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Publication Number
US-11576793-B2
Publication Date
2023-02-14
Expiration Date
Abstract
A nuclear disc implant includes an inner fillable enclosure and an outer fillable enclosure. After insertion into a enucleated disc cavity, the inner enclosure is filled with a fluid and the outer fillable enclosure is filled with a curable material. The curable material is allowed to cure and the fluid is removed from the inner enclosure to leave an inner enclosure surrounded by an cured outer enclosure. A reinforcing band may be provided around the nuclear disc implant. An inflation tool to fill the nuclear disc implant is provided.
Core Innovation
The disclosure relates to an implantable nuclear disc prosthesis implemented as an inner fillable enclosure and an outer fillable enclosure that are coupled together such that the outer fillable enclosure encapsulates the inner fillable enclosure. After insertion into an enucleated disc cavity, the inner enclosure is filled with a fluid, and the outer enclosure is filled with a curable elastomeric material that is cured in situ.
Following curing of the outer enclosure, the inner fluid is removed to leave an open or vented inner chamber surrounded by a cured outer ring. The resulting structure is described in connection with addressing issues such as modulus mismatch, shock absorption, and reinforcement for interaction with surrounding tissue.
The device includes optional textile annular reinforcing band features and an inflation stylus with paired lumens for interacting with the inner and outer fillable enclosures. In that arrangement, a first lumen is adapted to deliver and remove fluid from the inner fillable enclosure while a second lumen delivers fluid to the outer fillable enclosure, and the stylus may be used with a delivery sheath.
Claims Coverage
The independent claim coverage centers on a kit for implanting a nucleus replacement device using nested inner and outer fillable enclosures sealed by distal and proximal plugs, with a proximal plug having an access lumen that remains open after implantation, and an inflation stylus that mates with the proximal plug and includes lumens for inner fluid exchange and outer fluid delivery. Three inventive features are identified.
Nested inner and outer fillable enclosures encapsulated together
An inner fillable enclosure and an outer fillable enclosure are coupled together so that the outer fillable enclosure encapsulates the inner fillable enclosure.
Distal and proximal plug sealing with proximal access lumen retained open after implantation
A distal plug seals the distal opening in the distal end of the inner fillable enclosure and a proximal plug seals the proximal opening in the proximal end of the inner fillable enclosure, with the proximal plug having an access lumen for providing access to the inner fillable enclosure and a receptacle with an aperture for providing access to the outer fillable enclosure, wherein the access lumen remains open after implantation.
Mated inflation stylus with adjustable first lumen and second lumen
An inflation stylus mates with the proximal plug and comprises an adjustable first lumen for movably extending through the access lumen to deliver and remove fluid from the inner fillable enclosure, and a second lumen for delivering fluid to the outer fillable enclosure.
The core inventive coverage is provided by the coupled nested enclosures, plug-based closure that preserves post-implant access to the inner fillable enclosure, and the mated inflation stylus with separate lumens for inner fluid exchange and outer fluid delivery.
Stated Advantages
Addresses modulus mismatch.
Provides shock absorption.
Provides reinforcement for interaction with surrounding tissue.
Documented Applications
No documented applications found
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