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Publication Number
US-12279963-B2
Publication Date
2025-04-22
Expiration Date
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 describes an implantable prosthetic device that includes an inner inflatable enclosure and an outer inflatable enclosure, where both enclosures have first and second openings generally opposite each other. The outer inflatable enclosure encapsulates the inner inflatable enclosure, and a valve assembly is sealingly coupled to the first opening of the outer inflatable enclosure and the first opening of the inner inflatable enclosure.
The valve assembly is configured to allow independent inflation of the outer and inner inflatable enclosures. The valve assembly architecture includes a valve core and an elastomeric membrane with a passageway connecting an interior of the inner inflatable enclosure to an exterior region associated with the outer inflatable enclosure, and an opening configuration in the valve core is offset from an opening in the elastomeric membrane to form a one-way valve.
A plug sealingly coupled to the second opening of both the inner and outer inflatable enclosures seals the opposite openings. The document also describes a resealable, puncturable membrane for providing resealable access, and an outer inflatable enclosure formed to create an elastomer annular structure while maintaining a nuclear chamber functionality associated with the inner inflatable enclosure.
Claims Coverage
The provided independent claim coverage includes two independent inventive areas: an implantable prosthetic device having inner and outer inflatable enclosures with a valve assembly for independent inflation and a plug sealing opposite openings, and a valve assembly configured with a passageway elastomeric membrane, a valve core conduit with a resealable, puncturable access membrane, and an offset opening one-way valve configuration. Across these claim families, the main inventive features total five distinct elements.
Inner and outer inflatable enclosures with opposite openings and encapsulation
An inner inflatable enclosure having a first opening and a second opening generally opposite of the first opening; an outer inflatable enclosure having a first opening and a second opening generally opposite of the first opening of the outer inflatable enclosure, the outer inflatable enclosure encapsulating the inner inflatable enclosure.
Independent inflation valve assembly sealing coupled to first openings
A valve assembly sealingly coupled to the first opening of the outer inflatable enclosure and the first opening of the inner inflatable enclosure, the valve assembly being configured to allow independent inflation of the outer and inner inflatable enclosures.
Plug sealing opposite second openings of both enclosures
A plug sealingly coupled to the second opening of the inner inflatable enclosure and the second opening of the outer inflatable enclosure.
Elastomeric membrane passageway with valve core and offset one-way openings
An elastomeric membrane forming a passageway from an interior of the inner inflatable enclosure to an exterior of the outer inflatable enclosure; a valve core disposed in the passageway; and an opening in the valve core offset from an 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.
Resealable puncturable access membrane at the valve conduit
A resealable, puncturable membrane at the second end of the conduit for providing resealable access to the inner inflatable enclosure.
Overall, the claim coverage centers on a multi-chamber implantable prosthetic device with an inner and outer inflatable enclosure sealed by a valve assembly and a plug, combined with a valve assembly that provides independent inflation through an elastomeric membrane passageway, a valve core with an offset opening one-way configuration, and a resealable puncturable membrane for access to the inner inflatable enclosure.
Stated Advantages
The outer inflatable enclosure is associated with a curable elastomeric material.
A surrounding annular reinforcement band is described as anchoring in or at a distal plug to limit over-inflation and to encourage annulus fibrosus support, including reinforcement for tissue ingrowth and load stress redirection inward toward the nuclear chamber.
Documented Applications
Implantable prosthetic device.
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