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Publication Number
US-11406513-B2
Publication Date
2022-08-09
Expiration Date
Abstract
This specification describes technologies relating to an intervertebral disc prosthesis used to strengthen and stabilize the spine. Implementations of the technology described herein comprise a surgical device that is implanted through a small surgical incision into a portion of a human intervertebral disc, various support tools used to insert such a surgical device, and a method by which the device is used to strengthen and stabilize the spine.
Core Innovation
The invention relates to an intervertebral disc nucleus prosthesis and an implantation system configured to preserve motion between adjacent vertebrae. It provides minimally invasive percutaneous access by forming an access opening through an annulus fibrosus via a lateral approach, while penetrating the annulus fibrosus without excising annular tissue. The system performs percutaneous nucleotomy to remove a nucleus pulposus while leaving the annulus fibrosus substantially intact to create a void formerly occupied by the nucleus pulposus.
A deflated prosthetic implant is delivered through an access cannula and through the annulus fibrosus into the void. The implant includes a centrally located inner chamber and an outer chamber around the inner chamber, where the outer chamber is distinct from the inner chamber. The inner chamber is inflated, and the outer chamber is permanently inflated with a curable material so the outer chamber is substantially incompressible while the inner chamber remains comparatively compressible.
The system further includes dual-valve/sealing mechanisms and dual-fluid pathways that fluidly isolate the inner and outer chambers. This enables independently introducing an inert gas into the inner chamber and introducing a curable silicone into the outer chamber, optionally with imaging contrast agents. The curable material is cured, and surgical tools are provided including an access cannula, dilators, an inflation/fill stylus, and a hammer having a handle, an annular contact element, and a hinge, as well as anchoring and stabilization features such as memory/shape-expanding support wires and a reinforcement textile band with self-expanding metallic elements.
Claims Coverage
The provided set includes three independent method claims. Across these independent claims, the main inventive features cover forming and enlarging an access opening through an annulus fibrosus without excising annulus fibrosus, percutaneous nucleotomy that leaves the annulus substantially intact to define a void, and delivering a deflated multi-chamber implant through a cannula, with differential inflation of a distinct inner chamber and outer chamber using a curable material so the outer chamber is substantially incompressible and the chambers are isolated.
Lateral annulus penetration without excision and dilator enlargement
Forming an access opening through an annulus fibrosus by penetrating the annulus fibrosus using a first tool; increasing the size of the access opening by sequentially placing a plurality of dilators of successively larger cross-section diameter over the first tool; inserting an access cannula over the outermost dilator until the distal end reaches the distal margins of the annulus fibrosus; and removing the first tool and the plurality of dilators from the access cannula without excising any portion of the annulus fibrosus.
Percutaneous nucleotomy with annulus intact void
Removing the nucleus pulposus while leaving the annulus fibrosus substantially intact to create a void formerly occupied by the nucleus pulposus.
Deflated multi-chamber implant delivered and differentially inflated
Delivering a deflated prosthetic implant through the access cannula and through the annulus fibrosus into the void formerly occupied by the nucleus pulposus, the prosthetic implant having a centrally located inner chamber and an outer chamber around the inner chamber, the outer chamber being distinct from the inner chamber and forming an outer surface of the implant; inflating the inner chamber; permanently inflating the outer chamber with a curable material; allowing the curable material to cure so the outer chamber is substantially incompressible and the inner chamber is comparatively compressible; and removing the access cannula.
Chamber isolation via distinct inner and outer chambers with different materials
Delivering a deflated implant through the access cannula into the void defined by the annulus fibrosus, the implant having an outer chamber forming a periphery of the implant and an inner chamber inside the outer chamber forming a central portion of the implant, wherein the inner and outer chamber are distinct such that substances contained in one chamber cannot pass into the other chamber; inflating the inner chamber with a material different than the curable material; and permanently inflating the outer chamber with a curable material so the implant substantially fills the void defined by the annulus fibrosus.
Outer cannula placement and percutaneous nucleotomy while annulus intact
Placing an outer cannula over an outermost dilator until its distal end reaches the distal margins of the annulus fibrosus; removing the plurality of dilators and the first tool from the outer cannula; performing a percutaneous nucleotomy through the outer cannula and the access opening while leaving the annulus fibrosus substantially intact to create a void defined by the annulus fibrosus; percutaneously delivering a deflated multi-chamber implant through the outer cannula into the void defined by the annulus fibrosus; and inflating the implant using an inflation stylus, wherein the chambers of the multi-chamber implant are inflated with at least two materials, at least one of which comprises a curable silicone.
The independent claims collectively define a motion-preserving intervertebral disc implantation method centered on non-excisional access opening formation through the annulus fibrosus, removal of nucleus pulposus while leaving the annulus substantially intact, and delivery of a deflated multi-chamber implant that is differentially inflated so an outer chamber is permanently inflated with curable material to become substantially incompressible while an inner chamber remains comparatively compressible. The independent claim set further specifies chamber distinction and isolation, and in at least one case requires different materials for the inner and outer chambers, including at least one curable silicone.
Stated Advantages
Preserves motion between adjacent vertebrae.
Documented Applications
Implantation of a prosthetic intervertebral disc implant for preserving motion between adjacent vertebrae.
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