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Publication Number
US-12533245-B2
Publication Date
2026-01-27
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 invention relates to a spinal implant device described as an implantable “nuclear disc” prosthesis. The device includes an inner fillable enclosure configured to expand and having a proximal end with a proximal opening and a distal end with a distal opening. An outer fillable enclosure has a discoid shape and is configured to encapsulate an inner chamber formed by the inner fillable enclosure.
The proximal ends of the inner and outer fillable enclosures are coupled together, and the distal ends of the inner and outer fillable enclosures are coupled together. A proximal plug seals the proximal opening of the inner fillable enclosure, and the proximal plug includes an access lumen for providing access to the inner fillable enclosure. The proximal plug further includes a receptacle with an aperture for providing access to the outer fillable enclosure.
The described construction enables separate filling and curing of the enclosures, where the inner enclosure is filled with a fluid and the outer enclosure is filled with a curable elastomer and allowed to cure, and then the inner fluid is removed so the inner chamber remains open/vented within the cured outer material. The device is further described as optionally including an annular reinforcing band and a control element for deployment/positioning, and an inflation stylus with first and second lumens for delivering and removing fluid for the inner enclosure and delivering fluid to the outer enclosure.
Claims Coverage
The partial content provides two independent claims: one for the spinal implant device and one for a kit for implanting a nucleus replacement device. Across the independent claims, the coverage centers on the coupled inner and discoid outer fillable enclosures with a proximal plug providing access, and on an inflation stylus system having separate lumen functionality for inner enclosure fluid exchange and outer enclosure filling.
Coupled inner and discoid outer fillable enclosures with sealing proximal plug access
A spinal implant device comprising an inner fillable enclosure having a proximal end with a proximal opening and a distal end with a distal opening, the inner fillable enclosure being configured to expand; an outer fillable enclosure having a proximal end and a distal end, wherein the proximal ends of the inner and outer fillable enclosures are coupled together and the distal ends of the inner and outer fillable enclosures are coupled together, the outer fillable enclosure having a discoid shape; and a proximal plug for sealing the proximal opening in the proximal end of the inner fillable enclosure, the proximal plug including an access lumen for providing access to the inner fillable enclosure and including a receptacle with an aperture for providing access to the outer fillable enclosure.
Kit with inflation stylus having adjustable inner fluid delivery and removal and outer fluid delivery
A kit for implanting a nucleus replacement device, comprising a spinal implant device comprising an inner fillable enclosure having a proximal end with a proximal opening and a distal end with a distal opening, the inner fillable enclosure being configured to expand; an outer fillable enclosure having a proximal end and a distal end, wherein the proximal ends of the inner and outer fillable enclosures are coupled together and the distal ends of the inner and outer fillable enclosures are coupled together, the outer fillable enclosure having a discoid shape; and a proximal plug for sealing the proximal opening in the proximal end of the inner fillable enclosure, the proximal plug including an access lumen for providing access to the inner fillable enclosure and including a receptacle with an aperture for providing access to the outer fillable enclosure; and an inflation stylus adapted to mate with the proximal plug, wherein the inflation stylus 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.
Overall, the independent claims are directed to a nucleus replacement spinal implant device with a coupled expandable inner enclosure and a discoid-shaped outer fillable enclosure, sealed at the proximal inner opening by a proximal plug that enables access to both enclosures. In the kit claim, the inflatable access is implemented with an inflation stylus having an adjustable first lumen for delivering and removing fluid from the inner enclosure and a second lumen for delivering fluid to the outer enclosure.
Stated Advantages
Creates a shock-absorbing inner chamber with an open/vented condition after removal of the inner fluid within the cured outer material.
Supports reinforcement and tissue ingrowth via an optional annular reinforcing band.
Documented Applications
Implanting a prosthetic nucleus replacement device into an intervertebral space by penetrating the annulus fibrosus, removing the nucleus pulposus to form a disc cavity, inserting the spinal implant device, inflating the inner fillable enclosure with a fluidic medium, and inflating the outer fillable enclosure with a curable medium.
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