Retention structure for in situ formation of an intervertebral prosthesis

• US 8,092,536 B2
• Filed: 09/03/2008
• Issued: 01/10/2012
• Est. Priority Date: 05/24/2006
• Status: Expired due to Fees

• Current Assignee: Spinal Stabilization Technologies LLC
• Original Assignee: Disc Dynamics, Inc.
• Inventors: Ahrens, Michael, Martz, Erik O.
• Primary Examiner(s): Barrett, Thomas C.
• Assistant Examiner(s): BATES, DAVID W
• Application Number:
  US12/203,727
• Publication Number:
  US 20090012618A1
• Time in Patent Office: 1,224 Days
• Field of Search: 623 1711- 1716, 606/200
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/7094 Solid vertebral fillers; devices for inserting such fillers
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30079 magnetic
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30177 W-shaped, M-shaped or sigma shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30252 quadric-shaped
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30273 pyramidal
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30471 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30588 : filled with solid particles
• 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 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0056 : W-shaped, e.g. M-shaped, sigma-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0073 : Quadric-shaped
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2230/0086 : Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• 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 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures

Abstract

An assembly for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient. At least one retention structure is located in the intervertebral disc space. A distal end of at least one lumen is located proximate the at least one retention structure. One or more in situ curable biomaterials are delivered to the intervertebral disc space through the first lumen and into engagement with the retention structure. The retention structure serves to retain at least a portion of the biomaterial in the intervertebral disc space by surface tension, adhesion, mechanical capture, friction, viscosity, and/or a variety of other mechanisms. The at least partially cured biomaterial and the at least one retention structure cooperate to comprise the prosthesis.

Claims

1. An assembly for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient, the assembly comprising:

a plurality of retention structures adapted to be delivered sequentially through a lumen into the intervertebral disc space;

at least a first lumen adapted to be extended into the intervertebral disc space and having a distal end proximate the at least one retention structure;

one or more in situ curable biomaterials adapted to be delivered to the intervertebral disc space through the first lumen and into engagement with the retention structure, the biomaterial flowing into and around the retention structure, the retention structure adapted to retain at least a portion of the biomaterial in the intervertebral disc space, wherein the retention structure and the curable biomaterial are adapted to be retained in at least a portion of an anatomical annulus without a mold, wherein the at least partially cured biomaterial substantially encapsulates the at least one retention structure and cooperates with the at least one retention structure to comprise the prosthesis; and

wherein the prosthesis is configured as a motion preservation device.

2. The assembly of claim 1 wherein the retention structure comprises a generally planar structure with openings opposite end plates of the adjacent vertebrae.

3. The assembly of claim 1 wherein the retention structure comprises one or more collapsed retention structures adapted to expand when located in the intervertebral disc space.

4. The assembly of claim 1 wherein the retention structure comprises one or more collapsed retention structures adapted to expand during delivery of the curable biomaterial.

5. The assembly of claim 1 wherein the retention structure comprises an expandable or reorientable retention structure.

6. The assembly of claim 1 wherein the retention structure is adapted to be assembled within the intervertebral disc space.

7. The assembly of claim 1 wherein the retention structure comprises a plurality of interlocking members.

8. The assembly of claim 1 wherein the retention structure comprises one or more inflatable members.

9. The assembly of claim 1 wherein the retention structure comprises a plurality of members adapted to provide resistance to both tensile and compressive forces.

10. The assembly of claim 1 wherein the retention structure comprises a woven or a non-woven member.

11. The assembly of claim 1 wherein the retention structure comprises one or more coiled or kinked members.

12. The assembly of claim 1 wherein the retention structure comprises a plurality of magnetic members.

13. The assembly of claim 1 wherein the retention structure comprise one or more of individual strands, coils, woven or non-woven webs, open cell foams, closed cell foams, combination of open and closed cell foams, scaffolds, cotton-ball fiber matrix, or a generally honeycomb retention structure.

14. The assembly of claim 1 wherein the retention structure comprises:

a plurality of interconnected cavities; and

fluid flow devices interposed between at least some of the interconnected cavities, the fluid flow devices selectively controlling the flow of biomaterial into at least some of the cavities.

15. The assembly of claim 1 wherein the retention structure comprises a plurality of discrete cavities at least a portion of which are at least partially filled with biomaterial.

16. The assembly of claim 1 wherein the lumen is coupled to at least one retention structure.

17. The assembly of claim 1 wherein the retention structure comprises a mesh.

18. The assembly of claim 1 wherein the retention structure comprises an expandable mesh.

19. The assembly of claim 1 wherein the retention structure when in the intervertebral disc space comprises at least one cross-sectional area greater than a cross-sectional area of an opening in the first lumen.

20. The assembly of claim 1 wherein the lumen is releasably attached to the retention structure.

21. The assembly of claim 1 comprising at least one valve adapted to retain the biomaterial in the cavity after the lumen is removed.

22. The assembly of claim 1 wherein one or more of the retention structure or the biomaterial comprises a bioactive agent.

23. The assembly of claim 1 wherein delivery of the biomaterial positions the retention structure relative to the intervertebral disc space.

24. The assembly of claim 1 wherein the prosthesis comprises one of a nucleus replacement device, a partial nucleus replacement device, or a total disc replacement device.

25. The assembly of claim 1 wherein the retention structures is adapted to be delivered using minimally invasive techniques.

26. The assembly of claim 1 comprising a mold containing the retention structure and the curable biomaterial.

27. The assembly of claim 1 wherein the distal end of the first lumen is engaged with the retention structure.

28. An assembly for in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient, the assembly comprising:

a plurality of retention structures adapted to be delivered sequentially through a lumen into the intervertebral disc space, the retention structures filling less than the entire intervertebral disc space;

at least a first lumen having a distal end fluidly coupled to the retention structures;

one or more in situ curable biomaterials adapted to be delivered to the intervertebral disc space through the first lumen, the biomaterial flowing into and around the retention structure, the retention structures adapted to retain at least a portion of the biomaterial in the intervertebral disc space, wherein the retention structures and the curable biomaterial are adapted to be retained in at least a portion of an anatomical annulus without a mold, wherein an at least partially cured biomaterial substantially cooperates with the retention structures to comprise the prosthesis; and

wherein the prosthesis is configured as a motion preservation device.