Patent Document

RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Application Ser. No. 60/808,795, filed May 26, 2006, entitled “Fastening Assemblies for Disc Herniation Repair and Methods of Use.” This application is also related to U.S. Patent Application No. 60/748,518, filed Dec. 8, 2005, entitled “Cemented Sutures” and 60/738,833, filed Nov. 21, 2005, entitled “Sub-PLL Annular Repair Methods and Devices.” All of the above-mentioned applications are hereby expressly incorporated by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The subject invention resides in methods and apparatus for reconstructing the anulus fibrosus (AF) of a spinal disc and the ligaments of the spine. The invention is particularly well suited to the prevention of extrusion of material or devices placed into the disc space and to the prevention of excessive spinal motion. 
       BACKGROUND 
       [0003]    The human intervertebral disc is an oval to kidney bean-shaped structure of variable size depending on the location in the spine. The outer portion of the disc is known as the anulus fibrosus (AF). The anulus fibrosus is formed of approximately 10 to 60 fibrous bands or layers. The fibers in the bands alternate their direction of orientation by about 30 degrees between each band. The orientation serves to control vertebral motion (one half of the bands tighten to check motion when the vertebra above or below the disc are turned in either direction). 
         [0004]    The anulus fibrosus contains the nucleus pulposus (NP). The nucleus pulposus serves to transmit and dampen axial loads. A high water content (approximately 70-80%) assists the nucleus in this function. The water content has a diurnal variation. The nucleus imbibes water while a person lies recumbent. Nuclear material removed from the body and placed into water will imbibe water swelling to several times its normal size. Activity squeezes fluid from the disc. The nucleus comprises roughly 50% of the entire disc. The nucleus contains cells (chondrocytes and fibrocytes) and proteoglycans (chondroitin sulfate and keratin sulfate). The cell density in the nucleus is on the order of 4,000 cells per microliter. 
         [0005]    The intervertebral disc changes or “degenerates” with age. As a person ages, the water content of the disc falls from approximately 85% at birth to approximately 70% in the elderly. The ratio of chondroitin sulfate to keratin sulfate decreases with age, while the ratio of chondroitin  6  sulfate to chondroitin  4  sulfate increases with age. The distinction between the anulus and the nucleus decreases with age. Generally disc degeneration is painless. 
         [0006]    Premature or accelerated disc degeneration is known as degenerative disc disease. A large portion of patients suffering from chronic low back pain are thought to have this condition. As the disc degenerates, the nucleus and annulus functions are compromised. The nucleus becomes thinner and less able to handle compression loads. The anulus fibers become redundant as the nucleus shrinks. The redundant annular fibers are less effective in controlling vertebral motion. This disc pathology can result in: 1) bulging of the anulus into the spinal cord or nerves; 2) narrowing of the space between the vertebra where the nerves exit; 3) tears of the anulus as abnormal loads are transmitted to the anulus and the anulus is subjected to excessive motion between vertebra; and 4) disc herniation or extrusion of the nucleus through complete anular tears. 
         [0007]    Current surgical treatments for disc degeneration are destructive. One group of procedures, which includes lumbar discectomy, removes the nucleus or a portion of the nucleus. A second group of procedures destroy nuclear material. This group includes Chymopapin (an enzyme) injection, laser discectomy, and thermal therapy (heat treatment to denature proteins). The first two groups of procedures compromise the treated disc. A third group, which includes spinal fusion procedures, either remove the disc or the disc&#39;s function by connecting two or more vertebra together with bone. Fusion procedures transmit additional stress to the adjacent discs, which results in premature disc degeneration of the adjacent discs. These destructive procedures lead to acceleration of disc degeneration. 
         [0008]    Prosthetic disc replacement offers many advantages. The prosthetic disc attempts to eliminate a patient&#39;s pain while preserving the disc&#39;s function. Current prosthetic disc implants either replace the nucleus or replace both the nucleus and the annulus. Both types of current procedures remove the degenerated disc component to allow room for the prosthetic component. Although the use of resilient materials has been proposed, the need remains for further improvements in the way in which prosthetic components are incorporated into the disc space to ensure strength and longevity. Such improvements are necessary, since the prosthesis may be subjected to 100,000,000 compression cycles over the life of the implant. 
         [0009]    Current nucleus replacements (NRs) may cause lower back pain if too much pressure is applied to the anulus fibrosus. As discussed in co-pending U.S. patent application Ser. No. 10/407,554 and U.S. Pat. No. 6,878,167, the content of each being expressly incorporated herein by reference in their entirety, the posterior portion of the anulus fibrosus has abundant pain fibers. 
         [0010]    Herniated nucleus pulposus (HNP) occurs from tears in the anulus fibrosus. The herniated nucleus pulposus often applies pressure on the nerves or spinal cord. Compressed nerves cause back and leg or arm pain. Although a patient&#39;s symptoms result primarily from pressure by the nucleus pulposus, the primary pathology lies in the anulus fibrosus. 
         [0011]    Surgery for herniated nucleus pulposus, known as microlumbar discectomy (MLD), only addresses the nucleus pulposus. The opening in the anulus fibrosus is enlarged during surgery, further weakening the anulus fibrosus. Surgeons also remove generous amounts of the nucleus pulposus to reduce the risk of extruding additional pieces of nucleus pulposus through the defect in the anulus fibrosus. Although microlumbar discectomy decreases or eliminates a patient&#39;s leg or arm pain, the procedure damages weakened discs. 
       SUMMARY 
       [0012]    In one aspect of the invention, devices for fixing a defect in the anulus fibrosus of a patient are provided. The devices include a mesh patch, a first suture assembly, and a second suture assembly. The first suture assembly includes a first anchor and a first suture. The first anchor has a first portion adapted to be inserted into a bone and a second portion having an opening therethrough. The first suture has a first end and a second end, wherein the first suture is disposed through the hole in the first anchor and wherein the first end is capable of being coupled to the mesh patch. Similarly, the second suture assembly has a second anchor and a second suture. The second anchor has a first portion adapted to be inserted into a bone and a second portion having an opening therethrough. The second suture has a first end and a second end, wherein the second suture is disposed through the hole in the second anchor and wherein the first end is capable of being coupled to the mesh patch. 
         [0013]    The sutures may be attached to the mesh patch by welding the first ends of the first and second sutures to the mesh patch. The ends that are attached to the mesh patch may include an enlarged surface area; e.g., the enlarged surface area may be longer or wider than a diameter of the suture. Alternatively, the first ends of the sutures may include a transverse element adapted to anchor the first ends to the mesh patch. The sutures may be slidably disposed within the opening of its respective anchor. Alternatively, the suture may be fixedly attached to its respective anchor. The device may further include third and fourth suture assemblies, each of which has an anchor and suture as described above. The device may also include an anti-adhesion cover adapted to be connected to the mesh patch. 
         [0014]    In another aspect of the invention, a method of treating a defect in a vertebral disc of a patient is described. The method includes the steps of providing a device that includes a mesh patch, a first suture assembly, and a second suture assembly, as described above. The first portion of the first anchor is inserted into a vertebra cranial to the vertebral disc. The first portion of the second anchor is inserted into a vertebra caudal to the vertebral disc. The first ends of the first and second sutures are attached to the mesh patch. The mesh patch is positioned adjacent the defect by pulling on, or applying tension to, the second ends of the first and second sutures. The method may further include the step of placing an anti-adhesion cover adjacent the mesh patch. 
         [0015]    The first ends of the first and second sutures may be attached to the mesh patch by welding. Alternatively, the first ends of the sutures may comprise a transverse element and the mesh patch may have openings, and the sutures may be attached to the mesh patch by inserting the first ends of the sutures through the openings such that the transverse elements are positioned on a side of the mesh patch opposite of the second ends of the sutures. For instance, a longitudinal axis of the transverse element may be substantially perpendicular to a longitudinal axis of the suture near the first end. The second ends of the first and second sutures may be anchored, e.g., by attaching the second end of the first suture to the second end of the second suture. In one embodiment, the second ends may be anchored or attached together by welding. Third and fourth suture assemblies may also be provided. The first portion of the third anchor may be inserted into the vertebra cranial to the disc and the first portion of the fourth anchor may be inserted into the vertebra caudal to the disc. The first ends of the third and fourth sutures may be attached to the mesh patch and the mesh patch can then be positioned adjacent the defect by pulling on, or applying tension to, the second ends of the third and fourth sutures. 
         [0016]    In another aspect of the invention, a device for fixing a defect in the anulus fibrosus of a patient is described. The device includes a mesh patch, first and second sutures, and first and second anchors. The first and second sutures each have a first end and a second end, wherein the first end is adapted for coupling to the mesh patch. The first and second anchors each have a first portion adapted for insertion into a bone and a second portion having an opening, wherein the opening of the first anchor is adapted to receive the first suture and the opening of the second anchor is adapted to receive the second suture. The device may optionally include third and fourth sutures and third and fourth anchors, similar to the first and second sutures and anchors described above. 
         [0017]    The sutures may be attached to the mesh patch by welding the first ends of the first and second sutures to the mesh patch. The ends that are attached to the mesh patch may include an enlarged surface area, e.g., the enlarged surface area may be longer or wider than a diameter of the suture. Alternatively, the first ends of the sutures may include a transverse element adapted to anchor the first ends to the mesh patch. The sutures may be slidably disposed within the opening of its respective anchor. Alternatively, the suture may be fixedly attached to its respective anchor. The device may further include third and fourth suture assemblies, each of which has an anchor and suture as described above. The device may also include an anti-adhesion cover adapted to be connected to the mesh patch. 
         [0018]    In another aspect of the invention, a method for treating a defect in a vertebral disc of a patient is described. The method includes providing a device having a mesh patch, first and second sutures, and first and second anchors. The first and second sutures each have a first end and a second end, wherein the first end is capable of being coupled to the mesh patch. The first and second anchors each have a first portion adapted to be inserted into a bone and a second portion having an opening, wherein the first suture is threaded through the opening of the first anchor and the second suture is threaded through the opening of the second anchor. The first portion of the first anchor is inserted into a vertebra cranial to the vertebral disc. The first portion of the second anchor is inserted into a vertebra caudal to the vertebral disc. The first ends of the first and second sutures are attached to the mesh patch. The mesh patch is positioned adjacent the defect by pulling on, or applying tension to, the second end of the first and second sutures. The method may further include the step of placing an anti-adhesion cover adjacent the mesh patch. 
         [0019]    The first ends of the first and second sutures may be attached to the mesh patch by welding. Alternatively, the first ends of the sutures may comprise a transverse element and the mesh patch may have openings, and the sutures may be attached to the mesh patch by inserting the first ends of the sutures through the openings such that the transverse elements are positioned on a side of the mesh patch opposite of the second ends of the sutures. For instance, a longitudinal axis of the transverse element may be substantially perpendicular to a longitudinal axis near the first ends. The second ends of the first and second sutures may be anchored, e.g., by attaching the second end of the first suture to the second end of the second suture. In one embodiment, the second ends may be anchored or attached together by welding. Third and fourth sutures and third and fourth anchors may also be provided, similar to the first and second anchors described above. The first portion of the third anchor may be inserted into the vertebra cranial to the disc and the first portion of the fourth anchor may be inserted into the vertebra caudal to the disc. The first ends of the third and fourth sutures may be attached to the mesh patch and the mesh patch can then be positioned adjacent the defect by pulling on, or applying tension to, the second ends of the third and fourth sutures. 
         [0020]    In another aspect of the invention, a device for fixing a defect in the anulus fibrosus of a patient is described. The device includes a mesh patch; first, second, third, and fourth sutures; and first, second, third, and fourth anchors. The first, second, third, and fourth sutures each have a first end and a second end, wherein the first end is adapted for coupling to the mesh patch. The first, second, third, and fourth anchors each have a first portion adapted for insertion into a bone and a second portion having an opening, wherein the openings of the first, second, third, and fourth anchors are adapted to receive the first, second, third, and fourth sutures. 
         [0021]    Each of the sutures may be attached to the mesh patch by welding the first ends of the first and second sutures to the mesh patch. The ends that are attached to the mesh patch may include an enlarged surface area, e.g., the enlarged surface area may be longer or wider than a diameter of the suture. Alternatively, the first ends of the sutures may include a transverse element adapted to anchor the first ends to the mesh patch. The sutures may be slidably disposed within the opening of its respective anchor. Alternatively, the suture may be fixedly attached to its respective anchor. The device may further include third and fourth suture assemblies, each of which has an anchor and suture as described above. The device may also include an anti-adhesion cover adapted to be connected to the mesh patch. 
         [0022]    In another aspect of the invention, a method for treating a defect in a vertebral disc of a patient is described. The method includes providing a device having a mesh patch; first, second, third, and fourth sutures; and first, second, third, and fourth anchors, as described above. The first portions of the first and second anchors are inserted into a vertebra cranial to the vertebral disc. The first portions of the third and fourth anchors are inserted into a vertebra caudal to the vertebral disc. The first ends of the first, second, third, and fourth sutures are attached to the mesh patch. The mesh patch is positioned adjacent the defect by pulling on, or applying tension to, the second end of the first, second, third, and fourth sutures. 
         [0023]    The first ends of the first and second sutures may be attached to the mesh patch by welding. Alternatively, the first ends of the sutures may comprise a transverse element and the mesh patch may have openings, and the sutures may be attached to the mesh patch by inserting the first ends of the sutures through the openings such that the transverse elements are positioned on a side of the mesh patch opposite of the second ends of the sutures. For instance, a longitudinal axis of the transverse element may be substantially perpendicular to a longitudinal axis near the first ends. The second ends of the first and second sutures may be anchored, e.g., by attaching the second end of the first suture to the second end of the second suture. In one embodiment, the second ends may be anchored or attached together by welding. Third and fourth sutures and third and fourth anchors may also be provided. The first portion of the third anchor may be inserted into the vertebra cranial to the disc and the first portion of the fourth anchor may be inserted into the vertebra caudal to the disc. The first ends of the third and fourth sutures may be attached to the mesh patch and the mesh patch can then be positioned adjacent the defect by pulling on, or applying tension to, the second ends of the third and fourth sutures. 
     
    
     
       BRIEF DESCRIPTION OF FIGURES 
         [0024]      FIG. 1  is a lateral view of a suture anchor. 
           [0025]      FIG. 2A  is a posterior view of a surgical incision and an attached mesh device. 
           [0026]      FIG. 2B  is a posterior view of a surgical incision, a mesh device, a suture holding instrument, and an anti-adhesion cover. 
           [0027]      FIG. 3A  is lateral view of a mesh patch and two suture anchors. 
           [0028]      FIG. 3B  is a lateral view of the embodiment of the invention drawn in  FIG. 3A , with the mesh patch advanced towards the anchors. 
           [0029]      FIG. 4  is posterior view of the surgical incision with the mesh patch advanced into the wound. 
           [0030]      FIG. 5A  is a posterior view of a coronal cross section of the spine with a mesh patch attached via suture anchors. 
           [0031]      FIG. 5B  is a lateral view of the spine and the embodiment of the invention drawn in  FIG. 5A . 
           [0032]      FIG. 6A  is an oblique view of a portion of a mesh device loosely connected to an anti-adhesion cover. 
           [0033]      FIG. 6B  is a posterior view of the embodiment drawn in  FIG. 6A  with the anti-adhesion cover held outside the wound as the mesh patch is fastened to the spine using sutures and anchors. 
           [0034]      FIG. 6C  is a posterior view of a coronal cross section of the spine with an anti-adhesion component covering the mesh patch and attached with sutures. 
           [0035]      FIG. 6D  is a view of the undersurface of the mesh patch and the anti-adhesion cover connected through a loop or stitch of suture. 
           [0036]      FIG. 7A  is an oblique view of an alternative embodiment of the invention with an anti-adhesion cover fastened to the mesh patch at or near an edge of mesh patch. 
           [0037]      FIG. 7B  is an oblique view of the undersurface of the embodiment of the invention drawn in  FIG. 7A . 
           [0038]      FIG. 7C  is a posterior view of an anti-adhesion cover connected or coupled to a mesh device along an edge, where the mesh patch has been connected to anchors with welded sutures. 
           [0039]      FIG. 7D  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 7C . 
           [0040]      FIG. 7E  is a view of the undersurface of the mesh patch drawn in  FIG. 7D . 
           [0041]      FIG. 8A  is a posterior view of an alternative embodiment where the suture is threaded through anti-adhesion cover, such that the stitch or loop of suture is on the anti-adhesion cover. 
           [0042]      FIG. 8B  is a posterior view of a surgical incision and the embodiment of the invention drawn in  FIG. 8A  with the ends of the sutures welded or otherwise fastened to the mesh patch. 
           [0043]      FIG. 8C  is a posterior view of a surgical incision and the embodiment of the invention drawn in  FIG. 8B  with the anti-adhesion cover tightened and welded or otherwise secured over the mesh patch. 
           [0044]      FIG. 8D  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8C . 
           [0045]      FIG. 8E  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8D  with the cranial half of the anti-adhesion cover folded in a caudal direction (towards the feet) to expose the mesh patch and the welded ends of sutures in the vertebra cranial to disc. 
           [0046]      FIG. 8F  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8E  with the anti-adhesion cover folded in a cranial direction (towards the head) and the free ends of the sutures from the anchors in the vertebra caudal to disc welded together. 
           [0047]      FIG. 8G  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8F . 
           [0048]      FIG. 9A  is a posterior view of an exploded alternative embodiment of a suture including a component, such as a flattened mesh component, that is fastened to the end of the suture. 
           [0049]      FIG. 9B  is a posterior view of the embodiment of the invention drawn in  FIG. 9A  with the component attached to the end of the suture to increase the surface area of suture. 
           [0050]      FIG. 9C  is a posterior view of the embodiments of the invention drawn in  FIGS. 8A and 9B  with the enlarged ends of the sutures welded to the mesh patch. 
           [0051]      FIG. 9D  is a lateral view of a portion of a suture covered with a biocompatible polymer sleeve. 
           [0052]      FIG. 9E  is a lateral view of the tip of the instrument used to melt the polymer sleeve drawn in  FIG. 9D . 
           [0053]      FIG. 9F  is a lateral view of a portion of the mesh patch and the tip of suture with the sleeve drawn in  FIG. 9D . 
           [0054]      FIG. 9G  is cross section of the embodiment of the mesh patch and the suture drawn in  FIG. 9F . 
           [0055]      FIG. 9H  is view of the embodiments of a mesh patch and sutures drawn in  FIG. 9G . 
           [0056]      FIG. 9I  is a lateral view of the ends of two sutures and a polymer sleeve having two holes that can be melted to connect the ends of the two sutures. 
           [0057]      FIG. 10  is an oblique view of a tip of an instrument that may be used to create abrasions over the AF, vertebrae, and the periosteum. 
           [0058]      FIG. 11  is a posterior view of a coronal cross section of the spine, sutures from four anchors, and preferred area of abrasion surrounding and including the defective region within the anulus fibrosus of the disc. 
           [0059]      FIG. 12A  is a posterior view of a coronal cross section of the spine and an alternative embodiment of the invention with the ends of the sutures welded or otherwise fastened to the mesh patch. 
           [0060]      FIG. 12B  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 12A  with the free ends of the sutures welded to the free ends of the sutures anchored to the adjacent vertebra rather than to the sutures from the same vertebra. 
           [0061]      FIG. 13A  is a posterior view of a coronal cross section of the spine and an alternative embodiment of the invention including suture assemblies with sutures having first ends that are attached or connected to anchors and second or free ends. 
           [0062]      FIG. 13B  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 13A  where the free ends of the sutures were welded to each other over the mesh patch. 
           [0063]      FIG. 14A  is a posterior view of a support structure comprising a body and eyelets. 
           [0064]      FIG. 14B  is a posterior view of a coronal cross section of the spine with a mesh patch and associated sutures where the sutures pass through the eyelets of the support structure. 
           [0065]      FIG. 15A  is an anterior view of an alternative embodiment of the mesh patch having reinforced corners with holes or eyelets. 
           [0066]      FIG. 15B  is a lateral view of a suture anchor having a suture with a stiff component and screw (or anchor). 
           [0067]      FIG. 15C  is a lateral view of the embodiments of the invention drawn in  FIGS. 15A and 15B  with the stiff or transverse component adjacent to the eyelet in the mesh patch. 
           [0068]      FIG. 15D  is a posterior view of the embodiments of the invention drawn in  FIG. 15C  with the stiff or transverse component placed through the eyelet. 
           [0069]      FIG. 15E  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 15D  with four sutures placed through the corners of the mesh patch. 
           [0070]      FIG. 16A  is an exploded lateral view of an alternative embodiment of the invention drawn in  FIG. 15C . 
           [0071]      FIG. 16B  is a posterior view of the embodiment of the invention drawn in  FIG. 16A . 
           [0072]      FIG. 17  is a posterior view of an alternative embodiment of the invention drawn in  FIG. 16B  wherein four sutures with enlargements at the first ends of the sutures are passed through eyelets in the corners of the mesh patch and then passed through eyelets in the anchors. 
           [0073]      FIG. 18A  is a lateral view of an alternative embodiment of a suture anchor wherein one end of the suture has a deformable component. 
           [0074]      FIG. 18B  is a lateral view of a mesh patch with the deformable end of the suture passed through an opening in the mesh patch. 
           [0075]      FIG. 18C  is a lateral view of the embodiment of the invention drawn in  FIG. 18B  where the deformable component prevents the suture from pulling out of the mesh patch. 
       
    
    
     DETAILED DESCRIPTION 
       [0076]    Materials could be placed into the defective region or regions of the Annulus Fibrosus (AF) to promote healing across the entire thickness of the defective region of the AF. For example, a clot of blood marrow aspirated from the vertebrae or other bone in the skeleton could be injected into and over the defective region of the AF. The marrow aspirate could also be injected into and over the in-growth mesh patch or sheet. The cells of the marrow aspirate could be concentrated using such systems as the “Harvest Select” system by DePuy spine. Alternative materials, such as fibrin glue (“Tisseal”, Baxter), or other bio-glue could be inserted into and/or over the defective region of the AF. Portions of the vertebrae near the defective region of the AF, could be perforated, for example with a 1-2 mm diameter drill bit or bur, to improve the blood supply to the relatively avascular AF. The holes are preferably drilled through the vertebral endplates (VEPs) near the defective region of the AF. 
         [0077]    The invention may seal the defective region of the AF to promote healing on one side of the device and to prevent anti-adhesion materials from entering the defective region of the AF. Additionally, anti-adhesion materials such Coseal (Baxter) could be injected over the device. 
         [0078]      FIG. 1  is a lateral view of suture anchor  100 . Suture anchor  100  comprises suture  101  with a flattened end  102  and screw (or anchor)  103 . Anchor  103  has a first portion capable of being inserted into or otherwise attached to a bone, such as a vertebrae. Anchor  103  also has a second portion with an opening  104  adapted to receive a suture therethrough. In one embodiment, anchor  103  is a screw having a hole through the head of screw. Suture  101  is threaded through hole  104 . Suture  101  is preferably made of polyester or other weldable material and has a break-strength of greater than about 22 lbs. Screw or anchor  103  is preferably about 3 mm in diameter, alternatively about 4 mm in diameter, and between about 5 mm and about 10 mm in length. However, alternative sized sutures or screws may be used with this invention. Anchors  103  are preferably made of a MRI compatible and radio-opaque material such as Titanium. Plastic or bioresorbable anchors may also used with this invention. Anchors  103  are preferably self-drilling and self-tapping. 
         [0079]      FIG. 2A  is a posterior view of a surgical incision and a mesh device  111 , attached thereto. Mesh device  111  has four suture anchors  100   a - d  coupled to mesh patch (or mesh sheet)  110 . Screws  103  (or anchors) are located underneath/behind the surgical incision  108 . The size of mesh patch  110  will depend on the defect being treated. In one embodiment, the size may be between about 5 and about 45 mm in width, and between about 5 and about 25 mm in height. The shape of mesh patch  110  will also depend on the defect being treated. The mesh patches could be supplied to surgeons in various sizes and shapes. Alternatively, surgeons could cut the mesh patch and anti-adhesion cover at the time of surgery. Mesh patch  110  may be a symmetrical or an asymmetrical shape. Shapes of mesh patch  110  may include, but not be limited to, a rectangle, a square, a polygon, a circle, an ellipse, an oval, a planar disc, and a triangle. Flattened ends  102   a - b  of sutures  101   a - d  have been attached to the corners of mesh patch  110 . In one embodiment, flattened ends  102   a - b  may be attached by welding. Mesh patch  110  is preferably made of polyester or other material with pores of approximately 1 mm in diameter, alternatively approximately 1.5 mm in diameter, alternatively approximately 2.0 mm in diameter, or any other pore size that will facilitate tissue in-growth. Mesh patch  110  is preferably less than 1 mm thick and has a burst strength of greater than 738 kPa and a break-strength of greater than 400 N. Additionally, mesh patch  110  is preferably inelastic. For example, mesh patch  110  could have a break elongation % (ASTM D-5034) of at least 112 MD and 109 CMD. Mesh patch  110  may also include reinforced areas (not shown). Mesh patch  110  preferably overlaps the intact AF and/or the vertebrae by at least 2 mm, alternatively by at least 2.5 mm, alternatively by at least 3.0 mm, alternatively by at least 3.5 mm, alternatively by at least 4.0 mm, alternatively by at least 4.5 mm, alternatively by at least 5.0 mm, alternatively by at least 5.5 mm, alternatively by at least 6.0 mm, in one or more directions around the defect or surgical incision. 
         [0080]    In use, sutures  101   a - d  are preferably welded or otherwise attached to mesh patch  110  after threading the anchors  103  into the vertebrae. Sutures  101   a - d  may be welded or otherwise attached to mesh patch  110  outside surgical wound  108 . The break-strength of the weld (or attachment) between the flattened end  102   a - d  of sutures  101   a - d  and mesh patch  110  preferably exceeds 22 lbs. Free ends  105   a - d  of sutures  101   a - d  may then be pulled in order to bring mesh patch  110  flush against the defect. 
         [0081]    Alternatively, flat ends  102   a - d  of sutures  101   a - d  may be attached to mesh patch  110  prior to inserting anchors  103 , or other fastening members, to the spine. Anchors  103  may be forced into the vertebrae rather than threaded into the vertebrae in the alternative embodiment of the invention. The anchors may include deployable components that lock the anchors into the vertebrae. The anchors or fixation members do not pass through the mesh in either embodiment of the device. 
         [0082]    Sutures  101   a - d  may be attached to mesh patch  110  in numerous ways. As discussed previously, flattened ends  102   a - d  may be welded to the corners of mesh patch  110  using a welding tool. The materials could be welded with a tool from Axya Medical (Beverly, Mass.). The welding tool could weld one suture at a time to the mesh patch. The mesh could be treated to increase the strength of the weld to the sutures. For example, the mesh could be abraided, treated with acid, or an adhesive material to strengthen the weld. Alternatively, more than one suture could be welded to the mesh patch simultaneously. The ends of the sutures could also be fastened to the mesh in other manners. For example, the ends of the sutures could be passed through holes in the mesh and welded to the sutures to create loops at the ends of the sutures (not shown). 
         [0083]      FIG. 2B  is a posterior view of a surgical incision and an alternative embodiment of a mesh device comprising the embodiment of the invention drawn in  FIG. 2A , a suture holding instrument, and an anti-adhesion cover. Anti-adhesion cover  115  is made of a material that discourages tissue in-growth or adhesions. For example, anti-adhesion cover  115  may be made of ePTFE, Sepratfilm, allograft, or absorbable materials. These absorbable materials include oxidized atelocollagen type I, polyethylene glycol, glycerol, or combinations thereof. Anti-adhesion cover  115  will have interstitial pore sizes of 3 microns or less to discourage tissue in-growth. Anti-adhesion cover  115  will have a larger size than mesh patch  110 . Anti-adhesion cover  115  may have a symmetrical or asymmetrical shape. Shapes of anti-adhesion cover  115  may include, but not be limited to, a rectangle, a square, a polygon, a circle, an ellipse, an oval, a planar disc, and a triangle. This will enable complete coverage of welded sutures  101   a - d  and anchors  103   a - d  once it is deployed, thereby discouraging tissue in-growth and adhesions from outside the wound site. Anti-adhesion cover  115  is loosely connected to mesh patch  110  by a loop (not shown) of suture  117 . This loose connection through suture  117  allows anti-adhesion cover  115  to be moved away from mesh patch  110  while sutures  101   a - d  are welded or otherwise fastened to mesh patch  110 . In one embodiment, suture  117  may be passed through reinforced sections of mesh patch  110 . After sutures  101   a - d  have been attached to mesh patch  110 , anti-adhesion cover  115  may be brought into contact with mesh patch  110  by sliding anti-adhesion patch  115  along suture  117  towards mesh patch  110 . Mesh patch  110  may be brought into contact with the wound by pulling free ends  105   a - d  of sutures  101   a - d  either before or after anti-adhesion device is brought into contact with mesh patch  110 . 
         [0084]    Free ends  105   a - d  of sutures  101   a - d  may be held away from the wound site until needed using suture holding instrument  118 , which is preferably made of an elastomeric material. Free ends  105   a - b  of the top two sutures are held in openings  119   a - b  in the corners of suture holding instrument  118 . Free ends  105   c - d  of the bottom two sutures have not yet been placed into holes  119   c - d  in the bottom of suture holding instrument  118 . Suture holding instrument  118  is designed to allow more movement of sutures  101   a - d  within holes  119   a - d  of the device than within slits  120   a - d  leading to holes  119   a - d  of the device. Holes  119   a - d  of the device may accommodate both ends of each suture. Surgeons may use the tool to organize the ends of the sutures during surgical procedures. 
         [0085]      FIG. 3A  is lateral view of mesh patch  110  and two suture anchors  101 . Flattened ends  102  of the sutures have been welded or otherwise attached to the corners of mesh patch  110 . Flattening the ends of the sutures increases the weldable surface area and reduces the profile of the assembled device. 
         [0086]      FIG. 3B  is a lateral view of the embodiment of the invention drawn in  FIG. 3A . Mesh patch  110  is advanced towards anchors  103  by pulling on free ends  105  of the sutures. The eyelets  104  in anchors  103  are designed to minimize injury to the suture as sutures  101  are advanced through eyelets  104 . Multifilament sutures are also used to further reduce the risk of damaging the sutures as the sutures are advanced through the eyelets. 
         [0087]      FIG. 4  is posterior view of the surgical incision drawn in  FIG. 2A . Mesh patch  110  has been advanced into the wound by pulling on free ends  105   a - d  of sutures  101   a - d.    
         [0088]      FIG. 5A  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 2A . The spine has been bisected through the pedicles of the vertebrae. Two anchors  103   a - b  have been inserted into the vertebra  122  cranial (towards the head) to the disc  120  and two anchors  103   c - d  have been inserted into the vertebra  124  caudal (towards the feet) to the disc  120 . The free ends  105   a - b  of the sutures that pass through the anchors  103   a - b  in the cranial  122  vertebra were welded to each other and the free ends  105   c - d  of the sutures that pass through the anchors  103   c - d  in the caudal vertebra  124  were welded to each other. Tension is applied to the ends of the sutures before welding or otherwise connecting the ends of the sutures. Mesh patch  110  is smaller than the area between the four anchors  103   a - d . The mesh patch could be smaller than the distance between the anchors by a ratio of 4:5. For example, if the distance between the anchors in the same vertebra is about 10 mm and the distance between anchors in the adjacent vertebra is about 15 mm, a rectangular mesh patch would preferably be about 8 mm×12 mm. Alternatively, the ratio may be about 4.5:5, alternatively about 3.5:5, alternatively about 3.0:5, alternatively about 2.5:5. The size of the mesh patch could be determined by the pair of suture anchors that are closest together in the vertical and the horizontal directions. The configuration enables the welded sutures  101   a - d  to apply tension to the four corners of mesh patch  110 . 
         [0089]      FIG. 5B  is a lateral view of the spine and the embodiment of the invention drawn in  FIG. 5A . 
         [0090]      FIG. 6A  is an oblique view of a portion of the alternative mesh device described in  FIG. 2B . Suture  117 , such as a 2-0 nylon suture, loosely connects mesh patch  110  and anti-adhesion cover  115 . For example, the anti-adhesion cover could be a sheet of ePTFE that is attached to the mesh patch  110 . Anti-adhesion cover  115  has a thickness of preferably about 0.4 mm or less, alternatively about 0.3 mm or less. Anti-adhesion cover  115  preferably has a pore size that inhibits tissue in-growth. The interstices of anti-adhesion cover  115  may be approximately 3.0 microns, alternatively approximately 3.5 microns, alternatively approximately 4.0 microns. Suture  117  is preferably made of a monofilament suture in order to reduce the risk of adhesions. The device is preferably supplied to hospitals in the assembled configuration. 
         [0091]      FIG. 6B  is a posterior view of the embodiment of the invention drawn in  FIGS. 2B and 6A . Anti-adhesion cover  115  is held outside the wound as mesh patch  110  is fastened to the spine using sutures  101   a - d  and anchors  103   a - d.    
         [0092]      FIG. 6C  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 6B . The ends of suture  117  have been welded together. Anti-adhesion cover  115  covers mesh patch (not shown) and the attached sutures  101 . The invention reduces the risk of adhesions to the nerves within the spinal canal. 
         [0093]      FIG. 6D  is a view of the undersurface of mesh patch  110  and the anti-adhesion cover  115  connected through loop or stitch of suture  117  through the pores of mesh patch  110 . 
         [0094]      FIG. 7A  is an oblique view of an alternative embodiment of the invention drawn in  FIG. 6D . Anti-adhesion cover  115  has been fastened to mesh patch  110  at or near an edge of mesh patch  110 . As seen in  FIG. 7A , a stitch of suture  117  located near the edge of anti-adhesion cover  115  and mesh patch  110  can be used to connect them. Alternatively, the components may be fastened together with other technologies such as adhesives. 
         [0095]      FIG. 7B  is an oblique view of the undersurface of the embodiment of the invention drawn in  FIG. 7A . The ends of suture  117  have been welded over or onto mesh patch  110 . 
         [0096]      FIG. 7C  is a posterior view of the embodiment of the invention drawn in  FIGS. 5A and 7A . Anti-adhesion cover  115  is connected or coupled to mesh device  110  along an edge. Mesh patch  110  has been connected to anchors  103   a - d  with welded sutures  101   a - d . The device is opened like a book to enable welding of mesh patch  110  to sutures  101   a - d.    
         [0097]      FIG. 7D  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 7C . Anti-adhesion cover  115  has been folded over mesh patch  110  (not shown), much like closing a book. 
         [0098]      FIG. 7E  is a view of the undersurface of mesh patch  110  drawn in  FIG. 7D . The drawing shows the free ends of suture  117  welded together. Placing the suture weld under mesh patch  110  may reduce the risk of adhesions. 
         [0099]      FIG. 8A  is a posterior view of an alternative embodiment of the invention drawn in  FIG. 6B . In this embodiment, suture  117  is threaded through anti-adhesion cover  115 , such that stitch or loop of suture  117  is on anti-adhesion cover  115 . The ends of suture  117  extend from mesh patch  110  rather than anti-adhesion cover  115 . Anti-adhesion cover  115  and mesh patch  110  may have a marking  128 , such as a circle, to determine the orientation of the components. 
         [0100]      FIG. 8B  is a posterior view of a surgical incision and the embodiment of the invention drawn in  FIG. 8A . Ends  102   a - d  of sutures  101   a - d  have been welded or otherwise fastened to mesh patch  110 . Anchors  103   a - d  (not shown) have also been attached to the surrounding vertebra. 
         [0101]      FIG. 8C  is a posterior view of a surgical incision and the embodiment of the invention drawn in  FIG. 8B . After welding the ends  102   a - d  (not shown) of the sutures to mesh patch  110  (not shown), suture  117  (not shown) connecting mesh patch  110  (not shown) and anti-adhesion cover  115  has been tightened and welded or otherwise secured. Anti-adhesion cover  115  and mesh patch  110  are fastened together before placing or tightening the assembled device onto the spine by pulling free ends  105   a - d  of sutures  101   a - d  through eyelets  104   a - d  (not shown) of anchors  103   a - d  (not shown). 
         [0102]      FIG. 8D  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8C . Free ends  105   a - d  of sutures  101   a - d  can be seen extending beyond anti-adhesion cover  115 . 
         [0103]      FIG. 8E  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8D . The cranial half of anti-adhesion cover  115  has been folded in a caudal direction (towards the feet) to expose mesh patch  110  and the welded ends of sutures  101   a - b  in the vertebra  122  cranial to disc  120 . The invention facilitates welding of sutures  101   a - b  from the anchors  103   a - b  in the vertebrae  122  cranial to disc  120 . Tension is applied to free ends  105   a - b  of the sutures before welding the sutures. 
         [0104]      FIG. 8F  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8E . Anti-adhesion cover  115  has been folded in a cranial direction (towards the head). Free ends  105   c - d  of the sutures from anchors  103   c - d  in the vertebra  124  caudal to disc  120  have been welded together. Welding fixation sutures  101   c - d  under tension applies tension to mesh patch  110 . The distance between anchors  103   c - d  is greater than the length of mesh patch  110  in the vertical and horizontal directions. 
         [0105]      FIG. 8G  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 8F . Anti-adhesion patch  115  will have a larger size than mesh patch  110 . This will enable complete coverage of welded sutures  101   a - d  and anchors  103   a - d  once it is deployed, thereby discouraging tissue in-growth and adhesions from outside the wound site. As seen in  FIG. 8G , anti-adhesion cover  115  has been unfolded to cover mesh patch  110  (not shown), fixation sutures  101   a - d  (not shown), and anchors  103   a - d  (not shown). 
         [0106]      FIG. 9A  is a posterior view of an exploded alternative embodiment of the suture drawn in  FIG. 1 . The invention includes component  202 , such as a flattened mesh component, that is fastened to the end of suture  201 . Component  202  could be welded or otherwise attached to the end of suture  201 . Suture  201  has mark  206  that can be used to help surgeons determine the optimal place to weld suture  201  onto mesh patch  110 . 
         [0107]      FIG. 9B  is a posterior view of the embodiment of the invention drawn in  FIG. 9A . Component  202  has been attached to the end of suture  201  to increase the surface area of suture  201 . 
         [0108]      FIG. 9C  is a posterior view of the embodiments of the invention drawn in  FIGS. 8A and 9B . Enlarged ends  202   a - d  of the sutures  201   a - d  have been welded to mesh patch  110 . 
         [0109]      FIG. 9D  is a lateral view of a portion of an alternative embodiment invention drawn in  FIG. 9A . The end of suture  201  is covered with biocompatible polymer sleeve  207 . For example, sleeve  207  could be made of polyurethane, silicon, polyethylene, polyester, or other biocompatible material. The end of suture  201  distal to sleeve  207  could be enlarged in alternative embodiments of the invention (not shown). An enlarged end of the suture would increase the pullout resistance of the suture through polymer sleeve. 
         [0110]      FIG. 9E  is a lateral view of the tip of instrument  210  used to melt the polymer sleeve  207  drawn in  FIG. 9D . Instrument  207  is used outside the surgical incision. Jaws  211  of instrument  210  apply heat and pressure to the mesh patch and the tip of suture  201  drawn in  FIG. 9D . 
         [0111]      FIG. 9F  is a lateral view of a portion of mesh patch  110  and the tip of suture  201  with sleeve  207  drawn in  FIG. 9D . 
         [0112]      FIG. 9G  is cross section of the embodiment of mesh patch  110  and suture  201  drawn in  FIG. 9F . Polymer sleeve  207  has been melted by instrument  210  drawn in  FIG. 9E . The melted polymer  208  flowed and set within the porous mesh, thus attaching suture  201  to mesh patch  110 . Alternatively, a melted polymer could be injected between suture and the mesh. The alternative embodiment would be similar to injecting hot glue with a “glue gun.” The polymer could have adhesive properties or simply form a mechanical lock with the pores of the mesh patch. 
         [0113]      FIG. 9H  is view of the embodiments of mesh patch  110  and sutures  201   a - d  drawn in  FIG. 9G , on the disc surface. The melted polymer  208  can be seen within the pores of mesh patch  110 . The melted polymer could pass through adjacent pores and flow together, thus surrounding portions of mesh patch  110 . 
         [0114]      FIG. 9I  is a lateral view of the ends of two sutures  201  and an alternative embodiment of the polymer sleeve drawn in  FIG. 9D . Sleeve  216  has two holes. Sleeve  216  can be melted to connect the ends of two sutures  201 . 
         [0115]      FIG. 10  is an oblique view of tip  221  of instrument  220  that may be used to create abrasions over the AF, vertebrae, and the periosteum. Tip  221  is covered with an abrasive material such as a wire mesh or a wire brush. 
         [0116]      FIG. 11  is a posterior view of a coronal cross section of the spine, sutures  101   a - d  from four anchors  103   a - d , and preferred area of abrasion  222  surrounding and including defective region  224  within the anulus fibrosus of disc  120 . 
         [0117]      FIG. 12A  is a posterior view of a coronal cross section of the spine and an alternative embodiment of the invention drawn in  FIG. 5A . Ends  102   a - d  of the sutures are welded or otherwise fastened to mesh patch  110 . Free ends  105   a - d  of the sutures can be seen extending through eyelets  104   a - d  (not shown) in anchors  103   a - d.    
         [0118]      FIG. 12B  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 12A . Free ends  105   a - d  of the sutures were welded to the free ends of the sutures anchored to the adjacent vertebra rather than to the sutures from the same vertebra. For example, where sutures  101   a  and  b  are anchored to vertebrae  122  cranial to disc  120  and sutures  101   c  and  d  are anchored to vertebrae  124  caudal to disc  120 , free ends  105   a  and  105   d  are welded together and free ends  105   b  and  105   c  are welded together. The sutures could be relatively elastic to allow spinal movement across the disc. Alternatively, in-elastic sutures could be used to restrict spinal flexion and axial rotation across the disc. Restricting spinal motion reduces the pressure on the defective region of the AF. 
         [0119]      FIG. 13A  is a posterior view of a coronal cross section of the spine and an alternative embodiment of the invention drawn in  FIG. 12A . The suture assemblies of this invention comprise sutures  251   a - d  having first ends  251   a - d  and second or free ends  255   a - d . First ends  251   a - d  are attached or connected to anchors  250   a - d . Anchors  250   a - b  are inserted into or otherwise attached to vertebrae  122  cranial to disc  120 . Anchors  250   c - d  are inserted into or otherwise attached to vertebrae  124  caudal to disc  120 . 
         [0120]      FIG. 13B  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 13A . Free ends  255   a - d  of the sutures were welded to each other over mesh patch  110 . Two of the sutures, for example, sutures  251   a  and  b  or sutures  251   c  and  d , pass through mesh patch  110 . The sutures may pass through a reinforced portion (not shown) of mesh patch  110 . Sutures  251   a - d  are not welded to mesh patch  110  in this embodiment of the invention. 
         [0121]      FIG. 14A  is a posterior view of an alternative embodiment of the invention. Support structure  270  comprises body  272  and eyelets  274   a - b . The number of holes or eyelets  274  may vary depending on the number of sutures present. There may be 2 holes or eyelets, alternatively 3 holes or eyelets, alternatively 4 holes or eyelets, alternatively 5 holes or eyelets, alternatively 6 holes or eyelets. Eyelets  274  are adapted to receive sutures  251  therethrough. Support structure  270  is preferably stiffer than the porous mesh and is able to provide more structural support. Support structure  270  serves to reinforce mesh patch  110 . Support structure  270  could be made of absorbable materials such as Hydrosorb (Macropore, San Diego, Calif.) or non-absorbable materials such as PEEK or polyethylene. 
         [0122]      FIG. 14B  is a posterior view of a coronal cross section of the spine and the embodiments of the invention drawn in  FIGS. 14A and 13B . Sutures  251   a - b  pass through eyelets  274   a - b . Free ends  255   a  and  d  are welded together or otherwise attached. Similarly, free ends  255   b  and  c  are welded together or otherwise attached. 
         [0123]      FIG. 15A  is an anterior view of an alternative embodiment of the mesh patch drawn in  FIG. 2A . The corners  312   a - d  of mesh patch  310  are reinforced and have holes or eyelets  314   a - d.    
         [0124]      FIG. 15B  is a lateral view of suture anchor  300 , an alternative embodiment of the invention drawn in  FIG. 1 . Suture anchor  300  comprises suture  301  with stiff component  302  and screw (or anchor)  103 . Anchor  103  has a first portion capable of being inserted into or otherwise attached to a bone, such as a vertebra. Anchor  103  also has a second portion with an opening  104  adapted to receive a suture therethrough. In one embodiment, anchor  103  is a screw having a hole through the head of screw. Suture  301  is threaded through hole  104 . Suture  301  is preferably made of polyester or other weldable material and has a break-strength of greater than about 22 lbs. Screw or anchor  103  is preferably about 3 mm in diameter, alternatively about 4 mm in diameter, and between about 5 mm and about 10 mm in length. However, alternative sized sutures or screws may be used with this invention. Anchors  103  are preferably made of a MRI compatible and radio-opaque material such as Titanium. Plastic or bioresorbable anchors may also used with this invention. Anchors  103  are preferably self-drilling and self-tapping. Stiff component (or enlarged or transverse component)  302  is attached to one end of suture  301 . The ends of stiff component  302  are blunt to prevent penetration into or injury of the nerves or disc. Stiff component  302  is attached at angle, preferably about ninety degrees, alternatively about 85 degrees, alternatively about 80 degrees, alternatively about 75 degrees, alternatively about 70 degrees, alternatively about 60 degrees, relative to a longitudinal axis of a region of suture  301  near or adjacent to stiff component  302 . Holes or eyelets  314  are adapted to receive stiff component  302  therethrough. Stiff component (or transverse component  302 ) may be a T-anchor. 
         [0125]      FIG. 15C  is a lateral view of the embodiments of the invention drawn in  FIGS. 15A and 15B . Stiff or transverse component  302  is adjacent to eyelet  314  in mesh patch  310 . The flexibility of suture  301  allows the angle between the suture and stiff or transverse component  302  to vary between about 90 degrees and about 180 degrees. In other words, in a resting state and/or when deployed, stiff or transverse component  302  is substantially non-parallel, or approximately perpendicular, to a longitudinal axis of a region of the suture near or adjacent to the point of attachment of stiff or transverse component  302  and suture  301 . Stiff or transverse component  302  can, however, be manipulated for delivery such that its longitudinal axis is substantially parallel to the longitudinal axis of a region of the suture near or adjacent to the point of attachment of stiff or transverse component  302  and suture  301 . Changing the angle between suture  301  and stiff component  302  facilitates insertion of stiff component  302  through eyelet  314  in mesh patch  310 . Stiff components  302  of four sutures are placed through mesh patch  310  outside the surgical incision in the preferred embodiment of the device. 
         [0126]      FIG. 15D  is a posterior view of the embodiments of the invention drawn in  FIG. 15C . Stiff or transverse component  302   a  has been placed through eyelet  314   a  (not shown) in mesh patch  310 . Stiff component  302   a  prevents suture  301   a  from pulling out of mesh patch  310  when tension is applied to the suture. 
         [0127]      FIG. 15E  is a posterior view of a coronal cross section of the spine and the embodiment of the invention drawn in  FIG. 15D . Four sutures  301   a - d  have been placed through corners  312   a - d  of mesh patch  310 . As described in the text of  FIG. 12B , the second ends  305   a - d  of the sutures have been welded or otherwise fastened to each other under tension. Anti-adhesion cover  115  can be seen connected to mesh patch  310  through suture  117 . 
         [0128]    In an alternative embodiment (not shown), anti-adhesion cover  115  could be laminated to mesh patch  310 . Stiff components  302  from the suture anchors could be passed through eyelets in mesh patch  310  and anti-adhesion cover  115 . The second ends of sutures  301   a - d  could be welded over the combined mesh patch/anti-adhesion cover. The alternative embodiment provides a tighter seal of the disc. The tight seal helps prevent the extrusion of the NP and the escape of liquids, gels, or other therapeutic material that may be placed into the disc. Alternative materials, such as Dual Mesh (W.L. Gore and Associates, Flagstaff, Ariz.), with anti-adhesion and tissue in-growth sides on a single patch component could be used the alternative embodiment of the invention. The second ends of the sutures  301   a - d  may be welded in various configurations that help seal liquids or gels within the disc. Mesh patches with smaller pores could be also be used to seal the disc. The mesh patch could have variable porosity. For example, the mesh patch could have large pores (about 1000 microns) around the periphery of the mesh patch and small pores (less than about 999 microns to about 3 microns) directly in the center of the mesh. The configuration encourages tissue in-growth over the portion of the device that overlies intact regions of the AF and seals the disc over portion of the device that overlies an aperture or defective regions of the AF. Bio-glues, such as Tisseal, may be placed between the patch and the AF to help seal the disc. Lastly, the anti-adhesion cover may be used without the mesh patch component in embodiments of the invention that are designed to seal the disc. 
         [0129]      FIG. 16A  is an exploded lateral view of an alternative embodiment of the invention drawn in  FIG. 15C . Stiff component  302  is attached to one end of suture  301  after passing one end of suture  301  through eyelet  104  in reinforced mesh patch  310 . Stiff component  302  may be welded to suture  301 . Alternative methods may be used to fasten the components including but not limited to the use of adhesives, press-fit components, or the use of plastic components that snap together. The components are fastened together outside the surgical wound. 
         [0130]      FIG. 16B  is a posterior view of the embodiment of the invention drawn in  FIG. 16A . 
         [0131]      FIG. 17  is a posterior view of an alternative embodiment of the invention drawn in  FIG. 16B . Four sutures  301   a - d  with enlargements  322   a - d  at the first ends of the sutures are passed through eyelets  314   a - d  (not shown) in the corners of mesh patch  310  then passed through eyelets  104   a - d  in anchors  103   a - d . Anchors  103   a - d  are placed into the vertebrae after assembling the components. Enlarged ends  322   a - d  of the sutures are rotated in the opposite directions that screws  103   a - d  were rotated to remove the twists that occur in sutures  301   a - d  during anchor insertion. Sutures  301   a - d  freely rotate with eyelets  314   a - d  of mesh patch  310 . A tool, such as a wire twister, may be used to grasp and counter rotate the sutures. The second ends (or free ends)  305   a - d  of the sutures are fastened to each other as previously described, after the sutures are counter-rotated. 
         [0132]      FIG. 18A  is a lateral view of an alternative embodiment of the invention drawn in  FIG. 15B . One end of suture  301  has deformable component  332 . One or more arms of deformable component  332  bend in one direction easier than they bend in a second direction. 
         [0133]      FIG. 18B  is a lateral view of mesh patch  310  and the embodiment of the invention drawn in  FIG. 18A . Deformable end  332  of the suture was passed through opening  314  in mesh patch  310 . The shape of deformable component  332  allows the component to be passed through a hole in the mesh. 
         [0134]      FIG. 18C  is a lateral view of the embodiment of the invention drawn in  FIG. 18B . Tension has been applied to free end  305  of suture  301 . Deformable component  332  prevents suture  301  from pulling out of mesh patch  310 . Deformable component  332  resists bending beyond about ninety degrees. Shape memory materials, such as Nitinol, or elastic materials, such as plastics or metals may be used in this embodiment of the invention. 
         [0135]    Although the foregoing invention has, for the purposes of clarity and understanding, been described in some detail by way of illustration and example, it will be obvious that certain changes and modifications may be practiced which will still fall within the scope of the appended claims.

Technology Category: 1