oblong apertures
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30836 knurled
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof

Abstract

An implant unit used in surgery has a body made from osteogenic implantable material and including an implant portion and a retaining portion, which is coupled to and extends transversely to the implant portion. The retaining portion is attached to the sidewall of the adjoining vertebral body or mammal bone to prevent displacement of the implant portion relative to the vertebral body or mammal bone and to accelerate fusion therebetween.

Claims

1. An implant unit for repairing a vertebral segment or segments or a bone repair site in mammalian bone comprising:

an implant portion for insertion into an intervertebral space or bone repair site extending in an insertion plane and juxtaposed with surfaces to be repaired, the implant portion having a top surface and a bottom surface, wherein the top surface and bottom surface of the implant portion are contoured to complement the surfaces to be repaired; and

a retaining portion for retaining the implant portion in the intervertebral space or bone repair site, the retaining portion being formed of an osteogenic material and extending in its longest dimension transversely to the insertion plane of the implant portion, being provided on a proximal end of the implant portion, and being attachable to a sidewall of the at least one vertebral body or a mammalian bone, the retaining and implant portions being configured and coupled to one another so that during the period of repair the retaining portion substantially prevents displacement of the implant unit relative to the surface to be repaired and the implant unit carries loads over the intervertebral space or the mammalian bone,

wherein the implant portion has a flange extending laterally outwards from at least one end of the implant portion, the flange being received in a stepped central opening of the retaining portion and being dimensioned so that the flange extends flush with an outer surface of the retaining portion after the implant unit is inserted into the intervertebral space or bone repair site.

2. The implant unit according to claim 1 wherein the implant portion and the retaining portion are formed from an implantable material comprising bone tissue selected from the group consisting of bone particles, bone powder, bone chips, and/or a combination of these, and/or a bone composite comprising bone tissue distributed in a polymeric binder;

and contain at least one osteogenic component, and at least one medical agent and/or drug.

3. A method of using an implant unit for joining spaced vertebral bodies each having an inner face to be fused and a sidewall extending transversely to the inner face, comprising the steps of:

providing an implant portion comprising implantable biocompatible material;

providing a retaining portion comprising osteogenic material, the retaining portion being attachable to the sidewall and coupled to a proximal end of the implant portion so that the retaining portion and implant portions extend transversely to one another, wherein the implant portion has a flange extending laterally outwards from at least one end of the implant portion, the flange being received in a stepped central opening of the retaining portion and being dimensioned so that the flange extends flush with an outer surface of the retaining portion after the implant unit is inserted into the intervertebral space or bone repair site;

recessing a portion of the sidewall to form a niche;

and positioning the implant unit such that the retaining portion is partially nested within the previously formed niche of the recessed sidewalls to bear loads imposed upon the spine, the retaining portion substantially prevents displacement of the implant unit relative to the surface to be repaired, and the retaining portion extends in its longest dimension transversely to an insertion plane of the implant portion.

4. The method according to claim 3, wherein the implant portion and the retaining portion are formed from an implantable material comprising bone tissue selected from the group consisting of bone particles, bone powder, bone chips, and/or a combination of these, and/or a bone composite comprising bone tissue distributed in a polymeric binder;

and contain at least one osteogenic component, and at least one medical agent and/or drug.

5. The method according to claim 3, wherein the implant portion has a thickness greater than the distance between the opposing inner faces defining the intervertebral space.

6. The method according to claim 3, wherein the implant portion is provided with opposing top and bottom surfaces each formed with serrations, ridges, knurling and/or other surface roughening features.

7. The method according to claim 6, wherein at least one of the top and bottom surfaces has a ledge defining a stepwise face extending complementary to the respective adjacent inner face of the surfaces to be fused.

8. The method according to claim 3, wherein the retaining portion has an inner surface facing the sidewalls and having a ledge, wherein the ledge extends generally parallel to the insertion plane of the implant portion and is juxtaposed with an inner surface of the niche formed in the sidewalls of the adjoining vertebral bodies to provide a greater contact area for the transmission of loads.

9. The method according to claim 3, wherein the retaining portion has an outer peripheral surface extending substantially parallel to the insertion plane of the implant portion and supporting the surface which defines the niche provided in the sidewalls of the vertebral bodies.

10. The method according to claim 3, further comprising a plurality of fasteners traversing respective openings formed in the retaining portions and penetrating the sidewall of the adjoining vertebral bodies.

11. The method according to claim 10, wherein each of the openings is so dimensioned that the fasteners are capable of being multi-directionally displaced therein before being fixed to the sidewalls of the adjoining vertebral bodies to provide desired positioning of the implant portion.

12. The method according to claim 3, wherein the implant and retaining portions are detachably coupled.

13. An implant unit for joining spaced vertebral bodies each having an inner face to be fused and a sidewall extending transversely to the inner face, wherein at least the sidewalls have been recessed to form a niche, the implant unit comprising:

an implant portion extending in an insertion plane and into the intervertebral space and being interposed between the inner faces following discectomy, wherein a height of the implant portion gradually decreases and wherein the implant portion has a truncated conical portion narrowing in a posterior direction; and

a retaining portion comprising osteogenic material, the retaining portion being attachable to the sidewall, being coupled to a proximal end of the implant portion, and extending in its longest dimension transversely to the insertion plane of the implant portion and shaped to engage the recessed sidewalls, wherein the retaining portion is configured to substantially prevent displacement of the implant unit relative the surface to be repaired, the retaining portion being so dimensioned that upon insertion of the implant portion into the intervertebral space, the retaining portion is at least partially nested within the niche of the recessed sidewalls to bear loads imposed upon the spine;

wherein the implant portion has a flange extending laterally outwards from at least one end of the implant portion, the flange being received in a stepped central opening of the retaining portion and being dimensioned so that the flange extends flush with an outer surface of the retaining portion after the implant unit is inserted into the intervertebral space or bone repair site.

14. The implant unit according to claim 13, wherein the implant portion has a thickness greater than the distance between the opposing inner faces defining the intervertebral space.

15. The implant unit according to claim 13, wherein the implant portion is provided with opposing top and bottom surfaces each formed with serrations, ridges, knurling and/or other surface roughening features.

16. The implant unit according to claim 13, wherein the implant portion is provided with opposing top and bottom surfaces and wherein at least one of the top and bottom surfaces has a ledge defining a stepwise face extending complementary to the respective adjacent inner face of the surfaces to be fused.

17. The implant unit according to claim 13, wherein the implant portion is provided with opposing top and bottom surfaces and wherein at least one of the top and bottom surfaces is contoured to complement a surface to be repaired.

18. The implant unit according to claim 13, wherein the implant portion and the retaining portion are formed from an implantable material comprising bone tissue selected from the group consisting of bone particles, bone powder, bone chips, and/or a combination of these, and/or a bone composite comprising bone tissue distributed in a polymeric binder.

19. The implant unit according to claim 18, wherein the implant portion and the retaining portion further comprise at least one osteogenic component, and at least one medical agent and/or drug.

20. The implant unit according to claim 13, wherein the retaining portion has an inner surface facing the sidewalls and having a ledge, wherein the ledge extends generally parallel to the insertion plane of the implant portion and is juxtaposed with an inner surface of the niche formed in the sidewalls of the adjoining vertebral bodies to provide a greater contact area for the transmission of loads.

21. The implant unit according to claim 13, wherein the retaining portion has an outer peripheral surface extending substantially parallel to the insertion plane of the implant portion and supporting the surface which defines the niche provided in the sidewalls of the vertebral bodies.

22. The implant unit according to claim 13, further comprising a plurality of fasteners traversing respective openings formed in the retaining portions and penetrating the sidewall of the adjoining vertebral bodies.

23. The implant unit according to claim 22, wherein each of the openings is so dimensioned that the fasteners are capable of being multi-directionally displaced therein before being fixed to the sidewalls of the adjoining vertebral bodies to provide desired positioning of the implant portion.

24. The implant unit according to claim 13, wherein the implant and retaining portions are detachably coupled.