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Publication Number
US-8636803-B2
Publication Date
2014-01-28
Expiration Date
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.
Core Innovation
The invention relates to a nuclear prosthesis for percutaneous implantation into a de-nucleated inter-vertebral disc space of a human. The nuclear prosthesis includes an annular enclosing layer that substantially forms an annular enclosure and a nuclear enclosing layer adjacent an inner margin of the annular enclosing layer that encloses and defines a nuclear enclosure.
The annular reinforcement band adjacent an outer margin of the annular enclosing layer comprises a plurality of at least partially interwoven layers of biocompatible fibers that form a three dimensional structure. The three dimensional structure includes a warp knitted outer layer for enhancing in-growth of soft tissue, at least one intermediate layer formed of substantially helical loops of the biocompatible fibers, and an inner layer formed of thin biocompatible fibers.
A sealing valve assembly includes a sealing valve core disposed within the annular enclosure and bonded to the annular enclosing layer, an indwelling catheter extending outward through the nuclear enclosing layer, and a sealing plug insertable within the indwelling catheter. The sealing valve assembly conducts compressible fluid into the nuclear enclosure and deformable fluid into the annular enclosure, with an inlet port and an outlet port associated with the sealing valve core and a pore in the indwelling catheter for conduction of the fluid into the nuclear enclosure.
Claims Coverage
The relevant set includes one independent claim that defines the complete nuclear prosthesis structure, including the annular fiber reinforcement architecture and the sealing valve assembly for fluid conduction into both a nuclear enclosure and an annular enclosure.
Percutaneously implantable nuclear prosthesis with annular and nuclear enclosures
A nuclear prosthesis for percutaneous implantation into a de-nucleated inter-vertebral disc space, comprising an annular enclosing layer defining an annular enclosure and a nuclear enclosing layer adjacent an inner margin defining a nuclear enclosure.
Fiber-based three dimensional annular reinforcement band
An annular reinforcement band adjacent an outer margin of the annular enclosing layer, comprising a plurality of at least partially interwoven layers of biocompatible fibers forming a three dimensional structure with a warp knitted outer layer, at least one intermediate layer of substantially helical loops, and an inner layer of thin biocompatible fibers, with adjacent layers partially interwoven.
Sealing valve assembly with sealing valve core and indwelling catheter
A sealing valve assembly comprising a sealing valve core disposed within the annular enclosure and bonded to the annular enclosing layer, an indwelling catheter extending outward through the nuclear enclosing layer, and a sealing plug insertable within the indwelling catheter.
Inlet and outlet ports for fluid conduction into annular enclosure
An inlet port disposed within the sealing valve core lateral to the indwelling catheter and opening into the annular enclosure for conduction of fluid into the annular enclosure, and an outlet port substantially opposite the inlet port and lateral to the indwelling catheter for receiving return of the fluid conducted into the annular enclosure.
Pore in indwelling catheter for fluid conduction into nuclear enclosure
The indwelling catheter includes a pore for conduction of the fluid into the nuclear enclosure.
Across the independent claim, the inventive coverage centers on a percutaneous nuclear prosthesis that uses an annular enclosing layer with a fiber-based three dimensional reinforcement band and a sealing valve assembly that conducts compressible fluid to the nuclear enclosure through a catheter pore and conducts deformable fluid to the annular enclosure through inlet and outlet ports.
Stated Advantages
Improved tissue ingrowth via porous or velour outer reinforcement.
Progressive compliance.
Reduced end-plate stress.
Improved sealing to prevent leakage.
Percutaneous deployability.
Documented Applications
Percutaneous implantation into a de-nucleated inter-vertebral disc space of a human as a nuclear prosthesis.
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