INTERBODY FUSION RING AND METHOD OF USING THE SAME

• US 20060293749A1
• Filed: 06/01/2006
• Published: 12/28/2006
• Est. Priority Date: 06/02/2005
• Status: Active Grant

• Current Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Hestad, Hugh D., Viker, Thomas O., Casutt, Guido, Chapman, Melanie, Thompson, Rosemary, Hudgins, Robert Garryl
• Granted Patent: US 8,007,535 B2
• Time in Patent Office: Days
• US Class Current: 623/17.11
• 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:

(a) an injectable annular ring;

(b) a web within an internal volume of the ring to control cross-sectional expansion of the ring;

(c) at least one access port located on an exterior surface of the ring open to the internal volume of the ring; and

(d) at least one access port located on an exterior surface of the ring open to an 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 monofilament or multifilament 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 comprising:

(a) an injectable hollow annular ring including a web within the internal volume of the ring to control cross-sectional expansion of the ring, 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;

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

(c) 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 method of implanting an intervertebral spinal fusion device comprising:

(a) performing a discectomy while preserving an outer annular tissue between adjacent vertebrae to provide an intervertebral space;

(b) preparing the adjacent vertebrate end plates;

(c) inserting an injectable annular ring having a web within the internal volume of the ring to control cross-sectional expansion of the ring, at least one 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; and

(d) directing a load-bearing, hardenable material into the internal volume of the ring in an amount sufficient to fill the internal volume of the ring.

38. The method of claim 37 further comprising inserting a balloon through the access port of the ring into the interior space into the interior cavity bordered by the ring.

39. The method of claim 37 further comprising filling the balloon to deploy the ring within the intervertebral space and distract the adjacent vertebrae.

40. The method of claim 37 further comprising removing the balloon from the interior cavity and directing an osteobiologic composition into the interior cavity.

41. The method of claim 37 wherein the ring is inserted in a collapsed state into the intervertebral space with an insertion device.

42. The method of claim 38 wherein the balloon is inserted into the interior cavity of the ring and both are inserted in the intervertebral space with an insertion device.

43. The method of claim 42 wherein the balloon and ring are fitted to a balloon catheter for insertion into the intervertebral space.

44. A spinal implant kit comprising:

(a) an injectable annular ring having a web within the internal volume of the ring to control cross-sectional expansion of the ring, at least one 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;

(b) a load-bearing, hardenable material;

(c) an osteobiologic composition;

(d) 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;

(e) at least one injection device to inject the load-bearing material into the internal volume of the ring, to fill a balloon sized and shaped to fit through the access port of the ring into the interior cavity bordered by the ring, or to inject the osteobiologic composition into the interior cavity of the ring; and

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

45. A method of fusing adjacent vertebrae comprising:

(a) accessing adjacent vertebrate to be fused;

(b) performing a partial or complete discectomy;

(c) creating an intervertebral interior space having prepared top and bottom vertebral endplate surfaces;

(d) inserting a balloon through an access port of injectable annular ring having a web within the internal volume of the ring to control cross-sectional expansion of the ring, at least one 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;

(e) collapsing the balloon and ring;

(f) placing the collapsed balloon and ring into the intervertebral space;

(g) filling the balloon with an incompressible fluid to deploy the ring and decompress surrounding neurological structures;

(h) injecting the ring with a load-bearing, hardenable material;

(i) hardening the load bearing material;

(j) removing the fluid from the balloon;

(k) removing the balloon from the interior cavity of the ring; and

(l) filling the interior cavity of the ring with an osteobiologic material.

46. The method of claim 45 further comprising sealing the access port to retain the osteobiological material within the cavity.

47. Using an injectable annular ring to treat a deteriorating spinal disc comprising means for placing the annular ring in a collapsed or folded state through a small annular opening into an intervertebral space within the annulus having prepared vertebral endplates using minimally invasive techniques;

means for deploying or unfolding the annular ring in the intervertebral space having a sufficient foot print to prevent substantial penetration of the endplates and to provide an interior cavity bordered by the ring that is in direct contact with the vertebral endplates; and

means for injecting an internal volume of the annular ring with a load-bearing hardenable material to maintain intervertebral spacing and prevent the ring from being expelled from the interior cavity through the small annular opening.

48. A method of treating a patient having a deteriorating spinal disc comprising:

(a) accessing the deteriorated spinal disc;

(b) using minimally invasive techniques to place a collapsed or folded annular ring through a small opening into an intervertebral space within the annulus having prepared vertebral endplates;

(c) deploying the ring in the intervertebral space to provide an interior cavity bordered by the ring that is in direct contact with the vertebral endplates;

(d) injecting a load-bearing hardenable material into an internal volume of the ring to maintain intervertebral spacing and prevent the ring from being expelled from the interior cavity through the small annular opening; and

(e) filling the intervertebral space with a osteobiologic material that is in direct contact with the prepared vertebral endplates.