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 method of implanting a nuclear prosthesis into a de-nucleated inter-vertebral disc space comprising:
providing a nuclear prosthesis comprising:
an annular tubular elastomeric enclosure forming a fluid-tight inflatable annular chamber, the annular enclosure having an inner region;
an inflatable nuclear enclosure forming a gas-tight inflatable nuclear chamber, the nuclear enclosure being disposed 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;
inserting the nuclear prosthesis into a de-nucleated inter-vertebral disc space;
inflating the nuclear enclosure with a pressurized fluid comprising saline;
inflating the annular enclosure with a pressurized fluid comprising a curable elastomeric material; and
allowing the curable elastomeric material to cure.
2. The method of claim 1 , further comprising replacing the saline in the nuclear enclosure with gas.
3. The method of claim 2 , further comprising sealing the second channel to seal the gas in the nuclear enclosure.
4. The method of claim 1 , further comprising providing an annular reinforcement band around the annular enclosure.
5. The method of claim 1 , further comprising loading said nuclear prosthesis into a delivery apparatus.
6. The method of claim 5 , wherein said delivery apparatus comprises a delivery cannula and a release cannula.
7. The method of claim 6 , further comprising manipulating the release cannula to release the nuclear prosthesis from the delivery apparatus.
8. A method of implanting a nuclear prosthesis comprising:
creating a de-nucleated inter-vertebral disc space by performing a percutaneous nuclectomy through a percutaneous access device;
inserting a delivery apparatus carrying a nuclear prosthesis into the de-nucleated inter-vertebral disc space, said nuclear prosthesis 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 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;
deploying the nuclear prosthesis into the de-nucleated inter-vertebral disc space;
inflating the nuclear enclosure with a pressurized fluid comprising saline;
inflating the annular tubular enclosure with a pressurized fluid comprising a curable elastomeric material; and
allowing the curable elastomeric material to cure.
9. The method of claim 8 , further comprising replacing the saline in the nuclear enclosure with gas.
10. The method of claim 9 , further comprising sealing the second channel to seal the gas in the nuclear enclosure.
11. The method of claim 8 , wherein said delivery apparatus comprises a delivery cannula and a release cannula.
12. The method of claim 11 , further comprising manipulating the release cannula to release the nuclear prosthesis from the delivery apparatus.
13. The method of claim 12 , further comprising removing the delivery cannula.
14. A method of implanting a nuclear prosthesis into a de-nucleated inter-vertebral disc space comprising:
creating a de-nucleated inter-vertebral disc space by performing a percutaneous nuclectomy through a percutaneous access device;
providing a system for inserting a nuclear prosthesis into the de-nucleated inter-vertebral disc space, said system comprising:
a nuclear prosthesis 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 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;
a delivery apparatus for percutaneously delivering the nuclear prosthesis, comprising a delivery cannula and a release cannula; and
an inflation stylus for inflating a the nuclear prosthesis, the inflation stylus at least partially within the delivery cannula and detachably connected to the nuclear prosthesis;
deploying the nuclear prosthesis into the de-nucleated inter-vertebral disc space using the delivery apparatus;
inflating the nuclear enclosure with a pressurized fluid comprising saline using the inflation stylus;
inflating the annular tubular enclosure with a pressurized fluid comprising a curable elastomeric material using the inflation stylus; and
allowing the curable elastomeric material to cure.
15. The method of claim 14 , further comprising replacing the saline in the nuclear enclosure with gas using the inflation stylus.
16. The method of claim 15 , further comprising sealing the second channel to seal the gas in the nuclear enclosure.
17. The method of claim 14 , further comprising manipulating the release cannula to release the nuclear prosthesis from the delivery apparatus.
18. The method of claim 17 , further comprising removing the delivery cannula.