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Publication Number
US-10575967-B2
Publication Date
2020-03-03
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 including an inner fillable enclosure and an outer fillable enclosure that are coupled at proximal ends and distal ends so that the outer fillable enclosure substantially encapsulates the inner fillable enclosure. The inner and outer fillable enclosures include proximal and distal openings sealed by a distal plug and a proximal plug, respectively. The proximal plug provides an access lumen for providing access to the inner fillable enclosure that is configured to remain open after implantation.
The implant further includes a proximal plug that is bonded to the proximal opening and adapted to receive an inflation stylus having at least one lumen extending substantially longitudinally through the proximal plug. In the inflation arrangement, the lumen communicates with an outer chamber defined by the outer fillable enclosure, and in further refinements the proximal plug includes a second longitudinal lumen communicating with an inner chamber defined by the inner fillable enclosure. The inner and outer fillable enclosures comprise a unitary piece of material.
The described implant concept is a minimally invasive/percutaneous nuclear disc implant/prosthesis formed in situ by filling an inner chamber with a fluid and forming an outer cured encapsulating structure from a curable elastomeric material. After curing, the inner fluid is removed via the inflation/contrast lumen such that the inner chamber remains vented/open, while the outer material forms a cured encapsulating structure with an internal hollow cavity. An optional annular reinforcing band constrains expansion and promotes annulus fibrosus tissue ingrowth.
Claims Coverage
The provided independent claims are clm-00001 and clm-00033. Across these independent claims, the coverage centers on a two-part fillable enclosure arrangement with encapsulation and plug sealing, plus a proximal access lumen that remains open after implantation and supports an inflation stylus with longitudinal lumen(s).
Inner and outer fillable enclosures substantially encapsulating each other
The device includes an inner fillable enclosure and an outer fillable enclosure, coupled at proximal ends and coupled at distal ends so that the outer fillable enclosure substantially encapsulates the inner fillable enclosure.
Sealing inner openings with distal and proximal plugs
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.
Proximal access lumen configured to remain open after implantation
The proximal plug has an access lumen for providing access to the inner fillable enclosure, where the access lumen is configured to remain open after implantation.
Inflation stylus with longitudinal lumen through the proximal plug
The proximal plug is bonded to the proximal opening and adapted to receive an inflation stylus comprising at least one lumen extending substantially longitudinally through the proximal plug.
Inflation stylus lumen communicating with an outer chamber
The proximal plug is adapted to receive an inflation stylus comprising a first lumen extending substantially longitudinally and configured to communicate with an outer chamber defined by the outer fillable enclosure.
Unitary piece of material enclosures
The inner and outer fillable enclosures comprise a unitary piece of material.
The independent claims collectively require inner and outer fillable enclosures with plug sealing and a proximal access lumen that remains open after implantation, together with an inflation stylus having longitudinal lumen(s) for communicating with the outer chamber, with further refinement possibilities for communication with an inner chamber.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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