Implantable nuclear prosthesis, kits, and related methods
AssigneeSpinal Stabilization Technologies LLC
InventorsW. Loren Francis, Mark A. Novotny, Cory R. A. Hallam, Jake Ganem
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Abstract
The present disclosure includes devices, apparatuses, kits, and methods for replacing a nucleus pulposus of an intervertebral disc with an implantable nuclear prosthesis filled with a curable silicone material in situ. Configurations of the present spinal implant devices include a flexible body defining an outer fillable enclosure that defines an outer chamber, an inner fillable enclosure that defines an inner chamber, and a proximal plug configured to be coupled to the inner fillable enclosure.
Claims20
A method of replacing a nucleus pulposus of an intervertebral disc with a spinal implant device, the method comprising:
- dilating an annulus fibrosus to gain access to an intervertebral disc;
- performing a nuclectomy to create an enucleated intervertebral disc cavity;
- using a first imaging balloon to assess completeness of the nuclectomy, to interrogate the enucleated intervertebral disc cavity for defects and/or contraindications, or both;
- using a second imaging balloon to determine a size for a spinal implant for the enucleated intervertebral disc cavity, the second imaging balloon different from the first imaging balloon;
- inserting a spinal implant device into the enucleated intervertebral disc cavity;
- inflating an inner chamber of the spinal implant device with a fluidic medium, the inner chamber defined by an inner fillable enclosure;
- inflating an outer chamber of the spinal implant device with a curable medium;
- allowing the curable medium to cure;
- removing the fluidic medium from the inner chamber;
- and
- leaving the inner fillable enclosure vented so that fluids may enter and exit the inner fillable enclosure.
A method of replacing a nucleus pulposus of an intervertebral disc with a spinal implant device, the method comprising:
- dilating an annulus fibrosus to gain access to an intervertebral disc;
- performing a nuclectomy to create an enucleated intervertebral disc cavity;
- using a first imaging balloon to assess completeness of the nuclectomy, to interrogate the enucleated intervertebral disc cavity for defects and/or contraindications, or both;
- using a second imaging balloon to determine a size for a spinal implant for the enucleated intervertebral disc cavity, the second imaging balloon different from the first imaging balloon;
- inserting, into the enucleated intervertebral disc cavity, a dual-chambered spinal implant device having an inner chamber that is at least partially surrounded by an outer chamber;
- inflating the inner chamber with a fluidic medium, the inner chamber defined by an inner fillable enclosure;
- inflating the outer chamber with a curable medium and monitoring pressure on the inner chamber during inflation;
- allowing the curable medium to cure;
- removing the fluidic medium from the inner chamber;
- and
- leaving the inner fillable enclosure vented so that fluids may enter and exit the inner fillable enclosure.
A method of confirming implantation of a spinal implant device, the method comprising:
- inserting an imaging balloon into an enucleated intervertebral disc cavity that has been previously assessed for completeness, contraindications, or both by an imaging technique;
- inflating the imaging balloon with a radiopaque fluid to a threshold pressure;
- imaging one or more views of the inflated imaging balloon to determine a size for a spinal implant for the enucleated intervertebral disc cavity;
- removing the imaging balloon, inserting, into the enucleated intervertebral disc cavity, a dual-chambered spinal implant device having an inner chamber that is at least partially surrounded by an outer chamber based on a determination of the size of the spinal implant;
- inflating the inner chamber of the dual-chambered spinal implant device with a fluidic medium, the inner chamber defined by an inner fillable enclosure;
- inflating the outer chamber of the dual-chambered spinal implant device with a curable medium and monitoring pressure on the inner chamber during inflation;
- stopping inflation of the outer chamber of the dual-chambered spinal implant device when the monitored pressure reaches a threshold pressure;
- allowing the curable medium to cure;
- removing the fluidic medium from the inner chamber;
- leaving the inner fillable enclosure vented so that fluids may enter and exit the inner fillable enclosure;
- imaging one or more views of the spinal implant device corresponding to the one or more views imaged of the inflated imaging balloon;
- and
- comparing the one or more views of the spinal implant device with the one or more views of the inflated imaging balloon to assess the spinal implant device.
Dependencies are inferred from the claim text.