Abstract: A vented needle 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 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 and an inflatable trial device. The trial device is removably introduced into the intradiscal space and inflated to determine the available size of said intradiscal space.

Abstract: 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.

Abstract: A vented needle is provided for use in 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 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 into the needle. The seal includes a vent extending therethrough the seal 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 and an inflatable trial device.

Abstract: 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.

Abstract: A method for treating a spinal disc having an outer relatively intact annulus defining a disc space and an inner defective nucleus pulposus within the disc space, 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 needle is placed initially within the center of the nucleus pulposus and then withdrawn during the injection to approximately the inner border of the annulus.

Abstract: 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.

Abstract: 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.

Abstract: Improvements are provided for a syringe-to-syringe mixing system to improve the mixing characteristics of the system. In one embodiment, a mixing apparatus includes opposite fittings for mounting to a pair of syringes. The mixing apparatus defines a fluid passageway therethrough and includes a flow modifying element disposed within the passageway. The flow modifying element is configured to increase the flow velocity, disrupt the fluid flow or introduce turbulence into the fluid flow between the two syringes. In another embodiment, a nozzle element is disposed within the tip of the syringe, the element configured to increase the fluid flow therethrough. The nozzle element can be a nozzle insert removably mounted within the tip, or an integrally formed nozzle within the tip.

Abstract: A fusion implant apparatus for facilitating fusion of adjacent bone structures includes a threadless implant member which is positioned between adjacent opposed bone structures. The implant member defines a longitudinal axis and first and second longitudinal ends and has an outer wall which is dimensioned to engage the opposed bone structures upon positioning therebetween in supporting relation therewith. The outer wall defines an internal cavity for the reception of bone growth inducing substances and includes a plurality of apertures which extend therethrough in communication with the internal cavity to permit fusion of vertebral bone tissue. The implant member also includes an intermediate portion which defines a cross-sectional dimension transverse to the longitudinal axis which is greater than the respective cross-sectional dimensions of the first and second longitudinal ends of the implant member.

Abstract: A fusion implant apparatus for facilitating fusion of adjacent bone structures includes a threadless implant member which is positioned between adjacent opposed bone structures. The implant member defines a longitudinal axis and first and second longitudinal ends and has an outer wall which is dimensioned to engage the opposed bone structures upon positioning therebetween in supporting relation therewith. The outer wall defines an internal cavity for the reception of bone growth inducing substances and includes a plurality of apertures which extend therethrough in communication with the internal cavity to permit fusion of vertebral bone tissue. The implant member also includes an intermediate portion which defines a cross-sectional dimension transverse to the longitudinal axis which is greater than the respective cross-sectional dimensions of the first and second longitudinal ends of the implant member.

Abstract: A fusion implant apparatus for facilitating fusion of adjacent bone structures includes an implant member for positioning between adjacent opposed bone structures. The implant member defines a longitudinal axis and first and second longitudinal ends and has an outer wall dimensioned to engage the opposed bone structures upon positioning therebetween in supporting relation therewith. The outer wall includes at least one thread for facilitating positioning between the opposed bone structures. The implant member has an intermediate portion which defines a cross-sectional dimension transverse to the longitudinal axis which is greater than respective cross-sectional dimensions of the first and second longitudinal ends of the implant member.

Abstract: A fusion implant apparatus for facilitating fusion of adjacent bone structures includes a threadless implant member which is positioned between adjacent opposed bone structures. The implant member defines a longitudinal axis and first and second longitudinal ends and has an outer wall which is dimensioned to engage the opposed bone structures upon positioning therebetween in supporting relation therewith. The outer wall defines an internal cavity for the reception of bone growth inducing substances and includes a plurality of apertures which extend therethrough in communication with the internal cavity to permit fusion of vertebral bone tissue. The implant member also includes an intermediate portion which defines a cross-sectional dimension transverse to the longitudinal axis which is greater than the respective cross-sectional dimensions of the first and second longitudinal ends of the implant member.

Abstract: A fusion implant apparatus for facilitating fusion of adjacent bone structures includes n implant member for positioning between adjacent opposed bone structures. The implant member defines a longitudinal axis and first and second longitudinal ends and has an outer wall dimensioned to engage the opposed bone structures upon positioning therebetween in supporting relation therewith. The outer wall includes at least one thread for facilitating positioning between the opposed bone structures. The implant member has an intermediate portion which defines a cross-sectional dimension transverse to the longitudinal axis which is greater than respective cross-sectional dimensions of the first and second longitudinal ends of the implant member.