Percutaneous implantable nuclear prosthesis
An inter-vertebral disc prosthesis intended for percutaneous deployment comprises an expandable annular enclosure and an expandable nuclear enclosure. The expandable annular enclosure incorporates a reinforcing annular band along its periphery and is filled with in-situ curable rubber. The expandable nuclear enclosure is filled with a gas. The nuclear prosthesis further incorporates a novel, integrally molded sealing valve assembly and is stretchable and collapsible into a minimal profile for ease of insertion into a specially designed delivery cannula, and is inflation-assisted expandable into an inter-vertebral disc in which complete percutaneous nuclectomy has been performed.
1. A nuclear prosthesis for percutaneous implantation into a de-nucleated intervertebral disc comprising:
an inflatable annular enclosure comprising an annular enclosing layer having an outer margin, a center region, and a fluid-tight annular inner space;
a reinforcement band;
a sealing valve assembly in fluid communication with the fluid-tight annular inner space, the sealing valve assembly comprising a sealing valve core comprising resilient material and at least partially secured to the annular enclosing layer; and
a nuclear enclosure comprising a nuclear enclosing layer, and an inflatable gas-tight nuclear inner space, wherein the nuclear enclosure is at least partially situated within the center region of the annular enclosure.
2. The prosthesis of claim 1 wherein the inflatable annular enclosure further comprises an in situ curable elastomeric material.
3. The prosthesis of claim 2 wherein the curable resilient material comprises a curable rubber or curable elastomer.
4. The prosthesis of claim 1 wherein the reinforcement band is associated with the outer margin of the annular enclosing layer.
5. The prosthesis of claim 1 wherein the sealing assembly is at least partially secured within the fluid-tight annular inner space.
6. The prosthesis of claim 1 wherein the nuclear enclosing layer is mounted on a indwelling catheter extending into the gas-tight nuclear inner space and partially extending through the sealing valve core, with the indwelling catheter having a lumen for conduction of fluid along its length from within the sealing valve assembly and into the gas-tight nuclear inner space.
7. The prosthesis of claim 6 wherein the nuclear enclosing layer is secured onto an interior surface of the annular enclosing layer and the sealing valve core and is inflatable within an open area in a center region of the annular enclosure.
8. The prosthesis of claim 6 wherein the indwelling catheter and the sealing valve core provide a sealing valve to the annular enclosure and the nuclear enclosure.
9. The prosthesis of claim 1 wherein multiple open pathways are present within the sealing valve core that provide fluid-tight sealing for the annular enclosure and the nuclear enclosure.
10. The prosthesis of claim 1 wherein the sealing valve is within the fluid-tight annular inner space, and multiple open pathways are present within the sealing valve core; each of the multiple open pathways passing through the reinforcement band.
11. The prosthesis of claim 1 wherein the fluid-tight annular inner space contains a cured resilient material.
12. The prosthesis of claim 1 wherein the reinforcement band comprises a multi-layered reinforcement band.
13. The prosthesis of claim 12 wherein the multi-layered reinforcement band comprises textile reinforcing components.
14. The prosthesis of claim 13 wherein the gas-tight nuclear inner space is inflated with air.
15. The prosthesis of claim 1 wherein the gas-tight nuclear inner space is inflatable with gas.
16. The prosthesis of claim 1 where the annular enclosure is doughnut shaped.
17. The prosthesis of claim 1 wherein the prosthesis is configured to be implanted in a human.
18. The prosthesis of claim 1 wherein the reinforcement band comprises a textile multi-layered reinforcement band at least partially associated with the outer margin of the annular enclosing layer.
19. The prosthesis of claim 18 wherein the gas-tight inner space is inflatable by air, and wherein the fluid-tight annular inner space is inflatable by an in situ curable rubber material.
20. The prosthesis of claim 1 further comprising a sealing valve within the sealing valve core in fluid communication with the fluid-tight annular inner space.
21. A nuclear prosthesis for percutaneous implantation into a de-nucleated intervertebral disc, comprising:
an annular tubular elastomeric enclosure forming a fluid-tight inflatable annular chamber, the annular enclosure having an outer perimeter and an inner region;
an annular reinforcement member contiguous to at least a portion of the outer perimeter of the annular enclosure for reinforcing the annular enclosure;
an inflatable nuclear enclosure forming a gas-tight inflatable nuclear chamber, the nuclear enclosure being disposed at least partially within the inner region of the annular enclosure; and
a resilient core secured to the annular enclosure, the resilient core having at least a first channel for providing closable access to the annular chamber and a second channel for providing access to the nuclear chamber.
22. The nuclear prosthesis of claim 21 , wherein the nuclear enclosure is configured for long term maintenance of a gas cushion in an inflated state.
23. The nuclear prosthesis of claim 21 , wherein the annular tubular elastomeric enclosure is configured to be fluid tight to an in-situ curable elastomer.
24. The nuclear prosthesis of claim 21 , wherein the annular reinforcement member comprises a biocompatible textile band.