Abstract: Methods and devices are described for occluding openings in an annulus fibrosis to prevent conditions such as disc herniation and recurrent disc herniation. An occluding device having an intradiscal component, an extradiscal component, and a barrier element disposed between the intradiscal and extradiscal components is provided. The intradiscal component has first and second arms having a collapsed state with a horizontal dimension less than the width of the opening and an expanded state having a horizontal dimension greater than the width of the opening. The barrier element and the intradiscal component in the collapsed state are inserted through the annulus fibrosis opening, the extradiscal component being positioned adjacent an outer surface of the annulus fibrosis. The intradiscal component assumes the expanded state in the intradiscal space, the first and second arms urging the barrier element against the inner wall of the annulus fibrosis adjacent the opening, thereby occluding the opening.

Abstract: One or more sutures can be used in spinal applications to hold an intradiscal device in place between two vertebrae or repair a defect in the soft tissue of the spine, such as the annulus fibrosis or the dura. Tension can also be applied to the sutures to stabilize a spinal segment having an intradiscal device to prevent or minimize excessive spinal extension, lateral bending, and axial rotation of the spinal segment. Anchors are placed in two adjacent vertebrae and sutures are passed through each anchor. The sutures can be passed through portions of the intradiscal device. Alternatively, the sutures can be passed through a mesh patch which is held against the vertebrae to hold the intradiscal device in place. Tension is applied to the first and second ends of the sutures and the sutures are welded together. The sutures can be welded in a cross-braced arrangement minimize or prevent extension, lateral bending, and rotation of the spinal segment.

Abstract: Methods for spinal stabilization operative to prevent lateral bending, extension, and rotation across two or more adjacent vertebrae are described. Broadly, the method includes placing two or more anchors at each vertebral level, passing one or more sutures through each anchor at each level, applying tension to the sutures and joining the sutures in a cross-braced arrangement over the disc space between two or more vertebrae to prevent lateral bending, extension, and rotation of the spinal segment. The sutures can be welded in any combination of diagonal and vertical patterns across the adjacent vertebrae. In some embodiments, two or more sutures can be threaded through some of the suture anchors such that multiple vertebral levels can be joined in a cross-braced arrangement. Two or more sutures can also be used in multiple anchors in two adjacent vertebrae to provide additional reinforcement or stabilization across different portions of the two vertebrae.

Abstract: Methods for spinal stabilization operative to prevent lateral bending, extension, and rotation across two or more adjacent vertebrae are described with particular emphasis on preventing excessive forces on the facet joins. Broadly, the method includes placing one or more anchors, each having one or more sutures at each vertebral level on a posterior portion of the vertebrae, applying tension to the sutures and joining the sutures over the disc space between two or more vertebra. The sutures can be wrapped around the spinous process of the adjacent vertebrae. Alternatively, the sutures can be welded in a cross-braced pattern extending between the spinous process of the adjacent vertebrae.

Abstract: A spinal alignment system is disclosed and includes vertebral connectors, elongated elements that link the vertebral connectors, and fasteners that lock the elongated elements in position. An elongated element has at least one shaped end that is received by a coupling member of the connector. The shaped end permits the elongated element to be angularly moveable with respect to the coupling member until locked in place with a fastener received in the coupling member. The elongated element also preferably includes a length adjustment mechanism, such as a telescoping or threaded section to provide a desired length in conjunction with a desired degree of alignment. Various coupling mechanisms are disclosed to provide multiple degrees of freedom prior to fixation.

Abstract: A spinal alignment system is disclosed and includes vertebral connectors, elongated elements that link the vertebral connectors, and fasteners that lock the elongated elements in position. An elongated element has at least one shaped end that is received by a coupling member of the connector. The shaped end permits the elongated element to be angularly moveable with respect to the coupling member until locked in place with a fastener received in the coupling member. The elongated element also preferably includes a length adjustment mechanism, such as a telescoping or threaded section to provide a desired length in conjunction with a desired degree of alignment. Various coupling mechanisms are disclosed to provide multiple degrees of freedom prior to fixation.

Abstract: An anterior thoracic/lumbar system comprising a thin plate and fasteners for securing the plate to vertebrae or other osseous material. The plate may be hinged along the central axis, with a pair of collinear holes on each portion of the plate. Each of the holes accommodates a bolt which is screwed into the vertebrae and secured to the plate using a nut.

Abstract: Barriers are used to hold prosthetic components, including intradiscal devices, in position while allowing natural movement within a “safe zone.” In the preferred embodiments, the barrier is in the form of a “buttress” plate coupled to a controlled linkage that prevents the device from moving into a dangerous position. The movable member(s) allow an intradiscal device to move through a safe zone while permitting mobile artificial disc replacements (ADRs) or other intradiscal devices to self-center with movement of the vertebrae. The link member(s) broadly serve as a “tether” to prevent extrusion of the intradiscal device into the spinal canal, or outside of the disc space. The intradiscal device may be mobile, or attached to one or both of the vertebral endplates. Other mechanisms to accommodate the movable link members are also disclosed. The plates are preferably constructed of metal, but the invention is not limited in terms of the biocompatible material(s) used for the plate or link members.

Abstract: Instrumentation for determining the integrity of a natural or synthetic implant includes a component that is at least temporarily attached to or constrained by a bone or tissue, and a handle coupled to the component including a force-measurement gauge. Operation of the device permits a user to push or pull on the handle and determine the integrity of the component by referring to the force-measurement gauge. The handle may be modularly attachable to a plurality of different components or the same component at different sizes for different uses. One preferred embodiment resides in a disc pressure gauge that helps in determining the risk of extrusion of intradiscal devices. Although described in terms of spinal applications, the invention is not limited in this regard, and may be used in any medical, dental, surgical/orthopaedic, or veterinarian application through appropriate extension.

Abstract: Spacerless artificial disc replacements (ADRs) are disclosed. One preferred embodiment includes two saddle-shaped components to facilitate more normal spinal flexion, extension, and lateral bending while limit axial rotation, thereby protecting the facet joints and the annulus fibrosus (AF). Either or both the superior and inferior components are made of a hard material such as chrome cobalt, titanium, or a ceramic including alumina, zirconia, or calcium phosphate. The articulating surfaces of the ADR are also preferably highly polished to reduce friction between the components. Metals, alloys or other materials with shape-memory characteristics may also prove beneficial.

Abstract: A biomedical material for transplant to a subject is provided according to embodiments of the present invention which includes an isolated donor tissue enzyme-treated to reduce the amount of proteoglycans in the donor tissue compared to untreated tissue. Isolated cells are optionally added to the enzyme-treated donor tissue, including leukocytes, particularly monocytes; macrophages; platelets; cells derived from an intervertebral disc such as chondrocyte-like nucleus pulposus cells; fibrocytes; fibroblasts; mesenchymal stem cells; mesenchymal precursor cells; chondrocytes; or a combination of any of these. The isolated donor tissue is articular cartilage or an intervertebral disc tissue such as nucleus pulposus tissue and/or annulus fibrosis tissue enzyme-treated to remove proteoglycans normally present in these tissues. A biomedical material of the present invention is administered to a subject to treat a disorder or injury, such as a disorder or injury to connective tissue.

Abstract: Devices and methods for fixing defects in the anulus fibrosus (vertebral disc) of a patient are described. The devices a mesh patch; first, second, third, and fourth sutures; and first, second, third, and fourth anchors. Each anchor has a first portion adapted for insertion into a bone and a second portion having an opening. The sutures are disposed through the openings of the anchors. The first portions of the first and second anchors are inserted into a cranial vertebra. The first portions of the third and fourth anchors are inserted into a caudal vertebra. The mesh patch is positioned adjacent the defect. An end of first suture can be attached to an end of the third suture. An end of the second suture can be attached to an end of the fourth suture. The other ends of each of the first, second, third, and fourth sutures can then be anchored.

Abstract: Devices and methods for fixing defects in the anulus fibrosus (vertebral disc) of a patient are described. The devices include a mesh patch, and first and second suture assemblies, each of which include an anchor and a suture. The anchor has a first portion adapted to be inserted into a bone and a second portion having an opening therethrough. The suture is adapted to be disposed through the opening and has a first end is adapted to couple to the mesh patch. The method of treatment includes inserting the first portion of the first anchor into a cranial vertebra and inserting the second portion of the second anchor into a caudal vertebra. The first ends of the sutures are attached to the mesh patch. The mesh patch is positioned adjacent the defect by pulling on, or applying tension to, the second ends of the sutures.

Abstract: Artificial disc (ADR) and joint replacement components, particularly those associated with the knee and hip, use compressible, resilient materials to approximate natural kinematics, often in conjunction with elastic or spring components to tether articulating components to avoid dislocation, excessive compression, flexion or other out-of-range movements. The preferred embodiments require only two or a few articulating components. The designs allow for normal flexion, extension, lateral bending, rotation, and translocation, depending upon the application.

Abstract: Methods and apparatus for treating disc herniation provide a conformable device which assumes a first shape associated with insertion and a second shape or expanded shape to occlude the defect which typically follows partial discectomy. The device may take different forms, including patches sized to cover the defect, plugs adapted to fill the defect, or a mesh screen collapsed into an elongated form for the purposes of insertion, thereby minimizing the size of the requisite incision while avoiding delicate surrounding nerves. Such a configuration also permits the use of instrumentation to install the device, including, for example, a hollow tube or sheath adapted to hold the collapsed screen and a push rod to expel the collapsed device out of the sheath for use in occluding the disc defect. A device may further include one or more anchors to assist in permanently affixing the device with respect to the defect.

Abstract: An artificial disc replacement (ADR) is designed to protect a cushioning component from excessive force. Physical features on the front and back of the ADR enable the device to replicate the normal movements of the spine through predetermined, limited, movements of the endplate components relative to one another. For example, though not limited to these characteristics, the components of the ADR could be dimensioned to allow 15 degrees of flexion, 5 degrees of extension, 5 degrees of lateral bending, and 1-2 mm of translocation. In the preferred embodiment the physical features are axles that extend through overlapping lateral portions associated with the endplate components. A desirable configuration includes a pair of axles, one in the anterior portion and another in the posterior portion, wherein some or all of the axles extend through an oversized aperture that allows the limited relative movement of the endplate components.

Abstract: A method for stabilizing upper and lower spinal vertebrae having a disc space situated therebetween is described. First and second fasteners are inserted into the upper vertebra. Third and fourth fasteners are inserted into the lower vertebra, such that the first and third fasteners are substantially vertically aligned and the second and fourth fasteners are substantially vertically aligned. The first and third fasteners are connected with a first elongate element. The second and fourth fasteners are connected with a second elongate element. The first and fourth fasteners are connected with a third elongate element. The second and third fasteners are connected with a fourth elongate element.

Abstract: Methods and devices for fixing a defect in a vertebral disc of a patient. One method includes inserting a guide wire into a disc using an anterior approach to create a path. At least a portion of the herniated nucleus pulposus is removed. A disc reconstruction device is then advanced into the disc and fastened to the disc or at least one of the surrounding vertebrae. Alternatively, a passage could be formed in the cranial or caudal vertebra using an angled anterior approach that terminates in a region of the disc containing the herniated nucleus pulposus. At least a portion of the herniated nucleus pulposus is removed. A disc reconstruction device that has a bone in-growth component and a soft tissue in-growth component is then implanted in the passage. Devices having bone and soft tissue in-growth components and having a flexible spine with a plurality of ribs are also described.

Abstract: Methods and apparatus for treating disc herniation provide a conformable device which assumes a first shape associated with insertion and a second shape or expanded shape to occlude the defect which typically follows partial discectomy. The device may take different forms according to the invention, including patches size to cover the defect or plugs adapted to fill the defect. In a preferred embodiment, however, the device is a gel or other liquid or semi-liquid which solidifies to occlude the defect from within the body of the disc itself. In another preferred embodiment, a mesh screen is collapsed into an elongated form for the purposes of insertion, thereby minimizing the size of the requisite incision while avoiding delicate surrounding nerves.

Abstract: One or more rigid components associated with an articulating bone are used to encase, encapsulate, contain, or otherwise protect a compressible/resilient member. The embodiments are applicable not only to artificial disc replacement (ADR) devices, but also to joint situations including total knee and hip arthroplasty. The cushion elements in the preferred embodiments include synthetic rubbers, hydrogels, elastomers, and other polymeric materials such as viscoelastic polymers and foam polyurethanes. The invention effectively combines the advantages of such materials (cushioning, shape memory, and expansion after insertion in the case of hydrogels), while providing increased protection, particularly the elimination of shear stresses. When applied to an ADR, the invention also minimizes the risk of extrusion.