Abstract: An occlusion device for occluding a defect in a spinal disc anulus, including a plate and a retention device. The plate defines an anulus contact face. The retention device extends from the contact face of the plate and defines an anulus engagement portion. The retention device is deflectable relative to the plate such that in a deployed state, the retention device biases the plate against material disposed between the contact face of the plate and the anulus engagement portion. Upon final deployment, the retention device bears against the exterior surface of the anulus, biasing the plate into contact with the interior surface of the anulus. In a preferred embodiment, the retention device includes a pair of L-shaped arms each extending in an opposing, angular fashion from the plate.

Abstract: The present invention relates to an ultrasonic cutting system including a protective sheet for protecting a cutting blade. The ultrasonic cutting system includes an ultrasonic cutting device, a base plate, and a protective device. The ultrasonic cutting device is configured to cut a material and includes a cutting blade. The base plate is configured to support the material during interaction with the cutting blade. The protective device includes a protective sheet routed over the base plate. During use of the ultrasonic cutting system, the material is routed over the protective sheet prior to interaction with the cutting blade, and the protective sheet is configured to decrease contact between the cutting blade and the base plate.

Abstract: An occlusion device for occluding a defect in a spinal disc anulus, including a plate and a retention device. The plate defines an anulus contact face. The retention device extends from the contact face of the plate and defines an anulus engagement portion. The retention device is deflectable relative to the plate such that in a deployed state, the retention device biases the plate against material disposed between the contact face of the plate and the anulus engagement portion. Upon final deployment, the retention device bears against the exterior surface of the anulus, biasing the plate into contact with the interior surface of the anulus. In a preferred embodiment, the retention device includes a pair of L-shaped arms each extending in an opposing, angular fashion from the plate.

Abstract: An occlusion device for occluding a defect in a spinal disc anulus having interior and exterior surfaces, and defining an internal cavity. The occlusion device includes a first member, a second member, and a connector. The first member is configured for deployment within the internal cavity and placement against the interior surface of the anulus. The second member is configured for placement against the exterior surface of the anulus. Finally, the connector connects the first and second members and is preferably adapted to provide an adjustable spacing therebetween. With this construction, the device is configured such that upon final deployment, the first and second members are rigidly secured against the anulus, at opposite surfaces thereof, in a region of the defect via the connector.

Abstract: A prosthetic spinal disc nucleus comprising a hydrogel core surrounded by a constraining jacket. The hydrogel core is configured to expand from a dehydrated state to a hydrated state. In the dehydrated state, the hydrogel core has a shape selected to facilitate implantation through an anulus opening. Further, in the hydrated state, the hydrogel core has a shape corresponding generally to a portion of a nucleus cavity, the hydrated shape being different from the dehydrated shape. Upon hydration, the hydrogel core transitions from the dehydrated shape to the hydrated shape.

Abstract: A packaged prosthetic disc nucleus including a prosthetic disc nucleus and a retainer. The prosthetic disc nucleus includes a hydrogel core formed to hydrate from a dehydrated state. Further, the prosthetic disc nucleus is configured to such that following implantation into a nucleus cavity, the hydrogel core hydrates to a final hydrated state. The retainer selectively contains the prosthetic disc nucleus. Further, upon contact with a hydration liquid, the retainer is configured to allow the hydrogel core to hydrate from the dehydrated state while preventing the hydrogel core from hydrating to the final hydrated state. Thus, the prosthetic disc nucleus is constrained by the retainer in a partially hydrated state. In one preferred embodiment, the combination prosthetic disc nucleus/retainer is sealed within an outer enclosure, such as a pouch, that also contains a hydration liquid for hydrating the hydrogel core.

Abstract: A prosthetic spinal disc nucleus comprising a hydrogel core surrounded by a constraining jacket. The hydrogel core is configured to expand from a dehydrated state to a hydrated state. In the dehydrated state, the hydrogel core has a shape selected to facilitate implantation through an anulus opening. Further, in the hydrated state, the hydrogel core has a shape corresponding generally to a portion of a nucleus cavity, the hydrated shape being different from the dehydrated shape. Upon hydration, the hydrogel core transitions from the dehydrated shape to the hydrated shape.

Abstract: An adjustable surgical dilator for dilating an opening formed in a bodily tissue structure, such as an anulus of a spinal disc. The dilator includes an outer tube and an inner rod. The outer tube includes a proximal section, a distal section and a central lumen extending from the proximal section to the distal section. The distal section terminates in a distal end and includes first and second arms each defining an inner surface and an outer surface. The arms combine to define a head tapering to the distal end. The head is configured to contact bodily tissue and has a variable cross-sectional outer dimension as defined by the outer surfaces of the arms. The inner rod is co-axially disposed within the central lumen and includes a proximal portion and a distal portion. The distal portion extends from the proximal portion and forms a bearing surface for selectively engaging the inner surfaces of the first and second arms, respectively.

Abstract: A wedge-shaped prosthetic spinal disc nucleus including a hydrogel core surrounded by a constraining jacket. The hydrogel core is preshaped to form the wedge shape in a hydrated state. The constraining jacket is flexible, but substantially inelastic and is configured to prevent the hydrogel core from conforming to an anulus upon hydration. The prosthetic spinal disc nucleus corresponds generally to anatomical variations in disc space geometry, generally defined by separable areas or compartments, thus improving performance. In one preferred embodiment, the prosthetic spinal disc nucleus includes a radiopaque marker for indicating a location and orientation following implant.

Abstract: A trial implant for evaluating a size of an intradiscal space for subsequent implantation of a prosthetic spinal disc nucleus. The trial implant is comprised of an elongated central body and a retrieving body. The elongated body is formed from a rigid, surgically safe material and preferably has a volume less than a volume of a nucleus cavity portion of the intradiscal space. The retrieving body is associated with the central body and is configured to facilitate retrieval of the trial implant from an enclosed area, such as the nucleus cavity. A plurality of trial implants are included with a trial implant kit, with each of the plurality of trial implants housing a different size and/or shape. During use, the trial implant provides an indication as to whether a similarly sized prosthetic spinal disc nucleus will fit within a particular intradiscal space.

Abstract: A prosthetic spinal disc nucleus comprising a first prosthetic body, a second prosthetic body and a coupling means. The first and second prosthetic bodies each have sufficient structural integrity for maintaining a desired separation between an opposing pair of vertebrae and a volume that is less than a volume of the nucleus cavity. The coupling means selectively associates the first prosthetic body with the second prosthetic body. During use, the first prosthetic body is inserted into a nucleus cavity through an opening in an anulus. The coupling means is configured such that the second prosthetic body does not impede insertion of the first prosthetic body. The second prosthetic body is similarly implanted. Following implant, the coupling means relatively fixes the first and second prosthetic bodies to prevent subsequent movement of the prosthetic spinal disc nucleus, or any portion thereof, back through the opening in the anulus.

Abstract: A capsule-shaped prosthetic spinal disc nucleus for implantation into a human intradiscal space, made of a substantially inelastic constraining jacket surrounding an amorphous polymer core. The constraining jacket has a generally fixed maximum volume and defines a height. The amorphous polymer core fills an initial volume of the constraining jacket and develops an internal pressure. In response to the internal pressure, the constraining jacket transitions toward the maximum volume, increasing substantially in height.

Abstract: An elongated, capsule shaped prosthetic spinal disc nucleus body for implantation into a human inter vertebral spinal disc, made of a hydrogel core and a constraining jacket surrounding the hydrogel core that permits the hydrogel core to deform and reform. The constraining jacket is configured to allow the hydrogel core to hydrate to a predetermined volume and will deform and reform in a desired fashion in response to various loads placed upon the spinal tract. The prosthetic spinal disc nucleus assists in restoring the natural physiology of the human intervertebral disc. By implanting two prosthetic spinal disc nuclei side-by-side into a damaged disc of a human spine, both height and motion can be maintained.

Abstract: An elongated, pillow shaped prosthetic spinal disc nucleus body for implantation into a human intervertebral spinal disc, made of a hydrogel core and a flexible constraining jacket surrounding the hydrogel material core that permits the hydrogel core to expand and contract. The hydrogel core has a length approximating the sagittal diameter of a nucleus of the human disc, a width less than the length, and a height less than the length or width. The hydrogel core will expand and contract in a desired fashion as it imbibes and expels fluids in response to various loads placed upon the spinal tract. The constraining jacket is porous to allow fluids to pass through to the hydrogel core, but prevents the hydrogel from escaping, thus fostering the natural physiology of the human intervertebral disc. By implanting two prosthetic spinal disc nucleus bodies side-by-side into a damaged disc of a human spine, both height and motion can be maintained.

Abstract: A surgical method and tools for anchoring a suture to bone is disclosed. The method includes forming an opening through a top surface of the bone, positioning a suture within the opening and crimping a region of the top surface of the bone surrounding the opening to anchor the suture within the opening. The tools used with the disclosed surgical method include a punch, a broach, a guide and a swage. The punch and the broach are used to create a uniform diameter opening in the bone by compressing bone material. The guide is used to position a suture, preferably having a shoulder, in the opening. Finally, the suture is used to crimp the region of the top surface of the bone surrounding the opening.

Abstract: A spinal anulus cutter for cutting a multisided flap in an encapsulating ligament, such as an anulus of a human intervertebral disc, to provide access to an interior space or material surrounded by the ligament. The spinal anulus cutter is characterized by a knife blade comprised of a plurality of walls which are connected together to define a closed side and an open side. Further, a cutting edge is formed at the forward edge of the walls which is configured to cut the multisided flap in the ligament when an axial force is transmitted to the knife blade in a direction towards the cutting edge. The flap will conform in shape and size to the form of the knife blade, whereby the open side of the knife blade will not cut the ligamentary tissue.

Abstract: A method for surgically implanting a prosthetic spinal disc nucleus body into a human spinal disc space is disclosed. The spinal disc space contains adjacent vertebrae and an anulus having a posterior side. The method includes cutting a flap through the anulus in the disc space to create an opening. The vertebrae adjacent to the disc space are slightly separated and a prosthetic spinal disc nucleus body is inserted through the opening into the disc space.