Percutaneous implantable nuclear prosthesis
AssigneeSpinal Stabilization Technologies LLC
InventorsNadi Salah HIBRI, James Douglas LUTZ
Life of this patent
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Abstract
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.
Claims19
1-41. (canceled)
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.
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.
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.
Dependencies are inferred from the claim text.