Intervertebral nucleus and annulus implants and methods of use thereof
The invention encompasses devices and methods for treating one or more damaged, diseased, or traumatized intervertebral discs to reduce or eliminate associated back pain. Specifically, the invention encompasses intervertebral nucleus and annulus implants that are resistant to migration in and/or expulsion from an intervertebral disc space. The invention further encompasses kits including the implantable devices of the invention and associated delivery tools to treat annular and nuclear tissue.
1. A nucleus pulposus replacement device comprising:
an outer shell comprised of a biocompatible material defining a central fillable cavity having a central cavity and one or more envelope cavities completely surrounding an outer perimeter of the central cavity;
an inner surface capable of receiving a load bearing polymeric or elastomeric material;
a valve to allow filling of the inner surface; and
a sealing crimp.
2. The device of claim 1 , wherein device is insertable with an endoscope.
3. The device of claim 1 , wherein the outer shell is comprised of a metallic material.
4. The device of claim 3 , wherein the metallic material comprises NiTi alloy, stainless steel, titanium, or combinations thereof.
5. The device of claim 1 , wherein the outer shell is comprised of a polymeric material.
6. The device of claim 1 , further comprising filling the inner surface with the load bearing polymeric or elastomeric material, wherein the load bearing polymeric or elastomeric material includes a plurality of elastomeric beads or balls suspended in a biocompatible fluid or gel.
7. The device of claim 6 , wherein the plurality of elastomeric beads or balls comprises silicone, urethane, silicone-urethane copolymer, polycarbonate-urethane copolymer, polyethylene terephthalate, or combinations thereof.
8. The device of claim 1 , wherein the valve comprises a unidirectional valve.
9. The device of claim 1 , wherein the nucleus pulposus replacement device is cylindrically shaped.
10. The device of claim 1 , wherein the nucleus pulposus replacement device includes a textured top surface and a textured bottom surface.
11. A method of surgery comprising:
removing at least a portion of a nucleus pulposus through an annulus fibrosus to create a cavity;
inserting a nucleus pulposus replacement device in the cavity, wherein the device comprises:
an outer shell comprising a tubular ring having a top surface, a bottom surface, and lateral sides comprised of a biocompatible material;
an inner surface capable of receiving a load bearing polymeric or elastomeric material; and
a valve to allow filling of the inner surface;
wherein, when inflated with the load bearing polymeric or elastomeric material, the top and bottom surfaces and lateral sides of the tubular ring are rounded so that the nucleus pulposus replacement device is configured to fit firmly to the annulus fibrosus and vertebral endplates.
12. The method of claim 11 , wherein inserting the nucleus pulposus replacement device is performed using an endoscope.
13. The method of surgery of claim 11 , wherein the outer shell is comprised of a metallic material.
14. The method of surgery of claim 13 , wherein the metallic material comprises NiTi alloy, stainless steel, titanium, or combinations thereof.
15. The method of surgery of claim 11 , wherein the outer shell is comprised of a polymeric material.
16. The method of surgery of claim 11 , further comprising filling the inner surface with the load bearing polymeric or elastomeric material, wherein the load bearing polymeric or elastomeric material includes a plurality of elastomeric beads or balls suspended in a biocompatible fluid or gel.
17. The method of claim 16 , wherein the plurality of elastomeric beads or balls comprises silicone, urethane, silicone-urethane copolymer, polycarbonate-urethane copolymer, polyethylene terephthalate, or combinations thereof.
18. The method of claim 11 , wherein the valve comprises a unidirectional valve.
19. The method of claim 11 , wherein the nucleus pulposus replacement device is cylindrically shaped.
20. The method of claim 11 , wherein the nucleus pulposus replacement device includes a textured top surface and a textured bottom surface.