Interbody fusion ring and method of using the same

• US 8,007,535 B2
• Filed: 06/01/2006
• Issued: 08/30/2011
• Est. Priority Date: 06/02/2005
• Status: Expired due to Fees

• Current Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Casutt, Guido, Chapman, Melanie, Thompson, Rosemary, Hestad, Hugh D., Viker, Thomas O., Hudgins, Robert Garryl
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): Bates; David W
• Application Number:
  US11/421,571
• Publication Number:
  US 20060293749A1
• Time in Patent Office: 1,916 Days
• Field of Search: 623 1711- 1715
• US Class Current: 623/17.12
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4601 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 2002/30067 Coating or prosthesis-covering structure made of thermoplastic material
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

The present invention provides an injectable annular ring useful in treating a deteriorating spinal disc. When used, the annular ring may be collapsed or folded in order for it to be placed through a small opening in a prepared intervertebral space within the annulus using minimally invasive techniques. Deployment or unfolding the ring in the intervertebral space provides an interior cavity bordered by the ring that is in direct contact with the vertebral endplates. When an internal volume of the ring is inject or filled with a load-bearing, hardenable material, the filled ring maintains the intervertebral spacing and prevents the ring from being expelled from the interior cavity through the small annular opening.

Claims

1. An orthopedic device for implanting between adjacent vertebrae comprising:

an injectable annular ring having inner and outer side walls defining an internal volume, the ring defining and bordering an interior cavity, the ring having upper and lower surfaces configured to engage adjacent vertebrae;

a web disposed within the internal volume of the ring, the web extending transversely through the internal volume of the ring parallel to and spaced from the upper and lower surfaces, the web connecting inner and outer side walls of the ring, the web structured to control cross-sectional expansion of the ring at forces within a range that will be applied to the device when engaging adjacent vertebrae of a patient;

at least one access port located on an exterior surface of an outer side wall of the ring open to the internal volume of the ring; and

at least one access port located on an exterior surface of the ring open to the interior cavity bordered by the ring.

2. The device of claim 1 wherein the ring comprises a semi-permeable material porous to air and substantially non-porous to selected injectable fluids.

3. The device of claim 1 wherein the ring is a film, a knitted fabric, a woven fabric or a non-woven fabric.

4. The device of claim 3 wherein the fabric comprises threads or yarns.

5. The device of claim 2 wherein the ring is a fabric comprising a three-dimensional, non-orthogonal multifilament yarn structure.

6. The device of claim 5 wherein the three-dimensional structure comprises a honeycomb weave.

7. The device of claim 3 wherein the threads or yarns are comprised of fibers of polyacrylates, polyethylene, polypropylene, polyolefin copolymers, polycarbonates, polyesters, ether-ketone copolymers, polytetrafluoroethylene fibers, silk, polyurethanes, polyurethane co-polymers or mixtures thereof.

8. The device of claim 4 wherein at least a portion of the threads or yarns comprise consolidated, partially consolidated or heat set threads or yarns.

9. The device of claim 8 wherein the heat set threads or yarns provide a permanent shape memory to the fabric of the device.

10. The device of claim 4 wherein the threads or yarns comprise polyester fibers.

11. The device of claim 1 wherein the ring further comprises a flexible coating.

12. The device of claim 8 wherein the coating seals the ring.

13. The device of claim 8 wherein the coating promotes filling the internal volume of the ring with an injectable fluid.

14. The device of claim 8 wherein the coating comprises a thermal insulating material.

15. The device of claim 11 wherein the ring is coated with hydrogels, thermoset or thermoplastic urethanes, thermoset or thermoplastic elastomers, polytetrafluoroethylene fibers, polysiloxanes, polyvinylalcohols, proteins, collagen or mixture thereof.

16. The device of claim 15 wherein the ring is coated with a thermoplastic urethane.

17. The device of claim 1 wherein the web is a film, a knitted fabric, a woven fabric, a non-woven fabric, fibers, threads or yarns.

18. The device of claim 17 wherein the web is knitted or woven threads or yarns.

19. The device of claim 17 wherein the web is stitched threads or yarns.

20. The device of claim 17 wherein the web is stitched polyester threads.

21. The device of claim 1 wherein the web controls the cross-sectional expansion of the ring in a direction parallel to a horizontal mid-plane of the ring.

22. The device of claim 1 wherein cross-sectional expansion of the ring is greater in a direction perpendicular to a plane parallel to a horizontal mid-plane of the ring.

23. The device of claim 1 wherein the access ports are a single parallel port structure comprising at least one first aperture to the internal volume of the ring and at least one second aperture to the interior cavity bordered by the ring, wherein the first and second apertures are independent of each other.

24. The device of claim 1 wherein the access ports are a single coaxial port structure comprising at least one first aperture to the internal volume of the ring and at least one second aperture to the interior cavity bordered by the ring, wherein the first and second apertures are selectively independent of each other.

25. The device of claim 1 wherein the access ports are multiple structures comprising at least one first structure with an aperture to the internal volume of the ring and at least one second structure with an aperture to the interior cavity bordered by the ring.

26. The device of claim 1 further comprising a load-bearing, hardenable material.

27. The device of claim 26 wherein the load-bearing material comprises poly(lactic acid), poly(glycolic acid), p-dioxanone fibers, polyarylethyl, polyacrylates, polyurethanes, amino-acid-derived polycarbonates, polycaprolactones, aliphatic polyesters, calcium phosphate, unsaturated linear polyesters, vinyl pyrrolidones, polypropylene fumarate diacrylates, or mixtures thereof.

28. The device of claim 27 wherein the load-bearing material is polymethylmethacrylate.

29. The device of claim 27 wherein the load-bearing material is a bis-GMA polymer.

30. A spinal implant system for implantation between adjacent vertebrae comprising:

an injectable hollow annular ring including a web disposed within an internal volume of the ring, the web structured to control cross-sectional expansion of the ring at forces within a range that will be applied to the device when engaging adjacent vertebrae of a patient, wherein the web is attached to and extends between first and second opposing internal surfaces of the ring, the web extending parallel to and spaced apart from upper and lower walls of the ring, wherein the upper and lower walls are configured to engage adjacent vertebrae, at least one access port located on an exterior surface of the ring open to the internal volume of the ring, and at least one access port located on an exterior surface of the ring open to an interior cavity bordered by the ring;

a load-bearing material for injection in to the internal volume of the ring; and

an osteobiologic composition for placement in the interior cavity bordered by the ring.

31. The spinal implant system of claim 30 wherein the osteobiological composition comprises natural or synthetic graft substances promoting fusion of adjacent vertebrae.

32. The spinal implant system of claim 30 wherein the osteobiologic composition comprises mesenchymal stem cells, growth factors, cancellous bone chips, hydroxyapatite, tri-calcium phosphate, polylactic acid, polyglycolic acid, polygalactic acid, polycaprolactone, polyethylene oxide, polypropylene oxide, polysulfone, polyethylene, polypropylene, hyaluronic acid, bioglass, gelatin, collagen, polymeric fibers or mixtures thereof.

33. The spinal implant system of claim 30 further comprising a balloon sized and shaped to fit through the access port of the ring into the interior cavity bordered by the ring when collapsed and to expand in the interior cavity to distract adjacent vertebrae when filled with a fluid.

34. The spinal implant system of claim 30 further comprising at least one injection device to inject the load-bearing material into the internal volume of the ring, to expand a balloon sized and shaped to fit in the interior cavity bordered by the ring, or to inject the osteobiologic composition into the interior cavity bordered by the ring.

35. The spinal implant system of claim 30 further comprising at least one insertion device to place the ring in a collapsed state into an annular space between adjacent vertebrae.

36. The spinal implant system of claim 35 wherein the interior cavity of the ring contains a balloon that can be removed from the cavity through the access port.

37. A spinal implant kit for implantation between adjacent vertebrae comprising:

an injectable annular ring having upper and lower walls configured to engage adjacent vertebrae, the ring having a web disposed within an internal volume of the ring, the web extending transversely through the internal volume of the ring parallel to and spaced apart from upper and lower walls, connecting opposing side walls of the ring, the web structured to control cross-sectional expansion of the ring at forces within a range that will be applied to the device when engaging adjacent vertebrae of a patient, at least one access port disposed in a side wall of the ring, the access port open to the internal volume of the ring, and at least one access port open to an interior cavity bordered by the ring;

a load-bearing, hardenable material;

an osteobiologic composition;

a balloon sized and shaped to fit through the access port into the interior cavity bordered by the ring and to expand in the interior cavity to distract adjacent vertebrae;

at least one injection device to inject the load-bearing material into the internal volume of the ring, to fill the balloon, or to inject the osteobiologic composition into the interior cavity bordered by the ring; and

at least one insertion device to place the ring and balloon into a space between adjacent vertebrae.