Spine Wave, Inc.

Mark D LoGuidice

Thomas Wilson

Andrew James Carter

Lawrence M Boyd

Tyler Lipschultz

John A Pafford

Jared W Walkenhorst

Keith Collins

Steve Wysocki

Richard J Manzi

Dennis Lee

Peter Barreiro

Lance M Middleton

Joseph N Logan

Daniel Stephen Savage

Carl Michael Nilsson

Robert David Paxson

Lance Middlelton

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

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

An expandable interbody fusion device for implantation into the intradiscal space between two opposing vertebral bodies of a spine comprises a superior endplate member having an upper surface for engaging a superior vertebral body in a spine, and an inferior endplate member having a lower surface for engaging an inferior vertebral body in the spine. The superior endplate member and the inferior endplate member are releasably coupled and define a cavity therebetween. At least one expansion member is configured to be introduced into the cavity to move the superior endplate and the inferior endplate members relatively apart upon introduction and to thereby decouple the superior endplate member and the inferior endplate member. An inserter may be releasably coupled to the device to facilitate insertion of the device as well as to provide a track for insertion of the expansion members.

Expandable interbody fusion device

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 dynamic stabilization construct for implantation within the spine comprises bone anchors that include a flexible portion between the bone engaging and head portions of the anchor. The head portion is configured to mate with different types of stabilization elements adapted to span between spinal motion segments. The engagement portion can also be configured for different types of fixation to a motion segment, such as within the pedicle of a vertebra. The flexible portion permits limited bending of the bone anchor beneath the level of the stabilization element. In one embodiment, the flexible portion is integrated into the body of the bone anchor in the form of hinge elements. In another embodiment, a separate flexible element, such as a spacer or spring, is interposed between the head and engagement portions. In a further embodiment, the bone anchor includes a portion having a reduced cross-section. The flexible bone anchors may be used to tailor the dynamic flexibility of spinal stabilization instrumentation at each level of the construct.

Dynamic spinal stabilization system

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.

A method for treating a herniated spinal disc between opposing vertebral bodies having a damaged outer annulus and an inner nucleus pulposus comprises the steps of: providing access to the nucleus pulposus through the annulus; removing at least a portion of the nucleus pulposus to create an intradiscal space; applying a first distraction force on the opposing vertebral bodies from within the intradiscal space; applying a second distraction force on the opposing vertebral bodies externally of the intradiscal space; and introducing a curable biomaterial through the annulus access directly into the intradiscal space. The first distraction force is applied within the disc space to distract the anterior aspect of the intradiscal space, while the second distraction force is applied exterior to the disc to act on the posterior aspect of the vertebral bodies. The first distraction force is applied prior to the application of the second distraction force and then removed. The second distraction force is maintained during the introduction of the biomaterial into the intradiscal space.

Methods for treating defects and injuries of an intervertebral disc

A vented needle assembly is provided for sealably injecting biomaterial into an intradiscal space interiorly of the annulus of a spinal disc and for providing an exhaust for the intradiscal space. The vented needle assembly comprises a compressible seal body for pressing against an outer surface of the annulus, and a needle extending through the seal. The needle may be configured to connect to a syringe for pressure injection of the biomaterial. The seal includes a vent extending therethrough with an opening for communication with the intradiscal space and an opening for the discharge of excess biomaterial filling the intradiscal space. A kit of parts is also provided for use in the treatment of a spinal disc, the kit comprising the vented needle assembly and an inflatable trial device. The trial device is removably introduced into the intradiscal space and inflated to determine the available size of the intradiscal space.

Devices for injecting a curable biomaterial into a intervertebral space

A method for treating a diseased or damaged spinal disc having an inner nucleus pulposus and an outer annulus is provided comprises the steps of: providing access to the nucleus pulposus through the annulus; removing at least a portion of the nucleus pulposus to create an intradiscal space; determining the integrity of the annulus; and then sealably introducing under pressure a curable biomaterial through the annulus access directly into the intradiscal space. The step of determining the integrity of the annulus may be accomplished by introducing into the disc a fluid solution under a first pressure. The curable biomaterial may subsequently be introduced through the annulus directly into said intradiscal space at a second pressure that is increased or decreased from the first pressure as a function of the viscosity of the biomaterial relative to the fluid solution. In certain embodiments, a distraction force is applied to the disc space.

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Southport, CT, United States of America

Mark D LoGuidice