Spine Wave, Inc.

Thomas Wilson

Mark D LoGuidice

Keith Collins

Andrew James Carter

John A Pafford

Jared W Walkenhorst

Lawrence M Boyd

Dennis Lee

Peter Barreiro

Lance M Middleton

Tyler Lipschultz

Steve Wysocki

Richard J Manzi

Spanky Raymond

Robert T Potash

Ulrich Berlemann

Peter Wronski

Thomas Douville

Michael E Landry

Frank S Bono

Joseph N Logan

Steven J Wysocki

Lance Middlelton

A composition suitable for use as replacement material for all or part of a disc nucleus during percutaneous injection, the composition comprising:

Radiopaque injectable nucleus hydrogel compositions

A system for dynamic stabilization of the spine includes a bone engaging fastener configured to be anchored in a vertebra and a deflectable element mounted on the fastener. The deflectable element or bumper is configured and arranged to contact a portion of an adjacent vertebra, such as the facet, during extension of the spine, while offering no resistance during flexion. In certain embodiments, a cable may be fastened to the bone engaging fastener and arranged to contact a portion of the adjacent vertebra, such as the spinous process, during flexion of the spine. In one surgical technique of the invention, a contralateral approach is used to introduce the bone engaging fastener through the deflectable element and into the vertebra.

Dynamic stabilization system for the spine

A dynamic stabilization system includes a stabilization element, such as a spinal rod, a plurality of bone anchors, such as bone bolts, and a like plurality of connectors for connecting the bolts to the spinal rod. At least some of the connectors include a flexible element between the bone anchor and the rod and an adjustment element for adjusting the flexibility of the flexible element, to thereby adjust the dynamic flexibility between the rod and the bone anchor. In one embodiment, the flexible element is a flexible bearing element of a rod end bearing.

Dynamic spinal stabilization system

An assembly for sealably injecting a fluent material into an intradiscal space accessed through an opening in the annulus of a spinal disc comprises a cannula having a passageway for injecting the fluent material therethrough into the intradiscal space, a seal having a sealing surface for sealing engagement with the outer surface of the disc annulus and defining a central opening for, and an articulating joint defined between the central opening of the seal and the cannula configured to permit relative articulation between the components. The assembly may further comprise an anchor element extending through the central opening of the seal, the anchor element including an elongated threaded body sized for threaded engagement within the opening in the disc annulus and having a head configured to engage a distal end of the cannula.

Articulating injection cannula and seal assembly

A kit for injecting a biomaterial into an intradiscal space accessed through an opening in the disc annulus comprises a plurality of needles, each sized for introduction through the annulus opening with a passageway for injecting the biomaterial therethrough, and each including a distal end to be disposed within the intradiscal space when the needle extends through the annulus opening. Each needle includes a stop affixed thereto at different pre-determined distances from the distal end to define the location of the distal end within the intradiscal space when the needle extends through the opening in the annulus. The kit further includes a plurality of seals defining a bore for sliding engagement with a needle, each of the plurality of seals including a sealing face for engaging the annulus around the needle. Each sealing face defines a differently configured area of contact, such as circular, elliptical, tapered and threaded.

Kit for use in sealably injecting a biomaterial into an intradiscal space

A method for treating a diseased or damaged spinal disc comprises the steps of: (a) providing access to the nucleus pulposus through the annulus; (b) removing at least a portion of the nucleus pulposus to create an intradiscal space; (c) determining the size of the intradiscal space; and (d) sealably introducing under pressure a curable biomaterial through the annulus directly into the intradiscal space. The step of determining the size of the intradiscal space may be accomplished by expanding a compliant balloon within the intradiscal space using a contrast medium capable of visualization under fluoroscopy. The curable material is sealably introduced through a vented needle inserted through the opening. The curable biomaterial is introduced until a quantity of the material flows into the vent.

Methods for injecting a curable biomaterial into an intervertebral space

Modular injection needle and seal assembly

A kit of parts is provided that comprises: a cannula, the distal end of the cannula adapted to be inserted through the disc annulus; an injection needle, the distal end adapted to be inserted into the proximal end of the cannula and configured for relatively close sliding fit therewithin; and a syringe for containing a quantity of curable biomaterial, the syringe adapted to be coupled to the proximal end of the needle and to inject the biomaterial into the needle under pressure. The kit may further comprise a quantity of curable biomaterial that is selected to have upon curing strong adhesive properties such as a protein polymer.

Apparatus and kit for injecting a curable biomaterial into an intervertebral space

A system and method is provided for distracting opposite surfaces from the interior of a bone, such as a vertebral body. A working channel cannula provides a working channel through which an inserter and an injection cannula can simultaneously pass. The inserter transports a plurality of wafers into the interior of the bone to form a load-bearing stack bearing against the opposite surfaces. The injection cannula is used to inject a fluent material into and/or around the stack. In certain embodiments, the fluent material is a load-bearing or hardenable material, such as bone cement. In other embodiments, the fluent material can be a BMP, HAP, or other osteo-inductive, osteo-conductive, or pharmaceutical compositions. A syringe containing the fluent material is engaged to the injection cannula and is operable to inject the fluent material into the vertebral body under controlled pressure.

System for distracting opposing vertebral bodies of a spine

Apparatus and method for injecting fluent material at a distracted tissue site

Method for distracting opposing vertebral bodies of a spine

A method for treating a spinal disc comprises the steps of: determining the integrity of the annulus by subjecting the annulus to a first pressure applied internally of the annulus; providing access to the nucleus pulposus through the annulus without removing any tissue from the annulus or from the nucleus pulposus; and sealably injecting curable biomaterial through the annulus access directly into the nucleus pulposus at a second pressure correlated with the first pressure. The integrity of the annulus may be determined by a pre-operative discogram using a contrast medium that has a viscosity substantially similar to the viscosity of the biomaterial to be injected. The curable biomaterial may be injected under a pressure sufficient to distract opposing vertebral bodies communicating with the disc space.

Percutaneous methods for injecting a curable biomaterial into an intervertebral space

A method for treating a diseased or damaged spinal disc comprises the steps of: (a) providing access to the nucleus pulposus through the annulus; (b) removing at least a portion of the nucleus pulposus to create an intradiscal space; determining the size of the intradiscal space; and (c) sealably introducing under pressure a curable biomaterial through the annulus directly into the intradiscal space. The method may include the additional steps of applying a force to distract the opposing vertebral bodies about the intradiscal space and then removing the distraction force after the biomaterial has cured. The step of determining the size of the intradiscal space may be accomplished by expanding a compliant balloon within the intradiscal space using a contrast medium capable of visualization under fluoroscopy. The curable material is sealably introduced through a vented needle inserted through the opening. The curable biomaterial is introduced until a quantity of the material flows into the vent.

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Guilford, CT, United States of America

Thomas Wilson