Percutaneous implantable nuclear prosthesis
Inventors
Hibri, Nadi S. • FRANCIS, W. Loren • Novotny, Mark A.
Assignees
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Publication Number
US-11633287-B2
Publication Date
2023-04-25
Expiration Date
Abstract
A prosthesis for implantation in a de-nucleated intervertebral disc includes a fiber ring-like layer which encloses a polymeric layer to create an annular space. The annular space is inflatable with an in-situ curable liquid polymer and forms an interior cavity. The annular space may be expanded uniformly or differentially to be tailored to the needs of a particular vertebral segment and to achieve optimal disc space width and angle, thereby stabilizing the segment while preserving normal motion of the vertebral segment. The interior cavity provides a void that allows inward deformation of the implant during weight bearing activities and bending. The prosthesis can be elastically deformed through axial elongation to a reduced profile to load into a delivery cannula using pulling techniques.
Core Innovation
The invention relates to an implantable prosthetic device for an intervertebral disc space that includes an annular hollow inflatable membrane having an inflation port to receive a flowable, curable material. The annular inflatable membrane comprises a unitary, elastomeric member, and a fiber graft encloses the inflatable membrane. The fiber graft has a tubular shape and defines a hollow cavity when the annular hollow inflatable membrane is inflated.
An inflation stem is coupled to the inflation port for removably receiving an inflation stylet in a substantially leakproof manner, where the inflation stem is configured to expand responsive to receiving the inflation stylet and to collapse after removal of the inflation stylet. A one way valve assembly is provided in the inflation stem to allow injection of the flowable, curable material into the interior of the inflatable membrane. The one way valve assembly comprises a duckbill valve, and the inflation stem is configured to prevent the duckbill valve from inverting due to a pressure of the flowable, curable material in the annular hollow inflatable membrane when the inflation stem is collapsed.
The claimed device is described as percutaneously deployable and is used to form and deploy an implanted nuclear prosthesis supported by the fiber graft and inflatable membrane structure. Expansion of the inflatable membrane is used to tailor disc height and angle while an interior cavity enables inward deformation under loading to reduce stress on the central vertebral end plates. This configuration is described as limiting migration/subsidence and preserving motion without fusion.
Claims Coverage
The independent claim covers an implantable prosthetic device combining an annular hollow inflatable membrane enclosed by a tubular fiber graft with a specialized inflation stem, removable inflation stylet, and a duckbill-based one-way valve assembly that is prevented from inverting when the inflation stem collapses after stylet removal.
Annular hollow inflatable membrane with inflation port and unitary elastomeric member
The device includes an annular hollow inflatable membrane having an inflation port to receive a flowable, curable material, where the annular inflatable membrane comprises a unitary, elastomeric member.
Tubular fiber graft enclosing inflatable membrane to form hollow cavity upon inflation
A fiber graft encloses the inflatable membrane, and the fiber graft has a tubular shape to define a hollow cavity when the annular hollow inflatable membrane is inflated.
Leakproof, removable inflation stylet with inflation stem that expands and collapses
An inflation stem is coupled to the inflation port for removably receiving an inflation stylet in a substantially leakproof manner, where the inflation stem is configured to expand responsive to receiving the inflation stylet and to collapse after removal of the inflation stylet.
Duckbill one-way valve assembly in inflation stem with anti-inversion after collapse
A one way valve assembly in the inflation stem allows the flowable, curable material to be injected into the interior of the inflatable membrane, the one way valve assembly comprising a duckbill valve, wherein when the inflation stem is collapsed, the inflation stem is configured to prevent the duckbill valve from inverting due to a pressure of the flowable, curable material in the annular hollow inflatable membrane.
Overall, the claim coverage centers on the structural combination of an annular inflatable elastomeric membrane within a tubular fiber graft, together with a removable, substantially leakproof inflation-stem/stylet mechanism and a duckbill one-way valve assembly that is maintained against inversion by the collapsed inflation stem under material pressure.
Stated Advantages
Limits migration/subsidence.
Preserves motion without fusion.
Reduces stress on the central vertebral end plates by enabling inward deformation under loading.
Documented Applications
Percutaneously deployable intervertebral nuclear prosthesis implanted within an intervertebral disc space to tailor disc height and angle and maintain motion without fusion.
Implantation in an annular fibrosus context by creating an access opening, using an access cannula and a percutaneous deployment device, and implanting the prosthetic device within the annular fibrosus.
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