Implantable nuclear prosthesis
AssigneeSpinal Stabilization Technologies LLC
InventorsJames D. Lutz, W. Loren Francis, Mark Novotny
Life of this patent
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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.
Claims31
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;
- 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 are coupled together so that the outer fillable enclosure encapsulates the inner fillable enclosure;
- a distal plug for sealing the distal opening in the distal end of the inner fillable enclosure;
- and
- a proximal plug for sealing the proximal opening in the proximal end of the inner fillable enclosure, 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 for providing access to the inner fillable enclosure is configured to remain open after implantation;
- 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 enclosure;
- and
- a second lumen for delivering fluid to the outer enclosure.
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;
- 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 are coupled together so that the outer fillable enclosure substantially encapsulates the inner fillable enclosure;
- a distal plug for sealing the distal opening in the distal end of the inner fillable enclosure;
- and
- a proximal plug for sealing the proximal opening in the proximal end of the inner fillable enclosure, 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 for providing access to the inner fillable enclosure is configured to remain open after implantation.
A method of implanting a prosthetic device into an intervertebral space having a nucleus pulposus surrounded by an annulus fibrosus comprising:
- penetrating the annulus fibrosus to create an annulotomy;
- removing the nucleus pulposus to create a enucleated disc cavity through the annulotomy;
- inserting an fillable disc implant device into the enucleated disc cavity, the fillable disc implant device having an inner fillable enclosure and an outer fillable enclosure coupled to the inner fillable enclosure so that the outer fillable enclosure substantially completely encapsulates the inner fillable enclosure;
- inflating the inner fillable enclosure with a fluidic medium;
- inflating the outer fillable enclosure with a curable medium;
- allowing the curable medium to cure;
- removing the fluidic medium from the inner fillable enclosure;
- and
- leaving the inner fillable enclosure vented so that fluids may enter and exit the inner fillable enclosure.
A reinforcing band for a spinal disc implant, comprising:
- a textile band having a superior edge, an inferior edge, and a central zone between the superior and inferior edges;
- a superior drawstring disposed at the superior edge of the textile band for tightening the superior edge of the textile band when pulled;
- an inferior drawstring disposed at the inferior edge of the textile band for tightening the superior edge of the textile band when pulled;
- and
- a control element disposed in the central zone for expanding the central zone.
Dependencies are inferred from the claim text.