Patent Document

RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 11/442,483, filed May 26, 2006, which is a continuation of U.S. application Ser. No. 10/055,504, filed on Oct. 25, 2001, now issued as U.S. Pat. No. 7,258,700, which claims benefit to U.S. Provisional Application No. 60/311,586 filed Aug. 10, 2001 and is a continuation-in-part of U.S. application Ser. No. 09/696,636 filed on Oct. 25, 2000, now issued as U.S. Pat. No. 6,508,839, which is a continuation-in-part of U.S. application Ser. No. 09/642,450 filed on Aug. 18, 2000, now issued as U.S. Pat. No. 6,482,235, which is a continuation-in-part of U.S. application Ser. No. 09/608,797 filed on Jun. 30, 2000, now issued as U.S. Pat. No. 6,425,919, which claims benefit to U.S. Provisional Application No. 60/172,996 filed Dec. 21, 1999, U.S. Provisional Application No. 60/161,085 filed Oct. 25, 1999, and U.S. Provisional Application No. 60/149,490 filed Aug. 18, 1999, the entire teachings of these applications being incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to the surgical treatment of intervertebral discs in the lumbar, cervical, or thoracic spine that have suffered from tears in the anulus fibrosis, herniation of the nucleus pulposus and/or significant disc height loss. 
     2. Description of the Related Art 
     The disc performs the important role of absorbing mechanical loads while allowing for constrained flexibility of the spine. The disc is composed of a soft, central nucleus pulposus (NP) surrounded by a tough, woven anulus fibrosis (AF). Herniation is a result of a weakening in the AF. Symptomatic herniations occur when weakness in the AF allows the NP to bulge or leak posteriorly toward the spinal cord and major nerve roots. The most common resulting symptoms are pain radiating along a compressed nerve and low back pain, both of which can be crippling for the patient. The significance of this problem is increased by the low average age of diagnosis, with over 80% of patients in the U.S. being under 59. 
     Systems and methods for repairing tears in soft tissues are known in the art. Also, disclosed in the art are methods of augmenting the intervertebral disc. However, the efficacious treatment of intervertebral discs has not been adequately addressed using the systems and methods in the art. Accordingly, there still remains a need for devices and methods to treat intervertebral discs that have been compromised, including, but not limited to, discs that have suffered from tears in the anulus fibrosis, herniation of the nucleus pulposus and/or significant disc height loss. 
     SUMMARY OF THE INVENTION 
     Various embodiments of the present invention seek to exploit the individual characteristics of various anulus and nuclear augmentation devices to optimize the performance of both within the intervertebral disc. A primary function of anulus augmentation devices is to prevent or minimize the extrusion of materials from within the space normally occupied by the nucleus pulposus and inner anulus fibrosus. A primary function of nuclear augmentation devices is to at least temporarily add material to restore diminished disc height and pressure. Nuclear augmentation devices can also induce the growth or formation of material within the nuclear space. Accordingly, the inventive combination of these devices can create a synergistic effect wherein the anulus and nuclear augmentation devices serve to restore biomechanical function in a more natural biomimetic way. Furthermore, according to the invention both devices may be delivered more easily and less invasively. Also, the pressurized environment made possible through the addition of nuclear augmentation material and closing of the anulus serves both to restrain the nuclear augmentation and anchor the anulus augmentation in place. 
     One or more of the embodiments of the present invention also provide non-permanent, minimally invasive and removable devices for closing a defect in an anulus and augmenting the nucleus. 
     One or more of the embodiments of the present invention additionally provide an anulus augmentation device that is adapted for use with flowable nuclear augmentation material such that the flowable material cannot escape from the anulus after the anulus augmentation device has been implanted. 
     There is provided in accordance with one aspect of the present invention, a disc augmentation system configured to repair or rehabilitate an intervertebral disc. The system comprises at least one anulus augmentation device, and at least one nuclear augmentation material. The anulus augmentation device prevents or minimizes the extrusion of materials from within the space normally occupied by the nucleus pulposus and inner anulus fibrosus. In one application of the invention, the anulus augmentation device is configured for minimally invasive implantation and deployment. The anulus augmentation device may either be a permanent implant, or removable. 
     The nuclear augmentation material may restore diminished disc height and/or pressure. It may include factors for inducing the growth or formation of material within the nuclear space. It may either be permanent, removable, or absorbable. 
     The nuclear augmentation material may be in the form of liquids, gels, solids, or gases. It may include any/or combinations of steroids, antibiotics, tissue necrosis factors, tissue necrosis factor antagonists, analgesics, growth factors, genes, gene vectors, hyaluronic acid, noncross-linked collagen, collagen, fibren, liquid fat, oils, synthetic polymers, polyethylene glycol, liquid silicones, synthetic oils, saline and hydrogel. The hydrogel may be selected from the group consisting of acrylonitriles, acrylic acids, polyacrylimides, acrylimides, acrylimidines, polyacrylnitriles, and polyvinyl alcohols. 
     Solid form nuclear augmentation materials may be in the form of geometric shapes such as cubes, spheroids, disc-like components, ellipsoid, rhombohedral, cylindrical, or amorphous. The solid material may be in powder form, and may be selected from the group consisting of titanium, stainless steel, nitinol, cobalt, chrome, resorbable materials, polyurethane, polyesther, PEEK, PET, FEP, PTFE, ePTFE, PMMA, nylon, carbon fiber, Delrin, polyvinyl alcohol gels, polyglycolic acid, polyethylene glycol, silicone gel, silicone rubber, vulcanized rubber, gas-filled vesicles, bone, hydroxy apetite, collagen such as cross-linked collagen, muscle tissue, fat, cellulose, keratin, cartilage, protein polymers, transplanted nucleus pulposus, bioengineered nucleus pulposus, transplanted anulus fibrosis, and bioengineered anulus fibrosis. Structures may also be utilized, such as inflatable balloons or other inflatable containers, and spring-biased structures. 
     The nuclear augmentation material may additionally comprise a biologically active compound. The compound may be selected from the group consisting of drug carriers, genetic vectors, genes, therapeutic agents, growth renewal agents, growth inhibitory agents, analgesics, anti-infectious agents, and anti-inflammatory drugs. 
     In accordance with another aspect of the present invention, there is provided a method of repairing or rehabilitating an intervertebral disk. The method comprises the steps of inserting at least one anulus augmentation device into the disc, and inserting at least one nuclear augmentation material, to be held within the disc by the anulus augmentation device. The nuclear augmentation material may conform to a first, healthy region of the anulus, while the anulus augmentation device conforms to a second, weaker region of the anulus. 
     In another aspect of the invention, a method of closing a defect in an anulus fibrosus of an intervertebral disc is provided. In one embodiment, a barrier is inserted through an opening into a disc and positioned relative to the defect such that the barrier obstructs passage of material from the interior of the disc into the defect. In one embodiment, the opening is spatially separated from said defect. In one embodiment, the opening is the defect. 
     In one embodiment, the barrier is larger than in area than the defect. In one aspect of the invention, the barrier is expandable. In another aspect, the barrier is expanded from a compressed state after insertion to the interior of the disc. In one embodiment, the barrier is expand within the intervertebral disc, but not inside said defect. 
     In one aspect of the invention, a method of repairing an annular defect in an intervertebral disc is provided. In one embodiment, a first barrier is inserted into an interior of the disc and positioned proximate to an interior aspect of the defect. A second barrier is positioned proximate to the exterior aspect of the defect and the first barrier is affixed to the second barrier using a fixation device. In one aspect, a suture and/or anchoring device is used to affix the first and second barriers. 
     Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when taken together with the attached drawings and claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. 
         FIG. 1A  shows a transverse section of a portion of a functional spine unit, in which part of a vertebra and intervertebral disc are depicted. 
         FIG. 1B  shows a sagittal cross section of a portion of a functional spine unit shown in  FIG. 1A , in which two lumbar vertebrae and the intervertebral disc are visible. 
         FIG. 1C  shows partial disruption of the inner layers of an anulus fibrosis. 
         FIG. 2A  shows a transverse section of one aspect of the present invention prior to supporting a herniated segment. 
         FIG. 2B  shows a transverse section of the construct in  FIG. 2A  supporting the herniated segment. 
         FIG. 3A  shows a transverse section of another embodiment of the disclosed invention after placement of the device. 
         FIG. 3B  shows a transverse section of the construct in  FIG. 3A  after tension is applied to support the herniated segment. 
         FIG. 4A  shows a transverse view of an alternate embodiment of the invention. 
         FIG. 4B  shows a sagittal view of the alternate embodiment shown in  FIG. 4A . 
         FIG. 5A  shows a transverse view of another aspect of the present invention. 
         FIG. 5B  shows the delivery tube of  FIG. 5A  being used to displace the herniated segment to within its pre-herniated borders. 
         FIG. 5C  shows a one-piece embodiment of the invention in an anchored and supporting position. 
         FIG. 6  shows one embodiment of the invention supporting a weakened posterior anulus fibrosis. 
         FIG. 7A  shows a transverse section of another aspect of the disclosed invention demonstrating two stages involved in augmentation of the soft tissues of the disc. 
         FIG. 7B  shows a sagittal view of the invention shown in  FIG. 7A . 
         FIG. 8  shows a transverse section of one aspect of the disclosed invention involving augmentation of the soft tissues of the disc and support/closure of the anulus fibrosis. 
         FIG. 9A  shows a transverse section of one aspect of the invention involving augmentation of the soft tissues of the disc with the flexible augmentation material anchored to the anterior lateral anulus fibrosis. 
         FIG. 9B  shows a transverse section of one aspect of the disclosed invention involving augmentation of the soft tissues of the disc with the flexible augmentation material anchored to the anulus fibrosis by a one-piece anchor. 
         FIG. 10A  shows a transverse section of one aspect of the disclosed invention involving augmentation of the soft tissues of the disc. 
         FIG. 10B  shows the construct of  FIG. 10A  after the augmentation material has been inserted into the disc. 
         FIG. 11  illustrates a transverse section of a barrier mounted within an anulus. 
         FIG. 12  shows a sagittal view of the barrier of  FIG. 11 . 
         FIG. 13  shows a transverse section of a barrier anchored within a disc. 
         FIG. 14  illustrates a sagittal view of the barrier shown in  FIG. 13 . 
         FIG. 15  illustrates the use of a second anchoring device for a barrier mounted within a disc. 
         FIG. 16A  is an transverse view of the intervertebral disc. 
         FIG. 16B  is a sagittal section along the midline of the intervertebral disc. 
         FIG. 17  is an axial view of the intervertebral disc with the right half of a sealing means of a barrier means being placed against the interior aspect of a defect in anulus fibrosis by a dissection/delivery tool. 
         FIG. 18  illustrates a full sealing means placed on the interior aspect of a defect in anulus fibrosis. 
         FIG. 19  depicts the sealing means of  FIG. 18  being secured to tissues surrounding the defect. 
         FIG. 20  depicts the sealing means of  FIG. 19  after fixation means have been passed into surrounding tissues. 
         FIG. 21A  depicts an axial view of the sealing means of  FIG. 20  having enlarging means inserted into the interior cavity. 
         FIG. 21B  depicts the construct of  FIG. 21  in a sagittal section. 
         FIG. 22A  shows an alternative fixation scheme for the sealing means and enlarging means. 
         FIG. 22B  shows the construct of  FIG. 22A  in a sagittal section with an anchor securing a fixation region of the enlarging means to a superior vertebral body in a location proximate to the defect. 
         FIG. 23A  depicts an embodiment of the barrier means of the present invention being secured to an anulus using fixation means. 
         FIG. 23B  depicts an embodiment of the barrier means of  FIG. 23A  secured to an anulus by two fixation darts wherein the fixation tool has been removed. 
         FIGS. 24A and 24B  depict a barrier means positioned between layers of the anulus fibrosis on either side of a defect. 
         FIG. 25  depicts an axial cross section of a large version of a barrier means. 
         FIG. 26  depicts an axial cross section of a barrier means in position across a defect following insertion of two augmentation devices. 
         FIG. 27  depicts the barrier means as part of an elongated augmentation device. 
         FIG. 28A  depicts an axial section of an alternate configuration of the augmentation device of  FIG. 27 . 
         FIG. 28B  depicts a sagittal section of an alternate configuration of the augmentation device of  FIG. 27 . 
         FIGS. 29A-D  depict deployment of a barrier from an entry site remote from the defect in the anulus fibrosis. 
         FIGS. 30A ,  30 B,  31 A,  31 B,  32 A,  32 B,  33 A, and  33 B depict axial and sectional views, respectively, of various embodiments of the barrier. 
         FIG. 34A  shows a non-axisymmetric expansion means or frame. 
         FIGS. 34B and 34C  illustrate perspective views of a frame mounted within an intervertebral disc. 
         FIGS. 35 and 36  illustrate alternate embodiments of the expansion means shown in  FIG. 34 . 
         FIGS. 37A-C  illustrate a front, side, and perspective view, respectively, of an alternate embodiment of the expansion means shown in  FIG. 34 . 
         FIG. 38  shows an alternate expansion means to that shown in  FIG. 37A . 
         FIGS. 39A-D  illustrate a tubular expansion means having a circular cross-section. 
         FIGS. 40A-D  illustrate a tubular expansion means having an oval shaped cross-section. 
         FIGS. 40E ,  40 F and  40 I illustrate a front, back and top view, respectively of the tubular expansion means of  FIG. 40A  having a sealing means covering an exterior surface of an anulus face. 
         FIGS. 40G and 40H  show the tubular expansion means of  FIG. 40A  having a sealing means covering an interior surface of an anulus face. 
         FIGS. 41A-D  illustrate a tubular expansion means having an egg-shaped cross-section. 
         FIG. 42A-D  depicts cross sections of a preferred embodiment of sealing and enlarging means. 
         FIGS. 43A and 43B  depict an alternative configuration of enlarging means. 
         FIGS. 44A and 44B  depict an alternative shape of the barrier means. 
         FIG. 45  is a section of a device used to affix sealing means to tissues surrounding a defect. 
         FIG. 46  depicts the use of a thermal device to heat and adhere sealing means to tissues surrounding a defect. 
         FIG. 47  depicts an expandable thermal element that can be used to adhere sealing means to tissues surrounding a defect. 
         FIG. 48  depicts an alternative embodiment to the thermal device of  FIG. 46 . 
         FIGS. 49A-G  illustrate a method of implanting an intradiscal implant. 
         FIGS. 50A-F  show an alternate method of implanting an intradiscal implant. 
         FIGS. 51A-C  show another alternate method of implanting an intradiscal implant. 
         FIGS. 52A and 52B  illustrate an implant guide used with the intradiscal implant system. 
         FIG. 53A  illustrates a barrier having stiffening plate elements. 
         FIG. 53B  illustrates a sectional view of the barrier of  FIG. 53A . 
         FIG. 54A  shows a stiffening plate. 
         FIG. 54B  shows a sectional view of the stiffening plate of  FIG. 54A . 
         FIG. 55A  illustrates a barrier having stiffening rod elements. 
         FIG. 55B  illustrates a sectional view of the barrier of  FIG. 55A . 
         FIG. 56A  illustrates a stiffening rod. 
         FIG. 56B  illustrates a sectional view of the stiffening rod of  FIG. 56A . 
         FIG. 57  shows an alternate configuration for the location of the fixation devices of the barrier of  FIG. 44A . 
         FIGS. 58A and 58B  illustrate a dissection device for an intervertebral disc. 
         FIGS. 59A and 59B  illustrate an alternate dissection device for an intervertebral disc. 
         FIGS. 60A-C  illustrate a dissector component. 
         FIGS. 61A-D  illustrate a method of inserting a disc implant within an intervertebral disc. 
         FIG. 62  depicts a cross-sectional transverse view of a barrier device implanted within a disc along the inner surface of a lamella. Implanted conformable nuclear augmentation is also shown in contact with the barrier. 
         FIG. 63  shows a cross-sectional transverse view of a barrier device implanted within a disc along an inner surface of a lamella. Implanted nuclear augmentation comprised of a hydrophilic flexible solid is also shown. 
         FIG. 64  shows a cross-sectional transverse view of a barrier device implanted within a disc along an inner surface of a lamella. Several types of implanted nuclear augmentation including a solid geometric shape, a composite solid, and a free flowing liquid are also shown. 
         FIG. 65  illustrates a sagittal cross-sectional view of a barrier device connected to an inflatable nuclear augmentation device. 
         FIG. 66  depicts a sagittal cross-sectional view of a functional spine unit containing a barrier device unit connected to a wedge shaped nuclear augmentation device. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     The present invention provides for an in vivo augmented functional spine unit. A functional spine unit includes the bony structures of two adjacent vertebrae (or vertebral bodies), the soft tissue (anulus fibrosis (AF), and optionally nucleus pulposus (NP)) of the intervertebral disc, and the ligaments, musculature and connective tissue connected to the vertebrae. The intervertebral disc is substantially situated in the intervertebral space formed between the adjacent vertebrae. Augmentation of the functional spine unit can include repair of a herniated disc segment, support of a weakened, torn or damaged anulus fibrosis, or the addition of material to or replacement of all or part of the nucleus pulposus. Augmentation of the functional spine unit is provided by herniation constraining devices and disc augmentation devices situated in the intervertebral disc space. 
       FIGS. 1A and 1B  show the general anatomy of a functional spine unit  45 . In this description and the following claims, the terms ‘anterior’ and ‘posterior’, ‘superior’ and ‘inferior’ are defined by their standard usage in anatomy, i.e., anterior is a direction toward the front (ventral) side of the body or organ, posterior is a direction toward the back (dorsal) side of the body or organ; superior is upward (toward the head) and inferior is lower (toward the feet). 
       FIG. 1A  is an axial view along the transverse axis M of a vertebral body with the intervertebral disc  15  superior to the vertebral body. Axis M shows the anterior (A) and posterior (P) orientation of the functional spine unit within the anatomy. The intervertebral disc  15  contains the anulus fibrosis (AF)  10  which surrounds a central nucleus pulposus (NP)  20 . A Herniated segment  30  is depicted by a dashed-line. The herniated segment  30  protrudes beyond the pre-herniated posterior border  40  of the disc. Also shown in this figure are the left  70  and right  70 ′ transverse spinous processes and the posterior spinous process  80 . 
       FIG. 1B  is a sagittal section along sagittal axis N through the midline of two adjacent vertebral bodies  50  (superior) and  50 ′ (inferior). Intervertebral disc space  55  is formed between the two vertebral bodies and contains intervertebral disc  15 , which supports and cushions the vertebral bodies and permits movement of the two vertebral bodies with respect to each other and other adjacent functional spine units. 
     Intervertebral disc  15  is comprised of the outer AF  10  which normally surrounds and constrains the NP  20  to be wholly within the borders of the intervertebral disc space. In  FIGS. 1A and 1B , herniated segment  30 , represented by the dashed-line, has migrated posterior to the pre-herniated border  40  of the posterior AF of the disc. Axis M extends between the anterior (A) and posterior (P) of the functional spine unit. The vertebral bodies also include facet joints  60  and the superior  90  and inferior  90 ′ pedicle that form the neural foramen  100 . Disc height loss occurs when the superior vertebral body  50  moves inferiorly relative to the inferior vertebral body  50 ′. 
     Partial disruption  121  of the inner layers of the anulus  10  without a true perforation has also been linked to chronic low back pain. Such a disruption  4  is illustrated in  FIG. 1C . It is thought that weakness of these inner layers forces the sensitive outer anulus lamellae to endure higher stresses. This increased stress stimulates the small nerve fibers penetrating the outer anulus, which results in both localized and referred pain. 
     In one embodiment of the present invention, the disc herniation constraining devices  13  provide support for returning all or part of the herniated segment  30  to a position substantially within its pre-herniated borders  40 . The disc herniation constraining device includes an anchor which is positioned at a site within the functional spine unit, such as the superior or inferior vertebral body, or the anterior medial, or anterior lateral anulus fibrosis. The anchor is used as a point against which all or part of the herniated segment is tensioned so as to return the herniated segment to its pre-herniated borders, and thereby relieve pressure on otherwise compressed neural tissue and structures. A support member is positioned in or posterior to the herniated segment, and is connected to the anchor by a connecting member. Sufficient tension is applied to the connecting member so that the support member returns the herniated segment to a pre-herniated position. In various embodiments, augmentation material is secured within the intervertebral disc space, which assists the NP in cushioning and supporting the inferior and superior vertebral bodies. An anchor secured in a portion of the functional spine unit and attached to the connection member and augmentation material limits movement of the augmentation material within the intervertebral disc space. A supporting member, located opposite the anchor, may optionally provide a second point of attachment for the connection member and further hinder the movement of the augmentation material within the intervertebral disc space. 
       FIGS. 2A and 2B  depict one embodiment of device  13 .  FIG. 2A  shows the elements of the constraining device in position to correct the herniated segment. Anchor  1  is securely established in a location within the functional spine unit, such as the anterior AF shown in the figure. Support member  2  is positioned in or posterior to herniated segment  30 . Leading from and connected to anchor  1  is connection member  3 , which serves to connect anchor  1  to support member  2 . Depending on the location chosen for support member  2 , the connection member may traverse through all or part of the herniated segment. 
       FIG. 2B  shows the positions of the various elements of the herniation constraining device  13  when the device  13  is supporting the herniated segment. Tightening connection member  2  allows it to transmit tensile forces along its length, which causes herniated segment  30  to move anteriorly, i.e., in the direction of its pre-herniated borders. Once herniated segment  30  is in the desired position, connection member  3  is secured in a permanent fashion between anchor  1  and support member  2 . This maintains tension between anchor  1  and support member  2  and restricts motion of the herniated segment to within the pre-herniated borders  40  of the disc. Support member  2  is used to anchor to herniated segment  30 , support a weakened AF in which no visual evidence of herniation is apparent, and may also be used to close a defect in the AF in the vicinity of herniated segment  30 . 
     Anchor  1  is depicted in a representative form, as it can take one of many suitable shapes, be made from one of a variety of biocompatible materials, and be constructed so as to fall within a range of stiffness. It can be a permanent device constructed of durable plastic or metal or can be made from a resorbable material such as polylactic acid (PLA) or polyglycolic acid (PGA). Specific embodiments are not shown, but many possible designs would be obvious to anyone skilled in the art. Embodiments include, but are not limited to, a barbed anchor made of PLA or a metal coil that can be screwed into the anterior AF. Anchor  1  can be securely established within a portion of the functional spine unit in the usual and customary manner for such devices and locations, such as being screwed into bone, sutured into tissue or bone, or affixed to tissue or bone using an adhesive method, such as cement, or other suitable surgical adhesives. Once established within the bone or tissue, anchor  1  should remain relatively stationary within the bone or tissue. 
     Support member  2  is also depicted in a representative format and shares the same flexibility in material and design as anchor  1 . Both device elements can be of the same design, or they can be of different designs, each better suited to being established in healthy and diseased tissue respectively. Alternatively, in other forms, support member  2  can be a cap or a bead shape, which also serves to secure a tear or puncture in the AF, or it can be bar or plate shaped, with or without barbs to maintain secure contact with the herniated segment. Support member  2  can be established securely to, within, or posterior to the herniated segment. 
     The anchor and support member can include suture, bone anchors, soft tissue anchors, tissue adhesives, and materials that support tissue ingrowth although other forms and materials are possible. They may be permanent devices or resorbable. Their attachment to a portion of FSU and herniated segment must be strong enough to resist the tensional forces that result from repair of the hernia and the loads generated during daily activities. 
     Connection member  3  is also depicted in representative fashion. Member  3  may be in the format of a flexible filament, such as a single or multi-strand suture, wire, or perhaps a rigid rod or broad band of material, for example. The connection member can further include suture, wire, pins, and woven tubes or webs of material. It can be constructed from a variety of materials, either permanent or resorbable, and can be of any shape suitable to fit within the confines of the intervertebral disc space. The material chosen is preferably adapted to be relatively stiff while in tension, and relatively flexible against all other loads. This allows for maximal mobility of the herniated segment relative to the anchor without the risk of the supported segment moving outside of the pre-herniated borders of the disc. The connection member may be an integral component of either the anchor or support member or a separate component. For example, the connection member and support member could be a length of non-resorbing suture that is coupled to an anchor, tensioned against the anchor, and sewn to the herniated segment. 
       FIGS. 3A and 3B  depict another embodiment of device  13 . In  FIG. 3A  the elements of the herniation constraining device are shown in position prior to securing a herniated segment. Anchor  1  is positioned in the AF and connection member  3  is attached to anchor  1 . Support member  4  is positioned posterior to the posterior-most aspect of herniated segment  30 . In this way, support member  4  does not need to be secured in herniated segment  30  to cause herniated segment  30  to move within the pre-herniated borders  40  of the disc. Support member  4  has the same flexibility in design and material as anchor  1 , and may further take the form of a flexible patch or rigid plate or bar of material that is either affixed to the posterior aspect of herniated segment  30  or is simply in a form that is larger than any hole in the AF directly anterior to support member  4 .  FIG. 3B  shows the positions of the elements of the device when tension is applied between anchor  1  and support member  4  along connection member  3 . The herniated segment is displaced anteriorly, within the pre-herniated borders  40  of the disc. 
       FIGS. 4A and 4B  show five examples of suitable anchoring sites within the FSU for anchor  1 .  FIG. 4A  shows an axial view of anchor  1  in various positions within the anterior and lateral AF.  FIG. 4B  similarly shows a sagittal view of the various acceptable anchoring sites for anchor  1 . Anchor  1  is secured in the superior vertebral body  50 , inferior vertebral body  50 ′ or anterior AF  10 , although any site that can withstand the tension between anchor  1  and support member  2  along connection member  3  to support a herniated segment within its pre-herniated borders  40  is acceptable. 
     Generally, a suitable position for affixing one or more anchors is a location anterior to the herniated segment such that, when tension is applied along connection member  3 , herniated segment  30  is returned to a site within the pre-herniated borders  40 . The site chosen for the anchor should be able to withstand the tensile forces applied to the anchor when the connection member is brought under tension. Because most symptomatic herniations occur in the posterior or posterior lateral directions, the preferable site for anchor placement is anterior to the site of the herniation. Any portion of the involved FSU is generally acceptable, however the anterior, anterior medial, or anterior lateral AF is preferable. These portions of the AF have been shown to have considerably greater strength and stiffness than the posterior or posterior lateral portions of the AF. As shown in  FIGS. 4A and 4B , anchor  1  can be a single anchor in any of the shown locations, or there can be multiple anchors  1  affixed in various locations and connected to a support member  2  to support the herniated segment. Connection member  3  can be one continuous length that is threaded through the sited anchors and the support member, or it can be several individual strands of material each terminated under tension between one or more anchors and one or more support members. 
     In various forms of the invention, the anchor(s) and connection member(s) may be introduced and implanted in the patient, with the connection member under tension. Alternatively, those elements may be installed, without introducing tension to the connection member, but where the connection member is adapted to be under tension when the patient is in a non-horizontal position, i.e., resulting from loading in the intervertebral disc. 
       FIGS. 5A-C  show an alternate embodiment of herniation constraining device  13 A. In this series of figures, device  13 A, a substantially one-piece construct, is delivered through a delivery tube  6 , although device  13 A could be delivered in a variety of ways including, but not limited to, by hand or by a hand held grasping instrument. In  FIG. 5A , device  13 A in delivery tube  6  is positioned against herniated segment  30 . In  FIG. 5B , the herniated segment is displaced within its pre-herniated borders  40  by device  13 A and/or delivery tube  6  such that when, in  FIG. 5C , device  13 A has been delivered through delivery tube  6 , and secured within a portion of the FSU, the device supports the displaced herniated segment within its pre-herniated border  40 . Herniation constraining device  13 A can be made of a variety of materials and have one of many possible forms so long as it allows support of the herniated segment  30  within the pre-herniated borders  40  of the disc. Device  13 A can anchor the herniated segment  30  to any suitable anchoring site within the FSU, including, but not limited to the superior vertebral body, inferior vertebral body, or anterior AF. Device  13 A may be used additionally to close a defect in the AF of herniated segment  30 . Alternatively, any such defect may be left open or may be closed using another means. 
       FIG. 6  depicts the substantially one-piece device  13 A supporting a weakened segment  30 ′ of the posterior AF  10 ′. Device  13 A is positioned in or posterior to the weakened segment  30 ′ and secured to a portion of the FSU, such as the superior vertebral body  50 , shown in the figure, or the inferior vertebral body  50 ′ or anterior or anterior-lateral anulus fibrosis  10 . In certain patients, there may be no obvious herniation found at surgery. However, a weakened or torn AF that may not be protruding beyond the pre-herniated borders of the disc may still induce the surgeon to remove all or part of the NP in order to decrease the risk of herniation. As an alternative to discectomy, any of the embodiments of the invention may be used to support and perhaps close defects in weakened segments of AF. 
     A further embodiment of the present invention involves augmentation of the soft tissues of the intervertebral disc to avoid or reverse disc height loss.  FIGS. 7A and 7B  show one embodiment of device  13  securing augmentation material in the intervertebral disc space  55 . In the left side of  FIG. 7A , anchors  1  have been established in the anterior AF  10 . Augmentation material  7  is in the process of being inserted into the disc space along connection member  3  which, in this embodiment, has passageway  9 . Support member  2 ′ is shown ready to be attached to connection member  3  once the augmentation material  7  is properly situated. In this embodiment, connection member  3  passes through an aperture  11  in support member  2 ′, although many other methods of affixing support member  2 ′ to connection member  3  are possible and within the scope of this invention. 
     Augmentation material  7  may have a passageway  9 , such as a channel, slit or the like, which allows it to slide along the connection member  3 , or augmentation material  7  may be solid, and connection member  3  can be threaded through augmentation material by means such as needle or other puncturing device. Connection member  3  is affixed at one end to anchor  1  and terminated at its other end by a support member  2 ′, one embodiment of which is shown in the figure in a cap-like configuration. Support member  2 ′ can be affixed to connection member  3  in a variety of ways, including, but not limited to, swaging support member  2 ′ to connection member  3 . In a preferred embodiment, support member  2 ′ is in a cap configuration and has a dimension (diameter or length and width) larger than the optional passageway  9 , which serves to prevent augmentation material  7  from displacing posteriorly with respect to anchor  1 . The right half of the intervertebral disc of  FIG. 7A  (axial view) and  FIG. 7B  (sagittal view) show augmentation material  7  that has been implanted into the disc space  55  along connection member  3  where it supports the vertebral bodies  50  and  50 ′.  FIG. 7A  shows an embodiment in which support member  2 ′ is affixed to connection member  3  and serves only to prevent augmentation material  7  from moving off connection member  3 . The augmentation device is free to move within the disc space.  FIG. 7B  shows an alternate embodiment in which support member  2 ′ is embedded in a site in the functional spine unit, such as a herniated segment or posterior anulus fibrosis, to further restrict the movement of augmentation material  7  or spacer material within the disc space. 
     Augmentation or spacer material can be made of any biocompatible, preferably flexible, material. Such a flexible material is preferably fibrous, like cellulose or bovine or autologous collagen. The augmentation material can be plug or disc shaped. It can further be cube-like, ellipsoid, spheroid or any other suitable shape. The augmentation material can be secured within the intervertebral space by a variety of methods, such as but not limited to, a suture loop attached to, around, or through the material, which is then passed to the anchor and support member. 
       FIGS. 8 ,  9 A,  9 B and  10 A and  10 B depict further embodiments of the disc herniation constraining device  13 B in use for augmenting soft tissue, particularly tissue within the intervertebral space. In the embodiments shown in  FIGS. 8 and 9A , device  13 B is secured within the intervertebral disc space providing additional support for NP  20 . Anchor  1  is securely affixed in a portion of the FSU, (anterior AF  10  in these figures). Connection member  3  terminates at support member  2 , preventing augmentation material  7  from migrating generally posteriorly with respect to anchor  1 . Support member  2  is depicted in these figures as established in various locations, such as the posterior AF  10 ′ in  FIG. 8 , but support member  2  may be anchored in any suitable location within the FSU, as described previously. Support member  2  may be used to close a defect in the posterior AF. It may also be used to displace a herniated segment to within the pre-herniated borders of the disc by applying tension between anchoring means  1  and  2  along connection member  3 . 
       FIG. 9A  depicts anchor  1 , connection member  3 , spacer material  7  and support member  2 ′ (shown in the “cap”-type configuration) inserted as a single construct and anchored to a site within the disc space, such as the inferior or superior vertebral bodies. This configuration simplifies insertion of the embodiments depicted in  FIGS. 7 and 8  by reducing the number of steps to achieve implantation. Connection member  3  is preferably relatively stiff in tension, but flexible against all other loads. Support member  2 ′ is depicted as a bar element that is larger than passageway  9  in at least one plane. 
       FIG. 9B  depicts a variation on the embodiment depicted in  FIG. 9A .  FIG. 9B  shows substantially one-piece disc augmentation device  13 C, secured in the intervertebral disc space. Device  13 C has anchor  1 , connection member  3  and augmentation material  7 . Augmentation material  7  and anchor  1  could be pre-assembled prior to insertion into the disc space  55  as a single construct. Alternatively, augmentation material  7  could be inserted first into the disc space and then anchored to a portion of the FSU by anchor  1 . 
       FIGS. 10A and 10B  show yet another embodiment of the disclosed invention,  13 D. In  FIG. 10A , two connection members  3  and  3 ′ are attached to anchor  1 . Two plugs of augmentation material  7  and  7 ′ are inserted into the disc space along connection members  3  and  3 ′. Connection members  3  and  3 ′ are then bound together (e.g., knotted together, fused, or the like). This forms loop  3 ″ that serves to prevent augmentation materials  7  and  7 ′ from displacing posteriorly.  FIG. 10B  shows the position of the augmentation material  7  after it is secured by the loop  3 ″ and anchor  1 . Various combinations of augmentation material, connecting members and anchors can be used in this embodiment, such as using a single plug of augmentation material, or two connection members leading from anchor  1  with each of the connection members being bound to at least one other connection member. It could further be accomplished with more than one anchor with at least one connection member leading from each anchor, and each of the connection members being bound to at least one other connection member. 
     Any of the devices described herein can be used for closing defects in the AF whether created surgically or during the herniation event. Such methods may also involve the addition of biocompatible material to either the AF or NP. This material could include sequestered or extruded segments of the NP found outside the pre-herniated borders of the disc. 
       FIGS. 11-15  illustrate devices used in and methods for closing a defect in an anulus fibrosis. One method involves the insertion of a barrier or barrier means  12  into the disc  15 . This procedure can accompany surgical discectomy. It can also be done without the removal of any portion of the disc  15  and further in combination with the insertion of an augmentation material or device into the disc  15 . 
     The method consists of inserting the barrier  12  into the interior of the disc  15  and positioning it proximate to the interior aspect of the anulus defect  16 . The barrier material is preferably considerably larger in area than the size of the defect  16 , such that at least some portion of the barrier means  12  abuts healthier anulus fibrosis  10 . The device acts to seal the anulus defect  16 , recreating the closed isobaric environment of a healthy disc nucleus  20 . This closure can be achieved simply by an over-sizing of the implant relative to the defect  16 . It can also be achieved by affixing the barrier means  12  to tissues within the functional spinal unit. In a preferred aspect of the present invention, the barrier  12  is affixed to the anulus surrounding the anulus defect  16 . This can be achieved with sutures, staples, glues or other suitable fixation means or fixation device  14 . The barrier means  12  can also be larger in area than the defect  16  and be affixed to a tissue or structure opposite the defect  16 , i.e. anterior tissue in the case of a posterior defect. 
     The barrier means  12  is preferably flexible in nature. It can be constructed of a woven material such as Dacron™ or Nylon™, a synthetic polyamide or polyester, a polyethylene, and can further be an expanded material, such as expanded polytetrafluroethylene (e-PTFE), for example. The barrier means  12  can also be a biologic material such as cross-linked collagen or cellulous. 
     The barrier means  12  can be a single piece of material. It can have an expandable means or component that allows it to be expanded from a compressed state after insertion into the interior of the disc  15 . This expandable means can be active, such as a balloon, or passive, such as a hydrophilic material. The expandable means can also be a self-expanding elastically deforming material, for example. 
       FIGS. 11 and 12  illustrate a barrier  12  mounted within an anulus  10  and covering an anulus defect  16 . The barrier  12  can be secured to the anulus  10  with a fixation mechanism or fixation means  14 . The fixation means  14  can include a plurality of suture loops placed through the barrier  12  and the anulus  10 . Such fixation can prevent motion or slipping of the barrier  12  away from the anulus defect  16 . 
     The barrier means  12  can also be anchored to the disc  15  in multiple locations. In one preferred embodiment, shown in  FIGS. 13 and 14 , the barrier means  12  can be affixed to the anulus tissue  10  in or surrounding the defect and further affixed to a secondary fixation site opposite the defect, e.g. the anterior anulus  10  in a posterior herniation, or the inferior  50 ′ or superior  50  vertebral body. For example, fixation means  14  can be used to attach the barrier  12  to the anulus  10  near the defect  16 , while an anchoring mechanism  18  can secure the barrier  12  to a secondary fixation site. A connector  22  can attach the barrier  12  to the anchor  18 . Tension can be applied between the primary and secondary fixation sites through a connector  22  so as to move the anulus defect  16  toward the secondary fixation site. This may be particularly beneficial in closing defects  16  that result in posterior herniations. By using this technique, the herniation can be moved and supported away from any posterior neural structures while further closing any defect in the anulus  10 . 
     The barrier means  12  can further be integral to a fixation means such that the barrier means affixes itself to tissues within the functional spinal unit. 
     Any of the methods described above can be augmented by the use of a second barrier or a second barrier means  24  placed proximate to the outer aspect of the defect  16  as shown in  FIG. 15 . The second barrier  24  can further be affixed to the inner barrier means  12  by the use of a fixation means  14  such as suture material. 
       FIGS. 16A and 16B  depict intervertebral disc  15  comprising nucleus pulposus  20  and anulus fibrosis  10 . Nucleus pulposus  20  forms a first anatomic region and extra-discal space  500  (any space exterior to the disc) forms a second anatomic region wherein these regions are separated by anulus fibrosis  10 . 
       FIG. 16A  is an axial (transverse) view of the intervertebral disc. A posterior lateral defect  16  in anulus fibrosis  10  has allowed a segment  30  of nucleus pulposus  20  to herniate into an extra discal space  500 . Interior aspect  32  and exterior aspect  34  are shown, as are the right  70 ′ and left  70  transverse processes and posterior process  80 . 
       FIG. 16B  is a sagittal section along the midline intervertebral disc. Superior pedicle  90  and inferior pedicle  90 ′ extend posteriorly from superior vertebral body  95  and inferior vertebral body  95 ′ respectively. 
     To prevent further herniation of the nucleus  20  and to repair any present herniation, in a preferred embodiment, a barrier or barrier means  12  can be placed into a space between the anulus  10  and the nucleus  20  proximate to the inner aspect  32  of defect  16 , as depicted in  FIGS. 17 and 18 . The space can be created by blunt dissection. Dissection can be achieved with a separate dissection instrument, with the barrier means  12  itself, or a combined dissection/barrier delivery tool  100 . This space is preferably no larger than the barrier means such that the barrier means  12  can be in contact with both anulus  10  and nucleus  20 . This allows the barrier means  12  to transfer load from the nucleus  20  to the anulus  10  when the disc is pressurized during activity. 
     In position, the barrier means  12  preferably spans the defect  16  and extends along the interior aspect  36  of the anulus  10  until it contacts healthy tissues on all sides of the defect  16 , or on a sufficient extent of adjacent healthy tissue to provide adequate support under load. Healthy tissue may be non-diseased tissue and/or load bearing tissue, which may be micro-perforated or non-perforated. Depending on the extent of the defect  16 , the contacted tissues can include the anulus  10 , cartilage overlying the vertebral endplates, and/or the endplates themselves. 
     In the preferred embodiment, the barrier means  12  comprises two components—a sealing means or sealing component  51  and an enlarging means or enlarging component  53 , shown in  FIGS. 21A and 21B . 
     The sealing means  51  forms the periphery of the barrier  12  and has an interior cavity  17 . There is at least one opening  8  leading into cavity  17  from the exterior of the sealing means  51 . Sealing means  51  is preferably compressible or collapsible to a dimension that can readily be inserted into the disc  15  through a relatively small hole. This hole can be the defect  16  itself or a site remote from the defect  16 . The sealing means  51  is constructed from a material and is formed in such a manner as to resist the passage of fluids and other materials around sealing means  51  and through the defect  16 . The sealing means  51  can be constructed from one or any number of a variety of materials including, but not limited to PTFE, e-PTFE, Nylon™, Marlex™, high-density polyethylene, and/or collagen. The thickness of the sealing component has been found to be optimal between about 0.001 inches (0.127 mm) and 0.063 inches (1.6 mm). 
     The enlarging means  53  can be sized to fit within cavity  17  of sealing means  51 . It is preferably a single object of a dimension that can be inserted through the same defect  16  through which the sealing means  51  was passed. The enlarging means  53  can expand the sealing means  51  to an expanded state as it is passed into cavity  17 . One purpose of enlarging means  53  is to expand sealing means  51  to a size greater than that of the defect  16  such that the assembled barrier  12  prevents passage of material through the defect  16 . The enlarger  53  can further impart stiffness to the barrier  12  such that the barrier  12  resists the pressures within nucleus pulposus  20  and expulsion through the defect  16 . The enlarging means  53  can be constructed from one or any number of materials including, but not limited to, silicon rubber, various plastics, stainless steel, nickel titanium alloys, or other metals. These materials may form a solid object, a hollow object, coiled springs or other suitable forms capable of filling cavity  17  within sealing means  51 . 
     The sealing means  51 , enlarging means  53 , or the barrier means  12  constructs can further be affixed to tissues either surrounding the defect  16  or remote from the defect  16 . In the preferred embodiment, no aspect of a fixation means or fixation device or the barrier means  12  nor its components extend posterior to the disc  15  or into the extradiscal region  500 , avoiding the risk of contacting and irritating the sensitive nerve tissues posterior to the disc  15 . 
     In a preferred embodiment, the sealing means  51  is inserted into the disc  15  proximate the interior aspect  36  of the defect. The sealing means  51  is then affixed to the tissues surrounding the defect using a suitable fixation means, such as suture or a soft-tissue anchor. The fixation procedure is preferably performed from the interior of the sealing means cavity  17  as depicted in  FIGS. 19 and 20 . A fixation delivery instrument  110  is delivered into cavity  17  through opening  8  in the sealing means  51 . Fixation devices  14  can then be deployed through a wall of the sealing means  53  into surrounding tissues. Once the fixation means  14  have been passed into surrounding tissue, the fixation delivery instrument  110  can be removed from the disc  15 . This method eliminates the need for a separate entryway into the disc  15  for delivery of fixation means  14 . It further minimizes the risk of material leaking through sealing means  51  proximate to the fixation means  14 . One or more fixation means  14  can be delivered into one or any number of surrounding tissues including the superior  95  and inferior  95 ′ vertebral bodies. Following fixation of the sealing means  51 , the enlarging means  53  can be inserted into cavity  17  of the sealing means  51  to further expand the barrier means  12  construct as well as increase its stiffness, as depicted in  FIGS. 21A and 21B . The opening  8  into the sealing means  51  can then be closed by a suture or other means, although this is not a requirement of the present invention. In certain cases, insertion of a separate enlarging means may not be necessary if adequate fixation of the sealing means  51  is achieved. 
     Another method of securing the barrier  12  to tissues is to affix the enlarging means  53  to tissues either surrounding or remote from the defect  16 . The enlarging means  53  can have an integral fixation region  4  that facilitates securing it to tissues as depicted in  FIGS. 22A ,  22 B,  32 A and  43 B. This fixation region  4  can extend exterior to sealing means  51  either through opening  8  or through a separate opening. Fixation region  4  can have a hole through which a fixation means or fixation device  14  can be passed. In a preferred embodiment, the barrier  12  is affixed to at least one of the surrounding vertebral bodies ( 95  and  95 ′) proximate to the defect using a bone anchor  14 ′. The bone anchor  14 ′ can be deployed into the vertebral bodies  50 ,  50 ′ at some angle between 0° and 180° relative to a bone anchor deployment tool. As shown the bone anchor  14 ′ is mounted at 90° relative to the bone anchor deployment tool. Alternatively, the enlarging means  53  itself can have an integral fixation device  14  located at a site or sites along its length. 
     Another method of securing the barrier means  12  is to insert the barrier means  12  through the defect  16  or another opening into the disc  15 , position it proximate to the interior aspect  36  of the defect  16 , and pass at least one fixation means  14  through the anulus  10  and into the barrier  12 . In a preferred embodiment of this method, the fixation means  14  can be darts  25  and are first passed partially into anulus  10  within a fixation device  120 , such as a hollow needle. As depicted in  FIGS. 23A and 23B , fixation means  25  can be advanced into the barrier means  12  and fixation device  120  removed. Fixation means  25  preferably have two ends, each with a means to prevent movement of that end of the fixation device. Using this method, the fixation means can be lodged in both the barrier  12  and anulus fibrosis  10  without any aspect of fixation means  25  exterior to the disc in the extradiscal region  500 . 
     In another aspect of the present invention, the barrier (or “patch”)  12  can be placed between two neighboring layers  33 ,  37  (lamellae) of the anulus  10  on either or both sides of the defect  16  as depicted in  FIGS. 24A and 24B .  FIG. 24A  shows an axial view while  24 B shows a sagittal cross section. Such positioning spans the defect  16 . The barrier means  12  can be secured using the methods outlined. 
     A dissecting tool can be used to form an opening extending circumferentially  31  within the anulus fibrosis such that the barrier can be inserted into the opening. Alternatively, the barrier itself can have a dissecting edge such that it can be driven at least partially into the sidewalls of defect  16 , annulotomy  416 , access hole  417  or opening in the anulus. This process can make use of the naturally layered structure in the anulus in which adjacent layers  33 ,  37  are defined by a circumferentially extending boundary  35  between the layers. 
     Another embodiment of the barrier  12  is a patch having a length, oriented along the circumference of the disc, which is substantially greater than its height, which is oriented along the distance separating the surrounding vertebral bodies. A barrier  12  having a length greater than its height is illustrated in  FIG. 25 . The barrier  12  can be positioned across the defect  16  as well as the entirety of the posterior aspect of the anulus fibrosis  10 . Such dimensions of the barrier  12  can help to prevent the barrier  12  from slipping after insertion and can aid in distributing the pressure of the nucleus  20  evenly along the posterior aspect of the anulus  10 . 
     The barrier  12  can be used in conjunction with an augmentation device  11  inserted within the anulus  10 . The augmentation device  11  can include separate augmentation devices  42  as shown in  FIG. 26 . The augmentation device  11  can also be a single augmentation device  44  and can form part of the barrier  12  as barrier region  300 , coiled within the anulus fibrosis  10 , as shown in  FIG. 27 . Either the barrier  12  or barrier region  300  can be secured to the tissues surrounding the defect  16  by fixation devices or darts  25 , or be left unconstrained 
     In another embodiment of the present invention, the barrier or patch  12  may be used as part of a method to augment the intervertebral disc. In one aspect of this method, augmentation material or devices are inserted into the disc through a defect (either naturally occurring or surgically generated). Many suitable augmentation materials and devices are discussed above and in the prior art. As depicted in  FIG. 26 , the barrier means is then inserted to aid in closing the defect and/or to aid in transferring load from the augmentation materials/devices to healthy tissues surrounding the defect. In another aspect of this method, the barrier means is an integral component to an augmentation device. As shown in  FIGS. 27 ,  28 A and  28 B, the augmentation portion may comprise a length of elastic material that can be inserted linearly through a defect in the anulus. A region  300  of the length forms the barrier means of the present invention and can be positioned proximate to the interior aspect of the defect once the nuclear space is adequately filled. Barrier region  300  may then be affixed to surrounding tissues such as the AF and/or the neighboring vertebral bodies using any of the methods and devices described above. 
       FIGS. 28A and 28B  illustrate axial and sagittal sections, respectively, of an alternate configuration of an augmentation device  38 . In this embodiment, barrier region  300  extends across the defect  16  and has fixation region  4  facilitating fixation of the device  13  to superior vertebral body  50  with anchor  14 ′. 
       FIGS. 29A-D  illustrate the deployment of a barrier  12  from an entry site  800  remote from the defect in the anulus fibrosis  10 .  FIG. 29A  shows insertion instrument  130  with a distal end positioned within the disc space occupied by nucleus pulposus  20 .  FIG. 29B  depicts delivery catheter  140  exiting the distal end of insertion instrument  130  with barrier  12  on its distal end. Barrier  12  is positioned across the interior aspect of the defect  16 .  FIG. 29C  depicts the use of an expandable barrier  12 ′ wherein delivery catheter  140  is used to expand the barrier  12 ′ with balloon  150  on its distal end. Balloon  150  may exploit heat to further adhere barrier  12 ′ to surrounding tissue.  FIG. 29D  depicts removal of balloon  150  and delivery catheter  140  from the disc space leaving expanded barrier means  12 ′ positioned across defect  16 . 
     Another method of securing the barrier means  12  is to adhere it to surrounding tissues through the application of heat. In this embodiment, the barrier means  12  includes a sealing means  51  comprised of a thermally adherent material that adheres to surrounding tissues upon the application of heat. The thermally adherent material can include thermoplastic, collagen, or a similar material. The sealing means  51  can further comprise a separate structural material that adds strength to the thermally adherent material, such as a woven Nylon™ or Marlex™. This thermally adherent sealing means preferably has an interior cavity  17  and at least one opening  8  leading from the exterior of the barrier means into cavity  17 . A thermal device can be attached to the insertion instrument shown in  FIGS. 29C and 29D . The insertion instrument  130  having a thermal device can be inserted into cavity  17  and used to heat sealing means  51  and surrounding tissues. This device can be a simple thermal element, such as a resistive heating coil, rod or wire. It can further be a number of electrodes capable of heating the barrier means and surrounding tissue through the application of radio frequency (RF) energy. The thermal device can further be a balloon  150 ,  150 ′, as shown in  FIG. 47 , capable of both heating and expanding the barrier means. Balloon  150 ,  150 ′ can either be inflated with a heated fluid or have electrodes located about its surface to heat the barrier means with RF energy. Balloon  150 ,  150 ′ is deflated and removed after heating the sealing means. These thermal methods and devices achieve the goal of adhering the sealing means to the AF and NP and potentially other surrounding tissues. The application of heat can further aid the procedure by killing small nerves within the AF, by causing the defect to shrink, or by causing cross-linking and/or shrinking of surrounding tissues. An expander or enlarging means  53  can also be an integral component of barrier  12  inserted within sealing means  51 . After the application of heat, a separate enlarging means  53  can be inserted into the interior cavity of the barrier means to either enlarge the barrier  12  or add stiffness to its structure. Such an enlarging means is preferably similar in make-up and design to those described above. Use of an enlarging means may not be necessary in some cases and is not a required component of this method. 
     The barrier means  12  shown in  FIG. 25  preferably has a primary curvature or gentle curve along the length of the patch or barrier  12  that allows it to conform to the inner circumference of the AF  10 . This curvature may have a single radius R as shown in  FIGS. 44A and 44B  or may have multiple curvatures. The curvature can be fabricated into the barrier  12  and/or any of its components. For example, the sealing means can be made without an inherent curvature while the enlarging means can have a primary curvature along its length. Once the enlarging means is placed within the sealing means the overall barrier means assembly takes on the primary curvature of the enlarging means. This modularity allows enlarging means with specific curvatures to be fabricated for defects occurring in various regions of the anulus fibrosis. 
     The cross section of the barrier  12  can be any of a number of shapes. Each embodiment exploits a sealing means  51  and an enlarging means  53  that may further add stiffness to the overall barrier construct.  FIGS. 30A and 30B  show an elongated cylindrical embodiment with enlarging means  53  located about the long axis of the device.  FIGS. 31A and 31B  depict a barrier means comprising an enlarging means  53  with a central cavity  49 .  FIGS. 32A and 32B  depict a barrier means comprising a non-axisymmetric sealing means  51 . In use, the longer section of sealing means  51  as seen on the left side of this figure would extend between opposing vertebra  50  and  50 ′.  FIGS. 33A and 33B  depict a barrier means comprising a non-axisymmetric sealing means  51  and enlarger  53 . The concave portion of the barrier means preferably faces nucleus pulposus  20  while the convex surface faces the defect  16 , annulotomy  416 , or access hole  417  and the inner aspect of the anulus fibrosis  10 . This embodiment exploits pressure within the disc to compress sealing means  51  against neighboring vertebral bodies  50  and  50 ′ to aid in sealing. The ‘C’ shape as shown in  FIG. 33A  is the preferred shape of the barrier wherein the convex portion of the patch rests against the interior aspect of the AF while the concave portion faces the NP. Used in this manner, the barrier or patch  12  serves to partially encapsulate the nucleus puposus  20  by conforming to the gross morphology of the inner surface of the anulus  10  and presenting a concave or cupping surface toward the nucleus  20 . To improve the sealing ability of such a patch, the upper and lower portions of this ‘C’ shaped barrier means are positioned against the vertebral endplates or overlying cartilage. As the pressure within the nucleus increases, these portions of the patch are pressurized toward the endplates with an equivalent pressure, preventing the passage of materials around the barrier means. Dissecting a matching cavity prior to or during patch placement can facilitate use of such a ‘C’ shaped patch. 
       FIGS. 34 through 41  depict various enlarging or expansion devices  53  that can be employed to aid in expanding a sealing element  51  within the intervertebral disc  15 . Each embodiment can be covered by, coated with, or cover the sealing element  51 . The sealing means  51  can further be woven through the expansion means  53 . The sealing element  51  or membrane can be a sealer which can prevent flow of a material from within the anulus fibrosis of the intervertebral disc through a defect in the anulus fibrosis. The material within the anulus can include nucleus pulposus or a prosthetic augmentation device, such as a hydrogel. 
       FIGS. 34 through 38  depict alternative patterns to that illustrated in  FIG. 33A .  FIG. 33A  shows the expansion devices  53  within the sealing means  51 . The sealing means can alternatively be secured to one or another face (concave or convex) of the expansion means  53 . This can have advantages in reducing the overall volume of the barrier means  12 , simplifying insertion through a narrow cannula. It can also allow the barrier means  12  to induce ingrowth of tissue on one face and not the other. The sealing means  51  can be formed from a material that resists ingrowth such as expanded polytetraflouroethylene (e-PTFE). The expansion means  53  can be constructed of a metal or polymer that encourages ingrowth. If the e-PTFE sealing means  51  is secured to the concave face of the expansion means  53 , tissue can grow into the expansion means  53  from outside of the disc  15 , helping to secure the barrier means  12  in place and seal against egress of materials from within the disc  15 . 
     The expansion means  53  shown in  FIG. 33A  can be inserted into the sealing means  51  once the sealing means  51  is within the disc  15 . Alternatively, the expansion means  53  and sealing means  51  can be integral components of the barrier means  12  that can be inserted as a unit into the disc. 
     The patterns shown in  FIGS. 34 through 38  can preferably be formed from a relatively thin sheet of material. The material may be a polymer, metal, or gel, however, the superelastic properties of nickel titanium alloy (NITINOL) makes this metal particularly advantageous in this application. Sheet thickness can generally be in a range of 0.1 mm to 0.6 mm and for certain embodiments has been found to be optimal if between 0.003″ to 0.015″ (0.0762 mm to 0.381 mm), for the thickness to provide adequate expansion force to maintain contact between the sealing means  51  and surrounding vertebral endplates. The pattern may be Wire Electro-Discharge Machined, cut by laser, chemically etched, or formed by other suitable means. 
       FIG. 34A  shows an embodiment of a non-axisymmetric expander  153  having a superior edge  166  and an inferior edge  168 . The expander  153  can form a frame of barrier  12 . This embodiment comprises dissecting surfaces or ends  160 , radial elements or fingers  162  and a central strut  164 . The circular shape of the dissecting ends  160  aids in dissecting through the nucleus pulposus  20  and/or along or between an inner surface of the anulus fibrosis  10 . The distance between the left-most and right-most points on the dissecting ends is the expansion means length  170 . This length  170  preferably lies along the inner perimeter of the posterior anulus following implantation. The expander length  170  can be as short as about 3 mm and as long as the entire interior perimeter of the anulus fibrosis. The superior-inferior height of these dissecting ends  160  is preferably similar to or larger than the posterior disc height. 
     This embodiment employs a multitude of fingers  162  to aid in holding a flexible sealer or membrane against the superior and inferior vertebral endplates. The distance between the superior-most point of the superior finger and the inferior-most point on the inferior finger is the expansion means height  172 . This height  172  is preferably greater than the disc height at the inner surface of the posterior anulus. The greater height  172  of the expander  153  allows the fingers  162  to deflect along the superior and inferior vertebral endplates, enhancing the seal of the barrier means  12  against egress of material from within the disc  15 . 
     The spacing between the fingers  162  along the expander length  170  can be tailored to provide a desired stiffness of the expansion means  153 . Greater spacing between any two neighboring fingers  162  can further be employed to insure that the fingers  170  do not touch if the expansion means  153  is required to take a bend along its length. The central strut  164  can connect the fingers and dissecting ends and preferably lies along the inner surface of the anulus  10  when seated within the disc  15 . Various embodiments may employ struts  164  of greater or lesser heights and thicknesses to vary the stiffness of the overall expansion means  153  along its length  170  and height  172 . 
       FIG. 35  depicts an alternative embodiment to the expander  153  of  FIG. 34 . Openings or slots  174  can be included along the central strut  164 . These slots  174  promote bending of the expander  153  and fingers  162  along a central line  176  connecting the centers of the dissecting ends  160 . Such central flexibility has been found to aid against superior or inferior migration of the barrier means or barrier  12  when the barrier  12  has not been secured to surrounding tissues. 
       FIGS. 34B and 34C  depict different perspective views of a preferred embodiment of the expander/frame  153  within an intervertebral disc  15 . Expander  53  is in its expanded condition and lies along and/or within the posterior wall  21  and extends around the lateral walls  23  of the anulus fibrosis  10 . The superior  166  and inferior  168  facing fingers  162  of expander  153  extend along the vertebral endplates (not shown) and/or the cartilage overlying the endplates. The frame  153  can take on a 3-D concave shape in this preferred position with the concavity generally directed toward the interior of the intervertebral disc and specifically a region occupied by the nucleus pulposus  20 . 
     The bending stiffness of expander  153  can resist migration of the implant from this preferred position within the disc  15 . The principle behind this stiffness-based stability is to place the regions of expander  153  with the greatest flexibility in the regions of the disc  153  with the greatest mobility or curvature. These flexible regions of expander  153  are surrounded by significantly stiffer regions. Hence, in order for the implant to migrate, a relatively stiff region of the expander must move into a relatively curved or mobile region of the disc. 
     For example, in order for expander  153  of  FIG. 34B  to move around the inner circumference of anulus fibrosis  10  (i.e. from the posterior wall  21  onto the lateral  23  and/or anterior  27  wall), the stiff central region of expander  153  spanning the posterior wall  21  would have to bend around the acute curves of the posterior lateral corners of anulus  10 . The stiffer this section of expander  153  is, the higher the forces necessary to force it around these corners and the less likely it is to migrate in this direction. This principle was also used in this embodiment to resist migration of fingers  162  away from the vertebral endplates: The slots  174  cut along the length of expander  153  create a central flexibility that encourages expander  153  to bend along an axis running through these slots as the posterior disc height increases and decreased during flexion and extension. In order for the fingers  162  to migrate away from the endplate, this central flexible region must move away from the posterior anulus  21  and toward an endplate. This motion is resisted by the greater stiffness of expander  153  in the areas directly inferior and superior to this central flexible region. 
     The expander  153  is preferably covered by a membrane that acts to further restrict the movement of materials through the frame and toward the outer periphery of the anulus fibrosis. 
       FIG. 36  depicts an embodiment of the expander  153  of  FIG. 33A  with an enlarged central strut  164  and a plurality of slots  174 . This central strut  164  can have a uniform stiffness against superior-inferior  166  and  168  bending as shown in this embodiment. The strut  164  can alternatively have a varying stiffness along its height  178  to either promote or resist bending at a given location along the inner surface of the anulus  10 . 
       FIGS. 37A-C  depict a further embodiment of the frame or expander  153 . This embodiment employs a central lattice  180  consisting of multiple, fine interconnected struts  182 . Such a lattice  180  can provide a structure that minimizes bulging of the sealing means  51  under intradiscal pressures. The orientation and location of these struts  182  have been designed to give the barrier  12  a bend-axis along the central area of the expander height  172 . The struts  182  support inferior  168  and superior  166  fingers  162  similar to previously described embodiments. However, these fingers  162  can have varying dimensions and stiffness along the length of the barrier  12 . Such fingers  162  can be useful for helping the sealer  51  conform to uneven endplate geometries.  FIG. 37B  illustrates the curved cross section  184  of the expander  153  of  FIG. 37A . This curve  184  can be an arc segment of a circle as shown. Alternatively, the cross section can be an ellipsoid segment or have a multitude of arc segments of different radii and centers.  FIG. 37C  is a perspective view showing the three dimensional shape of the expander  153  of  FIGS. 37A and 37B . 
     The embodiment of the frame  153  as shown in  FIGS. 37A-C , can also be employed without the use of a covering membrane. The nucleus pulposus of many patients with low back pain or disc herniation can degenerate to a state in which the material properties of the nucleus cause it to behave much more like a solid than a gel. As humans age, the water content of the nucleus declines from roughly 88% to less than 75%. As this occurs, there is an increase in the cross linking of collagen within the disc resulting in a greater solidity of the nucleus. When the pore size or the largest open area of any given gap in the lattice depicted in  FIGS. 37A ,  37 B, and  37 C is between 0.05 mm 2  (7.75×10 −5  in 2 ) and 0.75 mm 2  (1.16×10 −3  in 2 ), the nucleus pulposus is unable to extrude through the lattice at pressures generated within the disc (between 250 KPa and 1.8 MPa). The preferred pore size has been found to be approximately 0.15 mm 2  (2.33×10 −4  in 2 ). This pore size can be used with any of the disclosed embodiments of the expander or any other expander that falls within the scope of the present invention to prevent movement of nucleus toward the outer periphery of the disc without the need for an additional membrane. The membrane thickness is preferably in a range of 0.025 mm to 2.5 mm. 
       FIG. 38  depicts an expander  153  similar to that of  FIG. 37A  without fingers. The expander  153  includes a central lattice  180  consisting of multiple struts  182 . 
       FIGS. 39 through 41  depict another embodiment of the expander  153  of the present invention. These tubular expanders can be used in the barrier  12  embodiment depicted in  FIG. 31A . The sealer  51  can cover the expander  153  as shown in  FIG. 31A . Alternatively, the sealer  51  can cover the interior surface of the expander or an arc segment of the tube along its length on either the interior or exterior surface. 
       FIG. 39  depicts an embodiment of a tubular expander  154 . The superior  166  and inferior surfaces  168  of the tubular expander  154  can deploy against the superior and inferior vertebral endplates, respectively. The distance  186  between the superior  166  and inferior  168  surfaces of the expander  154  are preferably equal to or greater than the posterior disc height at the inner surface of the anulus  10 . This embodiment has an anulus face  188  and nucleus face  190  as shown in  FIGS. 39B ,  39 C and  39 D. The anulus face  188  can be covered by the sealer  51  from the superior  166  to inferior  168  surface of the expander  154 . This face  188  lies against the inner surface of the anulus  10  in its deployed position and can prevent egress of materials from within the disc  15 . The primary purpose of the nucleus face  190  is to prevent migration of the expander  154  within the disc  15 . The struts  192  that form the nucleus face  190  can project anteriorly into the nucleus  20  when the barrier  12  is positioned across the posterior wall of the anulus  10 . This anterior projection can resist rotation of the tubular expansion means  154  about its long axis. By interacting with the nucleus  20 , the struts  192  can further prevent migration around the circumference of the disc  15 . 
     The struts  192  can be spaced to provide nuclear gaps  194 . These gaps  194  can encourage the flow of nucleus pulposus  20  into the interior of the expander  154 . This flow can insure full expansion of the barrier  12  within the disc  15  during deployment. 
     The embodiments of  FIGS. 39 ,  40  and  41  vary by their cross-sectional shape.  FIG. 39  has a circular cross section  196  as seen in  FIG. 39C . If the superior-inferior height  186  of the expander  154  is greater than that of the disc  15 , this circular cross section  196  can deform into an oval when deployed, as the endplates of the vertebrae compress the expander  154 . The embodiment of the expander  154  shown in  FIG. 40  is preformed into an oval shape  198  shown in  FIG. 40C . Compression by the endplates can exaggerate the unstrained oval  198 . This oval  198  can provide greater stability against rotation about a long axis of the expander  154 . The embodiment of  FIGS. 41B ,  41 C and  41 D depict an ‘egg-shaped’ cross section  202 , as shown in  FIG. 41C , that can allow congruity between the curvature of the expander  154  and the inner wall of posterior anulus  10 . Any of a variety of alternate cross sectional shapes can be employed to obtain a desired fit or expansion force without deviating from the spirit of the present invention. 
       FIGS. 40E ,  40 F, and  40 I depict the expander  154  of  FIGS. 40A-D  having a sealing means  51  covering the exterior surface of the anulus face  188 . This sealing means  51  can be held against the endplates and the inner surface of the posterior anulus by the expander  154  in its deployed state. 
       FIGS. 40G and 40H  depict the expander  154  of  FIG. 40B  with a sealer  51  covering the interior surface of the anulus face  188 . This position of the sealer  51  can allow the expander  154  to contact both the vertebral endplates and inner surface of the posterior anulus. This can promote ingrowth of tissue into the expander  154  from outside the disc  15 . Combinations of sealer  51  that cover all or part of the expander  154  can also be employed without deviating from the scope of the present invention. The expander  154  can also have a small pore size thereby allowing retention of a material such as a nucleus pulposus, for example, without the need for a sealer as a covering. 
       FIGS. 42A-D  depict cross sections of a preferred embodiment of sealing means  51  and enlarging means  53 . Sealing means  51  has internal cavity  17  and opening  8  leading from its outer surface into internal cavity  17 . Enlarger  53  can be inserted through opening  8  and into internal cavity  17 . 
       FIGS. 43A and 43B  depict an alternative configuration of enlarger  53 . Fixation region  4  extends through opening  8  in sealing means  51 . Fixation region  4  has a through-hole that can facilitate fixation of enlarger  53  to tissues surrounding defect  16 . 
       FIGS. 44A and 44B  depict an alternative shape of the barrier. In this embodiment, sealing means  51 , enlarger  53 , or both have a curvature with radius R. This curvature can be used in any embodiment of the present invention and may aid in conforming to the curved inner circumference of anulus fibrosis  10 . 
       FIG. 45  is a section of a device used to affix sealing means  51  to tissues surrounding a defect. In this figure, sealing means  51  would be positioned across interior aspect  50  of defect  16 . The distal end of device  110 ′ would be inserted through defect  16  and opening  8  into the interior cavity  17 . On the right side of this figure, fixation dart  25  has been passed from device  110 ′, through a wall of sealing means  51  and into tissues surrounding sealing means  51 . On the right side of the figure, fixation dart  25  is about to be passed through a wall of sealing means  51  by advancing pusher  111  relative to device  110 ′ in the direction of the arrow. 
       FIG. 46  depicts the use of thermal device  200  to heat sealing means  51  and adhere it to tissues surrounding a defect. In this figure, sealing means  51  would be positioned across the interior aspect  36  of a defect  16 . The distal end of thermal device  200  would be inserted through the defect and opening  8  into interior cavity  17 . In this embodiment, thermal device  200  employs at its distal end resistive heating element  210  connected to a voltage source by wires  220 . Covering  230  is a non-stick surface such as Teflon tubing that ensures the ability to remove device  200  from interior cavity  17 . In this embodiment, device  200  would be used to heat first one half, and then the other half of sealing means  51 . 
       FIG. 47  depicts an expandable thermal element, such as a balloon, that can be used to adhere sealing means  51  to tissues surrounding a defect. As in  FIG. 18 , the distal end of device  130  can be inserted through the defect and opening  8  into interior cavity  17 , with balloon  150 ′ on the distal end device  130  in a collapsed state. Balloon  150 ′ is then inflated to expanded state  150 , expanding sealing means  51 . Expanded balloon  150  can heat sealing means  51  and surrounding tissues by inflating it with a heated fluid or by employing RF electrodes. In this embodiment, device  130  can be used to expand and heat first one half, then the other half of sealing means  51 . 
       FIG. 48  depicts an alternative embodiment to device  130 . This device employs an elongated, flexible balloon  150 ′ that can be inserted into and completely fill internal cavity  17  of sealing means  51  prior to inflation to an expanded state  150 . Using this embodiment, inflation and heating of sealing means  51  can be performed in one step. 
       FIGS. 49A through 49G  illustrate a method of implanting an intradiscal implant. An intradiscal implant system consists of an intradiscal implant  400 , a delivery device or cannula  402 , an advancer  404  and at least one control filament  406 . The intradiscal implant  400  is loaded into the delivery cannula  402  which has a proximal end  408  and a distal end  410 .  FIG. 49A  illustrates the distal end  410  advanced into the disc  15  through an annulotomy  416 . This annulotomy  416  can be through any portion of the anulus  10 , but is preferably at a site proximate to a desired, final implant location. The implant  400  is then pushed into the disc  15  through the distal end  410  of the cannula  402  in a direction that is generally away from the desired, final implant location as shown in  FIG. 49B . Once the implant  400  is completely outside of the delivery cannula  402  and within the disc  15 , the implant  400  can be pulled into the desired implant location by pulling on the control filament  406  as shown in  FIG. 49C . The control filament  406  can be secured to the implant  400  at any location on or within the implant  400 , but is preferably secured at least at a site  414  or sites on a distal portion  412  of the implant  400 , i.e. that portion that first exits the delivery cannula  402  when advanced into the disc  15 . These site or sites  414  are generally furthest from the desired, final implant location once the implant has been fully expelled from the interior of the delivery cannula  402 . 
     Pulling on the control filament  406  causes the implant  400  to move toward the annulotomy  416 . The distal end  410  of the delivery cannula  402  can be used to direct the proximal end  420  of the implant  400  (that portion of the implant  400  that is last to be expelled from the delivery cannula  402 ) away from the annulotomy  416  and toward an inner aspect of the anulus  10  nearest the desired implant location. Alternately, the advancer  404  can be used to position the proximal end of the implant toward an inner aspect of the anulus  20  near the implant location, as shown in  FIG. 49E . Further pulling on the control filament  406  causes the proximal end  426  of the implant  400  to dissect along the inner aspect of the anulus  20  until the attachment site  414  or sites of the guide filament  406  to the implant  400  has been pulled to the inner aspect of the annulotomy  416 , as shown in  FIG. 49D . In this way, the implant  400  will extend at least from the annulotomy  416  and along the inner aspect of the anulus  10  in the desired implant location, illustrated in  FIG. 49F . 
     The implant  400  can be any of the following: nucleus replacement device, nucleus augmentation device, anulus augmentation device, anulus replacement device, the barrier of the present invention or any of its components, drug carrier device, carrier device seeded with living cells, or a device that stimulates or supports fusion of the surrounding vertebra. The implant  400  can be a membrane which prevents the flow of a material from within the anulus fibrosis of an intervertebral disc through a defect in the disc. The material within the anulus fibrosis can be, for example, a nucleus pulposus or a prosthetic augmentation device, such as hydrogel. The membrane can be a sealer. The implant  400  can be wholly or partially rigid or wholly or partially flexible. It can have a solid portion or portions that contain a fluid material. It can comprise a single or multitude of materials. These materials can include metals, polymers, gels and can be in solid or woven form. The implant  400  can either resist or promote tissue ingrowth, whether fibrous or bony. 
     The cannula  402  can be any tubular device capable of advancing the implant  400  at least partially through the anulus  10 . It can be made of any suitable biocompatible material including various known metals and polymers. It can be wholly or partially rigid or flexible. It can be circular, oval, polygonal, or irregular in cross section. It must have an opening at least at its distal end  410 , but can have other openings in various locations along its length. 
     The advancer  404  can be rigid or flexible, and have one of a variety of cross sectional shapes either like or unlike the delivery cannula  402 . It may be a solid or even a column of incompressible fluid, so long as it is stiff enough to advance the implant  400  into the disc  15 . The advancer  404  can be contained entirely within the cannula  402  or can extend through a wall or end of the cannula to facilitate manipulation. 
     Advancement of the implant  400  can be assisted by various levers, gears, screws and other secondary assist devices to minimize the force required by the surgeon to advance the implant  400 . These secondary devices can further give the user greater control over the rate and extent of advancement into the disc  15 . 
     The guide filament  406  may be a string, rod, plate, or other elongate object that can be secured to and move with the implant  400  as it is advanced into the disc  15 . It can be constructed from any of a variety of metals or polymers or combination thereof and can be flexible or rigid along all or part of its length. It can be secured to a secondary object  418  or device at its end opposite that which is secured to the implant  400 . This secondary device  418  can include the advancer  404  or other object or device that assists the user in manipulating the filament. The filament  406  can be releasably secured to the implant  400 , as shown in  FIG. 49G  or permanently affixed. The filament  406  can be looped around or through the implant. Such a loop can either be cut or have one end pulled until the other end of the loop releases the implant  400 . It may be bonded to the implant  400  using adhesive, welding, or a secondary securing means such as a screw, staple, dart, etc. The filament  406  can further be an elongate extension of the implant material itself. If not removed following placement of the implant, the filament  406  can be used to secure the implant  400  to surrounding tissues such as the neighboring anulus  10 , vertebral endplates, or vertebral bodies either directly or through the use of a dart, screw, staple, or other suitable anchor. 
     Multiple guide filaments can be secured to the implant  400  at various locations. In one preferred embodiment, a first or distal  422  and a second or proximal  424  guide filament are secured to an elongate implant  400  at or near its distal  412  and proximal  420  ends at attachment sites  426  and  428 , respectively. These ends  412  and  420  correspond to the first and last portions of the implant  400 , respectively, to be expelled from the delivery cannula  402  when advanced into the disc  15 . This double guide filament system allows the implant  400  to be positioned in the same manner described above in the single filament technique, and illustrated in  FIGS. 50A-C . However, following completion of this first technique, the user may advance the proximal end  420  of the device  400  across the annulotomy  416  by pulling on the second guide filament  424 , shown in  FIG. 50D . This allows the user to controllably cover the annulotomy  416 . This has numerous advantages in various implantation procedures. This step may reduce the risk of herniation of either nucleus pulposus  20  or the implant itself. It may aid in sealing the disc, as well as preserving disc pressure and the natural function of the disc. It may encourage ingrowth of fibrous tissue from outside the disc into the implant. It may further allow the distal end of the implant to rest against anulus further from the defect created by the annulotomy. Finally, this technique allows both ends of an elongate implant to be secured to the disc or vertebral tissues. 
     Both the first  422  and second  424  guide filaments can be simultaneously tensioned, as shown in  FIG. 50E , to ensure proper positioning of the implant  400  within the anulus  10 . Once the implant  400  is placed across the annulotomy, the first  422  and second  424  guide filaments can be removed from the input  400 , as shown in  FIG. 50F . Additional control filaments and securing sites may further assist implantation and/or fixation of the intradiscal implants. 
     In another embodiment of the present invention, as illustrated in  FIGS. 51A-C , an implant guide  430  may be employed to aid directing the implant  400  through the annulotomy  416 , through the nucleus pulposus  10 , and/or along the inner aspect of the anulus  10 . This implant guide  430  can aid in the procedure by dissecting through tissue, adding stiffness to the implant construct, reducing trauma to the anulus or other tissues that can be caused by a stiff or abrasive implant, providing 3-D control of the implants orientation during implantation, expanding an expandable implant, or temporarily imparting a shape to the implant that is beneficial during implantation. The implant guide  430  can be affixed to either the advancer  404  or the implant  406  themselves. In a preferred embodiment shown in  FIGS. 52A and 52B , the implant guide  430  is secured to the implant  400  by the first  424  and second  426  guide filaments of the first  426  and the second  428  attachment sites, respectively. The guide filaments  424  and  426  may pass through or around the implant guide  430 . In this embodiment, the implant guide  430  may be a thin, flat sheet of biocompatible metal with holes passing through its surface proximate to the site or sites  426  and  428  at which the guide filaments  422  and  424  are secured to the implant  400 . These holes allow passage of the securing filament  422  and  424  through the implant guide  430 . Such an elongated sheet may run along the implant  400  and extend beyond its distal end  412 . The distal end of the implant guide  430  may be shaped to help dissect through the nucleus  10  and deflect off of the anulus  10  as the implant  400  is advanced into the disc  15 . When used with multiple guide filaments, such an implant guide  430  can be used to control rotational stability of the implant  400 . It may also be used to retract the implant  400  from the disc  15  should this become necessary. The implant guide  430  may also extend beyond the proximal tip  420  of the implant  400  to aid in dissecting across or through the anulus  10  proximate to the desired implantation site. 
     The implant guide  430  is releasable from the implant  400  following or during implantation. This release may be coordinated with the release of the guide filaments  422  and  424 . The implant guide  430  may further be able to slide along the guide filaments  422  and  424  while these filaments are secured to the implant  400 . 
     Various embodiments of the barrier  12  or implant  400  can be secured to tissues within the intervertebral disc  15  or surrounding vertebrae. It can be advantageous to secure the barrier means  12  in a limited number of sites while still insuring that larger surfaces of the barrier  12  or implant juxtapose the tissue to which the barrier  12  is secured. This is particularly advantageous in forming a sealing engagement with surrounding tissues. 
       FIGS. 53-57  illustrate barriers  12  having stiffening elements  300 . The barrier  12  can incorporate stiffening elements  300  that run along a length of the implant required to be in sealing engagement. These stiffening elements  300  can be one of a variety of shapes including, but not limited to, plates  302 , rods  304 , or coils. These elements are preferably stiffer than the surrounding barrier  12  and can impart their stiffness to the surrounding barrier. These stiffening elements  300  can be located within an interior cavity formed by the barrier. They can further be imbedded in or secured to the barrier  12 . 
     Each stiffening element can aid in securing segments of the barrier  12  to surrounding tissues. The stiffening elements can have parts  307 , including through-holes, notches, or other indentations for example, to facilitate fixation of the stiffening element  300  to surrounding tissues by any of a variety of fixation devices  306 . These fixation devices  306  can include screws, darts, dowels, or other suitable means capable of holding the barrier  12  to surrounding tissue. The fixation devices  306  can be connected either directly to the stiffening element  300  or indirectly using an intervening length of suture, cable, or other filament for example. The fixation device  306  can further be secured to the barrier  12  near the stiffening element  300  without direct contact with the stiffening element  300 . 
     The fixation device  306  can be secured to or near the stiffening element  300  at opposing ends of the length of the barrier  12  required to be in sealing engagement with surrounding tissues. Alternatively, one or a multitude of fixation devices  306  can be secured to or near the stiffening element  300  at a readily accessible location that may not be at these ends. In any barrier  12  embodiment with an interior cavity  17  and an opening  8  leading thereto, the fixation sites may be proximal to the opening  8  to allow passage of the fixation device  306  and various instruments that may be required for their implantation. 
       FIGS. 53A and 53B  illustrate one embodiment of a barrier  12  incorporating the use of a stiffening element  300 . The barrier  12  can be a plate and screw barrier  320 . In this embodiment, the stiffening element  300  consists of two fixation plates, superior  310  and inferior  312 , an example of which is illustrated in  FIGS. 54A and 54B  with two parts  308  passing through each plate. The parts  308  are located proximal to an opening  8  leading into an interior cavity  17  of the barrier  12 . These parts  8  allow passage of a fixation device  306  such as a bone screw. These screws can be used to secure the barrier means  12  to a superior  50  and inferior  50 ′ vertebra. As the screws are tightened against the vertebral endplate, the fixation plates  310 ,  312  compress the intervening sealing means against the endplate along the superior and inferior surfaces of the barrier  12 . This can aid in creating a sealing engagement with the vertebral endplates and prevent egress of materials from within the disc  15 . As illustrated in  FIGS. 53A and 53B , only the superior screws have been placed in the superior plate  310 , creating a sealing engagement with the superior vertebra. 
       FIGS. 55A and 55B  illustrate another embodiment of a barrier  12  having stiffening elements  300 . The barrier  12  can be an anchor and rod barrier  322 . In this embodiment, the stiffening elements  300  consist of two fixation rods  304 , an example of which is shown in  FIGS. 56A and 56B , imbedded within the barrier  12 . The rods  304  can include a superior rod  314  and an inferior rod  316 . Sutures  318  can be passed around these rods  314  and  316  and through the barrier means  10 . These sutures  318  can in turn, be secured to a bone anchor or other suitable fixation device  306  to draw the barrier  12  into sealing engagement with the superior and inferior vertebral endplates in a manner similar to that described above. The opening  8  and interior cavity  17  of the barrier  12  are not required elements of the barrier  12 . 
       FIG. 57  illustrates the anchor and rod barrier  322 , described above, with fixation devices  306  placed at opposing ends of each fixation rod  316  and  318 . The suture  18  on the left side of the superior rod  318  has yet to be tied. 
     Various methods may be employed to decrease the forces necessary to maneuver the barrier  12  into a position along or within the lamellae of the anulus fibrosis  10 .  FIGS. 58A ,  58 B,  59 A and  59 B depict two preferred methods of clearing a path for the barrier  12 . 
       FIGS. 58A and 58B  depict one such method and an associated dissector device  454 . In these figures, the assumed desired position of the implant is along the posterior anulus  452 . In order to clear a path for the implant, a hairpin dissector  454  can be passed along the intended implantation site of the implant. The hairpin dissector  454  can have a hairpin dissector component  460  having a free end  458 . The dissector can also have an advancer  464  to position the dissector component  460  within the disc  15 . The dissector  454  can be inserted through cannula  456  into an opening  462  in the anulus  10  along an access path directed anteriorly or anterior-medially. Once a free-end  458  of the dissector component  460  is within the disc  15 , the free-end  458  moves slightly causing the hairpin to open, such that the dissector component  460  resists returning into the cannula  456 . This opening  462  can be caused by pre-forming the dissector to the opened state. The hairpin dissector component  460  can then be pulled posteriorly, causing the dissector component  460  to open, further driving the free-end  458  along the posterior anulus  458 . This motion clears a path for the insertion of any of the implants disclosed in the present invention. The body of dissector component  460  is preferably formed from an elongated sheet of metal. Suitable metals include various spring steels or nickel titanium alloys. It can alternatively be formed from wires or rods. 
       FIGS. 59A and 59B  depict another method and associated dissector device  466  suitable for clearing a path for implant insertion. The dissector device  466  is shown in cross section and consists of a dissector component  468 , an outer cannula  470  and an advancer or inner push rod  472 . A curved passage or slot  474  is formed into an intradiscal tip  476  of outer cannula  470 . This passage or slot  474  acts to deflect the tip of dissector component  468  in a path that is roughly parallel to the lamellae of the anulus fibrosis  10  as the dissector component  468  is advanced into the disc  15  by the advancer. The dissector component  468  is preferably formed from a superelastic nickel titanium alloy, but can be constructed of any material with suitable rigidity and strain characteristics to allow such deflection without significant plastic deformation. The dissector component  468  can be formed from an elongated sheet, rods, wires or the like. It can be used to dissect between the anulus  10  and nucleus  20 , or to dissect between layers of the anulus  10 . 
       FIGS. 60A-C  depict an alternate dissector component  480  of  FIGS. 59A and 59B . Only the intradiscal tip  476  of device  460  and regions proximal thereto are shown in these figures. A push-rod  472  similar to that shown in  FIG. 59A  can be employed to advance dissector  480  into the disc  15 . Dissector  480  can include an elongated sheet  482  with superiorly and inferiorly extending blades (or “wings”)  484  and  486 , respectively. This sheet  482  is preferably formed from a metal with a large elastic strain range such as spring steel or nickel titanium alloy. The sheet  482  can have a proximal end  488  and a distal end  490 . The distal end  490  can have a flat portion which can be flexible. A step portion  494  can be located between the distal end  490  and the proximal end  488 . The proximal end  488  can have a curved shape. The proximal end can also include blades  484  and  486 . 
     In the undeployed state depicted in  FIGS. 60A and 60B , wings  484  and  486  are collapsed within outer cannula  470  while elongated sheet  482  is captured within deflecting passage or slot  474 . As the dissector component  480  is advanced into a disc  15 , passage or slot  478  directs the dissector component  480  in a direction roughly parallel to the posterior anulus (90 degrees to the central axis of sleeve  470  in this case) in a manner similar to that described for the embodiment in  FIGS. 59A and 59B . Wings  484  and  486  open as they exit the end of sleeve  470  and expand toward the vertebral endplates. Further advancement of dissector component  480  allows the expanded wings  484  and  486  to dissect through any connections of nucleus  20  or anulus  10  to the endplates that may present an obstruction to subsequent passage of the implants of the present invention. When used to aid in the insertion of a barrier, the dimensions of dissector component  480  should approximate those of the barrier such that the minimal amount of tissue is disturbed while reducing the forces necessary to position the barrier in the desired location. 
       FIGS. 61A-61D  illustrate a method of implanting a disc implant. A disc implant  552  is inserted into a delivery device  550 . The delivery device  550  has a proximal end  556  and a distal end  558 . The distal end  558  of the delivery device  550  is inserted into an annulotomy illustrated in  FIG. 61A . The annulotomy is preferably located at a site within the anulus  10  that is proximate to a desired, final implant  552  location. The implant  400  is then deployed by being inserted into the disc  15  through the distal end  558  of the delivery device  550 . Preferably the implant is forced away from the final implant location, as shown in  FIG. 61B . An implant guide  560  can be used to position the implant  400 . Before, during or after deployment of the implant  400 , an augmentation material  7  can be injected into the disc  15 . Injection of augmentation after deployment is illustrated in  FIG. 61C . The augmentation material  7  can include a hydrogel or collagen, for example. In one embodiment, the delivery device  550  is removed from the disc  15  and a separate tube is inserted into the annulotomy to inject the flowable augmentation material  7 . Alternately, the distal end  558  of the delivery device  550  can remain within the annulotomy and the fluid augmentation material  554  injected through the delivery device  550 . Next, the delivery device  550  is removed from the annulotomy and the intradiscal implant  400  is positioned over the annulotomy in the final implant location, as shown in  FIG. 61D . The implant  400  can be positioned using control filaments described above. 
     Certain embodiments, as shown in  FIGS. 62-66 , depict anulus and nuclear augmentation devices which are capable of working in concert to restore the natural biomechanics of the disc. A disc environment with a degenerated or lesioned anulus cannot generally support the load transmission from either the native nucleus or from prosthetic augmentation. In many cases, nuclear augmentation materials  7  bulge through the anulus defects, extrude from the disc, or apply pathologically high load to damaged regions of the anulus. Accordingly, in one aspect of the current invention, damaged areas of the anulus are protected by shunting the load from the nucleus  20  or augmentation materials  7  to healthier portions of the anulus  10  or endplates. With the barrier-type anulus augmentation  12  in place, as embodied in various aspects of the present invention, nuclear augmentation materials  7  or devices can conform to healthy regions of the anulus  10  while the barrier  12  shields weaker regions of the anulus  10 . Indeed, the anulus augmentation devices  12  of several embodiments of the present invention are particularly advantageous because they enable the use of certain nuclear augmentation materials and devices  7  that may otherwise be undesirable in a disc with an injured anulus. 
       FIG. 62  is a cross-sectional transverse view of an anulus barrier device  12  implanted within a disc  15  along the inner surface of a lamella  16 . Implanted conformable nuclear augmentation  7  is also shown in contact with the barrier  12 . The barrier device  12  is juxtapositioned to the innermost lamella of the anulus. Conformable nuclear augmentation material  7  is inserted into the cavity which is closed by the barrier  12 , in an amount sufficient to fill the disc space in an unloaded supine position. As shown, in one embodiment, fluid nuclear augmentation  554 , such as hyaluronic acid, is used. 
     Fluid nuclear augmentation  554  is particularly well-suited for use in various aspects of the current invention because it can be delivered with minimal invasiveness and because it is able to flow into and fill minute voids of the intervertebral disc space. Fluid nuclear augmentation  554  is also uniquely suited for maintaining a pressurized environment that evenly transfers the force exerted by the endplates to the anulus augmentation device and/or the anulus. However, fluid nuclear augmentation materials  554  used alone may perform poorly in discs  15  with a degenerated anulus because the material can flow back out through anulus defects  8  and pose a risk to surrounding structures. This limitation is overcome by several embodiments of the current invention because the barrier  12  shunts the pressure caused by the fluid augmentation  554  away from the damaged anulus region  8  and toward healthier regions, thus restoring function to the disc  15  and reducing risk of the extrusion of nuclear augmentation materials  7  and fluid augmentation material  554 . 
     Exemplary fluid nuclear augmentation materials  554  include, but are not limited to, various pharmaceuticals (steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics); growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils); and saline. One skilled in the art will understand that any one of these materials may be used alone or that a combination of two or more of these materials may be used together to form the nuclear augmentation material. 
     Any of a variety of additional additives such as thickening agents, carriers, polymerization initiators or inhibitors may also be included, depending upon the desired infusion and long-term performance characteristics. In general, “fluid” is used herein to include any material which is sufficiently flowable at least during the infusion process, to be infused through an infusion lumen in the delivery device into the disc space. The augmentation material  554  may remain “fluid” after the infusion step, or may polymerize, cure, or otherwise harden to a less flowable or nonflowable state. 
     Additional additives and components of the nucleus augmentation material are recited below. In general, the nature of the material  554  may remain constant during the deployment and post-deployment stages or may change, from a first infusion state to a second, subsequent implanted state. For example, any of a variety of materials may desirably be infused using a carrier such as a solvent or fluid medium with a dispersion therein. The solvent or liquid carrier may be absorbed by the body or otherwise dissipate from the disc space post-implantation, leaving the nucleus augmentation material  554  behind. For example, any of a variety of the powders identified below may be carried using a fluid carrier. In addition, hydrogels or other materials may be implanted or deployed while in solution, with the solvent dissipating post-deployment to leave the hydrogel or other media behind. In this type of application, the disc space may be filled under higher than ultimately desired pressure, taking into account the absorption of a carrier volume. Additional specific materials and considerations are disclosed in greater detail below. 
       FIG. 63  is a cross-sectional transverse view of anulus barrier device  12  implanted within a disc  15  along an inner surface of a lamella  16 . Implanted nuclear augmentation  7  comprised of a hydrophilic flexible solid is also shown. Nuclear augmentation materials include, but are not limited to, liquids, gels, solids, gases or combinations thereof. Nuclear augmentation devices  7  may be formed from one or more materials, which are present in one or more phases.  FIG. 63  shows a cylindrical flexible solid form of nuclear augmentation  7 . Preferably, this flexible solid is composed of a hydrogel, including, but not limited to, acrylonitrile, acrylic acid, polyacrylimide, acrylimide, acrylimidine, polyacrylonitrile, polyvinylalcohol, and the like. 
       FIG. 63  depicts nuclear augmentation  7  using a solid or gel composition. If required, these materials can be designed to be secured to surrounding tissues by mechanical means, such as glues, screws, and anchors, or by biological means, such as glues and in growth. Solid but deformable augmentation materials  7  may also be designed to resist axial compression by the endplates rather than flowing circumferentially outward toward the anulus. In this way, less force is directed at the anulus  10 . Solid nuclear augmentation  7  can also be sized substantially larger than the annulotomy  416  or defect  8  to decrease the risk of extrusion. The use of solid materials or devices  7  alone is subject to certain limitations. The delivery of solid materials  7  may require a large access hole  417  in the anulus  10 , thereby decreasing the integrity of the disc  15  and creating a significant risk for extrusion of either the augmentation material  7  or of natural nucleus  20  remaining within the disc  15 . Solid materials or devices  7  can also overload the endplates causing endplate subsidence or apply point loads to the anulus  10  from corners or edges that may cause pain or further deterioration of the anulus  10 . Several embodiments of the present invention overcome the limitations of solid materials and are particularly well-suited for use with liquid augmentation materials  7 . The barrier device  12  of various embodiments of this invention effectively closes the access hole  417  and can be adapted to partially encapsulate the augmented nucleus, thus mitigating the risks posed by solid materials. 
     Solid or gel nuclear augmentation materials  7  used in various embodiments of the current invention include single piece or multiple pieces. The solid materials  7  may be cube-like, spheroid, disc-like, ellipsoid, rhombohedral, cylindrical, or amorphous in shape. These materials  7  may be in woven or non-woven form. Other forms of solids including minute particles or even powder can be considered when used in combination with the barrier device. Candidate materials  7  include, but are not limited to: metals, such as titanium, stainless steels, nitinol, cobalt chrome; resorbable or non-resorbing synthetic polymers, such as polyurethane, polyester, PEEK, PET, FEP, PTFE, ePTFE, Teflon, PMMA, nylon, carbon fiber, Delrin, polyvinyl alcohol gels, polyglycolic acid, polyethylene glycol; silicon gel or rubber, vulcanized rubber or other elastomer; gas filled vesicles, biologic materials such as morselized or block bone, hydroxy apetite, cross-linked collagen, muscle tissue, fat, cellulose, keratin, cartilage, protein polymers, transplanted or bioengineered nucleus pulposus or anulus fibrosus; or various pharmacologically active agents in solid form. The solid or gel augmentation materials  7  may be rigid, wholly or partially flexible, elastic or viscoelastic in nature. The augmentation device or material  7  may be hydrophilic or hydrophobic. Hydrophilic materials, mimicking the physiology of the nucleus, may be delivered into the disc in a hydrated or dehydrated state. Biologic materials may be autologous, allograft, zenograft, or bioengineered. 
     In various embodiments of the present invention, the solid or gel nuclear augmentation material  7 , as depicted in  FIG. 63 , are impregnated or coated with various compounds. Preferably, a biologically active compound is used. In one embodiment, one or more drug carriers are used to impregnate or coat the nuclear augmentation material  7 . Genetic vectors, naked genes or other therapeutic agents to renew growth, reduce pain, aid healing, and reduce infection may be delivered in this manner. Tissue in-growth, either fibrous (from the anulus) or bony (from the endplates), within or around the augmentation material can be either encouraged or discouraged depending on the augmentation used. Tissue in-growth may be beneficial for fixation and can be encouraged via porosity or surface chemistry. Surface in-growth or other methods of fixation of the augmentation material  7  can be encouraged on a single surface or aspect so as to not interfere with the normal range of motion of the spinal unit. In this way, the material is stabilized and safely contained within the anulus  10  without resulting in complete fixation which might cause fusion and prohibit disc function. 
       FIG. 64  is a cross-sectional transverse view of anulus barrier device  12  implanted within a disc  15  along an inner surface of a lamella  16 . Several types of implanted nuclear augmentation  7 , including a solid cube, a composite cylindrical solid  555 , and a free flowing liquid  554  are shown. The use of multiple types of nuclear augmentation with the barrier  12  is depicted in  FIG. 64 . The barrier device  12  is shown in combination with fluid nuclear augmentation  554 , solid nuclear augmentation  7 , in the form of a cube, and a cross-linked collagen sponge composite  555  soaked in a growth factor. In several embodiments of the present invention, a multiphase augmentation system, as shown in  FIG. 64 , is used. A combination of solids and liquids is used in a preferred embodiment. Nuclear augmentation  7  comprising solids and liquids  554  can be designed to create primary and secondary levels of flexibility within an intervertebral disc space. In use, the spine will flex easily at first as the intervertebral disc pressure increases and the liquids flows radially, loading the anulus. Then, as the disc height decreases and the endplates begin to contact the solid or gelatinous augmentation material, flexibility will decrease. This combination can also prevent damage to the anulus  10  under excessive loading as the solid augmentation  7  can be designed to resist further compression such that the fluid pressure on the anulus is limited. In a preferred embodiment, use of multiphase augmentation allows for the combination of fluid medications or biologically active substances with solid or gelatinous carriers. One example of such a preferable combination is a cross-linked collagen sponge  555  soaked in a growth factor or combination of growth factors in liquid suspension. 
     In one aspect of the invention, the nuclear augmentation material or device  7 ,  554  constructed therefrom is phase changing, i.e. from liquid to solid, solid to liquid, or liquid to gel. In situ polymerizing nuclear augmentation materials are well-known in the art and are described in U.S. Pat. No. 6,187,048, herein incorporated by reference. Phase changing augmentation preferably changes from a liquid to a solid or gel. Such materials may change phases in response to contact with air, increases or decreases in temperature, contact with biologic liquids or by the mixture of separate reactive constituents. These materials are advantageous because they can be delivered through a small hole in the anulus or down a tube or cannula placed percutaneously into the disc. Once the materials have solidified or gelled, they can exhibit the previously described advantages of a solid augmentation material. In a preferred embodiment, the barrier device is used to seal and pressurize a phase changing material to aid in its delivery by forcing it into the voids of the disc space while minimizing the risk of extrusion of the material while it is a fluid. In this situation, the barrier or anulus augmentation device  12  may be permanently implanted or used only temporarily until the desired phase change has occurred. 
     Another aspect of the present invention includes an anulus augmentation device  12  that exploits the characteristics of nucleus augmentation devices or materials to improve its own performance. Augmenting the nucleus  20  pressurizes the intervertebral disc environment which can serve to fix or stabilize an anulus repair device in place. The nucleus  20  can be pressurized by inserting into the disc  15  an adequate amount of augmentation material  7 ,  554 . In use, the pressurized disc tissue and augmentation material  7 ,  554  applies force on the inwardly facing surface of the anulus augmentation device  12 . This pressure may be exploited by the design of the anulus prosthesis or barrier  12  to prevent it from dislodging or moving from its intended position. One exemplary method is to design the inwardly facing surface of the anulus prosthesis  12  to expand upon the application of pressure. As the anulus prosthesis  12  expands, it becomes less likely to be expelled from the disc. The prosthesis  12  may be formed with a concavity facing inward to promote such expansion. 
     In several embodiments, the anulus augmentation device  12  itself functions as nuclear augmentation  7 . In a preferred embodiment, the barrier  12  frame is encapsulated in ePTFE. This construct typically displaces a volume of 0.6 cubic centimeters, although thicker coatings of ePTFE or like materials may be used to increase this volume to 3 cubic centimeters. Also, the anulus augmentation device may be designed with differentially thickened regions along its area. 
       FIG. 65  depicts a sagittal cross-sectional view of the barrier device connected to an inflatable nuclear augmentation device  455 . The barrier device  12  is shown connected via hollow delivery and support tube  425  to an nuclear augmentation sack  455  suitable for containing fluid material  554 . The tube  425  has a delivery port or valve  450  that extends through the barrier device and can be accessed from the access hole  417  after the barrier device  12  and augmentation sack  455  has been delivered. This nuclear and anulus augmentation combination is particularly advantageous because of the ease of deliverability, since the sack  455  and the barrier  12  are readily compressed. The connection of the barrier  12  and the augmentation sack  455  also serves to stabilize the combination and prevent its extrusion from the disc  15 . The nuclear augmentation  7  may be secured to the anulus augmentation prosthesis  12  to create a resistance to migration of the overall construct. Such attachment may also be performed to improve or direct the transfer of load from the nuclear prosthesis  7  through the anulus prosthesis  12  to the disc tissues. The barrier  12  and augmentation  7  can be attached prior to, during, or after delivery of the barrier  12  into the disc  15 . They may be secured to each other by an adhesive or by a flexible filament such as suture. Alternatively, the barrier  12  may have a surface facing the augmentation material  7  that bonds to the augmentation material  7  though a chemical reaction. This surface may additionally allow for a mechanical linkage to a surface of the augmentation material  7 . This linkage could be achieved through a porous attachment surface of the barrier  12  that allows the inflow of a fluid augmentation material  7  that hardens or gels after implantation. 
     Alternatively, the anulus augmentation device  12  and nuclear augmentation material  7  may be fabricated as a single device with a barrier  12  region and a nuclear augmentation region  7 . As an example, the barrier  12  may form at least a portion of the surface of an augmentation sack  455  or balloon. The sack  455  may be filled with suitable augmentation materials  7  once the barrier has been positioned along a weakened inner surface of the anulus  10 . 
     The sequence of inserting the barrier  12  and nuclear augmentation  7  in the disc can be varied according to the nuclear augmentation  7  used or requirements of the surgical procedure. For example, the nuclear augmentation  7  can be inserted first and then sealed in place by the barrier device  12 . Alternatively, the disc  15  can be partially filled, then sealed with the barrier device  12 , and then supplied with additional material  7 . In a preferred embodiment, the barrier device  12  is inserted into the disc  15  followed by the addition of nuclear augmentation material  7  through or around the barrier  12 . This allows for active pressurization. A disc  15  with a severely degenerated anulus can also be effectively treated in this manner. 
     In an alternative embodiment, the nuclear augmentation material  7  is delivered through a cannula inserted through an access hole  417  in the disc  15  formed pathologically, e.g. an anular defect  8 , or iatrogenically, e.g. an anuulotomy  416  that is distinct from the access hole  417  that was used to implant the barrier  12 . Also, the same or different surgical approach including transpsoas, presacral, transsacral, tranpedicular, translaminar, or anteriorly through the abdomen, may be used. Access hole  417  can be located anywhere along the anulus surface or even through the vertebral endplates. 
     In alternative embodiments, the anulus augmentation device  12  includes features that facilitate the introduction of augmentation materials  554  following placement. The augmentation delivery cannula may simply be forcibly driven into an access hole  417  proximal to the barrier  12  at a slight angle so that the edge of the barrier  12  deforms and allows passage into the disc space. Alternatively, a small, flexible or rigid curved delivery needle or tube may be inserted through an access hole  417  over (in the direction of the superior endplate) or under (in the direction of the inferior endplate) the barrier  12  or around an edge of the barrier  12  contiguous with the anulus  15 . 
     In several embodiments, ports or valves are installed in the barrier  12  device that permit the flow of augmentation material into, but not out of, the disc space. One-way valves  450  or even flaps of material held shut by the intervertebral pressure may be used. A collapsible tubular valve may be fashioned along a length of the barrier. In one embodiment, multiple valves or ports  450  are present along the device  12  to facilitate alignment with the access hole  417  and delivery of augmentation material. Flow channels within or on the barrier  12  to direct the delivery of the material  554  (e.g. to the ends of the barrier) can be machined, formed into or attached to the barrier  12  along its length. Alternatively, small delivery apertures (e.g. caused by a needle) can be sealed with a small amount of adhesive or sutured shut. 
       FIG. 66  is sagittal cross-sectional view of a functional spine unit containing the barrier device unit  12  connected to a wedge-shaped nuclear augmentation  7  device.  FIG. 66  illustrates that the geometry of the nuclear augmentation  7  can be adapted to improve the function of the barrier. By presenting nuclear augmentation  7  with a wedge-shaped or hemicircular profile towards the interior of the intervertebral disc space, and attaching it in the middle of the barrier device  12  between the flexible finger-like edges of the barrier device, the force exerted by the pressurized environment is focused in the direction of the edges of the barrier device sealing them against the endplates. Accordingly, this wedge-shaped feature improves the function of the device  12 . One skilled in the art will understand that the nuclear augmentation material  7  may also be designed with various features that improve its interaction with the barrier, such as exhibiting different flexibility or viscosity throughout its volume. For example, in certain applications, it may be preferable for the augmentation  7  to be either stiff at the interface with the barrier  12  and supple towards the center of the disc, or vice versa. The augmentation  7  can also serve to rotationally stabilize the barrier  12 . In this embodiment, the augmentation is coupled to the inward facing surface of the barrier and extends outward and medially into the disc forming a lever arm and appearing as “T-shaped” unit. The augmentation device  7  of this embodiment can extend from the middle of the disc  15  to the opposite wall of the anulus. 
     One skilled in the art will appreciate that any of the above procedures involving nuclear augmentation and/or anulus augmentation may be performed with or without the removal of any or all of the autologous nucleus. Further, the nuclear augmentation materials and/or the anulus augmentation device may be designed to be safely and efficiently removed from the intervertebral disc in the event they no longer be required. 
     While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.

Technology Category: 1