Percutaneous implantable nuclear prosthesis

Inventors

Hibri, Nadi S. • Lutz, James D.

Assignees

Spinal Stabilization Technologies LLC

Abstract

A multi-chamber balloon for a nuclear implant has an elastomeric membrane defining inner and outer chambers integral with a valve body. The valve body includes a core portion and sealing membrane for sealing the inner and outer chambers. An assembly for manufacturing the multi-chamber balloon includes a balloon mandrel which may be dip coated in a silicone dispersion to create an elastomeric membrane for the inner and outer chambers integral with the valve body. The elastomeric membrane formed on the mandrel is partially inverted to form a coaxial elastomeric structure with the smaller inner chamber disposed within the larger outer chamber. The valve is incorporated into the inner and outer chambers to form a unitary structure.

Core Innovation

The invention relates to an implantable prosthetic device that provides a multi-chamber prosthesis having an inner inflatable enclosure and an outer inflatable enclosure, where the outer inflatable enclosure encapsulates the inner inflatable enclosure. Each enclosure includes a first opening and a second opening generally opposite of the first opening, and a plug sealingly couples the second opening of the inner inflatable enclosure and the second opening of the outer inflatable enclosure.

A valve assembly is sealingly coupled to the first opening of the outer inflatable enclosure and the first opening of the inner inflatable enclosure to enable independent inflation of the outer and inner inflatable enclosures. The valve assembly includes an elastomeric membrane forming a passageway from an interior of the inner inflatable enclosure to an exterior of the outer inflatable enclosure, and the elastomeric membrane has an opening into an interior of the outer inflatable enclosure.

A valve core is disposed in the passageway such that the elastomeric membrane surrounds the valve core, and the valve core includes a conduit extending from a first end to a second end. A resealable, puncturable membrane at the second end of the conduit provides resealable access to the inner inflatable enclosure, while an opening in the conduit is offset from the opening in the elastomeric membrane to form a one-way valve allowing material introduced into the interior of the conduit to pass into the interior of the outer inflatable enclosure.

In one device embodiment, the inner inflatable enclosure is filled with a compressible gas, and the outer inflatable enclosure is filled with a cured silicone material, substantially encapsulating the inner inflatable enclosure. A reinforcement band is provided around the periphery of the outer inflatable enclosure, and the structure supports independent inflation and controlled material introduction from the conduit interior into the outer inflatable enclosure.

Claims Coverage

The document provides three independent claims. Across the independent claims, there are six inventive features centered on nested inflatable enclosures, a sealing valve assembly with independent inflation capability, resealable puncturable access, a one-way valve function formed by offset openings, sealed plug coupling across opposite openings, and a reinforcement band around the outer enclosure periphery.

Overall claim coverage is directed to an implantable prosthetic device with nested inner and outer inflatable enclosures, a valve assembly configured for independent inflation, a plug sealingly coupling opposite openings, and a reinforcement band around the outer periphery. The valve assembly claim further specifies an elastomeric membrane passageway, a valve core with a conduit, resealable puncturable access to the inner enclosure, and a one-way valve function produced by offset conduit and membrane openings. The second device independent claim adds specific filling materials: compressible gas inside and cured silicone in the outer enclosure.

Stated Advantages

Documented Applications