Spine Wave, Inc.

Keith Collins

Thomas Wilson

Andrew James Carter

Mark D LoGuidice

Jared W Walkenhorst

Lawrence M Boyd

John A Pafford

Dennis Lee

Lance M Middleton

Robert T Potash

Spanky Raymond

Lance Middlelton

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 syringe-to-syringe mixing apparatus comprises first and second syringes adapted to be coupled at their respective outlets to fluidly connect the syringes. The first syringe includes a plunger having a hollow plunger barrel and a distal end defining a lumen therethrough. The lumen is initially closed by a septum, which in one embodiment is an elastomeric stopper mounted over the end of the plunger. The mixing apparatus further includes a third syringe slidably disposed within the plunger barrel. The third syringe includes a hollow needle adapted to pierce the septum to allow fluid from the third syringe to be injected into fluid within the coupled first and second syringes.

Systems and methods for mixing fluids

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 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.

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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Milford, CT, United States of America

Keith Collins