PARTIALLY RESORBABLE IMPLANTS AND METHODS

• US 20170182222A1
• Filed: 05/18/2016
• Published: 06/29/2017
• Est. Priority Date: 05/18/2015
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Stryker European Holdings I, LLC (Stryker Corporation)
• Inventors: Cipoletti, Robert, Paddock, Bradley William, Havener, Matthew B., Wollowick, Adam Laurance, Willis, Steven, Long, Marc Gilles, Sharifi-Mehr, Amir Ali, Buchert, Oliver
• Granted Patent: US 10,537,666 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30883 dovetail-shaped
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/4629 connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

Implants including non-resorbable frameworks and resorbable components, as well as methods of use thereof are disclosed. The embodiments include different combinations of a non-resorbable framework (in some case structural and in other cases non-structural), and a resorbable component embedded within and/or around the framework (again, in some cases structural and in other cases non-structural). The disclosed implants provide an efficient means of providing structural support for the vertebral bodies post-implantation, as well as encouraging resorption of the implant and fusion of the associated vertebral bodies without negative side effects and/or failure, such as subsidence of the implant or cracking/fracturing of a portion of the implant when implanted.

Claims

1. An implant sized and adapted for insertion into an intervertebral space between adjacent vertebral bodies comprising:

a non-resorbable, structural framework having top and bottom bone-contacting surfaces and a plurality of struts defining geometric openings between the top and bottom surfaces, the struts providing structural support for the framework, wherein the framework includes a plurality of support columns extending between proximal and distal ends of the framework, the plurality of support columns being spaced apart from each other to define vertical openings in the framework; and

a resorbable material component within and/or around the framework for resorption and formation of new bone to fuse the vertebral bodies together.

2. An implant according to claim 1, wherein the framework defines at least one opening extending through its top and bottom surfaces, and the resorbable material component is positioned within the at least one opening so as to encourage new bone formation through the at least one opening.

3. An implant according to claim 1, wherein the resorbable material component is a structural component that includes top and bottom bone-contacting surfaces configured to support post-surgical loads experienced after implantation of the implant.

4. An implant according to claim 1, wherein the resorbable material component is non-structural.

5. An implant according to claim 1, wherein the plurality of support columns extend longitudinally from the proximal end to the distal end of the framework.

6. An implant according to claim 1, wherein the plurality of struts defining geometric openings at least partially form each support column.

7. An implant according to claim 1, wherein the resorbable material component includes at least one vertical opening extending through a main body of the resorbable material component.

8. An implant according to claim 1, wherein the implant further comprises a bone anchor having a bladed portion and a keyed interconnection portion, and the framework includes at least one keyed opening sized and shaped to receive the keyed interconnection portion.

9. An implant according to claim 8, wherein once engaged with the framework, the bladed portion of the bone anchor extends outwards from either the top or bottom surface of the framework.

10. An implant according to claim 8, wherein the resorbable material component further comprises a keyed interconnection portion that is substantially the same shape as the keyed interconnection portion of the framework, and wherein the keyed interconnection portions of the resorbable material component and the framework, respectively, are aligned to allow engagement of the bone anchor with the implant.

11. An implant according to claim 1, wherein the resorbable material component is composed of a material selected from the group consisting of bioactive glass, bone, polylactides, collagen, magnesium alloy, or a Cross-Linked Microstructure (CLM) bioglass material.

12. A method of reducing subsidence of an implant into bone comprising:

providing an implant having a non-resorbable structural framework and a resorbable structural component positioned within and/or around the framework;

implanting the framework between first and second adjacent vertebral bodies so that top and bottom surfaces of the framework contact vertebral endplates of the first and second vertebral bodies; and

implanting the resorbable component between the first and second adjacent vertebral bodies so that top and bottom surfaces of the resorbable component contact the vertebral endplates, wherein the top and bottom surfaces of the resorbable component contact the vertebral endplates over a contact surface area sufficient to reduce peak stresses between the framework and the vertebral bodies by an amount effective to eliminate or reduce subsidence of the framework into the vertebral bodies.

13. A method of reducing subsidence according to claim 12, wherein in the absence of the resorbable component, peak stresses between the framework and the vertebral bodies is above a stress required for the vertebral endplates to fail.

14. A method of reducing subsidence according to claim 12, wherein the resorbable component reduces peak stresses between the framework and the vertebral bodies by about 40-80%.

15. A method of reducing subsidence according to claim 12, wherein the contact surface area is between about 30-70% of an overall contact surface area of the implant in contact with the vertebral endplates.

16. A method of reducing subsidence according to claim 12, wherein the resorbable component occupies about 50-80% of an overall volume of the implant, and the framework occupies about 20-50% of the overall volume of the implant.

17. An implant sized and adapted for insertion into an intervertebral space between adjacent vertebral bodies comprising:

a non-resorbable, structural framework having top and bottom bone-contacting surfaces and a plurality of struts defining geometric openings between the top and bottom surfaces, the struts providing structural support for the framework; and

a resorbable material component within and/or around the framework for resorption and formation of new bone to fuse the vertebral bodies together, wherein the resorbable material has top and bottom bone-contacting surfaces, and the top and bottom surfaces of the resorbable component are arranged to contact the vertebral endplates over a contact surface area sufficient to reduce peak stresses between the framework and the vertebral bodies by an amount effective to reduce or eliminate subsidence of the framework into the vertebral bodies.

18. An implant as claimed in claim 17, wherein the contact surface area is between about 30-70% of an overall contact surface area of the implant in contact with the vertebral endplates.

19. An implant as claimed in claim 17, wherein the resorbable component reduces peak stresses between the framework and the vertebral bodies by about 40-80%.

20. An implant as claimed in claim 17, wherein in the absence of the resorbable component, peak stresses between the framework and the vertebral bodies is above a stress required for the vertebral endplates to fail.