Abstract: A catheter and a method of making a device having an outer member, a primer, and an inner liner laminated to the outer member. The primer is provided between the outer member and the inner liner and annealed to secure the inner liner to the outer member.

Abstract: Spinal stabilization devices for addressing back pain originating in the facet joints and the spinous processes of the vertebrae. One embodiment of the present invention includes a substantially T-shaped facet implant for insertion between the facets of two successive vertebrae after a desired amount of the articulating surfaces have been resected. The long and flat portion of the T-shaped facet implant is inserted in between the facets and then the wings of the T-shape, also called fixation tabs, are secured to the spine to secure the facet implant into place. The T-shape implant may also be a part of a spinal stabilization system that includes a facet implant, a spinous process spacer, and a flexible connecting member securing the same.

Abstract: A length-adjustable vertebral body balloon catheter in which the location of the balloon can now be manipulated once an access cannula has been placed in the vertebral body.

Abstract: The present invention is related to spinal stabilization devices. More particularly, this invention relates to devices for addressing back pain originating in the facet joints and the spinous processes of the vertebrae. One embodiment of the present invention includes a substantially T-shaped facet implant for insertion between the facets of two successive vertebrae after a desired amount of the articulating surfaces have been resected. The long and flat portion of the T-shaped facet implant is inserted in between the facets and then the wings of the T-shape, also called fixation tabs, are secured to the spine to secure the facet implant into place. The T-shape implant may also be a part of a spinal stabilization system that includes a facet implant, a spinous process spacer, and a flexible connecting member securing the same.

Abstract: The present invention relates to flexible members for stabilizing a spinal column and methods for making the flexible members. In one embodiment, a flexible member comprises an inner elastomeric member and an outer fabric layer situated securely around the inner elastomeric member. The inner elastomeric member has a first elasticity to provide the flexible member with a desired flexibility. In another embodiment, the flexible member includes an outer covering that defines an outer elastomeric member. The outer elastomeric member may be situated securely around the outer fabric layer with the inner elastomeric member, the outer fabric layer, and the outer elastomeric member having the common lengthwise axis and defining the body including the opposing first and second ends. The outer elastomeric member may have a second elasticity that is less than the first elasticity.

Abstract: Methods and devices for insertion between adjacent vertebrae in a spine following removing at least a portion of a nucleus from within a disc. In one embodiment, the device includes a member having a flexible wall surrounding an internal volume and a coupler that is secured to the flexible wall. The member is adapted to expand when filled with a first filler material to form an interior cavity. The coupler has a first access point, a second access point, a first coupler side hole, and an optional second coupler side hole. The first and second access points are adapted to removably receive one or more fill tubes. The fill tubes cooperate with the first and optional second coupler side holes to direct the first filler material into the internal volume and a second filler material into the interior cavity.

Abstract: A method and apparatus for fluidly coupling a reservoir containing a flowable biomaterial to a mold. The flow of the flowable biomaterial into the mold is controlled in accordance with a first operating parameter. At least one injection condition is monitored. The flow of the flowable biomaterial is controlled in accordance with a second operating parameter in response to one or more of the injection conditions reaching a threshold level. The second operating parameter is maintained during at least a portion of the curing of the flowable biomaterial. In some embodiments, the second operating parameter may optionally include permitting a portion of the flowable biomaterial to be expelled from the mold.

Abstract: The present invention provides blend water-swellable materials and hydrogels suitable for use in biomedical or other applications. The blend water swellable materials and hydrogels have at least one hydrophilic polymer and at least one other polymer or oligomer having both hydrophobic and hydrophilic recurring units where the blend phase separates and is opaque and immiscible in the presence of water. Methods of making these blend water-swellable materials and hydrogels are also described.

Abstract: The present invention provides an injectable annular ring useful in treating a deteriorating spinal disc. When used, the annular ring may be collapsed or folded in order for it to be placed through a small opening in a prepared intervertebral space within the annulus using minimally invasive techniques. Deployment or unfolding the ring in the intervertebral space provides an interior cavity bordered by the ring that is in direct contact with the vertebral endplates. When an internal volume of the ring is inject or filled with a load-bearing, hardenable material, the filled ring maintains the intervertebral spacing and prevents the ring from being expelled from the interior cavity through the small annular opening.

Abstract: An implant for stabilizing adjacent vertebrae, the implant includes a stabilizing body expandable along a longitudinal axis from a first size state to a second size state. A cavity is defined in the stabilizing body for receiving a quantity of curable filler material sufficient to expand the stabilizing body from the first size state to the second size state. The implant further includes an attachment member for attaching the stabilizing body to the adjacent vertebrae. The stabilizing body is expandable along an arcuate axis to exert a restoring moment of movement on the attached vertebrae.

Abstract: The present invention provides a hydrogel composition comprising a mixture of a hydrophilic polymer and a polymer chain modifying agent, wherein the polymer chain modifying agent is selected from the group consisting of an aromatic tetracarboxylic dianhydride, a titanate, and a polyetherimide. The present invention also provides a method for producing a phase separated, branched, copolymer hydrogel comprising a mixture of a hydrophilic polymer and a polymer chain modifying agent. The present invention also provides an implantable medical device comprising a phase separated, branched, copolymer hydrogel wherein the phase separated, branched, copolymer hydrogel is formed of a hydrophilic polymer and a polymer chain modifying agent.

Abstract: A device for facilitating bone fusion of two vertebrae. The device is sized and shaped to at least extend between the two vertebrae to be fused, and includes an outer wall member disposed about an inner portion. A space between the outer wall member and the inner compartment is adapted to contain an osteogenic bone fusion material. The inner portion includes a compartment adapted to contain an inner fill material, such as a bone cement or an in situ curable polymer. The inner portion may operate as a structural member to maintain a desired amount of spacing between the vertebrae to be fused, and to support the spinal column prior to formation of the fused bone joint. The device is also configured to locate the osteogenic material away from the centers of the vertebrae to be fused, providing a fused joint with high bending and torsional rigidity.

Abstract: The present invention is an apparatus and method for stabilizing the facet joints of the spine. One aspect of the present invention is the stabilization of the facet joint by insertion of a facet implant through two opposing facet surfaces. The facet joint is not fixedly frozen by insertion of the screw, but instead the facet surfaces are flexibly and movably anchored to preserve movement because the screw or anchor includes a flexible intermediate portion which is positioned between the facet surfaces. The facet implant may be in the form of a screw or other anchor with the intermediate portion in the form of a polyaxial head, a cord, a spring, etc. The facet implant may furthermore be used in conjunction with a facet spacer that is placed between the first and second facet.

Abstract: A method of treating a diseased or damaged intervertebral disc having a nucleus pulposus and an annulus. The method includes the steps of accessing and preparing the intervertebral disc for receipt of the biomaterial by removing at least a portion of the nucleus pulposus to create a nuclear cavity. A quantity of the curable biomaterial is delivered under pressure to the nuclear cavity. The delivered biomaterial is at least partially cured in such a manner to retain it in the nuclear cavity. The at least partially cured biomaterial is contoured to achieve a desired conformation approximating that of the nuclear cavity.

Abstract: A system for repairing an intervertebral disc by delivering and curing a biomaterial in situ within the disc. The system includes both a device, having an insertable balloon and related lumen, controls and adapters, as well as an in situ curable biomaterial (and related biomaterial delivery means). The system can allow the doctor to determine a suitable endpoint for biomaterial delivery, by controlling distraction and/or biomaterial delivery pressure, and in turn, to deliver a desired quantity of biomaterial to the balloon in order to achieve improved polymer cure and implant characteristics. Also provided is a related method for repairing an intervertebral disc by using such a system to deliver and cure the biomaterial in situ. The system can be used to implant a prosthetic total disc, or a prosthetic disc nucleus in a manner that leaves the surrounding disc tissue substantially intact.

Abstract: The present disclosure concerns implants to at least partially replace the nucleus of a spinal disc. In one embodiment, a prosthetic implant is provided which includes a bag structure having a fixation component or member, the bag operable to contain at least one internal implant within the bag. In other embodiments, a bag structure is provided with a flange adaptable to anchor the structure to a vertebral body and a sinusoidal-shaped structure made of a flexible material is provided with various unique configurations. In one embodiment, for delivery, a bag structure with a flange may be attached to a vertebral body. In another embodiment, a sinusoidal-shaped implant structure is alternately woven from one end to the other with a second sinusoidal-shaped structure.

Abstract: The present disclosure concerns implants to at least partially replace the nucleus of a spinal disc. In one embodiment, a prosthetic structure is provided which includes a bag operable to contain at least one internal implant within the bag. In another embodiment, a sinusoidal-shaped structure made of a flexible material is provided with various unique configurations to act as the internal implant and once released from a stretched or compressed configuration resumes nearly its original shape. In one embodiment, for delivery, a sinusoidal-shaped structure may be in a reduced amplitude state. In another embodiment, a sinusoidal-shaped structure is alternately woven from one end to the other with a second sinusoidal-shaped structure.

Abstract: The present disclosure concerns implants to at least partially replace the nucleus of a spinal disc. In one embodiment, a prosthetic implant is provided which includes a bag structure having a fixation component or member, the bag operable to contain at least one internal implant within the bag. In other embodiments, a bag structure is provided with a flange adaptable to anchor the structure to a vertebral body and a sinusoidal-shaped structure made of a flexible material is provided with various unique configurations. In one embodiment, for delivery, a bag structure with a flange may be attached to a vertebral body. In another embodiment, a sinusoidal-shaped implant structure is alternately woven from one end to the other with a second sinusoidal-shaped structure.

Abstract: The present invention provides a hydrogel composition comprising a mixture of a hydrophilic polymer and a polymer chain modifying agent, wherein the polymer chain modifying agent is selected from the group consisting of an aromatic tetracarboxylic dianhydride, a titanate, and a polyetherimide. The present invention also provides a method for producing a phase separated, branched, copolymer hydrogel comprising a mixture of a hydrophilic polymer and a polymer chain modifying agent. The present invention also provides an implantable medical device comprising a phase separated, branched, copolymer hydrogel wherein the phase separated, branched, copolymer hydrogel is formed of a hydrophilic polymer and a polymer chain modifying agent.

Abstract: The present invention relates to flexible members for stabilizing a spinal column and methods for making the flexible members. In one embodiment, a flexible member comprises an inner elastomeric member and an outer fabric layer situated securely around the inner elastomeric member. The inner elastomeric member has a first elasticity to provide the flexible member with a desired flexibility. In another embodiment, the flexible member includes an outer covering that defines an outer elastomeric member. The outer elastomeric member may be situated securely around the outer fabric layer with the inner elastomeric member, the outer fabric layer, and the outer elastomeric member having the common lengthwise axis and defining the body including the opposing first and second ends. The outer elastomeric member may have a second elasticity that is less than the first elasticity.