Abstract:
The present invention relates to a device and method to perform 1) disc fusion, 2) artificial replacement of the nucleus, 3) artificial replacement of the annulus, or 4) artificial replacement of both the nucleus and annulus. The device is designed to be placed into the intervertebral space following discectomy. The invention includes a delivery catheter and an substantially fixed sized mesh loop with a lumen within the mesh loop and a center hole. The mesh loop partially self expands diametrically in diameter upon removal of the introducer sheath and can be further expanded by mechanical means.

Description:
CROSS-REFERENCES 
       [0001]    The present application is a continuation-in-part of patent application Ser. No. 11/153,776 filed on Jun. 15, 2005, 11/173,034 filed on Jul. 1, 2005, 11/273,299 filed on Nov. 14, 2005, 11/359,335 filed on Feb. 22, 2006, the 11/700,509 filed on Jan. 31, 2007 and the 12/316,789 filed on Dec. 16, 2008. These applications are incorporated herein by this reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention generally relates to devices and methods for the repair of intervertebral discs. More, specifically, the present invention relates to devices and methods for the treatment of spinal disorders associated with the nucleus, annulus and intervertebral disc. 
       BACKGROUND OF THE INVENTION 
       [0003]    Intervertebral disc disease is a major worldwide health problem. In the United States alone almost 700,000 spine procedures are performed each year and the total cost of treatment of back pain exceeds $30 billion. Age related changes in the disc include diminished water content in the nucleus and increased collagen content by the 4 th  decade of life. Loss of water binding by the nucleus results in more compressive loading of the annulus. This renders the annulus more susceptible to delamination and damage. Damage to the annulus, in turn, accelerates disc degeneration and degeneration of surrounding tissues such as the facet joints. 
         [0004]    The two most common spinal surgical procedures performed are discectomy and spinal fusion. These procedures only address the symptom of lower back pain. Both procedures actually worsen the overall condition of the affected disc and the adjacent discs. A better solution would be implantation of an artificial disc for treatment of the lower back pain and to restore the normal anatomy and function of the diseased disc. 
         [0005]    The concept of a disc prosthesis dates back to a French patent by van Steenbrugghe in 1956. 17 years later, Urbaniak reported the first disc prosthesis implanted in animals. Since this time, numerous prior art devices for disc replacement have been proposed and tested. These are generally divided into devices for artificial total disc replacement or artificial nucleus replacement. The devices proposed for artificial total disc replacement, such as those developed by Kostuik, that generally involve some flexible central component attached to metallic endplates which may be affixed to the adjacent vertebrae. The flexible component may be in the form of a spring or alternatively a polyethylene core (Marnay). The most widely implanted total artificial disc to date is the Link SB Charite disc which is composed of a biconvex ultra high molecular weight polyethylene spacer interfaced with two endplates made of cobalt-chromium-molybdenum alloy. Over 2000 of these have been implanted with good results. However device failure has been reported along with dislocation and migration. The Charite disc also requires an extensive surgical dissection via an anterior approach. 
         [0006]    The approach of artificial nucleus replacement has several obvious advantages over artificial total disc replacement. By replacing only the nucleus, it preserves the remaining disc structures such as the annulus and endplates and preserves their function. Because the annulus and endplates are left intact, the surgical procedure is much simpler and operative time is less. Several nuclear prostheses can be placed via a minimally invasive endoscopic approach. The nucleus implant in widest use today is the one developed by Raymedica (Bloomington, Minn.) which consists of a hydrogel core constrained in a woven polyethylene jacket. The pellet shaped hydrogel core is compressed and dehydrated to minimize size prior to placement. Upon implantation the hydrogel begins to absorb fluid and expand. The flexible but inelastic jacket permits the hydrogel to deform and reform in response to compressive forces yet constrain the horizontal and vertical expansion (see U.S. Pat. Nos. 4,904,260 and 4,772,287 to Ray). Other types of nuclear replacement have been described which include either an expansive hydrogel or polymer to provide for disc separation and relieve compressive load on the other disc components (see U.S. Pat. No. 5,192,326 to Boa). Major limitations of nuclear prostheses are that they can only be used in patients in whom disc degeneration is at an early stage because they require the presence of a competent natural annulus. In discs at later stages of degeneration the annulus is often torn, flattened and/or delaminated and may not be strong enough to provide the needed constraint. Additionally, placement of the artificial nucleus often requires access through the annulus. This leaves behind a defect in the annulus through which the artificial nucleus may eventually extrude compressing adjacent structures. What is clearly needed is a replacement or reinforcement for the natural annulus which may be used in conjunction with these various nuclear replacement devices. 
         [0007]    Several annular repair or reinforcement devices have been previously described. These include the annulus reinforcing band described by U.S. Pat. No. 6,712,853 to Kuslich, which describes an expansile band pressurized with bone graft material or like, expanding the band. U.S. Pat. No. 6,883,520B2 to Lambrecht et al, describes a device and method for constraining a disc herniation utilizing an anchor and membrane to close the annular defect. U.S. patent application Ser. No. 10/676,868 to Slivka et al. describes a spinal disc defect repair method. U.S. Pat. No. 6,806,595 B2 to Keith et al. describes disc reinforcement by implantation of reinforcement members around the annulus of the disc. U.S. Pat. No. 6,592,625 B2 to Cauthen describes a collapsible patch put through an aperture in the sub-annular space. U.S. patent application Ser. No. 10/873,899 to Milbocker et al. describes injection of in situ polymerizing fluid for repair of a weakened annulus fibrosis or replacement or augmentation of the disc nucleus. 
         [0008]    Each of these prior art references describes devices or methods utilized for repair of at least a portion of the diseased annulus, replacement of the damaged nucleus or conducting a spinal fusion. What is clearly needed is an improved spinal disc device and method capable of reinforcing the entire annulus circumferentially and/or replacing a damaged nucleus. In addition what is needed is an improved spinal disc device and method for performing spinal fusions. Additionally, what is clearly needed is a spinal disc device and method which may be easily placed into the intervertebral space and made to conform to this space. Furthermore, what is clearly needed is an improved spinal disc device and method capable of reinforcing the entire annulus that may be utilized either in conjunction with an artificial nucleus pulposis or may be used as a reinforcement for the annulus fibrosis and as an artificial nucleus pulposis. 
       SUMMARY OF THE INVENTION 
       [0009]    The present invention addresses this need by providing improved spinal disc device and methods for the treatment of intervertebral disc disease. The improved device and methods of the present invention specifically address disc related pain but may have other significant applications not specifically mentioned herein. For purposes of illustration only, and without limitation, the present invention is discussed in detail with reference to the treatment of damaged discs of the adult human spinal column. 
         [0010]    As will become apparent from the following detailed description, the improved spinal disc device and methods of the present invention may reduce if not eliminate back pain while maintaining near normal anatomical motion. The present invention relates to devices and methods which may be used to reinforce or replace the native annulus, replace the native nucleus, replace both the annulus and nucleus or facilitate fusion of adjacent vertebrae. The devices of the present invention are particularly well suited for minimally invasive methods of implantation. 
         [0011]    The spinal disc device is a catheter based or cannula based device with a unique delivery and expansion system which is placed into the intervertebral space following discectomy performed by either traditional surgical or endoscopic approaches. The distal end of the catheter is comprised of a fixed sized loop or mesh that is removably attached to a delivery tubular member using a locking collar assembly. Coaxially within the delivery tubular member is a delivery tubular member. The substantially flatten loop shaped mesh or toroidal shaped mesh is released from the jaws of the collar tubular member by retraction of collar tubular member over the delivery tubular member. The substantially flatten loop shaped mesh or toroidal shaped mesh may be formed of a woven, knitted, embroidered or braided material and may be made of PEEK (polyetheretherketone), Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluoroethylene (e-PTFE), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) commercially available as Spectra™ or Dyneema™, as well as other high tensile strength materials such as Vectran™, Kevlar™, natural or artificially produced silk and commercially available suture materials used in a variety of surgical procedures or a combination of these polymeric materials may be utilized. Alternatively the substantially flatten loop shaped mesh or toroidal shaped mesh portion of the catheter may be made of a biodegradable or bioabsorbable material such as resorbable collagen, LPLA (poly(l-lactide)), DLPLA (poly(dl-lactide)), LPLA-DLPLA, PGA (polyglycolide), PGA-LPLA or PGA-DLPLA, polylactic acid and polyglycolic acid which is broken down and bioabsorbed by the patient over a period of time. Alternatively the substantially flattened loop shaped mesh or toroidal shaped mesh may be formed from metallic materials, for example, stainless steel, elgiloy, Nitinol, or other biocompatible metals. Further, it is anticipated that the substantially flattened loop shaped mesh or toroidal shaped mesh b could be made from a flattened tubular knit, weave, mesh or foam structure. Again, a combination of these plastic, metal, or resorbable materials may be utilized in fabricating the present invention. 
         [0012]    The substantially flattened loop shaped mesh or toroidal shaped mesh is formed such that one end of the loop feeds into its other end (invaginating), similar to a snake eating its own tail, forming the shape of a toroid or a substantially flatten loop mesh with an inner chamber and an inside hole section. The outer loop or mesh and the inner loop or mesh is sewn together using a thread design which yields a mesh or loop with a specific circumference size. 
         [0013]    The present invention consists of a device and method, whereby the substantially flattened loop shaped mesh or toroidal shaped mesh is first delivered and fully expanded within the vertebral space to the limits of the inner portion of the native annulus to artificially replace all or a portion of a damaged nucleus. 
         [0014]    The present invention consists of a device and method, whereby the substantially flattened loop shaped mesh or toroidal shaped mesh is first delivered and expanded within the vertebral space to the limits of the inner portion of the native annulus and then allograph materials are delivered into the center of the substantially flattened loop shaped mesh or toroidal shaped mesh. 
         [0015]    The present invention consists of a device and method, whereby the substantially flattened loop shaped mesh or toroidal shaped mesh is first delivered and expanded within the vertebral space to the limits of the inner portion of the native annulus and then an injection of polymeric or hydrogel or like material is conducted to reinforce or artificially replace the native annulus. 
         [0016]    The present invention also consists of a device and method, whereby the substantially flattened loop shaped mesh or toroidal shaped mesh is first delivered within the vertebral space and into the area of the nucleus, which may have been previously removed, and expanded to the limits of the outer portion of the area of the native nucleus and then injected with a polymer or hydrogel or like material conducted to reinforce or artificially replace the native nucleus. 
         [0017]    The present invention also consists of a device and method, whereby the substantially flattened loop shaped mesh or toroidal shaped mesh is first delivered within the vertebral space and expanded within the vertebral space to the limits of the outer portion of the native annulus and then an injection of polymeric or hydrogel material is conducted to reinforce or artificially replace the native annulus. 
         [0018]    Alternately, the present invention is delivered into the nucleus area and expanded to the limits of the outer portion of the native nucleus or an artificial nucleus concurrently placed and then an injection of polymeric or hydrogel material is conducted to reinforce or artificially replace or reinforce the nucleus. 
         [0019]    The present invention also consists of a device and method, whereby the substantially flattened loop shaped mesh or toroidal shaped mesh is first delivered within the vertebral space and expanded within the vertebral space to the limits of the outer portion of the native annulus and then an injection of bone chips, autograft, allograft or osteoconductive/osteoinductive materials for spinal fusion is applied. 
         [0020]    The present invention and variations of its embodiments is summarized herein. Additional details of the present invention and embodiments of the present invention may be found in the Detailed Description of the Preferred Embodiments and Claims below. These and other features, aspects and advantages of the present invention will become better understood with reference to the following descriptions and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  is a partial sectional view the present invention showing the substantially flattened loop shaped mesh or toroidal shaped mesh engaged to the collar jaw means to a first and second tubular members and displaying the sewn inside and outside mesh. 
           [0022]      FIG. 2  is a side view taken from  FIG. 1  of the tubular member showing a sewing pattern which creates a fix-sized substantially tubular toroidal or flat loop shaped mesh. 
           [0023]      FIG. 3  is a partial sectional view of the present invention showing the coaxial relationship of the fill/delivery tubular member within the collar tubular member with substantially flattened loop shaped mesh or toroidal shaped mesh engaged to the jaws of the collar tubular member. 
           [0024]      FIG. 4  is a top-side view of a first embodiment of the collar tubular member. 
           [0025]      FIG. 5  is a top-side view of a first embodiment of the fill/delivery tubular member. 
           [0026]      FIG. 4   a  is a top-side view of a second embodiment of the collar tubular member. 
           [0027]      FIG. 5   a  is a top-side view of a second embodiment of the fill/delivery tubular member. 
           [0028]      FIG. 4   b  is a top-side view of a third embodiment of the collar tubular member. 
           [0029]      FIG. 5   b  is a top-side view of a third embodiment of the fill/delivery tubular member. 
           [0030]      FIG. 6  is a side view of the collar tubular member, the fill/delivery tubular member, the substantially flattened loop shaped mesh or toroidal shaped mesh and a sheath used to constrain the substantially flattened loop shaped mesh or toroidal shaped mesh. 
           [0031]      FIG. 7  is a partial cross-sectional view of an intervertebral disc with an optional balloon that confirms the extent and volume of the discectomy inserted through an access opening. 
           [0032]      FIG. 8  is a partial cross-sectional view of an intervertebral disc with the removable control element inserted through an access opening. 
           [0033]      FIG. 9  is a perspective view of a disc space volume chart for use with the present invention. 
           [0034]      FIG. 10  is a partial cross-section view of the distal end the present invention showing the substantially flattened loop shaped mesh or toroidal shaped mesh in a folded configuration and inserted within the distal end of the delivery sheath member. 
           [0035]      FIG. 11  is a partial cross-sectional of the treatment configuration of the present invention in position to be inserted into an access hole in an intervertebral disc. 
           [0036]      FIG. 12  is a partial cross-section view of the present invention with substantially flattened loop shaped mesh or toroidal shaped mesh deployed with the disc space and the removable control element deployed to expand the substantially flattened loop shaped mesh or toroidal shaped mesh against the inner wall of the disc space. 
           [0037]      FIG. 13  is a partial cross-section view of the present invention substantially flattened loop shaped mesh or toroidal shaped mesh fully expanded with the disc space and showing a series of autograft of allograft fill tube cartridges. 
           [0038]      FIG. 14  is a partial cross-section of a treated intervertebral disc showing the substantially flattened loop shaped mesh or toroidal shaped mesh filled with autograft or allograft material with the disc space. 
           [0039]      FIG. 15  is a flowchart depicting the general sequence of steps used with the present invention and its accessory components. 
           [0040]      FIG. 16  is a partial sectional top view of an intervertebral disc showing the substantially flattened loop shaped mesh or toroidal shaped mesh filled with autograft or allograft material within the disc space and two successive discs affixed using a plurality of facet screws. 
           [0041]      FIG. 17  is a partial sectional side view a first intervertebral disc and a second intervertebral discs affixed with a plurality of facet screws 
           [0042]      FIG. 18  is posterior view of an intervertebral disc showing the substantially flattened loop shaped mesh or toroidal shaped mesh filled with autograft or allograft material within the disc space and two successive discs affixed using a pair of pedicle screws for posterior support. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0043]      FIG. 1  shows a partial sectional view of the present invention showing the unfilled substantially flattened loop shaped mesh or toroidal shaped mesh  10  that is engaged to a collar jaw means to a first and second tubular members and displaying the sewn inside and outside mesh located on the distal end of the tubular members  30  and  36 . The substantially flattened loop shaped mesh or toroidal shaped mesh  10  is braided, knitted, woven or embroidered and substantially flatten loop mesh or toroidal shape mesh (also sometimes referred herein as the fixed sized mesh loop) and is comprised of an inner mesh  14  and an outer mesh  12  whereby a portion of the inner mesh  14  is inserted into a portion of the outer mesh  12  and held together with sewn area  16 . This design results in a substantially flattened loop shaped mesh or toroidal shaped mesh  10  having a substantially flatten loop mesh in a toroidal configuration with an inner chamber  20  and inside centrally located hole area  18 . The substantially flattened loop shaped mesh or toroidal shaped mesh  10  is fabricated as a knit, weave, embroidered, or braid and can be constructed from non-degradable materials. Suitable non-degradable materials for the substantially flattened loop shaped mesh or toroidal shaped mesh  10 , include, but are not limited to, PEEK (polyetheretherketone), Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluoroethylene (e-PTFE), polyetheretherketone (PEEK), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) commercially available as Spectra™ or Dyneema™, as well as other high tensile strength materials such as Vectran™, Kevlar™, natural or artificially produced silk and commercially available suture materials used in a variety of surgical procedures. The substantially flattened loop shaped mesh or toroidal shaped mesh  10  fabricated as a weave, knit, embroider or braid and can be constructed from biodegradable or bioabsorbable materials. Suitable biodegradable and bioabsorbable materials for the expandable mesh or loop  150  include, but are not limited to, resorbable collagen, LPLA (poly(l-lactide)), DLPLA (poly(dl-lactide)), LPLA-DLPLA, PGA (polyglycolide), PGA-LPLA or PGA-DLPLA, and biodegradable sutures made from polylactic acid and polyglycolic acid. 
         [0044]    In addition, for some embodiments, suitable metallic materials for the substantially flattened loop shaped mesh or toroidal shaped mesh  10  may be used that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. It is further contemplated that the metallic mesh can be interwoven with non-resorbable polymers such as nylon fibers, polypropylene fibers, carbon fibers and polyethylene fibers, among others, to form a metal-polymer composite weave. Further examples of suitable non-resorbable materials include DACRON and GORE-TEX. One feature of the substantially flattened loop shaped mesh or toroidal shaped mesh  10  is that it needs to have pore sizes or openings that are small enough to hold the filling material or nucleus from extruding out and large enough to maintain flexibility, expansion characteristics, and transport of biological materials for incorporation or fusion. 
         [0045]    For spinal delivery, a portion  33  of the substantially flattened loop shaped mesh or toroidal shaped mesh  10  is engaged using a locking jaw mechanism  32 . The locking jaws  32  is located on the distal end of a collar tubular member  30  and holds the engaged portion  33  of the substantially flattened loop shaped mesh or toroidal shaped mesh  10  between the locking jaws  32  and a fill/delivery tubular member  36 . The fill/delivery tubular member  36  is in coaxial association with the collar tubular member such that the two tubular members can move with respect to each other. Suitable metallic materials for the collar tubular member  30  and fill/delivery tubular member  36  may be used that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. In addition, suitable polymeric materials for the collar tubular member  30  and fill/delivery tubular member  36  may be used that include, but are not limited to, PEEK (polyetheretherketone), Nylon, Dacron, ABS, acrylics, polyamide, polypropylene, expanded polytetrafluoroethylene (e-PTFE), polyethylene, ultra-high molecular weight polyethylene (UHMWPE), Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. 
         [0046]      FIG. 2  is a side view taken from  FIG. 1  of the tubular member shows a portion of the inner mesh  14  is inserted into a portion of the outer mesh  12  and held together with sewn area  16 , which creates a fix-sized substantially tubular toroidal or substantially flattened loop shaped mesh  10 . To create the sewn area  16 , a PEEK monofilament threaded pattern is utilized. The PEEK monofilament thread has a diameter that ranges from 0.001″ to 0.015″ with a preferred range of 0.004″ to 0.008″. A multifilament thread could also be used and would increase the flexibility of the braid. The pattern shown is a single straight zigzag configuration that travels from approximately the top of the sewn area  16  to approximately the bottom of the sewn area  16 . The Applicants assert that there are numerous thread patterns that can be used, such as, but not limited to, double straight zigzag, single and double hourglass, single and double crosshatch patterns, and other patterns without deviating from the functional aspect required for the present invention. The substantially flattened loop shaped mesh or toroidal shaped mesh  10  could also be formed from a tubular braid, knit, weave, embroidered, or a flat knit or weave that has been sewn or melted formed together. 
         [0047]      FIG. 3  is a partial sectional view of the present invention showing in more detail the slidable coaxial relationship of the fill/delivery tubular member  36  within the collar tubular member  30  with fixed size substantially flattened loop shaped mesh or toroidal shaped mesh  10  removably engaged to the locking jaws  32  of the collar tubular member  30 . To aid in the removable engagement, a pair of raised ears  42  is located on the distal end of the fill/delivery tubular member  36 . Also shown in this Figure is a locking mechanism  37  which, when properly employed, maintains the relative position of the fill/delivery tubular member  36  within the collar tubular member  30 . As will be shown in  FIGS. 4 ,  4   a    4   b ,  5 ,  5   a  and  5   b  below there are several embodiments for achieving the locking functionality. 
         [0048]      FIG. 4  is a top-side view of a first embodiment of the fill/delivery tubular member  36  showing a deflectable button  31  that is designed to enter and exit the cutout  29 . The cutout  29  has a width that ranges from 0.075″ to 0.225″ with a preferred range of 0.125″ to 0.135″ and a length that ranges from 0.1″ to 0.5″ with a preferred range of 0.250″ to 0.300″. The deflectable button  31  is an integrated into the fill/delivery tubular member  36 . The deflectable button  31  has a diameter that ranges from 0.070″ to 0.220″ with a preferred range of 0.120″ to 0.130″ and a height that ranges from 0.01″ to 0.1″ with a preferred range of 0.02″ to 0.050″ above the surface of the tubular members. The deflectable button  31  is attached or engaged to a deflectable elongated tab  34  in the fill/delivery tubular member  36 . The deflectable tab  34  has a width that ranges from 0.001″ to 0.50″ with a preferred range of 0.01″ to 0.20″ and a length that ranges from 0.10″ to 3.0″ with a preferred range of 0.50″ to 1.5″. Both the cutout  29  and the deflectable elongated tab  34  are preferably fabricated by laser cutting but can be fabricated by other means, such as machining, wire electron discharge machining (EDM), stamping, etc. To aid in the removable engagement, a pair of raised ears  42  is located on the distal end of the fill/delivery tubular member  36 . When the button  31  is in its relaxed extended state, the button  31  protrudes through the cutout  29  in the collar tubular member  30  positioned coaxially over the fill/delivery tubular member  36 , restricting any rotational or longitudinal movement between the collar tubular member  30  and the fill/delivery tubular member  36 . In this non-movement state, the collar tubular member  30  and the fill/delivery tubular member  36  are designed such that the jaws on the distal end on the collar tubular member  30  come in close contact with the outside surface of the distal end of the fill/delivery tubular member  36 . In this non-movement state, the distal end of both tubular members,  30  and  36  are designed to engage a portion of the substantially flattened loop or toroidal shaped mesh  10 . When the button is depressed, the button exits the cutout  29  and longitudinal movement between the collar tubular member  30  and the fill/delivery tubular member  36  is allowed and retraction of the collar tubular member proximally over the fill/delivery tubular member  36  releases the engaged portion of the substantially flattened loop or toroidal shaped mesh  10 . 
         [0049]      FIG. 4   a  is a top-side view of a second embodiment of the collar tubular member  36 , male threads  43  that were cut into the fill/delivery tubular member  36  for screwably engaging the female threads  45  on inside surface of collar tubular member  30 . Shown in more detail are the locking jaws  32 . 
         [0050]      FIG. 5   a  is a top-side view of a second embodiment of the fill/delivery tubular member  36 . The male threads  43  are integrated into the outside surface of the fill/delivery tubular member  36  and the female threads are integrated within the inside surface of the collar tubular member  30 . The female threads have a thread size that ranges from 4-40 to ½-16 with a preferred range of 10-32 to ⅜″-24. The male thread size matches the female thread size and could also be a metric size or custom thread sizes. The male threads  43  and the female threads are fabricated using standard screw technology. When the fill/tubular member  36  is rotated counter clockwise inside the collar tubular member  30 , the distal end of the fill/deliver tubular member  36  moves proximally such that the distal ends of both the tubular members  30  and  36  are designed to engage a portion of the substantially flattened loop shaped mesh or toroidal shaped mesh  10 . When the fill/delivery tubular member  36  is rotated clockwise inside the collar tubular member  30 , the distal end of the fill/delivery tubular member  36  moves distally releasing the engaged portion of the substantially flattened loop shaped mesh or toroidal shaped mesh  10 . It is anticipated by the Applicants that the rotation of the tubular members can be reversed, e.g. rotated counter-clockwise to release a portion and clockwise to engage a portion of the substantially flattened loop shaped mesh or toroidal shaped mesh  10 . 
         [0051]      FIG. 4   b  is a top-side view of a third embodiment of the collar tubular member  30  showing a “L” configured cutout  38  in the collar tubular member  30  for receiving a non-deflectable button  40 . Shown in more detail are the locking jaws  32 . 
         [0052]      FIG. 5   b  is a top-side view of a third embodiment of the fill/delivery tubular member  36  showing a non-deflectable button  40  that is designed to track the “L” configured cutout  38 . The “L” configured cutout  38  has a longitudinal width that ranges from 0.01″ to 0.075″ with a preferred range of 0.03″ to 0.05″ and a longitudinal length that ranges from 0.2″ to 0.5″ with a preferred range of 0.25″ to 0.275″. The “L” configured cutout  38  has a perpendicular width that ranges from 0.001″ to 0.075″ with a preferred range of 0.03″ to 0.05″ and a perpendicular length that ranges from 0.01″ to 0.25″ with a preferred range of 0.225″ to 0.265″. The non-deflectable button  40  is an integrated into the fill/delivery tubular member  36 . The non-deflectable button  40  has a diameter that ranges from 0.010″ to 0.075″ with a preferred range of 0.03″ to 0.05″ and a height that ranges from 0.015″ to 0.035″ with a preferred range of 0.020″ to 0.040″. To aid in the removable engagement, a pair of raised ears  42  is located on the distal end of the fill/delivery tubular member  36 . The “L” configured cutout  38  is fabricated by laser cutting, machining, wire electron discharge machining (EDM) or stamping out an “L” configuration. When the non-deflectable button  40  is in the perpendicular groove or track, any longitudinal movement between the collar tubular member  30  and the fill/delivery tubular member  36  is restricted. In this non-restricted state, the collar tubular member  30  and the fill/delivery tubular member  36  are designed such that the jaws on the distal end on the collar tubular member  30  come in close contact with the outside surface of the distal end of the fill/delivery tubular member  36 . In this restricted state, the distal end of both tubular members,  30  and  36  are designed to engage a portion of the substantially flattened loop shaped mesh or toroidal shaped mesh  10 . When the non-deflectable button  40  is moved to the longitudinal groove or track in the “L” configured cut out  38 , longitudinal movement between the collar tubular member  30  and the fill/delivery tubular member  36  is allowed and retraction of the collar tubular member proximally over the fill/delivery tubular member  36  releases the engaged portion of the substantially flattened loop shaped mesh or toroidal shaped mesh  10 . 
         [0053]      FIG. 6  is a side view of the collar tubular member  30 , the fill/delivery tubular member  36 , the fixed-sized substantially flattened loop shaped mesh or toroidal shaped mesh  10  and a sheath  100 . As shown by this Figure, the sheath  100  is coaxially inserted over the fill/delivery tubular member  36 . The fill/delivery tubular member  36  coaxially is insertable within the collar tubular member  30 . The collar tubular member  30  can be fabricated from suitable metallic materials that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. In addition, suitable polymeric materials for the collar tubular member  30  may be used that include, but are not limited to, PEEK (polyetheretherketone), Nylon, Dacron, ABS, acrylics, polyamide, polypropylene, expanded polytetrafluoroethylene (e-PTFE), fluorinated ethylene propylene (FEP), polyethylene. ultra-high molecular weight polyethylene (UHMWPE), Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. The fill/delivery tubular member  36  can be fabricated from suitable metallic materials that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. In addition, suitable polymeric materials for the fill/delivery tubular member  36  may be used that include, but are not limited to, PEEK (polyetheretherketone), Nylon, Dacron, ABS, acrylics, polyamide, polypropylene, expanded polytetrafluoroethylene (e-PTFE), fluorinated ethylene propylene (FEP), polyethylene ultra-high molecular weight polyethylene (UHMWPE) Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. The sheath  100  can be fabricated from suitable metallic materials that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. In addition, suitable polymeric materials for the sheath may be used that include, but are not limited to, PEEK (polyetheretherketone), Nylon, Dacron, ABS, acrylics, polyamide, polypropylene, expanded polytetrafluoroethylene (e-PTFE), fluorinated ethylene propylene (FEP), polyethylene, ultra-high molecular polyethylene (UHMWPE), Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. Also shown in this Figure is the fixed sized substantially flattened loop shaped mesh or toroidal shaped mesh  10 . It is anticipated by the Applicants that the sheath  100  can be advanced over the fill/delivery tubular member  36 , the collar tubular member  30  and retained substantially flattened loop shaped mesh or toroidal shaped mesh  10  thus constraining the substantially flattened loop shaped mesh or toroidal shaped mesh  10  into a reduced diameter delivery configuration as will be described in more detail in  FIG. 10 . 
         [0054]      FIG. 7  is a partial cross-sectional view of an intervertebral disc  60  having spinal nerves  62  with an optional discectomy confirming contrast filled (volume measuring) balloon  90  mounted on a catheter shaft  92  with a proximally located inflation/deflation means  94 . The balloon  90  and catheter shaft  92  are inserted through an access opening  66  into the dissected disc space. 
         [0055]    The balloon  90  is flexible such that it can be deflated and contracted for insertion and removal through access opening  66  and then able to be inflated when within the disc space. Suitable materials for the balloon  90 , include, but are not limited to, Nylon, Dacron, synthetic polyamide, polypropylene, fluorinated ethylene propylene (FEP), polyethylene, Pebax, silicone and urethane materials, Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. 
         [0056]    Suitable materials for the catheter shaft  92 , include, but are not limited to, PEEK (polyetheretherketone), Nylon, Dacron, synthetic polyamide, polypropylene, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyetheretherketone (PEEK), polyethylene and ultra-high molecular weight fibers of polyethylene, Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. 
         [0057]    The balloon, when fully inflated within the disc space  64 , can provide a fluoroscopic assessment of the dissection. 
         [0058]      FIG. 8  is a partial cross-section of an intervertebral disc  60  and spinal nerves  62  with the removable control element  61  inserted through an access opening  66 . The control element is comprised of an outer shaft  70  which is in coaxial relationship with an inner shaft  71  which is fitted with an expandable distal loop  74 . The coaxial relationship between the outer shaft  70  and the inner shaft  71  is such that as the inner shaft  71  moves forward, the distal loop  74  expands and when the inner shaft is moved back, the distal loop  74  contracts. A thumb handle  76  is attached to the proximal end of the inner shaft  71  and a finger handle is attached to the proximal end of the outer shaft  70  for ergonomic assistance in moving the inner shaft forward and back. 
         [0059]    The inner shaft  71  and outer shaft  70  can be fabricated from suitable metallic materials that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. Suitable polymeric materials for inner shaft  71  and outer shaft  70 , include, but are not limited to, polyetheretherketone (PEEK), Nylon, Dacron, synthetic polyamide, polypropylene, polyethylene, silicone and urethane materials. Suitable non-degradable materials for the distal loop  74 , include, but are not limited to, PEEK (polyetheretherketone), Nylon, Dacron, synthetic polyamide, polypropylene, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polyethylene, ultra-high molecular polyethylene, Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal or from suitable metallic materials that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. 
         [0060]    The handles  76  and finger handle  78  can be fabricated from suitable metallic materials that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. Suitable polymeric materials for handle  76  and finger handle  78  include, but are not limited to, polyetheretherketone (PEEK), ABS, Ultem, Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. Suitable non-degradable materials for the handle  76 , include, but are not limited to, polyetheretherketone (PEEK), ABS, Ultem, Kraton (polyisoprene), PET (Polyethylene terephthalate) and acetal. 
         [0061]    The distal loop  74 , when fully expanded within the removable control element disc space  64 , can provide a circumference measurement in centimeters (cm) of the dissected disc space  64 . The distal loop can also be rotated 90 degrees and then can provide a height measurement in centimeters (cm). 
         [0062]      FIG. 9  is a perspective view of a disc space volume chart  80  for use with the removable control element  70 . The disc space volume chart  80  has a heading for estimating the disc volume in cubic centimeters (cc)  82 . The chart  80  uses the disk height (mm)  84  and disc circumference (cm)  85  to estimate the circumference measurement in centimeters (cm) of the disc space  64  using the formula for the volume of a cylinder v=πr 2  h where: 
         [0000]    V=the volume of a cylinder
 
Π=Pi=3.14 constant
 
R=radius of the cylinder or disc space
 
H=height of the cylinder or disc space
 
Since, the circumference (c)=2πr; the volume of the cylinder of disc space is estimated by
 
         [0000]    
       
         
           
             V 
             = 
             
               
                 
                   C 
                   2 
                 
                  
                 
                   ( 
                   h 
                   ) 
                 
               
               
                 4 
                  
                 π 
               
             
           
         
       
     
         [0000]    It is anticipated by the Applicants&#39; that this disc volume chart  80  can be included in a specific card or with instructions for use within the clinical kit or could be printed on one of the components in the clinical kit. 
         [0063]      FIG. 10  is a partial cross-section view of the distal end the present invention showing the fixed-sized substantially flattened loop shaped mesh or toroidal shaped mesh  10  in a folded configuration  11  and inserted within the distal end of the delivery sheath  100  resulting in a delivery configuration. Also shown in the cross-section is the fill/delivery tubular member  36  with the locking jaws  32  and terminal raised tabs  42 . 
         [0064]      FIG. 11  is a partial cross-sectional view of the delivery configuration  11  of the present invention in position to be inserted into an access hole  66  within an intervertebral disc  60  having a plurality of spinal nerves. The delivery configuration of the delivery sheath  100  is shown with the contracted and folded sewn mesh  11  engaged to the fill/delivery tubular member  36  having a pair of locking jaws  32  and terminal raised tabs  42 . Once the contracted and folded sewn mesh  11  is fully inserted within the intervertebral disc space  64 , the delivery sheath  100  is retracted allowing the contracted sewn mesh loop  11  to expand within the disc space  64 . 
         [0065]      FIG. 12  is a partial cross-section view of the present invention with substantially flattened loop shaped or toroidal shaped mesh  10  deployed within the disc space  64  and the removable control element  70  inserted though the fill/delivery tubular member  36  inside the substantially flattened loop shaped mesh or toroidal shaped mesh  10  and deployed to further expand the substantially flattened loop shaped mesh or toroidal shaped mesh  10  against the inner wall of the dissected disc space  64 . Advancing the handle  76  of the removable control element  70  expands the distal loop  74  circumferentially within the disc space  64  engaging the substantially flattened loop shaped mesh or toroidal shaped mesh  10  to the disc space wall. Applicants&#39; anticipate that the flexible balloon similar to that shown in  FIG. 7  could also be used to confirm expansion of or alternately expand the substantially flattened loop shaped mesh or toroidal shaped mesh  10  against the inner wall of the disc space  64 . 
         [0066]      FIG. 13  is a partial cross-section view of the present invention substantially flattened loop shaped mesh or toroidal shaped mesh  10  fully expand within the disc space  64  and showing a series of autograft or allograft fill cartridges  100   a ,  100   b , and  100   x  filled with an autograft bone material or allograft  102   a ,  102   b , and  102   x . The fill tube cartridges  100   a ,  100   b  and  100   x  are used with the delivery tamp member  103  which is labeled with a length denoting the fill length of the autograft or allograft material within the cartridges  100   a ,  100   b ,  100   x . By using the estimated volume of the disc space, one or more cartridges are used to deliver a specific volume of autograft bone material  102   a ,  102   b  or  100  to fill the central area of the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10 . It is anticipated by the Applicants&#39; that other biocompatible materials, such as one or more materials selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PV, PHEMA, PNVP, polyacrylamides, poly (ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate polyurethane (e.g, Corethane) other biocompatibile polymers, or combinations thereof, could be used to fill the central area of the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10 . It is also anticipated that biocompatible materials formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof, could be used to fill the central area of the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10 . In addition, it is anticipated by the Applicants&#39; that biocompatible materials selected from the group consisting of steroids, antibiotics, tumor necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, noncrosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof could be used to fill the central area of the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10 . Furthermore, it is anticipated that the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10  could be filled with biocompatible material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof. It is further anticipated that biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA 4 (PO 4 ) 2 0), Na 3 PO 4 ; Na 2 HPO 4 ; NaH 2 PO 4 ; Na 4 HPO 4 .7H 2 O; Na 3 PO 4 .12H 2 O; H 3 PO 4 ; CaSO 4 ; (NH 4 ) 3 PO 4 ; (NH 4 ) 2 HPO 4 ; (NH 4 )H 2 PO 4 ; (NH 4 ) 3 PO 4 .3H 2 O; NaHCO 3 ; CaCO3; Na 2 CO 3 ; KH 2 PO 4 ; K 2 HPO 4 ; K 3 PO 4 ; CaF 2 :SrF 2 ; Na 2 SiF 6 ; Na 2 PO 3 F, and combinations thereof. Furthermore, it is anticipated that an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof could be use alone or in conjunction with another biocompatible material to fill the central area of the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10 . 
         [0067]      FIG. 14  is a partial cross-section of a treated, intervertebral disc  60  having a plurality of spinal nerves  62 . The treated intervertebral disc  60  is shown with the substantially flattened loop shaped mesh or toroidal shaped mesh  10  central area filled with delivered autograft or autograft material  103  within the disc space  64 . The disc access hole  66  is void of the fill/delivery tubular member which has been retracted after delivery completion of the specific volume of the autograft bone material or allograft  103 . 
         [0068]      FIG. 15  is a flowchart  110  depicting the general sequence of steps used with the present invention and its accessory components. Box  112  represents accessing the intervertebral disc by standard hospital procedures. After obtaining access to the intervertebral disc, Box  114  requires a standard discectomy procedure. After the discectomy procedure is complete, Box  116  represents measuring the disc circumference using the removable control element  70 . Box  118  represents selected the correct substantially flattened loop shaped mesh or toroidal shaped mesh  10  for the measured disc circumference. Box  120  represents loading the contracted fixed mesh loop  11  into the delivery sheath. Box  122  represents inserting the contracted fixed sized mesh loop  11  into the intervertebral disc space through the access hole  66 . Box  124  represents retracting and removing the delivery sheath  100  and then Box  126  represents the functionality of the present invention whereby the substantially flattened loop shaped mesh or toroidal shaped mesh  10  partially self expands within the disc space  64 . Box  128  defines the method of fully expanding the substantially flattened loop shaped mesh or toroidal shaped mesh  10  using the removable control element Box  130  represents the optional procedures of inserting a flexible balloon  90  inside the intervertebral disc space  64  to confirm expansion of the substantially flattened loop shaped mesh or toroidal shaped mesh  10  within the disc space. The volume of the dissected disc space can also be estimated by the volume chart  80 . Box  132  represents the procedure of loading the correct number of cartridges  102   a ,  102   b ,  102   x  with a autograph or allograft bone material. Box  134  represents the procedure of delivering the autograft or allograft material into the disc space cavity. Box  136  represents repeating the procedure defined in Box  134  until the disc space cavity is full. Box  138  defines the procedure of packing the autograft or allograft material as needed. Box  140  represents the method of releasing the collar jaws  32  and removing the delivery system from the substantially flattened loop shaped mesh or toroidal shaped mesh  10 . Box  142  represents the procedure of manipulating the delivered and filled substantially flattened loop shaped mesh or toroidal shaped mesh  10  to close the delivery system opening. Box  144  represents the optional procedure of installing posterior stabilization  160  in the form of one or more pedicle screws  162  and/or one or more facet screws  150   a ,  150   b . Box  146  represents the step of closing the treatment site using standard hospital procedures. 
         [0069]      FIG. 16  is a partial sectional top view of the inter-vertebral disc  61  showing the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10  filled with autograft or allograft material  103  within the disc space  64  and two successive discs  61   a ,  61   b  affixed using a plurality of facet screws  150   a ,  150   b .  FIG. 17  is a partial sectional side view a first intervertebral disc  61   a  and a second intervertebral discs  61   b  showing the expanded substantially flattened loop shaped mesh or toroidal shaped mesh  10  filled with autograft or allograft material  103  and affixed with a plurality of facet screws  150   a ,  150   b.    
         [0070]      FIG. 18  is posterior view of an intervertebral disc showing the substantially flattened loop shaped mesh or toroidal shaped mesh  10  filled with autograft or allograft material  103  within the disc space  64  and two successive discs  61   a ,  61   b  affixed using a pair of pedicle screws  166  with stabilization bars  164  and pedicle screw nuts  166  for posterior support  160 .