Method and apparatus for implanting a hydrogel prosthesis for a nucleus pulposus
Inventors
Vresilovic, Edward • Keane, Michael • Schaer, Thomas Peter • Arthur, Amy • Singhatat, Wamis
Assignees
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Publication Number
US-8475532-B2
Publication Date
2013-07-02
Expiration Date
Abstract
An instrument for inserting an elongated hydrogel prosthesis into an intervertebral disc includes an insertion cannula that is inserted through the annulus fibrosus of an intervertebral disc to provide access to the nucleus region of the disc, an elongated hydrogel prosthesis packaged within a tubular container adapted to be coupled to a proximal end of the insertion cannula, and a source of fluid pressure adapted to be coupled to a proximal end of the tubular container. Auxiliary instruments for use in convenient insertion of the insertion cannula through the nucleus pulposus and providing for a complete and controlled passage of the hydrogel prosthesis through the insertion cannula are provided in a kit with the insertion cannula. A sizing apparatus for determining the volume of prosthesis to be inserted includes a catheter or cannula capable of being inserted through the insertion cannula into the nucleus region of the intervertebral disc and having at its distal end a balloon capable of being inflated within the intervertebral disc with a measurable volume of a fluid in order to determine the amount of hydrogel prosthesis to be injected.
Core Innovation
The invention describes a system for inserting a prosthesis into an intervertebral disc using an insertion cannula adapted for insertion through the annulus fibrosus. The insertion cannula defines a delivery lumen extending from a distal opening to a proximal opening, and is configured for fluid-pressure driven advancement of a prosthesis into the disc. A tapered cannula tip with a proximal end fastenable to the distal opening of the cannula further includes a ramped ending.
A storage container is provided with an outer wall forming a cavity for containing the prosthesis and includes couplings that couple to a coupling of the insertion cannula to provide communication between the delivery lumen and the cavity. A pressure generator is connected to the storage container to generate sufficient fluid pressure to advance the prosthesis from the container, through the insertion cannula, and into the intervertebral disc. The system further specifies a lateral delivery aperture located along the outer wall of the cannula.
The ramped ending of the cannula tip is aligned with the lateral delivery aperture to provide a path for the prosthesis to be guided from the delivery lumen through the lateral delivery aperture and into the intervertebral disc. The disclosed embodiments also include related components for implantation and delivery control, including auxiliary instruments for cannula placement, a balloon-based sizing apparatus for measuring intradiscal cavity volume, imaging-oriented features such as radiopaque markers, and optional pressure monitoring using a pressure transducer.
Claims Coverage
The independent claim provides four inventive features: the insertion cannula with delivery lumen and distal-tip geometry for lateral delivery, the storage container coupled to the cannula delivery lumen, the pressure generator that advances the prosthesis, and the alignment of a ramped cannula tip ending with a lateral delivery aperture.
Insertion cannula with delivery lumen and distal insertion configuration
An insertion cannula having a proximal portion and a distal portion, the cannula comprising an outer wall defining a delivery lumen, the distal portion having a distal opening and adapted and configured for insertion through the annulus fibrosus of an intervertebral disc, the proximal portion having a proximal opening and a coupling communicating with the delivery lumen, the delivery lumen extending from the distal opening to the proximal opening.
Storage container coupled to the delivery lumen
A storage container having a proximal portion and a distal portion, the storage container having an outer wall forming a cavity for containing the prosthesis, the distal portion of the storage container having a distal opening and a coupling for coupling to the coupling of the insertion cannula and providing communication between the delivery lumen and the cavity, the proximal portion of the storage container having a proximal opening and a coupling.
Pressure generator advancing prosthesis into the intervertebral disc
A pressure generator having a distal portion and a proximal portion, the distal portion adapted and configured for connecting to the coupling of the proximal portion of the storage container, the pressure generator adapted to generate sufficient fluid pressure when coupled to the storage container to advance the prosthesis contained therein from the container, through the insertion cannula and into the intervertebral disc.
Tapered cannula tip with ramped ending aligned to lateral delivery aperture
The distal portion of the insertion cannula further comprises a cannula tip having a distal end and proximal end, the distal end being tapered and the proximal end being insertable and fastenable to the distal opening of the cannula, the proximal end further comprising a ramped ending; a lateral delivery aperture located along the outer wall of the cannula; and wherein the ramped ending of the cannula tip is aligned with the lateral delivery aperture to provide a path for the prosthesis to be guided from the delivery lumen through the lateral delivery aperture and into the intervertebral disc.
The core coverage is directed to a mechanically coupled system for fluid-pressure advancement of a prosthesis into an intervertebral disc, with the distal cannula tip and lateral delivery aperture arranged so that a ramped ending aligned with the lateral delivery aperture guides prosthesis flow into the disc. Dependent claims refine the implementation with guide wire insertion guidance, pressure transducer monitoring, and structural mechanisms associated with the lateral delivery aperture.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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