Percutaneous implantable nuclear prosthesis
Inventors
Hibri, Nadi S. • FRANCIS, W. Loren • Novotny, Mark A.
Assignees
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Publication Number
US-10786360-B2
Publication Date
2020-09-29
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
An implantable percutaneously deployable nuclear intervertebral disc prosthesis includes a peripherally distributed annular ring structure that provides nucleus pulposus replacement. The prosthesis comprises an annular tubular inflatable membrane enclosed by a tubular fiber graft, and the annular tubular inflatable membrane is inflatable in situ through an inflation port communicating with an interior cavity of the membrane.
The annular interior cavity buffers inward deformation under load. The tubular fiber graft encloses the inflatable membrane and cooperates with coupling and retaining structures to stabilize the inflatable membrane within the prosthesis, while an inflation stem forms a substantially leakproof snug fit with a delivery cannula and an inflation stylet for controlled deployment and removal prior to curing.
An inflation stem includes a one-way valve assembly comprising a duckbill valve to allow fluid to be injected into the interior of the inflatable membrane and to reduce backflow or leakage. The injected fluid is an in-situ curable polymer or elastomer that, after curing, stabilizes and provides disc-height distraction while preserving motion.
Claims Coverage
The claims recite three independent claim themes centered on an annular unitary elastomeric inflatable membrane enclosed by a tubular fiber graft, with an inflation stem that receives an inflation stylet in a substantially leakproof manner and a one-way duckbill valve for injecting fluid into the membrane interior.
Unitary elastomeric annular inflatable membrane with coupling-member interface
A unitary, elastomeric annular hollow inflatable membrane having a first open end and a second open end coupled together by a coupling member, with an annular hollow inflatable membrane that includes an inflation port.
Tubular fiber graft enclosing the inflatable membrane with retaining member coupling
A tubular fiber graft enclosing the inflatable membrane, and a retaining member coupling the annular hollow inflatable membrane and the tubular fiber graft to the coupling member.
Inflation stem removably receives an inflation stylet substantially leakproof
An inflation stem coupled to the inflation port for removably receiving an inflation stylet in a substantially leakproof manner.
One-way valve assembly with duckbill valve at the inflation stem
A one-way valve assembly in the inflation stem to allow fluid to be injected into an interior of the inflatable membrane, the one-way valve assembly comprising a duckbill valve.
Delivery kit with delivery cannula, inflatable ring with inflation stem, and release cannula
A kit comprising a delivery cannula with an internal lumen; a graft comprising an annular inflatable ring with an inflation stem having a proximal end and an opposed distal end, the inflation stem disposed in the internal lumen of the delivery cannula and includes a duckbill valve; and a release cannula slidably disposed in the delivery cannula, with a distal portion configured to engage a proximal portion of the inflation stem.
Dimensional relationship and releasably press fit inflation stylet into inflation stem
The inner diameter of the delivery cannula and the outer diameter of the inflation stem are substantially the same; and an inflation stylet having at least one internal lumen with a distal portion configured to be releasably press fit into the inflation stem.
The claims focus on the annular inflatable membrane and tubular fiber graft arrangement, the substantially leakproof inflation stem and stylet interface, the duckbill valve for fluid injection, and the kit components and dimensional relationships used for deployment and release.
Stated Advantages
The central cavity and load distribution peripherally are used to reduce the risk of subsidence or migration and to distribute load under physiologic loading.
The prosthesis provides disc-height distraction while preserving motion.
The one-way valve assembly reduces backflow or leakage.
The inflation stem interface supports substantially leakproof engagement during inflation and controlled disengagement prior to curing.
Documented Applications
Nucleus pulposus replacement.
Implantable percutaneously deployable nuclear intervertebral disc prosthesis.
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